Gardasil VAERS Adverse Reactions

FDA Freedom of Information Distribution
Report run on: 07 SEP 2007 12:15

VAERS Line List Report Page 1
Vax Name: HPV (GARDASIL) , HPV (NO BRAND NAME) (Comb. w/OR) Reported Date: 10-MAY-07 - 07-SEP-07 All comb. w/AND
Vaers Id: 262735-1 (S) Related reports: 262735-2; 262735-3; 262735-4

Age Gender Vaccine Date Onset Date Days Received Date Status Date State Mfr Report Id Last Edit Date
17.0 F 31-Jul-2006 13-Aug-2006 13 07-Sep-2006 08-Sep-2006 MS 22-Dec-2006
VAX Detail: Type Manufacturer Lot Prev Doses Site Route Other Vaccine
MNQ AVENTIS PASTEUR 42107AA 0 Gluteous maxima Intramuscular
HPV4 MERCK & CO. INC. 0697F 0 Gluteous maxima Intramuscular
Seriousness: HOSPITALIZED, LIFE THREATENING, SERIOUS
MedDRA PT Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Proteinuria, Red blood cell sedimentation rate increased
Symptom Text: Vaccine was given on July 31 2006. She began having numbness and tingling in her feet and hands on or around August 13th or 14th, which persisted and
slightly worsened until she was seen in our office on August 21st. Her neurological examination was normal, she had an elevated sedimation rate (39), mild
protienuria, otherwize normal labs. MRI of her lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. She was referred to a neurologist and
was seen on August 25th and was found to have weakened severely and was admitted to PICU for suspected Guillian-Barre syndrome which was confirmed by
lumbar puncture. She was treated with IVIG with rapid improvement and has gone home. She is slowly improving and has residual weakness. Medical
records including neurology received/reviewed. Final diagnosis is GBS. Was treated with IVIG as indicated on VAERS form. Per records pt has residual
weakness. 12/19/06-progress notes received for and DC Summary DC DX: GBS.
Other Meds:
Lab Data: MRI of brain, cervical, thoracic and lumbosacral spine, drug screen, pregnancy test, sed rate, Blood count, blood chemistries, Lumbar Puncture.
History:
Prex Illness:
Prex Vax Illns:


16.0 F 31-Jul-2006 13-Aug-2006 13 15-Dec-2006 29-Dec-2006 MS 200602493 29-Dec-2006
MNQ AVENTIS PASTEUR 42107A Unknown Intramuscular
HPV4 MERCK & CO. INC. 0697F Unknown Intramuscular
Seriousness: HOSPITALIZED, SERIOUS
MedDRA PT Asthenia, Guillain-Barre syndrome, Hypoaesthesia
Symptom Text: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention (CDC). A 16 year old female patient had received an intramuscular,
first dose injection of Menactra, lot number reported as 42017AA; and an intramuscular, first dose injection of Human Papillomavirus Recombinant Vaccine, lot
number 0697F; on 31/Jul/2006. On or around 13/Aug/2006, the patient experienced numbness and tingling in her feet and hands. The symptoms persisted and
had slightly worsened at the time of her examination by a physician on 21/Aug/2006. At that time, "neurological examination was normal." She had and
elevated sedimentation rate (39), mild proteinuria, and "otherwise normal labs." Other laboratory tests performed, (specific results not provided), included a
blood count, blood chemistries, pregnancy test and drug screen. MRI was performed of the brain, cervical, thoracic and lumbosacral spine. MRI of the
lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. The patient was referred to and examined by a neurologist on 25/Aug/2006. During that
exam, she was found to have weakened severely. She was admitted to a pediatric intensive care unit for suspected Guillain Barre syndrome which was
confirmed by lumbar puncture. Lumbar puncture results were not provided. She was treated with IVIG with rapid improvement; and after five days of
hospitalization, was discharged to home. Per the reported, she is slowly improving and had residual weakness. Recovery status was documented as unknown.
As per the CDC this case was confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra
vaccination. Follow-up information received 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the reported, the patient was hospitalized
on 25/Aug/2006. The date of discharge was not reported. The patient's Guillain Barre Syndrome was confirmed by lumbar puncture testing.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


16.0 F 31-Jul-2006 13-Aug-2006 13 08-Mar-2007 09-Mar-2007 MS 200602493 09-Mar-2007
MNQ AVENTIS PASTEUR 42107A 0 Gluteous maxima Intramuscular
Areflexia, Asthenia, Asthenia, Cyst, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia, Laboratory test normal, Lumbar puncture, Muscular weakness,
MedDRA PT Nerve conduction studies abnormal, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Occupational therapy, Paraesthesia,
Physiotherapy, Pregnancy test, Proteinuria, Red blood cell sedimentation rate increased
Symptom Text: Initial report received on 22/Sep/2006. A 16-year-old female patient had received an intramuscular, first dose injection of Menactra, lot number reported as
42107AA (not a valid manufacturer lot number), and intramuscular, first dose injection of Gardasil, lot number 0697F, on 31/Jul/2006. On or around
13/Aug/2006 or 14/Aug/2006, the patient experienced numbness and tingling in her feet and hands. The symptoms persisted and had slightly worsened at the
time of her examination by a physician on 21/Aug/2006. At that time, neurological examination was normal. She had an elevated sedimentation rate (39), mild
proteinuria, and otherwise normal labs. Other laboratory tests performed, (specific results not provided), included a blood count, blood chemistries, pregnancy
test and drug screen. MRI was performed of the brain, cervical, thoracic and lumbosacral spine. MRI of the lumbosacral spine showed a (possibly old, chronic)
subarachoid cyst. The patient was referred to and examined by a neurologist on 25/Aug/2006. During that exam, she was found to have weakened severely.
She was admitted to a pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed by lumbar puncture. Lumbar puncture results
were not provided. She was treated with IVIG with rapid improvement, and after five days of hospitalization, was discharged to home. Per the reporter, she is
slowly improving and has residual weakness. Recovery status was documented as unknown. This case was confirmed as being Guillain Barre syndrome
following Menactra vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, the patient was hospitalized on 25/Aug/2006. The date of
discharge was not reported. The patient's Guillain Barre syndrome was confirmed by lumbar puncture testing. Literature citation, update: Guillain Barre
syndrome among recipients of Menactra Meningococcal conjugate vaccine June 2005-September 2006. Follow-up information received on 19 October 2006
from a health care professional concerning a publication.
Other Meds:
Lab Data: Blood chemistries normal, urinalysis Albuminuria, nerve conduction study GBS, MRI of LS spine, brain, Cervical, thoracic possibly old, Chronic subarachnoid
cyst, blood drug screen normal, erythrocyte elevated, serum beta human normal, CBC n
History: The patient was well on the day of immunization.
Prex Illness:
Prex Vax Illns:


16.0 F 31-Jul-2006 13-Aug-2006 13 10-Jul-2007 11-Jul-2007 -- WAES0611USA01724 11-Jul-2007
MNQ SANOFI PASTEUR 42107AA 0 Gluteous maxima Intramuscular
MedDRA PT Albuminuria, Areflexia, Areflexia, Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Nerve conduction studies abnormal, Paraesthesia
Symptom Text: It was reported in a published literature article title as stated above through MMWR on a review of reports, submitted to VAERS that a 16 year old (also
reported as 17 year old) female was vaccinated IM into the gluteus maxima on 31-JUL-2006 with a dose of Gardasil (lot # 653650/0697F) and a dose of
Menactra (lot # 42107AA) IM in the gluteus maximus. On 13-AUG-2006, she experienced numbness and tingling in her extremities. On 25-AUG-2006, she was
evaluated by a neurologist for increasing weakness and subsequently admitted to the hospital. On physical examination, she was found to have absence
reflexes bilaterally in the upper and lower extremities and had decreased muscle strength in the lower extremities. Nerve conduction studies were consistent for
Guillain-Barre syndrome. An analysis of the cerebrospinal fluid showed the protein to be 59 mg/dL with no white blood cells. The patient received IV
immunoglobulin improved and was discharged on 05-SEP-2006. As of 07-SEP-2006, the patient still had residual weakness but was continuing to improve. The
article also discussed the experience of a 43 year old male while on therapy with MMR (manufacturer unknown) (WAES# 0611USA01723) and a 15 year old
female on therapy with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (WAES#0611USA00989). This is a an amended report. The
statement "through MMWR on a review of reports, submitted to VAERS" has been added to the narrative and the primary and initial source type was changed
from physician to agency. Additional information was received from VAERS agency. On 13 or 14-AUG-2006, thirteen days after the vaccination, the patient
began having numbness and tingling in her feet and hands which persisted and slightly worsened until she was seen in our office on 21-AUG-2006. Her
neurological examination was normal. She had an elevated sedimentation rate (39), mild proteinuria (albuminuria), otherwise normal labs. Magnetic resonance
imaging (MRI) of her lumbosacral spine showed a (possibly old, chronic) subarachnoid cys
Other Meds: Unknown
Lab Data: nerve conduction study 08/25/06 - GBS, physical examination 08/25/06 - see narrative, diagnostic laboratory 08/13/06 - blood chemistries: normal, spinal tap
08/13?/06 - no result provided, magnetic resonance 08/13?/06 - of LS spine, brain,
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 263204-1 Related reports: 263204-2

21.0 F 18-Jul-2006 18-Jul-2006 0 19-Sep-2006 21-Sep-2006 KY WAES0608USA02804 18-Jul-2007
HPV4 MERCK & CO. INC. 0640F 0 Unknown Unknown
Seriousness: ER VISIT, NOT SERIOUS
MedDRA PT Anogenital warts, Dizziness, Dizziness, Dysarthria, Injection site pain, Musculoskeletal stiffness, Pallor, Paraesthesia, Shock, Skin papilloma, Speech disorder,
Syncope
Symptom Text: Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and
from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant
therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4
minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She
reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and
stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report,
the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past,
on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported
conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt
appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The
pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards.
The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did
not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described
th
Other Meds: Ortho Tri cyclen Lo
Lab Data: Blood pressure 7/18/06 130/80 records received 7/18/07-Positive yeast vaginal culture. BX on 5/30/07-mild sysplasia/HPV
History: Pap smear abnormal, Dysplasia, Breast Prosthesis user. 7/18/07-records received-HX papular condyloma.
Prex Illness:
Prex Vax Illns:

Vaers Id: 263204-2 (S) Related reports: 263204-1

22.0 F 18-Jul-2006 18-Jul-2006 0 15-May-2007 21-May-2007 KY 21-May-2007
HPV4 MERCK & CO. INC. 0640F 0 Unknown Intramuscular
Seriousness: PERMANENT DISABILITY, SERIOUS

MedDRA PT Anogenital warts, Disorientation, Dizziness, Dysarthria, Hearing impaired, Musculoskeletal stiffness, Underdose
Symptom Text: Was administered Gardasil .05 ml injection in doctor's office. First noticed arm feeling stiff then my hearing became muffled, dizzy, disoriented and severe
slurring of speech, hands drew up. The office and my mother were in a complete panic. Lasted for 1/2 hour. Slowly started to return to normal, except for my
hearing. Still isn't right. Less than 2 weeks later, vaginal warts appeared.
Other Meds: None
Lab Data: Still having hearing checked. No better after 10 months, am concerned. Had warts removed. Afraid to get the 2 remaining vaccines.
History: None
Prex Illness: None
Prex Vax Illns:


14.0 F 25-Oct-2006 26-Oct-2006 1 16-Nov-2006 17-Nov-2006 MI 07-Dec-2006
TDAP GLAXOSMITHKLINE AC52B012AA 0 Unknown Intramuscular
BIOLOGICALS
MNQ AVENTIS PASTEUR U1948AA 0 Unknown Intramuscular
FLU AVENTIS PASTEUR U2256AA Unknown Intramuscular
MedDRA PT Dehydration, Hypersensitivity, Muscle spasms, Pyrexia
Symptom Text: Pt received injections 10/25/06. Flu and HPV in one thigh. Tdap and Menactra in other thigh unk which thigh each given. Pt then went to allergist and received
allergy injection in each arm. Admitted 10/26/06 for fever 103, dehydration and muscle cramping, sent home 10/27/06. DC DX: allergic reaction. 2 day history
of fever. On same day as immunizations she received routine allergy shots. Immunizations received in thighs and allergy injections in arms. Complained of
arms puffed and welted evening prior to admission, became painful. Also blotchiness on legs. Complained of pain in legs. Headache since immunizations,
myalgias and arthralgias especially to shoulder area. Neck pain, prickly sensaton in feet. Previous immunization reacion 3 weeks ago with pain and
symptomatic problems. PMH: environmental allergens. Eczema. Roavirus at age 2 months. PE: Extremities, there is injection site visible. No rash, erythema
or exudate noted around the injection sites. No other rashes.
Other Meds: Nasocort, Zyrtec, Allergy injections.
Lab Data: Labs: Glucose 118, CO2 21, C-reactive protein 1.8.
History: Allergic Rhinitis. PMH: environmental allergens. Eczema. Roavirus at age 2 months.
Prex Illness:
Prex Vax Illns:


14.0 F 25-Oct-2006 26-Oct-2006 1 22-Jun-2007 25-Jun-2007 -- 200702171 26-Jun-2007
MNQ SANOFI PASTEUR NULL Unknown Intramuscular
DTIPV UNKNOWN MANUFACTURER NULL Unknown Intramuscular
FLU UNKNOWN MANUFACTURER NULL Unknown Intramuscular
MedDRA PT Dehydration, Hypersensitivity, Hypersensitivity, Muscle spasms, Pain, Pyrexia
Symptom Text: Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05099. The initial reporter to this manufacturer had been the
FDA, VAERS# not provided. Verbatim from the report: "Information has been received from a line listing obtained on request by the company from the FDA
under the Freedom of Information Act concerning a 14 year old female with rhinitis allergic environmental allergy and eczema and a history of immunization
reaction who on 25-OCT-2006 was vaccinated with Gardasil, IM thigh (lot 653978/0955F). Concomitant suspect immunizations included DTaP (unspecified) (IM
thigh); Menactra (IM thigh), influenza virus vaccine (unspecified) (IM same thigh as Gardasil). The same day patient received allergenic extract (both arms).
Additional concomitant medication included Nasocort and Zyrtec. The following day, on 26-OCT-2006 the patient was hospitalized with dehydration,
hypersensitivity, muscle spasms and pyrexia (103F). Exam revealed injection site visible on extremities, no rash, erythema or exudate noted around the site.
No other rashes. She was discharged the following day with diagnosis of allergic reaction. She also experienced pain and symptomatic problems 3 weeks prior
following allergy injection. No further information is available."
Other Meds: ALLERGENIC EXTRACT, NASOCORT, ZYRTEC
Lab Data: C-reactive protein 1.8, glucose 118, carbon dioxide 21
History: immunization reaction
Prex Illness: rhinitis allergic, environmental allergy, eczema
Prex Vax Illns:


12.0 F 25-Jan-2007 25-Jan-2007 0 31-Jan-2007 01-Feb-2007 MA 06-Aug-2007
HPV4 MERCK & CO. INC. 0688F 0 Left arm Intramuscular
Seriousness: NO CONDITIONS, NOT SERIOUS

MedDRA PT Dizziness, Presyncope
Symptom Text: After receiving vaccine and getting off table felt dizzy walked to appointment desk and became very "oozy" almost fainted mom caught her put in trendelenberg
position, given orange juice quickly felt better.
Other Meds:
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns:


12.0 F 25-Jan-2007 25-Jan-2007 0 18-Jun-2007 17-Jul-2007 MA WAES0705USA01679 06-Aug-2007

Symptom Text: Information has been received concerning a 12 year old female who on 25-JAN-2007 was vaccination with Gardasil, lot# 653735/0688F in the left arm (second
dose). On 25-JAN-2007 after receiving the vaccine and getting off the table the patient felt dizzy and walked to the appointment desk and became very "oozy" -
almost fainted. The patient's mother caught her and put her in a Trendelenberg Position. The patient was given orange juice and quickly felt better. Additional
information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:


22.0 F 27-Feb-2007 28-Feb-2007 1 06-Mar-2007 07-Mar-2007 IL 19-Jul-2007
HPV4 MERCK & CO. INC. 01874 0 Right arm Intramuscular

MedDRA PT Injection site mass, Injection site pain, Myalgia, Neck pain, Neuralgia
Symptom Text: pain of muscle/nerve, neck, arm, and upper back. Very tender arm at injection site and knot at injection site. Put on Prednisone and Mobic by doctor after exam
of site and pain. 7/19/07-records received-notes from 3/4/07-C/O pain in neck and difficulty moving her head. Received injection in right arm. Symptoms were
worse next day, thought it might be neuritis and was started on Medrol dose pack. Pain also in left shoulder and her entire body hurts. Instructed if symptoms
increased to go to ED.
Other Meds: BCP (YAZ)
Lab Data:
History: records received 7/19/07-HX complication after appedectomy in 2002. HX migraines. Nephrolithiasis.
Prex Illness: NONE
Prex Vax Illns:


22.0 F 27-Feb-2007 01-Mar-2007 2 18-Jun-2007 17-Jul-2007 IL WAES0705USA05719 17-Jul-2007
HPV4 MERCK & CO. INC. 0187U 0 Unknown Unknown

MedDRA PT Neck pain, Neuritis, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 22 year old female medical assistant, who on 27-FEB-2007 was vaccinated in the right arm, with
the first dose of Gardasil (Lot #656049/0187U). On 01-MAR-2007 the patient experienced neck and arm pain, and the physician question possible neuritis two
days later. The patient visited the office and was treated with MEDROL and supportive care, with slow improvement noted. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


1.2 F 16-Feb-2007 28-Feb-2007 12 14-Mar-2007 15-Mar-2007 OH 15-Mar-2007
MMRV MERCK & CO. INC. 0971F 0 Left leg Unknown

MedDRA PT Rash papular
Symptom Text: Broke in papular lesions started the day prior to being seen, and has continued to spread.
Other Meds: NONE
Lab Data: NONE
History:
Prex Illness: NONE
Prex Vax Illns:


1.2 F 16-Feb-2007 28-Feb-2007 12 13-Jul-2007 09-Aug-2007 -- WAES0703USA01953 10-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, Rash papular
Symptom Text: Information has been received from a physician concerning a 14 month old female, on 16-FEB-2007 (AM), was vaccinated in the left thigh with MMRV (Lot #
655267/0971E) There was no concomitant medication. On 28-FEB-2007 the patient developed papular lesions, one day prior to being seen by the doctor, and
they continued to appear over her body. Unspecified medical attention was sought. At the time of the report the final outcome was unknown. Additional
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


Unknown F Unknown Unknown 20-Mar-2007 21-Mar-2007 NY WAES0703USA01477 06-Apr-2007
HPV4 MERCK & CO. INC. NULL 1 Unknown Unknown

MedDRA PT Convulsion, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning an adolescent female (demographics not provided) who on an unspecified date was vaccinated
with the first dose of Gardasil (lot # not provided). Concomitant therapy included an unspecified anti malaria medication. Subsequently, on an unspecified date "
a few days later" the patient had a seizure. It was reported by the physician that at the time "the patient has a series of tests (NOS) but no diagnosis was found.
On another unspecified date the patient received the second dose of Gardasil (lot # not provided) and sixteen days post vaccination, on an unspecified date the
patient had seizure. The patient sought unspecified medical attention. The physician reported that it was not known if additional test were completed. The
physician reported that the patient had recovered from the seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional
Other Meds: Therapy unspecified
Lab Data:
History: UNK
Prex Illness:
Prex Vax Illns:


12.0 F 11-Dec-2006 21-Dec-2006 10 24-May-2007 25-May-2007 NY 200701736 25-May-2007
HPV4 MERCK & CO. INC. 1163F 0 Right arm Intramuscular
FLU SANOFI PASTEUR NULL Unknown Unknown
MedDRA PT Convulsion, Gaze palsy, Loss of consciousness
Symptom Text: Initial report received on 14 May 2007 from another manufacturer, report# WAES0703USA01477. The initial reporter to this manufacturer had been a health
care professional . Verbatim from the report:"Initial and follow up information has been received from a physician concerning a 12 year old adolescent female
with a history of a developmental delay (NOS) who on 11-DEC-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot#
654540/1163F). Concomitant therapy included mefloquine and Fluzone. Subsequently, on 21-DEC-2006 the patient had a seizure while at school. The seizure
was described to include both eye rolling and loss of consciousness lasting than one minute. The patient went to the emergency room where a
electroencephalography, magnetic resonance imaging and unspecified labs were completed. Results of all testing were normal/negative. On 21-DEC-2006
therapy with mefloquine was discontinued. On 19-FEB-2007 the patient received the second intramuscular vaccination of Gardasil (Lot# 655503/0012U) in the
left deltoid. It was also reported that on 07-MAR-2007 while at home at the breakfast table the patient had a second seizure which lasted less than one or two
minutes. It was reported by a physician that the patient did not have any illness at the time of vaccination and had no prior history of seizures. The physician
reported that the patient had recovered from both seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional
information has been requested."
Other Meds: Mefloquine
Lab Data: 21/Dec/2006: EEG-normal 21/Dec/2006: MRI-normal
History: The patient had a history of developmental delay.
Prex Illness:
Prex Vax Illns:


19.0 F 09-Nov-2006 11-Nov-2006 2 21-Mar-2007 22-Mar-2007 CA 22-Mar-2007
TDAP AVENTIS PASTEUR C2557AA 0 Left arm Intramuscular
MNQ AVENTIS PASTEUR U1932AB 0 Left arm Intramuscular
MedDRA PT Rash papular, Rash pruritic
Symptom Text: Itchy rash on both deltoids started 2 days after immunizations received. Rash is fine and papular.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


19.0 F 09-Nov-2006 12-Nov-2006 3 15-May-2007 23-May-2007 CA 05-Jun-2007
TDAP SANOFI PASTEUR C2557AA Left arm Intramuscular
MNQ SANOFI PASTEUR U1932AB 3 Left arm Intramuscular
MedDRA PT Urticaria
Symptom Text: Broke out with hives

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


18.0 F 06-Mar-2007 07-Mar-2007 1 27-Mar-2007 29-Mar-2007 AZ 04-Apr-2007
MNQ AVENTIS PASTEUR U2115AA 0 Right arm Intramuscular
Seriousness: ER VISIT, HOSPITALIZED, SERIOUS
MedDRA PT Back pain, Back pain, Body temperature, Bronchitis, Convulsion, Discomfort, Dizziness, Fall, Headache, Hyperventilation, Lack of spontaneous speech, Mental
status changes, Nystagmus, Pyrexia, Stridor, Syncope, Tetany, Viral infection
Symptom Text: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed
stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered
neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating.
Fever a few days ago and had been sick with viral syndrome. PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and
mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm. DC Summary for DOS 3/7-3/9/07. DC DX:Diseases
disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.
Other Meds:
Lab Data: Done in hospital LP: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56, protein 19. WBC 16.3, 90% neutrophil. Influenza A and B negative. EEG: mildly abnormal
EEG due to excessive presence of beta activity which could be drug related. The lack
History:
Prex Illness: Very minimal URI symptoms
Prex Vax Illns:


18.0 F 06-Mar-2007 07-Mar-2007 1 22-Jun-2007 25-Jun-2007 -- 200702141 26-Jun-2007
MNQ SANOFI PASTEUR U2115AA 0 Right arm Intramuscular
MedDRA PT Back pain, Back pain, Bronchitis, Convulsion, Discomfort, Dizziness, Fall, Gaze palsy, Headache, Hyperventilation, Lack of spontaneous speech, Mental status
changes, Nervous system disorder, Neurological symptom, Nystagmus, Pyrexia, Speech disorder, Stridor, Syncope, Tetany, Tetany, Viral infection
Symptom Text: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it
appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal
upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F).
Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness
and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus
and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered
neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze
toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with
viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with
a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with
the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3,
neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related.
The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus,
altered mental status, hyperventilation
Other Meds:
Lab Data: A lumbar puncture was performed in the hospital with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory
tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an E
History: fever a few days ago and had been sick with viral syndrome. Upper respiratory tract infection.
Prex Illness:
Prex Vax Illns:

Vaers Id: 275428-1 (D) Related reports: 275428-2

12.0 F 01-Mar-2007 07-Mar-2007 6 02-Apr-2007 03-Apr-2007 NY 30-Aug-2007
VARCEL MERCK & CO. INC. 0943R 1 Right arm Subcutaneously
HEPA MERCK & CO. INC. 1280F 1 Right arm Intramuscular
HPV4 MERCK & CO. INC. 0263U 0 Left arm Intramuscular
Seriousness: DIED, SERIOUS
MedDRA PT Abdominal pain, Autopsy, Cardiomegaly, Chest X-ray abnormal, Cough, Gastroenteritis, Mitral valve incompetence, Myocarditis, Nervousness, Palpitations,
Pyrexia, Rhinorrhoea, Ventricular tachycardia, Viral myocarditis
Symptom Text: presented to ED with Ventricular tachycardia. Preliminary autopsy finding of myocarditis. 4/3/07 Spoke w/ME who stated prelim COD as acute myocarditis,
presumably viral. States patient had PMH of heart murmur which was evaluated by ped cardiologist who found mild aortic & mitral valve insufficiency &
regurgitation. ME states did not see evidence of that on autopsy but did find cardiomegaly. Also states patient had been taken to ER on day of death for
abdominal pain w/fever & was dx w/gastroenteritis. CXR at that time revealed cardiomegaly. No EKG or cultures were done. Was d/c to home & continued to
not feel well. Parent found patient in bathroom unresponsive at approx 2AM & was transported to a second ER where she expired. ME states patient had
approx 2 week hx of cough & runny nose prior to death. 6/12/07 Received final Autopsy Report which reveals COD as acute probable viral etiology myocarditis
& manner of death as natural. 6/29/07 Received ER records from hospital where patient expired which reveal patient was in respiratory arrest & had been
intubated by EMS. ACLS measures were unsuccessful & patient pronounced. 8/24/07 Received cardiology consult which reveals patient evaluated for heart
murmur in 2005 which had been diagnosed for long time but never evaluated. Patient admitted to palpitations & nervousness. Patient history did not reveal
any evidence of rheumatic fever. Antibiotic endocarditis prophylaxis recommended prior to dental & surgical procedures. Patient was to f/u w/cardiology in 2-3
yearrs to document progress of valvular insufficiency. FINAL Cardiology DX: Aortic & mitral valve insufficiency of unknown etiology.
Other Meds:
Lab Data: ER LABS of 3/8/07: ABG pH 7.23, po2 62. Serum glucose 353, Creat 1.7, albumin 2.6, total protein 4.9, SGPT 62, SGOT 359. Blood c/s was neg. 2005
Cardiology LABS: echocardiogram revealed mild mitral valve & aortic valve insufficiency. Mi
History: aortic and mitral valve insufficiency, unknown aetiology
Prex Illness: none
Prex Vax Illns:


12.0 F 01-Mar-2007 07-Mar-2007 6 12-Jun-2007 13-Jun-2007 -- WAES0705USA05008 13-Jun-2007
HEPA MERCK & CO. INC. 1280F 1 Right arm Intramuscular
Seriousness: DIED, ER VISIT, SERIOUS
MedDRA PT Death, Myocarditis, Ventricular tachycardia
Symptom Text: Information has been received on request from the FDA under the Freedom of Information Act concerning a 12 year old female with a history of aortic and
mitral valve insufficiency (unknown etiology) who on 01-MAR-2007 was vaccinated IM into the left arm with a first dose of Gardasil (lot # 655849/0263U).
Concomitant suspect therapy included a second dose of Varivax (lot # 652082/0943R) SC into the right arm and a second dose of Vaqta (inactive) (lot #
656017/1280F) IM into the right arm. On 07-MAR-2007 the patient presented to the ED with ventricular tachycardia and died. Preliminary autopsy finding was
myocarditis. The original reporting source was not provided. A standard lot check investigation was performed (for Gardasil, Varivax and Vaqta). All in-process
quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the
batch prior to release met all release specifications. The lot met the requirements of the agency and was released. No further information is available. This
report was filed with the FDA. The VAERS number is 275428.
Other Meds: Unknown
Lab Data: Unknown
History: Aortic valve insufficiency; Mitral insufficiency
Prex Illness:
Prex Vax Illns:


19.0 F 12-Mar-2007 26-Mar-2007 14 02-Apr-2007 03-Apr-2007 CA 05-Jul-2007
MedDRA PT Cor pulmonale, Coronary artery thrombosis, Echocardiogram abnormal, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Sudden cardiac
death, Thrombosis
Symptom Text: Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 T/C to
coroners bureau to request prelim COD. Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is
actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden
cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the
right atrium & right ventricle. Letter faxed to pathology department to request final autopsy report. 6/25/07 Received Autopsy Report which reveals following
anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2.
Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


19.0 F 12-Mar-2007 26-Mar-2007 14 12-Jun-2007 13-Jun-2007 -- WAES0705USA05011 05-Jul-2007

MedDRA PT Circulatory collapse, Coronary artery thrombosis, Pulmonary embolism, Sudden cardiac death, Thrombosis, Thrombosis
Symptom Text: Information has been received on request from the FDA under the Freedom of Information Act concerning a 19 year old female with no history who on 12-MAR-
2007 was vaccinated IM into the left arm with a first dose of Gardasil (lot #655849/0263U). There was no adverse reaction reported. Subsequently on 26-MAR-
2007 the patient collapsed and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death
and pulmonary embolism." An echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right
atrium and right ventricle. Coronary artery thrombosis and thrombosis were also reported. The original reporting source was not provided. A Standard lot check
investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was
performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. No
further information is available. this report was filed with the FDA. The VAERS number is 275438.
Other Meds: Unknown
Lab Data: echocardiography 03/26/07 - very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
History: none
Prex Illness:
Prex Vax Illns:


13.0 F 03-Apr-2007 03-Apr-2007 0 06-Apr-2007 12-Apr-2007 FL 11-May-2007
MedDRA PT Computerised tomogram abnormal, Fall, Head injury, Headache, Neck pain, Subarachnoid haemorrhage, Syncope, Syncope, Unresponsive to stimuli
Symptom Text: Fainted within 10 min of receiving vaccines and fell backward and hit head on carpeted floor was unresponsive for 20-30 seconds. Complained of headache
and neck pain. Transported to ER - CT showed traumatic subarachnoid hemorrhage. Transferred to PICU. 5/11/07 Received medical records from hospital
which reveal patient experienced syncopal episode & fell backward w/o bracing herself, striking posterior head & becoming dazed & minimally responsive for
several minutes. Seen at outlying hospital & had CT scan which revealed SAH & skull fx. Exam revealed alert & oriented, hematomas over skull. Tx
w/dilantin. Neurosurg & neurology consults done. Seizure was ruled out & dilantin d/c. Strong suspicion for vascular abnormality due to amount of intracranial
bleeding after fall. FINAL DX: traumatic subarachnoid hematoma.
Other Meds:
Lab Data: LABS: CT at transfer hospital revealed hemorrhagic focus within medial left frontal high convexity adjacent to falx w/subdural hematoma along the falx. WBC
19.8. CT angiography was WNL. EEG was reported as neg but no report provided.
History: Allergic to penicillin ALLERGIES: PCN, urticaria. PMH: fainting episodes, mild concussion 3-5 mos ago from sports injury. Pounding headaches 1-3 x/week.
Family hx of headaches.
Prex Illness: none
Prex Vax Illns:


13.0 F 02-Apr-2007 02-Apr-2007 0 13-Apr-2007 16-Apr-2007 FL WAES0704USA00912 01-May-2007
Seriousness: ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, SERIOUS

MedDRA PT Dizziness, Fall, Head injury, Intensive care
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient with a history or vasovagal response to vaccine who on
02-APR-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included Menactra. On 02-APR-2007 the patient felt dizziness and fell
on the ground. The patient was hospitalized in intensive care for head injury but did not require any surgery. At the time of this report patient was still in the
hospital and had not recovered. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Vasovagal reaction
Prex Illness:
Prex Vax Illns:


13.0 F 02-Apr-2007 02-Apr-2007 0 04-May-2007 07-May-2007 FL 200701352 07-May-2007
MNQ AVENTIS PASTEUR NULL Unknown Unknown
MedDRA PT Dizziness, Fall, Head injury
Symptom Text: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00912. The initial reporter to this manufacturer had been a health
care professional. Verbatim from the report: "Information has been received from a Registered nurse (R.N.) concerning a 13 year old female patient with a
history of vasovagal response to vaccine who on 02-APR-2007 was vaccinated with a first dose of 0.5 mL of Gardasil. Concomitant therapy included
MENACTRA. On 02-APR-2007 the patient felt dizziness and fell on the ground. The patient was hospitalized in intensive care for head injury but did not require
any surgery. At the time of this report patient was still in the hospital and had not recovered. Additional information has been requested.
Other Meds:
Lab Data:
Prex Illness:
Prex Vax Illns:


13.0 F 03-Apr-2007 03-Apr-2007 0 20-Jun-2007 21-Jun-2007 FL 200702174 21-Jun-2007
MNQ SANOFI PASTEUR U226A 0 Unknown Intramuscular
HPV4 MERCK & CO. INC. 0188U 0 Unknown Intramuscular
MedDRA PT Fall, Head injury, Headache, Neck pain, Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
Symptom Text: This report was received from another manufacturer on 07 June 2007 (reference number WAES0705USA05078). The following is verbatim: "This report was
identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with a penicillin
allergy, was vaccinated on 03-APR-2007 with the first dose of Gardasil (Lot #657006/0188U), and the first dose of MENACTRA (Lot #U226AA). The listing
indicated that within 10 minutes of receiving the vaccinations, she fell backward and hit her head on the carpeted floor, and was transported to the ER. The
patient experienced syncope, a fall, head injury, headache, neck pain, subarachnoid hemorrhage, and was unresponsive to stimuli. A computerized
tomography (CT) in the ER was abnormal, and showed traumatic subarachnoid hemorrhage. The listing indicated that one or more of the events required a visit
to the emergency room and resulted in hospitalization in the pediatric intensive care unit (PICU). No further information is available. The original reporting
source was not provided."
Other Meds:
Lab Data: CT in the ER was abnormal: traumatic subarachnoid hemorrhage
History: Penicillin allergy
Prex Illness:
Prex Vax Illns:


23.0 F 15-Mar-2007 Unknown 13-Apr-2007 19-Apr-2007 DE 19-Apr-2007
HPV4 MERCK & CO. INC. 0187U 0 Left arm Unknown

MedDRA PT Injection site pain, Pain in extremity
Symptom Text: c/o soreness in arm since injection on 3/15/07. Pt came in 4/13/07 with above symptoms not note to us before this date
Other Meds:
Lab Data: none
History: None
Prex Illness: None
Prex Vax Illns:


Unknown F 15-Mar-2007 15-Mar-2007 0 17-May-2007 13-Jun-2007 -- WAES0704USA03073 13-Jun-2007
HPV4 MERCK & CO. INC. 0187U Unknown Intramuscular

MedDRA PT Injected limb mobility decreased, Injection site pain
Symptom Text: Information has been received from a nurse practioner and a licensed practical nurse concerning a female who on 15-MAR-2007 was vaccinated with Gardasil
(Lot # 656049/0187U). In approximately March 2007, the patient experienced pain at the injection site of the affected arm. On 13-APR-2007, the patient was
seen by the physician and still affected arm. On 13-APR-2007, the patient was seen by the physician and still had pain in at the injection site and could not lift
her arm. On 16-APR-2007, the patient was reported as recovering from the pain at the injection site. This is one of several patients reported by the same
source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 276336-1

13.0 F 12-Mar-2007 19-Mar-2007 7 16-Apr-2007 19-Apr-2007 NJ 20-Apr-2007
VARCEL MERCK & CO. INC. 1497F 1 Unknown Subcutaneously
HPV4 MERCK & CO. INC. NULL Unknown Intramuscular
MedDRA PT Rash papular, Rash pruritic, Rash vesicular
Symptom Text: Papular vesicular pruritic rash began 1 week after receiving Varivax booster.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


12.0 F 29-Mar-2007 29-Mar-2007 0 17-Apr-2007 19-Apr-2007 LA 20-Jun-2007
MNQ SANOFI PASTEUR U2061AA 0 Left arm Intramuscular
MedDRA PT Head injury, Headache, Loss of consciousness, Syncope
Symptom Text: patient collapsed 15 to 20 minutes after receiving MCV4 and Gardasil vaccines. 06/20/07-records received from facility for DOS 3/29-3/30/07-DC DX: Syncope.
Head Trauma. After injection positive loss of consciousness for about 2-3 minutes. No nausea, vomiting fever or chills but headache for about 2 days. No visual
changes.
Other Meds: None
Lab Data: CBC with diff, LMP, BHCG, EKG, Echocardiogram, head CT scan, Chest X-ray, EEG records received 6/20/07-CT head negative. Doppler echocardiogram
normal. Sinus tachycardia with sinus arrhythmia. EEG normal. EKG sinus rhythm with 1st degree A
History: Hx headaches / depression / systolic murmur records received 6/20/07-PMH: Migraines, depression and aggressive behavior.
Prex Illness:
Prex Vax Illns:


12.0 F 29-Mar-2007 29-Mar-2007 0 20-Jun-2007 21-Jun-2007 LA 200702173 21-Jun-2007
MNQ SANOFI PASTEUR U2061A 0 Left arm Intramuscular
HPV4 MERCK & CO. INC. 0960F Right arm Intramuscular
MedDRA PT Chest X-ray, Circulatory collapse, Computerised tomogram, Echocardiogram, Electrocardiogram, Electroencephalogram, Full blood count, Pregnancy test,
Syncope, White blood cell count
Symptom Text: Initial information received on 07 June 2007 from another manufacturer, report# WAES0705USA05083. The initial reporter to this manufacturer had been the
FDA, VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of Information Act
regarding a 12 year old female patient with a history of headaches, depression and systolic murmur, who on 29-MAR-2007 was vaccinated IM into the right arm
with a first dose of Gardasil (Lot# 654535/0960F). Concomitant therapy given on 29-MAR-2007 IM into the left arm included a first dose of MENACTRA (Lot#
U2061AA). On 29-MAR-2007, the patient collapsed 15 to 20 minutes after receiving the vaccines. The patient was hospitalized and lab data included a beta-
human chorionic gonadotropin test (unspecified), chest x-ray, complete blood cell count, "LMP", echocardiography, electrocardiogram,
electroencephalography, head computed axial tomography, and white blood cell differential. At the time of this report, the patient's outcome was unknown. The
original reporting source was not provided. No further information is available."
Other Meds:
Lab Data:
History: The subject had a history of headaches, depression and systolic murmur.
Prex Illness:
Prex Vax Illns:

Vaers Id: 276602-1 Related reports: 276602-2; 276602-3

18.0 F 03-Apr-2007 03-Apr-2007 0 17-Apr-2007 27-Apr-2007 PA 27-Apr-2007
TDAP GLAXOSMITHKLINE AC526014AA 0 Left arm Intramuscular
BIOLOGICALS
HEPA SMITHKLINE BEECHAM AHAVB14BAA 0 Right arm Intramuscular
HPV4 MERCK & CO. INC. 0263U 0 Right arm Intramuscular
MNQ AVENTIS PASTEUR U1968AA 0 Left arm Intramuscular
MedDRA PT Gaze palsy, Loss of consciousness, Muscle rigidity, Pallor, Staring
Symptom Text: 5 minutes after HPV vaccine was given patient became pale, her eyes rolled back in her head, and she became rigid, she lost conscious 30 seconds. When
she came to she had postical s/s of a blank stare for about 5-10 seconds. She did become A x O x S. BP 116/ 78 P 64, Pulse O2 97%. Before vaccine BP
115/65
Other Meds:
Lab Data:
History: Allergic rhinitis, exercise induced asthma
Prex Illness:
Prex Vax Illns:


Unknown U Unknown Unknown 23-Apr-2007 24-Apr-2007 PA WAES0704USA03302 22-May-2007
HPV4 MERCK & CO. INC. NULL Unknown Unknown

MedDRA PT Condition aggravated, Convulsion
Symptom Text: Information has been received from a physician concerning a 12-15 year old (exact age unknown) patient with a history of seizure disorder (date not known),
was vaccinated with a dose of Gardasil. The physician reported that the patient convulsed almost immediately after receiving the Gardasil, but he did not
witness the patient's experience. The physician's office followed up with the patient next day and the patient was doing fine. Upon internal review, convulsion
was considered to be an other important medical events. The physician reported that another patient in the same age group convulsed after receiving Gardasil.
Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Convulsion disorder
Prex Illness:
Prex Vax Illns:


18.0 F 03-Apr-2007 03-Apr-2007 0 14-May-2007 15-May-2007 PA 200701540 01-Jun-2007
MNQ SANOFI PASTEUR U1968A 0 Unknown Intramuscular
DTAP UNKNOWN MANUFACTURER AC52B014AA 0 Unknown Intramuscular
HEPA GLAXOSMITHKLINE AHAVB148AA 0 Unknown Intramuscular
BIOLOGICALS
MedDRA PT Convulsion, Convulsion, Eye rolling, Immediate post-injection reaction, Inappropriate schedule of drug administration, Loss of consciousness, Medication error,
Muscle rigidity, Musculoskeletal stiffness, Postictal state, Staring
Symptom Text: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 May 2007 from another manufacturer, report#
WAES0704USA03302. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Initial and follow-up information
has been received from a physician and a health care professional concerning a 18 year female patient with no known seizure disorder, allergic rhinitis,
exercise induced asthma and a history of passing out while giving blood who on 03-APR-2007 was vaccinated IM in right deltoid with a dose of Gardasil, lot
#655849/0263U. Concomitant therapy included HAVRIX, MENACTRA and Dtap. The physician reported that the patient convulsed almost immediately after
receiving the Gardasil, but he did not witness the patient's experience. He stated that approximately 5 minutes after receiving the injection the patient became
very stiff, rigid, eyes rolled back and passed out for approximately 30 seconds. He reported that this patient was "really out of it." Vital signs before and after the
seizure were normal. The physician's office followed up with the patient next day and the patient was doing fine. The physician did not consider the event to be
serious." "In follow-up report a health care professional reported that when the patient came to she had postictal signs and symptoms of a "blank stare" for
about 5-10 second. She became awake, alert and orient to time, place and people (AAOx3). Blood pressure was 116/78, pulse was 64 and pulse oximetry was
97%. Before vaccine was administered the blood pressure measurement was 115/65. On 03-APR-2007 patient recovered. The physician did not consider the
event to be serious. Upon internal review, convulsion was considered to be an other important medical event. The physician reported that another patient in the
same age group convulsed after receiving the Gardasil. Additional information is not expected." The reporter in this case is the same as in case 2007-01539.
Other Meds:
Lab Data: 03/Apr/2007: pulse oximetry 97%; heart rate, 64; blood pressure normal before and after seizure; BP before vaccine 115/65; BP after vaccine 116/78
History: Medical history: passed out; blood donor
Prex Illness: rhinitis allergic; asthma exercise induced
Prex Vax Illns:


Unknown F 10-Feb-2007 Unknown 17-Apr-2007 27-Apr-2007 DE 27-Apr-2007

MedDRA PT Pain in extremity
Symptom Text: C/O pain in her L arm where she got the Gardasil injection (02/10/07). Pain starts when she rotates arm inward or lift it shoulder level or above.
Other Meds:
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:


Unknown F 10-Feb-2007 Unknown 17-May-2007 13-Jun-2007 -- WAES0705USA01692 13-Jun-2007

MedDRA PT Injected limb mobility decreased, Injection site pain, Pain in extremity
Symptom Text: Information has been received from a nurse practioner and a licensed practical nurse concerning a female who on 10-FEB-2007 was vaccinated with Gardasil
(Lot number 656049/0187U). Subsequently the patient experienced pain at injection site and could not lift that arm. The pain occurred when the patient lifted
her arm above her shoulder or if she rotated her arm. The patient sought unspecified medical attention. As of 16-APR-2007, it was unknown if the patient will
get second dose. On 17-APR-2007, the patient was recovering from pain at injection site, inability to lift arm and pain when she lifted her arm above her head.
This is one of several patients reported from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


15.0 F 09-Apr-2007 10-Apr-2007 1 18-Apr-2007 27-Apr-2007 TX 27-Apr-2007
VARCEL MERCK & CO. INC. 1501F 1 Right arm Unknown
MNQ AVENTIS PASTEUR U2155UA 0 Right arm Unknown
HPV4 MERCK & CO. INC. 1424F 0 Right arm Unknown
HEPA MERCK & CO. INC. 1213F 0 Left arm Unknown
MedDRA PT Guttate psoriasis, Rash macular, Streptococcal identification test positive
Symptom Text: Patient returned to clinic within 24 hours of vaccination for macular rash on trunk. Macules approx 1-2 cm, annular. Pt did test (+) for strep and was diagnosed
with gutate psoriasis vs vaccine rxn.
Other Meds:
Lab Data: 4/10/07 (+) Strep
History: Acne
Prex Illness: none
Prex Vax Illns: fever~Vaccine not specified~~0~In Patient


15.0 F 09-Apr-2007 11-Apr-2007 2 24-Apr-2007 03-May-2007 TX 08-May-2007
VARCEL MERCK & CO. INC. 1501F 1 Left arm Subcutaneously
HEPA MERCK & CO. INC. 1213F 0 Left arm Intramuscular
MNQ SANOFI PASTEUR U2155CA 0 Right arm Intramuscular
MedDRA PT Rash erythematous
Symptom Text: Pt presented with rash discrete erythematous lesion on trunk, Afebrile no lesion prior to immunization.
Other Meds:
Lab Data:
History: Acne
Prex Illness:
Prex Vax Illns:


15.0 F 09-Apr-2007 09-Apr-2007 0 17-May-2007 13-Jun-2007 -- WAES0704USA04271 13-Jun-2007
VARCEL MERCK & CO. INC. NULL Unknown Unknown
HEPA MERCK & CO. INC. NULL Unknown Unknown
MedDRA PT Pharyngitis streptococcal, Rash
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 09-APR-2007 was vaccinated with Gardasil (lot #654885/1424F).
Concomitant therapy included Vaqta (Merck, Varivax (Merck) and Menactra. Within 24 hours, the patient experienced a rash on the trunk of her body. On 10-
APR-2007, the patient returned to the office and a strep test was positive for strep throat. The patient subsequently recovered from the strep throat and the rash
on the trunk of her body. Additional information has been requested.
Other Meds:
Lab Data: throat culture 04/10/07 + - strep
History: Unknown
Prex Illness:
Prex Vax Illns:


16.0 F 07-Mar-2007 11-Mar-2007 4 18-Apr-2007 23-Apr-2007 CA 27-Jun-2007
VARCEL UNKNOWN MANUFACTURER NULL Unknown Intramuscular
MNQ SANOFI PASTEUR U2002AC Unknown Intramuscular
TDAP UNKNOWN MANUFACTURER NULL Unknown Intramuscular
HPV4 MERCK & CO. INC. NULL 1 Unknown Intramuscular
MedDRA PT Blister, Blood culture negative, Chapped lips, Dehydration, Fluid replacement, Herpes simplex, Injection site erythema, Injection site pain, Injection site
swelling, Lip swelling, Stomatitis
Symptom Text: pt. received TDAP,HPV,VZV and MENING on 3/7/07. Within a week, one of the injections sites swelled,became painful and red. The doctor's office was notified
of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fith week after injection pt was
hospitalized for severe stomatitis. Please note, the pt has never suffered these symptoms before, nor has she seeked care for this problem prior to this
outbreak. Pt became dehydrated and needed i.v. care. Pt had blister type lesions that started on the outside of the lips and continued to spread to the back of
the throat. Pt has improved greatly and should have a full recovery. 6/27/07-records received from facility. Oral lesion, virus culture positive for herpes simplex
virus. Blood culture no growth. No documentation to support hospitalization.
Other Meds: none
Lab Data: lip culture and blood cultures.
History: none
Prex Illness: none
Prex Vax Illns:


16.0 F 07-Mar-2007 11-Mar-2007 4 20-Jun-2007 21-Jun-2007 CA 200702148 05-Jul-2007
VARCEL MERCK & CO. INC. NULL Unknown Intramuscular
TDAP UNKNOWN MANUFACTURER NULL Unknown Intramuscular
MNQ SANOFI PASTEUR NULL Unknown Intramuscular
MedDRA PT Chapped lips, Dehydration, Injection site erythema, Injection site pain, Injection site swelling, Lip blister, Lip swelling, Stomatitis, Wrong drug administered
Symptom Text: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05087. The initial reporter to this manufacturer had been the FDA,
VAERS# not provided. Verbatim from the report: "Information has been received on request from the FDA under the Freedom of information Act regarding a 16
year old female patient with no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a second dose of Gardasil. Concomitant suspect
therapy given on 07-MAR-2007 included a dose varicella virus vaccine live (manufacturer unknown). Other concomitant therapy included MENACTRA and a
dose of Dtap. On 11-MAR-2007, within a week one of the injection sites swelled and became painful and red. The doctor's office was notified of this reaction.
Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fifth week after injection the patient was
hospitalized for severe stomatitis. The patient has never suffered these symptoms before, nor has she seeked care for the problem prior to this. The patient
became dehydrated and needed I.V. care. The patient had blister type lesions that started on the outside of the lips and continued to spread to the back of the
throat. Diagnostic laboratory tests included blood culture and lip culture. The patient has improved greatly and should have a full recovery. The original
reporting source was not provided. No further information is available." It was reported in the structured field of the report that all vaccines had been
administered intramuscularly.
Other Meds:
Lab Data: diagnostic laboratory-lip culture, blood culture (no results provided).
History:
Prex Illness:
Prex Vax Illns:


Unknown F 01-Apr-2007 01-Apr-2007 0 23-Apr-2007 24-Apr-2007 PA WAES0704USA02668 25-Apr-2007

MedDRA PT Convulsion, Gaze palsy
Symptom Text: Information has been received from a physician concerning a 12-15 year old (exact age unknown) female patient who in April 2007, was vaccinated with a dose
of Gardasil. The patient started to convulse in front of the physician and her eyes rolled back after receiving the Gardasil. The patient received medical
attention. The physician's office followed up with the patient the next day and she was doing fine. Upon internal review, convulsion was considered to be an
other important medical event. The physician reported that another patient in the same age group convulsed after receiving the Gardasil. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


13.0 F 11-Apr-2007 11-Apr-2007 0 14-May-2007 15-May-2007 PA 200701539 15-May-2007
MNQ SANOFI PASTEUR NULL 0 Unknown Unknown
HPV4 MERCK & CO. INC. 0263U Left arm Intramuscular
HEPA GLAXOSMITHKLINE NULL Unknown Unknown
BIOLOGICALS
MedDRA PT Convulsion, Convulsion, Eye rolling, Headache, Hypotonia, Loss of consciousness, Muscle rigidity, Musculoskeletal stiffness, Pallor, Postictal state, Staring,
Unresponsive to stimuli
Symptom Text: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 May 2007 from another manufacturer, report#
WAES0704USA02668. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Initial and follow up information
has been received from a physician concerning a 13 year old female patient who on 11-APR-2007, was vaccinated IM in left deltoid with a dose of Gardasil, lot
#655849/0263U. Concomitant therapy included Varivax, MENACTRA and HAVRIX. The patient's blood pressure (BP) prior to vaccination was 112/68 mmHg.
The patient started to convulse in front of the physician and her eyes rolled back after receiving the Gardasil. Almost immediately the patient became very stiff,
rigid, and passed out for approximately 30 seconds. The physician reported that the patient was "really out of it." BP after seizure was 102/78 and pulse
oximetry was 98%. The patient recovered from the seizure but was experiencing headaches since the injection was given. The physician's office followed up
with the patient the next day and she was doing fine. The physician did not consider the event to be serious." "In follow-up report from the physician's office it
was reported that patient became pale for about one minute and when she came to she had postictal signs and symptoms of a blank stare for about five to ten
seconds and no response. She did walk back to the room without much time. When she got back to the room she became "limp" and needed to be lifted. On
11-APR-2007 the patient recovered. Upon internal review, convulsion was considered to be an other important medical event. The physician reported that
another patient in the same age group convulsed after receiving the Gardasil vaccine. Additional information is not expected." The reporter in this case is the
same as in case 2007-01540.
Other Meds:
Lab Data: 11/Apr/2007: pulse oximetry 98%; BP before seizure 112/68; BP after seizure 102/78
History:
Prex Illness:
Prex Vax Illns:


16.0 F 28-Mar-2007 28-Mar-2007 0 23-Apr-2007 02-May-2007 TX TX07026 03-May-2007

MedDRA PT Deafness, Fall, Head injury, Syncope, Visual disturbance
Symptom Text: Patient was administered the HPV (Gardasil) #1 vaccine at 12:30 pm. Patient was sitting when the vaccine was administered, she got up from the exam table,
standing besides the table. Patient fainted, falling on the floor, hitting her head to left side, pt. said she stopped hearing and saw everything white. She was
helped from the floor and placed on exam table on a laying position. She was resting for 1 hour. Pt after 1 hour felt better and left the office walking.
Other Meds: NONE
Lab Data:
History: NKDA
Prex Illness: Ingrown toenail
Prex Vax Illns:


12.0 F 30-Mar-2007 30-Mar-2007 0 17-May-2007 13-Jun-2007 TX WAES0704USA01609 13-Jun-2007

MedDRA PT Dizziness, Headache
Symptom Text: Information has been received from a physician concerning a 12 year old female patient with type II diabetes mellitus who on 30-MAR-2007 was vaccinated
with 0.5 mL of Gardasil, lot #654885/1424F. Concomitant therapy included sodium fluoride. On 30-MAR-2007 the patient developed headache and dizziness 2-
3 minutes after receiving the injection. Unspecified medical attention was sought. Subsequently, on an unspecified date, the patient recovered. Additional
Other Meds: sodium fluoride
Lab Data: Unknown
History: Type II diabetes mellitus
Prex Illness:
Prex Vax Illns:


12.0 F 30-Mar-2007 30-Mar-2007 0 23-Apr-2007 02-May-2007 TX TX07027 03-May-2007

Symptom Text: 3/30/07 10:00 AM HPV vaccine was administered on her left upper arm sitting on an exam table. 2-3 minutes after administering vaccine, pt. c/o a headache
and dizziness. Pt. was placed on exam table in a laying position.
Other Meds: Fluoride
Lab Data: No test performed at the office on 3-30-07.
History: No known drug allergies, just diagnosed with Type II Diabetes
Prex Illness: Type II Diabetes
Prex Vax Illns:


16.0 F 28-Mar-2007 28-Mar-2007 0 17-May-2007 13-Jun-2007 -- WAES0704USA01565 13-Jun-2007

MedDRA PT Head injury, Syncope
Symptom Text: Information has been received from a physician concerning a 16 year old female with no drug reactions/allergies who on 28-MAR-2007 was vaccinated, IM with
Gardasil (lot # 654885/1424F). On 28-MAR-2007 the patient fainted and hit her head after receiving an immunization with Gardasil. No lab diagnostics were
performed. Subsequently, the patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:


12.0 F 13-Apr-2007 13-Apr-2007 0 24-Apr-2007 25-Apr-2007 NM A0647898A 07-May-2007
HPV4 MERCK & CO. INC. 0187U Unknown Unknown
HEPA GLAXOSMITHKLINE AHAVB148AA 0 Left arm Unknown
BIOLOGICALS
MedDRA PT Dizziness, Loss of consciousness, Syncope
Symptom Text: This case was reported by a physician and described the occurrence of unconscious in a 12-year-old female subject who was vaccinated with Havrix, Gardasil
for prophylaxis. The subject was reported to be "otherwise healthy". The subject experienced on adverse events following previous vaccinations. There were no
concurrent medications. On 13 April 2007 at 11:00, the subject received the 1st dose of Havrix (.5 ml, unknown, left arm). On 13 April 2007 at an unspecified
time, the subject received the 1st dose of Gardasil. On 13 April 2007, 2 minutes after vaccination with Havrix and an unspecified time after vaccination with
Gardasil, the subject experienced two episodes of dizziness and fainting within five minutes of dosing. The subject was unconscious for a minute or less with
each episode. This case was assessed as medically serious by manufacturer. On 13 April 2007, the events were resolved.
Other Meds: No concurrent medication
Lab Data: UNK
History: The subject was reported to be "otherwise healthy". The subject experienced no adverse events following previous vaccinations.
Prex Illness: Unknown
Prex Vax Illns:



MedDRA PT Blood glucose normal, Conversion disorder, Nightmare, Syncope
Symptom Text: Information has been received from a physician concerning a 12 year old female who on 13-APR-2007 was vaccinated with the first dose of Gardasil (lot
#656049/0187U), 0.5 ml, injection. Concomitant therapy included hepatitis A virus vaccine (unspecified). On 13-APR-2007, the patient fainted and had pseudo
seizure like symptoms. The patient had dreams about receiving the shot and the physician felt that the reaction was anxiety related. The patient had the
following laboratory diagnostic tests performed after the incident: glucose 85, blood pressure 135/75, pulse 85 and one hour later the blood pressure 97/63,
pulse 73 and oxygen saturation 99%. No Benadryl was given to the patient. Subsequently the patient recovered from the events that same day. Additional
Other Meds:
Lab Data: blood pressure 04/13/07 135/7 - after incident blood pressure 04/13/07 97/63 - 1 hour after incident pulse oximetry 04/13/07 99% - 1 hour after incident serum
glucose 04/13/07 85 - after incident total heartbeat count 04/13/07 85 - afte
History: Unknown
Prex Illness:
Prex Vax Illns:


Unknown F Unknown Unknown 03-May-2007 04-May-2007 LA WAES0704USA06507 04-May-2007
MNQ AVENTIS PASTEUR NULL Unknown Unknown
MedDRA PT Loss of consciousness
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of
Gardasil, injection. Concomitant therapy included MENACTRA. Subsequently on an unspecified date, the patient "passed out" 15 minutes after receiving
Gardasil. The patient was sent to the hospital but the length of stay was unknown. Subsequently on an unspecified date, the patient recovered from the event.
Other Meds:
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:


Unknown F Unknown Unknown 23-May-2007 24-May-2007 LA 200701742 24-May-2007
MNQ SANOFI PASTEUR NULL Unknown Unknown
Symptom Text: Initial report received on 14 May 2007 from another manufacturer, report number WAES0704USA06507. The initial reporter to this manufacturer was a
physician. "Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first
dose of Gardasil, injection. Concomitant therapy included Menactra. Subsequently on an unspecified date, the patient "passed out" 15 minutes after receiving
Gardasil. The patient was sent to the hospital but the length of stay was unknown. Subsequently on an unspecified date, the patient recovered from the event.
Additional information has been requested."
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


22.0 F 02-Mar-2007 04-Mar-2007 2 04-May-2007 14-May-2007 OH 14-May-2007
HPV4 MERCK & CO. INC. 14258 0 Left arm Unknown

MedDRA PT Asthenia, Chills, Influenza like illness, Pyrexia
Symptom Text: per patient 2-3 days post vaccine "almost flu like" "mild" fever (pt did not take temp). "chills" "felt weak" all sx x 1 day only pt. did not report this until 2 months
later
Other Meds: Yasmin-birth control pill
Lab Data:
History: NKDA
Prex Illness:
Prex Vax Illns:



MedDRA PT Influenza like illness, Pyrexia
Symptom Text: Information has been received from a physician concerning a 23 year old female who on 02-MAR-2007 was vaccinated with Gardasil. Two or three days later,
on approximately 04-MAR-2007, the patient experienced flu like symptoms and fever. Subsequently, the patient recovered from flu like symptoms and fever.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:


18.0 F 27-Feb-2007 15-Mar-2007 16 04-May-2007 11-May-2007 MN 14-May-2007
HPV4 MERCK & CO. INC. 00114 0 Left arm Intramuscular

MedDRA PT Lymphadenopathy
Symptom Text: Gardasil given 2/27/07 developed lymphadenopathy (L) neck w/in 2 wks of vaccine.
Other Meds:
Lab Data: Elevated WBC 16, LAP
History: none
Prex Illness: Lymphadenopathy
Prex Vax Illns:


18.0 F 27-Feb-2007 06-Mar-2007 7 18-Jun-2007 17-Jul-2007 -- WAES0705USA01292 17-Jul-2007

Symptom Text: Information has been received from a physician concerning an 18 year old female with tic disorder unspecified who on 27-FEB-2007 was vaccinated with
Gardasil in her left deltoid muscle. Concomitant therapy included TENEX. The physician reported that the patient developed left supraclavicular
lymphadenopathy one week after receiving her first dose of Gardasil vaccine. The patient was referred for evaluation by an ears, nose and throat (ENT)
specialist, a chest x-ray was negative and the complete blood cell count (CBC) revealed WBC 16,000. The ENT physician prescribed a course of AUGMENTIN
850 mg bid. The patient had a follow up exam on 04-MAY-2007 which revealed the supraclavicular nodes decreased in size. As of 04-MAY-2007 the patient
was recovering. Additional information has been requested.
Other Meds: TENEX
Lab Data: Chest X-ray 03/06/07 - negative, complete blood cell 03/06/07, WBC count 03/06/07 16,00
History:
Prex Illness: Tic disorder, unspecified
Prex Vax Illns:


16.0 F 26-Feb-2007 15-Mar-2007 17 07-May-2007 17-May-2007 NH 17-May-2007

MedDRA PT Pain in extremity, Pain in extremity, Rheumatoid arthritis
Symptom Text: Two weeks after receiving Gardasil vaccine pt developed leg/arm pain. Blood test showed + R.A. After course of steroids, blood test normalized.
Rheumatologist suggested to pt to not get second Gardasil vaccine.
Other Meds:
Lab Data: + Rheumatoid factor
History:
Prex Illness: none
Prex Vax Illns:


16.0 F 26-Feb-2007 15-Mar-2007 17 18-Jun-2007 17-Jul-2007 NH WAES0705USA00601 17-Jul-2007

MedDRA PT Pain in extremity, Pain in extremity, Rheumatoid factor increased
Symptom Text: Information has been received from a certified nurse midwife concerning a 16 year old female student who on 26-FEB-2007 was vaccinated intramuscularly
with a first 0.5 mL dose of Gardasil (lot # 655849/0263U). Concomitant therapy included hormonal contraceptives (unspecified). On 15-MAR-2007 the patient
experienced vague left arm pain, vague leg pain. She was seen by a rheumatologist and serum rheumatoid factor was found to be elevated (positive. She was
successfully treated with a course of steroids and her symptoms and blood tests improved. On 25-APR-2007, the patient recovered from left arm pain, vague
leg pain, and serum rheumatoid factor elevated. The reporter felt that left arm pain, vague, leg pain, vague and serum rheumatoid factor elevated could be
related to therapy with Gardasil. No product quality complaint was involved. No further information is available.
Other Meds: Hormonal contraceptives
Lab Data: Diagnostic laboratory + rheumatoid factor
History: Unknown
Prex Illness:
Prex Vax Illns:


20.0 F 03-May-2007 Unknown 07-May-2007 17-May-2007 PA 17-May-2007
HPV4 MERCK & CO. INC. 0960F 1 Left arm Unknown

MedDRA PT Drug exposure during pregnancy
Symptom Text: Unknown pregnancy at time of vaccine about 6 weeks pregnant.

Other Meds: Paxil
Lab Data: + pregnancy test 5/7/07
History: Depression
Prex Illness: None
Prex Vax Illns:


20.0 F 03-May-2007 03-May-2007 0 18-Jun-2007 17-Jul-2007 PA WAES0705USA01656 17-Jul-2007

MedDRA PT Drug exposure during pregnancy, Metrorrhagia
Symptom Text: Information has been received from a physician's assistant from a pregnancy registry for Gardasil concerning a 20 year old female with depression and
gastrooesophageal reflux disease with a history of 0 pregnancies and 0 lives births who on 01-MAR-2007 was vaccinated with Gardasil, lot# 6454535/0960F.
On 03-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 654535/0960F. Concomitant therapy included PAXIL and PRILOSEC,
which was "on hold" as of approximately 07-MAY-2007. On 07-MAY-2007 the patient spotting and she went to her physician's office and was given a urine
pregnancy test which was positive. It was reported that there were "no adverse events". There were no other details provided. The patient sought medical
attention (not further specified). Additional information has been requested.
Other Meds: PRILOSEC 20 mg, PAXIL 20 mg
Lab Data: Urine beta-human 05/07/07 positive
History:
Prex Illness: Pregnancy NOS (LMP = 3/23/2007) Depression; Gastrooesophageal reflux disease
Prex Vax Illns:


17.0 F 01-May-2007 02-May-2007 1 08-May-2007 17-May-2007 CA 17-May-2007
MNQ SANOFI PASTEUR U2230AA 0 Right arm Unknown
MedDRA PT Asthma, Injection site erythema, Injection site swelling, Pharyngeal oedema, Wheezing
Symptom Text: Triggered asthma reaction-wheezing and mild throat swelling-had swelling and redness at injection site of R deltoid area
Other Meds: Asmanex, Loestrin, Singulair, Albuterol
Lab Data:
History: asthma-environment allergies-no hx latex or neomycin
Prex Illness: healthy
Prex Vax Illns:


17.0 F 01-May-2007 02-May-2007 1 18-May-2007 21-May-2007 CA 200701601 21-May-2007
HPV4 MERCK & CO. INC. 0387W 2 Unknown Unknown
MedDRA PT Asthma, Injection site erythema, Injection site swelling, Pharyngeal oedema, Wheezing
Symptom Text: Initial report received on 08 May 2007 from a Nurse Practitioner. A healthy 17 year-old female patient with a history of asthma, environmental allergies without
allergy to latex or Neomycin, had received a first, right arm injection of Menactra, lot number U2230AA, and a second, left arm booster dose of Gardasil, lot
number 0387W, on 01 May 2007 at approximately 13:30 P.M. The following day, at around 08:00 A.M., the patient had a triggered asthma reaction with
wheezing and mild feeling that her throat was swelling. She had swelling and redness at the Menactra injection site on the right deltoid. The patient self
medicated with Benadryl at home without relief and was subsequently treated by a physician with SoluCortef and oral steroids. The patient did not required
epinephrine treatment. The patient recovered.
Other Meds: ASMANEX, LOESTRIN, SINGULAIR, ALBUTEROL
Lab Data:
History: This was a healthy 17-year-old patient at the time of vaccination on 01May 2007. The patient has a past medical history of asthma, environmental allergies, and
no history of latex or Neomycin allergies.
Prex Illness:
Prex Vax Illns:


15.0 F 22-Mar-2007 07-Apr-2007 16 08-May-2007 17-May-2007 NY 31-May-2007
MNQ SANOFI PASTEUR UK2154CA 0 Left arm Intramuscular
MedDRA PT Arthralgia, Headache, Hypoaesthesia, Joint swelling, Rash maculo-papular, Urticaria
Symptom Text: (1) Headache. (2) Numbness on arms and legs, (3) Joint swelling and pain (Elbows, wrist, (4) Hives and Macucopapular rash on arms and legs. Menactra
verified.
Other Meds:
Lab Data: 4/20 ESR = 126, C3 = 216, ANA; Positive (1:20) (4/24) = 258, JGE = 601.00, C4 = 51
History: No
Prex Illness: None
Prex Vax Illns:


15.0 F 22-Mar-2007 08-Apr-2007 17 17-May-2007 13-Jun-2007 NY WAES0704USA04552 13-Jun-2007
MedDRA PT Arthralgia, Asthenia, Headache, Urticaria
Symptom Text: Information has been received from a physician, concerning a 15 year old female patient, who on 22-MAR-2007 was vaccinated with the first dose, 0.5ml, IM, of
Gardasil (Lot #655849/0263U). Concomitant therapy administered on 22-MAR-2007, included Menactra. On 08-APR-2007, the patient experienced
"generalized weakness, headache, upper and lower extremity joint pain, and upper and lower extremity hives." The physician reported that the generalized
weakness, headache and hives resolved on approximately 15-APR-2007 ("after one week"). At the time of this report, the patient's joint pain continued in both
her upper and lower extremities, though the physician confirmed that the patient was recovering from this event. The patient sought unspecified medical
attention. Additional information has been requested.
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 278268-1 (S) Related reports: 278268-2; 278268-3

12.0 F 24-Apr-2007 25-Apr-2007 1 09-May-2007 10-May-2007 TX WAES0705USA00797 12-Jun-2007
HIBV MERCK & CO. INC. NULL Unknown Unknown
Seriousness: ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS
MedDRA PT CSF culture negative, Groin pain, Headache, Herpes zoster, Herpes zoster, Meningitis viral, Meningitis viral, Nausea, Photosensitivity reaction, Rash
Symptom Text: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated
with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007,
the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was
negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed
with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral
meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered
from the events. Additional information has been requested. 5/18/2007 Received medical records from hospital which reveal patient experienced shingles,
severe HA which continued to worsen, photosensitivity, nausea. Opthal exam prior to admit was WNL. Admitted 5/3-5/6/07. ID consult obtained. Treated w/IV
antibiotics & antivirals. Symptoms resolved day after treatment started & patient continued to progress well. D/C home on no meds w/close outpatient PCP f/u.
FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected. 6/8/07 Received note from PCP stating
CSF PCRs for HSV & entervirus were neg. Also included name of admitting physician at hospital where PCP does not have privileges.
Other Meds:
Lab Data: diagnostic laboratory 04/25/07 - negative LABS: WBC 4.4, AST 43, Mag 2.5. CK 292, MBs neg. CSF WBC 55, RBC 10, lymphs 86, monos 14, protein 28,
glucose 44, pleocytosis of CSF. CSF herpes & VZ was neg. Blood & urine c/s neg. CT of head
History: Unknown PMH: hemolytic uremic syndrome requiring hospitalization & blood transfusions out of country, shingles 4/24/07. right wrist tendon injury & fracture of
growth plate.
Prex Illness:
Prex Vax Illns:


12.0 F 24-Apr-2007 25-Apr-2007 1 29-May-2007 30-May-2007 TX 200701799 08-Jun-2007
HEPA UNKNOWN MANUFACTURER NULL Unknown Unknown
HIBV MERCK & CO. INC. NULL Unknown Unknown
Seriousness: ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS
MedDRA PT Feeling abnormal, Headache, Herpes zoster, Pain
Symptom Text: Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00797. The initial reporter to this manufacturer had been a health
care professional. "Initial and follow up information has been received from a physician, concerning a 12 year old female patient with a history of hemolytic
uremic syndrome (date unspecified), who on 24-APR-2007 was vaccinated with the first dose, 0.5ml, IM of Gardasil (Lot #656372/0243U). Concomitant therapy
included hepatitis A (manufacturer unspecified), PEDVAXHIB and MENACTRA. On 25-APR-2007, the day following the vaccinations, the patient returned to the
office with complaints of pain from her spine to the right groin; blood work (unspecified) testing was performed, and was negative. On approximately 30-APR-
2007 (also reported as "a couple of days later"), the patient "developed herpes zoster on the L3 and L4 dermatomes and pain," and acyclovir was prescribed
acetaminophen (TYLENOL) and codeine. On 03-MAY-2007, the patient presented to the ER, "feeling awful and suffering from a massive headache," and was
admitted to the hospital. Diagnostic testing included a polymerase chain reaction (PCR) that was negative for herpes and enterovirus, and a lumbar puncture
that revealed the presence of "55 lymphocytes and 6 red blood cells;" a diagnosis of viral meningitis was confirmed. At the time of this report, the physician
verified that the "patient's symptoms had resolved" (date not specified). The reporter considered the event of viral meningitis to be disabling/incapacitating, and
an other important medical event. No further information is expected."
Other Meds:
Lab Data: 25/Apr/2007: diagnostic lab-negative; 03/May/2007: spinal tap-55 lymphocytes and 6 RBC, viral meningitis; 03/May/2007: enterovirus; PCR-neg
herpes/enterovirus
History: haemolytic uraemic syndrome
Prex Illness:
Prex Vax Illns:


12.0 F 24-Apr-2007 25-Apr-2007 1 11-Jun-2007 15-Jun-2007 TX 15-Jun-2007
TDAP SANOFI PASTEUR C2720AA 0 Left arm Unknown
MNQ SANOFI PASTEUR U2231AA 0 Left arm Unknown
HEPA MERCK & CO. INC. 0250U 0 Right arm Unknown
MedDRA PT Headache, Meningitis viral, Myalgia, Pain, Rash
Symptom Text: 4-24-07: Received 4 vaccines: Hep A, Gardasil, Menactra, Tdap. 4-25-07: Myalgia, pain over Right buttock, right leg area, R ST joint - no rash. 4-29-07: rash
over right L-3 and L-4 area HA started 5/3/07 Hospitalized for viral meningitis
Other Meds: none
Lab Data:
History: NKDA, etc
Prex Illness: none apparent
Prex Vax Illns:

Vaers Id: 278321-1

Unknown F Unknown Unknown 10-May-2007 21-May-2007 DE 21-May-2007

MedDRA PT Dizziness, Dizziness, Nausea
Symptom Text: c/o lightheaded, dizzy nausea (L) BP 110/60 (R) BR 104/60
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 278363-1

17.0 F 09-May-2007 09-May-2007 0 10-May-2007 19-May-2007 NC 21-May-2007

MedDRA PT Rash macular
Symptom Text: Non-pruritic purple macules on bilateral inner thighs several hours after 3rd injection. No side effects with previous injections. No new irritants used. Symptoms
persisting over 24 hours. No treatment used.
Other Meds: Claritin-D
Lab Data:
History: seasonal allergies
Prex Illness: none
Prex Vax Illns:

Vaers Id: 278379-1

24.0 F 19-Mar-2007 19-Mar-2007 0 11-May-2007 14-May-2007 PA WAES0704USA01265 14-May-2007

MedDRA PT Rash
Symptom Text: Information has been received from a registered nurse concerning a 24 year old female student (weight 113) who on 19-MAR-2007 was vaccinated with the
first dose of Gardasil, IM in the left deltoid (Lot number 657006/0188U). Concomitant medication was not reported. On 19-MAR-2007 in the evening, the patient
developed a rash on her neck and abdomen. There was not reaction at the injection site. The patient was treated with Benadryl. Subsequently on 30-MAR-
2007, the patient recovered from a rash on her neck and abdomen. Follow-up from a dermatologist indicated that the patient had a medical history of laser
treatment to the cervix and was on birth control pill concomitantly. The patient was seen in the office on 02-APR-2007 with multiforme rash of the torso and
neck. The dermatologist reported that the patient indicated that the rash began the evening that the patient was vaccinated. The rash started 2 weeks before it
was assessed by the dermatologist. The physician reported that the patient was treated with oral steroids to prevent serious criteria. The patient has recovered.
The dermatologist reported that the multiforme rash was an other important medical event. Additional information is not expected.
Lab Data:
History: Cervical laser therapy
Prex Illness:
Prex Vax Illns:

Vaers Id: 278380-1

25.0 F 31-Oct-2006 11-Nov-2006 11 11-May-2007 14-May-2007 TN WAES0705USA00787 14-May-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy
Symptom Text: Information has been received via the manufacturer pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, who
on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F). On 18-DEC-2006, the patient had a positive pregnancy test; the date
of the LMP was 11-NOV-2006, with an estimated date of delivery of 18-AUG-2007. The CMA confirmed that on 22-DEC-2006, the patient had a spontaneous
miscarriage, through hospitalization was not reported and testing of the miscarried fetus was unavailable. It was not specified if the patient sought medical
attention, nor if the patient had recovered from the spontaneous abortion. On 27-DEC-2006, the patient was vaccinated IM, with the second dose of Gardasil
(Lot #654540/0800F). Upon internal review, spontaneous miscarriage was determined to be an other important medical event. This patient also experienced a
pregnancy following vaccination with the second dose of Gardasil (WAES #0705USA01062). Additional information has been requested.
Other Meds: None
Lab Data: beta-human chorionic 12/18/06 - Positive
History:
Prex Illness: Pregnancy NOS (LMP = 11/11/2006)
Prex Vax Illns:

Vaers Id: 278381-1 (S)

16.0 F 27-Apr-2007 27-Apr-2007 0 11-May-2007 14-May-2007 FR WAES0705USA01162 14-May-2007

MedDRA PT Eye rolling, Muscle twitching, Syncope
Symptom Text: Information has been received from a health professional concerning a 16 year old female who on 27-APR-2007 was vaccinated, intramuscularly, in the right
deltoid muscle, with Gardasil (Lot number 655376/0572F : Batch number NE 45050). On 27-APR-2007 the patient experienced syncope, eyes rolling and
twitches of the right arm. The symptoms lasted for less than one hour. She was admitted to the hospital for monitoring. Further course and diagnostic (not
specified) was normal. Subsequently, the patient recovered completely. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 278394-1

18.0 F 08-May-2007 08-May-2007 0 11-May-2007 22-May-2007 VT 22-May-2007
TDAP GLAXOSMITHKLINE AC52B012AA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Abdominal pain upper, Asthenia, Body temperature increased, Chills, Ear pain, Erythema, Malaise, Nausea, Neck pain, Pain, Pallor
Symptom Text: 5/8/07 Sleeping and woke up with chills and c/o neck pain and aches-> Motrin 600 mg. 5/9/07 c/o nausea, stomachache, earaches T 102.4 deg at 3:00 pm
Ears ok one red canal only per school nurse-ES Tylenol given and slept 3-4-07 pale and c/o weak and not feeling well. School nurse checked -> adeq
strength/BP 102/60 P72 no numbness/tingling All s/s resolved in pm.
Other Meds: PPD acne facial Rx products Clindamycin gel + Diff gel
Lab Data: none
History: Allergies-Ceclor, minocycline, benzyl peroxide
Prex Illness: none
Prex Vax Illns:

Vaers Id: 278395-1

16.0 F 21-Mar-2007 22-Mar-2007 1 11-May-2007 22-May-2007 IN 22-May-2007
HPV4 MERCK & CO. INC. 0014U 0 Right arm Unknown

MedDRA PT Injection site pruritus, Injection site rash
Symptom Text: Patient's mother reported rash and itching at injection site approximately 6cm.
Other Meds: Necon 50
Lab Data:
History: NKDA
Prex Illness:
Prex Vax Illns:

Vaers Id: 278425-1

19.0 F 10-May-2007 11-May-2007 1 11-May-2007 19-May-2007 NY 21-May-2007

MedDRA PT Diarrhoea, Nausea, Vomiting
Symptom Text: Pt c/o nauesa during the first night after injection. vomitting in the morning and loose stools.
Other Meds: prenatal vitamins
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 278439-1

11.0 F 03-May-2007 03-May-2007 0 11-May-2007 19-May-2007 FL 21-May-2007
TDAP SANOFI PASTEUR C2644AA 0 Left arm Intramuscular
HPV4 MERCK & CO. INC. 021OU 0 Right arm Intramuscular
MedDRA PT Acne, Oedema peripheral, Rash, Swollen tongue, Tongue disorder
Symptom Text: called 05/03/2007 complaining of tongue swelling and rash. Was told to go to emergency room. I called on 05/04/07 for follow up and was told by father that
patient was fine, only complained of "tongue heaviness and had a few pimples", did not go to er. Again was called 05/09/2007 when physician not in office,
with arm swelling, was told to go to emergency room since there was no physician available for 24 hours to examine patient.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 278443-1

13.0 F 08-May-2007 09-May-2007 1 11-May-2007 19-May-2007 NJ 21-May-2007
VARCEL MERCK & CO. INC. 03624 1 Left arm Subcutaneously
MedDRA PT Injection site erythema, Injection site oedema, Injection site pruritus
Symptom Text: localized edema, erythema, itching at vaccine site; starting approx 24h after injection
Other Meds:
Lab Data:
History: no
Prex Illness: no
Prex Vax Illns:

Vaers Id: 278468-1

MNQ SANOFI PASTEUR U2276BA 0 Left arm Intramuscular
MedDRA PT Local swelling, Pharyngeal oedema, Tonsillitis
Symptom Text: Patient awoke in the middle of the night with a swollen throat, but had no difficulty breathing. Her father, who is a physician, said that her tonsils and uvula
looked swollen. Mom felt her neck looked swollen. She had not had any other exposures such as to insects. The child went to school the next day and did not
worsen. Mom went to the school and gave otc benadryl 50mg to the child, which caused the symptoms to resolve completely in 20 minutes . The child was
never seen in our office for the reaction. All information was supplied to us by the mother of the patient. The child has no residual problems.
Other Meds: OTC IBUPROFEN as needed for headaches
Lab Data: none
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 278478-1

TDAP UNKNOWN MANUFACTURER C2457AA 1 Left arm Intramuscular
HEPA GLAXOSMITHKLINE AHAVB129AA 1 Left arm Intramuscular
BIOLOGICALS
IPV SANOFI PASTEUR Z0326-2 5 Left arm Intramuscular
MedDRA PT Diarrhoea, Pyrexia, Vomiting
Symptom Text: vomiting, diarrea, fever

Other Meds: Albuterol, Benedryl, Hydrocortizone
Lab Data:
History: Asthma
Prex Illness: Asthma
Prex Vax Illns:


13.0 F 02-May-2007 08-May-2007 6 14-May-2007 21-May-2007 NV 29-May-2007
HPV4 MERCK & CO. INC. UNKNOWN 1 Right arm Intramuscular HPV4

MedDRA PT Gait disturbance, Guillain-Barre syndrome, Muscular weakness
Symptom Text: Sudden onset of muscle weakness on 5/8/07 during 5th period of middle school (about 1:30 pm). Gradual worsening by 5/10/07. Seen in ED 5/10/07. GBS
diagnosis made by attending MD, Neuro consult 5/11/07 concurred diagnosis. Patient transferred to on 5/11/07. Currently still hospitalized, awaiting transfer to
rehab center in closer to patient's home. 05/15/07-records received for DOS5/11-5/14/07-DC DX: Guillain Barre syndrome. Seen in ER for extremity weakness
times four with increasing intensity the more distal on extremity. Weak grip and altered gait. Treated with IVIG. No significant improvement in extremity
weakness however no ascension of weakness either. DC home.
Other Meds: None
Lab Data: Ruled out WNV, Lyme, Mening., other muscular diseases. Confirmed dx. of GBS. records received5/15/07-CSF protein 24, glucose 62, WBC 1, RBC 5. CSF
culture no growth. CBC-WBC 14.9, neut/polys 74.0, lymph 18.9.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 278479-2 Related reports: 278479-1; 278479-3; 278479-4


MedDRA PT Muscular weakness
Symptom Text: Extreme weakness in extremities arms and legs.

Other Meds: none
Lab Data: 5/10,5/11-07
History: none
Prex Illness: none
Prex Vax Illns:


14.0 F 02-May-2007 10-May-2007 8 29-May-2007 30-May-2007 -- WAES0705USA03382 30-May-2007
MedDRA PT Asthenia, Autoimmune disorder, Feeling abnormal, Gait disturbance, Gait disturbance, Guillain-Barre syndrome, Monoplegia, Muscular weakness, Walking aid
user
Symptom Text: Information has been received from a health professional concerning a 14 year old female who on 02-MAY-2007, the patient was sitting in fifth period at school
and started feeling weak. She could barely walk to the car by the end of the period, and by later that afternoon she was in the emergency room of a hospital.
The patient stated "I was getting weak, like it felt weird to walk and to like open the care door." She also stated that "I was fine earlier that day." The patient
couldn't move her legs and her arms felt weak. It was reported that the patient's "legs are paralyzed, her arms are affected and she was very weak in her
arms." The patient has to "use a walker and even with that she can't get to the bathroom and she can't stand up at all." The patient was diagnosed with Guillain-
Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The patient's Guillain-Barre syndrome persisted. The patient's neurologist felt that
Guillain-Barre syndrome was related to therapy with Gardasil. Upon internal review Guillain-Barre syndrome was considered to be an other important medical
event. Additional information is not expected.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:


Unknown F 02-May-2007 09-May-2007 7 08-Jun-2007 11-Jun-2007 -- WAES0705USA05776 11-Jun-2007

MedDRA PT Guillain-Barre syndrome
Symptom Text: Information has been received from a physician concerning a female who on 02-MAY-2007 was vaccinated with Gardasil. On 09-MAY-2007, the patient was
admitted to the hospital with Guillain-Barre syndrome. At the time of the report, the patient remained in the hospital. She was being treated by a neurologist. No
other information was available. Upon internal review it was determined that Guillain-Barre syndrome was an other important medical event. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 278497-1 (S)

18.0 F 01-Dec-2006 01-Dec-2006 0 14-May-2007 15-May-2007 IA WAES0705USA00475 15-May-2007
Seriousness: EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS
MedDRA PT Convulsion, Drug exposure during pregnancy, Premature baby
Symptom Text: Information has been received from a manufacturer pregnancy registry via a registered nurse concerning an 18 year old female with pertinent medical history
and drug reactions/allergies reported as none who in December 2006 was vaccinated with the first dose of Gardasil (lot #653736/0868F), 0.5 ml, IM.
Concomitant therapy included MENACTRA. In February 2007, the patient was vaccinate with the second dose of Gardasil, 0.5 ml, IM. the nurse reported that
the patient received 2 doses of Gardasil while she was pregnant. The patient stated that she did not know that she was pregnant. The patient received no
prenatal care. The patient delivered a female infant with and estimated gestational age of 32-36 weeks on April 22 or 23, 2007. In April 2007 after delivery, the
infant experienced seizures. The nurse reports that after delivery the infant was transferred to another hospital. After internal review, seizure was considered to
be an other important medical event. Additional information has been requested.
Other Meds:
Lab Data:
History:
Prex Illness: Pregnancy NOS (LMP = Unknown)
Prex Vax Illns:


18.0 F 14-May-2007 14-May-2007 0 14-May-2007 22-May-2007 TX 22-May-2007
MedDRA PT Cold sweat, Dizziness, Syncope
Symptom Text: Pt C/O feeling dizzy, pt fainted, skin cold and clammy; pt regained consciousness and vital were within normal range; pt rested with a cold pack to her
forehead.
Other Meds:
Lab Data:
History: NKDA
Prex Illness:
Prex Vax Illns:


18.0 F 14-May-2007 14-May-2007 0 18-Jun-2007 17-Jul-2007 -- WAES0705USA02758 17-Jul-2007
HPV4 MERCK & CO. INC. 1424F Unknown Unknown

MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning an 18 year old female who on 14-MAY-2007 was vaccinated with the first dose of Gardasil (lot #
654885/1424F, and experienced syncope. Concomitant therapy included meningitis vaccine. Unspecified medical attention was sought. On the same day, the
patient recovered from syncope. No other information was provided. This is one of several reports from the same source. Additional information has been
requested.
Other Meds:
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:


18.0 M 14-May-2007 14-May-2007 0 14-May-2007 22-May-2007 TX 22-May-2007
MedDRA PT Dizziness, Fatigue, Nausea, Vomiting
Symptom Text: Pt complaining with nausea, dizziness, and fatigue, vomiting.

Other Meds:
Lab Data:
History: NKDA
Prex Illness:
Prex Vax Illns:



MedDRA PT Dizziness, Nausea, Vomiting
Symptom Text: Information has been received from a licensed visiting nurse, concerning an 18 year old female patient, who on 14-MAY-2007 was vaccinated with the first
dose of Gardasil (Lot #654885/1424F). Concomitant therapy included meningococcal vaccine (manufacturer unspecified). On 14-MAY-2007, following the
vaccination, the patient experienced vomiting, nausea and dizziness. At the time of this report, it was unknown if the patient had recovered. The patient sought
unspecified medical attention. Additional information has been requested.
Other Meds: meningococcal vaccine
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


18.0 F 14-May-2007 14-May-2007 0 14-May-2007 22-May-2007 TX 22-May-2007
MedDRA PT Dizziness, Dizziness, Paraesthesia
Symptom Text: Pt c/o light headiness, dizziness, and tingling at injection site. Pt was instructed to lie down and rest.
Other Meds:
Lab Data:
History: NKDA
Prex Illness:
Prex Vax Illns:



MedDRA PT Asthenia, Dizziness, Paraesthesia
Symptom Text: Information has been received from a nurse concerning an 18 year old female who on 14-MAY-2007 was vaccinated with the first dose of Gardasil lot #
655619/1427F. Concomitant therapy included meningitis vaccine. On 14-MAY-2007 the patient experienced lightheadedness, weakness and tingling in her
injection site arm. The patient recovered from lightheadedness, weakness and tingling in her injection site arm on the same day. Unspecified medical attention
was sought. No other information was available. This is one of several reports from the same source. Additional information has been requested.
Other Meds:
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:


16.0 F 02-May-2007 02-May-2007 0 14-May-2007 22-May-2007 OH 22-May-2007
HPV4 MERCK & CO. INC. NULL 1 Left arm Unknown

MedDRA PT Fatigue, Headache, Pain, Pyrexia
Symptom Text: Fever (102.2), body aches, fatigue, headache - SX lasted > 24 hours
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:


16.0 F 02-May-2007 02-May-2007 0 18-Jun-2007 17-Jul-2007 OH WAES0705USA01678 17-Jul-2007

MedDRA PT Dyspnoea, Myalgia, Pyrexia
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female (142 lbs. 5'5") who on 02-MAY-2007 the patient developed a fever of
102.9, muscle aches and shortness of breath and went to the ER for evaluation. The outcome of the events was unknown. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 278577-1 (S)

17.0 F Unknown 07-May-2007 15-May-2007 16-May-2007 FR WAES0705AUS00041 16-May-2007

MedDRA PT Aphasia, Facial paresis, Muscular weakness, Neurological symptom, Neuropathy, Syncope
Symptom Text: Information has been received from the foreign Department of Health, via CSL as part of a business agreement (manufacturer's number not yet advised). As
part of the regular school-based immunisation program funded by the government, a 17 year old female student was vaccinated with Gardasil (Lot No.
655743/0313U, Batch No. J1022, Expiry date August 2009). Subsequently the patient experienced fainting and was taken to hospital. The patient had
neurological symptoms and her reaction was serious enough to warrant consideration to intubation (confirmed as not intubated in follow-up information). The
provisional diagnosis appears to be "hysterical reaction". The reporter felt that her reactions were related to therapy with Gardasil (Lot No. 655743/0313U,
Batch No. J1022, Expiry date August 2009). Further information was received from a physician. It was stated that the patient was previously well. The patient
had no significant medical history and no previous reaction to immunisation. There was no concurrent medication. On 07-MAY-2007, after the first dose of
Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009), the patient developed ascending neuropathy with weakness of limb muscles and
facial muscles and aphasia and was hospitalised. The records of testing prior to release of the lot in question have been rechecked and found to be
satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information has been requested. This is one of
several reports received from the same source.
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


25.0 F 09-May-2007 11-May-2007 2 15-May-2007 23-May-2007 FL 04-Jun-2007
HPV4 MERCK & CO. INC. 0388U Right leg Unknown

MedDRA PT Mouth ulceration
Symptom Text: Developed 2 Ulcers in mouth. one on top of the tongue. Second on right side of tongue
Other Meds:
Lab Data:
History: none
Prex Illness: No
Prex Vax Illns:


25.0 F 09-May-2007 11-May-2007 2 18-Jun-2007 17-Jul-2007 FL WAES0705USA02906 17-Jul-2007

MedDRA PT Tongue ulceration
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female with no allergies and no pertinent medical history who on 09-MAY-2007
was vaccinated with 0.5 ml of the first dose of Gardasil (Lot #657622/0388U). On 11-MAY-2007 the patient developed two sores on her tongue, one on top and
one on the right side. Subsequently, the patient recovered from the sores on her tongue. Medical attention was sought
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 278591-1

26.0 F 20-Mar-2007 09-Apr-2007 20 15-May-2007 23-May-2007 MI 23-May-2007

Symptom Text: Injection given IN (R) Deltoid on 3/20/07. 4/9/07 Pt. phoned with c/o sore arm. Unable to Raise it above her head. Sent to ER for eval
Other Meds:
Lab Data: CK, CBC, all normal results
History: Allergy: PCN, Compazine
Prex Illness: None
Prex Vax Illns:

Vaers Id: 278641-1

25.0 F 07-May-2007 10-May-2007 3 15-May-2007 19-May-2007 NC 21-May-2007

MedDRA PT Injection site pain, No reaction on previous exposure to drug, Pain in extremity
Symptom Text: My left arm where vaccine was administered was sore for the first three to four days as expected. However, it has now been 8 days and my arm continues to
have a dull ache and throbbing. I did not expierence this with the first shot of the series.
Other Meds:
Lab Data: N/A
History:
Prex Illness: N/A
Prex Vax Illns:

Vaers Id: 278653-1

12.0 F 23-Apr-2007 13-May-2007 20 15-May-2007 19-May-2007 IL 21-May-2007

MedDRA PT Erythema, Oedema peripheral, Pain, Skin warm
Symptom Text: 5/15/2007 Mother reports that Shantel's arm is red, swollen and warm to touch. Denies any fever. States school nurse put cool compress on it 5/14/2007 and
Shantel complained that it hurt worse.Instr to try a warm compress and take tylnol or motrin for the pain and swelling. Also instr to f/u with MD. Question if it
may have been a bite of some sort. Mother unsure.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 278654-1

13.0 F 01-Mar-2007 27-Apr-2007 57 15-May-2007 19-May-2007 IL 21-May-2007
Seriousness: NOT SERIOUS, ER VISIT

MedDRA PT Abdominal pain, Henoch-Schonlein purpura, Rash
Symptom Text: HPV administered on 3/1/07. Abdominal pain and rash started 4/27/07. Diagnosed with HSP on 5/2/07.
Other Meds: None
Lab Data: CBD, Urinalysis, Blood Pressure, Physical exam
History: allergic rhinitis, history of bronchospasm, Osgood Schlatter, International travel - Africa summer 2006, India January 2007
Prex Illness: None, presented at visit with acne
Prex Vax Illns:

Vaers Id: 278663-1

20.0 F 03-Nov-2006 06-Nov-2006 3 15-May-2007 23-May-2007 CA 23-May-2007

MedDRA PT Urticaria
Symptom Text: Broke out with hives 3 days after vaccination which lasted for approximately 3 weeks
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 278665-1

12.0 F 13-Mar-2007 08-Apr-2007 26 15-May-2007 23-May-2007 MN 24-May-2007
DTAP SANOFI PASTEUR C2688AA 1 Left arm Intramuscular
MedDRA PT Diarrhoea, Fatigue, Headache, Malaise, Nausea, Vomiting, Wrong drug administered
Symptom Text: ILLNESS WITH HEADACHE, NAUSEA, VOMITING DIARRHEA AND FATIGUE FROM 4/8/07 - 4/13/07; RECEIVED GARDASIL VACCINATION ON 3/13/07;
NO TREATMENT
Other Meds: NONE
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 278785-1

23.0 F 08-Dec-2006 14-Dec-2006 6 17-May-2007 18-May-2007 WI WAES0612USA02963 18-May-2007

Symptom Text: Initial and follow up information has been received from a nurse and manufacturer pregnancy registry concerning a 23 year old black female patient with one
previous pregnancy who on 08-DEC-2006 was vaccinated with a dose of Gardasil. On 14-DEC-2006 a pregnancy test was positive. The patient's LMP was late
November 2006. On 07-MAY-2007 the nurse reported that the patient had not been to the office since the original prenatal appointment on 12-FEB-2007. She
had cancelled 3 appointments on 05-March-2007, 12-MAR-2007 and 19-MAR-2007. Follow up information from the nurse indicated that on 16-NOV-2006
patient had her last menstrual period and her estimated delivery date 20-AUG-2007. She called back on 07-MAY-2007 but did not give any information about
the miscarriage. On 24-APR-2007 patient reported that she had miscarried. No date was identified when the patient miscarried. Unspecified medical attention
was sought. The outcome was unknown. Upon internal review, miscarriage was considered an other important medical event. Additional information has been
requested.
Other Meds: Unknown
Lab Data: beta-human chorionic 12/14/06 - positive
History: Pregnancy NOS (LMP = 11/16/2006)
Prex Illness:
Prex Vax Illns:

Vaers Id: 278786-1

25.0 F 09-Feb-2007 01-Mar-2007 20 17-May-2007 18-May-2007 IN WAES0704USA03160 26-Jul-2007

MedDRA PT Antepartum haemorrhage, Foetal heart rate abnormal, Urinary tract infection, Uterine dilation and curettage
Symptom Text: Initial and follow up information has been received, via the manufacturer pregnancy registry, from a registered nurse, and a 25 year old female with a history of
one previous full term delivery with no complications (date unspecified), who on 09-FEB-2007, was vaccinated with a first dose of Gardasil (Lot
#654741/0013U). There was no concomitant medication. On 16-APR-2007, the patient reported that she was "four or five weeks pregnant." The date of the
LMP and estimated date of delivery were not provided. Follow up information received from a registered nurse, indicated that the patient was taking prenatal
vitamins (PRENATAL ELITE), and had experienced bleeding during her pregnancy. On 26-APR-2007, an ultrasound confirmed the presence of a yolk sac, but
a fetal heart sound or fetal motion was not detected. On 29-APR-2007, the patient was diagnosed with a urinary tract infection and was treated with
MACROBID 100mg, twice daily, from 29-APR-2007 through 03-MAY-2007. During this time, an human chorionic gonadotroin test (HCG) test result confirmed
an "abnormal rise" in the value (date not specified). On 04-MAY-2007, a repeat ultrasound confirmed the previous finding of yolk sac, but no detection of a fetal
heart sound or fetal motion. a dilatation and curettage (D&C) was performed, and the products of conception was examined (results not specified). At the time
of this report, it was unknown if the patient had recovered. Upon internal review, no fetal heart rate (resulting in a D&C) was determined to be an other
important medical event. Additional information has been requested.
Other Meds: None
Lab Data: ultrasound 04/26/07 - Yolk sac, no fetal heart rate, ultrasound 05/04/07 - Yolk sac, no fetal heart rate, total serum human 04/26?/07 - Abnormal rise
History: Normal delivery
Prex Illness:
Prex Vax Illns:

Vaers Id: 278787-1

Unknown F 01-Mar-2007 01-Mar-2007 0 17-May-2007 18-May-2007 -- WAES0704USA06194 18-May-2007

MedDRA PT Monoplegia, Pain, Paraesthesia
Symptom Text: Initial and follow-up information has been received from a licensed practical head nurse, concerning a mentally challenged female who in March 2007, was
vaccinated with Gardasil. Almost immediately after the vaccination, the patient experienced pain, tingling, and slight paralysis going down the arm. The licensed
practical head nurse thought the complaint of "paralysis" was a result of having to hold the patient down. Subsequently, the patient recovered from the pain,
tingling and slight paralysis going down the arm before she left the office. Upon internal review, slight paralysis going down the arm was considered to be an
important medical event. This is one of two reports from the same source. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Mental disability
Prex Vax Illns:

Vaers Id: 278788-1 (S)

12.0 F 01-Apr-2007 06-Apr-2007 5 17-May-2007 18-May-2007 PA WAES0705USA02024 18-May-2007
Seriousness: ER VISIT, PERMANENT DISABILITY, SERIOUS

MedDRA PT Abdominal pain upper, Blood bilirubin increased, Dysstasia, Hypoventilation
Symptom Text: Information has been received from a mother concerning her 12 year old daughter with hypersensitivity to red dye who in February 2007, was vaccinated with a
first dose of Gardasil. In April 2007, the patient was vaccinated with her second dose of Gardasil there were no concomitant medications. On approximately 06-
APR-2007 the patient experienced stomach pain, difficulty standing, and shallow breathing. The patient went to the emergency room where laboratory data
revealed bilirubin was elevated. At the time of the report, the patient was recovering from the stomach pain, difficulty standing, shallow breathing, and elevated
bilirubin. The consumer considered stomach pain, difficulty standing, shallow breathing, and elevated bilirubin to be disabling. Additional information has been
requested.
Other Meds: None
Lab Data: complete blood cell 04/06?/07 - results not reported, total serum bilirubin 04/06?/07 - bilirubin was elevated
History:
Prex Illness: Hypersensitivity
Prex Vax Illns:

Vaers Id: 278789-1 (S)

24.0 F 04-May-2007 04-May-2007 0 17-May-2007 18-May-2007 -- WAES0705USA02132 18-May-2007
HPV4 MERCK & CO. INC. 0388U Unknown Subcutaneously
Seriousness: ER VISIT, LIFE THREATENING, SERIOUS

MedDRA PT Dysphagia, Dyspnoea, Incorrect route of drug administration, Throat tightness
Symptom Text: Information has been received from a registered nurse concerning a 24 year old female with gastrooesophageal reflux disease and a history of anaphylactic
reaction while on therapy with VICODIN who on 04-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of Gardasil (lot 657622/0388U).
Concomitant therapy included NUVARING, PRILOSEC, cholestyramine resin, vitamins (unspecified) and probiotics "PB8". The patient left the office after
receiving the dose of Gardasil. Within 15 minutes, the patient started to have shortness of breath, difficulty swallowing, and a feeling of her throat tightening.
The patient was never unconscious and had no other symptoms. The patient went to the emergency room where she received possibly prednisone,
BENADRYL, and TAGAMET IV. The patient was discharged to home after 4 hours. Subsequently, the patient recovered and was not receiving further treatment
for the event. Shortness of breath, difficulty swallowing and throat tightness were considered to be immediately life-threatening by the reporter. Additional
Other Meds: cholestyramine resin, NUVARING, PRILOSEC, probiotics (unspecified), vitamins (unspecified) tablet
Lab Data: Unknown
History: Anaphylactic reaction
Prex Illness: Gastrooesophageal reflux disease; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 278790-1

Unknown F Unknown Unknown 17-May-2007 18-May-2007 -- WAES0705USA02215 18-May-2007
MedDRA PT Convulsion
Symptom Text: Information has been received from a nurse concerning a female who was vaccinated with Gardasil concomitantly with hepatitis A virus vaccine (manufacturer
unspecified). Subsequently the patient experienced a seizure. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 278791-1

15.0 F Unknown Unknown 17-May-2007 18-May-2007 NJ WAES0705USA02221 18-May-2007

Symptom Text: Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil. Subsequently the patient experienced
seizures. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 278865-1 (D)

15.0 F 02-Mar-2007 01-Mar-2007 -1 17-May-2007 18-May-2007 AZ 16-Jul-2007
HPV4 MERCK & CO. INC. 1424F 1 Left arm Intramuscular HPV4
TDAP
Seriousness: DIED, ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS
MedDRA PT Acute respiratory distress syndrome, Chest pain, Cough, Cough, Influenza, Mechanical ventilation, Multi-organ failure, Myalgia, Nasal congestion,
Pharyngolaryngeal pain, Pneumonia staphylococcal, Pyrexia, Respiratory failure, Rhinorrhoea, Sepsis, Staphylococcal infection
Symptom Text: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia. Respiratory failure on 3/6/07. 6/1/07 Received Death Certificate from epidemiologist
which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection. Medical records
included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS. Reportedly had
been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever. COntinued to worsen & developed myalgias,
chest pain & nonproductive cough w/higher fever. Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza. Sent home & developed nausea,
vomiting & diarrhea as well as petechial rash over abdomen. Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher
level of care. Respiratory status declined further & was placed on oscillator & ECMO. Peds ID consult done. Consult states had HPV vax at PCP on 3/2 & no
other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider. Reveals that on 1/2/07, patient received TDaP &
HPV. On 3/2/07 received HPV #2. VAERS database updated w/same. On day of vax patient also dx w/right CTS, migraine HA, scoliosis. She was referred to
Neuro & PT for the CTS & HA.
Other Meds: Topamax
Lab Data: Influenza B isolated by viral culture. Specimen sent to CDC for antigenic characterization. LABS: Throat & urine c/s neg. Blood & endotrachael c/s + for
MRSA. Nasal swab + for influ B virus. Lymph node c/s were neg. from PCP office, St
History: PMH: migraine headaches. Family HX: younger sister also w/strep neg sore throat. Letter from school that group A strep infections present.
Prex Illness:
Prex Vax Illns:

Vaers Id: 278877-1

11.0 F 15-May-2007 16-May-2007 1 17-May-2007 23-May-2007 VA 23-May-2007
HPV4 MERCK & CO. INC. N/A Unknown Unknown

MedDRA PT Injection site erythema, Injection site pain, Pyrexia
Symptom Text: Complained of very sore vaccine location (slightly red) and spiked a fever of 103.6 (oral) approximately 12 hours after the vaccination (3rd HPV vaccine in set).
Fever treated with Motrin, came down fairly quickly. No fever as of noon today, and fever has not recurred as of yet.
Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 278962-1 (S)

Seriousness: LIFE THREATENING, SERIOUS

MedDRA PT Smear cervix abnormal
Symptom Text: Information has been received from a consumer concerning a female who was vaccinated with the first dose of Gardasil. Approximately two months after
receiving the vaccine, the patient had an abnormal pap smear. The consumer considered the abnormal pap smear to be immediately life-threatening. This is
one of two reports received from the same source.
Other Meds: Unknown
Lab Data: Cervical smear - abnormal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 278963-1 (S)

25.0 F 01-Mar-2007 03-May-2007 63 18-May-2007 21-May-2007 -- WAES0705USA02234 21-May-2007

Symptom Text: Information has been received from a female in her mid-20's who in approximately March 2007, was vaccinated with the first dose of Gardasil. On
approximately 03-May-2007 the patient had an abnormal pap smear. The patient considered the abnormal pap smear to be immediately life-threatening.
Additional information is not expected. This is one of two reports received from the same source.
Other Meds: Unknown
Lab Data: cervical smear 05/03?/07 - abnormal
History: Unknown
Prex Illness:
Prex Vax Illns:


17.0 F 15-May-2007 15-May-2007 0 18-May-2007 25-May-2007 SD 29-May-2007

MedDRA PT Asthma, Pharyngolaryngeal pain, Productive cough, Wheezing
Symptom Text: Patient had 1st shot of Gardasil yesterday 20 minutes after started wheezing and sore throat. No Ceoniad dyspnea. She has asthma, O2 96%. Today 5/16, she
has a productive cough and wheezing.
Other Meds:
Lab Data:
History: known asthma, seasonal allergies - takes allergy injections
Prex Illness: None
Prex Vax Illns:


17.0 F 15-May-2007 15-May-2007 0 25-May-2007 01-Jun-2007 SD 05-Jun-2007

MedDRA PT Dyspnoea, Oxygen saturation normal, Pharyngolaryngeal pain, Productive cough, Wheezing
Symptom Text: Patient had first shot of Gardasil on 5/15, 20 min after patient started wheezing and had sore throat, cervical dyspnea. 02 96%. On 5/16 had productive cough
and weezing.
Other Meds:
Lab Data:
History: Know asthma, seasonal allergies, takes allergy injections.
Prex Illness:
Prex Vax Illns:


18.0 F 29-Jan-2007 31-Jan-2007 2 18-May-2007 25-May-2007 SD 29-May-2007

MedDRA PT Erythema, Pruritus, Urticaria
Symptom Text: Noted to have hives around lip / lower trunk area, walnut size, reddened, raised - c/o itching - took Zyrtec 10mg.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:


18.0 F 29-Jan-2007 31-Jan-2007 2 25-May-2007 01-Jun-2007 SD 05-Jun-2007

MedDRA PT Pruritus, Urticaria
Symptom Text: Noted to have hives around hip/lower trunk area, walnut sized, red, raised c/o itching- took Zyrtec 10mg.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 278994-1


MedDRA PT Pruritus, Rash generalised, Rash macular, Rash pruritic
Symptom Text: Within 4 hours of receiving vaccine in left arm, received rash (red, macular, lacy) which was itching and extended to rest of her body lasting 3-4 days.
Other Meds: none
Lab Data: none
History: Ankle sprain, no allergies, birth defects
Prex Illness: none
Prex Vax Illns:

Vaers Id: 278996-1

13.0 F 13-Mar-2007 14-Mar-2007 1 18-May-2007 25-May-2007 NY 29-May-2007

MedDRA PT Abdominal pain upper
Symptom Text: Patient stated she had stomach pain x 3 weeks after 1st Gardasil Imm.
Other Meds:
Lab Data:
History: Mild asthma, sinus allergies (Environmental)
Prex Illness:
Prex Vax Illns:

Vaers Id: 279017-1

16.0 F 16-May-2007 16-May-2007 0 18-May-2007 23-May-2007 WA 23-May-2007
TDAP GLAXOSMITHKLINE AC52B015BA 0 Right arm Intramuscular
BIOLOGICALS
MNQ SANOFI PASTEUR U2223AA 0 Gluteous maxima Intramuscular
HEPA MERCK & CO. INC. 0246U 0 Left arm Intramuscular
MedDRA PT Grand mal convulsion, Loss of consciousness
Symptom Text: A few seconds after the vaccines were administered the pt. passed out and then had tonic clonic seizure lasting approx. 1 minute.
Other Meds:
Lab Data:
History:
Prex Illness: pt. complained of dizziness for last 5 days
Prex Vax Illns:

Vaers Id: 279035-1

21.0 F Unknown Unknown 17-May-2007 12-Jun-2007 VA WAES0702USA03571 13-Jun-2007

MedDRA PT Dehydration, Dizziness, Incorrect dose administered
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female who on an unspecified date was vaccinated with Gardasil (lot # not
reported) 0.7 ml IM injection. The physician reported that when she went to administer the vaccine to the patient, the vaccine delivered 0.7ml as opposed to 0.5
ml. Subsequently the patient experienced dizzy spells; work-up was negative. The physician reported that the dizzy spells were not related to Gardasil but to
dehydration. No further information was available at the time of reporting. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279036-1

25.0 F Unknown 01-Sep-2006 17-May-2007 12-Jun-2007 -- WAES0704USA00305 13-Jun-2007

MedDRA PT Drug administered at inappropriate site, Injection site erythema, Injection site mass, Injection site pain, Injection site scar, Skin discolouration
Symptom Text: Information has been received from a registered nurse concerning her 25 year old daughter who in September 2006, was vaccinated with her first dose of
Gardasil, intramuscular injection in "gluteal region". There was no concomitant medication. In November 2006, the patient received her second dose of
Gardasil, intramuscular injection in deltoid. On 08-MAR-2007, the patient received her third dose of Gardasil, intramuscular injection in deltoid. On 09-MAR-
2007, the patient experienced tenderness at injection site, erythema at injection site, a raised lump size of quarter at injection site and scar at injection site
which was described as the skin being discolored and having a different texture with underlying hardness. As of 02-APR-2007, the patient had not recovered.
The product quality complaint unit was not involved. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279037-1

23.0 F 02-Apr-2007 02-Apr-2007 0 17-May-2007 12-Jun-2007 IN WAES0704USA00315 13-Jun-2007

MedDRA PT Dyspnoea, Nausea
Symptom Text: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history who on approximately 02-FEB-2007
was vaccinated with a first dose of Gardasil. On 02-APR-2007, the patient was vaccinated, intramuscularly, with a second dose of Gardasil. Concomitant
therapy included hormonal contraceptives (unspecified). On 02-APR-2007, within a few hours of the vaccination, the patient experienced shortness of breath
and nausea. She called the physician's office and the physician prescribed Benadryl. There were no laboratory or diagnostic tests performed. The patient's
outcome was unknown. Additional information has been requested.
Other Meds: hormonal contraceptives
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279038-1

22.0 F Unknown Unknown 17-May-2007 12-Jun-2007 -- WAES0704USA00327 13-Jun-2007

MedDRA PT Papilloma viral infection
Symptom Text: Information has been received from a company representative, reporting in a literature article (article name and author not specified) concerning a 22 year old
female who was vaccinated with a dose or doses of Gardasil (date unspecified). According to the article, the woman "became infected with the 4 strains of
HPV, "although she was "involved in the studies" for Gardasil and had shown a "strong conversion" during the studies. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279039-1

22.0 F 14-Mar-2007 17-Mar-2007 3 17-May-2007 12-Jun-2007 NE WAES0704USA00334 13-Jun-2007

MedDRA PT Pain, Pain in extremity, Sleep disorder
Symptom Text: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on 14-MAR-2007 was vaccinated
with the first dose, 0.5ml, IM, of Gardasil. On 17-MAR-2007 the patient experienced "pain in lower right leg (down from the knee), aching" and reported a
problem with sleeping. At the time of this report, the leg pain, aching and problem with sleeping had not resolved. The patient sought unspecified medical
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279040-1

19.0 F 01-Dec-2006 10-Mar-2007 99 17-May-2007 12-Jun-2007 -- WAES0704USA00354 13-Jun-2007

MedDRA PT Human papilloma virus test positive, Smear cervix abnormal
Symptom Text: Information has been received from a physician concerning a 19 year old female patient with a negative pap smear on March 2006. In October 2006, the
patient was vaccinated with the first dose 0.5 mL, of Gardasil, on December 2006 with the second dose 0.5 mL of Gardasil. On 10-MAR-2007 the patient
presented with positive HPV with atypical squamous cells of undetermined significance (ASCUS) pap smear after receiving second vaccination. The patient did
not have the third vaccination as of this report date and the outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Pap test 03/??/06 - negative Pap test 03/??/07 - positive for HPV with atypical squamous
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279041-1

12.0 F 24-Mar-2007 26-Mar-2007 2 17-May-2007 12-Jun-2007 CA WAES0704USA00365 13-Jun-2007

MedDRA PT Genital rash, Vulvovaginal pruritus
Symptom Text: Information has been received from a physician concerning a 12 year old female patient who on 24-MAR-2007 was vaccinated with a second dose of Gardasil.
On 26-MAR-2007 the patient developed a rash around the genital area and vaginal itch. It was unknown whether the physician plan to administer the third
dose. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279042-1

15.0 F 20-Feb-2007 20-Feb-2007 0 17-May-2007 13-Jun-2007 MD WAES0704USA00395 05-Jul-2007

MedDRA PT Arthritis, Dizziness, Nausea, Vomiting
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 15 year old female patient who on 20-FEB-2007 was vaccinated with her first 0.5
mL dose of Gardasil in the left arm. On 26-FEB-2007, the patient called the office complaining of nausea, vomiting, dizziness and arthritic like symptoms.
Laboratory evaluation revealde normal CBC, ANA, and RA. She was seen in the office on 28-MAR-2007 and was limping. Follow-up on 27-APR-2007 indicated
that the patient was doing better, but still had hip discomfort. It was noted that the injection was not administered in the hip. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279043-1

18.0 F 01-Apr-2007 01-Apr-2007 0 17-May-2007 13-Jun-2007 MN WAES0704USA00397 13-Jun-2007

MedDRA PT Urticaria
Symptom Text: Information has been received from a consumer concerning her daughter, an 18 year old female, who on 01-APR-2007 was vaccinated with a dose, 0.5ml, of
Gardasil. There was no concomitant medication. The consumer reported that on 01-APR-2007 after receiving the vaccination, her daughter "broke out in
hives." At the time of this report, the consumer's daughter had not recovered from the hives. The patient sought unspecified medical attention. Additional
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279044-1

15.0 F 01-Jan-2007 01-Jan-2007 0 17-May-2007 13-Jun-2007 -- WAES0704USA00418 13-Jun-2007

MedDRA PT Cellulitis, Eschar, Injection site abscess, Injection site erythema, Localised infection, Pharyngolaryngeal pain
Symptom Text: Information has been received from a physician concerning a 15 year old female who in January 2007, was vaccinated with the first dose of Gardasil.
Concomitant medication was not reported. In January 2007 within days of the vaccination, the patient developed redish patches on her distal arm near injection
site after her first vaccination with Gardasil. Near the injection site was a small abscess with tiny eschar over it. The event was inferior and anterior to the
injection site. The physician stated that it could be an infected follicle or low grade cellulitis. The patient also had a sore throat. The patient sought unspecified
medical attention and was treated with Keflex. The patient's redish patches on distal arm near injection site, small abscess with tiny eschar over it and sore
throat persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279045-1

Unknown F Unknown Unknown 17-May-2007 13-Jun-2007 -- WAES0704USA00422 13-Jun-2007

MedDRA PT Hot flush
Symptom Text: Information has been received from a nurse practitioner concerning a teenage female (age not reported) who on unspecified dates was vaccinated with the first
and second doses of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified dates, the patient developed hot flashes after her
first and second doses of Gardasil. The onset of the hot flashes began within 24 hours post vaccination and the hot flashes lasted for a couple of days. The
patient sought unspecified medical attention. The outcome and action taken with regards to therapy with Gardasil was not reported. Additional information has
been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279046-1


MedDRA PT Chills, Dizziness, Pain
Symptom Text: Information has been received from a certified medical assistant concerning a 25 year old female with no pertinent medical history and with penicillin allergy
who on 28-MAR-2007, was vaccinated with first dose of Gardasil (Lot#655618/0186U). There was no concomitant medication. On 30-MAR-2007, the patient
developed widespread body aches, chills and dizziness two days after receiving the vaccine. On 31-MAR-2007, within 24 hours, the patient recovered from
widespread body aches, chills and dizziness without treatment. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: none
Lab Data: none
Prex Illness:
Prex Vax Illns:

Vaers Id: 279047-1

24.0 F 14-Mar-2007 16-Mar-2007 2 17-May-2007 13-Jun-2007 OH WAES0704USA00522 13-Jun-2007

MedDRA PT Blood glucose increased
Symptom Text: Initial and follow-up information has been received from a registered nurse concerning a 24 year old, female, receptionist, whose reported weight was 130
pounds and whose reported height was 62.5 inches with juvenile onset diabetes, insulin dependent diabetic with penicillin allergy and atropine allergy, who at
10:00 a.m. on 14-MAR-2007 was vaccinated into the right deltoid muscle with the first dose of Gardasil, (lot # 656049/0187U). Concomitant therapy included
insulin human (Humulin), Synthroid, Lipitor, and calcium (unspecified), "zelnoim", vitamins (unspecified), "yazmin". It was reported that the patient had 4-5 days
of increased blood sugars in the range of 500-600. This began 1 1/2 days, approximately on 16-MAR-2007, after receiving Gardasil. The patient's blood sugars.
"The patient did constant, intermittent blood sugars using a bolus of insulin to counteract". It was reported that it took several days to stablize the patient's blood
sugars. Additional information has been requested.
Other Meds: (therapy unspecified), LIPITOR, calcium (unspecified), HUMULIN, SYNTHROID, vitamins (unspecified)
Lab Data: Unknown
History:
Prex Illness: Diabetes cellulitis juvenile onset; Penicillin allergy; Diabetes mellitus insulin-dependent; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 279048-1

HEPA UNKNOWN MANUFACTURER NULL Unknown Intramuscular
MedDRA PT Arthralgia, Musculoskeletal stiffness
Symptom Text: Information has been received from a health professional concerning a 12 year old white female patient who on 24-JAN-2007 was vaccinated IM with a first
dose 0.5 mL of Gardasil lot #655619/1427F. Concomitant therapy included hepatitis A virus vaccine (unspecified) also administered IM on 24-JAN-2007. In
approximately 27-JAN-2007, the patient developed joint pain and stiffness after receiving the vaccination. Subsequently, the patient recovered from joint pain
and stiffness after few weeks. Additional information has been requested.
Other Meds:
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279049-1


MedDRA PT Adverse event
Symptom Text: Information has been received from a company representative, reporting on a literature article (article name and author not specified) concerning female
patients who were vaccinated with a dose of doses of Gardasil. According to the article, there have been "injuries" when the vaccine is given concomitantly with
"vaccines other than Recombivax HB. The article indicated that "1/3 of the "adverse events" occurred in girls who were 16 years old or younger who were given
Gardasil concomitantly" with other vaccines. According to the representative, the article also stated that Gardasil can "enhance cancer when given to a woman
who is already infected with one of the strains of the virus included in the vaccine," although in this instance, the representative did not indicate a specific
patient was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279050-1

Unknown U Unknown Unknown 17-May-2007 13-Jun-2007 -- WAES0704USA00572 13-Jun-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a company representative, reporting on a literature article (article name and author not specified) concerning patients who
were vaccinated with a dose or doses of Gardasil (date unspecified). According to the article, there were 4 cases of fainting after receiving Gardasil. Additional
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279051-1


MedDRA PT Petechiae
Symptom Text: Information has been received from a health professional concerning a female consumer who in March 2007, was vaccinated with Gardasil. In March 2007, the
patient experienced petechiae rash all over her body within 24 hours after receiving the first dose of Gardasil. No medical attention was required. This is one of
two reports received from the same source. Additional information has been requested.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279052-1


MedDRA PT Abdominal discomfort, Dizziness, Dizziness, Hypotension, Nausea
Symptom Text: Information has been received from a nurse concerning a 20 year old female student with sulfonamide allergy, house dust allergy and mycotic allergy and a
history of mitral value prolapse, mitral value regurgitation, "other episodes" of syncope, cardiac disorder and migraines who on 29-MAR-2007 was vaccinated
with Gardasil IM in the left deltoid. Concomitant therapy included Ortho-Tri-Cyclen. On 29-MAR-2007, immediately following vaccination, the patient felt faint
and nauseous. The patient's blood pressure was 117/86. The patient was treated with smelling salts, cool compress, food and cranberry juice. The patient went
home after feeling better. On 30-Mar-2007 the patient visited the physician in the student health center at school where the patient complained of
nauseousness and dizziness. The physician's diagnosis was hypotension and GI upset. On 03-Apr-2007 the nurse contacted the patient who was fully
recovered from the events. The patient will continue the series of vaccinations. Additional information has been requested.
Other Meds: ORTHO TRI-CYCLEN
Lab Data: blood pressure 03/30/07 117/8
History: Mitral value prolapse; Mitral regurgitation; Cardiac disorder; Syncope; Migraine
Prex Illness: Sulfonamide allergy; House dust allergy; Mycotic allergy
Prex Vax Illns:

Vaers Id: 279053-1

Unknown F Unknown Unknown 17-May-2007 13-Jun-2007 TX WAES0704USA00600 13-Jun-2007

MedDRA PT Fatigue
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient became
extremely tired. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not
recovered. Additional information has been requested.
Other Meds: Unk
Lab Data: none
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279054-1

Unknown F 02-Apr-2007 02-Apr-2007 0 17-May-2007 13-Jun-2007 -- WAES0704USA00601 13-Jun-2007

MedDRA PT Injection site pain
Symptom Text: Information has been received from a nurse practitioner concerning a female who on 02-APR-2007 was vaccinated with a first dose of Gardasil. On 02-APR-
2007 the patient experienced soreness at the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was
unknown. Additional information has been requested.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279055-1

Unknown F Unknown Unknown 17-May-2007 13-Jun-2007 IA WAES0704USA00605 13-Jun-2007

MedDRA PT Burning sensation, Headache, Injection site irritation
Symptom Text: Information has been received from a receptionist in a physician's office concerning her daughter who was "not too long ago" vaccinated with a first dose of
Gardasil. The patient stated to her mother that the injection site burned like fire. The patient also developed a headache after leaving the office. The patient's
physician was not contacted by the reporter or the patient regarding the patient's experience. It was reported that the patient's injection site irritation and
headache did improve. Additional information has been requested.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279056-1


MedDRA PT Cold compress therapy, Dizziness
Symptom Text: Information has been received from a registered nurse concerning a multiple female patients who on unspecified dates (since October 2006) were vaccinated
with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on unspecified dates, the patient felt faint after receiving Gardasil, 0.5
ml, IM. The patient's were treated with smelling salts, cool compress, food and cranberry juice. The nurse reported that the patient's usually had not eaten prior
to the vaccination. The outcome and causality of the event was not reported. Additional information has been requested.
Other Meds: Unk
Lab Data:
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279057-1

MedDRA PT Swelling
Symptom Text: Information has been received from a physician concerning a 15 year old female who on approximately 20-MAR-2007, "a couple weeks ago", was vaccinated
with a first dose of Gardasil. Subsequently the patient developed swelling. The patient sought unspecified medical attention. At the time of this report, the
patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds:
Lab Data: none
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279058-1

Unknown F 20-Feb-2007 20-Feb-2007 0 17-May-2007 13-Jun-2007 FL WAES0704USA00671 13-Jun-2007

MedDRA PT Injection site erythema, Injection site pruritus
Symptom Text: Information has been received from a nurse practitioner concerning a female (age not reported) who on approximately 20-FEB-2007 (approximately 6 weeks
ago) was vaccinated with the first dose of Gardasil, injection. Concomitant medication was not reported. On 20-FEB-2007 (approximately 6 weeks ago), the
patient developed erythema in the arm in which she was vaccinated as well as a pruritic rash. The symptoms developed the same day she was vaccinated. The
patient sought unspecified medical attention. Subsequently, the patient recovered from erythema arm and pruritic rash approximately 36 hours later. Additional
Other Meds: Unk
Lab Data:
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279059-1

15.0 F 01-Feb-2007 02-Feb-2007 1 17-May-2007 13-Jun-2007 -- WAES0704USA00739 13-Jun-2007

MedDRA PT Rash generalised
Symptom Text: Information has been received from a nurse practitioner, via a company representative, concerning a 15 year old female patient, who on 01-FEB-2007 was
vaccinated with the first dose of Gardasil (Lot # 655503/0012U). There was no concomitant medication. On 02-FEB-2007, within 24 hours after the vaccination,
the patient developed a rash on the arm and trunk. On approximately 04-FEB-2007 ("48 hours later") the patient's rash spread to the legs. The nurse
practitioner stated that the rash "lasted 2 weeks with no fever or itching," and confirmed that the patient had recovered from the rash. The patient sought
Other Meds: none
Lab Data: none
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279060-1

18.0 F 26-Mar-2007 30-Mar-2007 4 17-May-2007 13-Jun-2007 MT WAES0704USA00745 13-Jun-2007

MedDRA PT Injection site reaction, Lymphadenopathy
Symptom Text: Initial and follow-up information has been received from a physician concerning an 18 year old female patient who on approximately 26-MAR-2007 was
vaccinated in her left upper arm with a first dose of Gardasil. About 4 days after the vaccination she developed 4 swollen lymph nodes in the injection site area,
but the physician said the injection site did not drain to these lymph nodes. The physician recommended no treatment and was following up with the patient in 2
weeks. A blood count was done which was normal. At the time of this report, the outcome of the patient was unknown. Additional information has been
requested.
Other Meds: Unk
Lab Data: complete blood cell normal
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279061-1


MedDRA PT Injection site induration, Injection site swelling, Metrorrhagia
Symptom Text: Information has been received from a nurse concerning a 22 year old female patient who in April 2007, was vaccinated with a first dose of Gardasil. The patient
developed a knot and swelling at the injection site, after the vaccination. The next day the patient developed spotty vaginal bleeding. Unspecified medical
attention was sought. The patient's outcome was unknown. Follow-up from the patient's physician stated that the patient did not feel that the vaginal bleeding
was related to vaccination with Gardasil. No further details are available.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279062-1

MEN UNKNOWN MANUFACTURER NULL Unknown Unknown
MedDRA PT Anorexia, Chills, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Movement disorder, Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a Physician Assistant (P.A.) concerning a 20 year old female with a history of depression who on 23-JAN-2007 was
vaccinated with a first dose of Gardasil. Concomitant therapy included possible meningococcal vaccine, and hormonal contraceptives (unspecified). On 23-
JAN-2007 immediately post vaccination the patient "blacked out and then threw up." The patient arrived home and she felt like she "passed out or fell right to
sleep", when awoke she developed chills, low grade fever, sweating, nausea, no appetite, and felt like she "could not move." This happened two or three times
all night between sleeping, and waking cycles with symptoms. However, at 4:00AM all symptoms stopped. Unspecified medical attention was sought. On 24-
JAN-2007 patient recovered. Additional information has been requested.
Lab Data: Unk
History: Depression
Prex Illness:
Prex Vax Illns:

Vaers Id: 279063-1


MedDRA PT Rash, Urticaria
Symptom Text: Information has been received from a physician (allergist) concerning a female between 18 to 20 years old who on 11-JAN-2007 was vaccinated with first dose
of Gardasil. Concomitant therapy included dicloxacillin from 04-JAN-2007 to 14-JAN-2007. On 28-JAN-2007, the patient developed a hives rash over her arms
and legs when administered the vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: dicloxacillin
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279064-1

24.0 F 26-Jan-2007 27-Jan-2007 1 17-May-2007 13-Jun-2007 PA WAES0704USA00843 13-Jun-2007

Symptom Text: Initial and follow up information has been received from a physician and a nurse concerning a 24 year old female patient, who on 26-JAN-2007 (reported by
the nurse as 25-JAN-2007) was vaccinated with the first dose, 0.5ml, of Gardasil, and on approximately 26-MAR-2007 ("two months later") with the second
dose of Gardasil. There was no concomitant medication. On 27-JAN-2007 the patient developed diarrhea, nausea and vomiting. The patient recovered from the
events (date unspecified); following the second vaccination, the physician reported that there were "no ill effects." The patient sought unspecified medical
attention. No further information is expected.
Other Meds: none
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279065-1

17.0 F 21-Mar-2007 04-Apr-2007 14 17-May-2007 13-Jun-2007 AZ WAES0704USA00863 13-Jun-2007

MedDRA PT Anogenital warts
Symptom Text: Information has been received from a physician's assistant concerning a 17 year old female who on 21-MAR-2007 was vaccinated with the first dose of
Gardasil. On 04-APR-2007 the patient was diagnosed with genital warts. unspecified medical attention was sought. At the time of this report, the patient's
genital warts persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279066-1


MedDRA PT Immediate post-injection reaction, Injection site pain, Nausea, Pyrexia
Symptom Text: Information has been received from a nurse concerning her 15 year old daughter who on 17-MAR-2007 was vaccinated with a dose of Gardasil, IM.
Concomitant medication was not reported. On 17-MAR-2007, the patient experienced pain at the injection site immediately after vaccination with Gardasil. The
pain resolved by the end of the day. On 20-MAR-2007 (three days later), the pain came back and it was associated with nausea and fever. The patient sought
unspecified medical attention. It was also mentioned that no other vaccinations were administered that day. The symptoms resolved after an unspecified time.
Other Meds: Unk
Lab Data:
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279067-1

18.0 F 01-Apr-2007 01-Apr-2007 0 17-May-2007 13-Jun-2007 OH WAES0704USA00906 14-Jun-2007

Symptom Text: Information has been received from a health professional (Nurse) concerning an 18 year old female patient who in approximately April 2007, was vaccinated
with a first dose 0.5 mL of Gardasil. The patient experienced pain in the injection site right after receiving the injection. Unspecified medical attention was
sought. Subsequently, the patient recovered. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279068-1

26.0 F 30-Mar-2007 30-Mar-2007 0 17-May-2007 13-Jun-2007 PA WAES0704USA00908 13-Jun-2007

MedDRA PT Influenza like illness, Pain in extremity, Pyrexia
Symptom Text: Information has been received from a physician concerning a 26 year old female with no medical history or known drug allergies who on approximately 30-
MAR-2007 ("last week") was vaccinated with a 0.5 mL first dose of Gardasil. There was no concomitant medications. On same day after she received the
vaccination, the patient experienced arm pain. The next day, the patient started to experience flu like symptoms and developed a fever of 103 degrees. That
same day, the patient had started to take MERIDIA. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. No
product quality complaint was involved. The reporter did not believe that the flu like symptoms and fever of 103 degrees were related to therapy with Gardasil.
Additional information is not expected.
Other Meds: None
Lab Data: body temp 03/31?/07 103 degrees
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279069-1

12.0 F 08-Mar-2007 08-Mar-2007 0 17-May-2007 13-Jun-2007 MN WAES0704USA00928 14-Jun-2007

MedDRA PT Condition aggravated, Hyperhidrosis, Pyrexia, Rash, Tremor
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 12 year old female patient who on 08-MAR-2007 was vaccinated with a second
dose of Gardasil. Patient had a rash before getting the vaccination. On 08-MAR-2007 the patient's rash (on her chest and neck) became worse and she was
shaking, had fever and sweating. Unspecified medical attention was sought. The patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: rash
Prex Vax Illns:

Vaers Id: 279070-1


MedDRA PT Headache, Nausea, Pain
Symptom Text: Information has been received from a certified medical assistant (CMA), via a company representative, concerning a 14 year old female patient, who on 29-
MAR-2007 was vaccinated with the first dose of Gardasil (Lot # 656372/0243U). The CMA reported that on 29-MAR-2007 the patient "experienced headache,
nausea and general achy symptoms." At the time of this report, the patient had recovered from the events. The patient sought unspecified medical attention.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279081-1

TDAP GLAXOSMITHKLINE AC52B013AA 0 Right arm Intramuscular
BIOLOGICALS
HEPA GLAXOSMITHKLINE AHAVB148AA 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Pruritus generalised, Rash
Symptom Text: On 5/16/07 received Tdap, #1Hep A, #1HPV and MCV4. On 5/17/07 she felt itchy all over especially her neck area. On 5/18/07 she woke up with a
itchy/painful rash from the neck down. Father denies any problems with previous immunizations. Denies ingesting or having contact with anything new. Father
has appled Flucocinolone Acetonide 0.025% cream to the rash area a couple of times since it developed. Recommended MD and advised to stop using the
Flucocinolone Acetonide 0.025% cream (it had not been prescribed). Father states that he is taking his son to their family doctor.
Other Meds: None
Lab Data: None at this time
History: None
Prex Illness: None Known
Prex Vax Illns:


14.0 F 28-Mar-2007 30-Apr-2007 33 21-May-2007 25-May-2007 FL 06-Jun-2007
BIOLOGICALS
MedDRA PT Areflexia, Facial palsy, Facial palsy, Guillain-Barre syndrome, Hypoaesthesia, Pain, Paraesthesia, Paraesthesia, Paraesthesia
Symptom Text: Patient presented 5/10/07 with a ten history of tingling in the right hand. On 5/14/07, she presented with right foot pain and numbness as well. She was
referred to the Neurologist where she had an appointment 5/15/07. Patient was admitted, after ER evaluation, on 5/16/07. Patient was treated with IVIG in the
hospital and multiple tests were ordered. Patient's working diagnosis is Landry-Guillain-Barre Miller-Fisher variant. 06/05/07-records received from facility for
DOS 05/16-05/21/07-DC DX: Guillain Barre variant. Left Bell's Palsy. Paresthesias. C/O numbness in dorsum of right hand progressing up her forearm also left
foot numbness progressing up her leg and a left facial droop. Numbness started in right hand approximately 1 month after received HPV, Hep A and Menactra
vaccine. HX of living in woods and a family pet with ticks. PE: Crainal nerves II through XII intact with exception of mild left facial droop. Paresthesias of bilateral
lower extremity and hands and arms in glove and stocking formation. Strength and motor intact. Treated with IVIG. Symptoms without progression and slight
improvement daily. Lost reflex in lower extremities but at time of discharge 2+ of right but have not returned on left
Other Meds:
Lab Data: CT Scan, MRI of head and Spine, Nerve Conduction Studies, multilpel lab studies records received 6/5/07-CXR normal. CT of brain and MRI of brain normal.
MRI c-spine, t-spine and l-spine normal. EEG normal. CSF cultures negative. Hep A,B, a
History: Persistent left sided chest pain of unclear origin since Jan 19, 2007. Has speckled positive ANA 1:160 since Jan 22, 2007. Cleared by cardiology and was to be
seen by rheumatology.
Prex Illness: Recurring chest pain. Evaluated by dermatology for multiple nevi.
Prex Vax Illns:


14.0 F 28-Mar-2007 28-Apr-2007 31 21-May-2007 29-May-2007 FL 07-Aug-2007
HPV UNKNOWN MANUFACTURER NULL Unknown Unknown
MedDRA PT CSF white blood cell count, Facial palsy, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia
Symptom Text: Guillain Barre Syndrome, with numbness of hands and feet, and (L) Bells Palsy; no motor weakness otherwise, but Loss of LE DTR's (0) and UE 2+. Onset
4/28/07, seen in ER and admitted 5/16/07, received IVIG x 3 days, DC 5/21/07.
Other Meds: None
Lab Data: CSF - WNL, 1 WBC, Protein 37, MRI of brain & Spine WNL, other labs WNL
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279084-1

21.0 F 11-Jan-2007 21-May-2007 130 21-May-2007 23-May-2007 PA 24-May-2007

Symptom Text: vulvar condyloma 3months after second vaccine given--treating with aldara cream
Other Meds: lutera OCP
Lab Data: Normal Pap with negative HPV 12/22/06 with no visable lesions at that time
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 279093-1 (S)

21.0 F 28-Apr-2007 02-May-2007 4 21-May-2007 22-May-2007 NY WAES0705USA02556 22-May-2007
HPV4 MERCK & CO. INC. NULL 0 Left arm Intramuscular

MedDRA PT Dizziness, Haematochezia, Headache, Vision blurred, Vomiting
Symptom Text: Information has been received from a physician concerning a 21 year old female patient with 2.4 centimeter haemorrhagic ovarian cyst, possible irritable bowel
syndrome, gastrointestinal symptoms and anxiety. On 28-APR-2007 she was vaccinated IM In the left arm deltoid with a first dose of Gardasil. 3 days post
vaccination on 02-MAY-2007 the patient experienced headache, dizziness, blurred vision and "vomiting all the time." On 06-MAY-2007 the patient went to
emergency room (ER) and was seen but not hospitalized. On 06-MAY-2007 patient was hospitalized with unknown diagnosis. All types of test were performed;
head computed axial tomography (CT scan of the brain), complete blood cell count (CBC), magnetic resonance imaging (MRI) with normal results. Stool culture
test was taken and there was a trace amount of blood. She was treated with intravenous (IV) fluids. On 09-MAY-2007 she was released from the hospital. She
was still dizzy. The outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: head computed axial 05/06/07 - normal, magnetic resonance 05/06/07 - normal, complete blood cell 05/06/07 - normal, stool culture 05/06/07 - trace amount of
blood
History: Haemorrhagic ovarian cyst; Irritable bowel syndrome; Distress gastrointestinal; Anxiety
Prex Illness:
Prex Vax Illns:

Vaers Id: 279094-1 (S)

17.0 F 25-Apr-2007 28-Apr-2007 3 21-May-2007 22-May-2007 FR WAES0705USA02669 22-May-2007

MedDRA PT C-reactive protein increased, Flank pain, Renal failure acute, Ultrasound kidney abnormal
Symptom Text: Information has been received from a physician concerning a 17 year old female patient who on 25-APR-2007 was vaccinated IM in to left upper arm with a first
dose of Gardasil. On approximately 28-APR-2007 (3-4 days) post vaccination the patient experienced pain flank. On 04-MAY-2007 she was admitted to the
hospital and was diagnosed with Acute renal failure. Her creatinine was 2.0 mg/dL, serum C-reactive protein test (CRP) was slightly increased. Sonographic
analysis showed big swollen kidneys. She was treated by Intravenous (IV) fluids therapy. No specified medication was given. The patient improved step by step
since 07-MAY-2007. Additional information is not expected.
Other Meds: Unknown
Lab Data: serum ANA 04May07 Normal; serum C-reactive protein slightly elevated 04May07; serum creatinine 04May07 2.0 mg/dL; serum creatinine 05May07 2.5
mg/dL; serum creatinine 06May07 2.8 mg/dL; serum creatinine 10May07 1.4 mg/dL
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279095-1

Unknown F 01-May-2007 01-May-2007 0 21-May-2007 22-May-2007 -- WAES0705USA03111 22-May-2007

Symptom Text: Information has been received from a health professional concerning a female who on approximately 01-MAY-2007 was vaccinated. The nurse reported that
the patient experienced a seizure after receiving the first dose of Gardasil. No additional information was reported. Upon internal review, the patient's seizure
was considered an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


16.0 F 01-May-2007 01-May-2007 0 21-May-2007 22-May-2007 -- WAES0705USA03117 27-Jun-2007
MedDRA PT Acute respiratory distress syndrome, Cardiomyopathy, Chest pain, Diastolic dysfunction, Disseminated intravascular coagulation, Dyspnoea, Headache,
Intensive care, Intubation, Pneumonia, Productive cough, Pyrexia
Symptom Text: Information has been received from a physician concerning a 17 year old female who in approximately May 2007 was vaccinated with Gardasil. The physician
reported that the patient was rushed to the hospital the day following vaccination with Gardasil. The patient was admitted to the intensive care unit and was still
there as of 16-MAY-2007. The patient was diagnosed with cardiomyopathy and pneumonia, which required ICU management and intubation. The physician
considered the cardiomyopathy and pneumonia to be life-threatening and other important medical events. Additional information has been requested. 6/27/07-
records received from facility for DOS 5/9-5/17/07-DC DX: Acute respiratory syndrome. Disseminated intravascular coagulation. Diastolic dysfunction. Seen in
PCP office for shortness of breath and chest pain. Three days prior to admission began to experience tactile fevers and headaches. Became short of breath
day she received Gardasil vaccine. Including midsternal chest pain and productive cough. Complaints on admission vomiting and palpitations. Temp 99.9. HR
117. Respirations 60.
Other Meds: Unknown
Lab Data: Unknown Records received 6/27/07-Abnormal pap smear. Echo Doppler. No evidence of inter-atrial septal shunt. Mild regurgitation of pulmonic valve. Global
hypokinesis of left ventrilce worse along the anterior septal walls. MV inflow patter
History: Unknown Records received 6/27/07-PMX: Bronchitis.
Prex Illness:
Prex Vax Illns:


17.0 F 08-May-2007 09-May-2007 1 08-Jun-2007 12-Jun-2007 DC 200701 12-Jun-2007

MedDRA PT Acute respiratory distress syndrome, Cardiomyopathy, Disseminated intravascular coagulation, Intensive care, Pneumonia
Symptom Text: (1) ARDS (2) DIC (3) cardiomyopathy (4) Pneumonia Requiring ICU management
Other Meds:
Lab Data: Multiple CABG including ECHO, X-rays chemistry, PT/PTT INR
History: none
Prex Illness: none
Prex Vax Illns:


20.0 F 07-Dec-2006 Unknown 21-May-2007 29-May-2007 AZ 20-Jun-2007
MedDRA PT Chest pain, Constipation, Dizziness, Headache, Insomnia, Orthostatic hypotension, Palpitations, Postural orthostatic tachycardia syndrome, Syncope,
Tachycardia paroxysmal, Vision blurred
Symptom Text: Dizziness, syncope, headaches, blurred vision, constipation, insomnia, racing heart, chest pain 12/06 to present. Treatment: Florinef, Midrodone, Mestinon
6/7/07-records received from facility for DOS 5/10-5/15/07-Impression:orthostatic intolerance. EEG, somewhat disorganized occipital dominant rhythm. CT
head unremarkable. CBC WNL. Echocardiogram normal. Tilt table test with electrophysiologic study no orthostatic hypotension with head-up tile but a
prominent tachycardia. Apparent stimulation of A-V nodal pathway showed no evidence of an A-V nodal re-entrant tachycarida. HX of recurrent syncope. Onset
of occasional chest pain and a fleeting sensation of palpitations. Without any other symptoms until January of this year. C/O being dizzy a lot. PE WNL except
for some palmar hyperhidrosis. 6/20/07-record received fro DOS 1/9-5/29/07. One year history of significant recurrent arrhythmia with heart pounding especially
when laying flat or bending forward. No syncope during exercise. Possible mitral valve prolapse. DC DX: from 1/9-1/11/07-Orthostatic paroxysmal tachycardia.
DC DX for DOS 3/15-3/20/07-Postural orthostatic tachycardia syndrome. Recurrent syncope. Orthostatic hypotension.
Other Meds: Yasmin
Lab Data: EEG, EPS negative, EKG positive, ECG negative, tilt table positive, ARS negative records received 6/20/07-Normal 2D echocardiogram.Normal EEG. CT head
normal.
History: records received 6/20/07-One year history of significant recurrent arrhythmia with heart pounding especially when laying flat or bending forward.
Prex Illness: None
Prex Vax Illns:


21.0 F 07-Dec-2006 05-Jan-2007 29 29-May-2007 04-Jun-2007 -- 05-Jun-2007
MedDRA PT Accidental exposure, Chest pain, Dizziness, Fatigue, Head injury, Incorrect dose administered, Loss of consciousness, Medication error, Palpitations,
Periorbital haematoma, Syncope
Symptom Text: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a
month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge.
On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in
the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I
fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007
fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10,
2007 I visited a neurologist at the Mayo clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.
Other Meds:
Lab Data: Jan 5, 2007 had an EKG Jan 11, 2007 had Tilt Table Test and EPS March 5, 2007 had a cat scan and x-ray of left shoulder March 16, 2007 had an EEG May
14, 2007 had an ARS May 15, 2007 had an EEG
History: No allergies, pregnancy or liver/kidney problems. No alcohol or smoking use.
Prex Illness:
Prex Vax Illns:

Vaers Id: 279125-1

12.0 F 14-May-2007 14-May-2007 0 21-May-2007 25-May-2007 RI 25-May-2007

MedDRA PT Malaise, Syncope
Symptom Text: Child received Gardasil - within 3-4 minutes stated "I don't feel good" - within 7-8 minutes after injection, child fainted to the floor. Child woke right away.
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:


HPV4 MERCK & CO. INC. NULL 1 Right arm Intramuscular

MedDRA PT Asthenia, Dizziness, Lymphadenopathy, Pharyngolaryngeal pain
Symptom Text: Weakness, dizziness, sore throat, swollen glands w/in 2d of vaccine.
Other Meds: Tetracycline, Yasmin
Lab Data:
History: denies
Prex Illness: denies
Prex Vax Illns:


23.0 F 08-May-2007 08-May-2007 0 18-Jul-2007 15-Aug-2007 -- WAES0706USA02268 22-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, Pharyngitis
Symptom Text: Information has been received from a 23 year old female who on 09-APR-2007 was vaccinated with a first dose of Gardasil and one month early on 08-MAY-
2007, she was vaccinated with a second dose of Gardasil. After being vaccinated the second time she developed Pharyngitis. Patient stated that she tolerated
the first dose without any event and plans to receive the third dose. The patient did seek unspecified medical attention. At the time of the report, the patient had
recovered shortly after receiving the second dose. No product quality complaint was involved. Additional information is not expected.
Other Meds: Yasmin; tetracycline
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279131-1

24.0 F 25-Apr-2007 01-May-2007 6 21-May-2007 25-May-2007 DE 25-May-2007

MedDRA PT Dizziness, Feeling abnormal, Weight decreased
Symptom Text: fogginess of head, dizziness weight loss

Other Meds: Ortho tricycles
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 279132-1

20.3 F 15-May-2007 15-May-2007 0 21-May-2007 25-May-2007 NJ 25-May-2007

MedDRA PT Dizziness, Syncope
Symptom Text: Pt felt dizzy and faint. She laid down and was given soda.
Other Meds: Vitamins
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


19.0 F 10-May-2007 13-May-2007 3 21-May-2007 30-May-2007 MD 30-May-2007

MedDRA PT Injection site erythema, Injection site rash
Symptom Text: Patient noticed red bumps around injection site on 5/13/07. The patient is not sure how long the bumps had been there. She received the injection on 5/10/07.
Had injection Left deltoid.
Other Meds: Yasmin, Topamax, Lithium
Lab Data:
History: none
Prex Illness: None
Prex Vax Illns:


19.0 F 10-May-2007 13-May-2007 3 18-Jun-2007 17-Jul-2007 MD WAES0705USA03192 17-Jul-2007

MedDRA PT Injection site erythema, Injection site pruritus, Injection site rash
Symptom Text: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 19 year old female patient with depression who on 10-MAY-2007 was
vaccinated IM in left deltoid with a dose of Gardasil lot #657006/0188U. Concomitant therapy included YASMIN AND LITHIUM. On -MAY-2007 patient called
the office and reported that she had injection site rash following vaccination and noticed it on 13-MAY-2007, but could have been present earlier. The rash was
described as red bumps around the injection site that were itchy. The rash had not changed sine noticed on 13-MAY-2007. The patient was instructed to use
BENADRYL. The patient's injection site rash persisted. Additional information has been requested.
Other Meds: YASMIN, lithium sulfate
Lab Data: Unknown
History:
Prex Illness: Depression
Prex Vax Illns:

Vaers Id: 279151-1

VARCEL MERCK & CO. INC. 1512F 1 Right arm Unknown
HEPA MERCK & CO. INC. 03040 1 Right arm Unknown
MedDRA PT Injection site erythema, Injection site swelling
Symptom Text: Redness and swelling right deltoid region after 1 day.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279155-1

20.0 F 08-Mar-2007 09-Mar-2007 1 21-May-2007 30-May-2007 MN 30-May-2007

MedDRA PT Chills, Hyperhidrosis, Pyrexia, Tremor
Symptom Text: 1am - Woke up shaking/ shivering x 1 1/2 hour. 430am - Broke out sweating with fever.
Other Meds: Trinessa
Lab Data: See Pace records
History: Augmentin (rash/hives), Hx of asthma
Prex Illness: Possible light rash. No c/o
Prex Vax Illns:



MedDRA PT Dizziness, Rash
Symptom Text: After patient received injection she began feeling dizzy sat for approximately 10 minutes felt fine and went home. Later developed rash on knees and legs.
Mom gave her Benadryl and resolved.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


17.0 F 10-May-2007 10-May-2007 0 18-Jun-2007 17-Jul-2007 CA WAES0705USA05639 17-Jul-2007

MedDRA PT Rash
Symptom Text: Information has been received from a nurse practitioner, concerning a 17 year old female who on 10-MAY-2007 was vaccinated IM, with the first dose of
Gardasil. Following the vaccination, the patient felt dizzy while still in the physician's office; she sat down for 10 minutes and was fine. Later that day, 10-MAY-
2007, she developed a rash on her legs; treatment with BENADRYL brought relief of the rash. The next morning, however, the rash also reappeared on her
arms, and treatment with diphenhydramine again brought relief. The patient has had recurrence of rash "off and on" at different locations. At the time of this
report, the outcome of the rash was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279159-1


MedDRA PT Rash pruritic
Symptom Text: Noticed within 24 hours of injection itchy rash - joints - armpit - elbows - knees - ankles - stomach.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279160-1

14.0 F 02-Feb-2007 02-Feb-2007 0 17-May-2007 13-Jun-2007 GA WAES0704USA00985 14-Jun-2007

MedDRA PT Drug administered at inappropriate site, Injection site pain
Symptom Text: Information has been received from a physician's assistant and a nurse, concerning the nurse's 14 year old daughter, who on 02-FEB-2007, was vaccinated in
the right hip, with the first dose, 0.5ml, of Gardasil, and on 04-APR-2007 was vaccinated in the back of her right arm, with the second dose, 0.5ml, of Gardasil.
The nurse reported that on 04-APR-2007, the vaccination was administered near her daughter's elbow "in the area of subcutaneous fat," and added that her
daughter experienced "injection site soreness" in her right arm. The nurse reported that the arm soreness resolved on the same day, 04-APR-2007. Additional
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279161-1

21.0 F 02-Apr-2007 05-Apr-2007 3 17-May-2007 13-Jun-2007 FL WAES0704USA01001 13-Jun-2007

MedDRA PT Erythema, Rash generalised
Symptom Text: Information has been received from a physician, via a company representative, concerning a 21 year old female patient, who on 05-FEB-2007 was vaccinated
IM, with the first dose of Gardasil, and on 02-APR-2007 with the second dose of Gardasil (Lot #654535/0136U). Concomitant therapy included an antibiotic
containing sulfa (unspecified). On 05-APR-2007, three days later after the second dose was administered, the patient developed a red rash from her chin to her
toes. The physician indicated he believed "the antibiotic containing sulfa" was "the cause of the rash." At the time of the report, it unknown if the patient had
recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279162-1

16.0 F 27-Mar-2007 27-Mar-2007 0 17-May-2007 13-Jun-2007 PA WAES0704USA01021 14-Jun-2007

MedDRA PT Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site swelling
Symptom Text: Information has been received from a physician via a company representative concerning a 16 year old female who on 27-MAR-2007 was vaccinated with a
first dose of Gardasil (lot # not reported) IM from a single dose vial. On 27-MAR-2007, the patient experienced an injection site reaction almost immediately
where the injection site swelled up bright red, like a balloon. Medical attention was sought. The physician reported that they rubbed it and put ice on the area in
an attempt to control the swelling. The reporter stated that the physician may have given the patient Benadryl to treat the experience, but was not 100% certain.
At the time of reporting, the patient improved and "is fine". Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279163-1

Unknown F 26-Oct-2006 01-Feb-2007 98 17-May-2007 13-Jun-2007 NJ WAES0704USA01034 13-Jun-2007

MedDRA PT Basilar migraine, Paraesthesia, Vertigo, Vertigo
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on 26-OCT-2006 was vaccinated with a first dose of Gardasil. In
February 2007, approximately 3 to 4 months after receiving Gardasil, the patient experienced a spinning sensation along with tingly, paralyzed feeling. The
physician stated that it was possibly basilar artery migraine, and the physician referred the patient to a neurologist. The physician did not plan to continue the
series of injections. At the time of this report, the outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279164-1

12.0 F Unknown 23-Mar-2007 17-May-2007 13-Jun-2007 -- WAES0704USA01049 14-Jun-2007

MedDRA PT Menorrhagia
Symptom Text: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of Gardasil, IM.
Concomitant medication was not reported. On 23-MAR-2007, the patient got her period, it has not ended and it has been 14 days as of today. The patient
sought unspecified medical attention. The outcome and action taken were not reported. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279165-1


Symptom Text: Information has been received from the father of a 22 year old female consumer who on approximately 15-MAR-2007 (about three weeks ago) was vaccinated
with the second dose of Gardasil, injection. Concomitant medication was not reported. On approximately 22-MAR-2007 a week after getting the second dose of
Gardasil, the patient experienced swelling in her lymph nodes and shoulder nodes. The patient sought unspecified medical attention and her cells were
checked for cancer and liver tests were performed. The patient's swelling in lymph nodes and shoulder nodes persisted. Additional information has been
requested.
Other Meds: Unknown
Lab Data: diagnostic laboratory ?/?/07 - checked cells for cancer - results not reported, hepatic function tests ?/?/07 - results not reported
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279166-1

16.0 F 16-Feb-2007 Unknown 17-May-2007 13-Jun-2007 -- WAES0704USA01084 13-Jun-2007

MedDRA PT Drug exposure during pregnancy, Headache, Nausea, Pyrexia
Symptom Text: Information has been received through the Merck pregnancy registry from a health professional concerning her 16 year old daughter who on 16-FEB-2007 was
vaccinated with a dose of Gardasil (lot #655618/0186U). There was no concomitant medication. Subsequently, the patient became pregnant (date of
conception was reported as 14-FEB-2007). The patient had a pregnancy test with positive results on 20-MAR-2007. it was reported that the patient experienced
headache, nausea and may also have had a slight fever. Additional information has been requested.
Other Meds: None
History:
Prex Vax Illns:

Vaers Id: 279167-1 (S)


MedDRA PT Fluid replacement, Nausea, Vomiting
Symptom Text: Information has been received from a pharmacist, concerning a female patient with dyspepsia, who was vaccinated with a dose of Gardasil (date and dose not
specified). The pharmacist reported that several hours after the vaccine was administered, the patient experienced severe nausea and vomiting, and was
hospitalized. Treatment included intravenous fluids and medication (unspecified) to treat the nausea and vomiting. At the time of this report, the pharmacist
stated the patient was recovering. Severe nausea and vomiting was considered to be an other important medical event. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Dyspepsia
Prex Vax Illns:

Vaers Id: 279168-1

23.0 F 19-Jan-2007 19-Jan-2007 0 17-May-2007 13-Jun-2007 NJ WAES0704USA01198 14-Jun-2007

MedDRA PT Inappropriate schedule of drug administration, Injection site erythema, Injection site irritation, Injection site irritation, Injection site pain, Urticaria
Symptom Text: Information has been received from a nurse concerning a 23 year old female patient with an unspecified food allergy who on 19-JAN-2007 was vaccinated IM
with a first dose of Gardasil lot #654702/0011U. Concomitant therapy included Yasmin and Advair. On 19-JAN-2007 the patient experienced some irritation
around the injection site after the first injection. She reported soreness, burning, erythema at injection site. On 05-APR-2007 patient's father (a physician)
administered the second dose of Gardasil lot #656372/0243U to the patient. Within 24 hours of receiving the second injection she developed hives which
covered her entire body. The injection site was red, swollen, and burned. She was prescribed Benadryl. The patient was recovering. Additional information has
been requested.
Other Meds: ADVAIR
Lab Data: Pap test -
History:
Prex Illness: Food allergy
Prex Vax Illns:

Vaers Id: 279169-1

26.0 F 08-Oct-2006 08-Oct-2006 0 17-May-2007 13-Jun-2007 -- WAES0704USA01200 14-Jun-2007

MedDRA PT Insomnia
Symptom Text: Information has been received from a physician concerning a 26 year old female who on 08-OCT-2007 was vaccinated with her first dose of Gardasil (lot #
653736/0689F). Concomitant therapy included Yasmin. The patient received her second dose of Gardasil (lot # 653736/0689F) on 08-DEC-2006 and her third
dose (lot # 653736/0014U) on 03-APR-2007. The patient experienced insomnia after each dose was given. No lab diagnostics were performed. Subsequently
she recovered. No further information is available.
Other Meds: YASMIN
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279170-1


MedDRA PT Dizziness, Drug exposure during pregnancy, Fatigue
Symptom Text: Information has been received foe the Pregnancy Registry from an 18 year old female with penicillin allergy and sulfonamide allergy and a history of
tonsillectomy who in January 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. The same day of vaccination, the
patient felt dizzy and tired. These events only lasted for one day and the patient recovered. Subsequently the patient learned that she is pregnant. The exact
date of conception is not known; however, she believes it was right around the time of vaccination (LMP 10-JAN-2007, EDD 17-OCT-2007). With regard to her
pregnancy, she has not had any adverse symptoms. Therapy was stopped when she learned she was pregnant. Unspecified medical attention was sought.
Other Meds: None
Lab Data: beta-human chorionic 01/??/07 -
History: Tonsillectomy
Prex Illness: Pregnancy NOS (LMP = 1/10/2007), Penicillin allergy; Sulfonamide allergy
Prex Vax Illns:

Vaers Id: 279171-1


MedDRA PT Dizziness, Dizziness, Drug administered at inappropriate site, Stomach discomfort
Symptom Text: Information has been received from a registered nurse concerning a 20 year old female patient with allergies to Sulfa, dust and mold who on 29-MAR-2007 was
vaccinated IM into the left deltoid (previously reported as gluteus) with a first dose of Gardasil (lot # 656372/0243U). The patient became faint after the
injection, but did not lose consciousness. The patient put her head down, used a cool cloth, spirits of ammonia and laid down in the exam table. The patient
was give apple juice. The patient's blood pressure was 117/86 with a pulse of 63. On 30-MAR-2007, the patient returned to the office and stated that she had
felt woosy and experienced a sensitive stomach the 24 hours following the vaccination. The patient recovered from her experience on 30-MAR-2007. No
product quality complaint was involved. Additional information is not expected.
Other Meds: Unknown
Lab Data: blood pressure 03/29/07 117/8 total heartbeat count 03/29/07 63
History:
Prex Illness: Sulfonamide allergy; House dust allergy; Mycotic allergy
Prex Vax Illns:

Vaers Id: 279172-1

20.0 F 29-Mar-2007 03-Apr-2007 5 17-May-2007 13-Jun-2007 MA WAES0704USA01327 13-Jun-2007

MedDRA PT Burning sensation, Hypersensitivity, Hypoaesthesia, Injection site erythema, Pain in extremity
Symptom Text: Information has been received from a registered nurse, concerning a 20 year old female patient with an Bactrim allergy, who on 29-MAR-2007 was vaccinated
IM in the left deltoid, with a dose, 0.5ml, of Gardasil (Lot #654702/0011U). Concomitant therapy included Yasmin. On 03-APR-2007, five days after the vaccine
was administered, the patient was seen in the office as she had developed an "allergic reaction to (Gardasil)," with redness around the injection site. Treatment
included ice and an antihistamine (unspecified). On 05-APR-2007, the nurse stated the patient was seen again, and the redness had not changed, but the
patient then complained of burning in her lower arm, and "numbness past and below her elbow." The nurse reported that Gardasil had been discontinued. At
the time of this report, it was unknown if the patient had recovered. Additional information has been requested.
Other Meds: YASMIN
Lab Data: None
History:
Prex Illness: Sulfonamide allergy
Prex Vax Illns:

Vaers Id: 279173-1

20.0 F 03-Jan-2007 03-Jan-2007 0 17-May-2007 13-Jun-2007 MN WAES0704USA01334 13-Jun-2007
TTOX UNKNOWN MANUFACTURER NULL Unknown Unknown
FLU UNKNOWN MANUFACTURER NULL Unknown Unknown
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning her 20 year old daughter who on 03-JAN-2007 was vaccinated with a first dose 0.5
mL of Gardasil. Concomitant therapy included influenza virus vaccine (unspecified) and tetanus toxoid given in opposite arm where the Gardasil was given. On
03-JAN-2007 the patient experienced pain in the arm (which arm unknown) after receiving the first injection. As of 09-APR-2007 the patient had not received
the second dose of Gardasil. Unspecified medical attention was sought. On 04-JAN-2007 the patient recovered. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279174-1

17.0 F 04-Dec-2006 01-Jan-2007 28 17-May-2007 13-Jun-2007 NJ WAES0704USA01346 13-Jun-2007

MedDRA PT Basilar migraine, Dizziness, Fall, Gait disturbance, Nausea, Syncope vasovagal, Visual disturbance
Symptom Text: Information has been received from a physician concerning a 17 year old female patient with headache who on 09-OCT-2006 was vaccinated with a first dose
0.5 mL of Gardasil and on 04-DEC-2006 with a second dose 0.5 mL of Gardasil. In last week of January 2007, patient was dizzy, felt paralyzed, fell and needed
to hold onto something to walk. This lasted for 5 minutes. This was immediately followed with nausea and a "wavy like vision that looked like a kaleidoscope."
This lasted for 30 minutes, possible vasovagal reaction. On 04-DEC-2004 she also had her ears pierced. She was seen by her internist and then a neurologist.
She had blood tests, magnetic resonance imaging (MRI) and electroencephalography (EEG), all were negative. Patient's diagnosis was basal artery migraine.
She was treated with Periactin. The patient was reported as recovering. Additional information has been requested.
Other Meds: Unknown
Lab Data: electroencephalography - negative magnetic resonance - negative hematology - negative
History:
Prex Illness: Headache
Prex Vax Illns:

Vaers Id: 279175-1

23.0 F 01-Feb-2007 01-Feb-2007 0 17-May-2007 13-Jun-2007 -- WAES0704USA01362 02-Jul-2007

Symptom Text: Information has been received from a nurse practitioner concerning a 23 year old female who in approximately February 207, was vaccinated with the first dose
of Gardasil. The patient complained of a sore arm for several weeks after the injection. The patient recovered from the sore arm. The patient does not want to
return for the second dose. Medical attention was sought.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279176-1

37.0 F 11-Aug-2006 11-Aug-2006 0 17-May-2007 13-Jun-2007 -- WAES0704USA01468 05-Jul-2007

MedDRA PT Arthralgia, Diarrhoea, Dizziness, Inappropriate schedule of drug administration, Influenza like illness, Insomnia, Myalgia, Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a nurse practitioner (NP), concerning a 37 year old female patient with drug hypersensitivity to bacitracin, Neosporin who
on 11-AUG-2006 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #653650/0702F), and on 11-OCT-2006 with the second dose, 0.5ml, IM, of
Gardasil (Lot #654540/0800F). Concomitant therapy included Flonase and ibuprofen. The NP stated when the patient called to schedule her third dose of
Gardasil, she reported that on 12-AUG-2006 following the first vaccination, she experienced dizziness and had "flu-like symptoms," including nausea, vomiting,
diarrhea, arthralgia, myalgia, sleeplessness and fever (specified as "not above 100F"); she recovered on 17-AUG-2006. In addition, on 11-OCT-2006 following
her second vaccination, the patient experienced identical events, and recovered on 16-OCT-2006. The NP stated she was "not sure that the patient should
receive her third dose of the Gardasil." The patient sought unspecified medical attention. No further information is expected.
Other Meds: FLONASE, ibuprofen
Lab Data: Unknown
History:
Prex Illness: Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 279177-1

26.0 F 15-Feb-2007 23-Feb-2007 8 17-May-2007 13-Jun-2007 MA WAES0704USA01471 13-Jun-2007

MedDRA PT Dyspnoea, Injection site rash, Pallor, Palpitations, Urticaria
Symptom Text: Information has been received from a medical assistant, a 26 year old female patient with asthma, who on 15-FEB-2007 was vaccinated IM with a dose, 0.5ml,
of Gardasil. There was no concomitant medication. On 23-FEB-2007 the patient reported that she couldn't breathe, her heart and chest were pounding, and
she looked really pale. She also reported that she developed a rash at the injection site with "rectangular" hives. The MA added that she laid down when the
events occurred, and the symptoms went away "after half an hour." The patient sought unspecified medical attention. Additional information has been
requested.
Other Meds: None
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 279178-1

Unknown F Unknown Unknown 17-May-2007 13-Jun-2007 NJ WAES0704USA01480 13-Jun-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning female patients who were vaccinated with Gardasil. The patients had fainting episodes when
seeing size of the syringe. Some had fainting episodes after receiving the vaccine. Subsequently, the patients recovered. Additional information has been
requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279179-1


MedDRA PT Dizziness, Injection site pain, Syncope
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning an 11 year old female patient who on 26-MAR-2007 was vaccinated with the first
dose of 0.5 mL of Gardasil. The "patients became light headed and fainted after receiving the dose of Gardasil." The nurse reported that the patient had
"experienced 2 weeks of injection site soreness." Unspecified medical attention was sought by the patient. Injection site soreness persisted. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279180-1

23.0 F 03-Apr-2007 03-Apr-2007 0 17-May-2007 13-Jun-2007 PA WAES0704USA01509 14-Jun-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician, via a company representative, concerning a 23 year old female patient with drug hypersensitivity to Wellbutrin
who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #656050/0245U). Concomitant therapy included hormonal contraceptives
(unspecified). On 03-APR-2007, after the vaccine was administered, the patient fainted, the patient confirmed that she had not had breakfast before the
vaccination was given. The physician reported that the patient recovered on the same day. The patient sought unspecified medical attention. Additional
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 279181-1


MedDRA PT Rash
Symptom Text: Information has been received from a healthcare worker concerning a 22 year old female with a penicillin allergy and Benadryl allergy and no pertinent medical
history who on 21-MAR-2007 was vaccinated IM with 0.5 mL Gardasil (lot # 656372/0243U). There was no concomitant medication. On 25-MAR-2007 the
patient developed a rash on her torso. No lab diagnostic studies were performed. The rash was treated with an injection of prednisone, and as of 29-MAR-2007
the patient was fully recovered. Additional information has been requested.
Other Meds: None
Lab Data: None
History:
Prex Illness: Penicillin allergy; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 279182-1

Unknown F 01-Sep-2006 01-Sep-2006 0 17-May-2007 13-Jun-2007 FL WAES0704USA01537 14-Jun-2007

Symptom Text: Information has been received from a physician concerning her daughter, who in September 2006, was vaccinated in the buttocks with the first dose of
Gardasil, in November 2006, with the second dose of Gardasil, and in March 2007 with the third dose of Gardasil, in the arm. The physician reported that in
March 2007, following the third vaccination, her daughter experienced slight pain in her arm at the injection site. At the time of this report, it was unknown if the
patient had recovered from the injection site pain. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279183-1


MedDRA PT Erythema, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Symptom Text: Initial and follow-up information has been received from a Nurse Practitioner (N.P.) concerning a 16 year old female patient with Attention Deficit Hyperactivity
Disorder (ADHD) who on 29-MAR-2007 was vaccinated with a first dose of Gardasil. The patient was upset and crying prior to the first injection, because of fear
of vaccination. The patient said that when the injection was administered it felt as if they were injecting fire into her arm. The injection site immediately
developed an erythematous raised area about 3 inches in diameter. The raised area was red and warm to touch. The patient's mother reported that there was a
red area on the chest wall in addition to the reaction at the injection site. The nurse practitioner did not see the chest wall reaction. The patient was kept in the
office and was given Benadryl 50 mg and ice was applied to the injection site. On 29-MAR-2007 the reaction subsided and the patient recovered. Additional
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Attention deficit/hyperactivity disorder
Prex Vax Illns:

Vaers Id: 279184-1


MedDRA PT Drug exposure during pregnancy, Feeling hot, Nausea, Pyrexia, Vaginal discharge
Symptom Text: Initial and follow up information has been received from Merck pregnancy registry and from a 17 year old female consumer who on 15-MAR-2007 was
vaccinated with a first dose of Gardasil. Patient had an ultrasound and later it was determined she was pregnant. The LMP date was 16-FEB-2007, with an
estimated due date of 23-NOV-2007. On 15-MAR-2007 the patient reported that she experienced a fever, feeling hot in the night time and little nausea. She
also noticed a clear white discharge from the vagina. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was
Other Meds: Unknown
Lab Data: ultrasound
History:
Prex Vax Illns:

Vaers Id: 279185-1


Symptom Text: Information has been received from an RN concerning a female patient who was vaccinated with her first and second dose of Gardasil and subsequently
developed 'a bit of urticaria/rash on the body after getting both the first and second dose." It was reported that medical attention was sought and that "the rash
was not bad enough to discontinue the series yet". The patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279186-1


MedDRA PT Injection site nodule, Injection site pain
Symptom Text: Information has been received from a registered nurse concerning a 26 year old female who on 27-JAN-2007 was vaccinated with Gardasil (lot number
"0284"). Concomitant therapy included Seasonique. On 07-APR-2007 the patient experienced a 1 cm tender nodule at the injection site (deltoid muscle) after
receiving her second dose of Gardasil on 04-APR-2007. The patient's tender nodule persisted. Additional information has been requested.
Other Meds: SEASONIQUE
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279187-1

9.0 F 30-Mar-2007 02-Apr-2007 3 17-May-2007 13-Jun-2007 -- WAES0704USA01626 14-Jun-2007

MedDRA PT Rash generalised, Rash papular, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 9 year old female with asthma who on 30-MAR-2007 was vaccinated with Gardasil (Lot #
65503/0012U). Concomitant therapy included montelukast sodium. On approximately 02-APR-2007, within three to four days of vaccination with Gardasil, the
patient experienced itchy, papular rash on face, extremities and body. The patient sought unspecified medical attention. The patient was treated with Benadryl.
As of 10-APR-2007, the patient was recovering from itchy, papular rash on face, extremities and body. This is one of two reports from the same source.
Other Meds:
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 279188-1


MedDRA PT Rash generalised, Rash papular, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 10 year old female with a history of migraines who on 13-MAR-2007 was vaccinated with
Gardasil. There was no concomitant medication. On approximately 16-MAR-2007, 'within 3 to 4 days", the patient developed an itchy, papular rash on her face,
extremities and body. The patient sought medical attention and was treated with Benadryl. Subsequently, the patient was recovering. The product quality
complaint unit was not involved. Additional information has been requested. The physician also provided information regarding another patient's experience
with Gardasil (WAES#0704USA01626).
Other Meds: None
Lab Data: None
History: Migraine
Prex Illness:
Prex Vax Illns:

Vaers Id: 279189-1

Unknown F 22-Mar-2007 Unknown 17-May-2007 14-Jun-2007 FR WAES0704USA01691 15-Jun-2007

MedDRA PT Injection site pain, Mobility decreased, Pain in extremity
Symptom Text: Information has been received from a physician concerning a female who on 22-MAR-2007 was vaccinated with Gardasil. It was reported that the patient had
injection site pain after receiving the vaccination. On 10-APR-2007, the patient called the physician's office and reported that she was still having pain in the
arm and shoulder which was aggravated when raising the arm. The patient sought unspecified medical attention. At the time of the report, it was unknown if the
patient recovered. This is one of two reports received from the same source. Attempts are being made to obtain identifying information to distinguish the
individual patients mentioned in this report. Additional information will be provided if available. Upon follow-up it was reported by the physician that the patient
received Gardasil, (Lot # "0011V") on 22-MAR-2007. The physician stated that after 4 weeks, the patient's injection site pain was gone. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279190-1

16.0 F 01-Mar-2007 15-Mar-2007 14 17-May-2007 13-Jun-2007 CT WAES0704USA01692 12-Jul-2007

MedDRA PT Arthritis, Inflammation, Uveitis, Uveitis, Vision blurred
Symptom Text: Information has been received from a physician concerning a 16 year old female who in the "beginning of March" on approximately 01-MAR-2007 was
vaccinated with Gardasil. "Approximately one to two weeks after receiving the first dose of Gardasil on approximately 15-MAR-2007 the patient experienced
symptoms of uveitis. The diagnosis was confirmed with the patient's eye doctor. The physician noted that it could be related to arthritis. Additional information
has been requested. 05/25/07-records received. Ocular inflammation, with 3 week history of blurry vision in left eye. Impression. Acute bilateral uveitis seems
most like pars planitis.
Other Meds: Unknown
Lab Data: Unknown. Records received 5/25/07-ACE serum 42. Albumin 4.8. HLA-B27 positive. ANA screen negative. Rheumatoid factor 5. ESR 4.
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279191-1

24.0 F 01-Nov-2006 01-Nov-2006 0 17-May-2007 13-Jun-2007 -- WAES0704USA01772 14-Jun-2007

MedDRA PT Balance disorder, Dizziness, Headache, Nausea, Vomiting
Symptom Text: Information has been received from a health professional concerning a 24 year old female patient with environmental allergy and migraine syndrome who in
November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and allergenic extract. In
November 2006, the patient developed episodes of headache and dizziness after receiving the first injection. The episodes lasted 10 minutes and reoccurred
1-2 times per week for unknown number of weeks. In December 2006, the patient was vaccinated with the second dose of Gardasil and then she experienced
severe dizziness, nausea, vomiting lasting one week. Since the end of December 2006, the patient had experienced episodes of intermittent imbalance with
increasing frequency. The patient had medical evaluation with blood studies, computed axial tomography (CT) scan and magnetic resonance imaging (MRI) of
brain. Results of the testing was unknown. The patient has not recovered. Additional information has been requested.
Other Meds: allergenic extract, hormonal contraceptives
Lab Data: computed axial - Results unknown magnetic resonance - Results unknown
History:
Prex Illness: Environmental allergy; Migraine
Prex Vax Illns:

Vaers Id: 279192-1

19.0 F Unknown Unknown 17-May-2007 13-Jun-2007 TX WAES0704USA02168 14-Jun-2007

MedDRA PT Injection site reaction
Symptom Text: Information has been received from a licensed practical nurse concerning a 19 year old female who on an unspecified date was vaccinated with first dose of
Gardasil (lot # not reported). The patient sought medical attention. On an unspecified date, the patient developed a "smallpox like mark" or skin indentation
right below the injection site. At the time of reporting, the outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279193-1


MedDRA PT Hypoaesthesia
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a female patient who "one to two months ago" was vaccinated IM with a dose of
Gardasil. The patient developed numbness in her arm right after the injection. The patient was sent home. The patient's outcome was unknown. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279194-1

24.0 F 19-Feb-2007 19-Feb-2007 0 17-May-2007 13-Jun-2007 NY WAES0704USA02181 14-Jun-2007

MedDRA PT Headache, Nausea
Symptom Text: Information has been received from a registered nurse concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 19-
FEB-2007 was vaccinated with Gardasil (lot # 655618/0186U). There was no concomitant medication. On 19-FEB-2007, "about 2 hours after vaccination" the
patient experienced a severe headache and nausea. The patient stayed home from work and took Tylenol. The patient subsequently recovered from the severe
headache and nausea on 20-FEB-2007. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279195-1

24.0 F 29-Mar-2007 29-Mar-2007 0 17-May-2007 13-Jun-2007 TX WAES0704USA02205 14-Jun-2007

MedDRA PT Feeling hot
Symptom Text: Information has been received from a certified medical assistant concerning a 24 year old female who on unspecified dates was vaccinated with the first and
second doses of Gardasil. On 29-MAR-2007, the patient was vaccinated with a third dose of Gardasil. On 29-MAR-2007, the patient was feeling fine at first,
within the next five minutes or so, the patient was feeling very hot. The outcome was not reported. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279196-1


MedDRA PT Dizziness, Vaginal haemorrhage
Symptom Text: Information has been received from a physician office manager, via a company representative, concerning the office manager's 23 year old daughter, who was
vaccinated with a dose, 0.5ml, of Gardasil (date unspecified). Subsequently the patient experienced dizziness and menstrual bleeding. At the time of this
report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. No further information is expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279197-1

11.0 F 10-Apr-2007 11-Apr-2007 1 17-May-2007 13-Jun-2007 UT WAES0704USA02236 14-Jun-2007

MedDRA PT Nausea, Pain in extremity, Vomiting
Symptom Text: Information has been received from a physician concerning a 11 year old female who on 10-APR-2007 was vaccinated with Gardasil. Concomitant therapy
included tetanus antitoxin USP. On 11-APR-2007 the patient experienced a sore arm, nausea and vomiting. This is one of two reports received from the same
Other Meds: TETANUS ANTITOXIN USP
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279198-1


MedDRA PT Immediate post-injection reaction, Injection site pain, Pain in extremity
Symptom Text: Information has been received from a health professional concerning a female who on 14-MAR-2007 was vaccinated with the first dose of Gardasil, IM in the
right deltoid (lot# 655503/0012U). Concomitant therapy included Mircette and vitamins (unspecified) (One-A-Day Essential Vitamins). Subsequently,
immediately following the vaccination the patient experienced pain in the injection site arm. The patient recovered from the pain in "a day or two" but it returned
on approximately 18-MAR-2007. This pain was described as a shooting pain in the injection site arm "down to the elbow" that occurred when the arm was
moved. There was no pain on touch. It was reported that the pain was worst at the end of the day and immediately upon arising. The patient was treated with
Advil which was reported to have helped the pain. The patient was examined at her physician's office on 26-MAR-2007 and was prescribed Tylenol with
codeine. Subsequently, the patient called into the office on 09-APR-2007 and reported that the pain in the arm was still present and had worsened. The patient
was referred to her primary care physician for further evaluation. Additional information has been requested.
Other Meds: MIRCETTE ONE A DAY ESSENTIAL VITAMINS
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279199-1

Unknown F Unknown Unknown 17-May-2007 13-Jun-2007 OH WAES0704USA02264 14-Jun-2007

MedDRA PT Immediate post-injection reaction, Injection site pain
Symptom Text: Information has been received from a nurse concerning a "4th grader" female patient who was vaccinated with a first dose of Gardasil. The patient experienced
pain in the injection site right after receiving her injection. It was unknown if she sought medical attention. The outcome was unknown at the time of this report.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279200-1

18.0 F 05-Dec-2006 Unknown 17-May-2007 14-Jun-2007 -- WAES0704USA02272 15-Jun-2007

MedDRA PT Infectious mononucleosis
Symptom Text: Information has been received from a pharmacist, concerning an 18 year old female, who on 05-DEC-2006 was vaccinated with the first dose of Gardasil. The
pharmacist reported that the patient was experienced mononucleosis (date unspecified). At the time of this report, it was unknown if the patient had recovered.
The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279201-1

16.0 F Unknown Unknown 17-May-2007 13-Jun-2007 FL WAES0704USA02313 14-Jun-2007

MedDRA PT Influenza, Pyrexia
Symptom Text: Information has been received from a physician concerning a 16 year old female who was vaccinated with Gardasil and 24 hours later experienced fever and
flu symptoms. Subsequently, the patient recovered from fever and flu symptoms. The patient went to the ER but was not hospitalized. Additional information
has been requested.
Other Meds: MENACTRA
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279202-1

14.0 F 02-Mar-2007 Unknown 17-May-2007 13-Jun-2007 NY WAES0704USA02346 14-Jun-2007

MedDRA PT Rash maculo-papular
Symptom Text: Information has been received from a physician, concerning a 14 year old female patient, who on 02-MAR-2007 was vaccinated with the first dose of Gardasil.
There was no concomitant medication. Subsequently the patient experienced a generalized, non-pruritic, maculopapular rash (date not specified). At the time
of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279203-1

13.0 F 10-Apr-2007 10-Apr-2007 0 17-May-2007 13-Jun-2007 NJ WAES0704USA02348 14-Jun-2007

MedDRA PT Urticaria
Symptom Text: Information has been received from a registered nurse, concerning a 13 year old female patient, who on 10-APR-2007 was vaccinated with the first dose of
Gardasil (Lot #653938/0954F), and developed hives. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279204-1

25.0 F 30-Mar-2007 30-Mar-2007 0 17-May-2007 13-Jun-2007 NJ WAES0704USA0261 03-Jul-2007
HPV4 MERCK & CO. INC. NULL Unknown By Mouth

MedDRA PT Incorrect route of drug administration, Pain, Pain, Paraesthesia, Vaccination complication
Symptom Text: Information has been received from a consumer, a 25 year old female patient with high blood pressure, who on 30-MAR-2007 was vaccinated orally with the
first dose, 0.5ml, of Gardasil. There was no concomitant medication. On 31-MAR-2007 the patient reported that she had experienced tingling in her hands and
feet after the vaccine was administered. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional
information has been requested. 6/25/07 Received office note from reporter which reveals patient called office on 4/16 to report having been seen in ER for
complaints of body aches. Tx w/anti inflammatory meds & felling well now. Refused further HPV vaccine. FINAL DX: Adverse reaction to HPV vaccine.
Other Meds: None
Lab Data: None
History:
Prex Illness: Blood pressure high
Prex Vax Illns:

Vaers Id: 279205-1


Symptom Text: Information has been received from a nurse, concerning a female patient who was vaccinated with the first dose, 0.5ml, of Gardasil (date unspecified).
Subsequently the patient experienced a sore arm, confirmed as the same arm of the vaccination. At the time of this report, the nurse confirmed that the patient
had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279206-1

16.0 F 09-Apr-2007 12-Apr-2007 3 17-May-2007 13-Jun-2007 NY WAES0704USA02409 14-Jun-2007

MedDRA PT Urticaria
Symptom Text: Information has been received from a physician, concerning a 16 year old female patient, who on 12-FEB-2007 was vaccinated with the first dose of Gardasil,
and reported no symptoms or concerns. On 09-APR-2007, the patient was vaccinated with the second dose, 0.5ml, IM, of Gardasil (Lot #657617/0384U).
Concomitant therapy included Augmentin. On 12-APR-2007, three days after the second vaccination was administered, the patient experienced urticaria all
over her body, especially on her extremities and face. Treatment included Benadryl. At the time of this report, the physician confirmed the patient was
recovering from the urticaria. Additional information has been requested.
Other Meds: AUGMENTIN
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279207-1

Unknown F Unknown Unknown 17-May-2007 14-Jun-2007 MO WAES0704USA02499 14-Jun-2007

MedDRA PT Injection site swelling
Symptom Text: Information has been received from a physician, via a company representative, concerning a female patient who was vaccinated with the first dose of Gardasil
(date unspecified). The physician reported that before the needle was withdrawn, the patient developed substantial swelling at the injection site. At the time of
this report, the physician confirmed that the patient was recovering. The patient sought unspecified medical attention. Additional information has been
requested.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279208-1


MedDRA PT Abdominal pain, Drug exposure during pregnancy
Symptom Text: Information has been received from a health professional concerning an 18 year old female with no known allergies who on 20-MAR-2007 was vaccinated with
Gardasil (lot #655205/1426F). On 28-MAR-2007, the patient experienced abdominal pain. HCG was negative on that day. The patient was tested for
Chlamydia, which was negative. The patient's urine was also tested which was cloudy and showed trace blood, epithelial cells and bacteria (Group B
streptococcus). The patient was given a shot of ceftriaxone (ROCEPHIN) and azithromycin (ZITHROMAX) as a precaution. The patient's abdominal pain
subsequently resolved. On 09-APR-2007, the patient took a home pregnancy test which was positive. The patient's last menstrual period was 01-MAR-2007
with a EDC of 06-DEC-2007. Additional information has been requested.
Other Meds: none
Lab Data: diagnostic urinalysis 03/28/07 cloudy, trace blood, epithelial cells, Group B strep bacteria, Chlamydia trachomatis 03/28/07 negative, urine beta-human
03/28/07 negative, urine beta-human 04/09/07 positive
History: Pregnancy NOS (LMP=3/1/2007)
Prex Illness:
Prex Vax Illns:

Vaers Id: 279209-1


MedDRA PT Pain in extremity, Paraesthesia
Symptom Text: Information has been received from a female patient who was vaccinated with a dose of Gardasil. She developed arm pain which radiated from the elbow to the
4th or 5th finger. She also experienced "pins and needles" in the fingers. The patient's outcome was unknown. No further information is available.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279210-1

21.0 F 01-Jan-2007 01-Feb-2007 31 17-May-2007 14-Jun-2007 -- WAES0704USA02537 14-Jun-2007

Symptom Text: Information has been received from a Nurse Practitioner (N.P.) concerning a 21 year old female patient who in January 2007, was vaccinated IM with a first
dose of Gardasil. The patient developed genital warts within one month. Patient was treated with trichloroacetic acid (TCA) 80% on 06-MAR-2007 and on 10-
APR-2007. The outcome was unknown. Papanicolaou (PEP) test was performed, results unknown (done at another clinic). The NP reported two other patients
who had a similar experience. She verbalized concern that she had seen 3 episodes of genital warts developing soon after Gardasil. She believed the patient's
immune system can not handle the viral load. Additional information has been requested.
Other Meds: Unk
Lab Data: Pap test Result unknown
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279211-1


MedDRA PT Fall, Injection site pain, Syncope
Symptom Text: Information has been received from the mother concerning her 16 year old daughter who on 23-MAR-2007 was vaccinated with Gardasil. The patient fainted a
few minutes after being vaccinated. No injury was noted due to the fall. The patient also stated that the vaccination was very painful. Medical attention was
sought. At the time of reporting, the patient had recovered. No further information was available at the time of reporting. Additional information has been
requested.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279212-1


MedDRA PT Injection site erythema, Injection site rash, Injection site swelling
Symptom Text: Information has been received from a health professional concerning a 26 year old female patient who on 05-FEB-2007 was vaccinated IM with a first dose of
Gardasil lot #653736/0014U. On 09-APR-2007 the patient was vaccinated with a second dose of Gardasil. On 10-APR-2007 the patient developed rash at
injection site which was "a little swollen and red, but nothing major." On 11-APR-2007, she was struck on the injection site and reported that the rash got
"bigger," and was "two-three inches in diameter." The patient sought unspecified medical attention. The patient's outcome was unknown at the time of this
report. Additional information has been requested.
Other Meds: Unk
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279213-1

17.0 F Unknown Unknown 17-May-2007 14-Jun-2007 OK WAES0704USA02554 14-Jun-2007
MedDRA PT Pain, Pyrexia
Symptom Text: Information has been received from a physician concerning a 17 year old female who was vaccinated with a first 0.5 ml dose of Gardasil concomitantly with a
dose of MENACTRA. The day after vaccination, the patient experienced low grade fever and aching. Unspecified medical attention was sought. Subsequently,
the patient recovered. On an unspecified date the patient was vaccinated with a second dose of Gardasil by itself and there was no reaction. Additional
Other Meds:
Lab Data: Unk
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279214-1

Unknown F Unknown Unknown 17-May-2007 14-Jun-2007 NH WAES0704USA02560 14-Jun-2007
UNK UNKNOWN MANUFACTURER NULL Unknown Unknown
Symptom Text: Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was
vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient
received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory
diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is
one of several reports received from the same source. Additional information has been requested.
Other Meds:
Lab Data: none
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279215-1

13.0 F Unknown Unknown 17-May-2007 14-Jun-2007 WI WAES0704USA02596 14-Jun-2007

MedDRA PT Chest discomfort, Pyrexia, Throat tightness
Symptom Text: Information has been received from a physician concerning a 13 year old female who's family had been sick with a bacterial infection, including the patient's
sister who was also vaccinated with Gardasil (WAES#0705USA01566) who was vaccinated on an unspecified date with her second dose of Gardasil
intramuscularly. "Within about 18 hours after the vaccination," the patient experienced tightness in the chest and throat and a fever of 103 degrees. The
physician did a follow-up chest X-ray and the patient was "fine." Other unspecified lab tests revealed a "shift in neutrophils" which led to the physician to believe
this was a bacterial-related infection and not a result of Gardasil. The patient was treated with unspecified antibiotics and the condition resolved itself after
treatment. Additional information has been requested.
Other Meds: Unk
Lab Data: chest X-ray fine, neutrophil count "shift"
History: Unk
Prex Illness: Bacterial infection
Prex Vax Illns:

Vaers Id: 279216-1

26.0 F 12-Feb-2007 12-Feb-2007 0 17-May-2007 14-Jun-2007 OH WAES0704USA02663 14-Jun-2007

MedDRA PT Injection site irritation, Injection site pain
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 26 year old female with sulfonamide allergy and penicillin allergy who on 12-FEB-
2007 was vaccinated IM with a first dose of Gardasil, lot #654702/0011U and in APR, 2007 received the second dose of Gardasil. Concomitant therapy
included escitalopram oxalate (LEXAPRO) and TRI-NASAL (therapy unspecified). The patient reported a painful burning feeling at the injection site after both
dose one and dose two. The patient also reported that the injection site was sore for about two weeks after the first injection. Patient sought unspecified
medical attention. The patient was reported as recovering at the time of this report. Additional information has been requested.
Other Meds: [therapy unspecified] LEXAPRO
Lab Data: Unk
History: Sulfonamide allergy; Penicillin allergy
Prex Illness:
Prex Vax Illns:

Vaers Id: 279217-1

25.0 F 13-Feb-2007 13-Feb-2007 0 17-May-2007 14-Jun-2007 OH WAES0704USA02699 15-Jun-2007

MedDRA PT Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Reaction to previous exposure to any vaccine
Symptom Text: Information has been received from a Medical Assistant (M.A.) concerning a 25 year old female patient with a history of high fever after receiving the tetanus
toxoid years ago who on 13-FEB-2007 was vaccinated IM in the Left arm with a first dose of Gardasil lot #655618/0186U. Years ago the patient developed
swelling, redness and itching of left arm after the first injection and went to the Emergency Room (E.R.) and she was provided antibiotics. On an unspecified
date, patient was vaccinated in Right arm with a second dose of Gardasil lot #657617/0384U. She developed swelling, redness and itching of right arm after the
second injection and went to see her primary physician. The physician administered antibiotics and felt that event was Cellulitis without a cut causing the event.
Patient had high fever after receiving the tetanus toxoid years ago. The patient recovered from the events. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Fever; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 279218-1


MedDRA PT Asthenia, Breast pain
Symptom Text: Information has been received from a health professional concerning a 15 year old female who on 12-APR-2007 was vaccinated with Gardasil. Concomitant
therapy included Depo-Provera Injection for birth control. On 13-APR-2007 after receiving her first dose of the vaccine, the patient experienced soreness in her
breasts and weakness. It was reported that the patient received unspecified medical attention. No further information is available. Additional information has
been requested.
Other Meds: DEPO-PROVERA INJECTION
Lab Data: Unknown
History:
Prex Illness: Contraception
Prex Vax Illns:

Vaers Id: 279219-1

16.0 F 06-Apr-2007 06-Apr-2007 0 17-May-2007 14-Jun-2007 AZ WAES0704USA02778 15-Jun-2007

MedDRA PT Injection site rash, Rash
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who was vaccinated in left arm with a second dose of Gardasil lot
#657006/0188U. Concomitant therapy included Yasmin. On 06-APR-2007 about one hour later receiving the second injection she developed "red blotches" on
her left arm (injection site arm) and chest. Unspecified medical attention was sought by the patient. The reaction resolved spontaneously about 4 hours later.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279220-1


MedDRA PT Urticaria
Symptom Text: Information has been received from a Medical Assistant (M.A.) concerning an 18 year old female patient who on 04-NOV-2007 was vaccinated in deltoid with a
dose of Gardasil lot #656049/0187U. Concomitant therapy included Depo-Provera in the other arm. The patient developed hives about four hours after
receiving Gardasil. Benadryl was ordered. The patient's outcome was unknown. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279221-1


MedDRA PT Malaise, Viral infection
Symptom Text: Information has been received from an office manager concerning a female in her late teens who was vaccinated with Gardasil. Subsequently, the patient
received a dose of Gardasil and felt sick. The patient went to the emergency room. The reporter felt that felt sick was not related to therapy with Gardasil, but a
viral infection. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness: Viral infection
Prex Vax Illns:

Vaers Id: 279222-1

27.0 F Unknown 01-Apr-2007 17-May-2007 14-Jun-2007 AZ WAES0704USA02851 03-Jul-2007

MedDRA PT Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Symptom Text: Information has been received from a Medical Assistant (M.A.) concerning a 27 year old female patient who was vaccinated on 04-APR-2007 in to deltoid with
a third dose of Gardasil lot #656049/0187U one week earlier than the recommended schedule. Concomitant therapy included prenatal vitamins (manufacturer
unknown). After the third injection, the injection site area was "swollen, red and warm to touch". The size of the area was a 6 inch circumference. The patient
sought unspecified medical attention. Her outcome was unknown at time of this report. Additional information has been requested.
Other Meds: vitamins (unspecified)
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279223-1


MedDRA PT Nausea, Vomiting
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Within 12-15 hours, the patient experienced nausea
and vomiting. This is one of two reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279224-1

Unknown F Unknown 01-Apr-2007 17-May-2007 14-Jun-2007 AZ WAES0704USA02887 15-Jun-2007

MedDRA PT Laryngitis, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia, Reaction to previous exposure to any vaccine
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil and on April 11 or 12, 2007, was
vaccinated IM with a second dose of Gardasil. Four to five hours after receiving the second injection the patient developed "severe swollen glands, laryngitis, a
sore throat and a mild fever of 99 degrees". The physician reported that the patient had a mild reaction after her first injection. The patient saw her Primary
Care Physician (PCP) and was treated with Claritin and with other medications that were not specified. The patient's outcome was unknown at the time of this
report. Additional information has been requested.
Other Meds: Unknown
Lab Data: body temp 04/??/07 99
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279225-1

10.0 F Unknown Unknown 17-May-2007 14-Jun-2007 MS WAES0704USA03077 15-Jun-2007

MedDRA PT Rash pustular
Symptom Text: Information has been received from a physician, via a company representative, concerning a 10 year old female patient, who was vaccinated with the first dose
of Gardasil (date and dose not specified). "About 1 to 2 days later" the patient developed "a pustular rash on her hairline, face and abdomen. " The physician
indicated that the patient recovered from the event (date not specified). The patient sought unspecified medical attention. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279226-1


MedDRA PT Rash erythematous
Symptom Text: Information has been received from a pharmacist, concerning a 16 year old female patient with no pertinent medical history, who on 13-APR-2007 was
vaccinated with the first dose, 0.5ml, of Gardasil (Lot #654885/1424F). There was no concomitant medication. On 15-APR-2007 the patient developed a full
body rash. The pharmacist described the rash as not itchy but red, and noted it was located on the patient's chest, legs, arms and back. Treatment included a
Medrol Dose Pak. At the time of this report, the pharmacist confirmed the patient was recovering from the rash. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279227-1


MedDRA PT Body temperature increased, Pain, Pharyngolaryngeal pain
Symptom Text: Information has been received from a medical assistant, via a company representative, concerning a 15 year old female patient who had felt ill 2 weeks prior to
the vaccination, who on 26-MAR-2007 was vaccinated with the first dose, 0.5ml, of Gardasil. On approximately 30-MAR-2007 ("end of March 2007"), the patient
had a low grade temperature (not specified) for one day, was achy, had a sore throat, and felt run down for a few days. The patient sought unspecified medical
Other Meds: Unknown
Lab Data: Unknown
History: Malaise
Prex Illness:
Prex Vax Illns:

Vaers Id: 279228-1

21.0 F 02-Mar-2007 02-Mar-2007 0 17-May-2007 18-Jun-2007 AZ WAES0704USA03109 18-Jun-2007

MedDRA PT Anogenital warts, Fungal infection, Pruritus, Skin irritation, Vaginal candidiasis, Vaginitis bacterial
Symptom Text: Information has been received from a Nurse Practitioner concerning a 21 year old female patient with penicillin allergy who on 02-MAR-2007 was vaccinated IM
with a first dose of Gardasil. The NP reported that the patient had genital warts after receiving the Gardasil. On 19-MAR-2007 she first had itching and irritation.
On 21-MAR-2007 she was examined and had both bacterial vaginosis and yeast infection. On 19-MAR-2007 she was treated with Diflucan and on 21-MAR-
2007 she was treated with Flagyl. On 16-APR-2007 the genital warts were visually confirmed during the examination. The patient had tested positive for serum
human papillomavirus prior to the vaccination. The patient's genital wart was persisting. Additional information has been requested.
Other Meds: Unknown
Lab Data: laboratory test - Positive for HPV 43 laboratory test - positive for HPV 51 serum HPV 6 - positive serum octavalent HPV 11 - positive serum octavalent HPV 18
- positive
History:
Prex Illness: Penicillin allergy
Prex Vax Illns:

Vaers Id: 279229-1

20.0 F 25-Jan-2007 03-Feb-2007 9 17-May-2007 14-Jun-2007 -- WAES0704USA03117 15-Jun-2007

MedDRA PT Cough
Symptom Text: Information has been received from an advanced practice nurse (APN), concerning a 20 year old female student, who on 25-JAN-2007 was vaccinated with the
first dose, 0.5ml, IM, of Gardasil (Lot #654702/0011U). On 03-FEB-2007, nine days after the vaccination was administered, the patient developed a paroxysmal
cough, described by th APN as "almost laryngeal spasms, lasting 5 to 120 minutes, 4 days per week." The patient visited the ER three times, and treatment
included Lortab 10mg, Phenergan 25mg, epinephrine SQ twice, breathing treatment with albuterol three times daily, Valium, Xanax, Ativan, with no reported
relief of the symptoms. An ear, nose and throat exam and a neurological exam were both normal (date unspecified). The APN stated the symptoms lasted for
"6 weeks" and then resolved (approximately 17-MAR-2007). On 26-MAR-2007, the patient was vaccinated with the second dose, 0.5ml, IM, of Gardasil (Lot
#654702/0011U). The APN reported that once again, 9 days after the vaccine was administered (04-APR-2007), the patient experienced paroxysmal cough. At
the time of this report, the patient has not recovered, and was still receiving treatment (unspecified). Additional information has been requested.
Other Meds: Unknown
Lab Data: ears, nose, and throat - Normal neurological - Normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279230-1

21.0 F 20-Feb-2007 20-Feb-2007 0 17-May-2007 14-Jun-2007 CA WAES0704USA03189 15-Jun-2007

MedDRA PT Pruritus generalised
Symptom Text: Information has been received from a physician's assistant (PA), concerning a 21 year old female patient, who on 20-FEB-2007 was vaccinated with the first
dose of Gardasil (Lot #653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified). On 20-FEB-2007, following the vaccination, the
patient experienced itching from head to toe for 3-4 days, but no rash was present. Treatment involved Benadryl. On approximately 24-FEB-2007 (after "3-4
days"), the patient recovered. The PA felt that the itching was "from the vaccination" and related to therapy with Gardasil. Additional information has been
requested.
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279231-1

15.0 F 09-Apr-2007 09-Apr-2007 0 17-May-2007 14-Jun-2007 TX WAES0704USA03191 15-Jun-2007

MedDRA PT Injection site haematoma, Injection site reaction
Symptom Text: Information has been received from a physician concerning a 15 year old female who on approximately 09-APR-2007 was vaccinated with Gardasil. In April
2007, the patient experienced a crescent shaped burn-like area, over a small hematoma about 1 centimeter in diameter at the injection site. No pain was noted.
It was reported that the patient sought unspecified medical attention. It was also reported that the patient is recovering at this time. Additional information has
been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279232-1


MedDRA PT Nausea
Symptom Text: Information has been received from a LPN concerning her 14 year old daughter who was vaccinated with Gardasil. There was no concomitant medication.
Subsequently, the patient experienced nausea. The patient sought unspecified medical attention. Addition information has been requested.
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279233-1

22.0 F 09-Dec-2006 14-Dec-2006 5 17-May-2007 14-Jun-2007 -- WAES0704USA03438 15-Jun-2007

MedDRA PT Antepartum haemorrhage, Drug exposure during pregnancy
Symptom Text: Information has been received via the Merck pregnancy registry, from a nurse practitioner (NP), concerning a 22 year old female patient, who on 09-OCT-2006
was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #653735/0688F), and on 09-DEC-2006 was vaccinated with the second dose, 0.5ml, IM, of
Gardasil (Lot #654389/0961F). There was no concomitant medication. The NP reported that the patient is now pregnant; the date of the LMP was 14-DEC-
2006, with an estimated date of delivery on 20-Sep-2007. A blood test confirmed the pregnancy. The NP reported that the patient had developed "some
bleeding during pregnancy." The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: None
Lab Data: serum beta-human - Pregnant
History:
Prex Vax Illns:

Vaers Id: 279234-1


MedDRA PT Dizziness, Nausea
Symptom Text: Information has been received from a certified medical assistant concerning a 17 year old female with hypersensitivity who on 29-Jan-2007 was vaccinated with
a first dose of Gardasil (lot# 654741/1208F). Concomitant therapy included cough, cold, and flu therapies (unspecified). On 29-JAN-2007 the patient
experienced dizziness and nausea and sought unspecified medical attention. Subsequently, the patient recovered from the dizziness and nausea within a few
hours of vaccinations. The patient was subsequently vaccinated with her second dose of Gardasil on 16-APR-2007. Additional information has been requested.
Other Meds: cough, cold, and flu therapies
Lab Data:
History:
Prex Vax Illns:

Vaers Id: 279235-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse practitioner, via a company representative, concerning a 16 year old female patient, who in April 2007, was
vaccinated with a dose of Gardasil. Concomitant therapy included Menactra and Vaqta. The nurse practitioner stated that the patient "fainted after she received
the Gardasil vaccination. " The "patient was given liquids to drink and something to eat, and she was fine." Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279236-1

12.0 F 10-Apr-2007 10-Apr-2007 0 17-May-2007 14-Jun-2007 MA WAES0704USA03491 15-Jun-2007

MedDRA PT Injection site pruritus
Symptom Text: Information has been received from a physician, concerning a 12 year old female patient who on 10-APR-2007, was vaccinated with the first dose, 0.5ml, IM,
of Gardasil (Lot #656051/0244U). There was no concomitant medication. The physician reported that the patient developed pruritus at the injection site within
minutes of the vaccine administration. Treatment included Benadryl. At the time of this report, the physician confirmed that the patient had recovered (date not
specified). Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279237-1


MedDRA PT Axillary mass
Symptom Text: Information has been received from a physician's assistant (PA), concerning a 25 year old female patient with asthma and acne, who on 12-APR-2007 was
vaccinated IM in the left deltoid, with the first dose, 0.5ml, of Gardasil (Lot #657621/0387U). Concomitant therapy included Nuvaring, Accutane and albuterol.
On 13-APR-2007 the patient developed a lump in her left axilla, though the PA there was no swelling or redness present. Treatment consisted of warm soaks
and Motrin. At the time of this report, the patient had not recovered. Additional information has been requested.
Other Meds: albuterol NUVARING ACCUTANE
Lab Data: Unknown
History:
Prex Illness: Asthma Acne
Prex Vax Illns:

Vaers Id: 279238-1


Symptom Text: Information has been received from a Nurse Practitioner (N.P.) concerning a 25 year old female patient who on 16-APR-2007 was vaccinated IM with a first
dose of Gardasil. Concomitant therapy included Strattera. On 16-APR-2007 the patient experienced dizziness and headache. The headache was resolved
when patient awoke the next day. The patient's dizziness persisted. Unspecified medical attention was sought. The patient had not recovered. Additional
Other Meds: STRATTERA
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279239-1

19.0 F Unknown Unknown 17-May-2007 14-Jun-2007 FL WAES0704USA03537 15-Jun-2007

MedDRA PT Arthralgia
Symptom Text: Information has been received from a physician concerning a 19 year old female patient who was vaccinated with a dose of Gardasil. The patient experienced
joint pain after getting the injection. Unspecified medical attention was sought. Patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279240-1

14.0 F 18-Jan-2007 19-Jan-2007 1 17-May-2007 14-Jun-2007 MN WAES0704USA03595 15-Jun-2007

MedDRA PT Dizziness, Urticaria, Vomiting, Weight decreased
Symptom Text: Information has been received from the mother of a 14 year old female with no pertinent medical history or drug reactions/allergies, who on 18-JAN-2007 was
vaccinated with Gardasil (0.5 ml). There was no concomitant medication. On 19-JAN-2007 the patient experienced hives, vomiting, dizziness and weight loss.
At the time of this report, the patient's hives, vomiting, dizziness and weight loss persisted. Unspecified medical attention was sought and it was reported that
the patient underwent blood tests (results not provided). Additional information has been requested.
Other Meds: None
Lab Data: diagnostic laboratory - results not provided
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279241-1

Unknown F 17-Apr-2007 17-Apr-2007 0 17-May-2007 14-Jun-2007 CA WAES0704USA03609 15-Jun-2007

MedDRA PT Flushing
Symptom Text: Information has been received from a physician concerning a female patient with aspirin allergy who on 17-APR-2007 was vaccinated with a first dose of
Gardasil. On 17-APR-2007 the patient developed facial flushing with red cheeks and ears after receiving the injection. The patient was administered Benadryl
and her symptoms resolved within 10 minutes. The patient was fully recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 279242-1

15.0 F 19-Feb-2007 19-Feb-2007 0 17-May-2007 14-Jun-2007 CT WAES0704USA03658 15-Jun-2007

MedDRA PT Urticaria
Symptom Text: Information has been received from a healthcare worker concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on
19-FEB-2007 was vaccinated intramuscularly with Gardasil. There was no concomitant medication. On 19-FEB-2007, with a few hours of receiving the vaccine,
the patient developed hives. Unspecified medical attention was sought, and the patient took Benadryl for the symptoms. The hives subsequently resolved.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279243-1

Unknown F Unknown Unknown 17-May-2007 14-Jun-2007 -- WAES0704USA03682 05-Jul-2007

MedDRA PT Anogenital warts, Papilloma viral infection
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil (date and dose not provided). Subsequently at an
unspecified time, the patient had a Pap smear that tested positive for HPV 6 and HPV 11. It was also reported that the patient experienced a break out of
genital warts not long after vaccination with HPV. It was reported that the patient sought unspecified medical attention. Additional information has been
requested.
Other Meds: Unknown
Lab Data: serum prostatic acid - HPV6 HPV11
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279244-1


MedDRA PT Erythema, Injection site rash
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced a small red rash
at the injection site. The patient outcome was not reported and the patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279245-1


Symptom Text: Information has been received from a physician's assistant concerning a 13 year old female with seasonal allergy who in March 2007, was vaccinated IM with
the first 0.5 mL dose of Gardasil. The physician's assistant reported that within 21 days of vaccination the patient developed bilateral axillary lymph node
swelling. Multiple nodes were noted bilaterally. The patient was treated with Zithromax for three days. Unspecified laboratory tests were obtained; all reported
as normal. The patient recovered within 1-2 weeks of Zithromax therapy. It was reported that the opposite side of vaccination resolved first, "in several days,"
then the side of vaccination resolved. Additional information has been requested.
Other Meds: Unknown
Lab Data: diagnostic laboratory 03?/??/07 - all labs normal
History:
Prex Illness: Seasonal allergy
Prex Vax Illns:

Vaers Id: 279246-1


MedDRA PT Human papilloma virus test positive
Symptom Text: Information has been received from a consumer concerning her daughter who was vaccinated with the first and second doses of Gardasil. The consumer
reported that a week after the second vaccination, her daughter's pap test came back HPV positive. No further information was provided. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Pap test - HPV positive
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279247-1

Unknown F 09-Apr-2007 09-Apr-2007 0 22-May-2007 23-May-2007 FR WAES0705SGP00004 23-May-2007

MedDRA PT Abortion, Drug exposure during pregnancy
Symptom Text: Information has been received from a physician concerning a female who on 09-APR-2007 was vaccinated with the first dose of Gardasil. Subsequently the
patient was found to be 9 weeks pregnant when she came back for her second booster dose. The patient's last menstrual period was 01-MAR-2007. The
patient did not experience any other adverse effect. Subsequently, on 02-MAR-2007, the patient had an abortion. Upon internal review, this report was
considered an other important medical event. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Pregnancy NOS (LMP = 01Mar07)
Prex Vax Illns:

Vaers Id: 279248-1 (S)

Unknown F 01-Jan-2007 01-Jan-2007 0 22-May-2007 23-May-2007 MO WAES0705USA02247 23-May-2007

MedDRA PT Concussion, Head injury, Loss of consciousness
Symptom Text: Information has been received from the physician's office manager concerning a female who in January 2007, was vaccinated with her first dose of Gardasil. In
January 2007, after the patient was vaccinated, she walked to the front of the office and "passed out and hit her head on the floor". The patient was taken by
ambulance to the hospital where she was admitted with a possible concussion. The patient outcome was not reported. The reporting office manager considered
the event to be an other important medical event. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279249-1

21.0 F 08-May-2007 09-May-2007 1 22-May-2007 23-May-2007 CA WAES0705USA02623 23-May-2007

MedDRA PT Paralysis
Symptom Text: Information has been received from a nurse practitioner concerning a 21 year old female who had a biopsy on 08-MAY-2007 (reason not reported) and was
also vaccinated with Gardasil at 8:00 pm. Concomitant therapy included ethinyl estradiol (+) norethindrone acetate (LOESTRIN). On 09-MAY-2007 the patient
became paralyzed from the neck down while at school and was taken to the emergency room by ambulance. Upon internal review, paralyzed from the neck
down was considered to be an other important medical event. Additional information has been requested.
Other Meds: Loestrin
Lab Data: Unknown
History: Biopsy
Prex Illness:
Prex Vax Illns:

Vaers Id: 279250-1 (S)

23.0 F 19-Apr-2007 20-Apr-2007 1 22-May-2007 23-May-2007 WA WAES0705USA02873 23-May-2007

MedDRA PT Asthma, Condition aggravated, Dyspnoea
Symptom Text: Information has been received from a health professional concerning a 23 year old black/white female receptionist with asthma (diagnosed at the age of 5 year
old) and outdoor allergies who on 19-APR-2007 at 01:15 (AM or PM not reported) was vaccinated IM in left arm deltoid with a first dose of Gardasil lot
#655849/0263U. Concomitant therapy included montelukast sodium (MSD) loratadine (+) pseudoephedrine sulfate (LORATIDINE D) and albuterol sulfate
(VENTOLINE (albuterol sulfate)). On 20-APR-2007, Friday night at 11:00 PM patient woke up with short of breath. Her rescue inhaler did not help so she used
her nebulizer. On 21-APR-2007 she used her nebulizer again around 6:30 AM and through out that day 4 to 6x. On 22-APR-2007, Sunday she did 6 nebulizer
treatment within one-two hours before being admitted at the hospital. In the hospital she had additional nebulizer treatment (10+) times and steroid injections.
Patient stated that this was her worst asthma attack since being diagnosed. Patient recovered. Additional information is not expected.
Other Meds: VENTOLINE (ALBUTEROL SULFATE, LORATIDINE D, SINGULAIR
Lab Data: Unknown
History:
Prex Illness: Asthma; Hypersensitivity
Prex Vax Illns:

Vaers Id: 279251-1

26.0 F 13-Sep-2006 11-May-2007 240 22-May-2007 23-May-2007 -- WAES0705USA02904 23-May-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Symptom Text: Information has been received from a registered nurse for the pregnancy registry for Gardasil, concerning a 26 year old female with a drug reaction/allergy to
Wellbutrin, factor v laiden mutation/clotting disorder, prothrombin mutation, bipolar disorder, seizure disorder and Mthfr and a history of pulmonary embolism
and multiple deep vein thrombosis and herpes virus infection who on 13-SEP-2006 was vaccinated with her first Gardasil 0.5 ml IM (lot # 653735/0688F).
Concomitant therapy included Coumadin, Topamax and clonazepam. The nurse stated that the patient was very non-complaint and never returned for the
second or third dose of the vaccine. On 16-APR-2007, the patient was found to be pregnant which was confirmed by ultrasound and a pregnancy test. The
patient's last menstrual period, gestational age or due date were not reported. On 11-MAY-2007 the patient experienced spontaneous miscarriage which was
confirmed by ultrasound. The patient sought unspecified medical attention. The patient was not hospitalized. Upon internal review, spontaneous miscarriage
was determined to be an other important medical event. Additional information has been requested.
Other Meds: Clonazepam, Topamax, Coumadin
Lab Data: ultrasound 04/16/07 - + pregnancy confirmed, ultrasound 05/11/07 - positive miscarriage, beta-human chorionic 04/16/07 - + pregnancy confirmed
History: Pulmonary embolism; Deep vein thrombosis; Herpes virus infection
Prex Illness: Pregnancy NOS (LMP = Unknown); Drug hypersensitivity; Factor V Leiden mutation; 5-alpha reductase deficiency; Prothrombin level
Prex Vax Illns:

Vaers Id: 279252-1 (S)

15.0 F 13-Apr-2007 13-Apr-2007 0 22-May-2007 23-May-2007 -- WAES0705USA03002 23-May-2007

MedDRA PT Dysphagia, Dyspnoea, Pallor, Throat tightness
Symptom Text: Information has been received from a nurse practitioner concerning a 15 year old female with no pertinent medical history or history of drug reactions/allergies,
who on 13-APR-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM, right deltoid (lot # 653978/0955F). There was no concomitant medication. The
patient was in the waiting room for 5 to 10 minutes post injection when she experienced loss of coloration and had difficulty breathing and swallowing. The
patient felt like her throat was closing up. The patient was administered an EPI (epinephrine) injection and stayed in the office for 45 minutes. The events
improved after the epinephrine injection and was considered to have recovered from loss of coloration, difficulty breathing, difficulty swallowing and throat
closing up. The nurse practitioner considered the events to be an other important medical events and to be life threatening. Additional information has been
requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279259-1

15.0 F 26-Mar-2007 26-Mar-2007 0 22-May-2007 29-May-2007 NY 29-May-2007
HPV4 MERCK & CO. INC. 12/08F 0 Left arm Intramuscular

MedDRA PT Injection site urticaria, Tremor, Urticaria
Symptom Text: Pt became shaky, with hives on left arm at injection site and spread to R arm and chest.
Other Meds:
Lab Data:
History: Biaxin rash
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279264-1

11.0 F 16-May-2007 18-May-2007 2 22-May-2007 29-May-2007 MN 29-May-2007
VARCEL MERCK & CO. INC. 0367U 1 Left arm Subcutaneously
MedDRA PT Injection site erythema, Injection site pain
Symptom Text: RCV'd vaccine 5/16/07. Pain at site 5/17/07 school nurse called because 2 1/2 inch red raised spot at site of vaccine. No fever, no red streaks, no purulent
discharge.
Other Meds:
Lab Data: None
History: ADD combined type
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279265-1

14.0 F 14-May-2007 14-May-2007 0 22-May-2007 31-May-2007 NC 01-Jun-2007

MedDRA PT Head injury, Pyrexia, Syncope
Symptom Text: 1. Syncope shortly after with head injury (contusion) had CT scan in ER next day which was ok. 2. Fever next day (101.2)
Other Meds: LEXAPRO
Lab Data: CT Scan of head and skull X-ray (-) (obtained secondary to fall/ head injury)
History: None
Prex Illness: Allergic rhinitis, sinusitis
Prex Vax Illns:

Vaers Id: 279267-1

21.0 F 23-Apr-2007 Unknown 22-May-2007 30-May-2007 PA 30-May-2007

MedDRA PT Diarrhoea, Nausea, Stomach discomfort
Symptom Text: Upset stomach, diarrhea, nausea all symptoms started just a few days after I received the Gardasil vaccine.
Other Meds:
Lab Data: None
History:
Prex Illness: A few days after the vaccination
Prex Vax Illns:

Vaers Id: 279276-1

15.0 F 19-May-2007 19-May-2007 0 22-May-2007 31-May-2007 NY 01-Jun-2007
MedDRA PT Musculoskeletal stiffness, Syncope
Symptom Text: Syncope - lasting 15 seconds (with stiffening but no seizures) resolved spontaneously with conservative care (lying down).
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279291-1

17.0 F 22-Nov-2006 22-Nov-2006 0 22-May-2007 30-May-2007 MN 30-May-2007
FLU SANOFI PASTEUR 62244AA 0 Right arm Intramuscular
MedDRA PT Asthenia, Gait disturbance, Nausea, Photophobia, Vomiting
Symptom Text: generalized weakness, difficulty walking, photophobia, nausea. Started one hour after vaccine administered, lasted rest of day. Was gone the next morning.
Occurred with first vaccine on 11-22-06 and with the second vaccine on 1-25-07. Also, after second vaccine only she vomitted one time.
Other Meds: ortho evra
Lab Data: none, patient did not seek medical attention since it resolved on its own. She reported symptoms 5-22-07 when she presented to get her 3rd vaccination. 3rd
shot not given.
History: amoxicillin, latex allergies, recurrent uti's
Prex Illness: uti
Prex Vax Illns:

Vaers Id: 279313-1

15.0 F 07-May-2007 07-May-2007 0 23-May-2007 24-May-2007 MO 200701717 24-May-2007
MNQ SANOFI PASTEUR U2228AA Left arm Intramuscular
HPV4 MERCK & CO. INC. 0389U Right arm Intramuscular
MedDRA PT Fall, Loss of consciousness, Unresponsive to stimuli
Symptom Text: Initial report received on 10 May 2007 from a health care professional. A 15-year-old female patient, with no known past medical history, had received a left
deltoid, intramuscular injection of Menactra, lot number U2228AA; and a right deltoid, intramuscular injection of Gardasil, lot number 0389U; on 07 May 2007.
On the same day following vaccination, the patient "passed out" and fell to the floor. She was unresponsive for approximately 40 seconds. The patient did not
experience any respiratory distress, and the event fully resolved without medical intervention.
Other Meds:
Lab Data:
History: The patient had no illness at the time of vaccination and had no known pre-existing medical conditions.
Prex Illness:
Prex Vax Illns:

Vaers Id: 279317-1

17.0 F 02-May-2007 09-May-2007 7 23-May-2007 30-May-2007 HI 08-Jun-2007

MedDRA PT Injection site erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site pain, Injection site swelling
Symptom Text: Receive vaccine 5/2/07 L deltoid. No initial reaction (no fever, pain, swelling at site). On 5/9/07 noticed painful swelling L deltoid with redness, increased to
maximum size evening 5/9/07. Pt seen on 5/10/07 and had 2 1/2 cm subcutaneous erythematous area of induration - mobile, mildly tender on left deltoid (pt
said smaller then previous night). On phone following 5/12/07 pt said swelling almost gone (only small bump - nontender).
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279319-1

26.0 F 07-May-2007 09-May-2007 2 23-May-2007 30-May-2007 MO 30-May-2007
HPV4 MERCK & CO. INC. 03840 0 Right arm Unknown

MedDRA PT Dizziness, Injection site erythema, Injection site induration, Injection site pain, Nausea
Symptom Text: Vaccination given 05/07/07. Patient reports dizziness and nausea starting 5/09/07 et continues. 5/14/07 redness et hardness noted at injection site. Injection
site s/s worsened 5/15/07. On 5/16/07 site less red with 1.2 cm hardened area noted with slight tenderness.
Other Meds: None
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 279328-1

32.0 F 13-Feb-2007 13-Feb-2007 0 23-May-2007 24-May-2007 -- WAES0702USA02398 31-May-2007

MedDRA PT Drug exposure during pregnancy, Inappropriate schedule of drug administration, Intra-uterine death, Medication error, Umbilical cord abnormality
Symptom Text: Information has been received from a physician through a manufacturer pregnancy registry concerning a 32 year old female with a history of 5 pregnancies and
4 live births (one fetal loss at 16-20 weeks) who on 13-FEB-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F). Concomitant medication
was not reported. On 13-NOV-2006, an ultrasound was performed results reported were fetal leiometry which corresponds the size and dates. On 04-DEC-
2006, serum alpha-fetoprotein test was performed results were negative. On 13-FEB-2007, after the patient was vaccinated with Gardasil, the physician found
out that the patient was pregnant. The physician reported that the pregnancy was normal to date. Follow-up information has been received from a physician.
On 13-JAN-2007, an ultrasound performed showed adequate fetal growth since last sonography and fetal anatomy appears to be normal. On 13-APR-2007, an
ultrasound performed showed biophysical profile 8/8, AFI 20.5 cm, S/D ratio 2.71, cervical length 4.44cm. On 23-APR-2007, an ultrasound performed showed
adequate fetal growth since last ultrasound AFI 12.1 cm. On 24-APR-2007, the patient was diagnosed with intrauterine fetal demise and a female infant was
delivered on 26-APR-2007 at 06:40, 3.235 kg. The placenta and cord were sent to pathology with no pathological diagnosis. Autopsy was refused. Clinically
fetal death was due to cord accident, long umbilical cord, around body once and legs twice. Upon internal review, intrauterine fetal demise and umbilical cord
complication were considered to be other important medical events. Additional ifnormation is not expected.
Other Meds: Unknown
Lab Data: ultrasound 11/13/06 - fetal leiometry for size and dates, ultrasound 01/13/07 - adequate fetal growth since last ultrasound, fetal anatomy appears to be normal,
ultrasound 04/13/07 - decreased fetal movements, threatened preterm labor, biop
History: Intra-uterine death
Prex Illness:
Prex Vax Illns:

Vaers Id: 279329-1 (S)

15.0 F 03-Jan-2007 01-Feb-2007 29 23-May-2007 24-May-2007 -- WAES0705USA02428 26-Jul-2007
MedDRA PT Autoimmune thrombocytopenia, Contusion, Epistaxis, Evans syndrome, Eye disorder, Fall, Fatigue, Fatigue, Idiopathic thrombocytopenic purpura,
Menorrhagia, Petechiae, Syncope, Transfusion
Symptom Text: Information has been received from a physician concerning a 15 year old female with no pertinent medical history or known drug reactions or allergies who on
03-JAN-2007 was vaccinated with Gardasil 0.5 ml injection. In February 2007, the patient experienced heavy menstrual bleeding, nose bleeds and eye
problems and was hospitalized for four days (admittance and discharge dates not reported), and while hospitalized was diagnosed with Evans syndrome. The
patient needed a blood transfusion. The patient's Evans syndrome persisted. There was no product quality complaint. Additional information has been
requested. 06/06/07-records received from facility for DOS 5/7-5/10/07. DC DX: Evan's Syndrome, immune thrombocytopenia and anemia. Prolonged episode
of epistaxis. HX: Nosebleeds frequently since age of 3 or 4. In last 4 weeks have increased in frequency 6-7 times per day, harder to stop. Prior to admission
nosebleed from 21:30 through 9:30 with nausea and bloody emeses. HX of bruising easily. Menses 3 days longer in duration and heavier with clotting and
clumps. Petechia on lower extremities, more tired or fatigued. Feels faints if she stands up too quickly. Black out this morning. Fell. Follow up visits 5/17/07:
Impression Evan's Syndrome, Strong family history of autoimmunity. Abnormal labs including positive ANA, low complement.
Other Meds: Unknown
Lab Data: Unknown records received 6/6/07-On admission platelets 4, smear showed no blasts, large in size. Reticulocyte mild hypogammaglobulinemia and positive
direct Coombs. Trasnfusions of platelets. Bone marrow results were within normal limits w
History: None records received 6/6/07-nosebleeds
Prex Illness:
Prex Vax Illns:


16.0 F 16-May-2007 18-May-2007 2 23-May-2007 24-May-2007 MO 21-Jun-2007
MedDRA PT Arthralgia, Condition aggravated, Fatigue, Muscular weakness, Myalgia, Pain in extremity, Pain in extremity, Pain in extremity
Symptom Text: Pt. Having Symptoms of Guillain-Barre syndrome. Physicians office notified because of pt. hx. of this disease and they did nothing about it just blew us off. I
them took her to see her neurologist and he said she should never have received this vaccine. Clinic never gave pt. any info. on vaccine reactions until after
vaccine was given Clinic is pt. primary care physician so they are aware of her previous condition of GBS. Pt was having pain in arms and legs first c/o was
seen in office by Dr. Melanie Grgurich and told not to worry about it next day experienced weakness in legs and was examined bye her neurologist. 6/21/07-
office record received for DOS 5/22/07-Assessment:myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect
that patient does not have Guillain Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling
tired and also felt unsteady when she took her antihistamine mediction. Feeling pains very freuently on first few days after injection peaked on weekend
subsided since Monday. Currently here for a follow up visit because there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary
2006.
Other Meds:
Lab Data: We are watching her symptoms to see if they progress into GBS. Labs done and muscle testing and neurological exam performed bye the neurologist.
6/21/07-records received ESR and CRP normal.
History: Guillain-Barre Syndrome diagnosed 2-13-06 Pt. released from Neurologists care in March. 6/21/07-records received-Currently here for a follow up visit because
there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary 2006.
Prex Illness:
Prex Vax Illns:


16.0 F 16-May-2007 18-May-2007 2 02-Aug-2007 03-Aug-2007 -- 200702573 03-Aug-2007
MNQ SANOFI PASTEUR U2225A Right arm Unknown
MedDRA PT Arthralgia, Arthralgia, Balance disorder, Fatigue, Fatigue, Muscular weakness, Muscular weakness, Myalgia, Myalgia, Pain in extremity
Symptom Text: This case was received from another manufacturer (reference number WAES0707USA00713/VAERS # 279407) on 19 July 2007. The following information is
verbatim as it appears in the other manufacturer's report: This report was identified from a line listing obtained on request by the Company from the FDA under
the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome
(GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. It was reported that on 16-MAY-2007, the patient was vaccinated in the left
arm with the first dose of Gardasil (lot 4657006/0188U) and vaccinated in the right arm with a dose of Menactra (lot #U2225AA). On 18-MAY-2007, the patient
began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and
subsequently was told 'not to worry about it.' The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by
her neurologist. The neurologist's assessment was as follows: 'myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse event
reaction. Suspect the patient does not have Guillain-Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains,
muscle aches, feeling tired and also felt unsteady when she took her antihistamine medication. Feeling pains very frequently on first few days after injection,
peaked on weekend, subsided since Monday. Currently her for follow-up visit because there were concerns it she has a relapse of her GBS which was
diagnosed in February 2006. Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive Protein
(CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing
indicated that one or more of the event
Other Meds: ANTIHISTAMINE
Lab Data: On 22 May 2007: Reflexes normal, no sign of sensory loss. On May 2007: serum C reactive protein- normal; Erythrocyte sedimentation rate: normal.
History: Guillain-Barre syndrome (diagnosed on 13-Feb-2006)
Prex Illness:
Prex Vax Illns:


16.0 F 16-May-2007 18-May-2007 2 09-Aug-2007 10-Aug-2007 -- WAES0707USA00713 10-Aug-2007
MNQ SANOFI PASTEUR U2225AA 0 Unknown Unknown
MedDRA PT Arthralgia, Condition aggravated, Fatigue, Guillain-Barre syndrome, Muscular weakness, Muscular weakness, Myalgia, Pain in extremity
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with
Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness,
and pain in arms and legs. it was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot #657006/0188U)
and vaccinated in the right arm with a dose of MENACTRA (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs,
arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently, was told "not to worry about it." The
following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was
as follows: "myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect the patient does not have Guillain-Barre
syndrome. Reflexes are normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when
she took her antihistamine medications. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently
here for follow-up visit because there were concerns if she has a relapse of her GBS which was diagnosed in February 2006." Unspecified labs and muscle
testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were noted to be normal. The patient's symptoms
were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered
to be immediately life-threatening. The original reporting source was unknown. No further information is available. A standard lot check investigation was
performed. All in-process qualit
Other Meds: Unknown
Lab Data: Neurological 05/22/07 - Reflexes normal. No signs of sensory loss. Diagnostic laboratory 05?/??/07 - results not reported. Erythrocyte 05?/??/07 - normal,
serum C-reactive 05?/??/07 - normal
History:
Prex Illness: Guillain-Barre syndrome
Prex Vax Illns:

Vaers Id: 279424-1

26.0 F 30-Nov-2006 26-Dec-2006 26 23-May-2007 24-May-2007 -- WAES0702USA04650 24-May-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Surgery, Uterine dilation and curettage
Symptom Text: Information has been received from a registered nurse through the manufacturer pregnancy registry concerning a 26 year old female patient, with a "history of
asthma in 1999," who on 30-NOV-2006 was vaccinated with the first dose, 0.5ml, of Gardasil. The nurse stated that the patient reported she was "5 weeks
pregnant" on 30-JAN-2007. Pregnancy was confirmed via pregnancy test (not specified). The approximate date of conception was 26-DEC-2006, with an
estimated due date of 02-OCT-2007. On 22-FEB-2007, at approximately 8 weeks of pregnancy, the patient "had a miscarriage." The patient went to the
emergency room (ER) on 22-FEB-2007 due to the miscarriage, but she was not admitted. On 23-FEB-2007, the patient had a dilatation & curettage (D & C)
performed. The nurse reported that the patient "was not seen in the physician office for her pregnancy," and added that she "had recovered from the events"
(date not specified). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: beta-human chorionic 01/30/07 5 weeks pregnant
History: Asthma
Prex Illness:
Prex Vax Illns:


13.0 F 16-May-2007 16-May-2007 0 23-May-2007 29-May-2007 CA 25-Jul-2007
MedDRA PT Dyspnoea, Facial paresis, Guillain-Barre syndrome, Headache, Muscular weakness, Muscular weakness, Pain in extremity, Rash maculo-papular
Symptom Text: Weakness of legs, upper extremity, facial weakness rash all over body - was diagnosed with GB syndrome and hospitalized for IVIG and LP 7/25/07-records
received -DX: Guillain Barre. Day before admission 5/18/07-developed macular papular rash on face and headache pain in both legs, shortness of breath.
Admitted on 5/19/07- Unsuccessful spinal tap. Treated with IVIG and there was no progressive loss of muscle tone no loss of sensation. Good muscle tone
Other Meds: none
Lab Data: CBC LP-failed records received 7/25/07-WBC 13.9, neutrophils 79. ESR26
History: none
Prex Illness: none
Prex Vax Illns:


13.0 F 16-May-2007 16-May-2007 0 01-Aug-2007 02-Aug-2007 -- 200702574 08-Aug-2007
MNQ SANOFI PASTEUR U2158A Right arm Unknown
MedDRA PT Facial paresis, Guillain-Barre syndrome, Immunoglobulins, Lumbar puncture, Muscular weakness, Rash generalised
Symptom Text: This case was received from another manufacturer (reference number WAES0707USA00714 / VAERS # 279425) on 19 July 2007. The following information is
verbatim as it appears in the other manufacturer's report: "This report was identified from a line listing obtained on request by the Company from the FDA under
the Freedom of Information Act. A 13 year old female patient, on 16 May 2007, was vaccinated IM in the left arm with a second dose of Gardasil (lot#
655617/1447F) and in the right arm with Menactra (Lot# U2158AA). On 16 May 2007 the patient experienced weakness of her legs and upper extremities,
facial weakness and a rash all over her body. She was diagnosed with Guillain-Barre syndrome, and was hospitalized for intravenous immune globin (IVIG) and
lumbar puncture (LP). The outcome of the event was unknown. The original reporting source was not provided." the patient's medical history and concomitant
medications were unknown.
Other Meds:
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279430-1

11.0 F 10-Apr-2007 14-May-2007 34 23-May-2007 01-Jun-2007 WI 01-Jun-2007
TTOX GLAXOSMITHKLINE AC52B014BA Left arm Intramuscular
BIOLOGICALS
MedDRA PT Arthritis, Differential white blood cell count, Oedema peripheral, Pain in extremity
Symptom Text: Painful, swollen left heel without trauma arthritis left foot.
Other Meds:
Lab Data: C-reactive protein, X-ray foot, CBC with diff, Sedimentation rate
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279432-1

24.0 F 18-Apr-2007 18-Apr-2007 0 23-May-2007 01-Jun-2007 NC 01-Jun-2007

MedDRA PT Injection site nodule
Symptom Text: Approximately 3/4cm nodule at injection site

Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279433-1

14.0 F 16-May-2007 17-May-2007 1 23-May-2007 01-Jun-2007 NY 01-Jun-2007

MedDRA PT Urticaria
Symptom Text: Urticarial rash began about 24 hours after vaccines were given patient also had bloodwork drawn after receiving her vaccine. Patient returned to office 2 days
after vaccine was given; rash improved with Benadryl somewhat completely improved with Atarax.
Other Meds: None
Lab Data:
History: allergic rhinitis, allergen to ragweed pollen, mites and house dust
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279454-1

13.0 F 26-Mar-2007 26-Mar-2007 0 24-May-2007 25-May-2007 -- WAES0705USA03775 25-May-2007

MedDRA PT Chest pain, Dyspnoea, Nausea, Oedema peripheral, Pain in extremity, Swelling face, Vomiting
Symptom Text: Information has been received from a nurse practitioner concerning a 13 year old female who on 26-MAR-2007 was vaccinated with Gardasil. On 26-MAR-2007
the patient developed swelling of the arm, arm and chest pain, nausea, vomiting, facial swelling and difficulty breathing. The patient went to the emergency
room and was treated with Phenergan. Subsequently, the patient recovered. The nurse practitioner reported that she never saw this type of reaction before and
that the patient never reacted to any other vaccine. The reporter felt that the swelling of the arm, arm and chest pain, nausea, vomiting, facial swelling and
difficulty breathing were other important medial events. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279455-1 (S)

13.0 F 07-May-2007 07-May-2007 0 24-May-2007 25-May-2007 FR WAES0705AUS00079 25-May-2007

MedDRA PT Asthenia, Conversion disorder, Hypoaesthesia, Lethargy, Muscular weakness, Syncope
Symptom Text: Information has been received from the Department of Health as part of a business agreement (manufacturer's number: GARD 2007 05 16 004). As part of the
regular school-based immunisation program funded by the government, several female students was vaccinated with Gardasil vaccine (Lot No. 655743/0313U,
Batch No. J1022, Expiry date August 2009). Subsequently the patients experienced fainting (the patient reported as below does not have a record of fainting
according to follow-up information) and were taken to hospital. It was stated that most of the cases were not serious. The reporter felt that the reactions were
related to therapy with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). Follow-up information was received. At the time of
reporting on 08-MAY-2007, it was stated that all girl have recovered, although some were possibly admitted to hospital overnight. None were intubated. The
provisional diagnosis appeared to be "hysterical reaction." Follow-up information was received from a physician. The patient was a 13 year old female school
girl with no past medical history and no known allergy. After vaccination with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009) on
07-MAY-2007, she experienced general weakness. On neurological examination at "approximately 5 - 10 mins" post vaccination, the patient showed right leg
numbness (approximately L2 - L5) and right leg weakness (1/5 power whole leg). She was transferred to emergency department. Treatment was reported as
"observation". No sequelae were reported. At the time of reporting (date not reported), the patient had not yet recovered (also reported as recovered in follow-
up information on 08-MAY-2007). Follow-up information was received via a Surveillance of Adverse Events Following Vaccination in the Community. On 07-
MAY-2007, within minutes of vaccination with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009), the patient reported right leg
weakness of 1/5 power, no sensation to pain
Other Meds: Unknown
Lab Data: vital signs 07May07 normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279468-1

19.0 F 17-May-2007 18-May-2007 1 24-May-2007 31-May-2007 WA 31-May-2007

MedDRA PT Syncope
Symptom Text: Syncoval episode the day after administration

Other Meds: Spironolactone, Fluoxetine
Lab Data:
History: Paracystic ovary
Prex Illness: Vaginitis/MLL
Prex Vax Illns:

Vaers Id: 279470-1

26.8 F 16-May-2007 16-May-2007 0 24-May-2007 01-Jun-2007 GA NOC006410901 01-Jun-2007

MedDRA PT Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pain
Symptom Text: Patient called on 5/17/07 at 10:00 am (24 hours after injection to complain of immediate stinging at injection site followed by slight redness and severe pain.
Difficulty moving arm. Had 1st injection on 3/16/07 with no adverse reaction. (48 hours later still complain of slight soreness).
Other Meds: Yasmin 28
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279474-1

12.0 F 15-May-2007 17-May-2007 2 24-May-2007 01-Jun-2007 CA 01-Jun-2007
MedDRA PT Body temperature, Injection site erythema, Injection site induration
Symptom Text: 5/15/07 Child came in for well child exam visit; receiving Varicella and HPV vaccine. 5/17/07: Doctor visit progress notes read as follows: immunization 2 days
ago, HPV and Varicella. Sibling also here with similar reaction. Temp 97.2F. Physical examination: 1/2 dollar sized area of induration and erythema left arm at
injection site. Adv- Benadryl, rech prn.
Other Meds: Retin-A 0.1% Topical cream
Lab Data: None ordered
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279483-1

14.0 F 14-Sep-2006 14-Sep-2006 0 17-May-2007 14-Jun-2007 -- WAES0704USA03744 15-Jun-2007

MedDRA PT Pyrexia, Reaction to previous exposure to any vaccine
Symptom Text: Information has been received from a physician's nurse concerning her 14 year old daughter who on 14-SEP-2006 was vaccinated with the first dose Gardasil
(lot #653735/0688F). Concomitant therapy included Fluzone. On 09-NOV-2006, the patient received the second dose of Gardasil (lot653735/0688F). On 21-
MAR-2007, the patient received the third dose of Gardasil (lot #655503/0012U). The nurse reported that after her daughter received all three injections, she
experienced a high fever of 103-104 degrees fahrenheit. The fever resolved each time after about one day. Additional information has been requested.
Other Meds: FLUZONE
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279484-1

Unknown F Unknown 01-Dec-2006 17-May-2007 14-Jun-2007 WI WAES0704USA03900 15-Jun-2007

MedDRA PT Menstrual disorder
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) which borderline mental retardation who on an unspecified date
was vaccinated with a first dose of Gardasil. On an unspecified date, the patient was vaccinated with a second dose of Gardasil (lot # not reported) 0.5 ml
injection. In December 2006, the patient experienced an interruption of her menstrual cycle after receiving the second dose of vaccine. The patient sought
medical attention. At the time of reporting, the patient had not recovered. No further information was provided at the time of reporting. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Borderline mental impairment
Prex Vax Illns:

Vaers Id: 279485-1

25.0 F 13-Feb-2007 Unknown 17-May-2007 14-Jun-2007 MA WAES0704USA03901 15-Jun-2007

Symptom Text: Information has been received from a physician, concerning a 25 year old female patient who on 13-FEB-2007 was vaccinated with the first dose, 0.5ml, IM, of
Gardasil (Lot #655503/0012U). There was no concomitant medication. The physician reported that "shortly after her first dose of Gardasil," the patient
experienced nausea and vomiting. At the time of this report, the physician confirmed that the patient had recovered (date not specified). The patient sought
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279486-1


MedDRA PT Syncope
Symptom Text: Information has been received from a licensed practical nurse concerning a female "teenager" (exact age unspecified) who in March 2007, was vaccinated
intramuscularly with a first 0.5 mL dose of Gardasil. Shortly after administration of the vaccine, the patient fainted. It was noted that the patient received allergy
shots often and had never fainted prior to this event. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The
patient recovered the same day and did not have to go to the emergency room. No product quality complaint was noted. Additional information has been
requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279487-1

18.0 F 17-Apr-2007 17-Apr-2007 0 17-May-2007 14-Jun-2007 VA WAES0704USA03925 14-Jun-2007

MedDRA PT Syncope
Symptom Text: Initial and follow-up information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 year old female patient who on 17-APR-2007
was vaccinated IM in left deltoid with a first dose of Gardasil (lot # 0378U not valid). Concomitant therapy included cetirizine hydrochloride (ZYRTEC). On 17-
APR-2007 the patient fainted in her chair soon after the administration of her first injection. She recovered quickly after she was placed on the floor and her
legs were elevated. Additional information has been requested.
Other Meds: Zyrtec
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279488-1


MedDRA PT Dizziness, Nausea, Pallor, Syncope
Symptom Text: Information has been received from a physician concerning an 18 year old female with no known drug reactions/allergies who was vaccinated with Gardasil.
Subsequently, the patient experienced dizziness, nauseous, starting to faint throughout the evening and pale. Therapy with human papillomavirus vaccine was
discontinued. Subsequently, the patient recovered from dizziness, nauseous, starting to faint throughout the evening and turned pale. The product quality
complaint unit was not involved. No further information is available.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279489-1


MedDRA PT Adverse event, Unevaluable event
Symptom Text: Information has been received from a pharmacist concerning a patient who was vaccinated with Gardasil. Subsequently the patient experienced an unspecified
adverse experience. No further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279490-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse in a physician's office concerning a female patient in her "late teens" with no drug reactions/allergies and with a
history of anxiety problems who was vaccinated with Gardasil. Subsequently the patient fainted after receiving Gardasil. No lab tests were performed. The
patient sought unspecified medical attention. Additional information is not expected.
Other Meds: Unknown
Lab Data: None
History: Anxiety
Prex Illness:
Prex Vax Illns:

Vaers Id: 279491-1

Unknown F Unknown Unknown 17-May-2007 14-Jun-2007 CA WAES0704USA04049 15-Jun-2007

MedDRA PT Injection site irritation
Symptom Text: Information has been received from a registered nurse concerning "about 35" female patients who were vaccinated with 0.5 ml of Gardasil and who
experienced burning at the injection site. The patients sought unspecified medical attention. Therapy with Gardasil was discontinued. Attempts are being made
to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279492-1


MedDRA PT Rash, Reaction to previous exposure to any vaccine
Symptom Text: Information has been received from a 24 year old female who on an unspecified date, was vaccinated with her first dose of Gardasil. Subsequently the patient
experienced rash that went up from her arm to her shoulders. On 12-APR-2007 was vaccinated with her second dose of Gardasil. On 12-APR-2007 the patient
experienced rash that went up from her arm to her shoulders. Subsequently, the patient recovering. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279493-1

18.0 F 09-Apr-2007 Unknown 17-May-2007 14-Jun-2007 -- WAES0704USA04062 15-Jun-2007

Symptom Text: Initial and follow up information has been received from a physician concerning an 18 year old female patient, with a suspected strep infection on 27-MAR-2007
("two weeks prior"), who on 09-APR-2007 was vaccinated with the third dose of Gardasil (route and dose not specified). The physician reported that after
receiving Gardasil, the patient experienced arthralgia (date not specified). The physician reported that the following diagnostic testing had been performed
(dates not specified), antistreptolysin (ASO), elevated, C-reactive protein (CCRP), elevated antinuclear antibodies test (ANA), minimally elevated; erythrocyte
sedimentation rate, negative, rheumatoid factor, negative; and testing for Lyme disease, result pending. Patient outcome was unknown, as the physician was
unable to contact the patient. Additional information has been requested.
Other Meds: Unknown
Lab Data: Lyme disease assay - Pending erythrocyte - elevated serum C-reactive - elevated serum ANA - minimally elevated serum antistreptolysin - elevated serum
rheumatoid factor - negative
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279494-1

HEP UNKNOWN MANUFACTURER NULL Unknown Unknown
MedDRA PT Pain
Symptom Text: Information has been received from a pharmacist concerning her daughter, a 14 year old female with an amoxicillin allergy who on 06-FEB-2007 was
vaccinated with Gardasil. Concomitant therapy included hepatitis B virus vaccine (unspecified) in the other arm. On 06-FEB-2007, at the time of administration,
the patient experienced severe pain. The patient sought unspecified medical attention. On 07-FEB-20074, after a day, the patient recovered from severe pain.
Other Meds:
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 279495-1


MedDRA PT Injection site bruising
Symptom Text: Information has been received from a nurse, concerning a female patient who was vaccinated with the first dose, 0.5ml, Gardasil (date unspecified).
Subsequently the patient experienced bruising at the injection site. At the time of this report, the nurse confirmed that the patient had recovered. The patient
sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279496-1

Unknown F 18-Apr-2007 Unknown 17-May-2007 18-Jun-2007 -- WAES0704USA04210 18-Jun-2007

Symptom Text: Information has been received from a physician concerning a female (age unspecified) who on 18-APR-2007 was vaccinated with a first dose of Gardasil.
Subsequently, on an unspecified date, the patient experienced nausea and vomiting. The patient sought unspecified medical attention. At the time of this
report, the outcome was unknown. No product quality complaint was involved.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279497-1

26.0 F 14-Nov-2006 15-Nov-2006 1 17-May-2007 18-Jun-2007 OH WAES0704USA04225 18-Jun-2007

MedDRA PT Adnexa uteri pain, Nausea, Pain, Vomiting
Symptom Text: Information has been received from a registered nurse concerning her 26 year old female daughter who on 14-NOV-2006 was vaccinated with the first dose of
Gardasil, injection, 0.5 ml. Concomitant therapy included Ortho Tri-Cyclen. On 15-NOV-2006 the following day after receiving the first dose of Gardasil, the
patient experienced nausea, vomiting and severe ovary aches. On 12-DEC-2006, the second dose of Gardasil, the patient experienced nausea, vomiting and
severe ovary aches. The third dose of Gardasil was received on 13-APR-2007. On 14-APR-2007, the patient experienced nausea, vomiting and the patient has
recovered from the events. Additional information has been requested.
Other Meds: Ortho Tri Cyclen
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279498-1


MedDRA PT Throat irritation
Symptom Text: Information has been received from a nurse practitioner concerning a 15 year old female who on 09-APR-2007 was vaccinated with Gardasil. On 09-APR-2007
the patient experienced a tickly feeling in her throat for about 24 hours after receiving the vaccine. She needed to clear her throat constantly. It was reported
that the subject unspecified medical attention. Subsequently, the patient recovered from tickly feeling in her throat. This is one of two reports that was received
from the same source for a sibling. No further details were provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns: pharynx itchy sensation~HPV (Gardasil)~1~19~In Sibling

Vaers Id: 279499-1


Symptom Text: Information has been received from a physician concerning three female patients who were vaccinated with Gardasil. Subsequently the patients passed out
after receiving the vaccine. Subsequently, the patients recovered from passing out. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279500-1


MedDRA PT Neck pain, Pain
Symptom Text: Information has been received from a physician concerning a 16 year old female who on 13-FEB-2007 was vaccinated with the first dose of Menactra. The
physician reported that the patient experienced aching in her body and neck after receiving the first dose. The patient subsequently recovered. The patient had
since received the second dose of Gardasil and did not experience the symptoms again. Additional information has been requested.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279501-1


MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a 13 year old female with a history of eczema who in April 2007, was vaccinated with Gardasil. In
April 2007, within 24 hours later after receiving the vaccine, the patient experienced a rash behind her knee. It was reported that the patient sought unspecified
medical attention. No further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Eczema
Prex Illness:
Prex Vax Illns:

Vaers Id: 279502-1


MedDRA PT Presyncope
Symptom Text: Information has been received from a nurse practitioner concerning a female (age unknown) who on 19-APR-2007 was vaccinated with a first dose of Gardasil.
After receiving the Gardasil, the patient "almost fainted". The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On
19-APR-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279503-1

21.0 F 18-Dec-2006 18-Dec-2006 0 17-May-2007 18-Jun-2007 -- WAES0704USA04291 18-Jun-2007

Symptom Text: Information has been received from a registered nurse, concerning a 21 year old female student with asthma, polycystic ovaries and migraines, who on 18-
DEC-2006 was vaccinated IM in the gluteal area, with the second dose, 0.5ml, of Gardasil (Lot #654540/1161F). Concomitant therapy included Yasmin, Zomig,
Imitrex tablets and albuterol inhaler. The nurse reported that the patient complained of pain at the injection site. At the time of this report, the nurse confirmed
that the patient had recovered (date unspecified). The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: albuterol, YASMIN, IMITREX TABLETS, ZOMIG
Lab Data: None
History:
Prex Illness: Asthma, Polycystic ovaries; Migraine
Prex Vax Illns:

Vaers Id: 279504-1


MedDRA PT Chest pain, Dyspnoea, Limb discomfort, Muscle spasms
Symptom Text: Information has been received from an office receptionist concerning a 20 year old female patient with family history of heart disease, allergic reaction to
antibiotics, who on 02-FEB-2007 was vaccinated IM with a first dose of Gardasil lot #654741/0013U. Concomitant therapy included Ortho Tri-Cyclean Lo. On
02-FEB-2007 the patient developed arm soreness but otherwise felt fine. In April 2007 patient was vaccinated IM with the second dose of Gardasil lot
#657621/0387U. Within one to one and half hours after the second injection patient developed muscle spasm in chest area which radiated from left chest to
center. She described pain as sharp intermittent and took her breath away. On 18-APR-2007 she took Advil for something else (not specified) and it helped
pain a little but was not relieved. The physician instructed patient to go the emergency room (ER). Patient was planning to go to the ER on 19-APR-2007. At the
time of this report the patient had not recovered. Additional information has been requested.
Other Meds: ORTHO TRI-CYCLEN LO
Lab Data: Unknown
History:
Prex Illness: Allergic reaction to antibiotics
Prex Vax Illns:

Vaers Id: 279505-1

23.0 F 27-Feb-2007 27-Feb-2007 0 17-May-2007 18-Jun-2007 NH WAES0704USA04296 18-Jun-2007

MedDRA PT Cervical dysplasia, Drug exposure during pregnancy, Nausea
Symptom Text: Information has been received from a Certified Medical Assistant through Merck Pregnancy concerning a 23 year old female patient with moderate dysplasia of
the cervix and a history of loop electrosurgical excision procedure (LEEP) who on 02-JAN-2007 was vaccinated IM in right deltoid with a first dose of Gardasil
and had menstruation cycle on that day. On 27-FEB-2007 the patient was vaccinated IM in right deltoid with a second dose of Gardasil. Concomitant therapy
included Mirena IUD birth control. On 05-MAR-2007 the patient presented to office experiencing nausea. Urine pregnancy test was performed and it was
positive for pregnancy. The reporter stated that client had unusual history; her birth control was a Mirena IUD but on manual examination it was not found. The
MA stated that it must have expulsed. She had a cervical smear (PAP) test done which showed moderate dysplasia. On 04-NOV-2006 patient had Leep
procedure performed. The patient's outcome was unknown. Additional information has been requested.
Other Meds: MIRENA
Lab Data: cervical smear 03/05/07 - moderate dysplasia CIN, urine beta-human - positive
History: Loop electrosurgical excision procedure
Prex Illness: Pregnancy NOS (LMP = 1/2/2007); Dysplasia
Prex Vax Illns:

Vaers Id: 279506-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced
fainted. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279507-1

13.0 F 19-Apr-2007 Unknown 17-May-2007 18-Jun-2007 PA WAES0704USA04413 18-Jun-2007

MedDRA PT Asthenia, Dizziness
Symptom Text: Information has been received from a physician concerning a 13 year old female patient who on 19-APR-2007 was vaccinated with a dose of Gardasil. Patient
developed dizziness and weakness after the vaccine was administered. Unspecified medical attention was sought was unknown. Additional information has
been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279508-1


Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated "a few months ago" with a dose of Gardasil. The patient
experienced pain in the arm from the injection site to the fingers after receiving the dose of Gardasil. Unspecified medical attention was sought. Patient's
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279509-1

17.0 F 18-Apr-2007 18-Apr-2007 0 17-May-2007 18-Jun-2007 CA WAES0704USA04418 18-Jun-2007

Symptom Text: Information has been received from a physician concerning a 17 year old female patient who on 02-FEB-2007 was vaccinated with a first dose of Gardasil. On
18-APR-2007 she was vaccinated with a second dose of Gardasil lot #654702/0011U and developed a rash (site unknown) and hives. She was sent to Urgent
care center. Patient would not receive the third dose of Gardasil based on her experience with the second injection. The outcome of the event was unknown.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279510-1


MedDRA PT Menstruation irregular
Symptom Text: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil IM. Subsequently the patient experienced
menstrual irregularity. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279511-1


MedDRA PT Exposure to communicable disease, Urticaria, Varicella
Symptom Text: Information has been received from a nurse practitioner (NP), via a company representative, concerning an 11 year old female who on 12-APR-2007 was
vaccinated with the second dose Gardasil. Concomitant therapy included Boostrix. On 16-APR-2007 the patient experienced intermittent hives that look like tiny
pimples that are not itchy. The event persisted as of 20-APR-2007. Follow up information from the NP, via the company representative, confirmed that the
patient's hives/rash was "diagnosed as a case of chicken pox." The NP stated that there was an outbreak in the patient's school district. At the time of this
report, the patient had not recovered from the chicken pox. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: BOOSTRIX
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279512-1


Symptom Text: Information has been received from a Nurse Practitioner (N.P.) concerning a patient who was vaccinated with a dose of Gardasil. Subsequently the patient
developed genital warts. The outcome of the patient was unknown. The NP reported that two other patients developed genital warts after receiving the
Gardasil. She verbalized concern that she seen three episodes of genital warts developing soon after Gardasil. She believed the patient's immune systems can
not handle the viral load. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279513-1

15.0 F 12-Apr-2007 13-Apr-2007 1 17-May-2007 15-Jun-2007 CA WAES0704USA05020 18-Jun-2007

MedDRA PT Eye swelling, Eyelid oedema, Fatigue, Pyrexia, Rash, Swelling face, Urticaria
Symptom Text: Information has been received via The Poison Control Center and from a consumer concerning her daughter, a 15 year old female, who on 12-APR-2007 was
vaccinated with Gardasil. It was reported that on Friday, 13-APR-2007 and over the weekend, the patient experienced being very tired and developed puffy
eyes. On May, approximately, 16-APR-2007, the patient's eyelids started getting puffier. On Tuesday, approximately 17-APR-2007, it was reported that the
patient had increased puffiness of eyelids. On Wednesday, 18-APR-2007 the patient developed face swollen and was seen by ("ENT"). On Friday, 20-APR-
2007 the patient was seen by the primary care physician (PCP) and had developed rash and hives. At the time of the report, the patient had a fever of 102 and
increased rash and hives. It was recommended that the patient go to the Emergency Room (ER) for an evaluation. At the time of the report, it was unknown, if
the patient recovered. Additional information has been requested.
Other Meds:
Lab Data: body temp 04/20?/07 102
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 279514-1

Unknown F Unknown Unknown 17-May-2007 15-Jun-2007 AZ WAES0704USA05053 18-Jun-2007

MedDRA PT Erythema, Oedema peripheral, Pain in extremity, Skin warm
Symptom Text: Information has been received from a Medical Assistant (M.A.) concerning a female patient who was vaccinated with a first dose of Gardasil. The patient
developed her arm being sore, red and hot one day after the injection was given (a Friday). The patient was seen on Monday and the arm was not as red,
swollen and hot. She was told to take Tylenol for discomfort. The MA believed that the patient had the second dose of Gardasil and she was okay. The
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279515-1

21.0 F Unknown 01-Apr-2007 17-May-2007 15-Jun-2007 TN WAES0704USA05057 18-Jun-2007
MedDRA PT Contusion, Injection site erythema, Injection site irritation, Injection site pain, Injection site pain, Injection site pruritus, Injection site swelling, Injection site
warmth
Symptom Text: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female patient who on 08-FEB-2007 was vaccinated IM
with a first dose of Gardasil and on 17-APR-2007 was vaccinated IM in the left deltoid a second dose of Gardasil lot #655849/0263U. Concomitant therapy
included Adderall Tablets and thyroid medication (therapy unspecified). A few days after receiving the second injection, the patient developed tenderness,
soreness, erythema, swelling. warmth, burning and pruritus in the injection site area of her left arm. She also developed a red bruise on her chest, medical
attention was sought. Patient had not recovered. Additional information has been requested.
Other Meds: (therapy unspecified), ADDERALL TABLETS
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279516-1

16.0 F 21-Apr-2007 21-Apr-2007 0 17-May-2007 15-Jun-2007 OH WAES0704USA05060 18-Jun-2007

MedDRA PT Asthma
Symptom Text: Initial and follow up information has been received from a Certified Registered Nurse Practitioner (CRNP) concerning a 16 year old female student with asthma
who on 21-APR-2007 at 9:30 AM was vaccinated IM with a first dose of Gardasil (lot #0210U not valid). Concomitant therapy included montelukast sodium and
albuterol over the counter (OTC)-10. On 21-APR-2007 at 5:00PM the patient developed exacerbation of asthma with activity during two basketball games one
at 5:00PM and one at 8:00PM. She used albuterol 7 times during the basketball game. Normally she didn't need to use the albuterol that many times. On 22-
APR-2007 the patient recovered in the AM. Additional information is not expected.
Other Meds: albuterol, SINGULAIR
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 279517-1


MedDRA PT Cellulitis
Symptom Text: Information has been received from an office worker in a physician's office concerning her 13 year old daughter, who on 18-APR-2007 was vaccinated with a
first dose of Gardasil and developed cellulitis. She went to the Emergency Room (E.R.) and received an anti-biotic. The patient was recovering. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279518-1

33.0 F 09-Sep-2006 09-Sep-2006 0 17-May-2007 15-Jun-2007 IL WAES0704USA04497 13-Jul-2007
MedDRA PT Hypoaesthesia, Inappropriate schedule of drug administration, Medication error, Pain in extremity, Paraesthesia, Restless legs syndrome, Vaccine positive
rechallenge
Symptom Text: Information has been received from a nurse, via a company representative, concerning a 34 year old female patient, who on 09-SEP-2006 was vaccinated with
the first dose, 0.5ml, of Gardasil (Lot #653937/0637F). Concomitant therapy included Loestrin and Detrol LA. The nurse reported that after the vaccine was
administered (date unspecified), the patient "experienced tingling and numbness in most areas of her body." On an unspecified date, the patient received her
second dose, 0.5 ml, IM, of Gardasil (Lot #653938/0954F), and had a recurrence of the numbness and tingling in her body. On 20-MAR-2007, the patient
received her third dose, 0.5ml, IM, of Gardasil (Lot #655849/0263U), and once again had a recurrence of the numbness and tingling in her body (date
unspecified). A magnetic resonance imaging test was performed (date unspecified), and was negative. At the time of this report, the nurse confirmed that the
patient had not recovered. Additional information has been requested. 6/27/07-records received for DOS 3/27/07-6/15/07-On 3/27/07-presented with bilateral
leg pain, numbness and tingling. No strength issues. Seeing neurologist. Note on 4/26/07-suspect restless leg syndrome for her migratory sensory discomfort
in all 4 limbs and torso. Neuro exam did not show peripheral neuropathy. Note on 6/20/07-Sensory 85% better.
Other Meds: LOESTRIN, DETROL LA
Lab Data: MAGNETIC RESONANCE - Negative records received 7/12/07-CRP and ESR negative.MRI lumbo sacral spine Small diffuse bulge at L4-5. MRI thoracic
spine. Minimal degenerative disc disease within thoracic spine.MRI cervical spine. Minimal cervica
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 279519-1


MedDRA PT Molluscum contagiosum
Symptom Text: Information has been received from a Registered Nurse (R.N.) manager concerning a female patient who was vaccinated with a first dose of Gardasil. The
patient developed "a rash known as "Molloscum Contagiousum" on her stomach after the injection. The Nurse Manager did not believe that the rash was
related to Gardasil because it was a virus. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279520-1


MedDRA PT Vaccine positive rechallenge, Vomiting
Symptom Text: Information has been received from a nurse practitioner concerning a 25 year old female who on 20-OCT-2006 was vaccinated with the first dose of Gardasil,
injection, 0.5 ml. Concomitant therapy included Ortho Tri-Cyclen. On approximately 27-OCT-2006 one week after receiving the first dose of Gardasil, the patient
developed vomiting. On 19-DEC-2006, the patient received the second dose of Gardasil. On approximately 26-DEC-2006 one week after received the second
dose of Gardasil, the patient developed vomiting. The patient sought unspecified medical attention. Subsequently on unspecified dates, the patient recovered
from the events of vomiting. Additional information has been requested.
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279521-1


MedDRA PT Erythema, Injection site rash, Pyrexia, Rash, Urticaria
Symptom Text: Initial and follow up information has been received from a nurse practitioner (NP)/ certified nurse midwife, and a nurse, concerning a 17 year old caucasionr
female patient, who on 17-APR-2007, at 3:30pm was vaccinated IM in the left deltoid with the first dose of Gardasil (Lot #657617/0384U). Concomitant therapy
included Yasmin. There was no known illness at the time of vaccination. The nurse practitioner reported that 18-APR-2007, (previously reported by the nurse as
on the same day, 17-APR-2007), the patient developed a rash on the left arm (the arm of injection), which later spread to both arms; the rash was described as
"redness with urticarial raised patches." The nurse added that the patient also developed a fever. At the time of this report, the NP confirmed that the patient
had recovered from the rash and fever (date unspecified). The patient sought unspecified medical attention. No further information is expected. Additional
Other Meds: YASMIN
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279522-1


MedDRA PT Nausea, No reaction on previous exposure to drug, Vomiting
Symptom Text: Information has been received from a nurse practitioner concerning his 18 year old female step daughter who in 2007 was vaccinated with the third dose of
Gardasil. Concomitant medication was not reported. Nurse practitioner reported that the patient completed the series and did not experience a reaction with
dose one or two. In 2007 within 24 hours of receiving the third vaccination of Gardasil, the patient experienced nausea and vomiting. The patient sought
unspecified medical attention. Subsequently on an unspecified date, the patient recovered from nausea and vomiting. Additional information has been
requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279523-1

15.0 F 09-Mar-2007 09-Mar-2007 0 17-May-2007 18-Jun-2007 MO WAES0704USA04661 18-Jun-2007

MedDRA PT Influenza like illness, Nausea
Symptom Text: Information has been received from a physician, via a company representative, concerning the physician's daughter, age 15 or 16 years, who on approximately
09-MAR-2007 ("about six weeks ago") was vaccinated, IM, with the third dose of Gardasil. The physician reported that following the vaccination, his daughter
experienced flu-like symptoms and nausea, that lasted for three days after the vaccine had been administered, approximately 12-MAR-2007. The physician
confirmed that following the three days, his daughter was "fine". The patient's sister also experienced flu-like symptoms and nausea after vaccination with
Gardasil (WAES #0704USA05005). Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279524-1

16.0 F 06-Apr-2007 06-Apr-2007 0 17-May-2007 18-Jun-2007 MO WAES0704USA04710 18-Jun-2007

Symptom Text: Information has been received from a physician concerning a 16 year old female who on approximately 06-APR-2007 was vaccinated with the third dose of
Gardasil and experienced flu like symptoms and nausea. Subsequently, the patient recovered from flu like symptoms and nausea. Medical attention was
sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279525-1

20.0 F 01-Aug-2006 01-Aug-2006 0 17-May-2007 18-Jun-2007 TX WAES0704USA04711 18-Jun-2007

MedDRA PT Scar, Skin discolouration
Symptom Text: Information has been received from a nurse concerning a 20 year old white female student who in August 2006, was vaccinated with a first dose of Gardasil. In
August 2006, the patient developed discoloration and circular scarring. In November 2006, the patient was vaccinated with a second dose of Gardasil. At the
time of the report, the patient's outcome was unknown. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279526-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 NM WAES0704USA04725 18-Jun-2007

MedDRA PT Dizziness, Feeling cold, Hypoaesthesia, Hypotension, Injection site pain, Mobility decreased, Pyrexia
Symptom Text: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of Gardasil (lot # "0014V"). Almost
immediately after the vaccination, the patient experienced pain at the injection site, cold and numbness is her left arm and was unable to make a fist with her
left hand. Seven minutes later the patient experienced dizziness. The physician reported that the patient's blood pressure lower then normal at that time.
Fourteen minutes later the patient developed a fever of 101 degrees. The patient was treated with ibuprofen 600 mg. Twenty-five minutes later patient's fever
99.1 degrees and her other vital signs were stable. Subsequently, the patient recovered and was sent home. Additional information has been requested.
Other Meds: Unknown
Lab Data: body temp 99.1; body temp 101
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279527-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 PA WAES0704USA04742 18-Jun-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Immediately after the vaccination, the patient
experienced dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279528-1


Symptom Text: Information has been received from a registered nurse concerning a female who on 03-FEB-2007 was vaccinated with Gardasil. In 2007 the patient
experienced mononucleosis. The patient's mononucleosis persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279529-1

28.0 F 11-Apr-2007 11-Apr-2007 0 17-May-2007 18-Jun-2007 NM WAES0704USA04810 05-Jul-2007

MedDRA PT Inappropriate schedule of drug administration, Injection site swelling, Lethargy, Malaise, Nodule, Pyrexia, Swelling
Symptom Text: Information has been received from a physician's assistant concerning a 28 year old female (67inches, 227lbs.) with hypothyroidism, drug hypersensitivity to
morphine sulfate, DEMEROL and ZITHROMAX who on 11-APR-2007 was vaccinated with the first dose of Gardasil (Lot#657617/0384U) intramuscularly in the
left deltoid. Concomitant therapy included paroxetine, LEVOXYL and MIRCETE. Within 24 hours, on 12-APR-2007, the patient experienced significant swelling
at injection site, swelling/swollen nodular area over left clavicle, significant malaise/lethargy and low grade fever. As of 20-APR-2007 the patient was
significantly improved and considered recovered. The patient declined an appointment. Additional information has been requested.
Other Meds: MIRCETE; LEVOXYL; paroxetine
Lab Data: None
History:
Prex Illness: Hypothyroidism; Drug Hypersensitivity; Allergic reaction to antibiotics
Prex Vax Illns:

Vaers Id: 279530-1

Unknown U 03-Feb-2007 Unknown 17-May-2007 18-Jun-2007 -- WAES0704USA04814 18-Jun-2007

Symptom Text: Information has been received from a registered nurse concerning a patient who on 03-FEB-2007 was vaccinated with the first dose of Gardasil. The patient
had not yet received the second dose. The second dose was delayed since the patient developed mononucleosis in 2007. The outcome was not reported.
Additional information has been requested
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279531-1


one several reports received from the same source. Additional information has been requested.
Other Meds:
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279532-1

diagnostic studies were performed. the patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is
one of several reports received from the same source. Additional information has been requested.
Other Meds:
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279533-1

vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on and unspecified date, the patient felt dizzy and fainted. It was noted that the
patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No
laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was
involved. This is one of several reports received from the same source. Additional information has been requested.
Other Meds:
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279534-1

one of several reports from the same source. Additional information has been requested.
Other Meds:
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279535-1

Other Meds:
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279536-1

Other Meds:
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279537-1


Other Meds:
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279538-1


MedDRA PT Vomiting
Symptom Text: Information has been received from a registered nurse, concerning a 20 year old female patient, who on 23-APR-2007 was vaccinated with a dose, 0.5ml, IM,
of Gardasil (Lot #654272/0319U). The nurse reported that the patient "vomited 3 times within the first hour of vaccination." At the time of this report, the patient
had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: none
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279539-1

15.0 F 09-Mar-2007 09-Mar-2007 0 17-May-2007 18-Jun-2007 MO WAES0704USA05005 18-Jun-2007

Symptom Text: Information has been received from a physician, via a company representative, concerning the physician's daughter, age 15 or 16 years, who on approximately
09-MAR-2007 ("about six weeks ago") was vaccinated, IM, with the third dose Gardasil. The physician reported that following the vaccination, his daughter
experienced flu-like symptoms and nausea, that lasted for three days after the vaccine had been administered, approximately 12-MAR-2007. The physician
confirmed that following the three days, his daughter was "fine." The patient's sister also experienced flu-like symptoms and nausea after vaccination with
Gardasil (WAES#0704USA04661). Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279540-1


MedDRA PT Drug exposure during pregnancy, Pregnancy induced hypertension
Symptom Text: Information has been received from a physician through a Merck Pregnancy Registry concerning a female with asthma, back pain and depression who on 05-
FEB-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (Lot # 654535/0960F). The date of the patient's last menstrual period (LMP)
was 14-MAR-2007. On 18-APR-2007, the patient was vaccinated, intramuscularly with the second 0.5 mL dose of Gardasil, (Lot # 654510/0962F). Concomitant
therapy included PERCOCET, prednisone, MOTRIN and albuterol. It was reported that the patient was pregnant and had gestational hypertension. The patient
sought unspecified medical attention. It was reported that the patient had laboratory evaluation of "prenatal ops". The estimated date of delivery was 19-DEC-
2007. Additional information has been requested.
Other Meds: PERCOCET; prednisone; MOTRIN; albuterol
Lab Data: diagnostic laboratory - "prenatal ops"
History:
Prex Illness: Pregnancy NOS (LMP = 3/14/2007); Asthma; Back pain; Depression
Prex Vax Illns:

Vaers Id: 279541-1

12.0 F 18-Apr-2007 18-Apr-2007 0 17-May-2007 18-Jun-2007 MA WAES0704USA05154 18-Jun-2007
MedDRA PT Condition aggravated, Oedema peripheral
Symptom Text: Information has been received from a physician concerning a 12 year old female with a history of plantar warts and gastrooesophageal reflux who on 18-APR-
2007 was vaccinated with Gardasil (lot #654535/0960F). Concomitant therapy included Varivax given at the same visit. On 18-APR-2007, shortly after receiving
the vaccination in her right deltoid, the patient experienced swelling in both of her hands but mostly in the right. The swelling occurred near areas of pre-existing
Plantar warts. The patient sought unspecified medical attention. No further information was provided. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Plantar warts; Gastrooesophageal reflux
Prex Illness:
Prex Vax Illns:

Vaers Id: 279543-1

23.0 F Unknown Unknown 17-May-2007 18-Jun-2007 NJ WAES0704USA05194 18-Jun-2007

MedDRA PT Axillary pain, Musculoskeletal pain, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 23 year old female who was vaccinated with Gardasil. Subsequently the patient experienced pain
in her arm pit and shoulder one week after receiving the vaccine. The patient sought unspecified medical attention. At the time of this report, the patient's pain
in arm pit and pain in shoulder persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279544-1

Unknown F 01-Feb-2007 01-Feb-2007 0 17-May-2007 18-Jun-2007 -- WAES0704USA05196 18-Jun-2007

MedDRA PT Injection site induration, Injection site pain, Pyrexia
Symptom Text: Information has been received from a health professional concerning a female who in February 2007, was vaccinated with Gardasil. Following vaccination, the
patient experienced pain and lump at the injection site and fever. The patient's pain and a lump at the injection site and fever persisted. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279545-1

23.0 F 01-Dec-2006 18-Dec-2006 17 17-May-2007 18-Jun-2007 KS WAES0704USA05220 18-Jun-2007

MedDRA PT Paraesthesia, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician her 23 year old daughter who in December 2006, was vaccinated with a first dose of Gardasil. On 18-DEC-
2006, following the vaccination, the patient developed paraesthesia from the shoulder to elbow. On approximately 25-DEC-2006 the patient recovered. In
February 2007, the patient was vaccinated with a second dose of Gardasil. On 14-FEB-2007, following the vaccination, the patient developed paraesthesia
from the shoulder to elbow. On approximately 21-FEB-2007, the patient recovered. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279546-1


MedDRA PT Headache, Vomiting
Symptom Text: Information has been received from a 16 year old female, who on 24-APR-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included sleeping
pills [therapy unspecified]. The patient reported that she experienced a headache and vomiting, which she felt were like "symptoms of pregnancy." At the time
of this report, the patient stated that her symptoms had not improved, but that otherwise she was "fine." The patient confirmed that she had not sought medical
Other Meds: [therapy unspecified]
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279547-1


MedDRA PT Injection site rash, Injection site swelling
Symptom Text: Information has been received from a licensed practical nurse concerning a 15 year old female who on 23-APR-2007 was vaccinated with the first dose of
Gardasil in the left deltoid (lot# 654702/0010U). On 23-APR-2007 the patient experienced a rash and swelling from injection site to her elbow. At the time of the
report the patient was recovering "on therapy" (not specified). Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279548-1

Unknown F 24-Apr-2007 24-Apr-2007 0 17-May-2007 18-Jun-2007 NY WAES0704USA05449 18-Jun-2007
MMR MERCK & CO. INC. NULL Unknown Unknown
Symptom Text: Information has been received from a nurse, via a company representative, concerning a female patient, who on 24-APR-2007 was vaccinated with a dose of
Gardasil (Lot #657617/0384U). Concomitant therapy may have included Varivax, MMR II and Vaqta. the nurse reported that "after receiving Gardasil, the
patient passed out." The nurse confirmed that the patient had recovered on the same day, 24-APR-2007. The patient sought unspecified medical attention.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279549-1


MedDRA PT Feeling cold, Loss of consciousness, Tremor
Symptom Text: Information has been received from a health professional concerning a 16 year old female who was vaccinated with Gardasil (date not provided).
Subsequently, following the vaccination the patient passed out for 45 seconds, felt cold and was shaking. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279550-1


MedDRA PT Injection site mass, No reaction on previous exposure to drug
Symptom Text: Information has been received from a health professional concerning a 23 year old female who was vaccinated with a second dose of Gardasil (date
unspecified). Subsequently, one week following the injection, the patient developed a bump at the injection site. It was reported that the patient had no adverse
events following the first dose of Gardasil (date unspecified). Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279551-1


MedDRA PT Choking sensation, Culture throat negative, Dyspnoea, Nausea, Pharyngeal oedema, Streptococcal identification test negative
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female who on 29-JAN-2007 at 10:20 am was vaccinated intramuscularly in
the right deltoid with the first dose of Gardasil (lot# not provided). On 10-APR-2007 at 14:30 the patient was vaccinated in the right deltoid with the second dose
of Gardasil (lot# 03480). On 10-APR-2007 three to four hours post vaccination the patient experienced a swollen throat and had a hard time breathing. The
patient was seen in the emergency room due to the severity of the experience. The patient complained of a "feeling of choking," slight nausea with no emesis.
The patient reported that no other people in her home were ill with any sickness and she had no known allergies. A quick strep test and throat culture were both
negative. The patient was treated with ibuprofen 600 mg, PO every eight hours as needed as well as salt water and loratadine as needed for discomfort.
Subsequently, on 12-APR-2007 the patient recovered from the experience.
Other Meds: Unknown
Lab Data: Streptococcus oralis, 04/10/2007, negative; throat culture, 04/10/2007, negative.
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279552-1

16.0 F 18-Apr-2007 18-Apr-2007 0 17-May-2007 18-Jun-2007 FL WAES0704USA05600 18-Jun-2007
MedDRA PT Abdominal pain upper, Diarrhoea, Dizziness, Hyperaesthesia, Hypersomnia, Injection site pain, Lethargy, Nausea, Pain in extremity, Pallor, Paraesthesia,
Presyncope, Vision blurred
Symptom Text: Information has been received from a consumer concerning her 16 year old daughter, with a sulfonamide allergy and drug hypersensitivity to codeine, who on
18-APR-2007 was vaccinated with the first dose, 0.5 ml, of Gardasil. There was no concomitant medication. The patient's mother reported that on 18-APR-
2007, immediately after receiving the vaccination, her daughter got pale, said she was going to throw up, and felt faint for about 15 minutes. The mother then
added that while going out to the car, her daughter had 3 recurrences of feeling like she was going to faint, and had to sit with an ice pack on her neck for 10
minutes with each occurrence. On the way home in the car, her daughter complained that her hands and feet felt tingly and her vision became blurred for about
10 minutes. Once at home, the mother explained that her daughter experienced severe stomach cramps, and then one hour later had diarrhea "which lasted
through the night and into the early afternoon of the next day." On 19-APR-2007 ("the next day"), she became extremely lethargic, fell asleep at 2pm and slept
until the next day. On approximately 20-APR-2007 ("the next day"), the mother said her daughter "felt better," however, the arm where the injection was
administered was extremely sore, and no pressure could be tolerated on that arm; she confirmed that her daughter had recovered from all of the symptoms,
with the exception of her sore arm, which was "still tender but gradually improving." Additional information has been requested.
Other Meds: None
Lab Data: None
History: Sulfonamide allergy, drug hypersensitivity
Prex Illness:
Prex Vax Illns:

Vaers Id: 279553-1

20.0 F 25-Feb-2007 Unknown 17-May-2007 18-Jun-2007 NJ WAES0704USA05631 18-Jun-2007

MedDRA PT Amenorrhoea
Symptom Text: Information has been received from a physician concerning an approximately 20 year old female who on approximately 25-FEB-2007 was vaccinated with a
first dose of Gardasil. Subsequently the patient developed amenorrhea. Unspecified medical attention was sought. It was reported that the patient planned to
discontinue the series of injections. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279554-1


MedDRA PT Injection site bruising, Injection site haemorrhage, Injection site swelling
Symptom Text: Information has been received from a physician concerning a 26 year old female patient who on 25-APR-2007 was vaccinated IM in the left deltoid with her
second dose of Gardasil. On the Friday after the injection, 27-APR-2007, swelling and bruising appeared at the injection site. On the Saturday after the
injection, the injection site began to bleed. The patient stopped the bleeding with a compress and sought medical attention. She was fully recovered on an
unspecified date. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279555-1

12.0 F 01-Mar-2007 01-Mar-2007 0 17-May-2007 18-Jun-2007 IN WAES0704USA05691 18-Jun-2007

MedDRA PT Injection site erythema, Injection site rash, Injection site swelling
Symptom Text: Information has been received from a physician concerning an approximately 12 year old female patient with sulfonamide allergy who was vaccinated with her
first dose of Gardasil and had a "slight" reaction with a red swelling rash at injection site. In March 2007, she was vaccinated IM with her second dose Gardasil
and had "a more extreme" rash. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 279556-1

Unknown F 03-Apr-2007 Unknown 17-May-2007 18-Jun-2007 -- WAES0704USA05697 18-Jun-2007

MedDRA PT Injection site mass, Injection site pain
Symptom Text: Information has been received from an office manager concerning a female (age not reported) who on 03-APR-2007 was vaccinated with the third dose of
Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date after the patient received her third dose of Gardasil, the patient
developed a lump and soreness at the injection site. The patient sought unspecified medical attention. The patient's lump and soreness at injection site
persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279557-1


MedDRA PT Urticaria
Symptom Text: Information has been received from a health professional concerning a 21 year old female who on 18-APR-2007 was vaccinated with Gardasil (Lot
#653978/0955F). Concomitant therapy included ORTHO TRI-CYCLEN. On the evening of 20-APR-2007 the patient experienced hives which were generalized
on her trunk. The patient was instructed to take BENADRYL but it did not help. She was examined by a physician in the emergency room on 22-APR-07. She
was not admitted. She was given ATARAX and prednisone. After the first dose of Atarax her rash resolved. It was reported that the patient took "CORICIDIN"
(therapy unspecified) for the first time the morning of 20-APR-2007. the patient's mother also stated that "her daughter often breaks out in hives". Additional
Other Meds: [therapy unspecified]; ORTHO TRI CYCLEN
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279558-1


MedDRA PT Asthenia, Dizziness, Nausea, Somnolence
Symptom Text: Information has been received from a 26 year old female with a history of asthma who on 24-APR-2007 was vaccinated with Gardasil. Concomitant therapy
included Sarafem and Yasmin. On 24-APR-2007 the patient experienced stomach nausea. She also felt very weak and went to bed early. The following day
she woke to feel very faint and again had stomach nausea. No further information was provided.
Other Meds: YASMIN, SARAFEM
Lab Data: Unknown
History: Asthma
Prex Illness:
Prex Vax Illns:

Vaers Id: 279559-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 24 year old female who on 23-APR-2007 was vaccinated with Gardasil (Lot# 657617/0384U). On
23-APR-2007 the patient fainted before receiving dose two. The patient recovered and received the second dose that same day. Additional information has
been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279560-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 LA WAES0704USA05739 18-Jun-2007

MedDRA PT Nausea
Symptom Text: Information has been received from a physician concerning a female nurse in his office who was vaccinated IM with a first dose of Gardasil. The patient
experienced "nausea" within 24 hours of receiving the first dose of Gardasil. Unspecified medical attention was sought. The patient was recovering. The
physician reported that two other patients experienced nausea after receiving Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279561-1


MedDRA PT Anogenital warts, Burning sensation, Headache, Inappropriate schedule of drug administration, Injection site irritation, Injection site pain
Symptom Text: Information has been received from a 27 year old female with a history of papilloma viral infection and loop electrosurgical excision procedure in January 2007,
who was vaccinated with Gardasil. Concomitant therapy included ALLEGRA and YAZ. Subsequently, the patient received two doses of the vaccine. After the
first vaccination she experienced pain that the injection site (right arm) which hurt and burn. She did not experience any injection site reactions after the second
injection (left arm). She experienced headache approximately one day after her first and second injections. About a week after the second injection, she
developed genital warts on her outer lip. She reported that she is not sexually active. At the time of this report, the genital warts persisted. Her last dose is due
on 17-MAY-2007. Additional information has been requested.
Other Meds: YAZ, ALLEGRA
Lab Data:
History: Papilloma viral infection; loop electrosurgical excision procedure
Prex Illness:
Prex Vax Illns:

Vaers Id: 279562-1

16.0 F 29-Nov-2006 29-Nov-2006 0 17-May-2007 18-Jun-2007 OK WAES0704USA05775 18-Jun-2007

MedDRA PT Pelvic inflammatory disease, Trichomoniasis, Urinary tract infection
Symptom Text: Information has been received from a health professional concerning a 16 year old sexually active female patient who is a smoker of tobacco and marijuana
who on 29-NOV-2006 was vaccinated with a first dose of Gardasil. On 29-NOV-2006 the patient was treated with Bactrim DS for 10 days for a urinary tract
infection. ON 14-DEC-2006 the patient was being treated with Omnicef for days and a single dose of Flagyl for trichomoniasis and a possible urinary tract
infection. On 22-JAN-2007 the patient received a second dose of Gardasil, IM into the right deltoid. On 22-JAN-2007 the patient was being treated with
Macrodantin, 100 mg twice a day for 10 days for a urinary tract infection. On 05-FEB-2007 the patient was taking Bactrim and clotrimazole. On 09-FEB-2007
the patient was treated with Flagyl for 10 days and Rocephin injection for Zithromax 1 gm for pelvic inflammatory disease. On 09-MAR-2007 the patient was
using a Xopenex inhaler and Advair and on 15-MAR-2007 she was taking Flagyl for 14 days. On 29-MAR-2007 she was taking Flagyl 500 mg and doxycycline
for 10 days. On 14-APR-2007 serial beta HCG test was 24529 and on 16-APR-2007 it was 54860. Her LMP was approximately 28-FEB-2007 (reported as "late
February 2007). Additional information has been requested.
Other Meds: Unknown
Lab Data: Chlamydia trachomatis, 02/09/2007, negative; Neisseria gonorrhoeae, 02/09/2007, negative; Rapid plasma reagin, 04/12/2007, negative for syphilis; beta-
human chorionic, 03/15/2007, negative; complete blood cell, 04/12/2007, normal; HIV antib
History: Pregnancy NOS (LMP = 02/28/2007); tobacco user; cannabis abuse; sexually active
Prex Illness:
Prex Vax Illns:

Vaers Id: 279563-1

17.0 F 29-Mar-2007 19-Apr-2007 21 17-May-2007 18-Jun-2007 CO WAES0704USA05797 18-Jun-2007

MedDRA PT Rash erythematous, Rash maculo-papular, Rash pustular
Symptom Text: Initial and follow up information has been received from a physician and a health care professional concerning a 19 year old white female student who on 29-
MAR-2007 at 1:00 pm was vaccinated IM in the left deltoid with a first dose of Gardasil. The physician reported after receiving the injection the patient
developed "small red bumps and pustules behind her ears and along her neck." Follow up report came from a healthcare professional and it was reported that
on 19-APR-2007 at 8:00 am the patient had fine, red, non-itchy maculo papular rash behind both ears/thighs. She was treated with prescription medication. The
outcome was unknown. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279564-1


MedDRA PT Adverse event, Syncope
Symptom Text: Information has been received from a healthcare worker concerning a female who on 24-APR-2007 was vaccinated with Gardasil. On 25-APR-2007 the patient
experienced fainting and other unspecified adverse experiences. Additional information is not expected.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279565-1


Symptom Text: Information has been received from a health professional that a high percentage of patients vaccinated with Gardasil subsequently experienced intense pain at
the injection site at the time the vaccine was administered to them. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279566-1


Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced genital warts. No
further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279567-1

26.0 F 16-Mar-2007 16-Mar-2007 0 17-May-2007 18-Jun-2007 FL WAES0704USA06014 18-Jun-2007

MedDRA PT Pruritus, Throat tightness
Symptom Text: Information has been received from a pharmacist concerning a 26 year old female who on 16-MAR-2007 was vaccinated with the first dose of Gardasil.
Concomitant therapy included ZYRTEC. On 16-MAR-2007 the patient experienced itching and the sensation that her throat was closing up after taking an
unspecified antihistamine. Medical attention was sought. Additional information has been requested.
Other Meds: ZYRTEC
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279568-1


MedDRA PT Injection site pain, Musculoskeletal pain
Symptom Text: Information has been received from a physician concerning a 16 year old female who is not pregnant who was vaccinated with Gardasil. Subsequently, the
patient experienced injection site pain about one week after vaccination. The pain diminished for a while and then returned as significant shoulder pain. She
had no other vaccinations at the same time. She has had no treatment so far. She had sought unspecified medical attention. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279569-1

26.0 F 28-Feb-2007 02-Mar-2007 2 17-May-2007 18-Jun-2007 -- WAES0704USA06031 18-Jun-2007

MedDRA PT Pruritus, Rash
Symptom Text: Information has been received from a certified medical assistant concerning a 26 year old female with no pertinent medical history and no prior drug reactions
who on 28-FEB-2007 was vaccinated with first dose of Gardasil 0.5 cc intramuscularly in the left deltoid (Lot#656049/0187U). On 02-MAR-2007, two days after
receiving the dose, the patient first noticed itching and then saw that she had broke out in red dots on her chest and legs. The symptoms lasted for 2 to 3 days
and on approximately 04-MAR-2007 the patient recovered from broke out in red dots on chest and legs and itching. Additional information has been requested.
Other Meds: ANAPROX DS
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279570-1

Unknown F 24-Apr-2007 24-Apr-2007 0 17-May-2007 18-Jun-2007 NY WAES0704USA06035 18-Jun-2007
Symptom Text: Information has been received from a nurse, via a company representative, concerning a female patient, who on 24-APR-2007 was vaccinated with a dose of
Gardasil (Lot #657617/0384U). Concomitant therapy may have included VARIVAX, MMR II and VAQTA. The nurse reported that "after receiving Gardasil, the
patient nearly passed out and was lightheaded." The nurse confirmed that the patient had recovered on the same day, 24-APR-2007. The patient sought
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279592-1 (D)

Seriousness: DIED, ER VISIT, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS

MedDRA PT Death, Thrombosis
Symptom Text: Information has been received from a licensed visiting nurse via a nurse practitioner. The nurse practitioner was told by a friend that a female patient was
vaccinated with Gardasil and two weeks alter developed a blood clot. Subsequently the patient died. The cause of death was from the blood clot. The reporting
licensed visiting nurse considered the blood clot to be immediately life-threatening and disabling. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279595-1 (S)

16.0 F 08-May-2007 15-May-2007 7 24-May-2007 29-May-2007 CT CT200708 05-Jul-2007

MedDRA PT Cough, Demyelination, Fall, Head injury, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia, Multiple sclerosis, Paraesthesia, Syncope, Vomiting
Symptom Text: Gardasil HPV vaccine Administered on 05/08/07 cough on 05/14/07 vomiting 5/15/07 morning at school, sweating followed by syncope few minutes no Tonic-
Clonic seizure. MRI done in ER showed Demyelinated Foci in Occipital, L temporal lobes and R frontal L 7/5/07-records received from facility for DOS 05/18-
05/23/07-DC DX: Multiple Sclerosis. Previously healthy femal who was admitted due to a lesion seen on brain MRI. Patient reports symtoms became in
December when she started having numbness in left thumb and slowly spread down her hands and arms. Also had some funny feeling in lower back.
Symptoms resolved. Since then she has intermittent numbness with more than 50 episodes per day last less than 1 minutes. On 5/14 she started having
nonproductive cough and sore throat, and posttussive vomiting the day after. Felt tingling over her left hand, right fingers and toes for less than 1 minute.
Lightheaded, fell and hit her head. Out for almost 10 minutes. Disoriented.
Other Meds: None
Lab Data: MRI - demyelinating disease of white matter cerebri and spinal cord cervical records received 7/5/07-CT and MRI head were abnormal shows periventricular
white matter lesions. MRI spine showed inactive C5 white matter lesion. Labs, CBC WNL,
History: Exercise induced asthma, poor vision, tingling of fingers not successful records received-7/5/07- PMH: asthma
Prex Illness: numbness or tingling of fingers
Prex Vax Illns:

Vaers Id: 279599-1

45.0 M 11-May-2007 12-May-2007 1 24-May-2007 01-Jun-2007 CA 16-Jun-2007

MedDRA PT Inappropriate schedule of drug administration, Rash generalised
Symptom Text: Rash over entire body

Other Meds: Viagra
Lab Data:
History: PCN, Bactrim
Prex Illness: HPV
Prex Vax Illns:

Vaers Id: 279600-1

16.0 F 22-May-2007 22-May-2007 0 24-May-2007 04-Jun-2007 FL 04-Jun-2007
MedDRA PT Dyskinesia, Syncope
Symptom Text: Pt has syncope and had jerky movement for a minute. Patients legs were elevated and monitored. Pt recovered after 45 min.
Other Meds:
Lab Data: None
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 279601-1

25.0 F 21-May-2007 22-May-2007 1 24-May-2007 01-Jun-2007 IN 01-Jun-2007

MedDRA PT Dizziness, Fatigue, Influenza like illness, Musculoskeletal pain
Symptom Text: Patient c/o flu-like symptoms, fatigue, musculoskeletal ache, dizziness.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279622-1


MedDRA PT Rash generalised, Vaccine positive rechallenge
Symptom Text: Information has been received from a health professional concerning a 19 year old female who on 22-FEB-2007 was vaccinated, in the deltoid, with Gardasil.
On 22-FEB-2007 the patient experienced mild rash all over her body. On 23-APR-2007 the patient was vaccinated with her second dose, IM injection in the
right deltoid and developed a severe rash all over body. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279623-1


MedDRA PT Dizziness, Visual disturbance
Symptom Text: Information has been received from a physician concerning a 21 year old female who on 25-APR-2007 was vaccinated with Gardasil. Concomitant therapy
included ZOLOFT and YASMIN. On 25-APR-2007 the patient reported feeling lightheaded and saw spots. Subsequently, the patient recovered from feeling
lightheaded and saw spots. This is one of two reports from the same source. Attempts are being made to obtain additional identifying information to distinguish
the individual patients mentioned in this report. Additional information has been requested.
Other Meds: ZOLOFT; YASMIN
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279624-1


MedDRA PT Diarrhoea, Nausea, No reaction on previous exposure to drug, Pyrexia, Vomiting
Symptom Text: Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil. After her second dose, the patient
experienced nausea, diarrhea, vomiting and fever. The patient did not experience any symptoms after her first dose. Subsequently, the patient recovered.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279625-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 GA WAES0704USA06056 18-Jun-2007

MedDRA PT Dizziness, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient became light-headed and
passed out when she got to the front door. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279626-1


Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. the patient came back for her second vaccination and
reported that she experienced pain at the injection site after her first vaccination. Subsequently, the patient recovered from pain at the injection site. Additional
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279627-1


MedDRA PT Injection site mass
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed a mass under her
skin at injection site. the patient's mass persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279628-1


Symptom Text: Information has been received from a health professional concerning an approximately 16 year old female, who on 23-APR-2007 received her second
vaccination with Gardasil. On 24-APR-2007 the patient experienced joint pain all over her body. The patient's joint pain persisted and was getting worse. Date
of first vaccination not reported. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279629-1

25.0 F 15-Nov-2006 Unknown 17-May-2007 18-Jun-2007 TX WAES0704USA06180 19-Jun-2007

MedDRA PT Papilloma viral infection, Smear cervix abnormal
Symptom Text: Information has been received from a health professional concerning an approximately 25 year old female with an allergy to Hydrocodone, who on 15-NOV-
2006 was vaccinated with Gardasil. Concomitant therapy included ORTHO-CYCLEN. A short time after her second dose, she had a routine Pap which was
positive for abnormal cells and positive for a high risk strain of HPV. No other symptoms were reported. Date of first vaccination not provided. Additional
Other Meds: ORTHO-CYCLEN
Lab Data:
History: Drug hypersensitivity
Prex Illness:
Prex Vax Illns:

Vaers Id: 279630-1

19.0 F 22-Feb-2007 22-Feb-2007 0 17-May-2007 18-Jun-2007 PA WAES0704USA06184 19-Jun-2007

MedDRA PT Erythema, Rash, Rash pruritic
Symptom Text: Information has been received from a health professional concerning a 19 year old female with a penicillin allergy who on 22-FEB-2007 was vaccinated with
Gardasil (Lot 655619/1427F). Concomitant therapy included YASMIN. On 22-FEB-2007 the patient experienced rash. On 23-APR-2007 the patient received her
second dose of Gardasil (Lot 657006/0188U). Within a few hours she developed a rash on her face, chest, arms and legs described as a red spotty and itchy.
The rash was treated with Benadryl. After a couple of days the rash resolved. Additional information has been requested.
Other Meds: YASMIN
Lab Data:
History:
Prex Vax Illns:

Vaers Id: 279631-1

25.0 F 20-Oct-2006 Unknown 17-May-2007 18-Jun-2007 CA WAES0704USA06225 19-Jun-2007

MedDRA PT Menstruation delayed, Menstruation irregular, Metrorrhagia
Symptom Text: Information has been received from a physician concerning a 25 year old female patient who on 20-OCT-2006 was vaccinated with her first dose of Gardasil.
The patient experienced her menstrual cycle a month late, and changes in flow and also spotting with less blood after receiving her first dose. On 21-DEC-2006
the patient received her second dose of Gardasil and experienced her menstrual cycle 10 days late. On 16-APR-2007 the patient received her third dose of
Gardasil. It was reported that the patient developed the same menstrual cycle symptoms after each dose. Medical attention was sought. The patient recovered.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279632-1

Unknown F 18-Jan-2007 18-Jan-2007 0 17-May-2007 18-Jun-2007 -- WAES0704USA06231 19-Jun-2007

MedDRA PT Gingival bleeding
Symptom Text: Information has been received from a physician's assistant concerning a female who on 18-JAN-2007 was vaccinated with Gardasil. There was no concomitant
medication. After vaccination on 18-JAN-2007 and 22-MAR-2007, the patient experienced bleeding gums. The duration and extent of the bleeding gums was
unknown. It was unknown if the bleeding got worse with the second vaccination. The patient's father is an oral surgeon and felt that the bleeding of the gums
was related to the Gardasil vaccination. The patient's bleeding gums persisted. Additional information has been requested.
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279633-1

11.0 F Unknown Unknown 17-May-2007 18-Jun-2007 GA WAES0704USA06235 18-Jun-2007

MedDRA PT Hallucination, Vaccine positive rechallenge
Symptom Text: Information has been received from a registered pharmacist concerning an 11 year old female who, on an unspecified date, was vaccinated with a second dose
of Gardasil. On 26-APR-2007, the patient was seen in the emergency room for hallucinations. The patient was discharged from the emergency room with
instructions to follow-up with her pediatrician. The reporter stated that the patient was "fine" when she left the hospital. It was also noted by the reporter that the
patient had reportedly experienced hallucinations after her first dose of Gardasil and was seen in the emergency room of another hospital. The reporter stated
that the patient may have received other vaccinations with one or both of the Gardasil vaccine doses. No product quality complaint was involved. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279634-1


Symptom Text: Information has been received from a health care worker concerning a 23 year old female with drug reactions to "emytin" and Cipro who on 02-APR-2007 was
vaccinated intramuscularly with a third dose of Gardasil (Lot # 657006/0188U). On 02-APR-2007 the patient developed a lump on her right arm after
administration of the vaccine. The patient sought unspecified medical attention. At the time of this report, the patient's lump on her right arm persisted. No
product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Drug hypersensitivity, allergic reaction to antibiotics
Prex Illness:
Prex Vax Illns:

Vaers Id: 279635-1


MedDRA PT Dizziness, Headache, Hypoaesthesia, Myalgia
Symptom Text: Information has been received from a physician concerning a 20 year old female who on approximately 25-FEB-2007 was vaccinated with Gardasil. On
approximately 25-FEB-2007 the patient experienced numbness, headache, dizziness and muscle tenderness. After one week, the patient recovered. On 24-
APR-2007 the second vaccination with Gardasil was given. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279636-1


MedDRA PT Lymphadenopathy, Pyrexia
Symptom Text: Information has been received from a consumer concerning her daughter who was vaccinated with the second dose of Gardasil. Subsequently the patient
experienced fever and swollen glands. The patient's outcome was not reported. Medical attention was not sought. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279637-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 LA WAES0704USA06391 19-Jun-2007

MedDRA PT Nausea
Symptom Text: Information has been received from a physician concerning the daughter of a nurse who was vaccinated with a first dose of Gardasil. Patient experienced
"nausea" within 24 hours after she received the first dose of Gardasil. It was not known if the patient sought medical attention. The patient's outcome was
unknown. The physician reported that two other patient experienced nausea after receiving Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279638-1


MedDRA PT Nausea
Symptom Text: Information has been received from a physician concerning a daughter of a nurse who was vaccinated with a first dose of Gardasil. Patient experienced
"nausea" within 24 hours after she received the first dose of Gardasil. It was not known if patient sought medical attention. The patient's outcome was unknown.
The physician reported that two other patient experienced nausea after receiving the first dose of Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279639-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, the patient
experienced fainting. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. This is one of several reports received
from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279640-1

11.0 F 15-Mar-2007 09-Apr-2007 25 17-May-2007 18-Jun-2007 FL WAES0704USA06523 19-Jun-2007

MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a 11 year old female who on 15-MAR-2007 was vaccinated with Gardasil (lot # 655619/1427F). On
09-APR-2007 the patient experienced rash that spread from the injection site down one arm and then to the other arm. Medical attention was sought. The
patient had unspecified blood work and had throat culture (results not reported). Subsequently, the patient recovered from rash. Additional information has
been requested.
Other Meds: Unknown
Lab Data: diagnostic laboratory - results not reported, throat culture - results not reported
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279641-1

18.0 F 25-Jan-2007 29-Mar-2007 63 17-May-2007 19-Jun-2007 -- WAES0704USA06596 19-Jun-2007

MedDRA PT Blister, Chest X-ray normal, Lip swelling, Oedema peripheral, Pain in extremity
Symptom Text: Information has been received from a Physician Assistant concerning an 18 year old female patient with a history of tuberculosis test positive with Mantoux test
and negative with chest x-ray who on 25-JAN-2007 was vaccinated IM with a first dose of Gardasil, lot # 653650/0702F. Concomitant therapy included
Nuvaring. On 29-MAR-2007 the patient was vaccinated with a second dose of Gardasil. The night of 29-MAR-2007 she developed pain in the medial aspect of
her left foot with swelling. On 30-APR-2007 (next day) she developed swelling of both feet. She then had blisters on both hips and swelling of her lower lip. On
04-APR-2007 she was seen in the Urgent Care and was treated with Diclofenac, Claritin D and tapered Prednisone for 6 days. Sedimentation rate, complete
Blood Count with differential studies performed. Lymphocytes was slightly elevated. The patient recovered. Additional information has been requested.
Other Meds: NUVARING
Lab Data: lymphocyte count - slightly elevated, complete blood cell, erythrocyte
History: Tuberculosis test positive; Chest X-ray
Prex Illness:
Prex Vax Illns:

Vaers Id: 279642-1


MedDRA PT Blood pressure decreased, Syncope
Symptom Text: Information has been received from a nurse concerning a 16 year old female, with asthma and an allergy to cefaclor (Ceclor), and a recent history of
lightheadedness in school, who on 30-OCT-2006 was vaccinated with Gardasil. Concomitant therapy included Zyrtec, Singulair and hormonal contraceptives
(unspecified). On 21-DEC-2006, the second vaccination with Gardasil was administered. The patient had no adverse event with the first or second vaccination.
On 26-APR-2007 the third vaccination with Gardasil was administered. Ten minutes later, the patient fainted in the waiting room. Her blood pressure was 90/50.
She had not eaten that afternoon before the vaccination. Subsequently, the patient recovered. Additional information has been requested.
Other Meds: ZYRTEC, hormonal contraceptives, SINGULAIR
Lab Data: Blood pressure, 04/26/2007, 90/50.
History: Lightheadedness
Prex Illness: Asthma, drug hypersensitivity
Prex Vax Illns:

Vaers Id: 279643-1

13.0 F 24-Apr-2007 24-Apr-2007 0 17-May-2007 18-Jun-2007 IN WAES0704USA06677 19-Jun-2007

MedDRA PT Dizziness, Flushing, Hyperhidrosis
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient who on 19-FEB-2007 was vaccinated IM a first dose of
with Gardasil lot #653736/0689F and on 24-APR-2007 she was vaccinated IM with a second dose of Gardasil lot # 655849/0263U. She became dizzy and
flushed with sweating within minutes after her second injection was given. She quickly recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279644-1

25.0 F 05-Apr-2007 05-Apr-2007 0 17-May-2007 18-Jun-2007 NH WAES0704USA06695 18-Jun-2007

MedDRA PT Diarrhoea, Faeces discoloured, Injection site erythema, Injection site swelling
Symptom Text: Information has been received from a registered nurse (RN) concerning a 25 year old female who on 15-FEB-2007 was vaccinated iM in the left deltoid with a
first dose of Gardasil lot # 653938/0954F and on 05-APR-2007 was vaccinated with a second dose of Gardasil lot # 653736/0014U. Concomitant therapy
included Nexium. On 05-APR-2007 the patient developed loose green stool, injection site redness and injection site swelling. The loose green stools lasted for
24 hours and then resolved. On 27-APR-2007 patient had an office visit and it was noted that the injection site redness and swelling resolved. Additional
Other Meds: Nexium
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279645-1

20.0 F 01-Mar-2007 Unknown 17-May-2007 18-Jun-2007 -- WAES0704USA06706 18-Jun-2007

MedDRA PT Alopecia
Symptom Text: Information has been received from a physician concerning a 20 year old female who in March 2007 was vaccinated with Gardasil. Subsequently the patient
experienced hair loss. The patient's hair loss persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279646-1

15.0 F 09-Apr-2007 10-Apr-2007 1 17-May-2007 18-Jun-2007 IA WAES0704USA06799 19-Jun-2007

Symptom Text: Information has been received from a nurse practitioner and a licensed practical nurse concerning a 15 year old, female, student with no illness at time of
vaccination with Bactrim allergy, rash who on 09-APR-2007 at 2:00 p.m. was vaccinated intramuscularly with the first dose of Gardasil, (Lot #656049/0187U). It
was reported that at 8:00 a.m. on 10-APR-2007, the patient had 'a tickly feeling in her throat - which caused her to clear her throat, constantly. It was reported
that the patient's "tickly feeling in her throat" which caused to clear her throat, constantly, went away after twenty four hours. It was reported that there was no
soreness to the injection site noted. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Sulfonamide allergy; Rash
Prex Vax Illns:

Vaers Id: 279647-1

15.0 F Unknown Unknown 17-May-2007 18-Jun-2007 NC WAES0705USA00004 19-Jun-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a office nurse in a physician's office concerning a female in her late teens who was vaccinated with Gardasil. Concomitant
therapy included Dtap. Subsequently the patient felt dizzy immediately after receiving the vaccine. Additional information is not expected.
Other Meds: diphtheria toxoid (+)
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279648-1


MedDRA PT Burning sensation
Symptom Text: Information has been received from a licensed practical nurse concerning a female who was vaccinated with Gardasil. There was no concomitant medication.
Subsequently the patient experienced burning sensation after receiving the vaccination and sought medical attention. Subsequently, the patient recovered from
the burning sensation. No product quality complaint was involved. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279649-1

15.0 F 23-Feb-2007 23-Feb-2007 0 17-May-2007 18-Jun-2007 IL WAES0705USA00037 19-Jun-2007

MedDRA PT Myalgia, Pain
Symptom Text: Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history who on 23-FEB-2007 was vaccinated
IM in her right arm with 0.5 ml, first dose of Gardasil (lot # 656049/0187U). There was no concomitant medications. On 23-FEB-2007 the patient experienced
initial stinging that turned into muscle soreness. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. As of 30-
APR-2007, the patient's initial stinging and muscle soreness persisted. Additional information has been requested.
Other Meds: None
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279650-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 TN WAES0705USA00045 19-Jun-2007

MedDRA PT Fungal infection
Symptom Text: Information has been received from a physician via a company representative concerning a female patient who was vaccinated IM with a 0.5ml first and second
dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced a yeast infection after each dose of the vaccination. It was
noted that the patient recovered on therapy from both yeast infections. Unspecified medical attention was sought. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279651-1

18.0 F 01-Apr-2007 Unknown 17-May-2007 18-Jun-2007 -- WAES0705USA00056 18-Jun-2007

Symptom Text: Information has been received from a physician concerning an 18 year old female who sometime in April 2007 was vaccinated with her first dose of Gardasil.
There was no concomitant medication. Subsequently, the patient claims that ever since she received the vaccination, she gets her "period every 13 days" as
opposed to every 28 days which is considered normal for her. Unspecified medical attention was sought. The patient's outcome was reported as unknown. No
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279652-1


MedDRA PT Depression, Fatigue
Symptom Text: Information has been received from a nurse concerning a 26 year old female patient who on 27-APR-2007 was vaccinated IM with a 0.5 ml first dose Gardasil.
There was no concomitant medication. Since 28-APR-2007 the patient felt depressed and fatigued. Unspecified medical attention was sought. Additional
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279653-1

Unknown F 21-Apr-2007 22-Apr-2007 1 17-May-2007 18-Jun-2007 LA WAES0705USA00068 19-Jun-2007

MedDRA PT Injection site rash, Rash, Rash
Symptom Text: Information has been received from a physician via a company representative concerning a female patient who on 21-APR-2007 was vaccinated IM in the
deltoid with a first dose of Gardasil. Concomitant therapy included Zyrtec. On 22-APR-2007 the patient went out in the sun and experienced rash on her legs
and on the arm she was given the injection. It was noted the that the rash was not itchy and lasted a couple of days before resolving completely. Unspecified
medical attention was sought. Additional information has been requested.
Other Meds: ZYRTEC
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279654-1

Unknown F 02-Nov-2006 Unknown 17-May-2007 18-Jun-2007 -- WAES0705USA00070 18-Jun-2007

MedDRA PT Inappropriate schedule of drug administration, Pain
Symptom Text: Information has been received from a consumer concerning her daughter who on 02-NOV-2006 was vaccinated with her first dose of Gardasil. There was no
concomitant medication. The patient's mother indicated that the shot her daughter received was extremely painful. She did not say if her daughter experienced
the same pain when she got the second shot on 22-APR-2007 which was more than two months later. No product quality complaint was involved. Additional
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279655-1

19.0 F Unknown 16-Apr-2007 17-May-2007 18-Jun-2007 NY WAES0705USA00071 19-Jun-2007

MedDRA PT Urinary tract infection
Symptom Text: Information has been received from a physician via a company representative concerning a 19 year old female patient who was vaccinated with 0.5 ml second
dose of Gardasil. Subsequently the patient experienced urinary tract infection. Unspecified medical attention was sought. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279656-1


MedDRA PT Cough, Epistaxis, Pain, Pharyngolaryngeal pain
Symptom Text: Information has been received from a company representative and a nurse concerning a 17 year old female patient who on 26-APR-2007 was vaccinated with
Gardasil (lot # 657621/0387U). On 26-APR-2007 the patient experienced body ache, cough, sore throat and a nose bleed. The nurse reported the following:
The patient did not go to dance class that night which is unlike her. On 27-APR-2007, the patient went to 'Six Flags:" and only went on one ride which is unlike
her. The patient did nothing over the weekend. The patient had 3 nose bleeds that started on 29-APR-2007 and the 3rd nose bleed lasted from 1:15 am on 30-
APR-2007. The patient did not go to school on 30-APR-2007. The patient will see her primary care physician for follow-up. The patient was not recovered at the
time of the report. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279657-1


MedDRA PT Erythema, Injection site mass, Oedema peripheral, Pain in extremity, Pruritus
Symptom Text: Information has been received from a 24 year old female with papilloma viral infection who on 23-FEB-2007 was vaccinated with Gardasil (lot #654702/0011U).
Concomitant therapy Nuvaring. Subsequently the patient experienced arm pain, swelling, itchiness, redness, and lump at injection site on left deltoid.
Unspecified medical attention was sought. The patient status was reported as recovering. No product quality complaint was involved. Additional information has
been requested.
Other Meds: NUVARING
Lab Data: None
History:
Prex Illness: Papilloma viral infection
Prex Vax Illns:

Vaers Id: 279658-1

11.0 F Unknown Unknown 17-May-2007 18-Jun-2007 MN WAES0705USA00082 18-Jun-2007

MedDRA PT Pyrexia
Symptom Text: Information has been received from a company representative and a nurse concerning a 11 year old female who was vaccinated with a 0.5 ml dose of Gardasil.
The patient developed a fever and missed at least one day aft school. The interval between administration of the vaccine and the onset of the fever is unknown.
The nurse mentioned that the patient also received four additional injections at the same office visit. Subsequently, the patient recovered from the fever.
Unspecified medical attention was sought. Additional information has been requested.
Other Meds: (therapy unspecified) (therapy unspecified) (therapy unspecified) (therapy unspecified)
Lab Data:
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279659-1


MedDRA PT Dizziness, Immediate post-injection reaction
Symptom Text: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient
experienced dizziness immediately following vaccination. The nurse practitioner reported that the patient was fine and recovered shortly thereafter. Unspecified
medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279660-1


MedDRA PT Asthenia, Nausea
Symptom Text: Information has been received from a registered nurse concerning a 23 year old female who was vaccinated with her first dose of Gardasil. There was no
concomitant medication. Subsequently the patient experienced weakness and nausea after receiving the vaccination. Unspecified medical attention was
sought. Subsequently, the patient recovered from the symptoms. No product quality complaint was involved. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279661-1


Symptom Text: Information has been received from a female who reported that she received the first two doses of Gardasil and "developed a lump at the injection site. At the
time of the report, it was unknown if the patient recovered. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279662-1


MedDRA PT Cyanosis, Dizziness, Injection site pain, Loss of consciousness, No reaction on previous exposure to drug
Symptom Text: Information has been received from a physician concerning a 15 year old female. The patient received her first dose of Gardasil and had no adverse reaction.
On the week of 23-APR-2007 the patient was vaccinated with Gardasil second dose. Immediately after receiving her second dose, the patient's arm which
received the injection began to hurt, the patient became dizzy and passed out. Her lips turned blue. Unspecified medical attention was sought. The patient was
not given any other vaccines on the day she was given her second dose of Gardasil. Subsequently, the patient recovered from the arm pain, dizziness, passing
out and lips turning blue. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279663-1

26.0 F 27-Dec-2006 Unknown 17-May-2007 18-Jun-2007 MO WAES0705USA00119 18-Jun-2007

MedDRA PT Injection site erythema
Symptom Text: Information has been received from a physician concerning a 26 year old female with no known medical history and allergies to penicillin, amoxicillin and Biaxin
who on 27-DEC-2006 was vaccinated intramuscularly with a second 0.5 mL dose of Gardasil (Lot #653937/0637F). There was no concomitant medication.
Subsequently, on an unspecified date, the patient developed a quarter size area of redness at the injection site. No laboratory diagnostic tests were performed.
Approximately one month after the injection was given, the patient recovered. No product quality complaint was involved. Additional information has been
requested.
Other Meds: None
Lab Data: None
History:
Prex Illness: Allergic reaction to antibiotics; Penicillin allergy
Prex Vax Illns:

Vaers Id: 279664-1


MedDRA PT Nausea, Pain, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning a female child (age not reported) who was the daughter of one of the reporting physician's patients.
On unspecified dates, the patient was vaccinated with a first, second and third 0.5 mL dose of Gardasil at her pediatrician's office. Subsequently the patient
experienced pain after each of her three doses of Gardasil, progressively getting worse each time. After the third dose, the patient also experienced nausea
and had to stay home from school. Subsequently, the patient recovered from pain and nausea. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279665-1


MedDRA PT Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Vaccine positive rechallenge
Symptom Text: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil, (No lot # was provided). Subsequently the
patient experienced immediately after being vaccinated, numbness, and tingling in the arm on both her first and second dose. The patient sought unspecified
medical attention. Subsequently, it was reported that the "patient was fine when she got home". It was reported that the patient was fine now. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279666-1

20.0 F 16-Apr-2007 16-Apr-2007 0 17-May-2007 18-Jun-2007 CO WAES0705USA00168 18-Jun-2007

MedDRA PT Injection site mass, Pain in extremity
Symptom Text: Information has been received from a registered nurse, concerning a 20 year old female who on approximately 16-APR-2007 was vaccinated with the first
dose, IM in the right deltoid, 0.5ml, of Gardasil. Concomitant therapy included Valtrex and hormonal contraceptives (unspecified). Immediately after the
injection (approximately 16-APR-2007), the patient's arm was sore. On 30-APR-2007, two weeks later, the nurse confirmed the soreness continued and the
patient complained her arm with any pressure applied; in addition, a small lump was present under the skin at the injection site. At the time of this report, the
patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: hormonal contraceptives, VALTREX
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 279667-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 14 female who on 11-APR-2007 was vaccinated with a 0.5 mL dose of Gardasil (Lot # "03874").
Subsequently, the patient fainted 5 minutes after receiving the Gardasil. At the time of this report, the patient had recovered. No product quality complaint was
involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279668-1


MedDRA PT Glossitis, Glossodynia, Paraesthesia oral
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 24-APR-2007 was vaccinated IM with a second dose of Gardasil (lot
#656051/0244U). On 26-APR-2007, the patient was seen by her physician with complaints of a sore and "tingling" tongue. The physician reported that the
patient stated she "may have had the tingling " before vaccination with Gardasil, although, "she wasn't sure." Upon physical examination, the patient's tongue
was noted to be reddened with some raised papules, and subsequently, the patient was diagnosed with glossitis. The patient was administered viscous
lidocaine and liquid Benadryl topically to the tongue, in order to decreased the irritation, and was instructed to contact the physician if the condition did not
improve. The physician did not feel that the patient's glossitis was an allergic reaction, and reported that the patient will continue with the vaccination series. At
the time of this report, the patient had not contacted the physician regarding the outcome of the glossitis. Additional information has been requested.
Other Meds: Unknown
Lab Data: physical examination 04/26/2007 - reddened tongue with raised papules
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279669-1


Symptom Text: Information has been received from a physician concerning a female who in 2007 was vaccinated with Gardasil. It was reported that the patient had injection
site pain after receiving the vaccination. The second dose was not given because of the continued pain. The patient sought unspecified medical attention. This
is one of two reports received from the same source. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned
in this report. Additional information will be provided if available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279670-1

17.0 F Unknown Unknown 17-May-2007 18-Jun-2007 TX WAES0705USA00372 18-Jun-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician, via company representative, concerning a 17 year old female patient who was vaccinated IM (date
unspecified), with the first dose of Gardasil. The physician reported that the patient "fainted in the office waiting room shortly after being vaccinated." The
physician stated the patient was presumed to be doing fine, though she had not heard from the patient. The patient sought unspecified medical attention.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279671-1


MedDRA PT Petechiae
Symptom Text: Information has been received from a health professional concerning a female consumer who in March 2007, was vaccinated with Gardasil. In March 2007, the
patient experienced petechiae rash all over her body within 24 hours after receiving the first dose of Gardasil. No medical attention was required. This is one of
two reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279672-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 NY WAES0705USA00423 18-Jun-2007

Symptom Text: Information has been received from a physician concerning her daughter who on an unspecified date was vaccinated with a dose of Gardasil (lot
654510/0926F). Immediately after receiving Gardasil, her daughter experienced severe pain in area of injection site. There was no visible reaction at the
injection site such as a rash or swelling. At the time of this report, the outcome was unknown. This is one of several reports from the same source. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279673-1


MedDRA PT Immediate post-injection reaction, Loss of consciousness
Symptom Text: Information has been received from a physician, via a company representative, concerning a 19 year old female patient who on 30-APR-2007 was vaccinated
with the first dose of Gardasil. The physician reported that the patient "passed out immediately after receiving first dose of Gardasil; "she added that that patient
had not eaten all day prior to receiving the vaccination. The patient recovered on 30-APR-2007, the same day of vaccination. The patient sought unspecified
medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279674-1

19.0 F Unknown Unknown 17-May-2007 18-Jun-2007 NJ WAES0705USA00497 18-Jun-2007

Symptom Text: Information has been received from a physician concerning a 19 year old female who was vaccinated with a dose of Gardasil. Subsequently the patient
developed amenorrhea. Unspecified medical attention was sought. It was reported the patient planned to discontinued the series of injections. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279675-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 TX WAES0705USA00500 18-Jun-2007

Symptom Text: Information has been received from a physician, via a company representative, concerning a female patient, who was vaccinated (date unspecified) with a
dose, 0.5ml, of Gardasil. The physician reported that the patient "experienced a full body rash," after the vaccination (date unspecified). At the time of this
report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279676-1

22.0 F Unknown Unknown 17-May-2007 18-Jun-2007 CA WAES0705USA00531 18-Jun-2007

MedDRA PT Diarrhoea, Hyperhidrosis, Nausea, Vomiting
Symptom Text: Information has been received from a physician concerning a 22 year old female who was vaccinated with her first dose of Gardasil. After the vaccination, the
patient became nauseous, sweaty, threw up and had diarrhea. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279677-1

Unknown U Unknown Unknown 17-May-2007 18-Jun-2007 MA WAES0705USA00534 18-Jun-2007

MedDRA PT Sensory disturbance
Symptom Text: Information has been received from a registered nurse concerning unspecified number of patients who were vaccinated with Gardasil. Subsequently, the
patients "felt vaccine going down their arm." This is one of several reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279678-1

9.0 F 10-Apr-2007 11-Apr-2007 1 17-May-2007 18-Jun-2007 UT WAES0705USA00653 18-Jun-2007

MedDRA PT Nausea, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 9 year old female who on 10-APR-2007 was vaccinated with Gardasil. On 11-APR-2007 the
patient experienced a sore arm and nausea. This is one of two reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279679-1


MedDRA PT Dizziness, Pallor, Presyncope
Symptom Text: Information has been received from a health professional concerning a "young" female who was vaccinated with Gardasil (date of vaccination unknown).
Subsequently, following the vaccination the patient lost her color, slumped over and almost fainted. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279680-1


MedDRA PT Malaise
Symptom Text: Information has been received from a physician concerning an approximately 11 year old female who on an unspecified date was vaccinated with a dose of
Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, two days after receiving the Gardasil, the patient became ill. The
reporting physician felt the event was not related to therapy with Gardasil. No further information is available.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279681-1


MedDRA PT Burning sensation, Loss of consciousness, Pain, Pain
Symptom Text: Information has been received from a health professional a female who was vaccinated with Gardasil. Subsequently the patient experienced pain, throbbing,
stinging, burning sensation and passed out. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279682-1


Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Within 12-15 hours, the patient experienced nausea
and vomiting. This is one of two reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279683-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient
experienced fainting. Unspecified medical attention was sought. At the time of report, the patient had not recovered. This is one of several reports received from
the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279684-1


MedDRA PT Syncope
Symptom Text: Information has been requested from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279685-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279686-1


Symptom Text: Information has been received from a nurse practitioner concerning a 19 year old female who on 09-APR-2007 the patient experienced a tickly feeling in her
throat for 24 hours after receiving the vaccine. She needed to clear her throat constantly. There was no soreness noted to the injection site. It was reported that
the patient sought unspecified medical attention. Subsequently, the patient recovered tickly feeling in her throat. This is one of two reports that was received
from the same source for a sibling. No further details were provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns: Pharynx itchy sensation~HPV (Gardasil)~1~15~In Sibling

Vaers Id: 279687-1


MedDRA PT Pain, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning a 23 year old female who on 03-OCT-2006 was vaccinated with Gardasil (lot # 653736/0689F). The
patient received her second dose of Gardasil (lot # 653736/0689F) on 08-DEC-2006 and her third dose (lot # 653736/0014U) on 02-APR-2007. The patient
experienced soreness and pain for 2 to 3 days after each dose of Gardasil. The patient's outcome was not recovered. No further information is available.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279688-1

Unknown F Unknown Unknown 17-May-2007 18-Jun-2007 WI WAES0705USA01566 18-Jun-2007

MedDRA PT Bacterial infection
Symptom Text: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with a dose of Gardasil. Subsequently, the
patient experienced a bacterial infection. The outcome was not reported. The patient's sister's experience with Gardasil was reported in
WAES#0704USA02596. Additional information was been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness: Bacterial infection
Prex Vax Illns:

Vaers Id: 279689-1


MedDRA PT Dizziness, Visual disturbance
Symptom Text: Information has been received from a physician concerning a 21 year old female who was vaccinated with Gardasil. Subsequently, the patient reported feeling
lightheaded and saw spots. Subsequently, the patient recovered from feeling lightheaded and saw spots. This is one of two reports received from the same
source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information
will be provided if available. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279693-1 (S)

22.0 F Unknown Unknown 25-May-2007 29-May-2007 -- WAES0705USA04056 29-May-2007
Seriousness: HOSPITALIZED, PERMANENT DISABILITY, SERIOUS

MedDRA PT Abdominal pain, Chills, Myalgia, Nausea
Symptom Text: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil. Concomitant
therapy included hormonal contraceptives (unspecified). Approximately two and half weeks after the vaccination, the patient experienced abdominal pain,
nausea, chills and muscle aches. She was hospitalized for 5-6 days. Multiple unspecified CT-scans, x-rays and blood tests were performed. All the results were
negative. She was treated with an unspecified antibiotic. Subsequently, the patient recovered. The physician felt that the abdominal pain, nausea, chills and
muscle aches were disabling. Additional information has been requested.
Lab Data: X-ray negative; computed axial negative; diagnostic laboratory negative
History: Unk
Prex Illness:
Prex Vax Illns:

Vaers Id: 279809-1

22.0 F 19-May-2007 19-May-2007 0 25-May-2007 01-Jun-2007 PA 01-Jun-2007

MedDRA PT Loss of consciousness, Syncope, Syncope
Symptom Text: Student fainted and lost consciousness for about 15 seconds at 11:00AM. Vital signs were stable before and after the episode of syncope. Student stated that
she had not eaten anything that morning. She told the nurse before receiving the vaccine that she had not had any reaction with the first dose of HPV vaccine.
After the syncope, she told the nurse that she had fainted with the first dose of HPV but she thought it was because she also had a large amount of blood
drawn for tests at that same visit. Student rested at the health center for a short time and then returned to her dorm room to get ready for the convocation for
graduation. She was informed about reaction symptoms and was instructed to return to the health center if she devloped any of these symptoms. She was
instructed to contact her doctor at home next week after graduation.
Other Meds: Synthroid
Lab Data:
History:
Prex Illness: none
Prex Vax Illns:


MNQ SANOFI PASTEUR U2278AA 0 Unknown Intramuscular
MedDRA PT Anaphylactic reaction, Dyspnoea, Dyspnoea, Flushing, Lip swelling, Throat irritation, Throat tightness
Symptom Text: About 1 hour and 15 minutes prior to receiving Menatra and Gardasil vaccinations in our office, the patient felt acute onset of throat tightness, throat burning,
flushed face and trouble breathing. 05/30/07-records received-5/27/07-trouble breathing. shortness of breath. flushed face. lips slightly swollen. DC:
anaphylactic reaction most likely to either Gardasil or Menactra
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


17.0 F 25-May-2007 25-May-2007 0 22-Jun-2007 25-Jun-2007 -- 200702170 26-Jun-2007
MNQ SANOFI PASTEUR U2278AA Unknown Unknown
Seriousness: ER VISIT, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS
MedDRA PT Anaphylactic reaction, Dyspnoea
Symptom Text: Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05515, VAERS# not provided. The initial reporter to this
manufacturer had been a health care professional. Verbatim from the report:"Information has been received from a physician and his physician and his office
manager concerning a 17 year old female with no known drug allergies who on 25-MAY-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot#
657737/0522U) and concomitant suspect therapy Menactra (lot# U2278AA). It was reported that the patient left the physician's office feeling fine after the
vaccinations, although, approximately one hour later returned to the office with severe shortness of breath. The patient was diagnosed with an anaphylaxis
reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the patient's breathing returned to normal, and the
patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who will evaluate the event and attempt to determine
the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results from the allergist are obtained. Anaphylactic
reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional information has been requested.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


17.0 F 25-May-2007 25-May-2007 0 18-Jun-2007 18-Jul-2007 NY WAES0705USA05515 02-Aug-2007
MNQ SANOFI PASTEUR U2278AA 0 Unknown Unknown
Seriousness: ER VISIT, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS
MedDRA PT Anaphylactic reaction, Dyspnoea
Symptom Text: Information has been received from a physician and his office manager concerning a 17 years old female with no known drug allergies who on 25-MAY-2007
was vaccinated with the first 0.5 mL dose of Gardasil (lot # 657737/05220) and concomitant suspect therapy Menactra (lot #U2278AA). It was reported that the
patient left the physician's office feeling fine after the vaccinations, although, approximately one hour later returned to the office with severe shortness of breath.
The patient was diagnosed with an anaphylaxis reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the
patient's breathing returned to normal, and the patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who
will evaluate the event and attempt to determine the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results
from the allergist are obtained. Anaphylactic reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279893-1

14.0 F 14-May-2007 14-May-2007 0 29-May-2007 30-May-2007 KY WAES0705USA04237 30-May-2007

MedDRA PT Dyskinesia, Heart rate decreased, Hypotension, Immediate post-injection reaction, Loss of consciousness
Symptom Text: Information has been received from a health professional, concerning a 14 year old female student, with no known drug allergies, who on 14-MAY-2007, at
3:00pm, was vaccinated IM in the left arm, with the third dose of Gardasil (Lot #657622/0388U). There was no illness at the time of vaccination. The reporter
indicated that immediately after vaccination, at 3:00pm, on 14-MAY-2007 the patient "passed out and started jerking all over the shot was given" (duration of
symptoms and treatment were not reported). The patient's vital signs included a blood pressure of 72/48mmHg, and a pulse of 38bpm. The reporter confirmed
that the patient recovered on the same day, 14-MAY-2007. The reporter stated that the events of passed out, jerking all over, pulse very low and blood
pressure very low, required medical intervention to prevent serious criteria, and were considered as an other important medical event. Additional information
has been requested.
Other Meds: Unknown
Lab Data: blood pressure 05/14/07 72/48 mmHg, total heartbeat count 05/14/07 38bpm
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279894-1 (S)

Unknown F Unknown Unknown 29-May-2007 30-May-2007 FR WAES0705USA04226 30-May-2007

MedDRA PT Thrombocytopenia
Symptom Text: Information has been received from a pharmacist concerning a female patient who was vaccinated with a dose of Gardasil. About 10-14 days post vaccination
the patient developed thrombocytopenia and was admitted to the hospital. The outcome was unknown. Other Business Partners include: E2007-03121.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279895-1

18.0 F 27-Apr-2007 06-May-2007 9 29-May-2007 30-May-2007 FR WAES0705AUS00150 30-May-2007

MedDRA PT Convulsion, Epilepsy, Malaise, Spinal fracture
Symptom Text: Information has been received from media monitors summarising the radio talk-back program. A mother of 18 year old female student contacted the radio talk-
back program and informed that on 27-APR-2007 her daughter was vaccinated with Gardasil as part of the regular school-based immunisation program funded
by the government. On 06-MAY-2007 the school girl got sick. "The hospital" found that she had had a seizure and fractured two vertebrae and the school girl
was diagnosed with juvenile epilepsy. "The hospital" did not believe that "the two events" were connected to Gardasil, but the mother was convinced they are.
The interviewee of the program, said that epilepsy could be caused by an number of things. Upon internal review, a seizure is determined to be an other
important medical event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279896-1

18.0 F 01-May-2007 01-May-2007 0 29-May-2007 30-May-2007 FR WAES0705CAN00155 02-Jul-2007

MedDRA PT Asthma, Blood pressure decreased, Condition aggravated, Convulsion, Deafness unilateral, Loss of consciousness
Symptom Text: Information has been received from a pharmacist concerning an 18 year old female with asthma who in May 2007, was vaccinated with Gardasil (lot number
not available). In May 2007, the patient has a reaction of seizure. It was also reported that the patient passed out, that her blood pressure dropped and that had
hearing loss in one ear ("for a short while"). Subsequently, the patient recovered from hearing loss in one ear. It was also reported that the patient's asthma
was not as well controlled since the injection of Gardasil. The pharmacist reported that the patient's mother did not want her daughter to have the other doses
of Gardasil. Upon internal review, seizure and hearing loss in one ear were considered as other important medical event. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 279900-1

17.0 F 16-Apr-2007 14-May-2007 28 29-May-2007 04-Jun-2007 -- 07-Jun-2007
HPV4 MERCK & CO. INC. 01884 1 Unknown Unknown

MedDRA PT Auricular swelling, Erythema, Erythema, Joint swelling, Joint swelling, Lip swelling, Pruritus, Serum sickness, Skin warm, Swelling, Urticaria, Urticaria
Symptom Text: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and
knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased
Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are
painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch
and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face.
5/29/07-continues to break out in hives in evening only. To see allergist.
Other Meds: Adderall XR 15mg 1 daily
Lab Data: CBC, Sed Rate, Lytes, BUN, Creat, Albumin WNL 5/15/07 records received 6/7/07-CBC and SED rate normal.
History: History ADHD on Adderall
Prex Illness:
Prex Vax Illns:

Vaers Id: 279914-1

HPV4 MERCK & CO. INC. 01810 0 Left arm Subcutaneously
HEPA MERCK & CO. INC. 1280 0 Right arm Subcutaneously
MedDRA PT Dizziness, Injection site pain, Nausea, Vision blurred
Symptom Text: Patient had blurry vision and dizziness initially. Patient's BP was stable throughout. Patient continued wtih dizziness and also developed nausea, nausea, and
pain at the shot site for 3-4 hours after shot given. Patient reported no symptoms after that time.
Other Meds: none
Lab Data: none done
History: none
Prex Illness: 3:10PM
Prex Vax Illns:

Vaers Id: 279917-1

17.0 F 25-May-2007 25-May-2007 0 29-May-2007 01-Jun-2007 MN 04-Jun-2007

MedDRA PT Rash, Rash pruritic
Symptom Text: Patient received Gardasil dose #1 Friday(5/25/07) and developed pinpoint, intensely pruritic rash on thighs to knees. Did not extend up onto trunk, did not
extend below knees. Presented to clinic this afternoon (first day open after holiday) with concern.
Other Meds: Depo Provera (given 5/7/07)
Lab Data: none
History: LSIL PAP on 11-15-06.
Prex Illness: no
Prex Vax Illns:

Vaers Id: 279920-1


MedDRA PT Chills, Fatigue, Headache, Pyrexia
Symptom Text: High fever (102)/chills, headache, fatigue

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 279926-1

18.0 F 22-May-2007 24-May-2007 2 29-May-2007 04-Jun-2007 MD 04-Jun-2007

MedDRA PT Dyspnoea, Food allergy, Urticaria
Symptom Text: On 5/22/07 rec'd vaccine. On 5/24/07 when at work and mixing cappuccino from powder (powder became aerosolized) Pt started with hives and SOB. Seen in
ES and rec'd Benadryl. Pt told by allergist had "small allergy to nuts" of skin testing at cappuccino powder has nuts.
Other Meds:
Lab Data:
History: nuts (only reaction, runny nose)
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279935-1

15.0 F 16-May-2007 17-May-2007 1 29-May-2007 04-Jun-2007 IL 04-Jun-2007
MNQ SANOFI PASTEUR 42223AA 0 Unknown Intramuscular
MedDRA PT Induration, Pruritus, Skin warm
Symptom Text: L arm developed large area of warm hard itchy (intense) induration
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279937-1

16.0 F 01-Mar-2007 01-Mar-2007 0 29-May-2007 04-Jun-2007 PA 02-Jul-2007
MedDRA PT Immediate post-injection reaction, Syncope
Symptom Text: Immediately after giving HPV shot child fainted.

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 279941-1

16.0 F Unknown Unknown 29-May-2007 04-Jun-2007 MI 02-Jul-2007
MedDRA PT Injection site erythema, Injection site pruritus, Injection site urticaria
Symptom Text: 26 hr after receiving varicella vaccine at our clinic pt. c/o Red hive like reaction at injections site-very itchy, given oral Benadryl-calamine to hive like rash with
some relief-to continue this until gone or if worse refer to private provider. 5-22-07 parent reports 1 hive like rash-itchy remains at injection site
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 279942-1

14.0 F 16-May-2000 17-May-2007 2557 29-May-2007 04-Jun-2007 NY 04-Jun-2007

MedDRA PT Blood test, Urticaria
Symptom Text: urticarial rash began about 24 hours after vaccines given pt also had bloodwork drawn after receiving her vaccine pt returned to office 2 days after vaccine was
given; rash improved with Benadryl somewhat. Completely improved with Atarax.
Other Meds: none
Lab Data:
History: Perenial allergic, rhino sinusitis, allergies to ragweed pollen, mites and house dust precordial catch syndrome
Prex Illness: none
Prex Vax Illns:

Vaers Id: 279973-1

16.0 F 09-May-2007 09-May-2007 0 30-May-2007 31-May-2007 FR WAES0705AUS00158 31-May-2007

MedDRA PT Confusional state, Disorientation, Dizziness, Headache, Nervous system disorder, Psychomotor hyperactivity
Symptom Text: Information has been received from a physician via an other company representative as part of a business agreement concerning a 16 year old female who on
approximately 09-MAY-2007 at 11:00 am was vaccinated with Gardasil. On approximately 09-MAY-2007 at 3:00 pm on the day the patient was vaccinated she
was taken to her physician. The patient experienced dizziness, hyperactive (also described as overactive/running/shouting), disoriented (also described as
confused behaviour), neurological type reaction and headache. The patient's blood pressure, temperature and Glasgow coma scale were found to be okay.
Subsequently, the patient recovered from feeling dizzy, hyperactive, disoriented, neurological type reaction and headache. The reporting physician considered
dizzy, hyperactive, disoriented and neurological type reaction to be other important medical events. Additional information has been requested.
Other Meds: Unknown
Lab Data: blood pressure measurement 09?May07 ok, temperature measurement 09?May07 ok, Glasgow coma scale 09?May07 ok,
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279985-1


MedDRA PT Dizziness, Injected limb mobility decreased, Myalgia, Pain in extremity, Syncope
Symptom Text: 1. Dizzy and faint immediately following immunization. Patient layed down on left side, drank juice and fully recovered within 20 minutes. 2. Pain in upper left
arm started after immunization. 15 Days later pain started to get worse. No fever. No redness at site. Hurts to lift arm up. Does not feel pain to touch states
"deep muscle pain", pain with arm movement. Pain level recently increased last 2 days. Home care - ice, Motrin as needed.
Other Meds:
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 279988-1

13.0 F 07-May-2007 07-May-2007 0 30-May-2007 05-Jun-2007 MA 05-Jun-2007
BIOLOGICALS
MedDRA PT Syncope
Symptom Text: Syncopal episode following Gardasil

Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


26.0 F 14-May-2007 Unknown 30-May-2007 05-Jun-2007 MN 06-Jun-2007

MedDRA PT Injection site bruising, Injection site pruritus, Myalgia, Nausea, Pharyngolaryngeal pain, Pruritus generalised, Vomiting
Symptom Text: The day after getting Gardasil, patient reported nausea, vomiting, sore throat, generalized myalgia, generalized itching and itching and bruise at injection site.
Symptoms resolved 5/16/07.
Other Meds: Nuvaring
Lab Data: None done
History:
Prex Illness: None apparent
Prex Vax Illns:


26.0 F 14-May-2007 15-May-2007 1 18-Jun-2007 17-Jul-2007 MN WAES0705USA04978 17-Jul-2007

MedDRA PT Injection site bruising, Injection site pruritus, Myalgia, Nausea, Pharyngolaryngeal pain, Vomiting
Symptom Text: Information has been received from a registered nurse, concerning a 26 year old female patient, who on 14-MAY-2007 was vaccinated with the first dose,
0.5ml, IM, of Gardasil (invalid lot # provided). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). On 15-MAY-2007 the patient
experienced "nausea, vomiting, myalgia, a sore throat, itching and bruising at the injection site." The following day, 16-MAY-2007, the patient recovered all of
the events. Additional information has been requested.
Other Meds: Nuvaring
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:


17.0 F 22-May-2007 22-May-2007 0 30-May-2007 05-Jun-2007 WA 06-Jun-2007
HPV4 MERCK & CO. INC. M0171U 0 Left arm Unknown

MedDRA PT Syncope
Symptom Text: Fainting episode within 5 minutes of Gardasil injection

Other Meds:
Lab Data: None
History: Anxiety/Panic attacks
Prex Illness: None
Prex Vax Illns:


17.0 F 22-May-2007 22-May-2007 0 18-Jun-2007 17-Jul-2007 WA WAES0705USA04556 17-Jul-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 22-MAY-2007 was vaccinated with Gardasil. On 22-MAY-2007 it was
reported that the patient experienced "a serious episode of fainting" after her first administration of Gardasil. The patient sought unspecified medical attention.
No other information was available. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 279994-1

15.0 F 22-May-2007 Unknown 30-May-2007 06-Jun-2007 MI 07-Jun-2007
MedDRA PT Medication error, Unevaluable event
Symptom Text: None noted. 6/7/07-Spoke with reporter, the patients received a second dose of Menactra by mistake.
Other Meds:
Lab Data:
History: None noted.
Prex Illness: None
Prex Vax Illns:

Vaers Id: 279995-1

18.0 F 22-May-2007 Unknown 30-May-2007 06-Jun-2007 MI 07-Jun-2007
MedDRA PT Medication error, Unevaluable event
Symptom Text: None noted. 06/07/07-Spoke with reporter, the patients received a second dose of Menactra by mistake.
Other Meds:
Lab Data:
History: None Known
Prex Illness: None
Prex Vax Illns:

Vaers Id: 280049-1

23.0 F 08-May-2007 15-May-2007 7 30-May-2007 01-Jun-2007 NC 04-Jun-2007

Symptom Text: Patient received vaccine on 5-8-2007 in L Deltoid. The site hurt initially but the discomfort was gone the next day. The site began hurting again 1 week later and
called office and was instructed to use warm compresses and Tylenol or Advil and to call back if no better.The patient denied any redness at the site and
denied fever. She states her arm did feel better but became very sore on May 27th. Hurts more at night than during the day. States she can not lift her arm
above her head and getting dressed is difficult. States she feels fine otherwise, denies redness, swelling at site or fever.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 280069-1 (S)

15.0 F Unknown Unknown 31-May-2007 01-Jun-2007 OH WAES0705USA04010 01-Jun-2007

MedDRA PT Encephalitis
Symptom Text: Information has been received from physician concerning a 15 year old female who was vaccinated with Gardasil. Subsequently the patient may have
experienced encephalitis and was hospitalized. The duration of the stay was not provided. The physician reporting was not the physician who administered the
vaccine but the treating physician. At the time of the report the patient had recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280070-1

Unknown F 01-May-2007 01-May-2007 0 31-May-2007 01-Jun-2007 FR WAES0705AUS00147 01-Jun-2007

MedDRA PT Convulsion, Syncope
Symptom Text: Information has been received from media monitors summarising the radio talk-back program. A mother of a 17 year old school girl contacted the radio talk-
back program and informed that earlier in May 2007 female students of her daughter's school were vaccinated with Gardasil as part of the regular school-based
immunisation program funded by the government. She informed that a female student of her daughter's year level had very adverse reactions, including a
seizure and fainting. Upon internal review, a seizure is determined to be an other important medical event. Additional information is not expected. This is one of
several reports from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280077-1

Unknown F 01-May-2007 01-May-2007 0 31-May-2007 01-Jun-2007 FR WAES0705AUS00155 01-Jun-2007

Symptom Text: Information has been received from media monitors summarising the radio talk-back program. A mother of a 17 year old school girl contacted the radio talk-
back program abd informed that earlier in May 2007 female students of her daughter's school were vaccinated with Gardasil as part of the regular school-based
immunisation program funded by the government. She informed that a female student of her daughter's year level had very adverse reactions, including a
seizure and fainting. Upon internal review, a seizure is determined to be an other important medical event. Additional information is not expected. This is one of
several reports from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280085-1

HPV4 MERCK & CO. INC. ME0181U 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Pyrexia, Rash, Varicella
Symptom Text: Outbreak of Varicella illness-rash, low grade fever.

Other Meds:
Lab Data: none
History: Asthma
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280089-1

18.0 F 31-May-2007 31-May-2007 0 31-May-2007 06-Jun-2007 FL 06-Jun-2007

MedDRA PT Convulsion, Fall, Nausea
Symptom Text: Approx 5 min after vacc adm. Pt was stopped at check out, seizure type movement noted as pt fell to floor. Fall somewhat blocked by another pt standing near.
Pt with nausea, no vomiting. Pt alert/talking few min after episode. BP 84/52 P-48 Pt to Urgent Care Ctr in Stable condition.
Other Meds:
Lab Data: none
History: none
Prex Illness:
Prex Vax Illns:

Vaers Id: 280094-1

20.0 F 10-May-2007 Unknown 31-May-2007 06-Jun-2007 OH 06-Jun-2007

Symptom Text: Reports she developed 1st outbreak of genital warts, treated after vaccine #1 (few external lesions, treated by her GYN). A more severe outbreak (extended
intravaginally) occurred 1-2 weeks after #2. No or mild outbreak occurred after #3.
Other Meds: None
Lab Data: No other outbreaks
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 280107-1

22.0 F 02-Feb-2007 12-Feb-2007 10 31-May-2007 01-Jun-2007 PA 04-Jun-2007

MedDRA PT Confusional state, Headache, Vision blurred
Symptom Text: Patient experienced bouts of confusion and blurry vision, headache described as starting over L eye and a "weird feeling" spreads accross the forehead.
Other Meds: none
Lab Data: Normal CBC, Normal ANA, lymes, etc. MRI showed lesion in L frontal lobe.
History: Childhood asthma
Prex Illness: none present
Prex Vax Illns:

Vaers Id: 280108-1

22.0 F 10-Mar-2007 17-Mar-2007 7 31-May-2007 01-Jun-2007 PA 04-Jun-2007
HPV4 MERCK & CO. INC. UNKNOWN 1 Left arm Intramuscular

MedDRA PT Balance disorder, Confusional state, Disturbance in attention, Headache, Similar reaction on previous exposure to drug, Vision blurred
Symptom Text: Confusion with a slight headache described as "weird feeling", unable to concentrate for 3 days, vision problems- blurry, unfocused- patient said was "very
scary, i kept telling myself where i was so i wouldn't forget because this happened with my last dose of the vaccine" loss of balance
Other Meds: none
Lab Data: EKG to rule out epilepsy- no epileptiform activity.
History: none
Prex Illness: none
Prex Vax Illns: confusion/ vision problems, ~HPV (Gardasil)~1~23~In Patient

Vaers Id: 280109-1

18.0 F 29-May-2007 29-May-2007 0 31-May-2007 01-Jun-2007 MA 04-Jun-2007

MedDRA PT Syncope
Symptom Text: syncope after adm of vaccine

Other Meds: Zovia 1/35E-28, 1-0.035 mg
Lab Data:
History: allergy to penicillin
Prex Illness:
Prex Vax Illns:

Vaers Id: 280123-1

13.0 F 14-Dec-2006 14-Dec-2006 0 31-May-2007 01-Jun-2007 CO 04-Jun-2007
MedDRA PT Immediate post-injection reaction, Injection site pain, Similar reaction on previous exposure to drug
Symptom Text: Significant pain at injection site immediately upon (and during) both first and second injections (12/14/2006 lot 0688f and 2/16/2007 lot 1447F). Pain decreased
rapidly within a minute but ache remained for approximately an hour. Daughter described pain as "worst pain after any injection she's ever had".
Other Meds: none
Lab Data: n/a
History: rash to amoxicillin and cefaclor, no birth defects or medical conditions
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280159-1

14.0 F 06-Nov-2006 20-Nov-2006 14 01-Jun-2007 04-Jun-2007 -- WAES0705USA05000 04-Jun-2007

Symptom Text: Information has been received from a consumer concerning her 14 year old daughter with a history of seizures who on 06-NOV-2006 was vaccinated with a 1st
dose of Gardasil. Concomitant therapy included oxcarbazepine (TRILEPTAL). Two weeks after getting the first dose of Gardasil she developed a seizure. She
sought medical attention, and no lab diagnostic studies were performed. Subsequently she recovered. As of 24-MAY-2007 she had yet to get the second and
third dose of Gardasil. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Other Meds: Trileptal
Lab Data: None
History: Convulsion
Prex Illness:
Prex Vax Illns:

Vaers Id: 280160-1

Unknown F Unknown Unknown 01-Jun-2007 04-Jun-2007 FR WAES0705AUS00175 04-Jun-2007

MedDRA PT Epilepsy
Symptom Text: Information has been received from a physician via an other company representative as part of a business agreement (manufacturer control # GARD 2007 05
24 001) concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced epileptic fits after vaccination with Gardasil which
needed 2 nurse to control the patient. The physician has referred the patient to specialist before the second dose of Gardasil. Upon internal medical review
epileptic fits after vaccination with Gardasil were considered to be an other important medical events. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280161-1

Unknown F Unknown Unknown 01-Jun-2007 04-Jun-2007 FR WAES0705USA05125 04-Jun-2007

MedDRA PT Condition aggravated, Epilepsy
Symptom Text: Information has been received from a gynecologist, concerning an adolescent female with a history of 2 epileptic seizures in childhood, who was vaccinated, IM
in the deltoid (date not specified), with the first dose of Gardasil (Batch #NE43160). Immediately following the vaccination, the patient experienced an epileptic
seizure; she recovered within a short time. The reporter started that an electroencephalogram (EEG) would be performed. The reporter considered the epileptic
seizure to be an other important medical event. No further information is available. Other business partner numbers include #200703213.
Other Meds: Unknown
Lab Data: Unknown
History: Epileptic seizure
Prex Illness:
Prex Vax Illns:

Vaers Id: 280163-1 (D)

11.0 F 01-May-2007 04-May-2007 3 01-Jun-2007 04-Jun-2007 -- WAES0705USA04839 04-Jun-2007
Seriousness: DIED, ER VISIT, LIFE THREATENING, SERIOUS

MedDRA PT Anaphylactic reaction, Cardiac arrest, Death
Symptom Text: Information has been received from a nurse practitioner who heard from an emergency room (ER) nurse that an 11 year old female was vaccinated "within in
the past month" in approximately May 2007 with a first dose of Gardasil. Subsequently, 3 days after vaccination the patient presented to an ER. She
experienced cardiac arrest, required lung bypass (ECMO) and "may not have expired." It was also reported by the same nurse that the physician from the
hospital said that "the death was due to an anaphylactic reaction to Gardasil." The anaphylactic reaction and cardiac arrest were considered to be life
threatening by the reporter. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280174-1

21.0 F 27-Apr-2007 01-Jun-2007 35 01-Jun-2007 06-Jun-2007 CA 06-Jun-2007
HPV4 MERCK & CO. INC. 0384D 1 Left arm Intramuscular

MedDRA PT Injection site cyst, Injection site pain, Skin lesion
Symptom Text: L Deltoid area Cyst like lesion 0.5 x 0.5cm + tenderness 5 wks after vaccine placed.
Other Meds: None
Lab Data: L Deltoid cyst like lesion
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 280184-1

16.0 F 29-May-2007 Unknown 01-Jun-2007 06-Jun-2007 CA 06-Jun-2007
Symptom Text: Patient was Pregnant at time of vaccine given.

Other Meds: Prozac, Lithium
Lab Data: B Hcg on 5/9/07 elevated
History: Bipolar
Prex Illness: Bipolar
Prex Vax Illns:

Vaers Id: 280230-1 (S)

16.0 F 22-May-2007 22-May-2007 0 04-Jun-2007 05-Jun-2007 FR WAES0705AUS00191 05-Jun-2007
MedDRA PT Brachial plexopathy, Hypokinesia, Injected limb mobility decreased, Injection site anaesthesia, Mobility decreased, Muscular weakness, Neck pain,
Paraesthesia, Paralysis, Pharyngeal hypoaesthesia
Symptom Text: Information has been received from a physician at an infectious diseases unit, who was notified of the following adverse event by a consultant neurologist who
was the treating physician. This information was reported to us via a agency, as part of a business agreement (manufacturer's case number: GARD 2007 05 28
003). The patient is a 16 year old female who on 22-MAY-2007 was vaccinated with Gardasil as prophylaxis. On 22-MAY-2007, following vaccination with
Gardasil, the patient experienced numbness at injection site which increased over the next five days. She was also unable to move her left leg but this resolved
on 27-MAY-2007, five days post-vaccination. On 27-MAY-2007 the patient developed paralysis of injected limb and was unable to move her left arm. She had
some left neck pain and paraesthesia and some throat numbness. She also experienced weakness in her left arm. The patient was hospitalised and at the time
of reporting on 28-MAY-2007 was awaiting investigation. The consultant neurologist (treating physician) made a clinical diagnosis of "probable post-vaccine
brachial plexopathy" but at the time of reporting a magnetic resonance imaging (MRI) and nerve conduction studies had not been performed. The patient's
numbness at injection site; inability to move left arm; weakness in left arm; left neck pain and paraesthesia, and throat numbness persisted. The reporter felt
that paralysis of injected limb; inability to move left arm and left leg; numbness at injection site; weakness in left arm; left neck pain and paresthesia, and throat
numbness were related to therapy with Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280231-1

16.0 F 26-Apr-2007 26-Apr-2007 0 04-Jun-2007 05-Jun-2007 FR WAES0705USA05126 05-Jun-2007

MedDRA PT Pyrexia, Thrombocytopenia
Symptom Text: Information has been received from a Gynecologist concerning a 16 year old female with no relevant history who on 26-APR-2007 was vaccinated with her first
dose of Gardasil (batch# NE24240, lot# 654884/09024F), into the deltoid muscle, intramuscularly. On 26-APR-2007, in the evening the patient experienced
fever up to 38.4 Celcius and recovered within one day. Subsequently the patient developed relapsing fever episodes. The patient was referred to a
hematologist. Thrombocytopenia was diagnosed on 22-MAY-2007. The Gynecologist considered the fever and thrombocytopenia as other important medical
events. Other business partner numbers include E2007-03254 (0). No further information is available.
Other Meds: Unknown
Lab Data: body temp 26Apr07 38.4 celcius
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 280232-1

19.0 F 11-May-2007 12-May-2007 1 04-Jun-2007 05-Jun-2007 CA WAES0705USA03807 05-Jun-2007

MedDRA PT Cold compress therapy, Heat therapy, Nausea, Paraesthesia, Pruritus generalised
Symptom Text: initial and follow up information has been received from a registered nurse, concerning a 19 year old female student with allergy to codeine, who was
vaccinated with a first dose of (date not specified) Gardasil with no reported problems, and on 11-MAY-2007 at 10:30am was vaccinated with the second dose
of Gardasil (Lot #657617/0384U). Concomitant therapy included ORTHO TRI-CYCLEN. On 12-MAY-2007 the patient started feeling nauseous; on 13-MAY-
2007, she started feeling a tingly sensation in her shoulder, neck and scapula (reported by patient's phone call on 14-MAY-2007); she was instructed to
alternate between hot and cold packs every 20 minutes and was prescribed MOTRIN 800mg, every 6-8 hours as treatment. On approximately 15-MAY-2007
("later"), she experienced itching all over her body (reported by patient's phone call on 21-MAY-2007). The nurse reported that by 21-MAY-2007, the patient had
completely recovered from all the symptoms. Follow up information indicated that the reporter considered one or more of the events to require medical
intervention to prevent more serious symptoms, and were therefore considered to be other significant medical events. No further information is expected.
Lab Data: None
History: Drug hypersensitivity
Prex Illness:
Prex Vax Illns:

Vaers Id: 280233-1 (S)

20.0 F 19-Apr-2007 26-Apr-2007 7 04-Jun-2007 05-Jun-2007 IN WAES0705USA04014 07-Jun-2007

MedDRA PT Diplopia, Headache, VIth nerve paralysis, Vision blurred
Symptom Text: Information has been received from a physician and a 20 year old female consumer with Ceclor and sulfonamide allergy who on 19-APR-2007 was vaccinated
with the first dose of Gardasil, IM. Concomitant medication was not reported. On approximately 26-APR-2007 ("within a week of receiving the vaccination), the
patient reported that she had continued blurred vision "MS type symptoms" and had a 3 day hospital stay. A physician reported that on 29-APR-2007, the
patient developed double vision which became progressively worse. The patient was diagnosed with sixth cranial nerve palsy. The patient had numerous
diagnostic tests performed which included MRI's, an angiogram, lumbar puncture, visual tests and blood tests including a complete blood count, metabolic
profile, antinuclear antibody (ANA) test, anticardiolipin antibody, sedimentation rate and blood test to rule out syphilis, Myasthenia Gravis, Sarcoidosis and
Lyme disease. All of these test results were within normal limits. The patient was treated with steroids and was improving. Additional information has been
requested. 06/06/07-records received from facility for DOS 5/1-5/2/07-DC DX: Left cranial nerve VI palsey on left. Mild hypertension. On 4/29/07 while watching
TV noticed double vision on looking to left. Gradual onset. On 4/30/07 woke with double vision when looking in all directions. Double vision is with one image
side by side to the other image. MRI brain showed right hemispheric lesion. Ophthamologist noted optic nerve lesion. Headache come on after having double
vision. No eye pain no numbness or weakness.
Other Meds: Unknown
Lab Data: angiography 04/29?/07 - within normal limits, diagnostic laboratory 04/29?/07 - within normal limits, diagnostic laboratory 04/29?/07 - Sarcoidosis: within normal
limits, magnetic resonance 04/29?/07 - within normal limits, visual acuity te
History: records received 6/6/07-HX:possible hypertension, seasonal allergies, dysmenorrhea and possible diabetes. Prescribed metformin but does not take it.
Prex Illness: Allergic reaction to antibiotics; Sulfonamide allergy
Prex Vax Illns:

Vaers Id: 280234-1

Unknown F Unknown Unknown 04-Jun-2007 05-Jun-2007 TN WAES0705USA05018 05-Jul-2007

Symptom Text: Information has been received from a physician for the pregnancy registry for Gardasil concerning a female who was vaccinated with an unknown number of
0.5 mL doses of Gardasil. "A few weeks ago," the patient developed a miscarriage in the first trimester. The patient's outcome was unknown. Upon internal
review, the patient's spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 280235-1

Unknown F Unknown Unknown 04-Jun-2007 05-Jun-2007 -- WAES0705USA05654 05-Jun-2007

MedDRA PT Coagulopathy
Symptom Text: Information has been received from a physician's assistant concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient
experienced "coagulation" (not further specified). The patient needed to return to see the physician's assistant on several occasions for unknown treatment or
follow-up. Subsequently, the patient recovered from "coagulation". "Coagulation" was determined to be an other important medical event by the reporting
physician's assistant. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280257-1

19.0 F 14-Oct-2006 16-Oct-2006 2 04-Jun-2007 07-Jun-2007 FL 07-Jun-2007

MedDRA PT Diarrhoea, Erythema nodosum, Similar reaction on previous exposure to drug, Vomiting
Symptom Text: After first injection diahrrea occurred for 3 weeks. After second injection vomiting/diahhrea occurred. After third injection what appears to be erythema
nodosum has occurred. Been to primary doctor twice. No explanations. Been to dermatologist, back to original obgyn and have been referred to a
rheumatologist.
Other Meds: Yasmin
Lab Data: 15 blood tests, and biopsy
History: n/a
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280258-1

15.0 F 22-May-2007 23-May-2007 1 04-Jun-2007 07-Jun-2007 MN 07-Jun-2007
HEPA MERCK & CO. INC. AHAVB149AA 0 Right arm Intramuscular
Symptom Text: childs parents brought in sister who had had a vzv injection on 5/22/07 also. the sister had a cellulitis on the arm of the injection. parents reported that this
patient had the same type of reaction. the parents were advised to bring this patient in for evaluation of reaction. the parents never brought this patient in so
the exact reaction is unknown and as far as the office knows no treatment was undertaken. contact with patient and family x2 were attempted, messages left
with no response
Other Meds:
Lab Data: none
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280259-1

12.0 F 26-Feb-2007 27-Feb-2007 1 04-Jun-2007 07-Jun-2007 LA 07-Jun-2007

MedDRA PT Cheilitis, Lip blister, Oral herpes
Symptom Text: Mom stated red lips 24 hours post injection. Mom stated fever blisters around lips 48 hours post injection. Mom called md today; Doctor, who stated not to give
second vaccine.
Other Meds:
Lab Data: None
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280260-1 (S)

13.0 F 22-May-2007 22-May-2007 0 04-Jun-2007 07-Jun-2007 MN 14-Jun-2007
BIOLOGICALS
MedDRA PT Cellulitis, Erythema, Induration, Metabolic syndrome, Obesity, Skin warm
Symptom Text: patient came into clinic on 5/24/07 to have reaction evaluated.cellulitis of left arm was diaagnosed, erythema,warmth, diffuse induration, no fever, about 15-20
cm. patient hospitalized 5/24-27/07 given iv ancef and vancomycin, blood cultures and nasal swab cultures done both negative, cbc and differential-wnl,
patient discharged home on bactrim and keflex 06/12/07-records received for DOS 5/24-5/27/07-DC DX:Left upper arm cellulitis, resolving. Obesity, rule out
metabolic syndrome. HX of present illness:erythema, warmth and induration diffusely over lateral left upper arm. Temperature on admission 37.3 and remained
afebrile for duration of hospital stay. WBC 6.6 with normal differential. Question of metabolic syndrome versus prediabetes. Given this cellulitis reaction and the
patient's obesity there was a question of an immunocompromised host.
Other Meds: hydrocortisone cream to face and benzoyl peroxide to face
Lab Data: cbc with differential, blood cultures, nasal swab for mrsa records received 6/12/07- Fasting Glucose 100. Hemoglobin A1c 5.5. Serum insulin level elevated in
mid 30s. Wound culture no growth. Blood culture no growth. C-Reactive Protein 55.
History: acne, eczema, acanthosis nigricans,extreme over weight
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280281-1

13.0 F 29-May-2007 29-May-2007 0 04-Jun-2007 08-Jun-2007 MA 08-Jun-2007

MedDRA PT Asthenia, Dizziness, Injection site reaction, Nausea, Pallor
Symptom Text: Injection given and pt became weak, color drained from face and felt nauseated and faint. Pt did not faint- no LOC
Other Meds:
Lab Data: none
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280295-1

16.0 F 04-Jun-2007 04-Jun-2007 0 04-Jun-2007 08-Jun-2007 MI 08-Jun-2007
MNQ SANOFI PASTEUR U2233CA 0 Left arm Unknown
Symptom Text: Patient blacked out about 5 mins after the Gardasil was given
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 280296-1

10.0 F 04-Jun-2007 04-Jun-2007 0 04-Jun-2007 08-Jun-2007 IN 08-Jun-2007

MedDRA PT Cold sweat, Dizziness, Dizziness, Malaise, Nausea, Pallor, Presyncope, Tinnitus, Vision blurred
Symptom Text: A few minutes after injection pt stated she didn't feel well. Pt put head down between legs, c/o nausea. Pt looked up and was completely pale, c/o blurred
vision, ringing in ears, dizzy, clammy, lightheaded. Assisted pt to car and transported to ER. Was dx as pre-syncope and drink fluids was discharged at 15:00
Other Meds:
Lab Data: None done
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 280392-1 (S)

15.0 F 01-Nov-2006 01-May-2007 181 05-Jun-2007 06-Jun-2007 IA WAES0705USA04412 06-Jun-2007
Seriousness: ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS
MedDRA PT Autoimmune thrombocytopenia, Evans syndrome, Leukopenia
Symptom Text: Information has been received from a physician concerning a 15 year old female with penicillin allergy and eczematous dermatitis who on 01-NOV-2006 was
vaccinated with a second dose of Gardasil (lot #656049/0187U). On 01-MAY-2007, "roughly at the end of this vaccination series," the patient developed
autoimmune thrombocytopenia and leukopenia. The patient was diagnosed with Evan's Syndrome. The patient was hospitalized for 5 days treated with
platelets, immunoglobulin and prednisone. At the time of the report, the patient had not recovered. The reporting physician considered Evan's syndrome and
leukopenia to be immediately life-threatening and disabling events. The reporting physician reported that he was not personally certain the Gardasil of the
events. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Penicillin allergy; Eczematous dermatitis
Prex Vax Illns:

Vaers Id: 280393-1 (S)

19.0 F 22-May-2007 22-May-2007 0 05-Jun-2007 06-Jun-2007 FR WAES0705USA05770 06-Jun-2007

MedDRA PT Convulsion, Epilepsy, Flushing, Loss of consciousness, Salivary hypersecretion, Syncope
Symptom Text: Information has been received from a gynecologist concerning a 19 year old female with a history of traffic accident (September 2006) and normal cranial CT
and EEG at that time, who on 22-MAY-2007 was vaccinated IM into the deltoid with a first dose of Gardasil (lot # 655671/1024F; batch # NE51780). On 22-
MAY-2007, 2.5 hours after vaccination, (in a department store, on a very hot and sticky day) she developed a questionable seizure for a short time. The
patient's mother reported that the patient was at the end of a large moving staircase and she suddenly fainted and "crooked" her whole body. Saliva was seen
at the corners of her mouth and red flushes in the area of the decollete. She was unconscious for about 3 minutes and subsequently recovered. An ambulance
was called and she was taken to the hospital. She was admitted to the hospital for monitoring and was discharged the same day. The ECG was normal. An
EEG and cranial MRI are scheduled for 29-MAY-2007. The reporter considered epileptic seizure and flushing to be other important medical events. Other
business partner numbers include E2007-03307. Additional information has been requested.
Other Meds: Unknown
Lab Data: electrocardiogram 22May07 normal
History: Computerised tomogram normal; Electroencephalogram; Traffic accident
Prex Illness:
Prex Vax Illns:

Vaers Id: 280394-1 (S)

20.0 F 16-Feb-2007 16-Feb-2007 0 05-Jun-2007 06-Jun-2007 MO WAES0705USA05082 20-Jun-2007
MedDRA PT Anxiety, Areflexia, Asthenia, Balance disorder, Dizziness, Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Incontinence, Injection site erythema, Injection
site swelling, Local reaction, Migraine, Panic attack, Paraesthesia, Paraesthesia oral, Urinary incontinence, Vaccine positive rechallenge
Symptom Text: Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female patient, who on 16-FEB-2007 was vaccinated, IM with the
first dose, 0.5ml, of Gardasil (Lot #655165/1425F). Concomitant therapy included ELMIRON. On 16-FEB-2007, the patient developed a local reaction of
redness and swelling at the injection site. On 19-Apr-2007, the patient was vaccinated IM with the second dose, 0.5ml, of Gardasil (Lot # 210U). Following the
second vaccination, the patient again developed a local reaction of redness and swelling. Sometime following the second vaccination, the patient also became
incontinent and developed numbness in her legs, feet, hands, and arms. On 03-MAY-2007, the patient was diagnosed with Guillian Barre syndrome; the next
day, 04-MAY-2007 she was hospitalized. The length of the hospital stay was unknown. On 17-MAY-2007, the patient was examined by her physician with some
improvement of the symptoms noted, though she continued to experienced weakness. The reporter considered one or more of the events following the second
vaccination, to be significantly disabling/incapacitating, to require hospitalization, and to have required intervention as an other significant medical event.
Additional information has been requested. 06/19/2007 MR received for ER visit of 4/23/07 and hospitalization 5/3-10/07. ER visit of 4/23/07 for c/o weakness,
paresthesias-numbness tongue, fingers and toes, impaired swallowing, balance difficulties and light-headedness. PE:WNL. Discharged from ED with DX of
Anxiety and Dizziness. Returned to ER on 5/3/2007 with c/o 3 week hx of numbness to her tongue and feet. Increased paresthesias of her lower extremities
including an episode of loss of bladder control. Developed anxiety/panic attack over worsening symptoms. Sent to ER for a full GBS workup. PE WNL except
for DTR's were not elicited in the lower extremities. Admitted with assessment of Paresthesias and loss of bladder control; R/O GBS. Final DX: Guillain-Barre
Syndrome. Polycystic ov
Other Meds: ELMIRON
Lab Data: Unknown Labs and Diagnostics: 4/23/07: CBC with WBCs of 3.4. Chemistry WNL, Mono screen (-), UA WNL. head CT normal. Labs and Diagnostics: Cervical
MRI WNL. Lumbar MRI shows DDD. EMG 4/30/07 suggestive of early demyelinating peripheral
History: None. PMH: DJD of the back, asthma, polycystic ovaries, Interstitial Cystitis. Tonsillectomy. Episode of pharyngitis, nausea & vomiting in early April '07. NKDA.
Prex Illness:
Prex Vax Illns:

Vaers Id: 280395-1


MedDRA PT Facial palsy
Symptom Text: Information has been received from a nurse concerning a female who was vaccinated with Gardasil. Subsequently, the patient developed Bell's palsy. Therapy
with human papillomavirus vaccine was discontinued. The patient's Bell's palsy persisted. The nurse indicated that she was unsure whether the human
papillomavirus vaccine caused the Bell's palsy. Upon internal review, Bell's palsy was determined to be an other important medical event. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280396-1


MedDRA PT Convulsion, Erythema, Fall, Feeling abnormal, Hypotension, Injection site erythema, Injection site streaking, Pallor, Tremor
Symptom Text: Information has been received from a nurse practitioner (NP) concerning an 18 year old female who on 31-MAY-2007 was vaccinated with Gardasil (LOT #
657736/0389U). Concomitant therapy included a cough expectorant (unspecified), which was taken on the same morning. On 31-MAY-2007, the patient went
out to the reception area after she received her second Gardasil, and began "shaking and fell down". The NP reported that she thought that the patient had
experienced "a short seizure that lasted about 15 seconds". The NP also reported that the patient had three red streaks running down her arm from the
injection site area and that the patient stated she felt a rush down her arm at the time she was vaccinated. The patient's blood pressure was "a little low" and
her lips were pale. The patient was sent to an urgent care facility to be further evaluated. The nurse indicated that the patient did not have a reaction to the first
dose of Gardasil. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Other Meds: cough, cold and flu therapies
Lab Data: blood pressure 05/31/07 - "a little low"
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280433-1

17.0 F 16-May-2007 27-May-2007 11 05-Jun-2007 08-Jun-2007 WA 02-Jul-2007

MedDRA PT Lymphadenopathy, Neck pain, Pharyngolaryngeal pain, Pyrexia
Symptom Text: Sore throat/pharyngitis, fever, neck pain cervical lymphadenopathy.

Other Meds: Yasmin
Lab Data: Rapid strep (-), Monospot (-), Throat Cx-Beta-stretpococcus not strep A
History: Cephalexin allergy
Prex Illness: none
Prex Vax Illns:


16.0 F 15-Mar-2007 13-May-2007 59 05-Jun-2007 08-Jun-2007 CT 18-Jul-2007
TDAP SANOFI PASTEUR AC14BD40CA 0 Unknown Intramuscular
MedDRA PT Blindness, Colour blindness, Eye pain, Eye pain, Fatigue, Headache, Optic neuritis, Papilloedema, Papilloedema, Visual acuity reduced
Symptom Text: Optic neuritis-hospitalized for 5 day course of prednisone. Onset 5/13. Hospitalized 5/18/07 (headache, eye pain, papilledema) (color blind and visually severly
impaired) 7/18/07-records received from facility for DOS 5/19-5/24/07- DC DX: Optic neuritis. One week piror to admission developed pain and vision loss in left
eye accompanied by headache. Seen by ophthalmologist who diagnosed disk edema and afferent pupillary defect on left side. Fatigue for 2 months since
about the time she received her tetanus and HPV vaccines. No diplopia. No viual changes in right eye. PE: Pain on left eye with ocular movements. Tender
globe in periorbital region on left side, afferent pupillary defect on left.
Other Meds:
Lab Data: MRI, PET scans, spinal tap, CBC, thyroid can Oligopeptides, Lyme records received 7/18/07-CT negative. MRI brain and spine normal exception of some slight
enlargement of left optic nerve. Labs unremarkable. CSF pending at time of discharge
History: obesity, insulin resistance, depression records received 7/18/07-PMH: Hallucinations and previous inpatient admissions to institute of living. Depression and
ADHD.
Prex Illness: none
Prex Vax Illns:


16.0 F 15-Mar-2007 18-May-2007 64 14-Jun-2007 15-Jun-2007 CT WAES0706USA01344 03-Jul-2007

MedDRA PT Blindness unilateral, Eye pain, Headache
Symptom Text: Information has been received from a physician concerning a 16 year old female with diabetes and many other unspecified medical conditions, who on 15-
MAR-2007 was vaccinated with a first dose of Gardasil. On 18-MAY-2007 the patient came back to the office for her second dose but it was not administered
because the patient was experiencing headache, eye pain and loss of vision in one eye (it was not known which eye). The patient was hospitalized because of
this and has been released. Subsequently, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Diabetes; General symptom
Prex Vax Illns:

Vaers Id: 280438-1

14.0 F 14-May-2007 16-May-2007 2 05-Jun-2007 08-Jun-2007 CA 08-Jun-2007

MedDRA PT Skin papilloma
Symptom Text: Pt developed small pimple on inner side of middle phalanx of little finger left on wk after HPV vaccine #3. 2 days later developed wart at site. Within on day was
the size of pts finger on same finger (8-10mm). Mom treating at home with freeze spray.
Other Meds: Albuterol Inh Claritin prn
Lab Data:
History: food allergies
Prex Illness: none
Prex Vax Illns:


16.0 F 29-May-2007 29-May-2007 0 05-Jun-2007 06-Jun-2007 -- 07-Jun-2007
VARCEL MERCK & CO. INC. 0455U 1 Left arm Unknown
MNQ SANOFI PASTEUR U2277AA Right arm Unknown
MedDRA PT Blood pressure decreased, Syncope
Symptom Text: After few moments of receiving multiple vax and Gardasil, patient had a syncope, blood pressure dropped. She recovered. 06/06/07-records received. Vaccine
record documents on 5/30/07 Gardasil lot# 0522U, Varicella Lot #0455U, Menactra lot#U2277AA, Hepatitis A 2 lot#0246U. After vaccination patien left room
and had loss of consciousness for 10 seconds. BP 88/54. Felt better after resting. Walked out of office with mother
Other Meds:
Lab Data: none
History: none
Prex Illness: none
Prex Vax Illns:


VARCEL MERCK & CO. INC. 0455U Unknown Intramuscular
MNQ SANOFI PASTEUR U2277AA Unknown Intramuscular
HEPA MERCK & CO. INC. 0246U Unknown Intramuscular
MedDRA PT Blood pressure decreased, Hypotonia
Symptom Text: Information has been received concerning a 16 year old female who on 30-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Varivax,
Vaqta, tuberculin purified protein derivative and Menactra. On 30-MAY-2007 the patient received the above vaccines without complaints or symptoms. She
stood and walked out of room with mother. The patient turned to ask a question, at that time her eyes closed and her body went limp. She was aided to the
floor without injury. She opened her eyes and spoke appropriately. Her legs were elevated for 15 minutes, BP 88/54. The patient then sat on a chair, never pale
or diaphoretic. After 10-15 minutes the patient walked out of the office with her mother. Additional information is not expected.
Other Meds: PPD
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280470-1

12.0 F 04-Jun-2007 04-Jun-2007 0 05-Jun-2007 07-Jun-2007 ID 07-Jun-2007
BIOLOGICALS
MedDRA PT Convulsion, Fall, Malaise, Pallor
Symptom Text: Client received vaccines, has passed out before from immunizations mother reported. After receiving vaccines client turned a little pale, client was laid down
on a bed and given apple juice to drink. She stayed down for approximately 10 minutes, then mother and daughter left, stating that she was feeling fine.More
than 20 minutes after vaccination, Client returned to clinic with mother and sister to have sister receive vaccinations. Client stated that she didn't feel well and
laid down on the chairs in waiting area. She mumbled something to mother and had a seizure and rolled off the chairs she was laying on. Mother caught her
and eased her to the floor. The seizure lasted less than a minute. Offer to call an ambulance was refused. Cold cloth was applied to forehead and arms.
Mother was encouraged to take her to the doctor. Mother was called 06-05-07 am, mother stated that Kendra had a doctors appointment today to be seen.
She stated that she was acting normal today and that she would call if the doctor stated anything wrong.
Other Meds: NONE
Lab Data:
History: amoxicillin
Prex Illness: No illness at time of vaccination
Prex Vax Illns:


16.0 F 30-May-2007 02-Jun-2007 3 05-Jun-2007 07-Jun-2007 PA 07-Jun-2007

MedDRA PT Arthralgia, Malaise
Symptom Text: Gardasil vaccination given on Wednesday, May 30, 2007. Patient reported general malaise and mild joint pain on Saturday, June 2, 2007. Pain became
increasingly more severe from Sunday, June 3 to Monday, June 4th. I took patient back to see the doctor on Monday, June 4th and described all symptoms to
doctors. Doctors cannot figure out what is wrong. Patient has normal body temperature of 97.8% and has not yet had a fever.
Other Meds: NONE
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns:


16.0 F 30-May-2007 03-Jun-2007 4 08-Jun-2007 14-Jun-2007 PA 14-Jun-2007

MedDRA PT Arthralgia, Musculoskeletal pain
Symptom Text: Joint pain sore shoulder next day increased pain 2nd day 3rd day knees, ankles wrist shoulder
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 280483-1

15.0 F 29-May-2007 30-May-2007 1 05-Jun-2007 07-Jun-2007 FL 07-Jun-2007

MedDRA PT Urticaria
Symptom Text: urticarial rash all over body esp.on belly

Other Meds: prednisone,sulfa,prozac
Lab Data: none05
History: allergic to amoxicillin,congential adrenal hyperplasia
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280485-1 (S)

11.0 F 15-Apr-2007 01-May-2007 16 06-Jun-2007 06-Jun-2007 TX 21-Jun-2007

MedDRA PT Aplastic anaemia, Contusion, Fatigue, Headache, Headache, Impaired healing, Menorrhagia, Pancytopenia, Transfusion
Symptom Text: In early May, increased bruising, slower wound healing, severe bleeding with menstruation, intermittent headaches, fatigue. Admitted to medical center on
06/01/07 following referred from primary pediatrician with pancytopenia. Diagnosed with aplastic anemia. Treatment to be determined. 6/21/07-records received
for DOS 6/1-6/5/07-DC DX: Severe pancytopenia. status post transfusion of RBC times 2 and platelets times 1. Seen in ER on 6/1/07 for increased bruising
and pancytopenia on her blood smear. No evidence of ITP. Severe aplastic anemia.
Other Meds:
Lab Data: CBC, Bone marrow aspirate & biopsy, Viral serologies records received 6/21/07-Bone marrow aspirate and biopsy showed absence of megakaryocytes and
decreased erythroid and meyloid precursors. Presented with hemoglobin 4.9, WBC 3 and platel
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280486-1

21.0 F 05-Jun-2007 05-Jun-2007 0 06-Jun-2007 19-Jun-2007 TN 19-Jun-2007
TD SANOFI PASTEUR U1953AA 1 Right arm Intramuscular
HEPA GLAXOSMITHKLINE AHAVB11BAB 1 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Immediate post-injection reaction, Nausea, Presyncope
Symptom Text: 1. (L) arm Hep A then Td 2. (L) arm Gardasil Immediate onset of nausea and pre syncopal symptoms, BP 80/60 Improved within 10 min lying down
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 280674-1

13.0 F 07-May-2007 07-May-2007 0 06-Jun-2007 07-Jun-2007 FR WAES0705AUS00082 07-Jun-2007

MedDRA PT Body temperature increased, Conversion disorder, Dizziness, Headache, Hemiplegia, Nausea, Tremor, Wheelchair user
Symptom Text: Information has been received from a nurse as part of a business agreement (manufacturer's case number: GARD 2007 05 11 002). On 07-MAY-2007, as part
of the regular school-based immunisation program funded by the government, a female student was vaccinated with Gardasil (Lot No. 655743/0313U, Batch
No. J1022, Expiry date August 2009). The patient was observed for 15 minutes after vaccination and return to the classroom. On 07-MAY-2007, on return to
the classroom, the student experienced headache, nausea and feeling faint. Subsequently the patient was "fine". The nurse, who gave the patient the vaccine,
considered that the events were due to "mass hysteria". In follow-up, the reporting nurse stated that during the 15 minute observation period after the
vaccination on 07-MAY-2007, the patient was symptom-free. The patient was not transported to hospital and was sent home complaining of headache, nausea
and feeling faint. This is one of several reports received from the same source. Further information was received from media monitors summarising a radio talk-
back program, a television evening news and a paper on 22-MAY-2007. The principal of the student's school stated that "the girl's reactions were not related to
the vaccination itself and it is not uncommon for girls of this age group to react to vaccinations in ways that are not necessarily physical in origin". The hospital,
where the other five female students of the school (other than this patient) were taken after fainting, released a statement indicating that they do not believe
Gardasil was responsible. Follow-up information was received from the principal of the patient's school. On 07-MAY-2007 approximately 590 girls were
vaccinated with Gardasil by two nurses over a morning beginning at 9:30 am and finishing around 1:00 pm. There was no interruption to the vaccinations after
some girls' adverse events, which occurred through out the morning. Some girls experienced adverse events immediately after vaccination, whilst others only
after that had returned t
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 280722-1

15.0 F 01-Jun-2007 02-Jun-2007 1 06-Jun-2007 13-Jun-2007 CA 13-Jun-2007
VARCEL MERCK & CO. INC. 0369U 1 Right arm Unknown
MedDRA PT Discomfort, Pruritus
Symptom Text: Pt instructed to apply warm moist compresses QID for discomfort, OTC Benadryl cream for itch.
Other Meds:
Lab Data:
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 280723-1

19.0 F 21-May-2007 21-May-2007 0 07-Jun-2007 13-Jun-2007 MD 13-Jun-2007

MedDRA PT Syncope
Symptom Text: Patient was administered her 2nd dose of Gardasil on 5/21/07. After 10 minutes the patient was exiting the office and experienced syncope.
Other Meds:
Lab Data:
History: Allergic to Bactrim
Prex Illness:
Prex Vax Illns:

Vaers Id: 280724-1

19.0 F Unknown Unknown 07-Jun-2007 13-Jun-2007 MD 13-Jun-2007

MedDRA PT Syncope
Symptom Text: 1st dose of Gardasil received on 5/31/07. Patient experienced syncope after 10-15 minutes.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 280725-1

16.0 F Unknown Unknown 07-Jun-2007 13-Jun-2007 MD 13-Jun-2007

MedDRA PT Syncope
Symptom Text: 1st dose of Gardasil received on 3/26/07. Patient experienced syncope after 10-15 minutes.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 280841-1 (S)

16.0 F 10-May-2007 12-May-2007 2 07-Jun-2007 08-Jun-2007 FR WAES0706USA00445 08-Jun-2007

MedDRA PT Leukocytoclastic vasculitis
Symptom Text: Information has been received from a health authority concerning a 16 year old female with no medical history, who on 10-MAY-2007 was vaccinated IM with a
first dose of Gardasil (lot# 1341F, batch# NF12410). On 12-MAY-2007, the patient experienced allergic vasculitis and was admitted to the hospital. At the time
of this report, the patient had not recovered. Other business partner numbers include: E200703502 and PEI2007004696. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: none
Prex Illness:
Prex Vax Illns:

Vaers Id: 280846-1

Unknown F 27-Apr-2007 01-May-2007 4 07-Jun-2007 13-Jun-2007 OH 13-Jun-2007

MedDRA PT Induration, Inflammation, Myalgia
Symptom Text: Prolonged inflammation (hard deltoid muscle, tender to touch) 3-4 weeks after injection
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 280847-1

19.0 F 29-May-2007 31-May-2007 2 07-Jun-2007 13-Jun-2007 CO 13-Jun-2007
VARCEL MERCK & CO. INC. 0011N 1 Right arm Subcutaneously
MedDRA PT Erythema, Pyrexia, Skin warm
Symptom Text: Vaccine MMR given 5/29/07 called 5/31/07 was was seen at pulmonologist office. Felt was more than just local reaction large hot red area back of right arm
fever 101, cold compresses Ibuprofen, Keflex
Other Meds: Flonase, Depakene, Tegretol, Duoneb, Singulair, Baclofen, Neurontin, Elavil, Oxygen, Miralax, Xopenex, Zyrtec, Pulmicort, Ibuprofen, Calcium Antacid tablets,
Vitamin D tablet MSM with Glucosamine
Lab Data:
History: G Tube, Delayed milestones, spastic Quadriplegia, surgeries
Prex Illness: Candidiasis
Prex Vax Illns: local reaction~Measles + Mumps + Rubella (no brand name)~2~17~In Sibling

Vaers Id: 280849-1

13.0 F 01-Jun-2007 01-Jun-2007 0 07-Jun-2007 13-Jun-2007 AZ 13-Jun-2007
TDAP GLAXOSMITHKLINE AC52B013AA 0 Left arm Unknown
BIOLOGICALS
MedDRA PT Fall, Syncope
Symptom Text: After giving last immunization. Pt was asked how she felt fine. 2-3 min later asked her again, she said fine. She then fell back on the bed and fainted. Doctor
called into the room to examine patient. Pt reacted 2-3 min later.
Other Meds:
Lab Data: EKG
History: Recurrent syncope episodes
Prex Illness:
Prex Vax Illns:

Vaers Id: 280867-1

11.0 F 16-May-2007 18-May-2007 2 07-Jun-2007 11-Jun-2007 TX 11-Jun-2007
VARCEL MERCK & CO. INC. 0267F 1 Right arm Subcutaneously
HEPA MERCK & CO. INC. 0001U 0 Right arm Intramuscular
MedDRA PT Erythema, Pain, Rash vesicular, Swelling, Tenderness
Symptom Text: Very red, swollen, little larger than quarter sized, and tender 05182007, give tyl for pain and apply ice, mom called back on 05252007 to report Chicken pox
rash, advised to give her benadryl
Other Meds: Retin-A Micro 0.1% Topical Gel
Lab Data:
History: no
Prex Illness: no
Prex Vax Illns:

Vaers Id: 280870-1


MedDRA PT Anorexia, Cold sweat, Discomfort, Dizziness, Fatigue, Nausea, Pallor
Symptom Text: Extremely dizzy, nausea, tiredness, loss of appetite, pale color, no fever but very uncomfortable/"clammy". Had vaccine (3rd of series) on June 5 and
symptoms began the following day. Are still present today, but doing better.
Other Meds: n/a
Lab Data: n/a
History: NKA
Prex Illness: n/a
Prex Vax Illns:

Vaers Id: 280882-1

15.0 F 02-Apr-2007 02-Apr-2007 0 07-Jun-2007 11-Jun-2007 NY 11-Jun-2007

MedDRA PT Pyrexia, Vomiting
Symptom Text: COMPLAINTS OF FEVER OF 102.0 FOR 2 DAYS AND VOMITING

Other Meds:
Lab Data:
History: ASTHMA
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 281020-1

15.0 F 21-May-2007 21-May-2007 0 08-Jun-2007 11-Jun-2007 NY WAES0705USA05241 11-Jun-2007

Symptom Text: Information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on 21-MAY-
2007 was vaccinated intramuscularly with the first dose of Gardasil. There was no concomitant medication. On 21-MAY-2007 the patient developed a rash that
started on the belly and spread to the back and both legs. The physician noted that it was unknown whether the rash was already there before the patient
received the vaccination, however the patient noticed the rash and mild itching the day that the vaccination was given. The patient was given cetirizine
hydrochloride (ZYRTEC). At the time of this report, the patient's rash and itching persisted. The reporting physician felt that the events were serious for another
other medical event due to treatment with cetirizine hydrochloride (ZYRTEC). Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281021-1

14.0 F 29-Jan-2007 16-May-2007 107 08-Jun-2007 11-Jun-2007 FR WAES0706CAN00027 11-Jun-2007
MedDRA PT Chills, Dizziness, Fatigue, Fatigue, Headache, Hypoaesthesia, Influenza like illness, Malaise, Mass, Migraine, Migraine with aura, Nausea, Pallor,
Paraesthesia, Paralysis, Pyrexia, Rash, Syncope, Tinnitus, Tremor, Vomiting
Symptom Text: Information has been received from a pharmacist and his wife concerning a 14 year old female, very athletic, who on 29-JAN-2007 (first dose) and 16-MAY-
2007 (second dose) was vaccinated with Gardasil. Concomitant therapy included Twinrix, vitamins (unspecified) and albuterol. Subsequently, after the first
dose of Gardasil, the patient experienced migraine. There was no reaction at the site of injection of Gardasil. On 16-MAY-2007, the patient received the second
dose of Gardasil. On 16-MAY-2007 the patient experienced migraine aura, tingling, numbness, dizziness, then fainted, was pale, shaking, some paralysis and
ringing in ears (it was reported that some paralysis and ringing in ears "lasted a long time") and headache. It was also reported that that whole evening, the
patient also experienced chills and was wiped out, slept. On 17-MAY-2007 and 18-MAY-2007 the patient was tired. On 19-MAY-2007 the patient experienced
slight rash on legs, which has been disappearing and coming back, "not a big issue". Therapy with Benadryl and witch hazel (+) Penaten was initiated for rash.
On 20-MAY-2007 the patient experienced, above the left clavicle, 3 painful lumps; 2 pea size, 1 bean size. From 21-MAY-2007 to 25-MAY-2007, the lumps
grew. On 25-MAY-2007, the patient experienced fever and chills, flu-like reaction. On 25-MAY-2007 the patient went to see a physician. There was no swollen
spleen or other swollen glands. It was reported that the physician did not think it "was viral". A complete blood cell count was done but "no info yet". From 25-
MAY-2007 to the time of report on 31-MAY-2007, the patient came from school exhausted, experienced a lot of malaise, general headaches, nausea, a bit of
vomiting and was still experiencing tingling but there was no diarrhea and the lumps were still swollen but less. Upon internal review, some paralysis was
considered as an other important medical event. Tingling and numbness were determined to be important medical events based on agency requirements. No
further is available.
Other Meds: albuterol Unk - Unk, hepatitis a virus inactivated (+ 29Jan07, hepatitis a virus vaccine inactivated (+ 16May07, vitamins (unspecified) Unk - Unk
Lab Data: complete blood cell count 25May07 "no info yet"
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 281022-1 (S)

14.0 F 08-Mar-2007 08-Apr-2007 31 08-Jun-2007 11-Jun-2007 CA WAES0706USA00562 05-Jul-2007
HPV4 MERCK & CO. INC. 0637F 0 Unknown Unknown HPV4
MedDRA PT Back pain, Depression, Diplegia, Hyperreflexia, Hypoaesthesia, Hypotonia, Hypotonia, Myelitis transverse, Pain in extremity, Paraesthesia, Paralysis flaccid,
Wheelchair user
Symptom Text: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on 11-JAN-2007 was vaccinated
with the first dose, 0.5ml, of Gardasil, with no adverse events reported, and on 08-MAR-2007 was vaccinated with the second dose, 0.5ml, of Gardasil. There
was no concomitant medication. On 08-APR-2007, the patient had experienced "extreme leg and back pain" and was diagnosed with acute transverse myelitis;
she was hospitalized. The duration of hospitalization was not known. At the time of this report, the patient had not recovered from the acute transverse myelitis.
Additional information has been requested. 6/19/07 Received PCP medical records which included vax records w/lot & dose #s. VAERS database updated
w/same. ALso included was hospital d/c summary which reveals patient admitted 4/17-4/20/07 with severe LE pain which had progressively worsened. Seen
by PCP who sent to neurologist prior to admit . Admitted for high dose steroids & close observation. Improved dramatically & d/c to home w/PCP & neuro f/u.
Seen by neuro in f/u on 4/23/07 being transported by ambulance on a gurney due to total paralysis of both LEs. Also had severe depression. 5/18/07 w/only
partial recovery. Continued to have severe low back & LE pain despite fentanyl patch & PT. Was unable to ambulate & was w/c bound. Exam revealed severe
flaccid hypotonic muscle weakness of LEs w/hyperreflexia. Bladder & bowel function were intact. Patch increased & was to continue PT. 7/3/07 Received
hospital medical records which reveal patient experienced severe LE pain which had progressively worsened. Admitted 4/17-4/20/07 for IV steroids & pain
management. Patient had URI w/sore throat & fever approx 3-4 wks prior to admit treated w/antibiotics. Then developed back pain which worsened & LEs also
became numb. Seen by PCP who consulted neurosurgeon & MRI was done which was neg. Patient continued to worsen & was seen by neurologist who dx
w/transverse myelitis & admitted to hospital.
Other Meds: None
Lab Data: None LABS: MRI of LS spine done prior to admit was WNL. WBC 8,300, neutros 62, lymphs 30, monos 7, eos 1. ESR is 16. CSF glucose 61, protein 44,
lymphs 100, c/s neg. MRI repeated on 4/18 revealed presumed discogenic disease at T10-11 an
History: None PMH: URI, sore throat & fever approx April 3. Back pain began approx April 4 w/paresthesias beginning approx April 5-6.
Prex Illness:
Prex Vax Illns:


21.0 F 07-Jun-2007 07-Jun-2007 0 08-Jun-2007 15-Jun-2007 NY 15-Jun-2007
HPV4 MERCK & CO. INC. 0011V 0 Left arm Unknown

MedDRA PT Eye pain, Headache, Nausea, Vomiting
Symptom Text: Pt received Gardasil vaccine at 9AM. Called at 4PM complaining of nausea, vomiting, and left side headache with left orbital pain
Other Meds:
Lab Data: None
History: No known drug allergies
Prex Illness: None
Prex Vax Illns:


21.0 F 07-Jun-2007 07-Jun-2007 0 18-Jul-2007 15-Aug-2007 NY WAES0706USA02004 22-Aug-2007

MedDRA PT Eye pain, Headache, Nausea, Vomiting
Symptom Text: Information has been received from a office worker concerning a 21 year old female with no pertinent medical history or drug reactions/allergies on 07-JUN-
2007 who was vaccinated with a first dose of Gardasil (lot # 654702/0011U) IM at 9 AM in the left deltoid. There was no concomitant medication used. On 07-
JUN-2007 the patient called at 4 PM complaining of nausea, vomiting, left frontal headache with left orbital pain. On 07-JUN-2007, the patient recovered from
nausea, vomiting, left frontal headache and left orbital pain. No additional information was given. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281045-1

12.0 F 29-May-2007 31-May-2007 2 08-Jun-2007 18-Jun-2007 VA 18-Jun-2007
VARCEL MERCK & CO. INC. 0126U 1 Right arm Subcutaneously
MedDRA PT Injection site cellulitis, Injection site induration, Injection site pain, Pain
Symptom Text: seen 5/31/07 4cm x 5 cm area with induration-severe tenderness (L) deltoid area. Diagnosed with Cellulitis secondary to Gardasil injection. Treated with
antibiotic-Augmentin 400 mg chews Ztabs po BID x 10 days. Motrin 2 tabs Q6hrs, as needed for pain.
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281048-1

26.0 F 01-May-2007 08-Jun-2007 38 08-Jun-2007 12-Jun-2007 GA 13-Jun-2007

Symptom Text: Patient has not experienced any adverse events. Patient received a positive pregnancy test 25 days after receiving her second dose of Gardisil (HPV).
Other Meds:
Lab Data: Patient is to notify her OB doctor. Steps taken unknown at this time.
History:
Prex Illness: Patient was not aware that she was pregnant during the time Gardisil ws administered.
Prex Vax Illns:

Vaers Id: 281051-1

8.0 F 04-Apr-2002 03-Jun-2007 1886 08-Jun-2007 13-Jun-2007 NY 31-Aug-2007
Symptom Text: 2 months following vaccine administration patient developed Bell's Palsy. Treated with Valtrex and prednisone.
Other Meds: None
Lab Data: Lyme titers sent and pending. Thyroid function within normal limits.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281058-1

19.0 F 04-May-2007 11-May-2007 7 08-Jun-2007 12-Jun-2007 WA 13-Jun-2007

MedDRA PT Lymphadenopathy, Pain, Pruritus, Wrong technique in drug usage process
Symptom Text: Pt received Gardasil injection in lower right back area on 5/4/07. The next week she noticed enlarged lymphnodes in her right groin area. It was painful when
she walked and she noticed some itching in the area. Pt was reassured about the lymphnodes in her right groin area. No info could be found on
Lymphandenopathy. Pt will monitor her lymph nodes for the next few weeks. If they increase in size will consider doing an ultrasound. It is most likely they will
decrease in size and eventually disappear over the next few months.
Other Meds: None
Lab Data:
History: Depression
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281068-1

HPV4 MERCK & CO. INC. ? Unknown Unknown

MedDRA PT Ear pain, Headache, Injection site pain, Irritability, Malaise, Muscle spasms, Nasal congestion, Pain in extremity, Pharyngolaryngeal pain, Pyrexia, Somnolence
Symptom Text: First shot, no problem. Second shot, (3 days ago) extremely painful shot almost passed out from pain of shot given to her. My arm still hurts 3 days later at site
of shot, but for the first day it hurt allot. They had me wait 15 minutes to see if I had a reaction, I felt ok, except pain from shot, so I left. Soon after I left, I felt
groggy and irritable. This groggy lasted the rest of the day. The following day I felt ok fine except for the arm pain. Wednesday 2 days after the shot I was sick
and today 6 days after I am still sick. My symptoms are, head ache, low grade fever, stuffy nose, extremely soar throat, and horrible muscle cramps in my
back, arms and stomach, ache in ears too.
Other Meds: tazarac
Lab Data: Has not seen a doctor yet
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 281086-1

15.0 F 05-Jun-2007 06-Jun-2007 1 08-Jun-2007 18-Jun-2007 PA 21-Jun-2007

MedDRA PT Back pain, Headache, Hypoaesthesia, Paraesthesia
Symptom Text: paraesthesias bilateral arms upon awakening frontal/temporal headache, lower back pain, thighs and arms numb. -All self resolved with in hours
Other Meds: None
Lab Data: None
History: allergic rhinitis
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281089-1

12.0 F 04-Jun-2007 04-Jun-2007 0 08-Jun-2007 18-Jun-2007 OH 18-Jun-2007
BIOLOGICALS
MNQ SANOFI PASTEUR U1974AB 0 Right arm Intramuscular
MedDRA PT Decreased appetite, Flushing, Muscular weakness, Nausea, Pain, Pyrexia
Symptom Text: fever (102.F), flushed cheeks, leg/arm pain, weakness in legs, nausea, poor appetite x 2 days
Other Meds: Zithromax, Diflucan
Lab Data: CBC w/diff (awaiting results)
History: Amoxicillin
Prex Illness: otitis yeast infection
Prex Vax Illns:

Vaers Id: 281095-1

18.0 F 15-Jan-2007 15-Jan-2007 0 11-Jun-2007 12-Jun-2007 IA WAES0701USA02073 12-Jun-2007

MedDRA PT Drug exposure during pregnancy, Foetal disorder, Medication error, Talipes, Umbilical cord abnormality
Symptom Text: Information has been received from a registered nurse concerning a patient who on 15-JAN-2007 was vaccinated with a dose of Gardasil that had been
improperly stored. It was noted that the patient was not experiencing any symptoms. Unspecified medical attention was sought. No product quality complaint
was involved. Follow-up information has been received through the Merck pregnancy registry from a nurse concerning an 18 year old female who on 27-OCT-
2006 was vaccinated with Gardasil, when she was 17 1/7 weeks pregnant, LMP 29-JUN-2006, EDD 05-APR-2007). Subsequently, the infant was born with a
left club foot and two vessel umbilical cord. The nurse felt that the left club foot and two vessel umbilical cord were other important medical events. Additional
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 281096-1

21.0 F 05-Jan-2007 15-Feb-2007 41 11-Jun-2007 12-Jun-2007 NY WAES0706USA00031 27-Jun-2007
MedDRA PT Biopsy, Epistaxis, Henoch-Schonlein purpura, Joint stiffness, Joint swelling, Leukocytoclastic vasculitis, Parvovirus infection, Pharyngitis streptococcal,
Purpura, Rash maculo-papular
Symptom Text: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 05-JAN-2007 was vaccinated with a
0.5 ml dose of Gardasil. Concomitant therapy included penicillin, prednisone and hormonal contraceptives (unspecified). On approximately 15-FEB-2007 the
patient experienced strep throat. On 21-FEB-2007 the patient sought medical treatment for rash/purpura and nose bleeds. On 28-FEB-2007 the patient had a
sinus biopsy and was diagnosed with leukocytoclastic vasculitis. It was determined that the patient had been exposed to parvovirus. The patient was referred to
an infectious disease physician who was "ruling out" the parvovirus. At the time of the report, the results of the parvovirus are unknown. After seeing several
specialist, the patient was diagnosed with Henoch-Schonlein purpura. At the time of the report, the patient had not recovered. Upon internal review, Henoch-
Schonlein purpura was considered to be an other important medical event. Additional information has been requested. 6/21/07-records received for DOS 2/27-
5/17/07-office visits. Presented on 2/27/07 with complaint of generalized maculopapular rash. Ecchymosis around ankles pruritic. Some resolving areas on
thighs and trunk and shoulders. Started superiorly and moved inferiorly. Likely viral exanthem. Seen on 3/8/07-rash continues, assessment:leukocytoclastic
vasculitis confirmed with biopsy. Seen on 3/29/07-continues to have intermittent episodes of joing swelling and stiffness, no rash at present. CT scan sinuses
negative. Recent infectious history included cold in late December, on a cruise in January and developed a sore throat. HPV vaccine early January. Patient had
a pet hedgehog and a python. Visit on 5/17/07-vasculitis substanitally improved.
Other Meds: hormonal contraceptives, prednisone
Lab Data: Sinus probe 02/28/07 - diagnosed with leukocytoclastic vasculitis records received 6/21/07-Labs: UA unremarkable. Borderline elevation of tranaminases.
Basic metabolic and liver panel normal. Proteinase 3 antibody normal. Sjogren's SSA an
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 281105-1

17.0 F 05-Jun-2007 05-Jun-2007 0 11-Jun-2007 20-Jun-2007 MA 20-Jun-2007
MedDRA PT Cold sweat, Dizziness postural, Pallor
Symptom Text: Patient sat for 5 minutes after vaccines, felt fine. Rose to stand slowly and was fine. Discharged from office. 5 minutes later felt dizzy while at the appointment
desk. Color pale, clammy skin. Recovered with supine position and Oxygen, OJ to drink. Had no lunch today. Discharged from office at 3:30 pm.
Other Meds: None
Lab Data: None
History: none
Prex Illness: None known or reported
Prex Vax Illns:

Vaers Id: 281108-1

14.0 F 11-May-2007 01-Jun-2007 21 11-Jun-2007 20-Jun-2007 CA 20-Jun-2007
MedDRA PT Varicella, Varicella post vaccine
Symptom Text: Patient had chickenpox after receiving varicella immunization. Had mild amount of involvement of legs, chrisind face.
Other Meds:
Lab Data: vv
History: thyroid goiter
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281112-1

14.3 F 25-May-2007 25-May-2007 0 11-Jun-2007 20-Jun-2007 PA 20-Jun-2007
TDAP SANOFI PASTEUR 2644AA 0 Left arm Intramuscular
MedDRA PT Syncope, Tremor
Symptom Text: Had Syncopal episode lasting 5 seconds immediately following injections (3). Brief shaking associated with syncope. PMH - similar episode when treated for
ingrown toenail.
Other Meds: None
Lab Data: None
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281114-1

18.0 F 24-Apr-2007 03-May-2007 9 11-Jun-2007 20-Jun-2007 NY 27-Jun-2007
MedDRA PT Anaemia, Antiphospholipid syndrome, Headache, Hypoaesthesia, Joint swelling
Symptom Text: Patient present to office for eval of swollen ankles beginning 5/3/07. Bloodwork showed mild anemia and abnormal coagulation panel. Patient further
complained of swelling, numbness to Right feet and daily headaches. Negative Doppler studies x2 for clots in legs. Patient received Garadasil #2 & Tdap
vaccine 4/24/07. Patient had normal CBC in 2/07. Patient now seeing hematogolist. 6/27/07-records received for DOS 4/23-5/21/07-Bilateral ankle edema, foot
pain headaches. HX running track. On 5/21/07-Edema resolved. Residual right foot numbness. No fever or swelling for 3 days. Antiphospholid syndrome. To
see hem/onc for anemia.
Other Meds: Minocycline
Lab Data: CBC (anemia), CBP (elevated), Sed rate, C3, Cy Total Complemax, Lupus panel (abnormal), Rheum factor ANA, Doppler studies x2 of lower extremities
negative for clots. records received 6/27/07-Increased ESR and CRP and normocytic anemia. Inc
History: none
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281378-1 (S)

15.0 F 01-Jun-2007 01-Jun-2007 0 12-Jun-2007 13-Jun-2007 VA WAES0706USA00635 13-Jun-2007

MedDRA PT Grand mal convulsion, Lethargy, Oxygen supplementation, Syncope vasovagal
Symptom Text: Information has been received from a physician concerning his 15 year old niece, with no known drug allergies and no history of seizures, who on 01-JUN-2007
was vaccinated with Gardasil (lot # 656051/0244U). There was no concomitant medication. On 01-JUN-2007, within 2 to 3 seconds of receiving the first dose of
Gardasil, the patient had a vasovagal reaction and sought unspecified medical attention. No laboratory/diagnostic tests were performed. The fainting lasted for
1 to 2 minutes and then she had a tonic clonic seizure that lasted 4 to 5 seconds. The patient was lethargic for about 1/2 hour. The patient was given oxygen
and pulse ox. On 01-JUN-2007, the patient recovered from vasovagal reaction and tonic clonic seizure. The physician considered one or more of the events to
be disabling and/or an other important medical event. Additional information has been requested.
Other Meds: none
Lab Data: none
History: Absence seizure
Prex Illness:
Prex Vax Illns:

Vaers Id: 281386-1

15.0 F 07-May-2007 07-May-2007 0 12-Jun-2007 20-Jun-2007 TX 20-Jun-2007
TDAP SANOFI PASTEUR C2454AA 5 Right arm Unknown
HEPA MERCK & CO. INC. 1281F 0 Right arm Unknown
MedDRA PT Abdominal pain upper, Headache, Injected limb mobility decreased, Injection site induration, Injection site swelling, Injection site warmth, Pain
Symptom Text: 5/10/07 0830 in ER with swollen, hot hard rt deltoid with c/o excessive pain and unwillingness to use arm. Pain rated 8 on 1-10. Blood drawn. no infection
noted. Warm packs and NSAID. 5/1107 0900 back in ER. "Twice as big" "hard", "head hurts", "stomach hurts", per mother. Augmentin and Hydrazine given.
Approx 12" x 8" per mom. 5/14/07 called mom. Went to another ER, was prescribed steroids per mom, all better. Will follow up 5/18
Other Meds: None
Lab Data: per moms description: Blood work to check for infection. Results reported as within normal limits.
History: Denied allergies
Prex Illness: None per mom and Patient
Prex Vax Illns:

Vaers Id: 281390-1

20.0 F 06-Jun-2007 06-Jun-2007 0 12-Jun-2007 21-Jun-2007 NC 22-Jun-2007

MedDRA PT Nausea, Syncope
Symptom Text: Injection given complained of feeling nauseated, given juice, sprite with relief obtained, observed for 25-30 minutes to check out, fainted-treated per internist.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 281394-1

Symptom Text: Patient became dizzy and syncopal and laid on table for 5 min. Blood pressure 100/50. Drank H2O. Walked out of office with mom 5 min later completely
recovered.
Other Meds: Benzaclea, Retina cream
Lab Data: none
History: none
Prex Illness: none
Prex Vax Illns: syncope~Vaccine not specified (no brand name)~~0~In Patient|syncope~Vaccine not specified (no brand name)~~0~In Sibling

Vaers Id: 281395-1

Unknown F 05-Jun-2007 06-Jun-2007 1 12-Jun-2007 21-Jun-2007 AZ 22-Jun-2007
VARCEL MERCK & CO. INC. 0308U2109 1 Right arm Unknown
MMRV MERCK & CO. INC. 42058AA 0 Left arm Unknown
MedDRA PT Cold compress therapy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Symptom Text: Warm, red, pruritic area 2x3" on Right deltoid. Tender to touch. Gave ice/melt on 20 minutes off 20 minutes.
Other Meds:
Lab Data: None
History: asthma
Prex Illness: none
Prex Vax Illns:

Vaers Id: 281400-1

16.0 F 03-May-2007 Unknown 12-Jun-2007 20-Jun-2007 MI 21-Jun-2007
VARCEL MERCK & CO. INC. 1309F 1 Unknown Subcutaneously
Symptom Text: Swelling at injection site.

Other Meds: None
Lab Data:
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281407-1

15.0 F 05-Apr-2007 10-Apr-2007 5 12-Jun-2007 20-Jun-2007 NC NC07058 05-Jul-2007
MedDRA PT Abdominal pain, Aura, Chest pain, Complex partial seizures, Convulsion, Grand mal convulsion, Nausea
Symptom Text: Had HPV and Menactra on 4-5-07 on 4-10-07 began to have chest and abdomen pain then had seizures (abd) a few days later which have developed into
grand mal seizures. 7/5/07-records received for DOS 4/16-5/29/17-seen by cardiologist on 4/16 for C/O chest pain, experiencing chest pain for several months,
3-5 times per day last from 1-3 minutes, occasionally becomes nauseous with pain. Associated sharp abdominal pain at time, left sided. Impression:
experiencing noncardiac chest pain. Seen by neurologist on 5/4/07- with C/O seizures versus migraines verus other. Having intermittent apells that are
confusing in spite of multiple work ups and evaluations. Episodes occur any time night or day, woken the patient up twice. Seem to be somewhat progressive,
patient first complains of chest pain and this occurs in epigastric region radiating to left chest and patient may tense up, episodes now described as being
normal and then 5-10 minutes spaces out. Seems to be in a trance and is amnesic and may fall to floow with cold sweats and cries and screams may ball up
into fetal position. Has had 4 back to back. Always happen on the left. Two weeks prior to onset of symptomatology patient had HPV vaccine and
meningiococcal vaccine. Follow up visit on 5/30/07-Currently all spells have been on Friday and Saturdays and consisting of trembling, shaking all over, both
hands are fists, she becomes stiff her eyes are squeezed tight. Ususally an aura of nausea prior to event. EEG normal and 6 hour vido EEG was normal.
Assessment: paroxysmal spells would could represent complex parital seizures versus nonepileptic events.
Other Meds: None
Lab Data: CT abd -, EKG -, Abd US -, Chest X-ray -, endoscopy -, echocardiogram records received 7/5/07-All EEGs, 6 hour video EEG and MRI of brain are normal.
Negative EGD study. Possible very low frequency midsystolic noise at apex. Echocardiogram
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281409-1

26.0 F 16-Mar-2007 16-Mar-2007 0 12-Jun-2007 13-Jun-2007 FL 13-Jun-2007

MedDRA PT Dyspnoea, Pharyngolaryngeal pain, Pruritus
Symptom Text: Patient had itchy ear, sore throat, and shortness of breath after receiving Gardasil (first dose). Pt at home when reaction occurred and took Zyrtec. Rxn
resolved
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 281418-1

12.0 F 08-Jun-2007 08-Jun-2007 0 12-Jun-2007 13-Jun-2007 SD 13-Jun-2007

MedDRA PT Dizziness, Dizziness, Dizziness, Dyspnoea, Hyperhidrosis, Nausea, Pallor
Symptom Text: Patient developed difficulty breathing, light-headed, dizzy skin-diaphoretic,pale nauseated-felt like she was going to faint. Symptoms started 2-3 minutes after
vaccination.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281434-1

23.0 F 08-May-2007 08-May-2007 0 12-Jun-2007 20-Jun-2007 KY 21-Jun-2007

MedDRA PT Syncope
Symptom Text: Became very faint after getting immunization (Gardasil) put in supine position w/legs elevated.
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 281435-1


MedDRA PT Dizziness, Loss of consciousness, Malaise, Nausea, Vomiting
Symptom Text: Within 10 minutes of injection, patient became light headed and passed out. Approximately 20 minutes after injection nausea and vomiting began. Sent to ER
due to persistence of feeling ill.
Other Meds:
Lab Data:
History: NKDA
Prex Illness: Sports Px
Prex Vax Illns:

Vaers Id: 281537-1

17.0 F 25-Apr-2007 25-Apr-2007 0 13-Jun-2007 14-Jun-2007 MI WAES0706USA00513 14-Jun-2007

Symptom Text: Information has been received from a registered nurse concerning a 17 year old female patient with a drug allergy to erythromycin and no medical history, who
on 21-FEB-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (Lot# 655324/0089U). There was no concomitant medication. On 25-APR-2007 the
patient received her second dose of the vaccine while pregnant (LMP 28-MAR-2007). On 16-MAY-2007, the patient experienced an uncomplicated
spontaneous miscarriage. Unspecified medical attention was sought. It was reported that the patient has not required any treatment and has not experienced
any further problems. Laboratory diagnostic studies included a quantitative HCG. At the time of this report, the patient was recovering. No product complaint
was involved. Upon internal review, uncomplicated spontaneous miscarriage was considered to be an other important medical event. Additional information has
been requested.
Other Meds: none
Lab Data: total serum human -
History:
Prex Illness: Pregnancy NOS (LMP = 3/28/2007); Allergic reaction to antibiotics
Prex Vax Illns:

Vaers Id: 281538-1

11.0 F Unknown Unknown 13-Jun-2007 14-Jun-2007 NY WAES0706USA00328 26-Jul-2007

Symptom Text: Information has been received from a physician concerning a 11 year old female with a history of convulsion disorder who was vaccinated with Gardasil. It was
reported that the patient had a seizure after receiving a dose of Gardasil. Unspecified medical attention was sought. It is not known which dose this was in the
series. Lot number was not available. No further information was given. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Convulsion disorder
Prex Illness:
Prex Vax Illns:

Vaers Id: 281539-1 (S)


MedDRA PT Deep vein thrombosis, Oedema peripheral, Pain in extremity, Pneumatic compression therapy, Thrombectomy, Thrombolysis, Thrombosis
Symptom Text: Information has been received from a nurse concerning a 17 year old female who on 30-MAY-2007 was vaccinated with Gardasil (Lot #657621/0387U). There
was no concomitant medication. On 30-MAY-2007 the patient developed impressive swelling and pain in her left shoulder down to her wrist. This occurred after
the patient went swimming. It was reported that "the swelling gets less when the arm is not used but comes back when the patient uses the arm". A physician in
the office told the patient to elevate and ice the arm in the area for a couple of days, but this did not help. On 04-JUN-2007 a Doppler ultrasound was performed
which revealed thrombosis in the arm. It was reported that the swelling and pain were disabling to the patient. The patient's swelling and pain persisted. No
further information is available at this time. Additional information has been requested. 6/21/07-records received for DOS 6/11 and 6/17/07- Letter from PCP
indicated that DVT is not thought to be due to vaccine it has probably been present for a few weeks. unfortunately it began to grow around the time of HPV thus
the apparent association. Received HPV 5 days ago from this visit of 6/4/07-developed impressive swelling and pain that day while swimming. Arm literally
twice normal size with pitting edema into arm pit. Swelling lessesn when not using arm but returns when she tries to swim or exerices. PE:left arm with non
pitting swelling over entire arm, skin over arm is warm and well perfused fingers are cool on both hands but well perfused. ROM fine. Treatment, thrombolysis
and mechanical thrombectomy, subclavian vein was virtually completely freed of thrombus. An underlying compression of the vein at the thoracic inlet was
documented
Other Meds: None
Lab Data: ultrasound 06/04/07 - thrombosis in the left arm records received 6/21/07-Color duplex ultrasound of upper extremity venous system demonstrated acute deep
vein thrombosis in left arm.
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281563-1

17.0 F 12-Jun-2007 12-Jun-2007 0 13-Jun-2007 13-Jun-2007 GA 13-Jun-2007
TDAP SANOFI PASTEUR C2572AA 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Dyskinesia, Malaise, Muscle twitching, Pallor, Syncope, Urinary incontinence
Symptom Text: Pt came into clinic with parent for vaccines, Tdap,Hepatitis A,Menactra, gardasil,varivax. After vaccines pt skin tone became white and she said "I don't feel
well" then pt had syncopal episode nurse used ammonia inhalant to bring pt around pt legs elevated ice applied to back of neck, pt initialy responded to nurse
and parent, then pt had what appeared to be another syncopal episode but pts body began twitching and jerking and then pt lost control of her bladder, another
ammonia inhalant was used to bring pt around. When pt was able she was assisted to exam table and placed in supine position with legs elevated. After
incident nurse questioned parent if pt had history of seizures and parent confirmed previous history although on immunization consent form questionairre
parent anwered no to question of history of seizures or neurological problems. pt given 8 ozs apple juice which she tolerated well and left clinic approximately
30 minutes later with parent. Parent instructed to follow up with MD.
Other Meds:
Lab Data:
History: After incident parent reported previous history of seizures.
Prex Illness: NONE
Prex Vax Illns: none reported~ ()~NULL~~In Patient|none reported~ ()~NULL~~In Sibling1

Vaers Id: 281568-1

14.0 F 12-Mar-2007 12-Mar-2007 0 13-Jun-2007 25-Jun-2007 GA 25-Jun-2007
HPV4 MERCK & CO. INC. NULL Unknown Subcutaneously

MedDRA PT Dizziness
Symptom Text: Pt. states she was dizzy for a short time after recieving vaccine.
Other Meds:
Lab Data:
History: Thyroid
Prex Illness:
Prex Vax Illns:

Vaers Id: 281569-1

22.0 F Unknown Unknown 13-Jun-2007 25-Jun-2007 -- 25-Jun-2007
HPV4 MERCK & CO. INC. NULL 1 Left arm Subcutaneously

MedDRA PT Pyrexia
Symptom Text: Pt. C/o fever 2 days after recieving vaccine. (102 degrees).
Other Meds:
Lab Data:
History: Seasonal
Prex Illness:
Prex Vax Illns:

Vaers Id: 281573-1

15.0 F 13-Jun-2007 13-Jun-2007 0 13-Jun-2007 24-Jun-2007 IA 25-Jun-2007
MNQ SANOFI PASTEUR U2061AA 0 Right leg Intramuscular
HPV4 MERCK & CO. INC. 0244U 0 Left leg Intramuscular
MedDRA PT Fall, Head injury, Pallor, Syncope
Symptom Text: Patient was given two vaccines(Menactra and HPV) and she looked pale after administered the vaccine, thus this nurse had her rest several minutes on an
exam table and then moved her to the hallway (waiting area) into a chair. This nurse returned to the vaccination room and heard a thump. Client was found on
the floor with an episode of syncope for approximately 15 to 30 seconds and then became responsive to verbal stimuli. Client made to rest on the floor for a
minute before getting up and then she returned to her chair for questioning. Client hit her head on the floor during her episode of syncope and thus was taken
to the Emergency Department on the second floor of this hospital for evaluation where she was released after examination by Dr. No apparent injury noted.
Other Meds: unknown
Lab Data:
History: None expressed in pre-screening
Prex Illness: no
Prex Vax Illns:

Vaers Id: 281574-1

15.0 F 13-Jun-2007 13-Jun-2007 0 13-Jun-2007 24-Jun-2007 FL 25-Jun-2007
HEPA GLAXOSMITHKLINE AHAVB114AN 1 Right arm Intramuscular
BIOLOGICALS
Symptom Text: Pt given HPV vaccine at 11:35 at 11:40 began to give Hep A vaccine, at beginning of administration client lost consciencousness. VS were as follows BP
110/70, pulse 74 Resp 20, client awoke independantly. EMT's had been called and responded by 11:44, benedryl 50mg given per MD order. Client recovered
and she and her mother declined transport to Emergency room.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 281576-1

18.0 F 12-Jun-2007 12-Jun-2007 0 13-Jun-2007 25-Jun-2007 WI 25-Jun-2007

MedDRA PT Blood pressure decreased, Cold compress therapy, Dizziness, Fatigue, Syncope
Symptom Text: Fainted immediately after vaccine; slow to recover. Was placed in supine position with legs elevated. Cold compress to face and neck applied. Became
concscious after a few minutes but it took about 50 minutes until she was able to sit up without feeling lightheaded again. C/o fatigue. After returning to
consciousness, given fluids ie, water, juice and cola. BP initally 100/60 P 80 but this fell to 80/40 and 60 before recovery.
Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 281583-1

MedDRA PT Injection site pain, Injection site swelling, Oedema, Pyrexia
Symptom Text: Rt arm sore and swollen, + 2 edema in office, fever (101.3), Tx with Tylenol, rest and increase fluids.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 281649-1 (S)

23.0 F 01-Mar-2007 01-May-2007 61 14-Jun-2007 15-Jun-2007 FR WAES0706TWN00004 15-Jun-2007

MedDRA PT Cervical dysplasia, Cervical dysplasia
Symptom Text: Information has been received from a physician concerning a 23 year old female who in March and April 2007, was vaccinated with the first and second doses
of Gardasil. In May 2007, the patient was done a cervical screening by a smear test and cervical biopsy and found an abnormal result showed cervical intra-
epithelial neoplasia II (CIN II). In May 2007, she was then hospitalized for cone biopsy for the abnormal cell changes and found cervical intra-epithelial
neoplasia III (CIN III). The patient was discharged after the test was finished. Additional information has been requested.
Other Meds: Unknown
Lab Data: cervical smear ??May07 Cervical intra-epithelial neoplasia II (CIN II), cervix biopsy ??May07 cervical intra-epithelial neoplasia II, cervix conization 01May07
cervical intra-epithelial neoplasia III
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 281650-1

Unknown F 28-May-2007 28-May-2007 0 14-Jun-2007 15-Jun-2007 -- WAES0706USA00646 15-Jun-2007

Symptom Text: Information has been received from a registered nurse concerning a female with no pertinent medical history who "last week," on approximately 28-MAY-2007,
was vaccinated with Gardasil. Concomitant therapy included "a couple of other vaccines (unspecified)." Subsequently, "last week, on approximately 28-MAY-
2007, the patient experienced a seizure in the treatment room. A blood pressure test was performed (results not provided). Subsequently, she recovered on the
same day at the office. Unspecified medical attention was sought. Upon internal review, the patient's seizure was considered to be an other important medical
event. Additional information has been requested.
Lab Data:
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281651-1


MedDRA PT Fatigue, Headache, Hypoaesthesia, Musculoskeletal pain, Nausea, Vomiting
Symptom Text: Information has been received from a Licensed Practical Nurse concerning an 18 year old female student (128 lb., 62.5 in.) with type I diabetes mellitus who on
17-MAY-2007 in the evening was vaccinated with Gardasil (Lot # 653736/0014U), intramuscular route (left arm). On 18-MAY-2007 in the morning the patient
experienced headache, fatigue, shoulder pain and transient numbness on two fingers of her hand on same side as injection. 48 hours after injection of
Gardasil, on approximately 19-MAY-2007, the patient experienced nausea and emesis. 24 hours later, on approximately 20-MAY-2007, the patient was treated
with Phenergan to "get resolution of symptoms" Subsequently, on 23-MAY-2007 the patient recovered from headache, fatigue, shoulder pain and transient
numbness on two fingers of her hand, nausea and emesis. The patient did not have an illness at the time of vaccination. The patient's headache, fatigue,
shoulder pain, transient numbness on two fingers of hand, nausea and emesis were considered to be an other important medical event by the reporting nurse.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Type I diabetes mellitus
Prex Vax Illns:

Vaers Id: 281653-1 (S)

24.0 F 01-Apr-2007 01-Apr-2007 0 14-Jun-2007 15-Jun-2007 NY WAES0706USA00814 15-Jun-2007

MedDRA PT Chest pain, Heart rate irregular, Nausea, Throat tightness
Symptom Text: Information has been received from a nurse concerning a 24 year old female patient who in April 2007, "about two months ago" was vaccinated IM with a first
dose of Gardasil. Within about a half an hour, the patient experienced chest pains, nausea, tightening of the throat, and an irregular heartbeat. The nurse
reported that the patient has been hospitalized twice for the irregular heartbeat since receiving Gardasil. The nurse also reported that the patient has no prior
history of heartbeat irregularities. Laboratory diagnostic studies included blood pressure and monitoring. At the time of this report, the patient's outcome was
unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: medical observation 04/??/07 - Blood Pressure Monitoring
History: Unknown
Prex Illness:
Prex Vax Illns:


17.0 F 15-May-2007 15-May-2007 0 14-Jun-2007 15-Jun-2007 CA 200702108 15-Jun-2007
TDAP SANOFI PASTEUR NULL Unknown Unknown
MedDRA PT Loss of consciousness, Syncope
Symptom Text: This information was received from manufacturer on 07 June 2007 under the manufacturer number WAES0705USA03292. "Information has been received
from a physician, concerning a 17 year old female patient, with a drug hypersensitivity to clindamycin/benzylperoxide (BENZACLIN), who on 15-MAY-2007 was
vaccinated with Gardasil (Lot #656371/0181U). Concomitant therapy involved an ear irrigation at the visit, and also included ADACEL, cetirizine hydrochloride
(ZYRTEC) and vitamins (unspecified medications, over the counter). The physician reported that the patient "Seemed fine" immediately after the vaccine was
administered, but 5 to 10 minutes later when she was checking out, the patient "fainted and almost hit her head on the counter;" she was unconscious for a few
seconds. The patient was taken to the emergency room for evaluation and was released and considered to be recovered on the same day, 15-MAY-2007. The
physician considered the event of "fainted and almost hit her head on the counter," to be disabling/incapacitating, and an other important medical event.
Additional information has been requested."
Other Meds: ZYRTEC, VITAMINS
Lab Data:
History: Drug hypersensitivity to Benzaclin; underwent ear irrigation during visit.
Prex Illness:
Prex Vax Illns:


Symptom Text: Information has been received from a physician, concerning a 17 year old female patient, with a drug hypersensitivity to Benzaclin, who on 15-MAY-2007 was
vaccinated with Gardasil (Lot #656371/0181U). Concomitant therapy involved an ear irrigation at the visit, and also included Adacel, Zyrtec and vitamins
(unspecified manufacturer, over the counter). The physician reported that the patient "seemed fine" immediately after the vaccine was administered, but 5 to 10
minutes later when she was checking out, the patient "fainted and almost hit her head on the counter;" she was unconscious for a few seconds. The patient
was taken to the emergency room for evaluation and was released and considered to be recovered on the same day, 15-MAY-2007. The physician considered
the event of "fainted and almost hit her head on the counter," to be disabling/incapacitating, and an other important medical event. Additional information has
been requested.
Other Meds: ZYRTEC, vitamins (unspecified)
Lab Data: Unknown
History:
Prex Illness: Ear irrigation; Drug hypersensitivity
Prex Vax Illns:


20.0 F 06-Jun-2007 08-Jun-2007 2 14-Jun-2007 25-Jun-2007 MA 25-Jun-2007
MedDRA PT Urticaria, Vaccine positive rechallenge
Symptom Text: Developed generalized hives this AM (6/8/07) Rx with Benadryl, per mom - same thing occurred 1 wk after HPV #1 and HPV #2
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns: hives~HPV (Gardasil)~1~19~In Patient


20.0 F 06-Jun-2007 08-Jun-2007 2 18-Jul-2007 16-Aug-2007 MA WAES0706USA03164 22-Aug-2007
TDAP SANOFI PASTEUR C2610AA Unknown Intramuscular
MedDRA PT Urticaria, Vaccine positive rechallenge
Symptom Text: Information has been received from a health professional concerning a 20 year old white female student who on 06-JUN-2007 at 04:30 PM was vaccinated IM
with a third dose of Gardasil, lot #657868/0523U. Concomitant therapy included Tdap. On 08-JUN-2007 at 09:00 AM, patient developed generalized hives. She
was treated with BENADRYL. Her mother reported that she had same reaction occurred one week after the first and second dose of Gardasil. On 08-JUN-2007
the patient recovered. Additional information is not expected.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 281688-1

18.0 F 13-Jun-2007 Unknown 14-Jun-2007 22-Jun-2007 MI 22-Jun-2007
MedDRA PT Inappropriate schedule of drug administration, No adverse effect
Symptom Text: Patient was given 2nd Menactra vaccine. First vaccine was not on client record. No reaction.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 281696-1

19.0 F 12-Jun-2007 12-Jun-2007 0 14-Jun-2007 25-Jun-2007 TX 25-Jun-2007

MedDRA PT Blood pressure increased, Chills, Dizziness, Eye pain, Headache, Throat tightness, Tremor
Symptom Text: Gardasil vaccine number 3 given at approximately 11:10am. Patient informed vaccine administrator that this was her third shot and she never had problems in
the past. During patient observation time she felt dizzy and had chills. Patient was placed in supine postition. BP taken 122/70. Patient Dr. (resident) and Dr.
were notified and assessed patient. Motrin 600mg was given to patient po. Patient stayed in observation in supine position for another hour. She stated that
she was feeling better and was released by Dr. At approximately 12:15 pm I received a call from patient in my office. She reported that she received her shot
and felt dizzy so they watched her. She stated that she is in her car in the parking garage and that she feels more dizzy, has a headache and eye pain and she
feels as if her throat is tightening up. She denied difficulty in breathing. I asked if she was able to walk and meet me in the clinic. She stated "yes". Upon her
immediate return to the clinic I escorted her to an exam room, had her lie on the exam bed with her head raised at 45 degrees. Her pulse ox was 98% on room
air, BP 145/85, HR 97, RR 16. Her lungs were CTA without wheezing. She had no SOB, but stated her throat felt tight. She had trembling of her extremities
but reported that she was not cold. I called for Dr. who was working in an adjacent clinic to asses patient as the morning MD's had left for their afternoon
assignments. Patient remained awake, alert oriented X3. Dr. assessed her and ordered Benadryl 25mg po. That was administered. Second set of vital signs
were O2 sat if 97% on room air, BP 132/85 RR 16, HR 98. Approximately 15 minutes past receiving Benadryl patient reported that she felt better. She stated
that her head felt better, she didnt feel as if her throat was tightening up, and her tremors were decreasing. Patient was observed until 4:00 pm until a family
memeber came to pick her up. Periodic assessments showed a RR 12 - 16 and steady. No difficulty in breathing or wheezing. Patient sl
Other Meds: Ortho Evra Patch
Lab Data:
History: Diagnosed with Breast Fibrocystic disease at same visit 6/12/07
Prex Illness:
Prex Vax Illns:

Vaers Id: 281699-1

BIOLOGICALS
MedDRA PT Cold sweat, Convulsion, Hypotonia, Loss of consciousness, Pallor
Symptom Text: Pt was given two shots and immediately after administered patient became pale, limp and clammy. Patient passed out and began to have seizure activity for a
few seconds. Pt regained consciousness and her vital signs were taken and were within normal range.
Other Meds:
Lab Data:
History:
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 281728-1

16.0 F 12-Jun-2007 13-Jun-2007 1 14-Jun-2007 25-Jun-2007 IA 25-Jun-2007
HEPA GLAXOSMITHKLINE AHBVB301AA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Nausea, Pyrexia, Vomiting
Symptom Text: Fever of 102.4 F 1 day after shots nausea and vomiting 1 day after shot. CT feels alot better on 6/14 -2 days after shots with no fever then.
Other Meds:
Lab Data:
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281733-1

11.0 F 13-Jun-2007 14-Jun-2007 1 14-Jun-2007 25-Jun-2007 FL 30-Jul-2007
BIOLOGICALS
MedDRA PT Erythema, Induration
Symptom Text: 2 inches diameter of redness and firmness located to left outer arm.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 281880-1 (S)

10.0 F 16-Jan-2007 17-Jan-2007 1 24-May-2007 25-Jun-2007 NJ WAES0701USA03067 26-Jun-2007
HPV4 MERCK & CO. INC. NULL Right arm Unknown
MedDRA PT Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth, Pyrexia
Symptom Text: Information has been received from a physician assistant concerning a 10 year old female with no allergies or medical history who on 22-APR-2002 was
vaccinated with a first dose of Varivax without any problems and on 16-JAN-2007 was vaccinated SC in the left deltoid with a 0.5 mL second dose of Varivax
(lot # 654131/1150F). Concomitant vaccination on the same day included a dose of Gardasil in the other arm. There was no illness at the time of vaccination.
On 17-JAN-2007, the patient developed an injection site rash. The rash was described as a cellulitis that was swollen, warm, and tender to the touch. The
patient was seen in the office on 18-JAN-2007 and the cellulitis was determined to be 4 cm in diameter and reported to be larger than it was on 17-JAN-2007.
The patient had a fever of 102 degrees Fahrenheit on 18-JAN-2007. Unspecified medical attention was sought and the patient was told to take Benadryl and to
use a warm compress. No diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. Follow-up information was
received from the physician assistant who reported that on 17-JAN-2007, the patient had red, indurated, warm cellulitis of the left upper extremity around the
injection site. It was greater than four inches in diameter with a central vesicle. Her temperature was 102.5. She was treated with Rocephin and Augmentin. The
patient recovered on 19-JAN-2007. The patient's experiences were considered to be disabling and other important medical events by the reporter. No further
information is expected.
Other Meds:
Lab Data: body temp 01/17/07 102.5 F
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281896-1

Unknown U Unknown Unknown 15-Jun-2007 18-Jun-2007 FR WAES0706AUS00022 18-Jun-2007

Symptom Text: Information has been received from an acquaintance of a patient who was vaccinated with Gardasil. Subsequently the patient experienced convulsions. An
ambulance was called. Upon internal review, the convulsion was felt to be an other important medical event. Additional information is expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 281897-1 (S)

26.0 F 01-Jun-2007 01-Jun-2007 0 15-Jun-2007 18-Jun-2007 -- WAES0706USA01210 18-Jun-2007

MedDRA PT Facial pain, Facial palsy, Facial paresis, Pain in extremity, Syncope
Symptom Text: Information has been received from a health professional concerning a 26 year old female with no medical history or allergies, who in June 2007, was
vaccinated with a dose of Gardasil. There was no concomitant medication. In June 2007, the patient experienced severe pain in her arm, fainted, facial
weakness, Bells Palsy, and facial pain after being vaccinated with Gardasil. The patient did go to the ER however, was not admitted to the hospital. At the time
if this report, the patient had not recovered. No product quality complaint was involved. Severe pain in arm, fainted, facial weakness, Bells Palsy, and facial pain
were considered to be disabling. Additional information is not expected.
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281898-1

Unknown F Unknown Unknown 15-Jun-2007 18-Jun-2007 OH WAES0706USA01231 18-Jun-2007

MedDRA PT Lymphadenopathy, Surgery
Symptom Text: Information has been received from a physician concerning his daughter (age not reported) with no pertinent medical history or drug reactions/allergies who on
an unspecified date was vaccinated with a first and second dose of Gardasil (Lot Numbers not provided). Concomitant therapy included cetrizine hydrochloride
(ZYRTEC). Within 2 weeks of the first vaccination, the patient experienced enlarged lymph nodes at different locations (unspecified) on the same side as the
Gardasil injection (side unspecified). Medical attention was sought. Outpatient surgery was performed to remove the lymph node (s) after the 1st dose of
Gardasil and "it came back reactive". Within 2 weeks of receiving the second dose of the vaccine, the patient developed enlarged lymph nodes on the side of
the neck. At the time of reporting the patient had not recovered and additional surgery was planned. The physician felt that the event was serious because
outpatient surgery was performed (other important medical event). Additional information has been requested.
Other Meds: Zyrtec
Lab Data: diagnostic laboratory - "it came back reactive"
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 281899-1 (S)

20.0 F 05-Jun-2007 05-Jun-2007 0 15-Jun-2007 18-Jun-2007 FR WAES0706PHL00004 18-Jun-2007

MedDRA PT Discomfort, Immediate post-injection reaction, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 20 year old female who on 05-JUN-2007 was vaccinated with Gardasil, LOT No.
655101/0513F/BATCH NO. NY48390. Patient has no concurrent conditions, no allergy to egg, and no concomitant therapies. Patient came in to request for
vaccination with Gardasil after learning about it from newspaper. Physician explained the benefits and possible adverse experiences to the patient. Patient
mentioned that she had several vaccinations during childhood. Patient also claimed that she can tolerate pain well. Before vaccination, patient's blood pressure
measurement was 110/70 while HR was 80bpm. Patient was vaccinated on the left arm. Within 30 seconds post-vaccination, patient was noted to be curling
down and was about to fall from her seat. She was caught by the physician and her parent before completely falling down. She was brought to patient's bed. A
few seconds after, patient regained consciousness. All she could remember was that there was discomfort on her left arm and felt as though the vaccine was
flowing through her left arm. Patient was monitored for vital signs which was found to be stable. She was admitted for further monitoring. On 06-Jun-2007,
patient was discharged. No further complaints noted. Loss of consciousness was considered by reporter as other important medical event. The reporter felt that
loss of consciousness was related to therapy with Gardasil. No further information is available.
Other Meds: Unknown
Lab Data: blood pressure measurement 05Jun07 110/70 mmHg, vital sign 05Jun07 80 bpm, heart rate-80bpm
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 281913-1

30.0 F 14-Jun-2007 14-Jun-2007 0 15-Jun-2007 25-Jun-2007 PA 05-Jul-2007
MedDRA PT Asthenia, Blood glucose increased, Blood pressure decreased, Body temperature increased, Dyspnoea, Flushing, Hyperhidrosis, Inappropriate schedule of
drug administration, Pallor
Symptom Text: Approx 15-20 seconds post injection pt stated she became flushed, diaphoretic and weak. Pt states she felt as if she could not take a deep breath. Pt temp 99
deg F. Pt feet elevated. BP 90/60, Pulse 83.Pt given orange juice and graham crackers and Tylenol 325 mg. After approx 15 min, pt verbalized she felt better.
BP 110/60, pulse 83. Pt was pale, but color returned after 15 minutes. Blood Glucose 115. Pt was able to stand without difficulty and walk. Total time 20
minutes.
Other Meds: multivitamin, fish oil capsule
Lab Data: Blood glucose finger stuck 115
History: allergic rhinitis - seasonal allergies - ragweed
Prex Illness: none
Prex Vax Illns:

Vaers Id: 281914-1

25.0 F 08-Jun-2007 12-Jun-2007 4 15-Jun-2007 25-Jun-2007 MO 25-Jun-2007
HPV4 MERCK & CO. INC. 0523U Gluteous maxima Unknown

MedDRA PT Drug administered at inappropriate site, Injection site pain, Lymphadenopathy, Tenderness, White blood cell count
Symptom Text: PT has Gardasil injection IM right hip upper outer quadrant on 6/8/07. On 6/13/07 pt was seen for painful swollen lymph node R inguinal area and tenderness
from area of injection to lymph node. WBC count was not elevated.
Other Meds: Levara
Lab Data: CBC
History:
Prex Illness: Molluscum contagiosum opposite side
Prex Vax Illns:

Vaers Id: 281915-1

12.0 F 12-Jun-2007 13-Jun-2007 1 15-Jun-2007 25-Jun-2007 CO 25-Jun-2007
VARCEL MERCK & CO. INC. 0172U 1 Right leg Subcutaneously
BIOLOGICALS
MedDRA PT Injection site erythema, Injection site warmth
Symptom Text: At site of injection red warm large area 2" x 1 1/2"
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 281918-1

MedDRA PT Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth, Pain
Symptom Text: Patient presented to the clinic with left upper arm redness (10x8cm), warm and tender. Temp=99.3 (ear). (2 days after administration). No treatment - Told to
return if worsening redness and pain, or drainage noted.
Other Meds:
Lab Data:
History: NKDA
Prex Illness: Back Pain, left side
Prex Vax Illns:

Vaers Id: 281926-1

Symptom Text: Passed out

Other Meds: None
Lab Data:
History: PCN allergy
Prex Illness: none
Prex Vax Illns:

Vaers Id: 281927-1

MedDRA PT Loss of consciousness, Vomiting
Symptom Text: Passed out, vomiting

Other Meds: Lexapro
Lab Data:
History: Amoxil allergy
Prex Illness: none
Prex Vax Illns:

Vaers Id: 281928-1

17.0 F 08-Jun-2007 08-Jun-2007 0 15-Jun-2007 26-Jun-2007 OH 02-Jul-2007
MNQ SANOFI PASTEUR U2276BA 0 Right arm Intramuscular
Symptom Text: passed out, vomiting

Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns: passed out~Vaccine not specified (no brand name)~UN~0~In Patient

Vaers Id: 281957-1

25.0 F 02-Feb-2007 02-Feb-2007 0 15-Jun-2007 25-Jun-2007 MO 25-Jun-2007
HPV4 MERCK & CO. INC. 03840 Unknown Intramuscular

MedDRA PT Dyspnoea
Symptom Text: Patient complained of shortness of breath after 1st shot. SOB lasted 2-3 minutes with no rash or swelling. We are delaying 2nd shot until our Medical Director
reviews the chart.
Other Meds:
Lab Data: None
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 281958-1


Symptom Text: Patient Recieved HPV vaccine in LA. Walked out of the clinic and building, tripped and fainted. Mom sent younger sister in to get me. We got a wheel chair and
brought her back into the clinic, on the way in she fainted again. Got her on to the bed and took BP 106/57. After 5 min sat her up and retook BP 105/54. Got
her to the wheel chair and gave her a drink of water and took her to the ER. Gave report to the ER nurse.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


13.0 F 30-May-2007 03-Jun-2007 4 15-Jun-2007 25-Jun-2007 MS 25-Jun-2007

MedDRA PT Convulsion, Loss of consciousness, Respiratory arrest, Urinary incontinence
Symptom Text: Patient had presumed seizure activity on 6/3/2007, 4 days after vaccine administration. Patient found unconscious by father -- not breathing and incontinent of
urine. Event lasted approximately 2-3 minutes. Patient taken to ER by ambulance.
Other Meds: Concerta 54mg qam
Lab Data: CT head negative. CBC, serum chemistries all normal. Urinalysis, urine drug screen, and urine pregnancy test all negative.
History: ADHD
Prex Illness: none
Prex Vax Illns:


13.0 F 03-May-2007 03-Jun-2007 31 22-Jun-2007 25-Jun-2007 MS WAES0706USA02841 25-Jun-2007

MedDRA PT Convulsion, Loss of consciousness, Respiratory arrest, Urinary incontinence
Symptom Text: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was
vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the
patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was
sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry,
urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient
recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be
Other Important Medical Events. Additional information has been requested.
Other Meds: Concerta
Lab Data: head computed axial 06/03/07 "normal", blood chemistry 06/03/07 "normal", urinalysis 06/03/07 "normal", urine drug screen 06/03/07 "normal", complete blood
cell 06/03/07 "normal"
History:
Prex Illness: Attention deficit/hyperactivity disorder
Prex Vax Illns:


13.0 F 28-May-2007 02-Jun-2007 5 02-Jul-2007 08-Jul-2007 MS 24-Jul-2007
HPV4 MERCK & CO. INC. UNKNOWN 0 Right arm Intramuscular

MedDRA PT Convulsion, Tremor, Tremor, Urinary incontinence, Wheezing
Symptom Text: Seizure occured 4 days after the vaccine was administered. Eyes open, loss of bladder, wheezing, trembling/shaking. CT Scan, blood work and urinalysis
after episode were all normal. Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up. Pediatrician sent
Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and
indicative of future seizures. The EEG results were normal. Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine
taken prior to the episode.
Other Meds: Concerta, 54mg daily
Lab Data: See above information on adverse events.
History: Attention Deficit Disorder (ADD)
Prex Illness: none
Prex Vax Illns:


13.0 F 28-May-2007 02-Jun-2007 5 12-Jul-2007 17-Jul-2007 -- 24-Jul-2007

MedDRA PT Convulsion, Tremor, Tremor, Urinary incontinence, Wheezing
Symptom Text: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of
bladder. ER physician said she had a seizure.
Other Meds:
Lab Data: CT Scan, blood work and urinalysis done at ER were normal. Follow up visit with family pediatrician resulted in having a EEG scheduled, results were normal.
Pediatrician stated that if the EEG was normal, it would be indicative of a one ti
History: The only other medical history is that she has Attention Deficit Disorders and has been taking Concerta for 5 years.
Prex Illness:
Prex Vax Illns:


12.0 F 13-Jun-2007 13-Jun-2007 0 15-Jun-2007 25-Jun-2007 CO 08-Aug-2007
VARCEL UNKNOWN MANUFACTURER NULL 1 Left arm Unknown
HPV UNKNOWN MANUFACTURER NULL 0 Right arm Unknown
MNQ SANOFI PASTEUR NULL 0 Left arm Unknown
MedDRA PT Convulsion, Dizziness, Fatigue, Headache, Pain in extremity, Pruritus, Syncope, Urticaria
Symptom Text: She fainted after the administration of the last of three vaccines administered that day. The third was the HPV Vaccine. She had on convulsion as she came
to. 36 hours after the vaccine she started having intense itching which broke in to hives after about 48 hours. She was very tired, dizzy, and had a bad
headache and sore arms for the 24 hours following the vaccines.
Other Meds: Strattera 25mg
Lab Data:
History: ADHD inattentive type
Prex Illness: none
Prex Vax Illns:


12.0 F 13-Jun-2007 14-Jun-2007 1 27-Jun-2007 09-Jul-2007 CO 08-Aug-2007
MedDRA PT Oedema peripheral, Urticaria
Symptom Text: Hives, swollen feet 24 hr after receiving HPV, Meningococcal and Varivax.
Other Meds: Takes Strattera
Lab Data:
History: NKDA History of ADHD
Prex Illness:
Prex Vax Illns:

Vaers Id: 282132-1

12.0 F 26-May-2007 26-May-2007 0 18-Jun-2007 19-Jun-2007 FR WAES0706PHL00001 19-Jun-2007

MedDRA PT Dizziness, Fall, Laceration, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 12 year old female who on 26-MAY-2007 was vaccinated with Gardasil, there were no reported
concomitant medications nor concurrent conditions. On the morning of 26-MAY-2007, before going to physician's clinic for vaccination, patient only had one
slice of bread and a glass of milk. While waiting for her turn, patient had a can of juice approximately 200mL. At around 11:30AM, patient was vaccinated with
Gardasil. Approximately 5-10 minutes after vaccination, patient complained of dizziness and subsequently lost consciousness and collapsed. Patient also
suffered a laceration on her lip when she hit the floor. A few minutes after, patient regained consciousness. There were no further complain of dizziness. The
reporter felt that loss of consciousness and dizziness were related to therapy with Gardasil. Laceration of the lips is not related to Gardasil. No further
information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282133-1

12.0 F 07-Jun-2007 07-Jun-2007 0 18-Jun-2007 19-Jun-2007 FR WAES0706AUS00039 19-Jun-2007

MedDRA PT Hypoaesthesia, Oedema peripheral, Oedema peripheral, Peripheral coldness, Sensation of heaviness
Symptom Text: Information has been received from a physician via as part of a business agreement (manufacturer control # GARD 2007 06 07 002) concerning a 12 year old
female who on 07-JUN-2007 was vaccinated with Gardasil at school. On 07-JUN-2007, 2 hours after vaccination with Gardasil, the patient experienced
heavyness in arm, swelling across the hand, cold hands and numbness in fingers and was taken to the medical centre. The patient's heavyness in arm,
swelling across the hand, cold hands and numbness in fingers persisted. The patient was referred to neurologist immediately. Heavyness in arm, swelling
across the hand, cold hands and numbness in fingers were considered to be an other important medical event by the reporting physician. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282134-1 (S)

Unknown F Unknown Unknown 18-Jun-2007 19-Jun-2007 FR WAES0706USA01521 19-Jun-2007

MedDRA PT Depression, Facial palsy
Symptom Text: Information has been received from a physician concerning an adult female who was vaccinated with Gardasil on an unspecified date. One week after
vaccination, the patient experienced facial paralysis and due to this depression. The patient was admitted to the hospital on an unspecified date. The patient's
outcome was not reported.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282153-1

18.0 F 18-Apr-2007 01-Jun-2007 44 18-Jun-2007 26-Jun-2007 LA LA070602 27-Jun-2007

Symptom Text: Gardasil vaccine administered without difficulty or reaction. RN notified that patient is pregnant approximately 10 weeks. Patient would have been 3 3/7 weeks
at administration.
Other Meds:
Lab Data: UPT positive on 6/1/07
History:
Prex Illness: None
Prex Vax Illns:


11.0 F 16-Jan-2007 29-Jan-2007 13 18-Jun-2007 28-Jun-2007 NJ 28-Jun-2007
HEPA GLAXOSMITHKLINE AHAVB143BA 0 Left arm Unknown
BIOLOGICALS
MedDRA PT Infection, Lymphadenopathy, Pyrexia, Vaccine positive rechallenge
Symptom Text: 1-16-07 _> 1st Gardasil + Hep A administered 1-29-07 Infected lymph nodes in neck w/fever Amoxicillin for 10 days. 4-4-07-2nd Gardasil shot only 5-18-07-
Infected lymph nodes in neck with fever Amoxicillin-10 days-didnt work-Ceftin 1000
Other Meds: None
Lab Data: CBC, Chem panel-Normal 5/07-mono test-negative
History: None
Prex Illness: None
Prex Vax Illns:


11.0 F 16-Jan-2007 29-Jan-2007 13 18-Jul-2007 16-Aug-2007 NJ WAES0706USA02980 22-Aug-2007
HEPA GLAXOSMITHKLINE AHAVB143BA 0 Unknown Intramuscular
BIOLOGICALS
MedDRA PT Lymphadenitis, Lymphadenopathy, Pharyngolaryngeal pain
Symptom Text: Information has been received from a physician concerning an 11 year old white female student who on 16-JAN-2007 at 6:15 p.m. was vaccinated IM in left
arm with her first dose of Gardasil, lot #655619/1427F. Concomitant therapy included a first dose of hepatitis A virus vaccine (unspecified), lot #AHAVB143BA,
also given IM in left arm on 16-JAN-2007 at 6:15 p.m. On 29-JAN-2007 the patient was seen in the office for sore throat and enlarged lymph nodes. "RST" and
24 hour throat culture were negative. She was put on amoxicillin. On 04-APR-2007 at 4:00 p.m. the patient was vaccinated IM in left arm with her second dose
of Gardasil, lot #657617/0384U. On 08-MAY-2007 she was diagnosed with lymphadenitis and put on AUGMENTIN. On 22-MAY-2007 the patient was seen by
ENT and put on CEFTIN. Her outcome was not reported. Additional information is not expected.
Other Meds:
Lab Data: throat culture 01/29/07 - negative
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282175-1

17.0 F 18-Jun-2007 18-Jun-2007 0 18-Jun-2007 26-Jun-2007 MI 27-Jun-2007
MedDRA PT Loss of consciousness, Unresponsive to stimuli
Symptom Text: Received Gardasil vaccine first, then HAV and within appx. 1 minute after vaccines client slumped to side while sitting in chair and was unresponsive for appx.
10 seconds. Staff assisted to floor and client became responsive prior to this. No injury occured. Given soda to drink. Client very thin. Oatmeal for breakfast but
no dinner the night before. Blood pressure laying 104/60 Pulse 76. B.P.sitting 94/60 pulse 74
Other Meds: NONE
Lab Data: NONE
History: NONE
Prex Illness: NO
Prex Vax Illns:

Vaers Id: 282180-1

MedDRA PT Syncope
Symptom Text: ADMIN HPV AND TDAP VACCINE, WITHIN ONE MIN OF ADMIN CHILD FAINTED INTO FATHERS ARMS, PT OBSERVED FOR 15 ADDITIONAL MIN WITH
NO PROBLEMS. VITALS WNL.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282183-1

17.0 F 16-Apr-2007 18-Jun-2007 63 18-Jun-2007 26-Jun-2007 NY 27-Jun-2007

MedDRA PT Ovarian cyst
Symptom Text: ovarain cyst developed 6-8 weeks after first vaccination with gaurdisil
Other Meds: albuterol
Lab Data:
History: Asthma: exercise induced, Pituitary adenoma
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282198-1

17.0 F 14-Jun-2007 15-Jun-2007 1 18-Jun-2007 27-Jun-2007 NY 27-Jun-2007
MNQ SANOFI PASTEUR 42329AA 0 Left arm Unknown
MedDRA PT Erythema, Rash generalised
Symptom Text: Generalized sunburn like red rash all over the body 4 hours after the vaccines. Got better after 50mg of Benadryl.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282203-1


MedDRA PT Asthenia, Syncope
Symptom Text: Given vaccine 6/18/07 / 2-3 minutes later patient was standing in hallway, felt weak and fainted. Did not lose consciousness. Allowed to rest, felt better and
walked out of clinic in 5 minutes. Vitals ok.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282215-1

19.0 F 22-Jan-2007 22-May-2007 120 19-Jun-2007 20-Jun-2007 -- WAES0705USA04050 20-Jun-2007

MedDRA PT Abortion induced, Drug exposure during pregnancy
Symptom Text: Initial and follow up information has been received, from a physician and a healthcare professional, concerning a 19 year old white female patient, with no
previous pregnancies and a history of an abnormal pap (indicating human papilloma virus, atypical squamous cell of undetermined significance and a low
grade squamous intraepithelial lesion; date unspecified), who on 21-NOV-2006, was vaccinated with the first dose of Gardasil (Lot #653650/0702F), and on 22-
JAN-2007 with the second dose of Gardasil (Lot #654540/1161F). On 22-MAY-2007, the patient took a pregnancy test in the doctor's office which was positive.
The patient was unsure of the date of her LMP. No problems were reported. Follow up information from the healthcare professional indicated the patient "had
decided to terminate the pregnancy," although the reason for the decision was not specified, and the date for the procedure was left blank; it was not confirmed
that the procedure had actually been completed. Upon internal review, decided to terminate the pregnancy was determined to be serious as an other important
medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Pap test-abnormal-ASCUS, LGSIL, HPV; beta-human chorionic 05/22/07 positive
History: Papilloma viral infection; Atypical squamous cells of undetermined significance; Low grade squamous intraepithelial lesion
Prex Illness:
Prex Vax Illns:

Vaers Id: 282216-1

18.0 F 04-Jun-2007 04-Jun-2007 0 19-Jun-2007 20-Jun-2007 PA WAES0706USA01993 20-Jun-2007
MedDRA PT Grand mal convulsion, Loss of consciousness, Syncope
Symptom Text: Information has been received from a physician concerning an 18 year old female with no pertinent medical history who on 04-JUN-2007 received her first dose
of Gardasil concomitantly with a dose of Menactra. After administration of the Gardasil on 04-JUN-2007, the patient fainted, was unconscious for 45-60
seconds and exhibited tonic-clonic seizure-like activity. There were no laboratory tests performed. She sought unspecified medical attention. No treatment was
required. The patient left the office fully recovered. Upon internal review, tonic-clonic seizure-like activity was considered to be an other important medical
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 282217-1


Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female who on 07-JUN-2007 was vaccinated with Gardasil. The nurse
practitioner reported that the patient fainted 45 minutes after receiving Gardasil. The nurse practitioner also reported that the "mother thought she was having a
seizure". Medical attention was sought. The outcome of the adverse event is unknown. no further information was provided. Upon internal review seizure was
considered to be an other important medical event. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 282218-1 (S)

13.0 F 16-Feb-2007 20-Feb-2007 4 19-Jun-2007 20-Jun-2007 FR WAES0706USA02450 20-Jun-2007

MedDRA PT Abdominal pain, Angioedema, Dyspnoea, Nausea
Symptom Text: Information has been received from a gynaecologist concerning a 13 year old female patient who on 16-FEB-2007 was vaccinated into the left upper arm with a
second dose of Gardasil, lot #654740/0859F, batch #NE25270. Four days post-vaccination the patient developed Quincke's edema, dyspnea, abdominal
cramps and nausea. Her symptoms were relapsing since then. On an unspecified date she was admitted to the hospital. Routine laboratory findings (not
specified) were normal. The patient's first dose of Gardasil had been well tolerated. Additional information has been requested. Other business partner
numbers included E2007-03733.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282228-1

12.0 F 05-Jun-2007 06-Jun-2007 1 19-Jun-2007 28-Jun-2007 NE 28-Jun-2007
MedDRA PT Cold compress therapy, Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site warmth, Vomiting
Symptom Text: 2-3cm area of erythema - right deltoid, warm to touch, tender, vomiting, diarrhea, headache, ice and Benadryl for treatment.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282235-1

17.0 F 11-Jun-2007 13-Jun-2007 2 19-Jun-2007 28-Jun-2007 WA 28-Jun-2007
HEPA MERCK & CO. INC. 0304U 0 Left arm Unknown
MedDRA PT Heart rate increased, Palpitations
Symptom Text: 2 episodes of palpitations - described as onset of fast heart beat, no cause noted (once while sitting) self-resolved in <3min on both occasions, happened 2
days after vaccine.
Other Meds: Zoloft, OCP
Lab Data:
History: Depression
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282239-1

17.0 F 29-May-2007 30-May-2007 1 19-Jun-2007 28-Jun-2007 FL 28-Jun-2007
MedDRA PT Blister, Herpes zoster, Rash
Symptom Text: Vaccines given 5/29/07 and "blistering" rash appeared on L back and L abdomen on 5/30/07. Exam consistent with Herpes Zoster
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282242-1

17.0 F 05-Jun-2007 05-Jun-2007 0 19-Jun-2007 28-Jun-2007 CA 30-Jul-2007
HEPA GLAXOSMITHKLINE AHAVB162CB 0 Right arm Unknown
BIOLOGICALS
MedDRA PT Syncope
Symptom Text: Patient fainted after 2-3 min. Vitals were normal. After observation for 15 min patient was able to walk on own and left office in care of her mom. No seizure
activity. LOC was brief perhaps <10 secs. Exam on departure were normal
Other Meds: none
Lab Data: none
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282251-1

18.0 F 12-Jun-2007 12-Jun-2007 0 19-Jun-2007 28-Jun-2007 KY 28-Jun-2007

MedDRA PT Blood glucose increased, Blood pressure decreased, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor, Retching, Syncope
Symptom Text: Pt in to get Gardasil and Depo hot. Pt given Depo 1st, then Gardasil. Immediately after Gardasil pt became nauseated, dry heaving, syncopal, BP dropped to
60 could not hear bottom number, HR 60, pale, diaphoretic. Pt aroused somewhat with ammonia. Blood sugar 107. Pt did state she had not eaten this morning.
Pt taken to in house ER where she was given a liter of LR, B/P increased pt improved and was discharged home.
Other Meds: Zyrtec, Depo Provera
Lab Data:
History: none known/environmental allergies
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282262-1

12.0 F 01-Jun-2007 02-Jun-2007 1 19-Jun-2007 28-Jun-2007 NJ 28-Jun-2007
MedDRA PT Injection site cellulitis, Injection site swelling, Injection site warmth
Symptom Text: L arm swollen and warm after vaccination - DX with cellulitis - Tx with Cefzil 500 BID
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282267-1

18.0 F 21-Feb-2007 21-Feb-2007 0 19-Jun-2007 19-Jul-2007 LA WAES0703USA01310 19-Jul-2007

MedDRA PT Drug exposure during pregnancy, Tonsillitis
Symptom Text: Information has been received from a nurse concerning an 18 year old female who on 21-FEB-2007 was vaccinated with Gardasil (lot no 654535/0960F). That
same day, she was vaccinated with Menactra. The nurse reported that the patient lied about her last menstrual period because her mother was in the room and
she was 3 1/2 pregnant when she was vaccinated. A pregnancy test was positive. Her LMP was 06-NOV-2006 and EDD 13-AUG-2007. She had not yet chosen
an OB/GYN physician. Information received on 25-MAR-2007 contained the following adverse experience: The patient was treated with Amoxil 875 mg twice
daily from 07-MAR-2007 to 17-MAR-2007 for tonsillitis. Additional information has been requested.
Lab Data: beta-human chorionic posit
History:
Prex Vax Illns:

Vaers Id: 282270-1

11.0 F 08-Jun-2007 08-Jun-2007 0 19-Jun-2007 28-Jun-2007 MN 29-Jun-2007
BIOLOGICALS
MedDRA PT Injection site inflammation, Rash pruritic
Symptom Text: Pruritic rash and immunization site inflammation - right arm 6/9/07 (vaccines 6/8/07)
Other Meds:
Lab Data: Throat culture for strep group A
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282274-1


MedDRA PT Nausea, Paraesthesia, Syncope
Symptom Text: Several minutes after IM injection with Gardasil vacc -patient felt nauseated and tingley. Fainted. Legs were elevated, BP taken, apple juice given. 10-15
minutes after later-felt better. Evaluated by doctor and was able to leave the office
Other Meds: None
Lab Data: BP 94/65 8:40 am taken again 94/61 8:50 am
History: Hyperlipidemia and mild Scoliosis
Prex Illness: None
Prex Vax Illns:


MNQ SANOFI PASTEUR NULL 0 Left arm Intramuscular
MedDRA PT Dyskinesia, Feeling abnormal, Pallor, Syncope, Tinnitus
Symptom Text: Patient recieved the MCV4 in the L deltoid and HPV in the R deltoid. When the patient got up from the table the color drained from her face and she asked if
she should "feel funny?" Here ears began ringing and everything went black. She fainted to the floor and her legs were fluttering from her legs being bent. Here
legs were down. The adminstering nurse helped her to the floor and put her arms around the patient. The episode lasted no more than a minute to a minute to
a minute and a half.
Other Meds: NONE
Lab Data:
History: Exema
Prex Illness: NONE
Prex Vax Illns:


17.0 F Unknown 18-Jun-2007 26-Jun-2007 02-Jul-2007 -- 02-Jul-2007
MedDRA PT Anorexia, Convulsion, Cyanosis, Deafness, Disorientation, Fall, Feeling abnormal, Loss of consciousness, Loss of consciousness, Skin discolouration,
Syncope, Tinnitus
Symptom Text: I have a 17 year old daughter who received her first shot of the HPV vaccine Gardasil After the shot she ask why did she feel funny She said her ears started to
ring then she could not hear anything She said everything went black She was standing up and fainted to the floor The whole time her eyes were open She
turned completely blue and green The direction she fell was toward the nurse The nurse fell behind her breaking her fall My daughter was not in a laying down
positive ever then she had a seizure. I started calling her name and asking the nurse what was she shaking all over for like that My 15 year old son was with me
and my daughter at the appointment He witnessed her faint and have a seizure My son nor my daughter have never ever had any drug allergy nor any side
effect to a vaccination shot they're entire lives I do not understand why she blacked out, lost consciousness, lost her hearing, turned blue and green, and had a
SEIZURE The rest of the day she was disoriented and had no appetite Her doctor came in and told me all that happened because of the stick of the needle I do
not believe that I expressed my concern to the doctor before leaving her office and over the telephone yesterday The doctor gave me instruction to bring her
back in two months from now to receive the second injection My daughter has not received any examination, testing, follow-up care absolutely nothing since
the shot and seizure Sirs, Can you please explain to me what this drug Gardasil has done to my child I do not understand why this happened My other question
is should my daughter receive the second injection in two months considering she blacked out, lost her hearing, fainted, and lost her natural skin color, and had
a seizure will she be as fortunate to remain alive with a second or third injection I thought she died her little brother thought she had as well Sirs. I would
appreciate a recommendation or referral in this matter as to any follow up care she can receive regarding the seizure as well as an explanation why this hap
Other Meds:
Lab Data: None
History: None my son and daughter are both healthy in fact we were at they're yearly well-child check ups neither child was ill part of the well-child check
Prex Illness:
Prex Vax Illns:

Vaers Id: 282303-1


MedDRA PT Muscular weakness, Pain in extremity
Symptom Text: Pain, weakness of arm

Other Meds: none
Lab Data: none
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282304-1

13.0 F 13-Jun-2007 13-Jun-2007 0 19-Jun-2007 28-Jun-2007 WA 29-Jun-2007

Symptom Text: 6-8 hrs post injection fever > 103, body aches. Resolved within hours. No source found
Other Meds: None
Lab Data: physical exam (-) no labs
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282369-1

17.0 F 11-Jun-2007 11-Jun-2007 0 20-Jun-2007 21-Jun-2007 WI WAES0706USA01961 21-Jun-2007

Symptom Text: Information has been received from a registered nurse concerning her 17 year old daughter with no relevant medical history reported who on 11-JUN-2007 was
vaccinated intramuscularly with a 0.5 ml dose of Gardasil. There was no concomitant medication. On 11-JUN-2007, the patient fainted and "exhibited seizure
like behavior" after receiving Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered on 11-JUN-2007. Upon internal
review, the patient's convulsion was considered an other important medical event. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 282370-1

20.0 F 19-Feb-2007 04-Apr-2007 44 20-Jun-2007 21-Jun-2007 TX WAES0706USA01990 21-Jun-2007

Symptom Text: Information has been received from a registered nurse concerning a 20 year old female with no relevant medical history who on 19-FEB-2007 was vaccinated
intramuscularly with a 0.5 mL first dose of Gardasil (lot 653735/0688F). Concomitant therapy included Ortho Tri-Cyclen Lo. Subsequently, she became
pregnant. Date of LMP was 04-APR-2007. The patient subsequently miscarried. The patient was seen in the emergency room on 14-MAY-2007 for the
miscarriage. She was not admitted to the hospital. The patient called the office on 17-MAY-2007 to notify the physician of the miscarriage, but had not returned
to the office for follow-up visits. Upon internal review, the patient's spontaneous abortion was considered an other important medical event. Additional
Other Meds: ORTHO TRI-CYCLEN LO
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 282371-1

26.0 F 06-Jun-2007 06-Jun-2007 0 20-Jun-2007 21-Jun-2007 MD WAES0706USA02196 21-Jun-2007

MedDRA PT Convulsion, Immediate post-injection reaction
Symptom Text: Information has been received from a physician, via a company representative, concerning a 26 year old female patient with Crohn's disease and a history of
"passing out" when blood is drawn, who on 06-JUN-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included
unspecified medication for Crohn's disease and hormonal contraceptives (unspecified). On 06-JUN-2007, "within 5 minutes" after she had received the
vaccination, the patient had a seizure. The physician then confirmed that the patient was completely "lucid" and conscious, and was oriented to the time, the
date and her name, however it was not specified whether the patient had recovered from the event. The physician, "does not believe" the seizure was related to
therapy with Gardasil. The patient sought unspecified medical attention. Upon internal review, had a seizure was considered to be serious as an other
Other Meds: (therapy unspecified), hormonal contraceptives
Lab Data: Unknown
History: Passed out
Prex Illness: Crohn's disease
Prex Vax Illns:

Vaers Id: 282372-1 (D)

17.0 F 01-Jun-2007 01-Jun-2007 0 20-Jun-2007 21-Jun-2007 FR WAES0706USA02451 21-Jun-2007

MedDRA PT Autopsy, Loss of consciousness, Resuscitation, Sudden death
Symptom Text: Information has been received from a gynecologist who was informed of the case from another gynecologist concerning a 17 year old female who in June 2007
(week 23), was vaccinated with a first dose of Gardasil (lot number, injection site and route not reported). During the evening of the same day, the patient was
found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died.
The cause of death was sudden death. It was noted that the patient had a dental surgery the day before she was vaccinated. An autopsy was done. The results
were not known. Other business partner numbers include E2007-03769. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Dental operation
Prex Illness:
Prex Vax Illns:

Vaers Id: 282383-1 (S)

13.0 F 22-Feb-2007 22-Feb-2007 0 20-Jun-2007 21-Jun-2007 -- 200702140 02-Jul-2007
HEPA GLAXOSMITHKLINE AHAVB141AA Right arm Intramuscular
BIOLOGICALS
DTAP GLAXOSMITHKLINE AC52B007AA Left arm Intramuscular
BIOLOGICALS
Seriousness: ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS
MedDRA PT Chest discomfort, Cough, Dyspnoea, Dyspnoea, Hypersensitivity, Tremor, Wheezing, Wrong drug administered
Symptom Text: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA,
VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the
patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy
included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after
receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic
reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The
patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were
performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and
Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the
time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and
tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further
information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
Other Meds: Nasonex
Lab Data: blood pressure-130/91; pulse oximetry-141; lymphocyte count 24.6; respiratory rate 20; neutrophil count 66
History:
Prex Illness: allergic to cats, nasal congestion
Prex Vax Illns:

Vaers Id: 282395-1

16.0 F 17-May-2007 17-May-2007 0 20-Jun-2007 02-Jul-2007 NY 02-Jul-2007

MedDRA PT Immediate post-injection reaction, Nausea, Syncope vasovagal, Vomiting
Symptom Text: Pt was given injection and immediately had a vagal reaction. Followed by nausea with vomiting 15 minutes post injection.
Other Meds: Orthrotricylen Lo
Lab Data:
History: NKA
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282409-1

10.0 F 19-Jun-2007 19-Jun-2007 0 20-Jun-2007 26-Jun-2007 GA 27-Jun-2007
MedDRA PT Varicella
Symptom Text: Patients father states " child had one bumplike area on mid right cheek on the evening of 6/19/07 did not complain about anything, woke up this morning eith
several red itchy bumplike areas on forehead and cheeks, only on face nowhere else." Patient and her father came to clinic on 6/20/07 to be seen. Dr.
examined patient and determined that patient had mild case of chicken pox, and talked with patient and her father medication was ordered for the patient.
Other Meds: Patient was placed on Floxin 0.3% soln. per Dr. on 6/19/07
Lab Data:
History: patient came in on 6/19/07 with c/o left ear pain for the last 3 to 4 days patient was sent to ENT clinc per Dr. then diagnosed as having tympanic membrane
perforation
Prex Illness: Pt.came in to see Dr. with c/o lear pain due to swimming and high dived approximately 3 to 4 days
Prex Vax Illns:

Vaers Id: 282413-1

13.0 F 17-Apr-2007 18-Apr-2007 1 20-Jun-2007 26-Jun-2007 MI 27-Jun-2007
MedDRA PT Asthenia, Coordination abnormal, Dizziness, Rash generalised, Urticaria
Symptom Text: Vaccines administered evening of 4/17/07, client did not have any adverse effect until next day. States while in school started feeling weak and dizzy, this
progressivly became worse, but did not require leaving school. That night symptoms still occuring and worsening. "almost drunk -like" Mother callled ER at
Hospital. Instruced to give Benadryl. Client Slept through night. Remained "dizzy and uncoordinated: the next morning, received more Benadryl. Symptoms
resolved that day. No rash during initial episode, but did C/O rash over majority of body, possibly hives, about 2 weeks after immunizations. Benadryl given
about TID during this episode and rash lasted about 3 days.No further symptoms. Informed of these events on 6/19/07 when client came in for HPV #2, incident
reviewed by Medical director and order obtained to give HPV #2, request that family call Health Department for any problems.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282414-1

11.0 F 19-Jun-2007 19-Jun-2007 0 20-Jun-2007 26-Jun-2007 FL 08-Aug-2007
TD UNKNOWN MANUFACTURER NULL 0 Left arm Unknown
HPV UNKNOWN MANUFACTURER NULL 0 Right arm Unknown
MNQ SANOFI PASTEUR O2351AA 0 Right arm Unknown
MedDRA PT Asthenia, Dizziness, Headache, Pain, Pyrexia
Symptom Text: 102 fever, headache, dizziness, weak, body aches.Given Motin 200mg(1) for fever & aches
Other Meds:
Lab Data: CBC BLOOD TEST, RESULTS- WBC-6.6;LY-21.8;MO-27.1;GR-51.1;LY-1.4;MO-1.8 & 2 PHYSICIANS CHECKING HER OUT AFTER SHOTS WERE
ADMINISTERED
History: Environmental allergies, Chronic asthma, has sensitivity to prlone, & albuterol & allergic to Loribid
Prex Illness: None
Prex Vax Illns: Christina Aponte~ ()~~11~In Patient

Vaers Id: 282416-1

20.0 F 20-Jun-2007 20-Jun-2007 0 20-Jun-2007 26-Jun-2007 CT 27-Jun-2007
HPV4 MERCK & CO. INC. UNKNOWN 0 Left arm Unknown

MedDRA PT Dysphonia, Dyspnoea, Panic reaction, Pharyngeal oedema
Symptom Text: Hoarseness, swelling of throat, diff breathing, panicky reaction, all lasting approx 2 hours until arrival in ER, treated with nebulizer and benadryl and zantac
through iv saline drip.
Other Meds: orthotricyclen
Lab Data:
History: asthma, history of allergies, hx of adverse rxn to flu vaccine, migraines
Prex Illness: no
Prex Vax Illns: asthma attack~Influenza (no brand name)~1~16~In Patient


15.0 F 15-Jun-2007 15-Jun-2007 0 20-Jun-2007 21-Jun-2007 NY A0658277A 21-Jun-2007
HEPA GLAXOSMITHKLINE AHAVB163AB 0 Unknown Unknown
BIOLOGICALS
MedDRA PT Cyanosis, Grand mal convulsion, Oxygen supplementation, Urinary incontinence
Symptom Text: This case was reported by a nurse and described the occurrence of generalized tonic clonic seizures in a 15-year-old female subject who was vaccinated with
Havrix, GlaxoSmithKline, Gardasil (non-gsk) for prophylaxis. The subject's medical history included neurocardiogenic syncope and hives after Septra. On 15
June 2007, the subject received 1st dose of Havrix (unknown, left arm), and unspecified dose of Gardasil (unknown). On 15 June 2007, less than one day after
vaccination with Gardasil and Havrix, the subject experienced generalized tonic clonic seizures, urinary incontinence and "tonic" cyanosis. The subject
experienced a seizure while sitting in the waiting room after her vaccinations were administered. This case was assessed as medically serious by GSK. The
subject was treated with oxygen and went to the emergency room and was later released. At the time of reporting, her vital signs were stable and the events
were resolved.
Other Meds:
Lab Data: UNK
History: NEUROCARDIOGENIC SYNCOPE, Relevant medical history included after Septra. The subject had not experienced any adverse events following previous
vaccinations.
Prex Vax Illns:


15.0 F 15-Jun-2007 15-Jun-2007 0 05-Jul-2007 06-Jul-2007 NY WAES0706USA04806 06-Jul-2007
HEPA GLAXOSMITHKLINE AHAVB163AB 0 Unknown Unknown
BIOLOGICALS
MedDRA PT Cyanosis, Grand mal convulsion, Urinary incontinence
Symptom Text: Information has been received from a registered nurse via Glaxo Smith Kline concerning a 15 year old female with a history of neurocardiogenic syncope and
hives after therapy with sulfamethoxazole (+) trimethoprim (SEPTRA), who on 15-JUN-2007 was vaccinated with Gardasil. Concomitant vaccinations given on
15-JUN-2007 included the first dose of Havrix (lot number AHAVB163B) given in the left arm. The patient had not experienced any adverse events following
previous vaccinations. On 15-JUN-2007, less than one day after vaccinations the patient experienced generalized tonic clonic seizures, urinary incontinence
and "tonic" cyanosis. The patient experienced the seizure while sitting in the waiting room after her vaccinations were administered. The patient was treated
with oxygen and went to the emergency room and was later released. At the time of this report, the patient's vital signs were stable and the events were
resolved. The events were felt to be serious for an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Syncope; Hives
Prex Illness:
Prex Vax Illns:

Vaers Id: 282557-1

14.0 F 26-Feb-2007 26-Feb-2007 0 06-Jun-2007 06-Jul-2007 TX WAES0703USA00495 06-Jul-2007
HEPA MERCK & CO. INC. 1281F Right arm Intramuscular
MedDRA PT Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Symptom Text: Information ahs been received from a registered nurse concerning a 14 year old female with a "cardiac history" and no drug reactions/allergies who on 26-FEB-
2007 was vaccinated intramuscularly in the right arm one dose of VAQTA (lot # 656320/1281F). Concomitant therapy included GARDASIL, ADACEL and
MENACTRA. On 26-FEB-2007 the patient experienced an injection site reaction from the vaccination. The reaction consisted of redness, swelling and pain in
the right arm. The patient sought unspecified medical attention. The patient was seen by the physician on 01-MAR-2007 and was still having the symptoms. No
diagnostic laboratory tests were performed. At the time of the report the patient was recovering. There was no product quality complaint. The records of testing
prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the CBER and was released by the
regulatory agency. Additional information has been requested.
Other Meds:
Lab Data: None
History: Cardiac disorder
Prex Illness:
Prex Vax Illns:

Vaers Id: 282581-1 (S)

15.0 F 16-Mar-2007 27-Mar-2007 11 21-Jun-2007 22-Jun-2007 -- WAES0705USA05081 22-Jun-2007

MedDRA PT Abasia, Abasia, Diarrhoea, Flushing, Hypokinesia, Hypotension, Infection, Inflammation, Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Pyrexia, Rash
Symptom Text: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with
no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient
experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and
within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient
experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia
and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been
an inflammed area on the back of the patient's earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the
events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original
reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot
complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest
X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-
2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture
negative, 04-Apr-2007 DA white blood cell count elevated.
Other Meds: Prevacid
Lab Data: chest X-ray 04/04?/07 - normal, diagnostic laboratory 04/04?/07 - negative, Streptococcus oralis 04/04?/07 - negative, Streptococcus oralis 04/04?/07 -
negative, serum C-reactive 04/04?/07 8.3, serum creatine kinase 04/04?/07 <7, WBC count
History: none
Prex Illness:
Prex Vax Illns:

Vaers Id: 282583-1

23.0 F 23-Jan-2001 13-Feb-2007 2212 21-Jun-2007 22-Jun-2007 FR WAES0706PER00006 22-Jun-2007

Symptom Text: Information has been received from a physician concerning a 23 year old female on 23-JAN-2001 was vaccinated with Gardasil. There was no concomitant
medication. On 13-FEB-2007 the patient experienced spontaneous abortion. The reporter felt that spontaneous abortion was an other medical event and was
not related to therapy with Gardasil. No further information is available.
Other Meds: None
Lab Data: beta-human chorionic gonadotropin (unsp) 13Feb07 Negative
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 282596-1

14.0 F 07-Jun-2007 19-Jun-2007 12 21-Jun-2007 02-Jul-2007 MN 02-Jul-2007
MedDRA PT Erythema, Joint swelling, Oedema peripheral, Pain, Tonsillitis, Urticaria
Symptom Text: 6/19/07 onset of urticaria , Left index finger swelling; 6/20/07 generalized urticaria, joint swelling of wrists/index finger, pain of coccyx, pain bilateral forearms
with redness slight tonsil/ 6/21/07 swelling severe of hands, wrists, knees, increased urticara.
Other Meds:
Lab Data:
History:
Prex Illness: none noted
Prex Vax Illns:

Vaers Id: 282602-1

11.0 F 15-Jun-2007 15-Jun-2007 0 21-Jun-2007 02-Jul-2007 OH 02-Jul-2007
HEPA MERCK & CO. INC. AHAVB141AA 0 Right arm Intramuscular
MMR MERCK & CO. INC. 0950F 1 Left arm Subcutaneously
MedDRA PT Dizziness, Fall, Hyperhidrosis, Syncope
Symptom Text: Pt received 5 vaccines was sitting in waiting room after injections, with her family. Approximately 5 minutes later mom yelled for help. Patient was lying on floor
face down. She had been feeling dizzy and fainted. BP 106/60, P 76 diaphoretic. Recovered after approx 5 minutes.
Other Meds: none
Lab Data: Dr called patients response a Vasovagal fainting episode
History: None Known of patient and younger sib. interpreted for mom who did not speak english.
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282608-1

16.0 F 29-Nov-2006 29-Nov-2006 0 21-Jun-2007 22-Jun-2007 FR B0475795A 22-Jun-2007
HEP GLAXOSMITHKLINE ABVB221BA Unknown Unknown
BIOLOGICALS
MedDRA PT Crying, Dyspnoea, Swollen tongue
Symptom Text: This case was reported by a regulatory authority and described the occurrence of difficulty breathing in a 16-year-old female subject who was vaccinated with
Engerix B and HPV vaccine. On 29 November 2006, the subject received a single dose of Engerix B (intravenous) a single dose of HPV vaccine. Thirty minutes
after vaccination with Engerix B and HPV vaccine, the subject experienced crying difficulty breathing and swollen tongue. The regulatory authority reported that
the events were clinically significant (or requiring intervention). The subject was treated with Piriton. At the time of reporting the outcome of the events were
unspecified.
Other Meds:
Lab Data: UNK
History:
Prex Vax Illns:


14.0 F Unknown Unknown 21-Jun-2007 02-Jul-2007 CT 02-Jul-2007

MedDRA PT Convulsion, Head injury, Loss of consciousness, Syncope, Vomiting
Symptom Text: Syncope head injury with loss of consciousness , questionable SZ, vomiting.
Other Meds:
Lab Data: CT head negative
History:
Prex Illness:
Prex Vax Illns:


14.0 F 21-Jun-2007 21-Jun-2007 0 03-Jul-2007 05-Jul-2007 CT WAES0706USA04210 05-Jul-2007

MedDRA PT Balance disorder, Convulsion, Dizziness, Eye rolling, Fall, Head injury, Headache, Loss of consciousness, Visual disturbance, Vomiting
Symptom Text: Information has been received from a registered nurse concerning a 14 year old female with seasonal allergies and no history of seizures who on 21-JUN-2007
was vaccinated with the first dose of Gardasil (Lot# 658094/0524U) 0.5 mL IM. Concomitant medication was not reported. On 21-JUN-2007 the patient's
mother was checking out of the office when the receptionist saw the patient's eyes roll back in her head and she passed out. The patient hit her head and entire
body on the concrete floor. The nurse and physician ran to the patient and it appeared as if she was coming out of a seizure. The patient had lost
consciousness and developed visual disturbance, dizziness, headache and vomiting. Medical attention was sought. On 21-JUN-2007 a computed axial
tomography (CAT SCAN) was performed and the results were found to be negative for bleeding. The patient was observed in the office for several hours and
released home with her mother. At time of reporting the patient had nausea, vomiting, headaches, visual disturbance and was still unsteady on feet. Additional
information is not available at the time of reporting. Upon internal review, seizure was determined to be an other important medical event. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Computed axial 06/21/07 - negative for bleeding
History:
Prex Vax Illns:

Vaers Id: 282643-1

17.0 F 10-Apr-2007 10-Apr-2007 0 22-Jun-2007 25-Jun-2007 AZ WAES0706USA02323 25-Jun-2007

MedDRA PT Dehydration, Drug exposure during pregnancy, Urinary tract infection, Vomiting
Symptom Text: Information has been received from a nurse concerning a 17 year old female who on 19-JAN-2007 was vaccinated with IM with a 0.5 ml first dose of Gardasil
(654389/0961F). On 10-APR-2007 was vaccinated with IM with a 0.5 ml second dose of Gardasil (657617/0384U). Concomitant therapy included vitamins
(unspecified). On 10-MAY-2007 the patient was seen in the emergency department because she experienced vomiting and dehydration. On 10-MAY-2007
serum beta-human chorionic gonadotropin test diagnosed the patient as pregnant. The patient was treated with unspecified intravenous solution and
ondansetron hydrochloride (ZOFRAN). Her last menstrual period was 28-MAR-2007. Estimated date of delivery was 02-JAN-2008. On approximately, 13-JUN-
2007, the patient developed a urinary tract infection. The patient was treated with nitrofurantoin (MACROBID). The reporting nurse practitioner considered
vomiting and dehydration and to be other important medical events. Additional information has been requested.
Lab Data: serum beta-human 05/10/07 posit
History:
Prex Vax Illns:

Vaers Id: 282644-1

18.0 F 27-Oct-2006 27-Oct-2006 0 22-Jun-2007 25-Jun-2007 IA WAES0706USA01399 25-Jun-2007

MedDRA PT Drug exposure during pregnancy, Talipes, Umbilical cord abnormality
Symptom Text: Initial and follow-up information has been received through the Merck pregnancy registry from a registered nurse concerning an 18 year old female with 1
previous pregnancy that resulted in miscarriage, who on 27-OCT-2006 was vaccinated with the first dose of Gardasil (lot # 653937/0637F) when she was 17
1/7 weeks pregnant, last menstrual period 29-JUN-2006. Concomitant medication included hormonal contraceptives (unspecified). On 03-DEC-2006 the patient
found out she was pregnant via a home beta-human chorionic gonadotropin test (unspecified) and concomitant medication was stopped. A full term baby was
born on 25-MAR-2007. Subsequently, the infant was born with a left club foot and two vessel umbilical cord. On 04-MAY-2007 the patient was vaccinated with
the second dose of Gardasil (lot # 0210U). There were no other birth defects in the family. The nurse felt that the left club foot and two vessel umbilical cord
were other important medical events. This is one of two patients received from the same source. This is an amended report. The terms Medication error and No
adverse effect and information regarding the events have been deleted from this report and entered into WAES 0701USA02073.
History: Miscarriage
Prex Illness:
Prex Vax Illns:

Vaers Id: 282645-1

Symptom Text: Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a female patient who was vaccinated with a dose
of Gardasil. Concomitant suspect therapy included a dose of M-M-R II. Other concomitant therapy included "other unspecified vaccines". The reporter
mentioned that the patient was pregnant but miscarried after receiving Gardasil. Unspecified medical attention was sought. No additional information was
available. Upon internal review, miscarriage was determined to be an other Important Medical Event. Additional information has been requested.
Other Meds: (therapy unspecified)
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 282646-1

TDAP UNKNOWN MANUFACTURER NULL Unknown Unknown
MedDRA PT Fluid replacement, Loss of consciousness, Oxygen supplementation
Symptom Text: Information has been received from a physician's assistant concerning an 11 year old female who on 01-JUN-2007 was vaccinated with Gardasil (lot #
657736/0389U) (doses # unspecified) injection. Concomitant therapy included "T-Dap", and Menactra both also given on 01-JUN-2007. On 01-JUN-2007,
approximately 20 minutes after receiving the Gardasil, the patient passed out in the reception area of the physician's office. Medical attention was sought. The
patient was fasting and did not have anything to eat before receiving the vaccine. The patient was treated with oxygen and fluids at the physician's office. She
was not taken to the emergency room. On 01-JUN-2007, the patient recovered. The reporting physician's assistant felt that the event was serious because the
patient was given oxygen (Other Important Medical Event). Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282647-1

21.0 F 20-Mar-2007 20-Mar-2007 0 22-Jun-2007 25-Jun-2007 FR WAES0706USA02449 25-Jun-2007

MedDRA PT Dyspnoea, Injection site inflammation, Total lung capacity decreased
Symptom Text: Information has been received from a gynecologist's assistant concerning a 21 year old female who on 20-MAR-2007 was vaccinated intramuscularly with a
first dose of Gardasil. The patient subsequently experienced mild injection site inflammation post vaccination with the first dose. The patient recovered from
injection site inflammation within an unspecified time. On 30-MAY-2007, the patient was vaccinated intramuscularly in the upper arm with a second dose of
Gardasil (batch NE35170, lot 654948/0903F). A half an hour later, already at home, the patient experienced severe dyspnea. She presented at the family
physician who administered corticosteroids IV. Lung capacity was measured and was reduced to 2 liters. Shortly after administration of corticosteroids, she
recovered (exact duration not reported). Booster dose will not be administered. The patient's dyspnea and total lung capacity low were considered other
important medical events. Other business partner numbers included E2007-03784 and E2007-03792. Additional information is not expected. Case is closed.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns: injection site inflammation~HPV (Gardasil)~0~21~In Patient

Vaers Id: 282662-1

11.0 F 12-Jun-2007 13-Jun-2007 1 22-Jun-2007 02-Jul-2007 NE 02-Jul-2007
MedDRA PT Injection site erythema, Injection site induration, Injection site warmth
Symptom Text: L arm 4-5 inch area of warmth, redness, mildly indurated - non-tender - Non- itchy, developed approximately 24 hours after injections - treated with ice,
Ibuprofen.
Other Meds:
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282664-1

24.0 F 18-Jun-2007 18-Jun-2007 0 22-Jun-2007 02-Jul-2007 NY 02-Jul-2007

MedDRA PT Injection site discolouration, Injection site rash
Symptom Text: Fine unraised pink rash immediately after Gardasil injection on her right deltoid. Rash resolved in 10 minutes. No other complaints. #3 Gardasil - No prior
reactions.
Other Meds: none
Lab Data: None
History: Penicillin
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282665-1


MedDRA PT Injection site erythema, Injection site rash, No reaction on previous exposure to drug
Symptom Text: Pt developed red unraised rash immediately after vaccine was given on her left deltoid. Rash completely resolved after 10 min. No reaction after first dose.
Tested other arm for sensitivity to alcohol without reaction.
Other Meds: Yasmin 28
Lab Data: None
History: Penicillin
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282701-1

15.0 F 17-May-2007 18-May-2007 1 22-Jun-2007 02-Jul-2007 CA CA070023 02-Jul-2007

MedDRA PT Fatigue, Hyperventilation, Livedo reticularis, Peripheral coldness
Symptom Text: Patient developed hyperventilation; cold, mottled hands. Normal vital signs normal blood sugar. Halfway through Albuterol treatment, patient looked tired --->
sent to ER via EMS.
Other Meds: Benzyl peroxide, Retin-A
Lab Data: Random blood sugar = 109
History: None
Prex Illness: Acne
Prex Vax Illns:

Vaers Id: 282710-1

10.0 F 19-Jun-2007 19-Jun-2007 0 22-Jun-2007 02-Jul-2007 CA 02-Jul-2007
VARCEL MERCK & CO. INC. 1250F Left arm Subcutaneously
TDAP GLAXOSMITHKLINE AC52B009AA Left arm Intramuscular
BIOLOGICALS
UNK UNKNOWN MANUFACTURER NULL 2 Left arm Unknown
MedDRA PT Injection site erythema, Injection site swelling, Injection site warmth
Symptom Text: Redness, heat and mild swelling to left upper arm at injection site. Denies pain.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282712-1

18.0 F 04-Jun-2007 05-Jun-2007 1 22-Jun-2007 02-Jul-2007 IA IA07008 02-Jul-2007
HEP MERCK & CO. INC. 1213R 1 Left arm Intramuscular
MedDRA PT Arthropod bite, Dyspnoea exertional, Fatigue, Pain, Swelling face
Symptom Text: 6/4/07 Eve - felt fatigued, mild achy then 6/5/07 awoke with extreme achiness, mild dyspnea with exertion and swelling of face. 6/4/07 Eve had been outdoors
fishing, one bug bite found on her hand. ER Visit attached. Recovered in 1 day.
Other Meds:
Lab Data: CXR negative, Mono spot negative, CBC unremarkable, Strep negative
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282724-1


Symptom Text: syncopal episode immediately after injection. patient quickly recovered and felt fine after about 15 seconds. no nausea, vomiting.
Other Meds:
Lab Data: EEG and echocardiogram have been ordered-patient has not had completed yet.
Prex Illness:
Prex Vax Illns:

Vaers Id: 282734-1

18.0 F 23-Jun-2007 23-Jun-2007 0 23-Jun-2007 26-Jun-2007 IL 27-Jun-2007
MedDRA PT Asthenia, Blood pressure decreased, Heart rate decreased, Musculoskeletal stiffness, Pallor, Tremor
Symptom Text: After 3 minutes of the application, the patient got paleness, weakness, shakeness, generalized stiffness. She asked then "What happened? The BP went down
to 80/60, and heart rate around 50's. The situation resolved in 15 minutes. No aditional treatment was given.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


18.0 F 21-Jun-2007 21-Jun-2007 0 23-Jun-2007 26-Jun-2007 IL 27-Jun-2007
MedDRA PT Hypotension, Malaise, Musculoskeletal stiffness, Pallor, Syncope
Symptom Text: Patient received Gardasil. Three minutes after the vaccine was given she said: "I don't feel good" Then she went pale, stiff, fainted. She didn't recall what
happened. She came back after 5 minutes. Her BP was low, 60/40 and received epi 0.3 mg.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:


18.0 F 21-Jun-2007 21-Jun-2007 0 03-Jul-2007 05-Jul-2007 IL WAES0706USA04707 05-Jul-2007
MedDRA PT Asthenia, Hypotension, Pallor, Syncope
Symptom Text: Information has been received from a certified medical assistant (CMA), concerning an 18 year old female patient, who on 21-JUN-2007 was vaccinated IM,
with the first dose, 0.5ml, of Gardasil (Lot #655503/0012U). Concomitant therapy included MENACTRA. Five minutes after the vaccination, the patient
"developed syncope," while she was in the process of making another appointment. The CMA reported that the patient also experienced weakness, low blood
pressure (value not specified), and paleness. Treatment involved administered epinephrine 0.3mg. The patient felt better after 10-15 minutes, and was
released with instructions to call the office if she had any further problems. The CMA reported that the patient had not called the office, but indicated the
outcome of the events was unknown. The CMA considered one or more of the events to be serious as an other significant medical event, as intervention to
prevent serious criteria was required. The CMA indicated episodes of syncope for 2 additional patients following vaccination with Gardasil (0706USA04697,
0706USA04722). Additional information has been requested.
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 282736-1 (S)

17.0 F 23-May-2007 11-Jun-2007 19 23-Jun-2007 27-Jun-2007 NC 16-Aug-2007

MedDRA PT Back pain, Kidney infection, Pyelonephritis, Pyrexia, Urinary tract infection, Vomiting
Symptom Text: Urinary tract infection moved into kidneys and caused kidney infection resulting in hospitalization and IV antibiotics. 7/6/07 Received hospital medical records
which reveal patient experienced fever, back pain & vomiting while away from home on mission trip. Exam revealed bilat CVA tenderness. Admitted 6/22-
6/23/07. D/C to f/u for outpatient oral antibiotics. FINAL DX: Pyelonephritis, resolving. 8/14/07 Received vax record which confirms HPV dose & lot # as
reported.
Other Meds:
Lab Data: Developed Urinary Tract infection that went to her kidneys and resulted in hospitalization for kidney infection. LABS: UA had 50-100 WBCs, c/s revealed gram
neg bacilli. WBC max 31.4, granulos 89.2, monos 8.4, lymphs 5.8. Blood c/s was ne
History: none
Prex Illness:
Prex Vax Illns:

Vaers Id: 282740-1

24.0 F 21-May-2007 23-May-2007 2 25-Jun-2007 27-Jun-2007 CA 27-Jun-2007
HPV4 MERCK & CO. INC. NULL 1 Left arm Unknown HPV4

MedDRA PT Erythema, Injection site rash, Pruritus, Rash generalised, Urticaria
Symptom Text: Received first Gardasil HPV vaccine on 3/19/07, received second vaccine on 5/21/07 by 5/23/07 had a rash on upper arms and shins (front bottom legs),
worsened and spread as each week went on. Took Claritin, went to Urgent Care on 6/13/07 received steroid shot in rear and 6 day Predizone pack, rash
continued to spread and worsen all over body (arms, legs, stomach, back, butt, hands, neck etc. (not currently on face or feet)- thousands of small bumps,
circular patches, hive type bumps (raised and dry) - very itchy and red) went to primary care physican on 6/22/07 told to continue with Claritin during the day
and Benedryl at night, also applying Coritizone Cream and Cortaid sent to lab for blood work and urine sample will have results on 6/25/07.
Other Meds: Ortho tri cyclen lo
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282745-1

26.0 F 30-Oct-2006 16-Nov-2006 17 25-Jun-2007 26-Jun-2007 KS WAES0611USA04683 26-Jun-2007

MedDRA PT Drug exposure during pregnancy, Pre-eclampsia
Symptom Text: Information has been received through the Merck pregnancy registry and from a 26 year old female with a sulfonamide allergy who on 30-OCT-2006 was
vaccinated with the first dose of Gardasil (Lot#653735/0688F). Concomitant therapy included prenatal vitamins. On 16-NOV-2006 the patient had an ultrasound
which confirmed she was pregnant. No adverse event was noted. Additional information received from a pediatrician indicated that on 04-JUN-2007 the patient
gave birth by c-section due to pre-eclampsia to a 4lb 4oz female. The patient was 35.6 weeks from LMP. On 16-JAN-2007, laboratory diagnostic studies
included tetra-screening at 16 weeks and was reported to be normal. The infant was reported to be normal. Upon internal review, pre-eclampsia was
considered to an other important medical event. Additional information is not expected.
Lab Data: ultrasound 11/16/06 - normal, ACTH stimulation 01/16/07 - negative
History:
Prex Illness: Pregnancy NOS (LMP = 9/28/2006); Sulfonamide allergy
Prex Vax Illns:

Vaers Id: 282746-1

Unknown U Unknown Unknown 25-Jun-2007 26-Jun-2007 -- WAES0706USA02027 26-Jun-2007
Symptom Text: Information has been received from a health professional at a health department concerning a patient who was vaccinated with a dose of Gardasil.
Concomitant vaccinations included a dose of hepatitis A vaccine (inactive (manufacturer unknown) Menactra. Subsequently the patient experienced guillain-
barre syndrome. No further information was available. Upon internal review, guillain-barre syndrome was considered an other important medical event.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282747-1 (D)

Unknown U Unknown Unknown 25-Jun-2007 26-Jun-2007 -- WAES0706USA02351 26-Jun-2007

MedDRA PT Death
Symptom Text: Information has been received from a physician who attended a conference that mentioned two patients who were vaccinated with Gardasil. Subsequently the
patients died. The cause of death not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients
mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282764-1

17.0 F 21-Jun-2007 Unknown 25-Jun-2007 03-Jul-2007 WA 05-Jul-2007
MedDRA PT Erythema, Injection site erythema
Symptom Text: 2 Hours after vaccine - spreading erythema from site across chest, face. No wheezing; Rx; Benadryl 25mg.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282768-1

MedDRA PT Asthma, Oedema peripheral
Symptom Text: Swollen right arm, asthma attack on 6-13-07.

Other Meds:
Lab Data:
History: NKDA
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282769-1

17.0 F 18-Jun-2007 18-Jun-2007 0 25-Jun-2007 03-Jul-2007 VA 05-Jul-2007
MedDRA PT Blood pressure decreased, Dizziness, Fall, Heart rate decreased, Hyperhidrosis, Pallor
Symptom Text: Became lightheaded, fell backwards and caught by mom. Placed on exam table where she became diaphoretic, pale, BP decrease 50/36, HR 40. Given fluids,
Recovered after 15 minutes, Hct 13.5, VS stable after 1/2 hr.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282770-1

19.0 F 23-Apr-2007 24-Apr-2007 1 25-Jun-2007 03-Jul-2007 TN 05-Jul-2007

MedDRA PT Fluid retention, Musculoskeletal pain, Pain in extremity
Symptom Text: Pain in arm where received Gardasil x 1 month waking up at night with arm and shoulder pain. Sent to orthopedic doctor and has MRI - found 8 mm fluid pocket
in left deltoid. Go back to Ortho in 1 month.
Other Meds: ZOLOFT
Lab Data: MRI- 8MM pocket of fluid found in arm
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282771-1

14.0 F 16-Jan-2007 16-Jan-2007 0 25-Jun-2007 05-Jul-2007 NY 05-Jul-2007
HEPA GLAXOSMITHKLINE AHANB124BA 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Vaccine positive rechallenge, Wheezing
Symptom Text: Significant exacerbation of wheezing. Pt had 2nd HPV 6/12/07 - Merck 0587V. Similar symptoms.
Other Meds: Albuterol M 02 prn
Lab Data:
History: Asthma
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282772-1

14.0 F 12-Jun-2007 12-Jun-2007 0 25-Jun-2007 05-Jul-2007 PA 11-Jul-2007
MedDRA PT Blood pressure decreased, Dizziness, Fall, Syncope vasovagal
Symptom Text: None stated

Other Meds: Albuterol PRN, Zyrtec PRN
Lab Data: Patient also received Menactra vaccine same day 7/11/07-spoke with reporter's office-patient became dizzy, fell in parking lot-returned to office BP 98/56.
Appeared to be vasovagal reaction to immunization. Observed and recovered.
History: Environmental allergies
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 282773-1

19.0 F 19-Jun-2007 19-Jun-2007 0 25-Jun-2007 05-Jul-2007 OH 05-Jul-2007

MedDRA PT Loss of consciousness, Muscle twitching, Musculoskeletal stiffness
Symptom Text: After administering vaccine, patient passed out. After being eased to floor body became stiff and head twitched slightly. Patient was given fluids by mouth and
crackers. Patient sent home.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282775-1


MedDRA PT Dizziness, Dizziness, Vomiting
Symptom Text: Vomited x 4, dizzy (light-headed) starting at 1 p.m.

Other Meds: Adderall 40 mg day Apri
Lab Data:
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282776-1


MedDRA PT Dizziness, Hyperhidrosis, Nausea, Pallor, Presyncope
Symptom Text: Pt had near syncopal episode. Pt became pale, diaphoretic, dizzy, nauseous.
Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282801-1

13.0 F 30-May-2007 30-May-2007 0 25-Jun-2007 02-Aug-2007 NV 02-Aug-2007
TDAP GLAXOSMITHKLINE AC52B014AA 0 Right arm Unknown
BIOLOGICALS
HPV4 MERCK & CO. INC. U2114AA 0 Left arm Unknown
MedDRA PT Muscle twitching, Rash macular, Swelling face
Symptom Text: Blotchy rash and puffiness on face, muscle twitching face, arms, legs, felt tight, twitching feeling and tightness resolved with Benadryl all Sx resided with in 2
days.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282812-1

15.0 F 13-Jun-2007 13-Jun-2007 0 25-Jun-2007 27-Jun-2007 FL 27-Jun-2007
HEPA GLAXOSMITHKLINE NULL Unknown Unknown
BIOLOGICALS
MedDRA PT Alopecia, Blindness, Burning sensation, Deafness, Headache, Immediate post-injection reaction, Loss of consciousness
Symptom Text: My daughter was given the HPV vaccination on 6-13-07. The lot # is 063U and the manufacturer is Merck & Co. She received her shot at the Health
Department. She has never had a reaction to a shot. Immediately after receiving the shot said her head hurt badly than she passed out falling to the floor
fortunately I was behind her and caught her. She was out for a bit probably 2-3 minutes and the nurse immediately called the paramedics and the doctor or
another nurse came in and gave her smelling salts which did not wake her. Not too long afterward she woke up and said she could not see or hear. Both her
vision an hearing came back shortly afterward and then she said her body was burning inside that eventually went away as well. Nurse gave patient 50mg of
Benedryl in her fanny to help and the paramedics arrived and took her blood pressure. We stayed for about 1/2 hour and came home she feels okay now but a
few days after the shot she has been loosing some of her hair. I am not going to take her for anymore of the HPV shots and would like to know if you have had
any other reactions and to make you aware of this information as it my help another child down the road. Anything you can do to help would be greatly
appreciated. If you would like to call.
Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282822-1

MedDRA PT Syncope
Symptom Text: She received 3 vaccines, the last of which was HPV. After the third vaccination, she had a syncopal episode and it took approximately 3 minutes to regain
consciousness. She was mentally alert and feeling fine by the time she left the clinic 15 minutes later. We elevated her feet and gave her something to drink.
Other Meds: None
Lab Data: Patient has a very small stature. She is 15.5 years old and is 4ft 10.5 inches and weighs 76 pounds.
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282848-1 (S)

17.0 F 27-Feb-2007 27-Feb-2007 0 26-Jun-2007 27-Jun-2007 CA WAES0706USA03288 27-Jun-2007

MedDRA PT Depression, Dizziness, Dizziness, Similar reaction on previous exposure to drug
Symptom Text: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on 27-FEB-2007 was vaccinated
IM, with the first dose of Gardasil (Lot # not provided). There was no concomitant medication. On approximately 27-FEB-2007 ("after getting her first dose"), the
patient reported feeling a "little woozy." Later on (onset date not specified), she experienced depression that was significant enough to require counseling. With
counseling, the depression cleared (date not specified). On approximately 25-MAY-2007, she was vaccinated IM with the second dose of Gardasil (Lot # not
provided). On 25-MAY-2007, following the vaccination, she felt lightheaded, and again "went into depression (onset date not reported); counseling was
reinitiated. At the time of this report, the outcome of feeling woozy, feeling lightheaded, and the second episode of depression were unknown. The physician
considered the episodes of depression to be significantly disabling or incapacitating. Additional information has been requested.
Other Meds: None
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282858-1

15.0 F 18-Jun-2007 18-Jun-2007 0 26-Jun-2007 06-Jul-2007 NC 30-Jul-2007
MedDRA PT Abdominal pain upper, Blood pressure decreased, Body temperature increased, Dizziness, Injection site pain, Injection site warmth
Symptom Text: Dizzy, stomach cramping, Rt arm pain down from deltoid to elbow. Immediate warmth around injection site. Temp 99.2, BP 90/60
Other Meds: Concerta
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282859-1

22.0 F 24-Apr-2007 24-Apr-2007 0 26-Jun-2007 06-Jul-2007 IL 06-Jul-2007

MedDRA PT Dizziness, Dizziness, Headache, Palpitations
Symptom Text: Shortly after receiving Gardasil on 4/24/07. Pt became "dizzy and lightheaded and heart was racing" - was reported to us today 6-25-07 also headache.
Other Meds: Depo Provera
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282867-1 (S)

18.0 F 14-Jun-2007 14-Jun-2007 0 26-Jun-2007 02-Jul-2007 -- 11-Jul-2007

MedDRA PT Fall, Head injury, Loss of consciousness
Symptom Text: Shortly after receiving Gardasil, pt blacked out and fell off exam table where she had been sitting. Her forehead struck the exam table stirrup, breaking it off, her
left thigh scrapped against broken metal from stirrup and pt landed on the floor, where was found the the nurse
Other Meds:
Lab Data:
History: healthy female
Prex Illness:
Prex Vax Illns:

Vaers Id: 282875-1

14.0 F 13-Jun-2007 14-Jun-2007 1 26-Jun-2007 06-Jul-2007 NM 06-Jul-2007
MedDRA PT Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Symptom Text: On 6/13/07 client was given Gardasil and VAR vaccines at public health office. Family reports client began to have reaction to VAR on 6/14, came to this office
6/15 reporting pain, swelling, itching around site of Varicella vaccine (L) arm-This area, reddened, hot with swelling noted by nurse. They returned that
afternoon, reaction somewhat larger, client had headache, itching arm pain. Referred to MD, began antibiotics that eve. soon improved. Resolved by 6/19/07.
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282901-1

11.0 F 22-Jun-2007 22-Jun-2007 0 26-Jun-2007 27-Jun-2007 OR 27-Jun-2007
TDAP GLAXOSMITHKLINE C2610AA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Fall, Head injury, Loss of consciousness, Somnolence, Syncope
Symptom Text: Approx 5 minutes after receiving vaccines which included Tdap, HPV#1 and Menactra, pt had syncopal episode, falling to the floor and hitting her head. She
was unconscious for approx 10-15 seconds, then groggy but oriented x 3. She was unable to remember the day's events and kept asking the same questions
repeatedly. Was observed in outpatient clinic x 2 hours with no improvement. Transported via ambulance to ER, CT of head was normal, was observed 2
more hours and discharged home.
Other Meds: none
Lab Data: CT of the head
History: none
Prex Illness: Cough x 5 days
Prex Vax Illns:

Vaers Id: 282909-1

15.0 F 16-Jan-2007 16-Jan-2007 0 27-Jun-2007 28-Jun-2007 AZ waes0705usa03252 28-Jun-2007

MedDRA PT Abortion induced, Drug exposure during pregnancy, No adverse effect
Symptom Text: Information has been received from a physician's assistant through the Merck Pregnancy registry concerning a 15 year old female patient with asthma who on
16-JAN-2007, was vaccinated IM with a second dose of Gardasil (Lot# 655617/1447F). Concomitant therapy included albuterol MDI. After the second dose, it
was discovered that she was pregnant. No adverse events were noted. On 24-MAY-2007, the patient elected to terminate the pregnancy. The patient was 21
weeks from last menstrual period. On 20-MAY-2007 and 22-MAY-2007, an ultrasound was performed and the results were unknown. At the time of this report,
the patient's outcome was unknown. It was also reported on 16-NOV-2006, the patient was vaccinated with a first dose of Gardasil (Lot# 653736/0868F). No
product quality complaint was involved. Upon internal review, elective termination was considered to be an other important medical event. Additional
information is not to be expected.
Other Meds: albuterol
Lab Data: Ultrasound 05/20/07 - unknown results, ultrasound 05/22/07 - unknown results
History:
Prex Illness: Pregnancy NOS (LMP = 1/1/2007) asthma
Prex Vax Illns:

Vaers Id: 282910-1 (S)


MedDRA PT Injection site inflammation, Injection site warmth, Muscle spasms, Neck deformity, Neck pain
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female with no allergies and with a urinary tract infection who on 12-JUN-
2007 was vaccinated intramuscularly with the third 0.5 mL dose of Gardasil, (Lot number known by the reporter). Concomitant therapy included "birth control"
"antibiotic" (unspecified) and sulfamethoxazole/trimethoprim (BACTRIM). On 14-JUN-2007, approximately 36 hours after vaccination, the patient developed
severe neck pain and spasms on the same side (unspecified) of her injection. The patient was seen and her neck was described as "crooked" and "off center".
The back of the patient's neck was palpitated up to the skull and the patient expressed severe pain. Also, the site of injection was warm to the touch with signs
of inflammation. The patient lost a day of work. The patient sought unspecified medical attention. It was reported that ice was used along with ibuprofen
(MOTRIN) for the symptoms. On the morning of 15-JUN-2007, the patient felt a little better but her neck was still "crooked". The patient had an appointment
with an orthopedist. No further information was available. At the time of the report, the patient had not recovered. The reporter considered the patient's neck
pain, spasms, neck described as "crooked" and "off center" and injection was warm to the touch with signs of inflammation to be disabling. Additional
Other Meds: antimicrobial (unspecified), hormonal contraceptives, Bactrim
Lab Data: Unknown
History:
Prex Illness: Urinary tract infection
Prex Vax Illns:

Vaers Id: 282911-1 (S)

19.0 F 20-Apr-2007 25-Apr-2007 5 27-Jun-2007 28-Jun-2007 TN WAES0706USA02796 26-Jul-2007

MedDRA PT Effusion, Hypokinesia, Injected limb mobility decreased, Musculoskeletal pain
Symptom Text: Information has been received from a physical therapist concerning a 19 year old female with an allergy to "vicryl sutures" who on approximately 20-APR-2007
was vaccinated with a dose of Gardasil. On approximately 25-APR-2007, five days after vaccination, the patient developed shoulder pain on the side where the
vaccination was given. She saw her pediatrician, and was referred to an orthopedic physician. Magnetic resonance imaging was performed and showed an 8
mm in diameter fluid filled sack underneath the deltoid. The patient can not use the arm due to the pain in her shoulder. The patient's shoulder pain and fluid-
filled sack underneath the deltoid have persisted. The physician considered the shoulder pain and fluid-filled sack underneath the deltoid to be disabling
events. Additional information has been requested.
Other Meds: Unknown
Lab Data: magnetic resonance 05/11/07 - 8 mm in diameter fluid filled sack underneath the deltoid
History:
Prex Vax Illns:


15.0 F 16-Jun-2007 16-Jun-2007 0 27-Jun-2007 28-Jun-2007 NY WAES0706USA03141 30-Jul-2007

MedDRA PT Grand mal convulsion, Oxygen supplementation, Syncope
Symptom Text: Information has been received from a physician and a registered nurse concerning a 15 year old female with a drug sensitivity to SEPTRA and a history of
seeing a neurologist and cardiologist for neurocardio syncope (Vasovagal) who on 26-MAR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil. On
approximately, 16-JUN-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil (lot # 657868/0523U). There was no concomitant
medications. On 16-JUN-2007, while in the physicians office, the patient fainted and then had a grand mal seizure. The patient was given oxygen. The office
called for an ambulance and the patient was taken to the emergency room and released. There were no laboratory or diagnostic test performed. On 16-JUN-
2007, the patient recovered from fainting and the grand mal seizure. On 18-JUN-2007, the patient was seen in the physicians office and was referred to a
neurologist. Upon internal review, grand mal seizure was considered to be an other important medical event. The registered nurse is requesting a lot check.
Other Meds: None
Lab Data: Unknown
History:
Prex Illness: Syncope vasovagal; Drug hypersensitivity
Prex Vax Illns:


15.0 F 16-Jun-2007 16-Jun-2007 0 28-Jun-2007 29-Jun-2007 NY WAES0706USA02753 29-Jun-2007

MedDRA PT Condition aggravated, Grand mal convulsion, Oxygen supplementation, Syncope, Urinary incontinence
Symptom Text: Information has been received from a physician concerning a 15 year old female with a history of syncopal attacks (NOS) who had been previously evaluated
for the syncopal attacks on unspecified dates by a neurologist and cardiologist. On 26-MAR-2007 the patient was vaccinated IM with the first dose of Gardasil
(lot# not provided). On 16-JUN-2007 the patient received the second dose of Gardasil (Lot#6578681/0523U). On the same day she also received a vaccination
of Havrix. Post vaccination the patient was sitting in the physician's waiting room where she experienced a syncopal episode followed by a tonic clonic seizure
which lasted approximately three minutes and included urinary incontinence. After the seizure resolved the patient was treated with oxygen in the physicians
office, was alert and oriented and was then transported to the emergency room for further evaluation. It was reported that after being evaluated in the ER, she
had residual, and was feeling well. It was also reported that the patient did not have any difficulties after her first vaccination. The patient was scheduled to
follow up with a neurologist as a precaution. Upon internal review the tonic clonic seizure was felt to be an other medical event. Additional information has been
requested.
Other Meds:
Lab Data:
History: Syncopal attack
Prex Illness:
Prex Vax Illns:


HEPA GLAXOSMITHKLINE AHAVB163AB 5 Left arm Unknown
BIOLOGICALS
MedDRA PT Cyanosis, Grand mal convulsion, Urinary incontinence
Symptom Text: Patient received Hep A and HPV vaccines and was in waiting room she called out to mother and mom called for help. Drs went to child - she was having a
generalized tonic-clonic seizure with mild perioral cyanosis, urinary incontenance - lasted about 3 min. O2 was given VS after seizure 1 AP 88, R:16, O2 sat:
100%, BP 92/62. During seizure sz no RRR chest CTA bilat. EMS activated during seizure and pt transported to ER.
Other Meds:
Lab Data: Taken by ambulance to ER (referred to neurology for final eval/tentative DX anoxic seizure, vasovagal syncope.
History: Septra (hives 3/18/93)
Prex Illness: Resolved sinusitis
Prex Vax Illns:

Vaers Id: 282913-1 (S)

14.0 F 14-Jun-2007 14-Jun-2007 0 27-Jun-2007 28-Jun-2007 IL WAES0706USA03415 28-Jun-2007

MedDRA PT Dizziness, Feeling abnormal, Hyperglycaemia, Lethargy
Symptom Text: Information has been received from a physician concerning a 14 year old female, with no pertinent medical history, who on 14-JUN-2007 was vaccinated IM,
with a first dose of Gardasil (lot # "02630"). There was no concomitant medication. Approximately, on 14-JUN-2007 it was reported the patient was "light-
headed", "out of it", and lethargic. On 15-JUN-2007 the patient had to be carried into the physicians office. Her sugar level was at 176 (hyperglycemic). She
was tested for diabetes but it came back "negative". It was reported that by 16-JUN-2007 the patient "was feeling much better." The physician considered "light-
headed", "out of it", lethargic, and a sugar level at 176 to be disabling. Additional information has been requested.
Other Meds: None
Lab Data: diagnostic laboratory 06/15/07 - not diabetic, fasting blood glucose 06/15/07 176
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 282914-1 (S)

24.0 F 30-Jan-2007 07-May-2007 97 27-Jun-2007 28-Jun-2007 FR WAES0706PER00010 28-Jun-2007

MedDRA PT Abortion spontaneous
Symptom Text: Information has been received from a physician concerning a 24 year old female who on 30-JAN-2007 was vaccinated with Gardasil. There was no
concomitant medication. On 07-MAY-2007 the patient experienced spontaneous abortion and was hospitalized. Subsequently, the patient recovered from
spontaneous abortion. No further information is available.
Other Meds: None
Lab Data: NONE
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 282915-1

24.0 F 29-May-2007 02-Jun-2007 4 27-Jun-2007 28-Jun-2007 NH WAES0706USA02113 28-Jun-2007

MedDRA PT Back pain, Headache, Hepatic enzyme increased, Infection, Malaise, Neutrophil count decreased, Pyrexia
Symptom Text: Initial and follow-up information has been received from a nurse and a physician concerning a 24 year old female assistant manager with a drug allergy to
DILANTIN who was vaccinated intramuscularly into the left deltoid with the first dose of Gardasil (lot # 657617/0684U) on 29-MAY-2007. Concomitant therapy
included LEXAPRO and YASMIN. On 02-JUN-2007, the patient "became sick" and went to the emergency room (ER). It was reported that she experienced
headache, elevated liver enzymes, fever, severe back pain and a complete blood count that revealed infectious process. The nurse reported that the patient
had a variety of tests performed on her in the ER, including a liver function test (LFT) which showed that the patient's liver enzymes were high. On 06-JUN-
2007, the patient underwent the following laboratory test: Lyme disease enzyme-linked immunosorbent assay, negative; absolute blood band neutrophil count,
2.35 K/uL, blood lymphocyte count, 10%; mean corpuscular volume, 75 fL, serum Epstein-Barr viral capsid antigen immunoglobulin G antibody test, positive;
serum alanine aminotransferase test (ALT (SGPT), 486 U/L; serum aspartate aminotransferase test (AST (SGOT), 311 U/L; mean corpuscular hemoglobin
(MCH), 26 pg. On 06-JUN-2007, the patient also underwent an abdominal ultrasound. The physician's impression was that there was no evidence of gallstones
or dilated intra-, extrahepatic biliary ducts and there was a stable splenic cyst present. On 11-JUN-2007, the patient underwent the following laboratory tests:
MCH, 26 pg, WBC count, 10.8 x 10E3/uL; AST (SGOT), 49 IU/L; ALT (SGPT), 147 IU/L. The nurse reported that the patient was doing better, but her liver
enzyme levels were still elevated. At the time of the report, the outcome of severe back pain, headache, infectious process and fever were unknown. The
reporting physician considered elevated liver enzymes, severe back pain, headache, fever, and complete blood count revealing infectious process to be other
important medical events. Additional information is not
Other Meds: Yasmin, Lexapro
Lab Data: abdominal ultrasound 06/06/07 - stable splenic cyst; no evidence of gallstones or dilated intra-, extrahepatic biliary ducts, serum alanine 06/06/07 486 U/L 0-65,
mean corpuscular volume 06/06/07 75 fl 80-100, mean corpuscular 06/06/07 26 p
History:
Prex Illness: Contraception; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 282920-1 (S)

4.0 M 17-Apr-2007 17-Apr-2007 0 27-Jun-2007 02-Jul-2007 MI 20-Jul-2007
PNC WYETH PHARMACEUTICALS, INC B068699F 0 Right leg Unknown
DTAP SANOFI PASTEUR C2605AA 4 Left leg Unknown
HPV4 MERCK & CO. INC. 1391F 0 Right leg Unknown
IPV SANOFI PASTEUR 20547 3 Left leg Unknown
MedDRA PT Anaphylactic reaction, Hypersensitivity, Inappropriate schedule of drug administration, Periorbital oedema, Rash, Swelling face
Symptom Text: anaphylactic reaction. 7/17/07 Received ER med records from hospital which reveal patient seen 4/19/07 after seen by pcp for vax same day. Developed
facial swelling, rash & periorbital edema. Tx at pcp office then transported to ER by EMS. Edema improved by arrival in ER per parents but still noted to by
significant by ER. Tx w/additional steroids & antihistamines & observed in ER. Improved & was d/c to home. FINAL DX: acute allergic reaction.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282927-1

16.0 F 26-Jun-2007 26-Jun-2007 0 27-Jun-2007 28-Jun-2007 SC 28-Jun-2007
BIOLOGICALS
MNQ SANOFI PASTEUR UE518AA 0 Left arm Intramuscular
MedDRA PT Haematuria, Urine analysis abnormal
Symptom Text: Apparent Hematuria (pink-red urine) approximately 6 hours after administration of 3 vaccines. Continued through the evening, tea-colored urine in morning and
then cleared. No other symptoms noted. NOrmal UA at the exam earlier in the day.
Other Meds: Motrin and Tylenol
Lab Data: none done
History: thyroglossal cyst and inguinal hernias as a child
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282941-1

20.0 F 26-Jun-2007 26-Jun-2007 0 27-Jun-2007 28-Jun-2007 IN 28-Jun-2007

MedDRA PT Blister
Symptom Text: blisters both upper arms and upper back that began approx 4 hours after injection...pt says the blisters went away and recurred today
Other Meds: Desogen
Lab Data: none
History: none known
Prex Illness: none known
Prex Vax Illns:

Vaers Id: 282949-1

13.0 F 13-Apr-2007 13-Apr-2007 0 28-Jun-2007 28-Jun-2007 FR WAES0706USA04634 28-Jun-2007

Symptom Text: Information has been received from a physician (a gynecologist), concerning a 13 year old female patient, who on 13-APR-2007 was vaccinated IM in the
upper arm, with the first dose, of Gardasil (Lot # not provided). On 13-APR-2007, immediately following vaccination, she had an episode of convulsive syncope;
she was helped to lay down with her legs raised, and recovered within a short time. On 15-JUN-2007, the reporting confirmed that the patient was vaccinated
with the second dose of Gardasil (Lot #655671/1024F; Batch NE51790), and the vaccination was well tolerated. This file is closed. Upon internal review,
convulsive syncope was considered to be serious as an other significant medical event. Other business partner numbers include: E2007-03766.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 282952-1

MNQ SANOFI PASTEUR U2276BA 0 Left arm Unknown
MedDRA PT Syncope
Symptom Text: Fainted after receiving injections. Per mom this is normal response after receiving injections occurs 10-15 min after that pt faints. Vital signs were stable.
Other Meds:
Lab Data: none
History: none
Prex Illness: none
Prex Vax Illns: Fainting~Vaccine not specified (no brand name)~~10~In Patient

Vaers Id: 282959-1

16.0 F 14-Jun-2007 Unknown 27-Jun-2007 09-Jul-2007 MI 27-Jul-2007
DTAP SANOFI PASTEUR C261005AA 5 Right arm Intramuscular
MedDRA PT Inappropriate schedule of drug administration
Symptom Text: None

Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282963-1

12.0 F 16-Jun-2007 16-Jun-2007 0 27-Jun-2007 09-Jul-2007 NJ 09-Jul-2007

MedDRA PT Urticaria
Symptom Text: Received 1st Gardasil shot in office around 11AM Later that day broke out with hives all over her torso and arms. Mom called Dr - Dose of Benadryl was
administered. Hives faded no other reaction reported. Spoke with mom on 6/18/07 child was fine.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282964-1

18.0 F 18-Jun-2007 18-Jun-2007 0 27-Jun-2007 09-Jul-2007 MA 09-Jul-2007
TD SANOFI PASTEUR C2720AA 0 Left arm Intramuscular
MedDRA PT Syncope
Symptom Text: Syncopal episode approx 5 min after administration

Other Meds: on Ortho-tri-cyclen 1 tab PO QD
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282966-1


MedDRA PT Feeling abnormal, Syncope
Symptom Text: Pt received vaccine and then sat for about 7-8 minutes. Upon checking out pt stated that she didn't feel right and fainted. Pt came around a minute later sat for
awhile and was released
Other Meds: Multivitamin
Lab Data:
History: Dizziness & lightheadedness
Prex Illness:
Prex Vax Illns:

Vaers Id: 282970-1

17.0 F 19-Jun-2007 19-Jun-2007 0 27-Jun-2007 09-Jul-2007 KY 09-Jul-2007

Symptom Text: Pt vomited 1 hr after getting vaccine 2nd several times during day, mom said and she though pt ran a fever but had no thermometer-2nd day pt. feeling better
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 282973-1

9.0 F 18-Jun-2007 19-Jun-2007 1 27-Jun-2007 09-Jul-2007 AZ 09-Jul-2007
VARCEL MERCK & CO. INC. 0308U 1 Unknown Subcutaneously
HPV4 MERCK & CO. INC. L425F 0 Unknown Intramuscular
MedDRA PT Injection site erythema, Injection site induration
Symptom Text: Large erythematous, indurated area at site of vaccination. Area about 5 cm diameter today, was larger on 6/19/07 per mom.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 282975-1

15.0 F 20-Jun-2007 20-Jun-2007 0 27-Jun-2007 09-Jul-2007 MI 09-Jul-2007

MedDRA PT Syncope
Symptom Text: Client fainted after receiving HPV4 vaccine. Fl up done by RN and staff. Client recovered after 15"-20".
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 282980-1

8.1 M 25-Jun-2007 25-Jun-2007 0 27-Jun-2007 09-Jul-2007 PA 30-Jul-2007

MedDRA PT Inappropriate schedule of drug administration, Urticaria
Symptom Text: Starting 6 hrs post immunization, pt has urticaria on trunk and extremities and face, no breathing issues, examined 24 hr later still had scattered urticaria, no
joint swelling no mucosal.
Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283098-1

11.0 F 27-Jun-2007 27-Jun-2007 0 28-Jun-2007 07-Jul-2007 TN 09-Jul-2007
DTAP UNKNOWN MANUFACTURER NULL Left arm Intramuscular
MedDRA PT Dizziness, Hypoaesthesia, Limb discomfort, Musculoskeletal stiffness, Pain in extremity, Pallor, Paraesthesia, Wrong drug administered
Symptom Text: Within minutes of receiving the HPV vaccination and a DTaP booster yesterday afternoon, my daughter complained of numbness extending down her right arm
(HPV vaccination site) to her finger tips. She then noted tingling in her other hand and both of her feet. She was sitting in the waiting area at this time. I noted
that her lips looked pale. I had her put her head in her lap. After a minute or so, she sat back up and her lips were redder. She remained a bit woozy for the
following hour or so. Pain and discomfort in her right arm continued over the next several hours. I treated her with 400mg advil when we got home about 2
hours after the vaccine. She continued to complain of pain and stiffness in her right arm throughout the evening last night. Today her right arm is better and
her left arm (DTaP site) is more painful. As a pediatrician myself (MD, FAAP), I was very concerned when I saw the incidence of syncope being reported with
the HPV vaccine. I spoke with a friend who has her PhD in child psychology. She does not think "adolescence" is an appropriate excuse for this adverse
reaction. I won't be giving my daughter the remaining doses until more has been studied regarding this reaction.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283107-1

12.0 F 25-Jun-2007 25-Jun-2007 0 28-Jun-2007 07-Jul-2007 MD 09-Jul-2007
BIOLOGICALS
MedDRA PT Fatigue, Flushing, Hyperhidrosis, Nausea, Paraesthesia, Visual acuity reduced, Vomiting
Symptom Text: child received Havrix Im in left deltoid, and then was given Gardasil .5ml IM. Immediately after Gardasil, pt experienced arm tingling, followed by flushing,
diaphoresis, "Couldn't see", nausea and emesis x1. Symptoms resolved within < 5 minutes and left office feeling "perfectly fine" No treatment necessary. Felt
tired the following day but otherwise no residual symptoms, nor any vaccine site localized rash/swelling.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283115-1


MedDRA PT Dizziness, Head injury, Headache, Loss of consciousness, Syncope
Symptom Text: Received her 2nd (In the set of three) IM injection in her left upper arm while standing in the doctor's office. She was unaffected initialy and left the office
walking and talking and in no apparent distress. Immediately upon exiting the docor's office however she lost consciousness and collapsed in the hallway,
striking her head on the tile floor. She regained consciousness immediately but complained of dizziness and head pain. She was removed back to the doctor's
office where her vital and neuro signs were assessed. Her vital signs were BP 110/70, pulse 72, resp 20; there were no postural changes to her blood
pressure.Her neuro exam was also unremarkable; PERLA, hand grasps equal and she was completely orientated to person, time and place. As she is
diagnosed with a rare bleeding disorder, Factor 7 deficiency, a call was placed to her hemotologist to determine further treatment. This physician felt that a CT
scan of her head was in order due to her continued complaints of head pain and dizziness. She was then taken to another hospital where the CT scan was
performed. She was then directed back to the pediatrician's office where we waited for her test results. The radiologist called to report a negative finding and
was discharged home with 48 hour head trauma precautions. 24 hours later her headache was much improved and the dizziness has disappeared.
Other Meds: Zoloft 50mg qd
Lab Data: Head Ct scan negative.
History: Depression; Asthma, Factor 7 deficiency
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283124-1

13.0 F 18-Jun-2007 18-Jun-2007 0 28-Jun-2007 10-Jul-2007 TX 10-Jul-2007

MedDRA PT Cold sweat, Pallor
Symptom Text: After 1st dose - 1 episode pallor and clamminess, After 2nd dose - 2 episodes pallor and clamminess symptoms self - resolved.
Other Meds: None
Lab Data: None
History: Over nutrition, high cholesterol, poor vision.
Prex Illness: None
Prex Vax Illns: pallor and clamminess~HPV (Gardasil)~1~13~In Patient

Vaers Id: 283126-1

11.0 F 22-Jun-2007 22-Jun-2007 0 29-Jun-2007 09-Jul-2007 MA 09-Jul-2007

MedDRA PT Dizziness, Nausea, Skin discolouration
Symptom Text: Within minutes of receiving Gardasil vaccine turned green and became lightheaded. After laying down for 20 minutes sat up and became nauseous. Patient
able to leave after being observed for 45 minutes - 1 hour.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283274-1


MedDRA PT Dizziness, Pallor, Presyncope
Symptom Text: Patient near syncope, felt faint, upset, pale in color.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283279-1

25.0 F Unknown Unknown 29-Jun-2007 09-Jul-2007 MO 09-Jul-2007

MedDRA PT Dizziness
Symptom Text: Light headed felt as though she might pass out.
Other Meds: GLUCOPHAGE, PHENTAMINE
Lab Data:
History: DM, Hypothyroid, Sulfa
Prex Illness: DM Type II
Prex Vax Illns:

Vaers Id: 283280-1

17.0 F 20-Jun-2007 Unknown 29-Jun-2007 09-Jul-2007 MT 09-Jul-2007
HEPAB GLAXOSMITHKLINE AHABB080AB 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Unevaluable event
Symptom Text: None

Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283286-1

21.0 F 23-Mar-2007 29-Mar-2007 6 29-Jun-2007 07-Jul-2007 TX 09-Jul-2007

Symptom Text: On 3-24-07 this patient developed acute pain (arthralgias) of her L shoulder, L elbow, L knee, L shin, and L ankle (without frank arthritis, per se). Injection site
was the L arm. All resolved within 3-4 days without sequelae.
Other Meds: only topical Gynazole Vaginal Cream
Lab Data: Normal Inflammatory Panel ( Nl CBC, - ANA, - RA, nl esr of 4)
History: only seasonal allergic rhinitis / acne
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283314-1

17.0 F 22-Jun-2007 29-Jun-2007 7 29-Jun-2007 09-Jul-2007 UT 09-Jul-2007

MedDRA PT Facial pain, Herpes zoster, Hyperaesthesia
Symptom Text: Right sided face pain and touch sensitivity consisted with herpes zoster prodrome for which Acyclovir was started today.
Other Meds: ZYRTEC D
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283319-1

15.0 F 19-Jun-2007 20-Jun-2007 1 29-Jun-2007 09-Jul-2007 MO 09-Jul-2007

MedDRA PT Cough, Nasal congestion, Sinusitis, Upper respiratory tract infection
Symptom Text: Nasal congestion and cough 1-2 days after vaccine x 3 - Dx URI/ Sinusitis, Treatment Z-Pak.
Other Meds: Yaz birth control pill
Lab Data: None
History:
Prex Illness:
Prex Vax Illns: URI~HPV (Gardasil)~2~0~In Patient

Vaers Id: 283518-1

Unknown F Unknown Unknown 02-Jul-2007 03-Jul-2007 FR WAES0706PHL00010 03-Jul-2007

MedDRA PT Anaphylactic shock
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced anaphylactic
shock. Outcome, causality and other patient demographics were unknown. Anaphylactic shock was considered as an other important medical event. No further
information is available at the time of report. Contact details of physician was not available. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283519-1

Unknown F Unknown Unknown 02-Jul-2007 03-Jul-2007 FR WAES0706PHL00011 03-Jul-2007

MedDRA PT Anaphylactic shock
Symptom Text: Information has been received from a physician concerning 2 female patients who were vaccinated with Gardasil. Subsequently the patients experienced
anaphylactic shock. Outcome, causality and other patient demographics were unknown. Anaphylactic shock was considered an other important medical event.
No further information is available at the time of report. Contact details of reporting physician was not available. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283520-1 (S)

17.0 F 06-Mar-2007 06-Mar-2007 0 02-Jul-2007 03-Jul-2007 MI WAES0706USA04112 11-Jul-2007

MedDRA PT Abortion, Deep vein thrombosis, Drug exposure during pregnancy, Dyspnoea, Thrombosis
Symptom Text: Information has been received from the Merck Pregnancy Registry from a physician concerning a 17 year old female with no pertinent medical history who on
06-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 656049/0187U). The patient was prescribed ethinyl estradiol (+)
norgestimate (ORTHO TRI-CYCLEN) on the day she received the vaccination, but the reporter did not have any information regarding whether the patient was
taking them or not. It was later learned that the patient was pregnancy when she received the vaccination. On 07-APR-2007, the patient experienced shortness
of breath. On 14-APR-2007, she was hospitalized due to shortness of breath. It was later determined that the patient was experiencing a blood clot in her left
leg, deep vein thrombosis (DVT). On 16-APR-2007, the hospital determined that the patient was 11 weeks and 1 day pregnant. The estimated date of delivery
was 04-NOV-2007. Subsequently, the patient had an abortion performed for personal reasons not related to the vaccine. On 14-JUN-2007, the patient had not
recovered from the blood clot and the reporter indicated that an unspecified blood thinner was recommended as treatment. At the time of the report, the blood
clot persisted. The physician considered shortness of breath, abortion and blood clot in left leg to be other important medical events. The physician considered
shortness of breath and blood clot in left leg to be immediately life threatening events. Additional information has been requested.
Other Meds: Unknown
History:
Prex Vax Illns:

Vaers Id: 283521-1

12.0 F Unknown Unknown 02-Jul-2007 03-Jul-2007 ME WAES0706USA04134 03-Jul-2007

MedDRA PT Blindness transient, Dizziness, Mydriasis
Symptom Text: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who was vaccinated (date not
specified) with the first dose of Gardasil, and following vaccination, felt like she was going to faint. The physician confirmed that the patient did not actually faint,
though she had dilated pupils and she "lost sight" for approximately 10 minutes. The patient was instructed to lie down for 10 minutes, and then reported "she
was okay." Upon internal review, "lost sight for approximately 10 minutes," was determined to be serious as an other important medical event. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283528-1

16.0 F 05-Jun-2007 12-Jun-2007 7 02-Jul-2007 10-Jul-2007 VA 10-Jul-2007

MedDRA PT Injection site reaction
Symptom Text: 4 x 4 cutaneous reaction at site of HPV injection.

Other Meds:
Lab Data:
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 283531-1

18.0 F 15-Jun-2007 16-Jun-2007 1 02-Jul-2007 10-Jul-2007 MA 10-Jul-2007
MedDRA PT Anxiety, Nausea, Palpitations, Pharyngolaryngeal pain
Symptom Text: Sore throat, palpitations, nausea, anxiety

Other Meds: Avian
Lab Data: Throat culture - neg
History: Anxiety D/O, obesity
Prex Illness:
Prex Vax Illns:

Vaers Id: 283534-1

11.0 F 26-Jun-2007 26-Jun-2007 0 02-Jul-2007 10-Jul-2007 AZ 10-Jul-2007

MedDRA PT Feeling abnormal, Mydriasis, Pallor, Syncope
Symptom Text: After receiving Gardasil at about 920am the pt stated R arm felt weird then turned pale, eyes dilated and fainted. Dr was called into the room immediately and
examined pt and observed her for 45-50 min, then pt acted normal and went home.
Other Meds:
Lab Data:
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283541-1

12.0 F 14-Jun-2007 15-Jun-2007 1 02-Jul-2007 10-Jul-2007 CO 10-Jul-2007
Symptom Text: Has a raised, red area on fatty area of Lt arm. Measures approximately 2" wide x 1 1/2" high - Probably where Varicella given - also outside with mosquito's?
Other Meds: Advair for asthma, Albuterol meds for allergies
Lab Data:
History: Molds, pollens, dust, peanuts ?cats/dogs.
Prex Illness:
Prex Vax Illns:

Vaers Id: 283547-1

25.0 F 25-Jun-2007 25-Jun-2007 0 02-Jul-2007 10-Jul-2007 MO 11-Jul-2007

MedDRA PT Abdominal pain, Body temperature increased, Fatigue, Headache, Influenza like illness, Loss of consciousness, Nausea
Symptom Text: Gardasil given 6/25/07. Patient reports flu-like symptoms, nausea temperature 102 during night of 6/25/07- 6/26/07 flu-like symptom. Nausea continued, loss of
consciousness "few minutes" at work. Has bad headaches, abdominal pain "feels like some one has hit me". C/O fatigue.
Other Meds: LO-OVRAL
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283548-1

17.0 F 21-Jun-2007 21-Jun-2007 0 02-Jul-2007 10-Jul-2007 PA 11-Jul-2007
MedDRA PT Dizziness, Dizziness, Presyncope
Symptom Text: Near syncopal episode, dizzy, lightheaded

Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283598-1

16.0 F 28-Jun-2007 Unknown 02-Jul-2007 08-Jul-2007 GA 09-Jul-2007
HEPAB GLAXOSMITHKLINE AHABB0686AA 0 Right arm Intramuscular
BIOLOGICALS
Symptom Text: twinrx given to a 16 yr old

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283605-1

23.0 F 02-Jul-2007 02-Jul-2007 0 02-Jul-2007 08-Jul-2007 NC 09-Jul-2007
HPV4 MERCK & CO. INC. ? 1 Left arm Intramuscular

MedDRA PT Asthenia, Dizziness, Nausea, Syncope
Symptom Text: Nausea, dizziness, weakness, fainted

Other Meds: Generic Birth Control
Lab Data: Normal blood pressure, pulse
History: no
Prex Illness: no
Prex Vax Illns:


20.0 F 07-Jun-2007 11-Jun-2007 4 02-Jul-2007 08-Jul-2007 FL 09-Jul-2007
HPV4 MERCK & CO. INC. 0522U 0 Gluteous maxima Intramuscular

MedDRA PT Hypoaesthesia, Injection site rash
Symptom Text: Administered dose of Gardasil 06/07/07 to right gluteus. Notified office, via telephone, on 06/11/07 of 3 episodes numbness in RLE and site rash since
injection. Went to ER 06/12/07 w/c/o RUE, RLE numbness.
Other Meds: Noncontributory
Lab Data: Noncontributory
History: Noncontributory
Prex Illness: None
Prex Vax Illns:


20.0 F 07-Jun-2007 11-Jun-2007 4 06-Aug-2007 09-Aug-2007 -- 09-Aug-2007

MedDRA PT Drug administered at inappropriate site, Injection site anaesthesia, Injection site rash, Pain in extremity
Symptom Text: Injection of Gardasil given to rt gluteus, as per office policy, on 06/07/07. On 06/11/07 notified office, via telephone, of rash at site and intermittent RLE
numbness -x 3 occasions- since injection. Told to f/u in office if persisted or go to ER for eval if worsened. Went to ER 06/12/07 w/c/o RUE and RLE pain,
numbness. Told by staff there that it could be related to recent injection and referred to Neuro for further evaluation.
Other Meds: None
Lab Data: Noncontributory
History: Noncontributory
Prex Illness:
Prex Vax Illns:

Vaers Id: 283644-1

31.0 F 10-May-2007 26-Mar-2007 -45 03-Jul-2007 05-Jul-2007 -- WAES0705USA02762 27-Jul-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Symptom Text: Initial and follow up information has been received through the Merck pregnancy registry, from a 31 year old female healthcare professional, who on 10-MAY-
2007 (previously reported as 30-APR-2007), was vaccinated intramuscularly with the second dose of Gardasil (Lot #657736/0389U), and recently found out
she was pregnant. The date of the LMP was reported as 26-MAR-2007, with an estimated delivery date on 31-DEC-2007. Unspecified medical attention was
sought. It was not known if the patient had been seen by OB/GYN. Follow up information from the healthcare professional, stated that she "had a miscarriage."
No further information or details were provided. Upon internal review, "had a miscarriage" was considered to be serious as an other significant medical event.
Other Meds: Unknown
Lab Data:
History:
Prex Vax Illns:

Vaers Id: 283645-1

14.0 F Unknown Unknown 03-Jul-2007 05-Jul-2007 PA WAES0706USA04875 05-Jul-2007

MedDRA PT Convulsion, Eye rolling, Loss of consciousness, Poor quality drug administered
Symptom Text: Information has been received from a nurse concerning a 14 year old female who was vaccinated with the second dose of the Gardasil (Lot # 658094/0524U)
on an unspecified date. It was reported that the patient experienced seizure like activity after receiving the vaccine. Her eyes rolled back in her head and briefly
lost consciousness. The patient sought unspecified medical attention. She recovered 40 minutes after injection. The nurse also reported that the refrigerator
where the vaccine was stored was "4 degrees colder than it should have been". Upon internal review, seizure-like activity was considered to be an other
important medical event. This report is one of two reports from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283646-1


MedDRA PT Convulsion, Eye rolling, Loss of consciousness, Poor quality drug administered
Symptom Text: Information has been received from a nurse concerning a 17 year old female who was vaccinated with the third dose of Gardasil on an unspecified date. It was
reported that the patient experienced seizure like activity after receiving the vaccine. Her eyes rolled back in her head and briefly lost consciousness. The
patient sought unspecified medical attention. She recovered 40 minutes after injection. The nurse also reported that the refrigerator where the vaccine was
stored was "4 degrees colder than it should have been". Upon internal review, seizure-like activity was considered to be an other important medical event. This
report is one of two reports from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283647-1

26.0 F 06-Jun-2007 06-Jun-2007 0 03-Jul-2007 05-Jul-2007 MD WAES0706USA05185 05-Jul-2007

MedDRA PT Dizziness, Grand mal convulsion, Urinary incontinence
Symptom Text: Information has been received from a healthcare professional concerning a 26 year old female who received a first dose of Gardasil (lot # 657005/0314U) IM
into the left deltoid on 06-Jun-2007. Five minutes later she felt lightheaded and experienced a tonic-clonic seizure and urinary incontinence that lasted 1-2
minutes in duration. She was awake, alert and oriented X 3 post event. Upon internal review tonic clonic seizure was considered to be an other important
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283648-1 (S)

18.0 F 21-Jun-2007 21-Jun-2007 0 03-Jul-2007 05-Jul-2007 CT WAES0706USA04917 05-Jul-2007

MedDRA PT Dyspnoea, Mobility decreased, Paraesthesia oral, Sensation of heaviness
Symptom Text: Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history who on 16-APR-2007 was
vaccinated with 0.5 ml of the first dose of the Gardasil. On 21-JUN-2007 at 8:45 am, the patient was vaccinated intramuscularly with 0.5 ml of the second dose
of Gardasil (Lot # 658100/0525U). There was no concomitant medication. A laboratory pregnancy test was performed and the result was negative. On 21-JUN-
2007, at noon, the patient experienced shortness of breath, intermittent tingling of the lips and the feeling of her arm being heavy and difficult to lift. The motion
of the patient's arm had gotten worse since 21-JUN-2007 and she found it difficult to do her hair because of the arm. Patient was scheduled to be evaluated at
her physician's office on 26-JUN-2007. At the time of the report, the patient's shortness of breath, intermittent tingling of the lips, and feeling of her arm being
heavy and difficult to lift persisted. The medical assistant considered the shortness of breath, intermittent tingling of the lips and feeling of her arm being heavy
and difficult to lift to be a disabling event. Additional information has been requested.
Other Meds: None
Lab Data: beta-human chorionic 06/21?/07 - negative
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 283658-1

17.0 F 22-Jun-2007 23-Jun-2007 1 03-Jul-2007 11-Jul-2007 CA 12-Jul-2007
TDAP SANOFI PASTEUR C2731AA Right arm Intramuscular
MedDRA PT Pain, Pruritus, Swelling
Symptom Text: Swelling and itching and pain 5/10

Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283665-1

19.0 F 11-May-2007 11-May-2007 0 03-Jul-2007 08-Jul-2007 NY 09-Jul-2007

MedDRA PT Menorrhagia
Symptom Text: Within hours of receiving the first HPV Gardasil shot, my daughter experienced irregular menstrual bleeding for 7 days. She had just had her regular menstrual
cycle 2 weeks prior to the vaccination.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283672-1

26.0 F 11-Jun-2007 11-Jun-2007 0 03-Jul-2007 08-Jul-2007 NC 09-Jul-2007

MedDRA PT Discomfort, Dizziness, Injection site irritation, Injection site irritation, Injection site pain, Nausea
Symptom Text: Intense pain and burning sensation at injection site that occurred 3 hours after vaccination was given. Pain and burning made me dizzy and nauseated. The
discomfort lasted about 30 minutes and the injection site remained sore for 4 days.
Other Meds:
Lab Data:
History: allergic to sulfa
Prex Illness:
Prex Vax Illns:


13.0 F 03-Jul-2007 03-Jul-2007 0 04-Jul-2007 08-Jul-2007 SC 09-Jul-2007
HPV UNKNOWN MANUFACTURER UNKNOWN 0 Right arm Unknown

MedDRA PT Pruritus, Rash, Urticaria
Symptom Text: Broke out in hives and large patchy spots over her body with sever itching. She was take to the hospital where they gave her a eppy pin injection and benedryl.
Other Meds: Malarone 250-100 mg tablet GSK
Lab Data:
History: allergies to turkey, lamb, lobster
Prex Illness: stye on right eye
Prex Vax Illns:


13.0 F 03-Jul-2007 03-Jul-2007 0 06-Jul-2007 16-Jul-2007 SC 17-Jul-2007

MedDRA PT Arthralgia, Hordeolum, Oedema peripheral, Urticaria
Symptom Text: Sore knees swollen right hand and hives on the arms to ER and got Epi. Patient was put on Benadryl 50 mg q 6 hr for 12 hours. Patient just returned from trip
to Africa. Patient was taking Malarone 250-100 mg tablet. Patient had right eye chalazion (stye)
Other Meds: Eye drops, Malarone Polytrim Opthalmic
Lab Data: patient has sore knees Rheumatoid Factor C3, C4 and ANA were down
History: Allergic Rhinitis
Prex Illness: Chazlion Allergic Rhinitis
Prex Vax Illns:

Vaers Id: 283732-1

20.0 F 08-Mar-2007 10-Mar-2007 2 18-Jun-2007 20-Jul-2007 NY WAES0703USA03940 20-Jul-2007

MedDRA PT Urticaria
Symptom Text: Information has been received from a registered nurse in a physician's office concerning a 20 year old patient with an allergy to sulfamethoxazole (+)
trimethoprim who on 08-MAR-2007 was vaccinated with a first dose of Gardasil (lot # 655618/0186U) in the left deltoid at 11:00 AM. The nurse reported that the
patient had received the second dose late (second dose was given on "01-OCT-2007"). No adverse experience is related to this event. No other information
was available at the time of reporting. Additional information was received. Conflicting information was received regarding the number of doses of vaccine that
the patient had received. The reporter indicated that this was the first dose of vaccine. On 10-MAR-2007, the patient experienced hives. On an unspecified
date, the patient recovered. The reporter felt that the hives were serious medical intervention was required (Other Important Medical Event). No additional
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 283825-1

13.0 F 25-May-2007 26-May-2007 1 05-Jul-2007 06-Jul-2007 FR WAES0706USA05283 06-Jul-2007

MedDRA PT Fatigue, Hypersomnia, Somnolence
Symptom Text: Information has been received from a health professional concerning a 13 year old female who on 25-MAY-2007 was vaccinated with a first dose of Gardasil.
On 26-MAY-2007 the patient experienced severe fatigue that was still ongoing one month after vaccination. It was also reported that the girl slept a lot and
sometimes fell asleep during the day. The girl used to have a lively character. It was also reported that according to the GP it was not likely that the vaccination
caused the fatigue however it could not be ruled out. Other underlying causes were under investigation and test for Lyme's disease and Pfiffer's disease were
negative. At the time of this report, the patient had not recovered. Fatigue and slept a lot were considered to be other important medical events. Other business
partner numbers include: E200704170. No further information is available.
Other Meds: Unknown
Lab Data: diagnostic laboratory test Pfieffer's disease negative, Lyme disease assay negative
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283826-1

17.0 F 03-May-2007 21-May-2007 18 05-Jul-2007 06-Jul-2007 KS WAES0705USA04344 06-Jul-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Metrorrhagia, Thrombosis
Symptom Text: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 17 year old female patient with folliculitis, genital
condyloma and no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655618/0186U). On 03-MAY-
2007 the patient received a second dose of Gardasil (Lot# 657621/0387U). Concomitant therapy included, AUGMENTIN and trichloroacetic acid. The patient
stated her last menstrual period was 15-APR-2007. The nurse reported that the patient kept changing the date at each visit. The patient was sent to an
OB/GYN and it was determined that she was 4 weeks pregnant as of 21-MAY-2007. Diagnostic laboratory studies performed were an ultrasound on 21-MAY-
2007 due to clotting/spotting which resulted as 5 week gestational sac. On 25-MAY-2007 and 30-MAY-2007, HCG quantitative test were performed which
resulted as 2231 and 118, respectively. The nurse mentioned that the patient has not experienced any difficulties with the pregnancy as this time. On 27-MAY-
2007, it was reported that the patient had a spontaneous abortion. She was 6 weeks from LMP. Unspecified medical attention was sought. At the time of this
report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, spontaneous abortion was considered to be an
other important medical event. Additional information is not expected.
Other Meds: AUGMENTIN mg, trichloroacetic acid
Lab Data: Ultrasound 05/21/07 - 5 week gestational sac Reason for test was clotting/spotting, total serum human 05/25/07 - 2231, total serum human 05/30/07 - 118
History:
Prex Illness: Pregnancy NOS (LMP = 4/15/2007) Folliculitis; Genital wart
Prex Vax Illns:

Vaers Id: 283827-1 (S)

16.0 F 13-Jun-2007 14-Jun-2007 1 05-Jul-2007 06-Jul-2007 FR WAES0706USA05134 06-Jul-2007

MedDRA PT Borrelia burgdorferi serology negative, Facial palsy
Symptom Text: Information has been received from a physician (general practitioner), concerning a 16 year old female patient, who on 13-JUN-2007 was vaccinated IM in the
left deltoid, with the first dose of Gardasil (Batch NF13760). On 14-JUN-2007, one day following vaccination, the patient developed facial paralysis. On 18-JUN-
2007, she was hospitalized for evaluation and diagnostics; serology testing including borrelia, was negative. At the time of this report the patient had not
recovered, but it was noted that on 22-JUN-2007, she had only "discrete symptoms." No further information is available. Other business partner number
included: E2007-04121.
Other Meds: Unknown
Lab Data: clinical serology test 18?Jun07 negative
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283838-1

16.0 F 26-Jun-2007 Unknown 05-Jul-2007 12-Jul-2007 GA 12-Jul-2007
MedDRA PT Injection site erythema, Injection site haemorrhage, Injection site swelling
Symptom Text: 6/26/07 Child received booster Varicella vaccine on 6/28/07 RTC for red swollen L arm at injection site 1 1/2 cm ecchymosis around site, 2" redness around
site. Advised to ice area and take Ibuprofen
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283840-1


MedDRA PT Erythema, Rash, Skin warm, Swelling face, Urticaria
Symptom Text: Warmth, swelling, rash of face within minutes of receiving HPV vaccine. Reported there signs and symptoms about 2 hours later. Appearance at time of RX
facial redness, swelling, urticaria. Treated with Benadryl PO, Prednisone PO, ranitidine PO.
Other Meds: B complex tabs, Yasmin, Lactaid, Topicort
Lab Data:
History: Lactose intolerance, environmental allergen, Xerosis
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283841-1

16.0 F Unknown Unknown 05-Jul-2007 12-Jul-2007 WV 12-Jul-2007

MedDRA PT Incorrect dose administered, No adverse effect
Symptom Text: No adverse event occurred. Advised by CDC phone contact to report that she had received additional vaccine at another facility.
Other Meds:
Lab Data: none
History: No allergies
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283844-1

16.0 F 28-Jun-2007 28-Jun-2007 0 05-Jul-2007 12-Jul-2007 NH 12-Jul-2007

MedDRA PT Pallor, Syncope
Symptom Text: Pt was noted to be pale, pt fainted. Brought in room in lay. BP checked, Pulse checked. MD notified and checked Pt after resting BP elevated to normal. Pt
released with mother to drive.
Other Meds:
Lab Data: Vitals
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283845-1

16.0 F 27-Jun-2007 27-Jun-2007 0 05-Jul-2007 12-Jul-2007 CO 12-Jul-2007
HPV4 MERCK & CO. INC. 0524C 0 Right arm Intramuscular
MedDRA PT Clonus, Dizziness, Head injury, Hypotension, Pallor
Symptom Text: Within a couple minutes of admin, she verbalized she felt faint, slumped and hit head against exam table mirror, became pale, clonic arm movements x 4 per
mom. Administered O2, elevated feet gave water, pretzels. Hypotensive in ER where she was sent with 1 hour in office.
Other Meds: Singulair, Albuterol
Lab Data: CBC WNL, EKG WNL, D-Dimer <.22 WNL
History: Stable exercise induced asthma, Allergic garamycin
Prex Illness:
Prex Vax Illns:

Vaers Id: 283846-1

BIOLOGICALS
Symptom Text: 10-12 cm of erythema, mildly swollen and warm at site of Varicella injection
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283850-1

14.0 F 25-Jun-2007 25-Jun-2007 0 05-Jul-2007 12-Jul-2007 MI 12-Jul-2007
VARCEL MERCK & CO. INC. 0364U Left arm Subcutaneously
TDAP SANOFI PASTEUR C2492BA Right arm Intramuscular
HPV4 MERCK & CO. INC. 0962F Left arm Intramuscular
MNQ SANOFI PASTEUR U2139AA Right arm Intramuscular
MedDRA PT Deafness, Dizziness, Hyperhidrosis, Pallor
Symptom Text: After administering the HPV vaccine, the patient lost her hearing, became dizzy and broke out in a sweat, pale. I had to wait to give the rest of the vaccines.
Patient laid down on exam table - drank some water and had cool cloth to the head. After 10 min - she was ok.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283856-1

13.0 F 11-Jun-2007 02-Jul-2007 21 05-Jul-2007 12-Jul-2007 ME 12-Jul-2007
MedDRA PT Pyrexia, Rash papular
Symptom Text: papules on back noted on 07/02/07 low grade fever.

Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283857-1

TDAP SANOFI PASTEUR C2720 0 Left arm Unknown
HPV4 MERCK & CO. INC. 0524V 0 Right arm Unknown
MedDRA PT Hyperhidrosis, Pallor
Symptom Text: Pt became pale, diaphoretic, after vaccine administered was given, sitting down, had not eaten all day BP 102/68 - 112/80 O2 98-100%.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 283893-1

18.0 F 14-Jun-2007 15-Jun-2007 1 05-Jul-2007 08-Jul-2007 NC 09-Jul-2007
MedDRA PT Asthenia, Facial palsy, Fatigue, Gait disturbance, Guillain-Barre syndrome, Headache, Heart rate increased, Muscular weakness, Muscular weakness,
Myalgia, Paraesthesia
Symptom Text: Guillain-Barre Syndrome. Within 24 hours of receiving HPV shot, patient experienced headache and extreme fatigue and weakness. Muscle weakness began
in legs and progressed to arms, head and neck. Tingling in hands and feet. Intense muscle pain in thighs, hips, and arms. By ninth day, patient's facial muscles
were drooping, experiencing rapid heartbeat and dragging right foot when trying to walk. By end of week 2 muscle function had returned and patient was
recovering. Extreme fatigue still remains.
Other Meds: Cymbalta
Lab Data: EMS, 1 abnormal nerve response in right leg.
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 283896-1

11.0 F 03-Jul-2007 04-Jul-2007 1 05-Jul-2007 08-Jul-2007 GA 09-Jul-2007
MNQ SANOFI PASTEUR U2B2UAA 0 Right arm Intramuscular
TDAP GLAXOSMITHKLINE AC52B0118BA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Erythema, Neck pain, Tenderness
Symptom Text: 6CM AREA OF ERYTHEMA, TENDERNESS TO LEFT ARM. SLIGHT NECK PAIN, BUT FULL RANGE OF MOTION
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


17.0 F 17-May-2007 01-Jun-2007 15 05-Jul-2007 08-Jul-2007 AR 08-Jul-2007

MedDRA PT Hypoaesthesia, Hypoaesthesia, Paraesthesia
Symptom Text: Two weeks after the Gardasil vaccine was administered, began complaining of tingling in her feet. It rapidly progressed to numbness in the feet, and now it is
tingling all the way up to her waist. We are worried sick. We have visited our primary care physician and done blood work and a nerve conduction test, all with
"normal" results. Our next step will be to consult a neurologist.
Other Meds: None, although Pamela did have a UTI infection the week before, and had her wisdom teeth out 5/30/07, and was on an antibiotic for this as well.
Lab Data: Nerve conduction testBlood work (not sure what was done)
History: None
Prex Illness: None
Prex Vax Illns:


17.0 F 17-May-2007 01-Jun-2007 15 20-Jul-2007 10-Aug-2007 AR 10-Aug-2007

Symptom Text: diagnosed with Guillian Barre by neurologist after 1 doses of Gardasil no hospitalization required.
Other Meds: NONE
Lab Data: No pregnancy
History: NO
Prex Illness: NO
Prex Vax Illns:


18.0 F 17-May-2007 01-Jun-2007 15 09-Aug-2007 10-Aug-2007 AR WAES0707USA03494 13-Aug-2007

MedDRA PT Guillain-Barre syndrome, Paralysis
Symptom Text: Initial and follow up information has been received from a nurse concerning an 18 year old female with no pertinent medical history who on 17-MAY-2007 was
vaccinated with a first dose of Gardasil (lot #657622/0388U). Subsequently, the patient developed unspecified paralysis and was referred to a local neurologist.
The patient's symptoms were severe enough that the patient felt she needed immediate care. The patient wanted to be seen sooner so she found a different
neurologist who diagnosed the patient with Guillain Barre Syndrome (GBS). GBS onset date was on 01-JUN-2007. At the time of the report the patient was
recovering. Upon internal review GBS and paralysis were considered to be another important medical event. Additional information is not expected.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283917-1

10.0 F 29-Jun-2007 Unknown 05-Jul-2007 16-Jul-2007 MA 16-Jul-2007
Symptom Text: Patient and parent noticed right arm swelling after immunization.
Other Meds: None
Lab Data: None
History:
Prex Illness: Well child exam
Prex Vax Illns:

Vaers Id: 283967-1

23.0 F 08-Feb-2007 08-Feb-2007 0 18-Jun-2007 20-Jul-2007 FL WAES0705USA02912 20-Jul-2007

Symptom Text: Information has been received from a nurse concerning a 23 year old female patient who on 08-FEB-2007 was vaccinated with a first dose of Gardasil lot
#654702/0011U. She received the second dose of Gardasil on an unspecified date. Concomitant therapy included azathioprine (IMURAN (azathioprine)),
ethinyl estradiol (+) levonorgestrel (SEASONALE) and balsalazide disodium (COLAZAL). On 08-FEB-2007 later that day patient experienced nausea and
vomiting. She was seen in the emergency room (ER) that night. She was treated with an unnamed antinausea medication and intravenous fluids. She was sent
home later. She had no adverse symptoms after the second injection. The patient recovered. The reporter felt that getting unnamed antinausea medication and
intravenous fluids was to prevent patient from being serious and considered this as a serious other medical event. Additional information has been requested.
Other Meds: Imuran (Azathioprine), Colazal, Seasonale
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283989-1

Unknown F Unknown Unknown 06-Jul-2007 09-Jul-2007 LA WAES0706USA05151 09-Jul-2007

MedDRA PT Convulsion, Fall
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently,
the patient fell down and had a seizure. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product
quality complaint was involved. upon internal review, seizure was considered to be an other important medical event. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 283996-1

11.0 M 19-Jun-2007 19-Jun-2007 0 06-Jul-2007 16-Jul-2007 TX 16-Jul-2007
TDAP SANOFI PASTEUR C2638AA 0 Unknown Intramuscular
HEP GLAXOSMITHKLINE AHBVB37AAE 3 Unknown Intramuscular
BIOLOGICALS
MMR MERCK & CO. INC. 0099U 2 Unknown Subcutaneously
MedDRA PT No adverse effect, Wrong drug administered
Symptom Text: No evidence of side effects, HPV vaccine given

Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 283997-1

13.0 F 18-Jun-2007 19-Jun-2007 1 06-Jul-2007 16-Jul-2007 TX 16-Jul-2007
VARCEL MERCK & CO. INC. 05U5U Right arm Subcutaneously
MNQ SANOFI PASTEUR 42208AA 0 Right arm Unknown
MedDRA PT Anorexia, Dizziness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction, Muscular weakness, Pyrexia
Symptom Text: injection site RXN - 8-8.5 annular, raised erythematous lesion, painful, pruritic to R arm systemic RX - lower limb weakness, dizziness, loss of appetite, fever.
Other Meds: Dytancs, Motrin, Westcort
Lab Data:
History: Asthma
Prex Illness: Upper respiratory infection
Prex Vax Illns:

Vaers Id: 284003-1

21.0 F 02-Jul-2007 02-Jul-2007 0 06-Jul-2007 16-Jul-2007 NH 16-Jul-2007

MedDRA PT Discomfort, Dizziness, Hyperhidrosis, Immediate post-injection reaction
Symptom Text: Within one minute of administering vaccine, Pt became light headed and sweaty. She was made to lie down and her feet elevated for 15 mins. She was given
fruit juice to drink. Discomfort lasted about 5 mins.
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284005-1

VARCEL MERCK & CO. INC. 0644U Left arm Subcutaneously
MedDRA PT Injection site pruritus, Injection site swelling
Symptom Text: Pt states she noticed arm swelling (L) arm 6/28/07 in the evening w/slight itching
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284013-1

14.0 F 25-Jun-2007 28-Jun-2007 3 06-Jul-2007 12-Jul-2007 NY 13-Jul-2007
MedDRA PT Erythema, Tenderness
Symptom Text: Red, hard, tender over right tricep --> 4-5cm diameter. Reassurance ice pack/ Motrin.
Other Meds:
Lab Data: None
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284017-1

12.0 F 06-Jul-2007 06-Jul-2007 0 06-Jul-2007 09-Jul-2007 IL 09-Jul-2007

MedDRA PT Loss of consciousness, Syncope, Vomiting
Symptom Text: Within one minute of receiving HPV vaccine, pt. had a sycopal episode, with LOC for 1-2 minutes, immediately followed by vomiting. Pt. observed for 15 min.
and made complete recovery.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284038-1 (S)

18.0 F 13-Jun-2007 01-Jul-2007 18 08-Jul-2007 11-Jul-2007 IL 20-Jul-2007
HPV4 MERCK & CO. INC. NULL 1 Right arm Unknown
MedDRA PT Choking, Convulsion, Decreased appetite, Dizziness, Eye disorder, Fatigue, Fatigue, Grand mal convulsion, Headache, Muscle contractions involuntary,
Muscle rigidity, Nausea, Pharyngolaryngeal pain, Pyrexia, Respiratory arrest, Syncope, Vomiting
Symptom Text: My daughter received her first does of Gardasil on April 19, 2007 she felt feverish minutes after and developed a sore throat the same day. The next day she
complained of a headache and contined to complain of headaches for the next 2 months. Also my daughter had a large decrease in appetite,dizziness, nausea
and fatigue that she had never felt before. On June 13, 2007 my daughter had the second dose of Gardasil. She again felt feverish, tired and complained of a
sore throat once again. The headaches increased within a few days of the second shot. She also told me she felt "slower" than normal and that she had to
think about things before doing them, like typing and using her cell phone. On July 1, 2007 my daughter said she had a "horrible" headache, with in 15 minutes
of saying this she fainted and stopped breathing. I had to give her mouth to mouth to get her breathing again. My daughter then had 2 back to back seizures.
Her entire body became ridgid with her hands and arms raising and all her muscles contracting. Her eyes seem to pop out of her head. She began to choke
and was unable to breath. I again gave her a breath of air and she then began to vomit and a few minutes later she came to. An ambulance took her to the
hospital where a cat scan, MRI/MRA and EEG tests were negative. Blood work showed a slightly raised pottasium level and small amounts of vicodin(last dose
taken 3 days before seizure) which she was taking for an unrelated arm injury. Urine tests were also normal and a strep test was negative. There is no family
history or seizures and my daughter was healthy until she received the Gardasil shots. 07/16/2007 MR received for o/n hospital stay 7/1/2007 for c/o
generalized tonoclonic seizure activity seen after pt fell to floor. Pt c/o post-ictal H/A as well as H/A prior to seizure. PE WNL. Neuro consult with Impression
of new Onset Seizure Disorder, etiology not clear.
Other Meds: vicodin for unrelated arm injury
Lab Data: Cat scan, MRI/MRA, EEG, Blood work, urine tests, step test. Labs and Diagnostics: Brain CT (-). CBC unremarkable. MRAs unremarkable. MRI-no
intracranial abnormalities. R shoulder X-ray WNL. EEG normal. Throat swab (-) for strep. West Ni
History: thoracic outlet syndrome of left arm PMH: Thoracic Outlet Obstruction. Allergies: Codeine and Naprosyn.
Prex Illness: none
Prex Vax Illns: none other than gardasil~ ()~~0~In Patient

Vaers Id: 284042-1

13.0 F 05-Jul-2007 06-Jul-2007 1 06-Jul-2007 12-Jul-2007 NV 13-Jul-2007

MedDRA PT Urticaria
Symptom Text: A hive type rash on her neck, both legs, both arms, elbow about 24 hours. Treatment: 50mg Benadryl Q6 PRN after 3rd HPV, urticaria type rash.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284086-1

16.0 F 25-Apr-2007 25-Apr-2007 0 09-Jul-2007 19-Jul-2007 MT 06-Aug-2007
MNQ SANOFI PASTEUR U2002AC 0 Right arm Intramuscular
MedDRA PT Gait disturbance, Lip swelling, Oedema peripheral, Oedema peripheral, Skin lesion, Skin warm, Swelling face
Symptom Text: The evening after receiving HPV, swelling of hands, pink warm splotches on her hands, fingers and extremities, lesions waxed and waned through the night.
Ended up having swelling of hands, feet and face the next several days making it hard to walk. Lip swollen, used Claritin and Benadryl.
Other Meds: None
Lab Data:
History: None - family Hx of rheumatoid arthritis/Lupus
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284100-1

18.0 F 26-Jun-2007 26-Jun-2007 0 09-Jul-2007 10-Jul-2007 AL WAES0706USA05121 10-Jul-2007

Symptom Text: Information has been received from a licensed practical nurse concerning an 18 year old female with gastrooesophageal reflux, depression and a penicillin
allergy who on 26-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of the Gardasil (Lot # 658094/0524U). Concomitant therapy included
LEXAPRO, SEASONALE and PROTONIX. Forty minutes after receiving the vaccination, the patient developed widespread hives and itching. The patient was
evaluated in the local emergency room and was given intravenous steroid treatment. The patient was not admitted to the hospital. No laboratory or diagnostic
tests were performed. The patient outcome was unknown. The licensed practical nurse considered the widespread hives and itching to be other important
medical events. Additional information has been requested.
Other Meds: LEXAPRO, SEASONALE, PROTONIX
Lab Data: None
History:
Prex Illness: Gastrooesophageal reflux; Depression; Penicillin allergy
Prex Vax Illns:

Vaers Id: 284101-1 (S)

19.0 F Unknown Unknown 09-Jul-2007 10-Jul-2007 FR WAES0707USA00445 10-Jul-2007

MedDRA PT Epistaxis, Pyrexia
Symptom Text: Information has been received from a 19 year old female consumer, who on an unspecified date was vaccinated with the third dose of Gardasil (Lot and Bach #
not provided). Subsequently, the patient developed a nosebleed and a fever (value not specified). The consumer visited the ER, as the nose bleed did not
resolve; it was indicated that she was hospitalized (dated and duration not provided). Subsequently, the patient recovered from the nosebleed and fever
(treatment and duration not reported). Additional information has been requested. Other business partner numbers include: E2007-04260.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284118-1

20.0 F 03-Jul-2007 04-Jul-2007 1 09-Jul-2007 11-Jul-2007 MI 11-Jul-2007

MedDRA PT Abdominal pain upper, Back pain, Nausea, Vomiting
Symptom Text: Client reports severe back pain and stomach pain, N&V on Wednesday July 4th starting in the afternoon and persisted until today and still effecting her. Went
to the ER and had a urine sample given and a x-ray of her back (urine was negative. Awaiting results for x-ray.
Other Meds: Zantac and Miralax
Lab Data:
History: take's Zantac and Miralax. History of "stomach problems"
Prex Illness: none
Prex Vax Illns:

Vaers Id: 284142-1

13.0 F 20-Oct-2006 08-Jan-2007 80 18-Jun-2007 24-Jul-2007 CO WAES0705USA03261 07-Aug-2007

MedDRA PT Pharyngitis, Viral pharyngitis
Symptom Text: Information has been received from a medical assistant concerning a 13 year old female patient with an amoxicillin allergy and no medical history, who on 20-
OCT-2006 was vaccinated IM into the upper arm with a first dose of Gardasil (Lot# 653978/0955F). Concomitant therapy included montelukast sodium (MSD)
and albuterol. It was reported that the patient got off the recommended dosing schedule because she was sick. On 05-JAN-2007 the patient was diagnosed
with pharyngitis (likely viral). The patient was told to take zinc and homeopathic medicine called "INFLAMMATION by Heal." On 08-JAN-2007, laboratory
diagnostic studies included a strep test and culture that was negative. On 12-JAN-2007, the patient was seen again and was diagnosed with pharyngitis and a
possible ear infection and was given a homeopathic medicine called ("EUPHORIM"), a nasal spray. On 01-FEB-2007 the patient came in for a second dose of
the vaccine (lot # 654702/0011U). It was reported that the patient no longer had an infection and subsequently recovered. No product quality complaint was
Lab Data: Streptococcus oralis, 01/08/07, stret test and culture negative
Prex Illness:
Prex Vax Illns:

Vaers Id: 284169-1


MedDRA PT Dizziness
Symptom Text: Information has been received from a registered nurse (RN), via a company representative, concerning the RN's 13 year old daughter, who in May 2007, was
vaccinated IM, with the first dose, 0.5ml, of Gardasil. The nurse reported that her daughter experienced dizziness after receiving the vaccination, and then
recovered (duration not specified). The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284170-1


MedDRA PT No reaction on previous exposure to drug, Rash
Symptom Text: Information has been received from a physician concerning an 18 year old female with no allergies, who on 15-MAY-2007 was vaccinated with a second 0.5 ml
dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 17-MAY-2007, the patient developed a small fine rash. It was
reported that on 15-MAR-2007, the patient received a first dose of Gardasil and did not experience any adverse event. Unspecified medical attention was
sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284171-1

Unknown F Unknown Unknown 18-Jun-2007 16-Jul-2007 FL WAES0705USA03914 17-Jul-2007

Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first 0.5 ml dose of Gardasil. Two days later, the patient
developed a full body rash. The patient's full body rash persisted. Unspecified medical attention was sought. At the time of this report, the patient had not
recovered. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284172-1

11.0 F Unknown Unknown 18-Jun-2007 16-Jul-2007 OR WAES0705USA03941 17-Jul-2007

MedDRA PT Immediate post-injection reaction, Loss of consciousness
Symptom Text: Information has been received from a physician concerning an 11 year old female who was vaccinated with Gardasil. It was reported that the patient passed
out 'almost immediately" after receiving the vaccine. No lot number was provided. The patient sought unspecified medical attention. The patient had her blood
pressure measured. It was reported that the "patient was fine". Additional information has been requested.
Other Meds: Unknown
Lab Data: blood pressure
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284173-1

34.0 F 04-Apr-2007 21-May-2007 47 18-Jun-2007 16-Jul-2007 IN WAES0705USA03949 02-Aug-2007

MedDRA PT Injection site reaction, Myalgia
Symptom Text: Information has been received from an approximately 34 year old female with an allergy to artificial sweeteners who on an unspecified dates, was vaccinated
with the first and second doses of Gardasil. The date that therapy was started was "about 6 months prior to receiving the third dose. On 04-APR-2007, the
patient was vaccinated with the third dose of vaccine by injection. Concomitant therapy included Yasmin. On an unspecified date, the patient experienced
muscle soreness after being vaccinated. On 21-MAY-2007, all three injection sites became visible. The patient thought it might be due to being out in the sun
and being involved in physical activity. She sought unspecified medical attention. At the time of reporting, the patient was recovering. No further information
was provided. Additional information has been requested.
Other Meds: YASMIN, MAXALT (RIZATRIPTAN BENZOATE)
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 284174-1

Unknown F Unknown Unknown 18-Jun-2007 16-Jul-2007 -- WAES0705USA03981 17-Jul-2007

MedDRA PT Headache
Symptom Text: Information has been received from a nurse practitioner, concerning her friend's daughter, an adolescent female who was vaccinated (date and dose not
specified) with a dose of Gardasil. Following the vaccination, the adolescent experienced a headache which lasted about 2 hours. No further information is
expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284175-1


MedDRA PT Musculoskeletal pain
Symptom Text: Information has been received from a physician concerning a female with drug hypersensitivity to codeine who on 09-MAY-2007 was vaccinated with Gardasil.
Concomitant therapy included Seasonale. In May 2007, the patient experienced left shoulder pain. An MRI showed that there was a focal fluid collected along
the facial plane at the deltoid and infraspinatus muscle. The patient was treated with Advil and Aleve. The patient had begun to get some relief on 22-MAY-
2007 but the pain had not resolved. No further details were provided. Additional information has been requested.
Other Meds: SEASONALE
Lab Data: magnetic resonance 05/??/07 - focal fluid collected along the facial plane deltoid and infraspinatus muscle
History:
Prex Vax Illns:

Vaers Id: 284176-1

21.0 F 19-Apr-2007 19-Apr-2007 0 18-Jun-2007 16-Jul-2007 -- WAES0705USA04020 17-Jul-2007

MedDRA PT Injected limb mobility decreased, Injection site discomfort, Mobility decreased, Myalgia, Pain in extremity
Symptom Text: Information has been received from a nurse concerning a 21 year old female who on 19-APR-2007 was vaccinated with Gardasil (Lot#657622/0388U). On 19-
APR-2007 the patient experienced deep muscle pain, her arm still hurts and she cannot lift her arm to dress. It was reported that the patient sought unspecified
medical attention. No further details were provided. Follow up information provided by a medical professional stated that on 02-MAY-2007 the patient had daily
discomfort only in her deltoid where the injection had been given. At the time of this report it was reported that the patient had not recovered from the
discomfort. Additional information has been requested.
Other Meds: LO/OVRAL
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284177-1

17.0 F 20-Mar-2007 20-Mar-2007 0 18-Jun-2007 16-Jul-2007 PA WAES0705USA04027 17-Jul-2007

MedDRA PT Drug exposure during pregnancy, No adverse effect
Symptom Text: Information has been received from a physician and the consumer for the Pregnancy Registry for Gardasil concerning a 17 year old female with no pertinent
medical history or drug reactions/allergies who on 20-MAR-2007 was vaccinated with first dose of Gardasil (lot number unknown) 0.5 mL injection. Concomitant
therapy included vitamins (unspecified). The patient found out that she became pregnant on 25-MAR-2007. The patient sought medical attention. No ill effects
were reported at this time. the estimated date of delivery is 30-DEC-2007. No further details were provided. Additional information has been requested.
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 284178-1

17.0 F 27-Apr-2007 18-May-2007 21 18-Jun-2007 16-Jul-2007 -- WAES0705USA04028 17-Jul-2007

MedDRA PT Injection site induration, Injection site pain, Injection site warmth
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 09-FEB-2007 was vaccinated with Gardasil (Lot #655205/1426F). On
27-APR-2007 the patient received her second dose of Gardasil (Lot #655619/1427F) which was given in her left upper arm. Concomitant therapy included
medroxyprogesterone acetate (DEPE-PROVERA) which was given to the patient on 27-APR-2007 in the right arm. It was reported that the patient did not
experience any adverse effects with the first dose of the vaccine of Gardasil. However, on approximately 18-MAY-2007 the patient experienced warmth, pain
and hardness at the injection site where Gardasil was given. It was reported that the patient sought unspecified medical attention. No further details were
provided. Additional information has been requested.
Other Meds: DEPO-PROVERA
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284179-1

Unknown F 01-Apr-2007 Unknown 18-Jun-2007 18-Jul-2007 -- WAES0705USA04044 19-Jul-2007

Symptom Text: Information has been received from a medical assistant concerning herself who was vaccinated with two doses of Gardasil. Subsequently she experienced
amenorrhea after each of the 2 doses of Gardasil she received. The first time the patient didn't have her menses for 6 to 8 weeks and now she has not had her
menses since her most recent injection in April 2007. The patient took home pregnancy tests both times and was not pregnant. Lot number was not provided. It
was reported that the patient sought unspecified medical attention. The patient has not recovered. No further details were provided. The medical assistant also
reported that another patient had a similar experience which is reported in WAES # 0705USA04921. Additional information has been requested.
Other Meds: Unknown
Lab Data: beta-human chorionic - negative, beta-human chorionic - negative
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284180-1

Unknown F Unknown Unknown 18-Jun-2007 16-Jul-2007 OH WAES0705USA04071 17-Jul-2007

Symptom Text: Information has been received from an office manager concerning about 20-30 females who were vaccinated with Gardasil and have complained about
injection site pain. Medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284181-1

Unknown F Unknown Unknown 18-Jun-2007 16-Jul-2007 MA WAES0705USA04074 17-Jul-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female with a history of fainting who was vaccinated with the first dose of Gardasil and fainted.
Medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Syncope
Prex Illness:
Prex Vax Illns:

Vaers Id: 284184-1

18.0 F 07-Jun-2007 07-Jun-2007 0 10-Jul-2007 11-Jul-2007 FR WAES0707AUS00055 11-Jul-2007

MedDRA PT Anaphylactic reaction, Feeling abnormal, Nausea, Pallor, Rash macular, Throat tightness, Urticaria
Symptom Text: Information has been received from the Department of health and Therapeutic Good Administration as part of a business agreement with follow-up information
on request by the Company received via a Line Listing from the department of Health. As part of the regular school-based immunisation program funded by the
government, on 07-JUN-2007 an 18 year old female was vaccinated with her second dose of Gardasil (Lot No. 655742/0138U, Batch No. J0800, Expiry date
07-AUG-2009). On 07-JUN-2007 there was no immediate reaction but minutes post vaccine she felt funny, nauseated, blotches were noted on her neck,
developed urticarial rash, tightness in throat and her colour was poor. It was stated that 0.5 ml adrenaline was given to the patient and she was sent to an
emergency department with no further treatment and the patient was discharged. This patient's event was considered as anaphylaxis by the health department.
Subsequently, the patient recovered from anaphylaxis. The reporter considered that anaphylaxis was probably related to with Gardasil. The original reporting
source was not provided. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284185-1


MedDRA PT Anaphylactic reaction, Anxiety, Dizziness, Rash macular, Throat tightness, Urticaria
Symptom Text: Information has been received from the Department of Health as part of a business agreement with follow-up information on request by the Company received
via a Line Listing from the Department of Health. As part of the regular school-based immunisation program funded by the government, on 21-JUN-2007 a 16
year old female was vaccinated with her second dose of Gardasil (Lot No. 655742/0138U, Batch No. J0800, Expiry date 07-AUG-2009). On 21-JUN-2007, 10
minutes post vaccine, the patient returned to the clinic with throat tightness, slight dizziness, urticarial blotchy rash across her face and upper chest and anxiety
was noted. It was stated that 0.5 ml adrenaline was given to the patient and she was sent to an emergency department. Subsequently, the patient recovered
from anaphylaxis. The reporter considered that anaphylaxis was probably related to therapy with Gardasil. The original reporting source was not provided.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284186-1


MedDRA PT Agitation, Anaphylactic reaction, Dyspnoea, Fall, Flushing, Nausea, Tachycardia, Unresponsive to stimuli
Symptom Text: Information has been received from the Department of Health, as part of a business agreement, with follow-up information received on request by the Company
year old female was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0800, expiry date 07-AUG-2009). Five minutes after being vaccinated with
Gardasil, the patient collapsed. Her face was flushed, spreading to her hairline, she was tachycardic and not responding. The patient became agitated,
nauseated and experienced mild shortness of breath. Subsequently, 0.5 ml of adrenaline was administered, with little effect, so the dose was repeated. The
patient was transferred to the emergency department of hospital and discharged PM, post EEG. The patient recovered from anaphylaxis. The reporter
considered that anaphylaxis was probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not
expected.
Other Meds: Unknown
Lab Data: electroencephalography 07Jun07
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284187-1

16.0 F 02-May-2007 02-May-2007 0 10-Jul-2007 11-Jul-2007 FR WAES0707AUS00058 11-Jul-2007

MedDRA PT Anaphylactic reaction, Dyspnoea, Immediate post-injection reaction, Nausea, Paraesthesia, Rash macular, Rash pruritic
via a Line Listing from the Department of Health. As part of the regular school-based immunisation program funded by the government, on 02-MAY-2007, a 16
year old female with a history of adrenaline received following a tetanus vaccination, was vaccinated with Gardasil as prophylaxis (Lot No. 655742/0138U),
Batch No. J0798, Expiry date 07-AUG-2009). Immediately post-vaccination, the patient felt nauseous, developed a blotchy, itchy rash on her face and
experienced laboured breathing. Adrenaline was administered and the patient improved. She was transferred to the emergency department of hospital.
Subsequently, one day post-vaccination, the patient was itchy all over her body and she experienced pins and needles in her hands. The patient recovered
from anaphylaxis. The reporter considered that anaphylaxis was probably related to therapy with Gardasil. The original reporting source was not provided.
Other Meds: Unknown
Lab Data: Unknown
History: Immediate post-injection reaction
Prex Illness:
Prex Vax Illns:

Vaers Id: 284188-1


MedDRA PT Anaphylactic reaction, Dizziness, Dizziness, Dyspnoea, Dyspnoea, Emotional distress, Nausea, Syncope vasovagal
year old female was vaccinated with her second dose of Gardasil (Lot No. 655742/0138U, Batch No. J0800, expiry date 07-AUG-2009) as prophylaxis. Five
minutes post-vaccination, the patient felt faint and dizzy. She was coherent and talking. The patient commenced to grab her neck and was gasping, distressed
and nauseous. The symptoms settled momentarily and then the difficulty breathing returned. Adrenaline 0.5 was administered and the patient was transferred
to the emergency department of hospital. The patient recovered. In the emergency department summary, "vasovagal" was reported rather than allergy. The
patient was also seen by her general physician. The reporter considered that anaphylaxis was possibly related to therapy with Gardasil. The original reporting
source was not provided. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284189-1

MedDRA PT Arrhythmia, Blood pressure decreased, Breath holding, Grand mal convulsion, Grand mal convulsion, Heart rate increased, Nausea, Syncope, Syncope
vasovagal, Unresponsive to stimuli, Vomiting
Symptom Text: Information has been received from a physician concerning a 13 year old female who on 26-JUN-2007 was vaccinated with a first dose of Gardasil ("batch #
NE47410") IM into the left deltoid muscle. On 26-JUN-2007, immediately post vaccination, the patient experienced a vasovagal convulsive syncope for a "short
time". She was unresponsive to verbal stimuli and her breath was held for a short time. Her blood pressure was decreased. She recovered. The episode was
not considered as serious by the reporter. On 26 and 29-JUN-2007, additional information was received from the girl's father who is a physician, too. Since
about 1 PM on 26-JUN-2007, the girl additionally complained about nausea and vomited. She recovered on 27-JUN-2007 in the evening. Additionally her pulse
was increased (96/min). On 28-JUN-2007, an electroencephalogram (EEG) was carried out and showed "alterations" (not specified). At that time, her pulse rate
was still increased (average 90/min). A cardiologic check up including ECG is scheduled for 02-JUL-2007. On 04-JUL-2007, the reporter was contacted by
phone. The case was upgrade to serious (other important medical events). The EEG showed "dysrhythmia" which might be a sign a "condition after
convulsion". Tonic-clonic convulsion was assumed. The results of the cardiologic check-up were pending. Other business numbers included: E2007-04114. No
further information is available.
Other Meds: Unknown
Lab Data: blood pressure measurement 26Jun07 decreased, electroencephalography 28Jun07 'alterations' not specified; dysrhythmia, total heartbeat count 27Jun07
96/min, total heartbeat count 28Jun07 avg. 90/min
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284190-1

Unknown F 02-May-2007 02-May-2007 0 10-Jul-2007 11-Jul-2007 FR WAES0707AUS00035 11-Jul-2007

MedDRA PT Abnormal behaviour, Confusional state, Drug toxicity, Immunisation reaction, Insomnia, Insomnia, Pruritus, Pruritus, Psychotic disorder, Speech disorder
Symptom Text: Information has been received from a parent via a blog web site concerning his daughter who on 02-MAY-2007 was vaccinated with Gardasil as part of the
regular school-based immunisation program funded by the government. In the evening of the vaccination on 02-MAY-2007, the female student started to
mumble erratically and started to make very disjointed comments and she found it difficult to sleep. She also complained of itchiness in her back in the morning
on 03-MAY-2007. The father stated that she became lost and confused, a very pale comparison to the daughter he was used to seeing. It was stated that she
used to be a modest, humble quiet, organised, kind and intelligent. The patient consulted a psychologist the next day to try to see what was wrong. The
psychologist was concerned with the responses that she made to his questions. The parents became extremely worried about her, undertaking urine and blood
tests as well as an MRI scan to the brain. Soon after, the school contacted the parents saying that they didn't want her to return unless she was psychiatrically
evaluated and that she would want her to return unless she was psychiatrically evaluated and that she would not harm herself or others. The patient's
conditions has steadily worsened and she recently had a more severe psychosis. For the first time "last night", on 11-JUN-2007, she did not sleep at all. She
has been on risperidone (Risperdal), which she started taking about 3 days ago, on approximately 08-JUN-2007, however her condition has been worsening.
The reporter stated that the treating physician believed that this was a classic example of a "major reaction of toxicity caused by a vaccine". The reporter felt
that severe psychosis were related to therapy with Gardasil. Upon internal medical review, severe psychosis was considered to be an Other Important Medical
Event. Additional information is not expected.
Other Meds: Unknown
Lab Data: diagnostic laboratory test ??May07, magnetic resonance imaging ??May07, urinalysis ??May07
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284191-1

Unknown F Unknown Unknown 10-Jul-2007 11-Jul-2007 FR WAES0707AUS00034 11-Jul-2007

Symptom Text: Information has been received from the Department of Health as part of a business agreement, concerning a female school student, aged between 13 and 17
years of age, who was vaccinated with Gardasil as part of the regular school-based immunisation program funded by the government. The patient was
vaccinated with one of the following batches - J0798, J0799, J0800 or J1021. Subsequently the patient experienced a seizure. Upon internal medical review,
seizure is considered to be an Other Important Medical Event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284192-1 (S)


MedDRA PT Anaphylactic reaction, Cyanosis, Dyspnoea, Dyspnoea, Erythema, Livedo reticularis, Nausea, Pharyngeal oedema, Swollen tongue
via a Public Case Detail form. As part of the regular school-based immunisation program funded by the government, on 24-MAY-2007 a 17 year old female was
vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0799, Expiry date 07-AUG-2009). On 24-MAY-2007 the patient experienced anaphylactic
reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue and was hospitalized. It was stated that the patient developed red, mottled face
to waist. The patient was nauseated and cyanosed, and experienced difficulty in breathing. The patient's throat and tongue restricted. However, no stridor
cough was developed. The patient was given adrenaline 0.5 ml with no improvement. Further adrenaline 0.5 ml was given 5 minutes later and the patient's
symptoms improved. On 24-MAY-2007 the patient recovered from anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen
tongue. The agency considered that anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue were probably related to
therapy with Gardasil. The original reporting source was not provided. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284193-1 (S)


MedDRA PT Anaphylactic reaction, Anxiety, Anxiety, Dyspnoea, Dyspnoea, Haematemesis, Stridor, Vomiting
via a Public Case Detail form. As part of the regular school-based immunisation program funded by the government, on 15-MAY-2007 a 16 year old female was
vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1021, Expiry date 08-AUG-2009). On 16-MAY-2007 the patient experienced anaphylactic
reaction, anxiety, dyspnoea, stridor and vomiting was hospitalised. It was stated that the patient experienced severe vomiting with mucous and blood within 10
minutes of injection. The patient had a feeling of impending doom and experienced difficulty of breathing, respiratory stridor. The patient's pulse was 68 and the
colour of the patient was good. This patient's event was considered as anaphylaxis by the agency. The patient was given intramuscular injection of adrenaline.
On 16-MAY-2007 the patient recovered from anaphylactic reaction, anxiety, dyspnoea, stridor and vomiting. The agency considered that anaphylactic reaction,
anxiety, dyspnoea, stridor and vomiting were probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is
not expected.
Other Meds: Unknown
Lab Data: Physical examination 16May07 pulse 68; colour-good
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284194-1

Unknown F Unknown Unknown 10-Jul-2007 11-Jul-2007 FR WAES0707AUS00025 11-Jul-2007

vaccinated with one of the following batches - J0798, J0799, J0800 or J1021. Subsequently the patient experienced a seizure. Upon internal medical review,
seizure is considered to be an Other Important Medical Event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284195-1

22.0 F 26-Feb-2007 18-Jun-2007 112 10-Jul-2007 11-Jul-2007 -- WAES0706USA05115 11-Jul-2007

Symptom Text: Information has been received for the Merck Pregnancy Registry from a licensed practical nurse concerning a 22 year old female with no pertinent medical
history who on 26-FEB-2007 was vaccinated with 0.5 ml of the first dose of Gardasil (Lot # 654540/0800F). There was no concomitant medication. On 02-MAY-
2007, the patient was vaccinated with 0.5 ml of the second dose of the Gardasil (Lot # 656050/0245U). It was reported that the patient was pregnant.
Unspecified medical attention was sought. Her last menstrual period was approximately 14-MAY-2007. The estimated date of delivery was 18-FEB-2008. Two
ultrasounds were performed (results not provided), and "hormone levels for pregnancy levels dropping was monitored by beta-human chorionic gonadotropin
test (bHCG)", On 18-JUN-2007, the patient went to the emergency room and experienced a miscarriage at 5 weeks gestation. It was reported that the patient
was recovering. Upon internal review, the miscarriage was determined to be an other important medical event. Additional information has been requested.
Other Meds: None
Lab Data: Ultrasound - results not provided, Beta-human chorionic - results not provided
History:
Prex Vax Illns:


14.0 F 09-Jul-2007 09-Jul-2007 0 10-Jul-2007 19-Jul-2007 NC NC07075 19-Jul-2007

MedDRA PT Syncope, Tremor, Unresponsive to stimuli
Symptom Text: Within 5 sec after giving shot, child started shaking, unresponsive for 15-30 sec then fainted.
Other Meds:
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:


HPV4 MERCK & CO. INC. NULL Unknown Unknown HIBV
HPV4
TTOX
MedDRA PT Abdominal pain, Asthenia, Convulsion, Feeling abnormal, Heart rate increased, Loss of consciousness, Pelvic pain
Symptom Text: Seizure-like behavior following vaccination, passed out, ongoing rapid heart beat, weakness, "just doesn't feel normal", lower abdominal/pelvic pain
Other Meds: Ibuprophen 200 mg
Lab Data: Blood test required by Dr. within hour of vaccination(results not yet available)
History: none known other than mono in months prior
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284206-1

20.0 F 05-Jul-2007 05-Jul-2007 0 10-Jul-2007 19-Jul-2007 AR 19-Jul-2007

MedDRA PT Dizziness, Fatigue, Feeling hot
Symptom Text: Injection given on 7-5-07, pt left office after 15 min of inj. okay. Called back states she had immediate response felt very tired feverish and dizzy.
Other Meds:
Lab Data:
History: Milk and ASA
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284211-1

17.0 F 02-Jul-2007 02-Jul-2007 0 10-Jul-2007 19-Jul-2007 NY 19-Jul-2007

MedDRA PT Abdominal pain upper, Headache, Skin warm, Tremor, Vaccine positive rechallenge
Symptom Text: Within a few hours of getting vaccine pt felt shaky. Headache, stomachache, felt warm. Last vaccine done 2-27-07 some reaction. Felt better after 2 days
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284229-1

13.0 F 03-Jul-2007 04-Jul-2007 1 10-Jul-2007 19-Jul-2007 AL 19-Jul-2007
MedDRA PT Injection site erythema, Injection site oedema, Injection site pain
Symptom Text: Pain, erythema and edema at injection site. Afebrile event 48 hrs post vaccination. Given Clindamycin and Advil.
Other Meds: Flonase, Proventil, Epipen
Lab Data: None
History: Allergic rhinitis, Scoliosis
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284234-1

16.0 F 15-Jun-2007 15-Jun-2007 0 10-Jul-2007 11-Jul-2007 TX 11-Jul-2007

MedDRA PT Abdominal pain, Dizziness, Hyperhidrosis, Pyrexia, Vomiting
Symptom Text: Vomitting, Fever, Sweats, abdominal pain, and light headness.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 284237-1

16.0 F 10-Jul-2007 10-Jul-2007 0 10-Jul-2007 11-Jul-2007 PA 11-Jul-2007
TDAP GLAXOSMITHKLINE AC52B018AD 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Convulsion, Fall, Injury, Syncope vasovagal
Symptom Text: Pt. had a vasovagal response to Gardasil vaccine in the office, falling onto the floor and hitting her face. Pt had seizure activity, per her mother. Pt was moved
to a chair, was sitting and talking and went on to have further seizure acitivty and 911 was called. we monitered the pt. until medics arrived and she was
transported to the ED.
Other Meds: NONE
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 284256-1

18.0 F 10-Jul-2007 10-Jul-2007 0 10-Jul-2007 11-Jul-2007 CA 11-Jul-2007
MedDRA PT Blood pressure, Dizziness, Dizziness, Lethargy
Symptom Text: Patient was given 1st dose of Gardasil, along with Menactra, in the left deltoid. Gardasil was given first, and then Menactra. Patient was seated at time of
administration of vaccines. Within 5 seconds of the vaccines being given, the patient felt faint and closed her eyes. She lay down and said she felt dizzy. She
was lethargic but responsive. I came into the room within 1 minute of this episode. The patient was laying down but felt better. She denied any visual changes
had occurred -- just that she felt faint and dizzy. Blood pressure was 102/70. She was given some juice. She felt much better after about 5 minutes and was
sent home. Her mother will watch her and call me if any further problems. No further Gardisil vaccines will be given to her.
Other Meds: NONE
Lab Data: none
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 284257-1

10.0 F 03-Oct-2006 04-Oct-2006 1 10-Jul-2007 11-Jul-2007 CA 11-Jul-2007
BIOLOGICALS
Symptom Text: This is report # 1 of 3, one for each Gardisil administered. Mother stated to me on 05/18/07, that 24 hours after Gardisil vaccine, patient had fever, and then
developed flu-like symptoms.
Other Meds: NONE
Lab Data: None
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 284259-1

10.0 F 05-Dec-2006 05-Dec-2006 0 10-Jul-2007 11-Jul-2007 CA 11-Jul-2007

MedDRA PT Influenza like illness, Nausea, Pyrexia, Vomiting
Symptom Text: This is report # 2 of 3 for this patient re: 3 Gardisil vaccines. Mother states that after Gardisil #2, she had a fever, nausea, and vomiting, and then within 24
hours developed flu-like symptoms. Mother feels that after Gardisil administration, patient seemed much more susceptible to flu-like illnesses and various
infections, e.g. sinusitis.
Other Meds: NONE
Lab Data: NONE
History: NONE
Prex Illness: NONE
Prex Vax Illns: fever, flu-like symptoms~HPV (Gardasil)~1~11~In Patient

Vaers Id: 284260-1

11.0 F 26-Apr-2007 27-Apr-2007 1 10-Jul-2007 11-Jul-2007 CA 11-Jul-2007
HEPA GLAXOSMITHKLINE AHAVB162CB 1 Right arm Unknown
BIOLOGICALS
Symptom Text: This is report # 3 of 3, one for each Gardisil administered. Mother stated to me on 05/18/07, that 24 hours after Gardisil vaccines, patient had fever, and then
developed flu-like symptoms. Mother feels that after Gardisil administration, patient seemed much more susceptible to flu-like illness and various infections,
e.g. sinusitis.
Other Meds: NONE
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns: flu-like symptoms ~HPV (Gardasil)~1~11~In Patient

Vaers Id: 284261-1

17.0 F 02-Jan-2007 02-Jan-2007 0 10-Jul-2007 11-Jul-2007 CA 11-Jul-2007
TDAP GLAXOSMITHKLINE AC52B014AA 0 Unknown Intramuscular
BIOLOGICALS
BIOLOGICALS
MedDRA PT Loss of consciousness, Visual disturbance
Symptom Text: On 4/11/2007, patient reported to me that after her 1st Gardisil vaccine on 01/02/2007, she had a "blackout" feeling as she was leaving the office. This
occurred again after the 2nd Gardisil vaccine was given on 3/28/2007.She stated that "everything went black" and she could not see. She was very much alert
and could hear, at that time. This episode lasted approximately 1 minute. These episodes have happened recurrently since that time, initially about once a
week, now occurring less often.
Other Meds: Allegra-D, Flonase, Ortho Tricyclen
Lab Data: MRI of brain was negative. Labs ordered but were not done.
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 284274-1

13.0 F 03-Jul-2007 04-Jul-2007 1 11-Jul-2007 19-Jul-2007 AZ 19-Jul-2007

MedDRA PT Dizziness, Dyspnoea, Headache, Nausea, Pain, Palpitations, Pyrexia
Symptom Text: Heart palpations, dizziness, headache, nausea, SOB - hurt to breathe, fever
Other Meds: Zantac, Albuterol, Pulmicort
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284283-1


Symptom Text: Pain at injection site - lasted 2 weeks post-injection

Other Meds: Trisprintec
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284287-1 (S)

18.0 F 21-Jun-2007 02-Jul-2007 11 11-Jul-2007 12-Jul-2007 IL 12-Jul-2007
VARCEL MERCK & CO. INC. 0594U Unknown Intramuscular
MNQ SANOFI PASTEUR U2155CA Unknown Intramuscular
MedDRA PT Guillain-Barre syndrome, Hypoaesthesia
Symptom Text: RECEIVED GARDASIL, VARICELLA VACCINE AND MENACTRA 6-21-07. DEVELOPED LOWER EXTREMITY NUMBNESS 7-2-07 AND DIAGNOSED WITH
GUILLAN-BARRE SYNDROME 7-5-07
Other Meds: NONE
Lab Data: POSITIVE EPSTEIN-BARR VIRUS TITER BY HISTORY
History: ENVIRONMENTAL ALLERGIES, MILD
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 284288-1

17.0 F 11-Jul-2007 11-Jul-2007 0 11-Jul-2007 12-Jul-2007 MI 12-Jul-2007
TDAP SANOFI PASTEUR 1208F Unknown Intramuscular MNQ
MNQ SANOFI PASTEUR AVU2277AA Unknown Intramuscular TDAP
HPV4 MERCK & CO. INC. C2638AA Unknown Intramuscular
MedDRA PT Cold sweat, Dyskinesia, Gaze palsy, Immediate post-injection reaction, Pallor, Peripheral coldness, Syncope
Symptom Text: Immed. after receiving injection client eyes rolled and tongue protruded (siezure like activity)became VERY pale and fainted. Skin was cold and clammy. Took
several minutes for her to come around. Client had 2 injection prior to getting the HPV.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 284293-1

BIOLOGICALS
MedDRA PT Arthritis, Joint effusion
Symptom Text: R hip and knee effusion; seen by orthopedics at ER of Hospital, ESR 23 CRP 4.5 felt to be c/w inflammatory, post-infectious type arthritis
Other Meds: cefdinir for 10 days starting on 6/6/07 azithromycin for 5 days starting on 5/31
Lab Data: ESR 23 CRP 4.5
History: rash to amoxicillin dx'd in 2000
Prex Illness: none
Prex Vax Illns:

Vaers Id: 284323-1

16.0 F 20-Jun-2007 21-Jun-2007 1 11-Jul-2007 19-Jul-2007 -- 19-Jul-2007

MedDRA PT Body temperature increased, Headache, Pain, Pain
Symptom Text: 1 day after HPV - Sharp pain in head lasted a few seconds, achy, low grade temp.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284324-1

Symptom Text: R arm, 5x3 cm zone of erythema, induration this was measured 2 days after the injection.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284326-1

11.0 F 29-May-2007 30-May-2007 1 11-Jul-2007 19-Jul-2007 PA 19-Jul-2007
Symptom Text: 1 day after injection, patient had erythema and induration measuring 2x3 inches on R upper arm.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284329-1

15.0 F 02-Apr-2007 02-Apr-2007 0 11-Jul-2007 19-Jul-2007 OH 20-Jul-2007

MedDRA PT Injection site bruising, Injection site swelling, Nausea, Pyrexia
Symptom Text: Nausea (within an hour) for 3 hours. Fever (within an hour) for 12 hours. Bruising at injection site - 4/3/07 - lasting two weeks - softball size. Swelling at injection
site - 4/2/07 lasting two weeks at injection site - 4/2/07 - lasting two weeks - softball size - non-responsive to Ibuprofen.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284330-1

14.0 F 29-Dec-2006 29-Dec-2006 0 11-Jul-2007 19-Jul-2007 OH 20-Jul-2007
HPV4 MERCK & CO. INC. 1425F Left arm Intramuscular
FLU SANOFI PASTEUR U2312AA Right arm Intramuscular
HEPA MERCK & CO. INC. 1008F Left arm Intramuscular
MedDRA PT Injection site bruising, Injection site swelling, Pyrexia
Symptom Text: Fever - 12/29/06, bruising at the injection site 12/30/06, swelling approximately golf size at the injection site - 12/30/06.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284343-1

21.0 F Unknown Unknown 11-Jul-2007 19-Jul-2007 NH 20-Jul-2007

MedDRA PT Erythema, Pruritus, Rash
Symptom Text: w/in 2 days pt developed small, red, itchy, raised rash to both arms.
Other Meds:
Lab Data:
History: Alg: Soy, Miralax
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284344-1


MedDRA PT Urticaria
Symptom Text: Pt developed hives over all her body requiring steroids and Benadryl went to PCP and allergist required high dose steroids.
Other Meds: Lo Estren
Lab Data:
History: NKDA
Prex Illness:
Prex Vax Illns:

Vaers Id: 284352-1

18.0 F 04-Jun-2007 04-Jun-2007 0 11-Jul-2007 12-Jul-2007 PA WAES0706USA01796 12-Jul-2007

Symptom Text: Information has been received from an 18 year old female who in 2007 was vaccinated IM with a dose of Gardasil. The patient reported that she is 8 weeks
pregnant and received the vaccine. No adverse reaction reported. Follow up information has been received from a physician concerning the 18 year old female
with 0 previous pregnancies and no medical history who on 04-JUN-2007 was vaccinated IM with a dose of Gardasil. The patient received an elective abortion
at 8 weeks. The elective termination occurred the week of 04-JUN-2007. Upon internal review, elective abortion was considered to be an other important
medical event. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 284353-1 (S)

Unknown F Unknown Unknown 11-Jul-2007 12-Jul-2007 PA WAES0707USA00854 12-Jul-2007

MedDRA PT Cyanosis, Cyanosis, Dizziness, Grand mal convulsion, Loss of consciousness, Myalgia, Respiratory arrest, Trismus, Vision blurred, Vision blurred
Symptom Text: Information has been received from a physician who received a fax from a patient, concerning a female patient who on an unspecified date was vaccinated with
Gardasil. Subsequently, following vaccination, the patient became dizzy, her "muscles were heavy", and she lost focus. It was reported that a nurse sat the
patient down, however sitting down did not make the symptoms any better. The physician then came into the room and gave the patient a shot of Benadryl.
After receiving the Benadryl the patient was placed in another room for a short time. After a couple of minutes, the nurse went back into the room to take the
patient's blood pressure and found the patient having a grand mal seizure. The physician again entered the room and found the patient unconscious, not
breathing, and her jaw was clamped and her lips were blue. The patient was subsequently hospitalized. At the time of this report, the outcome of the events
was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284390-1

16.0 F 13-Apr-2007 01-May-2007 18 12-Jul-2007 13-Jul-2007 FL WAES0705USA00509 13-Jul-2007

MedDRA PT Abortion spontaneous, Amenorrhoea, Drug exposure during pregnancy
Symptom Text: Initial and follow-up information has been received from a physician for the Pregnancy Registry for Gardasil concerning a 16 year old female with no medical
history or previous pregnancies who on 13-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil (lot # 655165/0137U). Concomitant
therapy included pre-natal vitamins. On 01-MAY-2007 a pregnancy test was performed because of amenorrhea and found to be positive with an HCG results of
29576. The estimated conception date was 7 weeks and the estimated delivery date was 22-DEC-2007 (LMP was not known). On 16-MAY-2007, an additional
HCG test was performed with a result of 74136. The patient sought unspecified medical attention. In May 2007, the patient experienced a spontaneous
abortion. It was noted that the patient was currently under a physician's care and that she was permitted to return to normal activities without limitations. At the
time of this report, the outcome was unknown. No further information is available.
Lab Data: beta-human chorionic 05/01/07 29576 - positive, beta-human chorionic 05/16/07 74136
History:
Prex Vax Illns:

Vaers Id: 284401-1

14.0 F 09-Jul-2007 09-Jul-2007 0 12-Jul-2007 20-Jul-2007 KS 20-Jul-2007
TDAP GLAXOSMITHKLINE AC528009AA 5 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Blood pressure decreased, Nausea, Syncope
Symptom Text: Fainted/nausea/decreased BP - Trendelenberg used. Unable to get a B/P but pt was alert. B/P after 10 min was 100/58 (normal per pt)
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284402-1

20.0 F 14-Feb-2007 15-Mar-2007 29 12-Jul-2007 20-Jul-2007 FL 20-Jul-2007

MedDRA PT Dizziness, Hyperhidrosis, Presyncope
Symptom Text: First Gardasil given 2-14-07 pt returned 4-11-07. Informed nurse of episode of dizziness severe with diaphoresis - near syncope - within 3 days of 1st injection -
ER visit - DX possible seizure - referred to neurology. Neuro cleared pt feels not related to Gardasil event occurred actually 3wks after injection.
Other Meds: Orthotricyclen - Lo
Lab Data: EEG 3-15-07 Neurology Evaluation/clearance 5-16-07
History: No Known allergies
Prex Vax Illns:

Vaers Id: 284404-1

18.0 F Unknown Unknown 12-Jul-2007 19-Jul-2007 NY 20-Jul-2007

MedDRA PT Eczema, Psoriasis, Rash
Symptom Text: 3-4 weeks after her Gardasil shot (#1) She began exhibiting a rash which escalated over the next 5-6 weeks until she was covered with psoriasis and eczema
on her arms (upper and lower), her legs (upper and lower), tops of her feet and hands, her neck, and slightly on her torso, body and face.
Other Meds: CONCERTA, YAZ birth control pills (daily)
Lab Data: Blood tests, dermatologic diagnosis
History: Asthma, ADHD
Prex Illness: Severe angry, red, itchy scaly rash, exhaustion
Prex Vax Illns:

Vaers Id: 284418-1

HPV4 MERCK & CO. INC. 0802U 1 Left arm Subcutaneously HPV4

MedDRA PT Blood pressure decreased, Cold compress therapy, Cold sweat, Heart rate, Pallor, Syncope
Symptom Text: Pt. given vaccine, was in the process of checking out and became fainty, clammy, poor skin color, would not acknowldege questions asked or instructions. BP
at that time was 70/40, with a pulse of 50. Cold compresses applied to forehead, fan was turned to pt.,coke and saltines to pt. BP 10 minutes later was 86/58 ,
pulse 74. Pt. continued to rest and vitals again taken after 10 minutes-BP 90/60 and pulse 74. Pt. was no longer clammy, was speaking when spoken to, color
good.Stated that she had not eaten anything this am. Felt better and was told to call the office prn.
Other Meds: Yaz
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284419-1

TD SANOFI PASTEUR C2631AA 0 Right arm Intramuscular
MedDRA PT Injection site pain, Injection site swelling
Symptom Text: Mother reportrd patient's arm swollen to the size of a lemon at the injection site and is sore. The swelling started after the shot but was larger today. The area is
not warm to touch. No fever. The patient does not feel bad. Dr advise to use 500mgs of Tylenol 2-3 times a day for 2-3days and warm compresses to the site
several times a day till the swelling resolves.
Other Meds:
Lab Data: None
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284426-1

13.0 F 12-Jul-2007 12-Jul-2007 0 12-Jul-2007 19-Jul-2007 WI 19-Jul-2007

MedDRA PT Chills, Deafness, Dizziness, Dizziness, Hyperhidrosis, Loss of consciousness
Symptom Text: Lightheadedness, dizziness, blackout, temporary loss of hearing, chills and sweats.
Other Meds: None (vitamin supplements)
Lab Data:
History: none
Prex Illness: Pink-eye infection
Prex Vax Illns: none~ ()~NULL~~In Patient

Vaers Id: 284429-1

HPV4 MERCK & CO. INC. UN 2 Right arm Unknown
MedDRA PT Chills, Headache, Hypokinesia, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Paraesthesia, Pruritus, Pyrexia, Restlessness,
Somnolence
Symptom Text: vaccine given at 10:30am in treatment room. soreness of right arm at injection site within 4 hours, painful to lift overhead. within 8 hours suffering headache,
neck stiffness & several (3) periods of tingling sensations in the left leg (lasting 10 minutes each or so)and a spell of itchiness. 12 hours after injection, went to
bed with headache (still), fever & chills. restless night. fever of 102F at 7AM (22 hours after shot). went back to sleep and was difficult to wake. i called doctor --
mentioned my concerns over a reaction of some sort & was told this vaccine did not cause these symptoms. i scheduled an appointment because this was not
normal for claire and i was not quite sure what to do. by noon, most symptoms were gone except for the headache. we saw the doctor who pronounced her fine
& told us to watch for other symptoms of illness. he told us that it was not the vaccine, but would note my concerns on her file as a precaution. this was the 3rd
and final injection of this vaccine, she had only soreness at the injection sight with the first two shots. she took an aleve around 8pm the night of the shot & 2
motrins - 6 hours apart - the next day because of the headache. no relief was provided by the pills.
Other Meds: none
Lab Data:
History: seasonal allergies / mild asthma
Prex Illness: none
Prex Vax Illns:

Vaers Id: 284443-1

18.0 F 09-Jul-2007 10-Jul-2007 1 12-Jul-2007 20-Jul-2007 IN 20-Jul-2007
MedDRA PT Back pain, Hyperhidrosis, Nausea, Neck pain
Symptom Text: c/o sore neck and back, nausea and sweating 7/10. 7/11 - some better, still no fever, cont. to have nausea and sweating. 7/12 feels better.
Other Meds: Levilite, Flexeril (PRN), Naprosyn (PRN)
Lab Data: None
History: 1/19/06 Menorrhagia, 1/5/07 L shoulder pain, allergic to some ear drop med, NAMC
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284446-1

15.0 F 09-Jul-2007 09-Jul-2007 0 12-Jul-2007 20-Jul-2007 OR 20-Jul-2007
MedDRA PT Injection site erythema, Injection site oedema, Injection site pain
Symptom Text: Back of R upper arm - redness area 8cm x 4cm with slight edema, pain at site - SQ injection of Varicella
Other Meds: Yaz, Claritin D
Lab Data:
History: Dysfunctional Uterine bleeding
Prex Illness:
Prex Vax Illns:

Vaers Id: 284447-1


Symptom Text: Dizzy, Nausea

Other Meds:
Lab Data:
History: NKDA
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284477-1

Unknown F 01-Apr-2007 Unknown 18-Jun-2007 16-Jul-2007 NC WAES0705USA04415 17-Jul-2007

MedDRA PT Mass
Symptom Text: Information has been received from a physician concerning a female who in April 2007, was vaccinated with the first dose of Gardasil. Subsequently the patient
experienced a small lump, similar to a mosquito bite, on her left shoulder. As of 23-MAY-2007, the patient had not recovered. It was not known whether the
second or third doses of vaccine would be administered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284481-1

12.0 F Unknown Unknown 18-Jun-2007 18-Jul-2007 -- WAES0705USA04478 18-Jul-2007
Symptom Text: Information has been received from a physician concerning her 12 year old daughter who was vaccinated with Gardasil. Concomitant therapy included
Menactra. Within 24 hours post vaccination, the reporter indicated that her daughter developed swelling, warmth and redness at the injection site. The
symptoms resolved within a week. Unspecified medical attention was sought. No other information was available. Additional information has been requested.
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284482-1

15.0 F 05-Apr-2007 05-Apr-2007 0 18-Jun-2007 18-Jul-2007 TX WAES0705USA04525 18-Jul-2007

MedDRA PT Erythema, Oedema peripheral
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 05-APR-2007 was vaccinated with Gardasil (Lot#654702/0011U). On
05-APR-2007 post vaccination the patient developed a red swollen arm. Unspecified medical attention was sought. On 09-APR-2007 the patient recovered
from the red swollen arm. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284483-1

17.0 F 03-Jan-2007 03-Jan-2007 0 18-Jun-2007 18-Jul-2007 -- WAES0705USA04564 18-Jul-2007
FLU SANOFI PASTEUR NULL Unknown Unknown
MedDRA PT Injection site erythema, Injection site warmth, Skin lesion, Skin ulcer, Tenderness
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female
experienced injection site erythema, injection site warmth, skin ulcer and tenderness following vaccination with Gardasil. The patient experienced on the left
deltoid site a 5 cm x 3 1/2 cm circular erythematous tender area that was warm to the touch, and a lesion that was very tender. No further information is
available. The original reporting source was not provided. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History:
Prex Illness: Latex allergy
Prex Vax Illns:

Vaers Id: 284484-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning an 18 year old female who on 09-MAY-2007 was vaccinated with the first dose of Gardasil (Lot #
657621/0387U). On 09-MAY-2007 the patient fainted after receiving the first dose of Gardasil. Subsequently, the patient recovered from fainting. Unspecified
medical attention was sought. No additional information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284485-1 (S)

Unknown F 01-May-2007 01-May-2007 0 18-Jun-2007 17-Jul-2007 -- WAES0705USA04595 17-Jul-2007

MedDRA PT Abdominal discomfort, Syncope, Vomiting
Symptom Text: Information has been received from a company representative as reported by a nurse concerning a female (age not reported) who in approximately May 2007
"within the last couple of weeks", was vaccinated with a dose of Gardasil (lot# not provided). In approximately May 2007 'within the last two weeks or so", the
patient experienced vomiting and fainting after receiving the first dose of the vaccine. The patient was hospitalized for about 5 days. Liver enzyme tests were
performed indicating that "she may have some liver enzyme elevation." The patient was complaining about GI upset. Subsequently the patient recovered.
There was no product quality complaint involved. No further information is available.
Other Meds: Unknown
Lab Data: hepatic function tests - patient may have liver enzyme elevation
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284486-1

Unknown U Unknown Unknown 18-Jun-2007 18-Jul-2007 -- WAES0705USA04921 18-Jul-2007

Symptom Text: Information has been received from a medical assistant concerning a patient who was vaccinated with Gardasil. Subsequently the patient experienced
amenorrhea. No further details were provided. The medical assistant also reported the same adverse experience for herself which was captured in WAES
#0705USA04044. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284487-1

15.0 F Unknown Unknown 18-Jun-2007 18-Jul-2007 DE WAES0705USA04955 18-Jul-2007

MedDRA PT Dyspnoea
Symptom Text: Information has been received from a physician concerning a 15 year old female patient with a history of asthma who was vaccinated with a first dose of
Gardasil. Within twenty-four hours after receiving the vaccine, the patient experienced difficulty breathing. Unspecified medical attention was sought. At the
time of this report the patient had recovered. It was reported that the patient will not complete the series. No product quality complaint was involved. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Asthma
Prex Illness:
Prex Vax Illns:

Vaers Id: 284488-1


MedDRA PT Syncope
Symptom Text: Information has been received from a registered nurse concerning a "couple of female patients" who were vaccinated with a 0.5 ml dose of Gardasil.
Subsequently, the patients' experienced syncope. The nurse stated that the events were not reported because there were no adverse outcomes and most of
the patients' had a history of fainting. Unspecified medical attention was sought. At the time of this report, the patients' recovered. No product quality complaint
was involved. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Syncope
Prex Illness:
Prex Vax Illns:

Vaers Id: 284489-1


Symptom Text: Information has been received from a physician concerning two females who were vaccinated with Gardasil. Subsequently the patients both developed fever
and vomiting. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional
information will be provided if available. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284490-1

25.0 F 25-Apr-2007 18-May-2007 23 18-Jun-2007 18-Jul-2007 NJ WAES0705USA04962 18-Jul-2007

MedDRA PT Hypoaesthesia, Hypoaesthesia
Symptom Text: Information has been received from a physician concerning a 25 year old female patient with no medical history or allergies, who on 25-APR-2007 was
vaccinated with a first dose of Gardasil. Concomitant therapy included Zovia 1/50E. It was noted the patient received the vaccine at another practice. On 18-
MAY-2007, the patient experienced numbness in the left leg which spread to the left foot. The numbness has since spread to all of her extremities. The
numbness was sporadic and there was no pattern to the numbness. The patient was examined by an internist (name unspecified) who has ordered blood tests
(unspecified). At the time of this report the patient has not recovered. No product quality complaint was involved. The internist suspected that Gardasil may be
responsible for the numbness. Additional information has been requested.
Other Meds: ZOVIA 1/50E
Lab Data: diagnostic laboratory - blood test
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284491-1

15.0 F 06-Dec-2006 06-Dec-2006 0 18-Jun-2007 18-Jul-2007 -- WAES0705USA05022 18-Jul-2007

MedDRA PT Injection site erythema, Injection site pain, Injection site pain, Injection site swelling
Symptom Text: Information has been received from the mother of a consumer concerning her 15 year old daughter with an allergic reaction to Septra and an allergy to Suprax
who on 06-DEC-2006 was vaccinated with Gardasil. Concomitant therapy included Augmentin and Flonase. On 06-DEC-2006 the patient experienced
soreness at injection site for a day or two. In February 2007, the patient was vaccinated with her second dose and experienced soreness at injection site for a
day or two. On 05-MAY-2007 the patient was vaccinated with her third dose of Gardasil. On 23-MAY-2007 the patient experienced swelling in the injection arm
and tenderness in the injection arm. And on 24-MAY-2007 the patient's arm turned red. The patient's swelling and tenderness in the injection arm and
reddened arm persisted. It was reported that the patient sought unspecified medical attention. No further details were provided. Additional information has been
requested.
Other Meds: AUGMENTIN, FLONASE
Lab Data: Unknown
History:
Prex Illness: Allergic reaction to antibiotics; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 284492-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated with Gardasil. There was no concomitant
medication. In April 2007, the patient fainted after receiving the vaccine. It was reported that the patient's blood pressure was taken. No further details were
Other Meds: None
Lab Data:
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284493-1


MedDRA PT Vomiting
Symptom Text: Information has been received from a physician concerning a 19 year old female with a history of type I diabetes mellitus who on 17-MAY-2007 was vaccinated
with Gardasil. Concomitant therapy included insulin. On 19-MAY-2007 the patient experienced vomiting. It was reported that the patient sought unspecified
medical attention. Subsequently, the patient recovered from vomiting. No further details were provided. Additional information has been requested.
Other Meds: insulin
Lab Data: Unknown
History: Type I diabetes mellitus
Prex Illness:
Prex Vax Illns:

Vaers Id: 284494-1


MedDRA PT Hypoaesthesia, Paraesthesia
Symptom Text: Information has been received from a physician concerning a 14 year old female who on 27-MAR-2007 was vaccinated with a first dose of Gardasil (lot not
reported) and a second dose on 21-MAY-2007 (Lot# 657737/0522U). There were no concomitant medications. During this second injection on 21-MAY-2007
the patient experienced tingling and numbness in her arm immediately upon injection which continued for the rest of the day. It was her entire arm, but "not to
the point of non-function". She needed no prescription treatment and subsequently recovered from tingling in arm and numbness in her arm. Additional
Other Meds: None
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284495-1

12.0 F 30-Mar-2007 04-Apr-2007 5 18-Jun-2007 18-Jul-2007 IN WAES0705USA05187 18-Jul-2007

Symptom Text: Information has been received from a pharmacist and the patient's mother concerning a 12 year old female who on 29-JAN-2007 was vaccinated with the first
dose of Gardasil. On 30-MAR-2007 the patient received a second dose of Gardasil. On 04-APR-2007 the patient was diagnosed with genital warts. The patient
had no other symptoms. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284496-1

18.0 F 25-May-2007 25-May-2007 0 18-Jun-2007 18-Jul-2007 VA WAES0705USA05188 18-Jul-2007

MedDRA PT Paraesthesia
Symptom Text: Information has been received from a health professional concerning an 18 year old female patient with an allergy to morphine who on 25-MAY-2007 was
vaccinated with a second dose of Gardasil (lot # 0212U). That same day, the patient experienced tingling of her right and left fingers, hands, lips, bridge of her
nose and eyelids which resolved after an hour. The patient sought unspecified medical attention. No further information is available. Additional information has
been requested.
Other Meds: Unknown
Lab Data:
History:
Prex Vax Illns:

Vaers Id: 284497-1

Unknown F Unknown Unknown 18-Jun-2007 18-Jul-2007 OH WAES0705USA05227 18-Jul-2007

MedDRA PT Hypoaesthesia, Hypoaesthesia
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated IM with Gardasil (date unknown). Three weeks after the
patient received her second dose of Gardasil, she experienced numbness in her arms and legs and went to the hospital. It was not clear if the patient was
admitted or not. However, at the hospital, the patient underwent testing. One test was described as a "drop test." During this test, the patient's arms were
released from above her head and "it dropped on her face." Subsequently, the patient recovered from the numbness in her arms and legs. The physician noted
that the patient was fine after she received her first dose of Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284498-1


MedDRA PT Headache, Hyperhidrosis
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated IM with Gardasil. Subsequently two to three days after the patient
was vaccinated, she experienced a headache and sweating. The patient sought unspecified medical attention. This is one of several reports received from the
same source. No further information is available.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284499-1

26.0 F 19-Mar-2007 19-Mar-2007 0 18-Jun-2007 18-Jul-2007 -- WAES0705USA05245 18-Jul-2007

MedDRA PT Abdominal pain, Diarrhoea, Fatigue, Nausea, Pain
Symptom Text: Information has been received from a healthcare worker concerning a 26 year old female with allergic reaction to Cipro who on 19-MAR-2007 was vaccinated
with Gardasil 9Lot # 656049/0187U). Concomitant therapy included Estrostep and acne medication. On 19-MAR-2007 the patient experienced abdominal
cramping, diarrhea, nausea, body aching and fatigue for 24 hours after receiving her first dose of the vaccine. The next day, 20-MAR-2007, the patient fully
recovered from abdominal cramping, diarrhea, nausea, body aching and fatigue. Additional information has been requested.
Other Meds: (therapy unspecified), Estrostep
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 284502-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female patient between 17 and 18 years old who was vaccinated with Gardasil. The patient
fainted after her first administration of Gardasil. She had also had her blood drawn at the same time and also received a dose of Menactra. The patient
recovered. No other information was reported. Continued on Additional Page
Other Meds: See Additional Page
Lab Data: Refer to Additional Page
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284503-1

17.0 F 01-May-2007 Unknown 18-Jun-2007 18-Jul-2007 NC WAES0705USA05333 18-Jul-2007

Symptom Text: Information has been received from a physician concerning a female teenager, probably between 17 and 18 year old patient who in May 2007, was vaccinated
with a second dose of Gardasil. The patient developed amenorrhea after the second injection. The physician felt that amenorrhea was not related to therapy
with Gardasil. It was unknown if the the patient sought medical attention. The outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284504-1

Unknown F Unknown Unknown 18-Jun-2007 18-Jul-2007 NY WAES0705USA05336 18-Jul-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11
and 19 who was vaccinated with a first dose of Gardasil. It was reported that the patient sat for a minute (after receiving the injection) and when she got up to
leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however, the physician will forward
other information including the lot numbers. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284505-1


MedDRA PT Syncope
Symptom Text: Initial information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages
of 11 and 19 who was vaccinated with a dose of Gardasil, it was reported that the patient sat for a minute (after receiving the injection) and when she got up to
leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however the physician will forward
other information including the lot numbers. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284506-1


MedDRA PT Syncope
of 11 and 19 who was vaccinated IM with a dose of Gardasil. It was reported that the patient sat for a minute (after receiving the injection) and when she got up
to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however, the physician will
forward other information including the lot numbers. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284507-1


MedDRA PT Syncope
of 11 and 19 who was vaccinated IM with a dose of Gardasil. It was reported that the patient sat for a minute (after receiving the injection) and when she got up
to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however, the physician will
forward other information including the lot numbers. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284508-1

35.0 F 29-Jan-2007 30-Jan-2007 1 18-Jun-2007 18-Jul-2007 FL WAES0705USA05395 30-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, Nausea, Vertigo
Symptom Text: Information has been received from a medical assistant concerning a 35 year old female with genital herpes who on 27-NOV-2006 and 29-JAN-2007 was
vaccinated IM with 0.5 ml of Gardasil (Lot #653978/0955F and 654741/0013U). Concomitant therapy included Valtrex as needed. On 30-JAN-2007 the patient
experienced vertigo and nausea. The vertigo and nausea resolved on its own by 2 PM. Medical attention was sought. Additional information has been
requested.
Other Meds: VALTREX
Lab Data: None
History:
Prex Illness: Genital herpes
Prex Vax Illns:



MedDRA PT Alopecia
Symptom Text: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced hair loss
two weeks after vaccination. Medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:



MedDRA PT Alopecia
Symptom Text: Information has been received from a nurse practitioner concerning a 12 year old female with no drug reactions/allergies a history of hernia surgery (March or
April 2007) who on 17-MAY-2007 was vaccinated IM in her left deltoid with 0.5 ml Gardasil (lot # 655618/0186U). There was no concomitant medication. On 21-
MAY-2007 the patient experienced hair loss after receiving her first dose of Gardasil. The patient was presently losing large clumps of hair. When she
showered the hair loss was so great her hair clogged the drain. The patient had an appointment with her physician on 29-MAY-2007. The patient's hair loss
Other Meds: None
Lab Data: None
History: Hernia; Surgery
Prex Illness:
Prex Vax Illns:

Vaers Id: 284510-1


MedDRA PT Injection site pain, Wrong technique in drug usage process
Symptom Text: Information has been received from a physician assistant concerning a 24 year old female who on 16-APR-2007 was vaccinated IM with 0.5 ml of the second
dose of Gardasil (Lot #657617/0384U). On 16-APR-2007 the patient received the vaccine but the needle hit the bone in her upper arm an she has has
soreness and pain in the site since then. The patient did not have any adverse symptoms after the first dose. Medical attention was sought. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284511-1

Unknown F Unknown Unknown 18-Jun-2007 18-Jul-2007 FL WAES0705USA05431 18-Jul-2007

MedDRA PT Breast pain, Menstruation delayed, Metrorrhagia
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil. Subsequently the patient has not
had a period since her vaccination and has slight vaginal spotting and sore breasts. The physician did not perform a pregnancy test. Medical attention was
sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284513-1

17.0 F 25-May-2007 25-May-2007 0 18-Jun-2007 18-Jul-2007 MA WAES0705USA05439 18-Jul-2007

MedDRA PT Injection site pain, Oedema peripheral, Pain, Rash
Symptom Text: Information has been received from a health professional concerning her 17 year old daughter who on 25-MAY-2007 was vaccinated IM in deltoid with a
second dose of Gardasil. On 25-MAY-2007 the patient experienced pain next to the injection site after vaccination and her arm started to swell. Two days later
bumps appeared on the same arm. She was given over the counter ibuprofen (Motrin) for pain. The reporter reported that patient experienced mild pain at the
injection site after getting her first dose of Gardasil. The patient has not recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284514-1

HPV4 MERCK & CO. INC. NULL Unknown Subcutaneously

MedDRA PT Incorrect route of drug administration, Injection site haematoma, Pain
Symptom Text: Information has been received from a medical assistant concerning a 16 year old female who on 24-MAY-2007 was vaccinated with Gardasil subcutaneously.
The patient experienced an injection site hematoma and reported the injection was "uncomfortable". Subsequently, the patient recovered. Additional
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284515-1


MedDRA PT Syncope
Symptom Text: Information has been received from a 23 year old female with no drug reactions/allergies and no medical history who on 29-MAR-2007 was vaccinated with her
first dose of Gardasil, 0.5 ml, intramuscularly. There was no concomitant medication. On 29-MAR-2007 the patient fainted after receiving the first dose of the
Gardasil. The patient sought unspecified medical attention. On 29-MAR-2007, the patient recovered from fainting. Additional information is not expected.
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284516-1

23.0 F 28-May-2007 07-Mar-2007 -82 18-Jun-2007 18-Jul-2007 -- WAES0705USA05488 02-Aug-2007

MedDRA PT Medication error, Syncope
Symptom Text: Information has been received from a registered nurse concerning a 23 year old female with no pertinent medical history who on 28-MAR-2007 was vaccinated
with her first dose of Gardasil, 0.5 ml, intramuscular administration (IM), Concomitant therapy included valacyclovir (Valtrex). Subsequently, the patient fainted
after receiving her initial dose of Gardasil and recovered that same day. The nurse reported that the Gardasil was improperly stored at room temperature for
three weeks prior to use (approximately 07-MAR-2007). Approximately two months later (28-MAY-2007) the patient received her second dose of Gardasil. It
was reported that the patient's second dose had been stored at room temperature for five days prior to use (approximately 23-MAY-2007). Product Quality
Control was not involved. Additional information has been requested.
Other Meds: VALTREX
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284517-1


MedDRA PT Injection site pruritus, Injection site rash
Symptom Text: Information has been received from a health professional concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient
experienced rash at injection site and itching at injection site. The patient's rash at injection site and itching at injection site persisted. The patient sought
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284519-1


MedDRA PT Crying, Injection site pain
Symptom Text: Information has been received from a Licensed Visiting Nurse (LVN) concerning a 16 year old female patient who was vaccinated IM with her first dose of
Gardasil. Almost immediately, the patient burst into tears. She commented on how much the vaccination hurt. She repeatedly said she was not dizzy although it
took her a long time to get out of the chair. Medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284520-1

13.0 F 29-May-2007 29-May-2007 0 18-Jun-2007 18-Jul-2007 PA WAES0705USA05644 18-Jul-2007

MedDRA PT Medical device complication
Symptom Text: Initial and follow-up information has been received from a physician and a medical assistant concerning a 13 year old female patient who on 29-MAY-2007 was
scheduled to be vaccinated with a dose of Gardasil (Lot #655324/0089U). However, when the medical assistant attempted to administer the vaccination, "the
plunger would not depress," and blood was aspirated into the syringe. The CMA added that she had made 2 unsuccessful attempts to get the syringe to work.
The physician reported that "the UltraSafe mechanism had not activated," so the patient did not get the vaccination, and had to be rescheduled " due to a
defective (Gardasil) syringe." Follow up information received from a nurse, confirmed the above events, and added that actually there was no medication in the
syringe. She reported the patient still has not received the vaccination. No further information is expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284521-1

15.0 F 15-Feb-2007 17-Feb-2007 2 18-Jun-2007 18-Jul-2007 -- WAES0705USA05666 18-Jul-2007

MedDRA PT Abdominal pain, Flushing, Headache, Nausea, Pain, Pyrexia, Vomiting
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 15 year old female patient who on 15-FEB-2007 was vaccinated with a first dose of
Gardasil lot #655619/1427F. On 17-FEB-2007 the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches,
abdominal pain and she was "flush all over". These symptoms lasted for ten days before dissipating. On 22-FEB-2007 five days after the adverse symptoms
began, the patient was given cetirizine hydrochloride (ZYRTEC) and patient said she felt a little better and her headaches stopped. The nurse who provided this
information works in a health department and the name of the patient's prescribing physician was not provided. Subsequently, the patient recovered. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284522-1


MedDRA PT Headache
Symptom Text: Information has been received from a physician concerning a 20 year old female with a penicillin allergy who in January 2007, was vaccinated with a first dose
of Gardasil. Concomitant therapy included Levora. In March 2007, the patient was vaccinated with a second dose of Gardasil. Within 24 hours of the second
vaccination, the patient developed a headache. The patient sought unspecified medical attention. The headache resolved on its own. The vaccination was not
administered at the physician's office. The patient picked up the vaccine from the pharmacy, and her mother, who was a physician, administered the vaccine at
home. The patient did not develop a headache after the first injection. Additional information has been requested.
Other Meds: LEVORA
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 284523-1

Unknown F Unknown Unknown 18-Jun-2007 18-Jul-2007 MI WAES0705USA05677 18-Jul-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a nurse concerning a female patient (age not reported) who unspecified dates was vaccinated with a first and second dose
of Gardasil. The patient felt faint after receiving the first dose of Gardasil. The patient sought unspecified medical attention. The patient did not end up fainting
and recovered the same day. The patient did not have this experience after receiving her second dose of Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284524-1


MedDRA PT Injection site nodule, Injection site pain, Injection site swelling
Symptom Text: Information has been received from a Doctor of Pharmacy concerning his 17 year old daughter who on 25-APR-2007 was vaccinated with 0.5 mL second dose
of Gardasil. There was no concomitant medication. Shortly after administration of the dose, the patient experienced swelling and pain at the injection site. The
swelling had gone down, but there was still a nodule present at the injection site that was painful when pressure was applied to it. No form of treatment was
used to help with the symptoms. At the time of this report, the patient was recovering. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284525-1

14.0 F 16-May-2007 16-May-2007 0 18-Jun-2007 18-Jul-2007 OH WAES0705USA05692 18-Jul-2007

Symptom Text: Information has been received from a registered nurse concerning a 14 year old female who "two weeks ago" on 16-MAY-2007 was vaccinated with her first
dose of Gardasil 0.5 ml intramuscularly. After receiving the vaccination on 16-MAY-2007, the patient turned white, grabbed her mother's arm and then fainted.
Subsequently, the patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284526-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning a female in her 20's who in the past few months , in 2007, was vaccinated IM with 0.5 ml Gardasil.
Subsequently the patient experienced syncope after the first and second doses of Gardasil. No treatment was required, and no lab diagnostic studies were
performed. Subsequently, the patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284527-1


Symptom Text: Information has been received from a physician concerning a 24 year old female who in 2007 was vaccinated with the first dose of 0.5 ml Gardasil
intramuscularly. There were no adverse events. The second Gardasil 0.5 ml dose was given intramuscularly on 29-MAY-2007. On 30-MAY-2007 the patient
experienced significant rash and hives. The patient's significant rash and hives persisted. No lab testing was performed. Additional information has been
requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284528-1

14.0 F Unknown Unknown 18-Jun-2007 18-Jul-2007 -- WAES0705USA05702 06-Aug-2007

MedDRA PT Frostbite, Hypoaesthesia, Skin discolouration
Symptom Text: Information has been received from a Nurse Practitioner concerning a 14 year old female with no history of drug reactions/allergies and a history of asthma who
on an unspecified date was vaccinated with Gardasil. Concomitant therapy included several other unspecified vaccines concomitantly and Necon.
Subsequently the patient developed frostbite of the toes/foot. The frostbite occurred some time in February in 40 degree weather outdoors at a football game
with socks and shoes. The patient was still experiencing numbness and discoloration of toes. The vaccination was administered at another unspecified
practice. The patient sought unspecified medical attention but did not undergo lab tests. As of 30-MAY-2007 the patient was recovering. Additional information
has been requested.
Other Meds: (therapy unspecified), NECON
Lab Data: Unknown
History: Asthma
Prex Illness:
Prex Vax Illns:

Vaers Id: 284529-1

27.0 F Unknown 17-May-2007 18-Jun-2007 18-Jul-2007 -- WAES0705USA05709 30-Aug-2007

MedDRA PT Dizziness, Feeling abnormal, Inappropriate schedule of drug administration, Injection site pain
Symptom Text: Information has been received from a 27 year old female who was vaccinated with Gardasil. Concomitant therapy Ortho Tri-Cyclen. On 17-MAY-2007 the
patient experienced injection site pain, dizziness and mental fogginess that lasted four days after receiving therapy with Gardasil. Subsequently, the patient
recovered from injection site pain, dizziness and mental fogginess. Additional information is not expected.
Other Meds: Ortho Tri-Cyclen
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284530-1

DTP UNKNOWN MANUFACTURER NULL Unknown Unknown
MedDRA PT Dizziness, Dizziness, Dizziness
Symptom Text: Information has been received from a physician concerning a 12 year old female who was vaccinated with Gardasil. Concomitant therapy included DPT and
Menactra. Subsequently the patient experienced dizziness and a lightheaded woozy feeling after receiving therapy with Gardasil. Subsequently, the patient
recovered from dizziness and lightheaded woozy feeling. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284531-1


Symptom Text: Information has been received from a registered nurse concerning a 20 year old female who on approximately 01-MAY-2007 was vaccinated with Gardasil.
Since the vaccination, the patient has experienced arm pain. The arm pain has persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284532-1

14.0 F Unknown Unknown 18-Jun-2007 18-Jul-2007 OH WAES0705USA05716 18-Jul-2007

Symptom Text: Information has been received from a physician concerning an approximately 14 or 15 year old female. Medical history and concomitant therapies not reported.
On an unspecified date the patient was vaccinated with the first dose of Gardasil. Subsequently the patient experienced an outbreak of genital warts. On an
unspecified date the patient was vaccinated with the second dose of Gardasil. Subsequently the patient experienced another outbreak of genital warts. The
patient sought unspecified medical attention. As of 30-MAY-2007 the patient did not receive a third dose and patient outcome was not reported. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284533-1

17.0 F 30-May-2007 30-May-2007 0 18-Jun-2007 18-Jul-2007 GA WAES0705USA05718 18-Jul-2007
MedDRA PT Injection site pain, Loss of consciousness
Symptom Text: Information has been received from a nurse concerning a 17 year old female who 30-MAY-2007 was vaccinated with a dose of Gardasil. The patient was
concomitantly vaccinated with a dose of Menactra. The patient reported to the nurse that the Gardasil injection was more painful than Menactra. Subsequently,
the patient passed out in the waiting room after Gardasil. The patient sought unspecified medical attention. The patient recovered from the event on 30-MAY-
2007. No further information is available.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284534-1

32.0 F Unknown 15-Nov-2006 18-Jun-2007 18-Jul-2007 NY WAES0705USA05721 30-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site pain, Injection site pain, Injection site swelling
Symptom Text: Information has been received from a physician concerning a 32 year old female who on 15-NOV-2006 was vaccinated with the first dose Gardasil 0.5 ml IM.
On an unspecified date the patient received the second dose Gardasil. On 16-MAY-2007 the patient received the third dose of Gardasil 0.5 ml IM. On 17-MAY-
2007 the patient experienced pain, swelling and tenderness at the injection site of the right deltoid muscle. The physician also mentioned that the patient had
trouble lifting her arm due to pain. The physician prescribed ibuprofen (Motrin). The patient was examined by the physician on 05-21-2007 and the symptoms
were resolving. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284535-1

13.0 F 25-May-2007 26-May-2007 1 18-Jun-2007 17-Jul-2007 WA WAES0705USA05726 18-Jul-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a Nurse Practitioner concerning a 13 year old female with a history of lightheadedness who on 25-MAY-2007 was
vaccinated with the first dose of Gardasil 0.5 ml. Concomitant therapy included DTaP (unspecified) and Menactra. The physician reported that the patient
fainted the day after receiving the vaccine. The patient was sitting and fainted when she stood up. The patient sought unspecified medical attention. As of 30-
MAY-2007 the patient had recovered. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Lightheadedness
Prex Illness:
Prex Vax Illns:

Vaers Id: 284536-1

Unknown F 19-Apr-2007 31-May-2007 42 18-Jun-2007 17-Jul-2007 -- WAES0705USA05727 18-Jul-2007

Symptom Text: Information has been received from a physician concerning a female who on 19-APR-2007 was vaccinated with Gardasil. On approximately 31-MAY-2007 the
patient developed injection site redness and injection site swelling. The patient has not recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284537-1


MedDRA PT Dizziness, Loss of consciousness
Symptom Text: Information has been received from a nurse concerning her 14 year old daughter who on 26-APR-2007 was vaccinated IM with 0.5 ml of Gardasil. On 26-MAY-
2007 after she was vaccinated, the patient experienced dizziness and passed out. The patient sought unspecified medical attention. Subsequently, the patient
recovered from the events. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284538-1

Unknown F 29-May-2007 29-May-2007 0 18-Jun-2007 17-Jul-2007 KS WAES0705USA05748 18-Jul-2007

Symptom Text: Information has been received from a physician concerning a female patient with a urinary tract infection who on 29-MAY-2007 was vaccinated IM with
Gardasil. Concomitant therapy included Menactra. That same day, the patient experienced pain and swelling at the injection site. The patient sought
Lab Data:
History:
Prex Illness: Urinary tract infection
Prex Vax Illns:

Vaers Id: 284539-1


MedDRA PT Headache, Hyperhidrosis
Symptom Text: Information has been received from a nurse concerning a 2 patients who were vaccinated IM with Gardasil. Subsequently the patients experienced a headache
and sweating. This is one of several reports received from the same source. No further information is available.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284540-1

Unknown F Unknown Unknown 18-Jun-2007 17-Jul-2007 MI WAES0705USA05760 18-Jul-2007

Symptom Text: Information has been received from a registered nurse concerning a female who was vaccinated IM with a 0.5 mL dose of Gardasil. Subsequently, post
vaccination, the patient experienced tingling of the same arm she was vaccinated. The patient sought unspecified medical attention. The patient's outcome was
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284541-1

20.0 F 01-Feb-2007 01-Feb-2007 0 18-Jun-2007 17-Jul-2007 TX WAES0705USA05763 18-Jul-2007

MedDRA PT Drug exposure during pregnancy, Inappropriate schedule of drug administration, Sinus congestion
Symptom Text: Information has been received from a licensed visiting nurse for the pregnancy registry for Gardasil concerning a 20 year old female with abdominal pain and
inguinal lymphadenopathy (treated with doxycline therapy) and a history of recurrent upper respiratory sinus infections who on 30-NOV-2006 was vaccinated
with the first dose of Gardasil. On 01-FEB-2007, the patient was vaccinated with the second dose of Gardasil. On 09-MAY-2007, the patient was seen in her
physician's office with a complaint of sinus congestion. On this visit, the patient reported that she was pregnant, and had seen her gynecologist one month ago.
The patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Sinus infection
Prex Illness: Abdominal pain; Lymphadenopathy inguinal; Pregnancy NOS (LMP = Unknown)
Prex Vax Illns:

Vaers Id: 284542-1

13.0 F Unknown Unknown 18-Jun-2007 17-Jul-2007 CA WAES0705USA05764 18-Jul-2007

MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a 13 year old female who was vaccinated with a dose of Gardasil. Subsequently, the patient
developed a bad rash after the vaccination. The patient visited and urgent care center for unspecified treatment. The patient's outcome was unknown.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284543-1

11.0 F Unknown Unknown 18-Jun-2007 17-Jul-2007 TX WAES0705USA05771 30-Aug-2007
DTAP UNKNOWN MANUFACTURER NULL Unknown Unknown
Symptom Text: Information has been received from a medical assistant concerning an 11 year old female who was vaccinated with the first dose of Gardasil. Concomitant
therapy included DTaP (unspecified) (+) Menactra, both administered in the opposite arm. It was reported that 20 seconds after vaccination with Gardasil, the
patient fainted. The patient recovered after five to ten seconds, although, bumped her head on the floor. X-rays of the patient's head were taken (results not
reported). The outcome of the patient's head injury was unknown. Additional information has been requested. This is one of two reports received fro the same
source.
Other Meds:
Lab Data: skull X-ray - unknown results
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284544-1

23.0 F 01-May-2007 Unknown 18-Jun-2007 17-Jul-2007 MO WAES0706USA00002 18-Jul-2007

MedDRA PT Injection site reaction, Urticaria
Symptom Text: Information has been received from a registered nurse concerning a 23 year old female who in approximately May 2007, was vaccinated with Gardasil.
Subsequently the patient experienced a red welt at injection site. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284545-1

22.0 F 14-Mar-2007 16-Apr-2007 33 18-Jun-2007 17-Jul-2007 -- WAES0706USA0011 18-Jul-2007

Symptom Text: Information has been received from a physician's assistant concerning a 22 year old female with a history of an unspecified reaction to Lortab who on 14-MAR-
2007 was vaccinated with her second dose of Gardasil (lot# 657617/0384U). Concomitant therapy included unspecified birth control. The patient experienced
pain at the injection site. As of 31-MAY-2007 she was recovering. Additional information has been requested.
Lab Data: None
History: Adverse drug reaction
Prex Illness:
Prex Vax Illns:

Vaers Id: 284546-1


MedDRA PT Tachycardia
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced tachycardia.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284547-1


MedDRA PT Nausea
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female who on 24-MAY-2007 was vaccinated with Gardasil. Concomitant
therapy included , given at the same time. On 24-MAY-2007 the patient was extremely nauseous after her vaccinations. Subsequently, the patient recovered.
Other Meds: diphtheria toxoid (+)
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284548-1


MedDRA PT Syncope
Symptom Text: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil. Subsequently the patient fainted. This is one of
several reports from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284549-1


MedDRA PT Dizziness, Vomiting
Symptom Text: Information has been received from a nurse concerning a 12 year old female who was vaccinated with Gardasil, 0.5 mL IM. Subsequently, the patient
experienced vomiting and dizziness. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from vomiting and
dizziness. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284550-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female who on 16-MAY-2007 was vaccinated with her first dose of Gardasil.
Concomitant therapy included Menactra. On 16-MAY-2007 the patient fainted. Subsequently, the patient recovered from fainted. Additional information has
been requested.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284551-1

Unknown F 22-Nov-2006 22-Nov-2006 0 18-Jun-2007 17-Jul-2007 -- WAES0706USA00023 18-Jul-2007

Symptom Text: Information has been received from a physician concerning a female who on 22-NOV-2006 was vaccinated with Gardasil. On 22-NOV-2006 the patient passed
out in the lobby 5 minutes after she was vaccinated. The patient recovered. It was noted that the patient's mother has a history of syncope. Subsequently, the
patient received dose 2 and dose 3 without any adverse experience. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284552-1


MedDRA PT Body temperature increased, Dizziness, Dizziness
Symptom Text: Information has been received from a health professional concerning an 11 year old female who on 27-MAR-207 was vaccinated with Gardasil (lot number
657736/0389U). Two months later, on 29-MAY-2007, she received her third dose of the vaccination (lot number 657736/0389U). On 30-May-2007 the patient
experienced dizziness, felt lightheaded and developed an elevated temperature. Degree of fever is unknown. At the time of this report, the patient had not
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284553-1


MedDRA PT Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Three to four days after she received the vaccination,
she experienced nausea, vomiting and fever. The physician felt that the nausea, vomiting and fever were not related to therapy with Gardasil. He noted that he
had a lot of patients with the flu. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284554-1


Symptom Text: Information has been received from a registered nurse, concerning a 12 year old female patient, who in May 2007, was vaccinated with a dose of Gardasil. Two
days after the vaccination, the patient had a "breakthrough menstrual period;" the patient's LMP was 2 weeks prior to the vaccination. The nurse clarified, this
was not 'spotting," but rather a "normal flow period," and confirmed that the patient had not experienced anything similar prior to the vaccination. The patient
sought unspecified medical attention. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284555-1

16.0 F Unknown 17-May-2007 18-Jun-2007 17-Jul-2007 MN WAES0706USA00033 18-Jul-2007

Symptom Text: Information has been received from a licensed practical nurse concerning a 16 year old female who was vaccinated IM with the second 0.5 ml dose of Gardasil.
On 17-MAY-2007 after receiving the vaccine the patient fainted and was unconscious for a few seconds. The patient sought unspecified medical attention. No
treatment was required. Subsequently, the patient recovered from fainting. The patient did not experience any adverse symptoms after the first dose. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284556-1

Unknown F Unknown Unknown 18-Jun-2007 17-Jul-2007 CA WAES0706USA00037 18-Jul-2007

MedDRA PT Dizziness, Injection site pain
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced
injection site soreness and dizziness. Unspecified medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284557-1

21.0 F 01-Nov-2006 01-Nov-2006 0 18-Jun-2007 17-Jul-2007 -- WAES0706USA00038 18-Jul-2007

MedDRA PT Asthenia, Pyrexia
Symptom Text: Information has been received from a certified nurse midwife concerning a 21 year old female with lactose intolerance who in November 2006, was vaccinated
with a first dose of Gardasil. There were no concomitant medications. Subsequently, 12 to 24 hours after the first, the patient experienced "extreme weakness"
and fever > 100 F. Unspecified medical attention was sought. Subsequently, the patient recovered from "extreme weakness" and fever > 100 F. On an
unspecified date, the patient was vaccinated with a second dose of Gardasil. Subsequently, 12 to 24 hours after the second, the patient experienced "extreme
weakness" and fever > 100 F. Unspecified medical attention was sought. Subsequently, the patient recovered from "extreme weakness" and fever > 100 F.
Other Meds: None
Lab Data: Unknown
History:
Prex Illness: Lactose intolerance
Prex Vax Illns:

Vaers Id: 284558-1

Unknown F Unknown Unknown 18-Jun-2007 17-Jul-2007 TX WAES0706USA00040 18-Jul-2007
MedDRA PT Syncope
Symptom Text: Information has been received from a licensed practical nurse concerning a female patient who was vaccinated with a first dose of Gardasil. Concomitant
therapy given on the same day included a dose of Varivax and a dose of DTaP on the same day. It was reported that Gardasil was the last in that series of
vaccines the patient received. Subsequently, the patient fainted. Unspecified medical attention was sought. On an unknown date, the patient recovered. No
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284559-1

19.0 F Unknown 30-May-2007 18-Jun-2007 17-Jul-2007 MO WAES0706USA00046 18-Jul-2007

Symptom Text: Information has been received from a physician concerning a 19 year old female patient who was vaccinated in the arm with a first dose of Gardasil.
Subsequently the day after, the injection complained of significant pain in the arm at the injection site and in her upper arm toward her shoulder. The soreness
in her arm lasted for one week and then dissipated. However, subsequently the soreness returned and as 30-MAY-2007 the patient was still experiencing pain
and soreness. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284560-1

13.0 F 01-Feb-2007 01-Feb-2007 0 18-Jun-2007 17-Jul-2007 CA WAES0706USA00047 18-Jul-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a staff member concerning her 13 year old daughter who in February 2007, was vaccinated with a first dose of Gardasil.
Subsequently, the patient fainted after receiving the vaccine. It was reported that the patient recovered, but she fainted again 3 weeks later in school.
Unspecified medical attention. Laboratory diagnostic studies included a CAT scan and was reported to be normal. On an unspecified date in April 2007 the
patient received a second dose of Gardasil and did not faint. At the time of this report, the patient recovered. No product quality complaint was involved.
Other Meds: Unknown
Lab Data: computed axial - normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284561-1

18.0 F 30-Apr-2007 30-Apr-2007 0 18-Jun-2007 17-Jul-2007 CA WAES0706USA00049 18-Jul-2007

Symptom Text: Information has been received from a physician concerning an 18 year old female who on approximately 30-APR-2007 was vaccinated with the first dose of
Gardasil. It was reported that as the patient was leaving the medical office, she lost consciousness and fainted. The patient regained consciousness and
remained in the office for a period of time for observation and was given liquids. The patient recovered and subsequently left the office. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284562-1

Unknown F 30-Jan-2007 Unknown 18-Jun-2007 17-Jul-2007 -- WAES0706USA00074 18-Jul-2007

MedDRA PT Menstruation delayed
Symptom Text: Information has been received from a female consumer who on 30-JAN-2007 was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently the patient
stated that as of 31-MAY-2007, she had not gotten her periods. At the time of this report, the patient had not received the second and third doses of the
vaccine. The patient did not have a physician at the time of this report. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284563-1


MedDRA PT Dizziness
Symptom Text: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced
dizziness. This is one of several reports from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284564-1

15.0 F Unknown Unknown 18-Jun-2007 17-Jul-2007 NY WAES0706USA00267 18-Jul-2007

MedDRA PT Dizziness, Loss of consciousness, Vomiting
Symptom Text: Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil. It was reported that "Patient experienced
dizziness, vomiting and lost consciousness for short period of time after receiving Gardasil. It is not known which dose this was in the series." Lot number was
not available. Unspecified medical attention was sought. No further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284565-1

12.0 F Unknown Unknown 18-Jun-2007 17-Jul-2007 NY WAES0706USA00304 18-Jul-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who was vaccinated with a dose
Gardasil (date and dose not specified). The physician reported that the patient experienced dizziness after receiving the vaccination, and subsequently,
recovered (duration not specified). Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284566-1


Symptom Text: Information has been received from a Nurse Practitioner (N.P.) concerning three patients who were vaccinated with a dose of Gardasil and developed genital
warts within a short period. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284567-1


Symptom Text: Information has been received from a certified medical assistant (C.M.A.) concerning a female patient between the ages of 11 to 15 years old who on an
unspecified date was vaccinated with a 0.5 mL dose of Gardasil, (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for
about a week. This is one of several reports from the same source. Additional information has been requested
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284568-1


about a week. This is one of several reports from the same source. Additional information has been requested
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284569-1


about a week. This is one of several reports from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284570-1


Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284571-1


Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284572-1


Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284573-1


unspecified date was vaccinated with a 0.5 mL dose of Gardasil, (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284574-1

Unknown F Unknown Unknown 18-Jun-2007 18-Jul-2007 -- WAES070601130 18-Jul-2007

Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284575-1


unspecified date was vaccinated with a 0.5 mL dose of Gardasil (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for
about a week. This is one of several reports from the source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284576-1


Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284577-1


MedDRA PT Arthralgia, Arthralgia, Body temperature increased, Headache
Symptom Text: Information has been received concerning a 25 year old female patient who on 09-MAY-2007 was vaccinated intramuscularly in the right deltoid with the third
dose of Gardasil (0.5 ml) (lot #657622/0388U). (Dates of the patient's first two injection were not provided). There was no concomitant medication. On 09-MAY-
2007, a few hours after vaccination, the patient experienced a headache, knee and joint soreness and a mild temperature (actual temperature not provided).
The patient took acetaminophen (Tylenol) for the "nagging headache". It was reported that she did not have shortness of breath, vertigo, nausea or vomiting. It
was reported that after 24 hours the symptoms resolved. Additional information has been requested.
Other Meds: None
Lab Data: vital sign 12/13/06 - normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284578-1


Symptom Text: Information has been received from a licensed practical nurse concerning a female patient in her 20's who was vaccinated with a dose of Gardasil and
experienced mild soreness at the injection site after the vaccination was given. The same source reported that another had the same reaction (WAES #
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284579-1


MedDRA PT Chills, Dyspnoea, Hyperhidrosis, Injection site swelling, Pyrexia
Symptom Text: Information has been received from a physician concerning a female with asthma who was vaccinated with the first dose of Gardasil "a few weeks ago."
Subsequently, while at home, the patient developed fever, chills, sweating, difficulty breathing and swelling at the injection site. The patient sought unspecified
medical treatment. On an unspecified date, the patient recovered. Additional information has been requested. This is one of two reports received from the same
source.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 284580-1

15.0 F Unknown Unknown 18-Jun-2007 18-Jul-2007 CA WAES0706USA01455 18-Jul-2007

MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a 15 year old female who was vaccinated with a dose of Gardasil. Subsequently, the patient
developed bad rash. The patient visited an urgent care center for unspecified treatment. The patient's outcome was unknown. Additional information has been
requested. This is one of two reports received from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284581-1

9.0 F Unknown Unknown 18-Jun-2007 16-Jul-2007 TX WAES0706USA01472 17-Jul-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a medical assistant concerning a 9 year old female who was vaccinated with the first dose of Gardasil. It was reported that
the patient appeared to be nervous prior to vaccination, and subsequently, 5-10 seconds after vaccination the patient fainted. The patient's mother caught her
so that she did not fall and incur any additional injury. The patient sought unspecified medical attention. It took 5-10 minutes for the patient to fully recover, and
then she was able to leave the office. Additional information has been requested. This is one of two reports received from the same source.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Nervousness
Prex Vax Illns:

Vaers Id: 284582-1

26.0 F Unknown Unknown 18-Jun-2007 16-Jul-2007 NJ WAES0706USA01484 17-Jul-2007

Symptom Text: Information has been received from a licensed practical nurse (LPN) concerning a 26 year old female, who was vaccinated with a dose of Gardasil.
Immediately after vaccination, the patient experienced numbness and tingling in the fingers on the hand of the arm the patient was vaccinated. The numbness
and tingling were of "fleeting duration," and subsequently, the patient recovered without sequelae. No further is available. This is one of two reports received
from the same reporter.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284583-1


MedDRA PT Sensation of heaviness
Symptom Text: Information has been received from a health professional concerning a patient who was vaccinated with a first dose of Gardasil. Subsequently the patient
became "lossy" and had a heavy feeling on the arm after the receiving the vaccine. Therapy with Gardasil was discontinued. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284584-1


Symptom Text: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently the
patient passed out after receiving the vaccine. Therapy with Gardasil was discontinued. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284585-1


Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284586-1


Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284587-1


patient became "lossy" and had a heavy feeling on the arm after receiving the vaccine. Therapy with Gardasil was discontinued. Additional information has
been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284588-1


been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284589-1


been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284624-1


MedDRA PT Tic
Symptom Text: Simple motor tic- shrugging shoulder, persistent x 1 month, 1st noted approximately 2d after Gardasil vaccine.
Other Meds: None
Lab Data: None
History: ADHD
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284651-1

13.0 F 10-May-2007 10-May-2007 0 16-Jul-2007 24-Jul-2007 PA 25-Jul-2007
UNK UNKNOWN MANUFACTURER 0368U 1 Right arm Unknown
Symptom Text: Andrea passed out on our way out of the DR office. She did come to pretty quickly without assistance. She has not had this happen before after shots. She
also had the Varinox #2 (Merck/0368U) shot that day - I couldn't find it on the drop-down box below.
Other Meds: NA
Lab Data: NA
History: Andrea has a VSD with no restrictions that has never caused her any problems.
Prex Illness: No
Prex Vax Illns:

Vaers Id: 284652-1

17.0 F 15-May-2007 15-May-2007 0 13-Jul-2007 16-Jul-2007 FR D0053905A 17-Jul-2007
TDAP GLAXOSMITHKLINE AC37B024CB Right arm Unknown
BIOLOGICALS
HPV4 MERCK & CO. INC. NE51790 Left arm Unknown
MedDRA PT Erythema multiforme, Injection site swelling, Rash papular, Urticaria
Symptom Text: This case was reported by a regulatory authority and described the occurrence of erythema exsudativum multiforme in a 17-year-old female subject who was
vaccinated with Boostrix for prophylaxis. The subject received no concomitant medication. Concomitant vaccination included Gardasil (Non-GSK) (Sanofi
Pasteur MSD). On 15 May 2007 the subject received the first dose of Boostrix (0.5 ml, unknown, left deltoid) and an unknown dose of Gardasil (0.5 ml,
unknown, right deltoid), contralaterally. Approximately one week post vaccination with Boostrix, on an unknown date in May 2007, the subject experienced
erythema exsudativum multiforme with generalized urticarial and papular rash. Additionally, the subject experienced very severe injection site swelling at the
site of vaccination with Boostrix. The injection site of vaccination with Gardasil was uneventful. This case was assessed as medically serious by GSK criteria.
The subject was not hospitalized for these events. The subject was treated with systemic corticosteroid (Corticoid). The events were resolved after some days
on an unknown date in 2007. The reporter considered that the causal relationship of the systemic events to vaccination with Boostrix was evident due to the
concurrent severe local injection site and due to the morphological similarity. No further information will be available.
Other Meds:
Lab Data: UNK
History:
Prex Vax Illns:

Vaers Id: 284666-1

BIOLOGICALS
MedDRA PT Erythema, Oedema peripheral, Skin warm
Symptom Text: No fever, redness, slight swelling, RA, warm to touch, slightly firm advised to go to ER. Treatment per ER physician Claritin, Benadryl, Ibuprofen 200mg.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284706-1

24.4 F 29-May-2007 29-Jun-2007 31 16-Jul-2007 17-Jul-2007 -- WAES0706USA02076 17-Jul-2007

MedDRA PT Abortion induced, Abortion induced, Drug exposure during pregnancy
Symptom Text: Information has been received from a licensed practical nurse through the Merck pregnancy concerning a female patient with latex allergy and a history of
bipolar disorder who on 29-MAY-2007, was vaccinated IM with a first 0.5 ml dose of Gardasil (Lot# 655324/0089U). Concomitant therapy included lamotrigine
(LAMICTAL), valacyclovir HCl (VALTREX), aripiprazole (ABILIFY), vitamins (unspecified), garlic extract (+) omega-3 marine triglycerides (+) vitamin E
(OPTIMUM OMEGA), calcium (unspecified), ascorbic acid and pyridoxine. Subsequently, the nurse reported that the patient had a positive pregnancy test and
will be terminating her pregnancy. Follow up information stated that the patient terminated her pregnancy on 29-JUN-2007. Unspecified medical attention was
sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, terminated her
pregnancy was considered to be an other important medical event. Additional information has been requested.
Other Meds: Abilify, ascorbic acid, calcium (unspecified), Optimum Omega, Lamictal, pyridoxine, Valtrex, vitamins (unspecified)
Lab Data: beta-human chorionic - positive
History: Bipolar disorder
Prex Illness: Pregnancy NOS (LMP = 5/6/2007), Latex allergy
Prex Vax Illns:

Vaers Id: 284707-1

17.0 F 16-Feb-2007 16-Feb-2007 0 16-Jul-2007 17-Jul-2007 -- WAES0707USA00454 17-Jul-2007

MedDRA PT Death neonatal, Drug exposure during pregnancy, Premature baby
Symptom Text: Information has been received from a nurse practitioner as part of the pregnancy registry for Gardasil concerning a 17 year old female with no history of drug
reactions/allergy who on 16-FEB-2007 was vaccinated with a first dose of Gardasil (lot # 656049/0187U) 0.5 ml IM. On 06-JUN-2007, was vaccinated with a
second dose of Gardasil (lot # 657736/0389U). There was no concomitant medication. Medical attention was sought. It was reported that the patient did not
know she was pregnant until a baby was delivered on the patient's bathroom floor on 21-JUN-2007 at an approximated gestation of 30 weeks. Estimated date
of delivery September 2007. The baby died eight days later on 29-JUN-2007 of schizencephaly. The patient claimed to be unaware of her pregnancy because
she had her menstrual periods throughout her pregnancy and did not gain weight. The patient had no prenatal care. No other information was available at the
time of reporting. Additional information has been requested.
Other Meds: None
Lab Data:
History:
Prex Vax Illns:

Vaers Id: 284708-1

21.0 F 01-Jun-2007 01-Jun-2007 0 16-Jul-2007 17-Jul-2007 FR WAES0707USA01348 06-Aug-2007

MedDRA PT Convulsion, Dizziness, Hypotension, Pulse pressure decreased, Syncope
Symptom Text: Information has been received from a health professional concerning a 21 year old female patient with a history of feeling dizzy following blood tests, who in
June 2007, was vaccinated with a first dose of Gardasil. Ten minutes post vaccination, the patient fainted, experienced a weak pulse, low blood pressure and
experienced a short fit. It was reported that there was no associated lip or tongue swelling. The patient received treatment with oxygen. Subsequently, the
patient recovered. The reporter considered a short fit, low blood pressure, fainted and weak pulse, to be other important medical events. Other business
partners numbers included: E200704423. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Dizziness
Prex Illness:
Prex Vax Illns:

Vaers Id: 284709-1


MedDRA PT Accommodation disorder, Cerebellar syndrome, Diplopia, Intention tremor, Nausea
Symptom Text: Information has been received from a pediatrician concerning a 15 year old female patient with no medical history who on 18-JUN-2007, was vaccinated with a
first dose of Gardasil. On 20-JUN-2007, the patient experienced dysdiadochokinesis, intention tremor, accommodation disorder with diplopia and nausea.
Laboratory diagnostic studies included EEG and MRI which showed normal results. In the Cerebral Spinal Fluid, protein was moderately increased (no exact
results reported). Blood tests were also taken, the results are not known. At the time of this report, the patient had not yet recovered. The reporter considered
dysdiadochokinesis, nausea, accommodation disorder and intention tremor to be other important medical events. Other business partners numbers include:
E200704378. No further information is expected.
Other Meds: Unknown
Lab Data: electroencephalography normal results, magnetic resonance imaging normal results, laboratory test increased serum lipids in liquor/blood test, cerebrospinal
fluid total protein test moderately increased
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284720-1

18.0 F 12-Jun-2007 12-Jun-2007 0 16-Jul-2007 14-Aug-2007 FL 200702231 15-Aug-2007
MedDRA PT Lip swelling, Oedema peripheral, Oedema peripheral, Pyrexia, Urticaria
Symptom Text: A case was reported by a health professional in the United States on 18 June 2007. An 18-year-old female patient experienced hives, swelling of the lip, hands,
and feet, and fever after receiving an intramuscular deltoid injection of Menactra (lot number U2339AA) and Gardasil (lot number 0523U). The vaccines were
administered on 12 June 2007, and within 24 hours the patient developed hives, swelling of the lip, hands, and feet, and fever (no documented temperature).
Treatment included Benadryl and Tylenol, and the patient was seen by her physician on 13 June 2007 and 18 June 2007. The patient had a history of scoliosis
with spinal fusion (07 July 2005). No concomitant medications were reported, and it was unknown if the patient had any illness at the time of vaccination.
Outcome was unknown.
Other Meds:
Lab Data:
History: Scoliosis, spinal fusion (08/Jul/2005)
Prex Illness:
Prex Vax Illns:

Vaers Id: 284726-1


MedDRA PT Throat irritation, Urticaria
Symptom Text: pt had a few hives on 7/10/07-later in day after the Gardasil. Hives were worse on 7/11/07 with itch throat. Went to ER-given Benadryl and Prednisone x 7 days.
pt also given an Epi Pen for future use.
Other Meds:
Lab Data:
History: h/o seasonal allergies, Suprax
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284746-1

15.0 F 07-Jun-2007 07-Jun-2007 0 16-Jul-2007 19-Jul-2007 VA 20-Jul-2007

MedDRA PT Erythema, Mobility decreased, Nodule, Swelling, Tenderness
Symptom Text: RECEIVED GARDASIL #2 6/7/07. SUBSEQUENTLY ARM BECAME MARKEDLY SWOLLEN, TENDER, AND ERYTHEMATUS. HAD DECREASED R.O.M.
SAW DR. WHO PLACED PATIENT ON KEFLEX FOR 10 DAYS. ON 7/2/07, ARM STILL TENDER WITH 3CM ERYTHEMATUS NODULEAR TENDER TO
TOUCH.
Other Meds:
Lab Data: NON
History:
Prex Illness: NONE
Prex Vax Illns:



MedDRA PT Injection site rash, Rash erythematous, Rash pruritic
Symptom Text: Gardasil shot on 6/5, 6/6 noticed bumps above shot area, (+) itch, 6/7 bumps spread across chest area. Patchy area on chest, red and bumpy. (+) itch Tx with
hydrocortisone cream, Caladryl cream + oatmeal baths. OTC itch cream.
Other Meds: Orthotryclen Lo
Lab Data: None
History: Seasonal allergies, otherwise none
Prex Illness: None
Prex Vax Illns:


24.0 F 05-Jun-2007 06-Jun-2007 1 18-Jul-2007 15-Aug-2007 -- WAES0706USA02372 22-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from a consumer concerning her 24 year old daughter with no pertinent medical history or drug reactions/allergies who on 05-
JUN-2007 was vaccinated with first dose of Gardasil (lot number unknown) 0.5 mL IM. There is no concomitant medication. The consumer reported that on 06-
JUN-2007, the next day her daughter broke out in a rash all over her chest. Medical attention was not sought. At the time of reporting, the patient was
recovering. No additional information is expected.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284774-1

16.0 F 13-Jul-2007 Unknown 16-Jul-2007 25-Jul-2007 CA 26-Jul-2007
Symptom Text: Syncope immediately post vaccination (Most likely vasovagal)

Other Meds:
Lab Data:
History: Hx Allergic Rhinitis/Hx Syncope/Near Syncope Vasovagal Dx cleared by cardiology
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284775-1

18.0 F 26-Jun-2007 Unknown 16-Jul-2007 25-Jul-2007 IA 06-Aug-2007
TDAP GLAXOSMITHKLINE AC52B002AB 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Feeling of body temperature change, Mydriasis, Pallor, Staring
Symptom Text: HPV#1 was given and pt c/o a warm feeling, she started to stare, pupils dilated and color went pale. Pt was quickly helped to a supine position and was
responsive and did not have a loss of consciousness due to quick action
Other Meds: None
Lab Data: Pt had a near syncopal episode but with quickly placing supine was averted. Pt. observed x 30 min. and left feeling fine. Pt had not eaten. Given water and
crackers.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284776-1

13.0 M 29-Jun-2007 06-Jul-2007 7 16-Jul-2007 25-Jul-2007 WI 06-Aug-2007
Symptom Text: (R) facial nerve palsy Treatment-Doxycycline 100 mg po bid Prednisone 50 mg po dd x 5 dy 7/19/07-records received-7/6/07 seen in ED. 7/12/07 follow-up
visit. Right facial nerve pasy. No headaches, no fever no ear pain. Improved mobility, noticing that she is able to open and close her eye a little bit more, able to
close eye 90% of way. . Speech better. No associated weakness. No joint swelling
Other Meds: None
Lab Data: ESR 13 Lyme titer 0.58 records received 7/19/07- Lyme titer negative.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284780-1

14.0 F 26-Jun-2007 26-Jun-2007 0 16-Jul-2007 25-Jul-2007 IA 26-Jul-2007

MedDRA PT Mydriasis, Pallor, Syncope
Symptom Text: Pt fainted with-in one minute after receiving Gardasil. Her eyes had dilated pupils and her color was pale. She was quickly placed supine. Mother stated she
woke her up and brought her in. She had not eaten or had fluids that morning. She was talking after being placed supine and had completely recovered 3 min
later.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284855-1 (S)

15.0 F 05-Apr-2007 24-Jun-2007 80 17-Jul-2007 18-Jul-2007 FR WAES0707USA00892 18-Jul-2007

MedDRA PT Encephalitis viral, Leukoencephalomyelitis
Symptom Text: Information has been received from a gynecologist concerning a 15 year old female with no medical history reported who on 05-APR-2007 was vaccinated with
first dose of Gardasil. On 30-MAY-2007, the patient was vaccinated with second dose of Gardasil (lot # 1340F; batch # NF14740). On 24-JUN-2007, the patient
was hospitalized due to suspicious virus-encephalitis. A magnetic resonance imaging was performed which showed alterations. The results of the lumbar
puncture were not reported in detail but no typical viruses causing a viral encephalitis were found. The diagnosis reported from the physician at the hospital was
acute disseminated encephalomyelitis. The treatment in the hospital was cortisone, antibiotics, and Zovirax (ACYCLOVIR). At the time of the report, the patient
was still in the hospital but recovering. The acute disseminated encephalomyelitis was considered to be immediately life-threatening. Other business partner
numbers included: E2007-04352. No further information is available.
Other Meds: Unknown
Lab Data: magnetic resonance imaging alterations; spinal tap no typical viruses causing viral encephalitis were found
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284856-1

26.0 F 03-Apr-2007 04-Jun-2007 62 17-Jul-2007 18-Jul-2007 -- WAES0707USA01083 18-Jul-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Ectopic pregnancy
Symptom Text: Information has been received from a registered nurse concerning a 26 year old female with no relevant medical history reported who on 03-APR-2007 was
vaccinated intramuscularly with a 0.5 mL dose of Gardasil. There was no concomitant medication. on 04-JUN-2007, the patient returned to the office for her
second dose of Gardasil. Dose 2 was not given because she tested positive for pregnancy on that day. In June 2007, the patient had a miscarriage. It was
determined that the patient experienced an ectopic pregnancy. The patient returned to the office on 06-JUL-2007 to receive dose 2 of Gardasil. The nurse
reported that the patient was "fine now". Upon internal review, ectopic pregnancy and miscarriage were determined to be other important medical events.
Other Meds: None
Lab Data: urine beta-human 06/04/07 positive
History:
Prex Vax Illns:

Vaers Id: 284857-1


MedDRA PT Circulatory collapse, Condition aggravated, Epilepsy, Immediate post-injection reaction
Symptom Text: Information has been received from a gynecologist, concerning a 17 year old female patient with a history of vascular collapse and epileptiform movement, who
on 08-JUN-2007, was vaccinated IM in the arm, with the first dose of Gardasil (Lot #655376/0572F; Batch NE45050). On 08-JUN-2007, immediately following
the vaccination, the patient experienced vascular collapse followed by epileptiform movement. The event lasted for 5 minutes, and the patient then recovered.
An examination was performed by a neurologist, and no pathologies were found. Additional exams were scheduled. The reporter considered vascular collapse
and epiltiform movement to be serious, as other important medical events. Other business partner numbers include: E2007-04376.
Other Meds: Unknown
Lab Data: Unknown
History: Vascular collapse; Epileptiform movement
Prex Illness:
Prex Vax Illns:

Vaers Id: 284858-1


Symptom Text: Information has been received from a physician concerning a 13 year old female, with no seizure history or family seizure history, who on an unspecified date
was vaccinated with a second dose of Gardasil on an unspecified date. Subsequently, on an unspecified date, the patient experienced a seizure in gym class.
The patient was taken to the hospital. The seizure occurred at a "period of time" after the 2nd vaccination. The patient was placed on seizure medication which
is controlling the seizures. The patient recovered. The patient has not had any other seizures since the first seizure. The patient was then vaccinated with a
third dose of Gardasil without any problems. Upon internal review, seizures was considered to be an other important medical event. Additional information has
been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284862-1

14.0 F 27-Feb-2007 01-Mar-2007 2 17-Jul-2007 27-Jul-2007 PA 27-Jul-2007

MedDRA PT Arthralgia, Pyrexia
Symptom Text: Arthralgias (in knees/ankles/feet i.e small jts) finges/toeswrist, Fever Sx approx. 2-3 days after Gardasil
Other Meds: None
Lab Data: All labs for arthritis/SLE negative per rheumatology
History: Possible early glaucoma
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284865-1

MedDRA PT Dizziness, Hyperhidrosis, Pallor
Symptom Text: Pt appeared very pale and diaphoretic "feel like I'm going to pass out"-occurred 10 min after injection. VSS. Rested on side x 15 min and observed for total of
30 min.
Other Meds:
Lab Data: None
History: Amoxicillin allergy
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284869-1 (S)

18.0 F 13-Jul-2007 13-Jul-2007 0 17-Jul-2007 20-Jul-2007 MO 25-Jul-2007
HEPA MERCK & CO. INC. 02504 1 Left arm Unknown
HPV4 MERCK & CO. INC. 0523Y 0 Right arm Unknown
MedDRA PT Disorientation, Feeling abnormal, Foaming at mouth, Gaze palsy, Grand mal convulsion, Grunting, Headache, Hyperventilation, Staring, Syncope vasovagal,
Vaccination complication
Symptom Text: Menactra, Gardasil, Hep A (Vaqta) given 7/13/07. Left here, shortly after felt disjointed and blank stares. At approx 2250 came home found to have tonic-clonic
approx 45 sec sz with heavy breathing and frothy. 911 called admitted x 2 nights. 7/19/07-records received: Seizure likely secondary to vasovagal reaction.
After vaccine felt a bit disjointed and had a somewhat blank stare. Clonic movements, snorting and grunting, frothing at mouth. Travel to Caribbean 2 weeks
prior. Headache. Neuro exam WNL. Assessment:Generalized tonic clonic seizure status post vaccines. Most likely a reaction of one of the vaccines.
Other Meds: Zyrtec
Lab Data: CT NL; Chem 7 NL; CBC NL records received 7/19/07-MRI negative. CT negative. WBC 13.8, poly 82. Glucose 125. urine culture negative
History: records received 7/19/07-HX of anxious spells starting in May occurring monthly similar to ones that increased prior to generalized tonic clonic seizure.
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284886-1

Unknown U Unknown Unknown 13-Jul-2007 13-Aug-2007 -- WAES0703USA03794 13-Aug-2007

MedDRA PT Incorrect route of drug administration, Injection site mass, Injection site pain
Symptom Text: Information has been received from a health professional concerning over 150 patients who were vaccinated with Gardasil in the hip instead of the deltoid area.
Many of the patient reported pain at the injection site and a lump forming at the injection site. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284887-1

18.0 F Unknown Unknown 13-Jul-2007 13-Aug-2007 -- WAES0703USA03999 13-Aug-2007

MedDRA PT Pallor
Symptom Text: Information has been received from a physician concerning an 18 year old female who was vaccinated with Gardasil. After receiving her second dose of
vaccine, the patient from turned "ghost white." The patient sought unspecified medical attention. On an unspecified date, the patient recovered with turning
"ghost white." This is one of several reports received from the same source. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284888-1


MedDRA PT Dizziness, Incorrect route of drug administration
Symptom Text: Information has been received from a LPN concerning an 18year old female with no pertinent medical history and no prior drug reactions who on 21-FEB-2007
was vaccinated with second dose Gardasil (Lot#653978/955F). Concomitant therapy included ORTHO TRI-CYCLEN and BENADRYL as needed for rash/itch.
The patient was administered her first and second dose of Gardasil via the gluteus. The first dose was administered at another practice (not administered by
the reporting nurse's practice). On 12-FEB_2007, the patient received her second dose of Gardasil and within minutes of vaccination, she experienced
dizziness. Subsequently, after a few minutes, the patient recovered from dizziness. The patient sought unspecified medical attention. Additional information has
been requested.
Other Meds: BENADRYL; ORTHO TRI-CYCLEN
Lab Data: None
History:
Prex Illness: Rash Pruritus
Prex Vax Illns:

Vaers Id: 284889-1

25.0 F 13-Feb-2007 13-Feb-2007 0 13-Jul-2007 13-Aug-2007 NY WAES0703USA04764 13-Aug-2007

MedDRA PT Drug exposure during pregnancy, Haemorrhage
Symptom Text: Information has been received from a physician for the Pregnancy Registry of Gardasil concerning a 25 year old female with Von Willebrand's disease with a
history of 0 pregnancies and 0 live births and a history of left retinoblastoma who on 13-DEC-2006 was vaccinated with Gardasil, lot # 654389/0961F. On 13-
FEB-2007 she was vaccinated with Gardasil, lot # 656049/0187U expiration 29-SEP-2009. On 20-MAR-07 the patient went to the health clinic and a urine
pregnancy test was performed and the results were positive (6 weeks gestation, LMP= approximately 23-JAN-2007). On 21-MAR-2007 the patient went to the
hospital due to bleeding. A sonogram was performed and HCG levels were monitored. The patient was not hospitalized and she did not miscarry. The patient's
HCG levels are being monitored. The patient was not hospitalized and she did not miscarry. The patient's HCG levels are being monitored. This is one of
several reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: ultrasound 03/21/07, total serum human 03/21/07, urine beta-human 03/20/07 positive
History: Retinoblastoma; Eye excision
Prex Illness: Pregnancy NOS (LMP=1/23/2007) Von Willebrand's disease
Prex Vax Illns:

Vaers Id: 284890-1


MedDRA PT Influenza like illness
Symptom Text: Information has been received from a physician concerning a patient (age and gender not reported) who on unspecified dates was vaccinated with the first and
second doses of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced flu-like symptoms after
receiving the first and second doses of Gardasil. The patient sought unspecified medical attention. The outcome and causality of the events were not reported.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284891-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 15 year old female with an empty stomach who was vaccinated with Gardasil. Subsequently the
patient fainted immediately after receiving the Gardasil. Subsequently, the patient recovered from fainting. This is one of several reports received from the
same source. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284892-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 17 year old female with an empty stomach who was vaccinated with Gardasil. Subsequently the
patient fainted immediately after receiving the Gardasil. Subsequently, the patient recovered from fainting. This is one of several reports received from the
same source. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284893-1

14.0 F 02-Apr-2007 02-Apr-2007 0 13-Jul-2007 13-Aug-2007 OK WAES0704USA02535 14-Aug-2007

MedDRA PT Eye pruritus, Eye swelling
Symptom Text: Initial and follow up information has been received from a physician concerning a 14 year old female student with possible penicillin allergy who on 02-APR-
2007 was vaccinated IM with a first dose 0.5 mL of Gardasil lot # 655205/1426F. On 02-APR-2007 the patient developed swollen eyes after receiving the
injection. On 03-APR-2007 the patient was seen in the emergency room (E.R.) for swollen eyes and itching and was given BENADRYL intravenous (IV) and
ATERAX by mouth (PO). No abnormality of the eye found. On 05-APR-2007 the patient recovered. In follow up it was indicated that on 03-APR-2007, at AM
patient developed swollen eyes and itching. She was seen in the emergency room (E.R.) on 03 APR-2007 and no abnormality of the eyes found. She was
given treatment of BENADRYL intravenous (IV) and ATERAX by mouth. On 05-APR-2007 patient recovered. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 284894-1


MedDRA PT Injection site pain, Injection site pain
Symptom Text: Initial and follow up information has been received from the nursing staff and practice manager of a pediatric practice concerning patients who were vaccinated
with a dose of Gardasil and experienced injection site pain routinely when the Gardasil was given. The number of patients experiencing the injection site pain
was unreported, and it was unknown if medical attention was sought. The outcome was unknown. The reporter reported that one other pediatric office and
another physician reported patient experiencing pain after receiving the Gardasil. In follow up it was indicated by the practice manager that the pain was a
generalization that the girls were reporting a tenderness after the shot of Gardasil, but they were coming back for the second and third dose. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284895-1

24.0 F 08-Nov-2006 23-Mar-2007 135 13-Jul-2007 13-Aug-2007 -- WAES0705USA00321 14-Aug-2007

MedDRA PT Metrorrhagia, Nausea, Pregnancy
Symptom Text: Information has been received for a Merck Pregnancy Registry via a health professional concerning a female who on 06-SEP-2006 was vaccinated with the first
dose of Gardasil (lot not reported). On 08-NOV-2006, the patient was vaccinated with the second dose of Gardasil (lot reported as "9725101"). The patient was
found to be pregnant after receiving her second dose, and it was noted as "second trimester". Routine vital signs were noted to be performed. The patient
sought unspecified medical attention. Follow up information has been received concerning the black 24 year old female who had her last menstrual period on
27-FEB-2007 (estimated date of delivery, 04-NOV-2007). From 23-MAR-2007 to 03-MAY-2007 the patient was treated with PROMETRIUM, 200 mg BID, for
low progesterone. From 23-MAR-2007 to the present she was treated with PHENERGAN, 25 mg PRN for nausea. On 26-MAR-2007 an ultrasound was
performed due to "spotting". The results of test were "Early IOP". Additional information has been requested.
Other Meds: Unknown
Lab Data: Ultrasound 03/26/07 - "early IOP"
History:
Prex Vax Illns:

Vaers Id: 284896-1

Unknown U Unknown Unknown 13-Jul-2007 13-Aug-2007 OH WAES0705USA00580 14-Aug-2007

Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil (lot number unknown). The physician
reported that the patient experienced pain at the injection site after receiving the Gardasil routinely; however she had not had any issues with patients coming
back for the second and third injections. The outcome was unknown. Additional information was received from the office manager via phone call who reported
that the pain did not linger. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284897-1


Symptom Text: Information has been received from the nursing staff of a pediatric practice concerning patients who were vaccinated with a dose of Gardasil (lot number
unknown) and experienced pain at the injection site after receiving Gardasil. The pain was worse than the pain with other vaccines. The outcome was unknown.
Additional information was received from a registered nurse via phone call who reported that there were too many patients to quantify who complained about
the pain of the injection. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284898-1

22.0 F 01-Jan-2007 01-Mar-2007 59 13-Jul-2007 13-Aug-2007 -- WAES0706USA00199 14-Aug-2007

MedDRA PT Chest pain, Ultrasound scan normal
Symptom Text: Information has been received from a physician concerning a 22 year old female with no pertinent medical history and no history of drug reaction/allergies who
in January 2007, was vaccinated with a first dose of Gardasil (lot # not reported) 0.5 ml IM. Concomitant therapy included hormonal contraceptives
(unspecified). In March 2007, the patient experienced left sided chest pain. Medical attention was sought. There was no radiation and treatment prescribed. In
March 2007, the patient had an electrocardiogram, blood work and ultrasound performed; all results were negative. The patient was taking birth control but was
discontinued in march 2007. The pain resolved on its own. When the patient was seen again by the physician at the end of April 2007, the pain had resolved
completely. The physician restarted the birth control after the patient's visit in April, 2007. The patient was requesting the second dose of Gardasil. No
additional information was available at the time of reporting. Additional information has been requested.
Lab Data: electrocardiogram 03/01/07 - negative; ultrasound 03/??/07 - negative; diagnostic laboratory 03/01/07 - blood work: negative
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 284899-1

15.0 F 25-Apr-2007 25-Apr-2007 0 13-Jul-2007 13-Aug-2007 MD WAES0706USA00207 14-Aug-2007

MedDRA PT Injection site discomfort, Injection site pain
Symptom Text: Information has been received from a registered nurse concerning a 15 year old white female who on 25-APR-2007 was vaccinated IM into the right deltoid with
a 0.5 ml first dose of Gardasil (lot# 657621/0387U). On 25-APR-2007 the patient experienced pain at the injection site for three to four weeks after her injection.
The patient obtained relief with MOTRIN. The patient has occasional discomfort at the injection site with movement currently. At the time of this report, the
patient was recovering. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284900-1

13.0 F 29-May-2007 30-May-2007 1 13-Jul-2007 13-Aug-2007 WV WAES0706USA00208 14-Aug-2007

MedDRA PT Rash generalised, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 13 year old female with penicillin allergy who on 29-MAY-2007 was vaccinated IM with 0.5 ml of
the first dose of Gardasil (Lot #654702/0011U). There was no concomitant medication. On 30-MAY-2007 the patient experienced an all over body rash with
itching. Prior to the injection, the patient complained of her eyes hurting, an upper respiratory infection, and fatigue. The patient did not have a fever. The
physician performed an Epstein-Barr titer that came back with a result of "convalescencing". The patient was given Depo-Medrol on 30-MAY-2007 and
Garamycin ointment for her eye. As of 01-JUN-2007, the patient was recovering. Medical attention was sought. Additional information has been requested.
Other Meds: None
Lab Data: Epstein-Barr virus - convalescencing
History:
Prex Illness: Eye pain; Fatigue; Upper respiratory tract infection; Penicillin allergy
Prex Vax Illns:

Vaers Id: 284901-1

Unknown F 31-May-2007 31-May-2007 0 13-Jul-2007 13-Aug-2007 FL WAES0706USA00213 14-Aug-2007

MedDRA PT Dizziness, Nausea, Pyrexia
Symptom Text: Information has been received from a physician concerning a female patient who on 31-MAY-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot#
657005/0314U). On 31-MAY-2007, the patient experienced a fever of 102 deg F along with dizziness and nausea. Unspecified medical attention was sought. At
the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: body temp 05/31/07 102 F Fever
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284902-1

TDAP GLAXOSMITHKLINE NULL Unknown Intramuscular
BIOLOGICALS
HEPA MERCK & CO. INC. NULL Unknown Intramuscular
MedDRA PT Abdominal pain lower
Symptom Text: Information has been received from a physician concerning an "18 year old" female who on 18-MAY-2007 who on 18-MAY-2007 was vaccinated IM in her left
arm with Gardasil. Concomitant therapy included VAQTA and BOOSTRIX. On 19-MAY-2007 the patient experienced severe lower right abdominal pain. The
patient sought medical attention at the hospital and had a CT Scan performed. It was reported the CT Scan was normal and the patient was not admitted to the
hospital. Subsequently, the patient recovered from severe lower right abdominal pain. Additional information has been requested.
Other Meds:
Lab Data: Computed axial 05/19/07 - normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284903-1


MedDRA PT Musculoskeletal chest pain
Symptom Text: Information has been received from a 22 year old female nurse who on 23-MAY-2007 was vaccinated with the first dose of Gardasil. On 24-MAY-2007 the
patient experienced pain in her oblique muscles of her rib area. Subsequently, the patient recovered from pain in her oblique muscles of her rib area. No further
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284904-1


Symptom Text: Information has been received from a nurse concerning a 21 year old female patient who on 24-MAY-2007 was vaccinated with Gardasil. On 25-MAY-2007 the
patient experienced dizziness and nausea. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284905-1

Unknown F 25-May-2007 25-May-2007 0 13-Jul-2007 13-Aug-2007 PA WAES0706USA00316 14-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female who on 25-MAY-2007 was vaccinated with the second dose of Gardasil (Lot
#657736/0389U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On 25-MAY-2007 the patient fainted after receiving the
vaccination. The patient recovered that day and plans to receive the third injection of the vaccine. Medical attention was sought. Additional information has
been requested.
Other Meds: Depo-Provera
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 284906-1

Unknown F Unknown Unknown 13-Jul-2007 13-Aug-2007 -- WAES0706USA00323 14-Aug-2007

MedDRA PT Injection site induration, Leukopenia, Pyrexia
Symptom Text: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of Gardasil. The physician reported
that "the patient was not pregnant but had miscarried three weeks prior" to vaccination. "Weeks of gestation was not known." The patient was seeing again by
the physician on 07-JUN-2007. It was reported that two days after the patient received her dose of Gardasil, she was sent to the emergency room because she
had developed a fever, leucopenia, and a lower platelet count of 80,000 (also reported as 86,000). The patient was treated with ciprofloxacin hydrochloride
(CIPROFLOXACIN) and was sent home. The physician reported that "she has done well" but has a "big knot at the injection site, outer later quad in her leg
(specific leg not specified)" which was "red before, no longer red now, just a knot, a fibrinous deposition there." The patient was told by her hematologist that "it
was the vaccine and that this can happen in an immunization situation and not to take it again." The physician stated that "they need to find out what exactly
caused this reaction in her." It was reported that "she has no other significant allergies but a family history of allergies, specifically a strong history of allergy to
iodine dye used in radiology procedures." The patient "never wants to attempt any dye after all this." There was no product quality complaint. No further
Other Meds: Unknown
Lab Data: platelet count 86000 thrombocytopenia, WBC count 2000 leukopenia
History: Miscarriage
Prex Illness:
Prex Vax Illns:

Vaers Id: 284907-1

20.0 F 15-May-2007 24-May-2007 9 13-Jul-2007 13-Aug-2007 VA WAES0706USA00324 14-Aug-2007

MedDRA PT Dyskinesia, Feeling hot, Headache, Hyperhidrosis, Loss of consciousness, Muscle rigidity, Nausea, Sinusitis, Syncope, Vision blurred
Symptom Text: Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergy who on 15-MAY-2007 was vaccinated
with the second dose of Gardasil (lot number not provided). Concomitant therapy included hormonal contraceptive (unspecified). On 24-MAY-2007 the patient
fainted under the hair dryer at a beauty salon. The patient reported feeling hot then slumped forward unconscious. She was sweaty, her lips were white, and
her right side was jerking. The paramedics were called and they could not find a pulse but her blood pressure was low and her blood sugar was 65. She came
to before being transported to the emergency clinic and had blurred vision. At the hospital her left side began jerking, her left arm was rigid, and she had a
severe headache and nausea. She had many lab tests in the clinic including an electrocardiogram which was normal, a CT scan that was normal except for
sinusitis. She had no fever her pulse ox was 99, pulse 80 on arrival then 64 later, her blood pressure was 78/50 on arrival then 90/60 later, and her blood sugar
was 85. She was not admitted. Subsequently, the patient recovered from fainted, sinusitis, left arm rigid, left side jerking, blurred vision, right side jerking, right
side jerking, loss of consciousness, severe headache and nausea. Additional information has been requested.
Lab Data: blood pressure 05/24/07 8/50 on arrival, blood pressure 05/24/07 90/60 post-arrival, electrocardiogram 05/24/07 normal, computed axial 05/24/07 normal,
except sinusitis, blood glucose 05/24/07 65, pulse oximetry 05/24/07 99 on arrival, tota
History:
Prex Vax Illns:

Vaers Id: 284908-1

18.0 F 24-Apr-2007 24-Apr-2007 0 13-Jul-2007 13-Aug-2007 -- WAES0706USA00378 14-Aug-2007

MedDRA PT Drug exposure during pregnancy, Inappropriate schedule of drug administration, Off label use, Weight gain poor
Symptom Text: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 28 year old pregnant female with allergy to iodine
who on 06-FEB-2007 was vaccinated intramuscularly in the right deltoid with the first 0.5 mL dose of Gardasil (lot# 654741/1208F). On 24-APR-2007, the
patient was vaccinated intramuscularly in the right deltoid with the second 0.5 mL dose of Gardasil (lot# 655205/1426F). It was reported that the patient was 4
weeks into her gestation period and has a delivery date of 24-JAN-2008. The patient sought unspecified medical attention. The registered nurse reported that
the patient did not have any weight gain in the last 10 week. There was no product quality complaint involved. Additional information has been requested.
Other Meds: None
Lab Data: beta-human chorionic 05/22/07 posit, body mass index 05/22/07 low, hemoglobin 05/22/07 results not provided.
History: Hypersensitivity
Prex Illness:
Prex Vax Illns:


14.0 F 10-Jul-2007 13-Jul-2007 3 17-Jul-2007 23-Jul-2007 AL 29-Aug-2007
HPV4 MERCK & CO. INC. 0384U 2 Right leg Unknown

MedDRA PT Injection site induration, Local reaction, Pain, Pyrexia, Surgery, Swelling, Tenderness, Vaccine positive rechallenge
Symptom Text: 1st shot 3 days later swelling, fever, in right arm & breast next week later surgery 2 month later had nurse to put in opposite arm swelling reaction from
neck down on left side lots of pain no one told us of these side affects. 8/13/2007 MR received for ER visit 7/17/2007 for c/o swelling and tenderness in L
deltoid. PE (+) minimal induration at injection site and tenderness to palpation of the L back. DX: Local reaction to vaccination.
Other Meds:
Lab Data:
History: None. PMH: Cellulitis after 1st injection.
Prex Illness: hospilization surgery fever swelling
Prex Vax Illns: swelling pain fever hospilization~HPV (no brand name)~2~15~In Patient


14.7 F 10-Jul-2007 12-Jul-2007 2 18-Jul-2007 30-Jul-2007 AL 30-Jul-2007
MedDRA PT Discomfort, Injection site swelling, Injection site warmth, Pain
Symptom Text: Patient was seen on 7/17/07 with (L) arm swelling and warmth and complaints of (L) sided discomfort including face, arm, leg, and back, no other physical
findings. Sxs began 7/12/07 and worsened next 5-7 days. No fever but generalized aches.
Other Meds: None
Lab Data: None, treated with Naprosyn
History: After vaccines 5/4/07, breast cellulitis
Prex Illness: Local reaction/inflammatory
Prex Vax Illns:

Vaers Id: 284970-1

HPV4 MERCK & CO. INC. 1427E 1 Right arm Intramuscular

MedDRA PT Erythema multiforme
Symptom Text: Erythema Multiforme 12 days post Gardasil vaccine. Eruptions started on 10 day post vaccine
Other Meds:
Lab Data: CBC Herpes H2 Mono Aso Chem Sed Rate
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284971-1

12.0 F 17-Jul-2007 17-Jul-2007 0 17-Jul-2007 27-Jul-2007 FL 30-Jul-2007
MNQ SANOFI PASTEUR 02069AA Right arm Unknown
HPV4 MERCK & CO. INC. 0245U Left arm Unknown
MedDRA PT Dizziness
Symptom Text: Pre faint in parking lot

Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284978-1

16.0 F 16-Jul-2007 16-Jul-2007 0 17-Jul-2007 27-Jul-2007 CA 08-Aug-2007
MedDRA PT Contusion, Disorientation, Fall, Loss of consciousness, Syncope
Symptom Text: Patient passed out/fainted, fell to floor from examination table. Bruised, disoriented.
Other Meds: topical wart remover
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 284990-1

MedDRA PT Syncope
Symptom Text: Lacey fainted soon after receiving her vaccines she awoke after approx 3 sec and didn't know what happened to her. She then laid down on the table w/feet
elevated for approx 15 min and 2 sets of vitals were taken.
Other Meds: Insulin
Lab Data: Vital signs #1 BP 116/64 heart rate 54 #2 BP 107/68 heart rate 53
History: IDDM
Prex Illness: None
Prex Vax Illns:

Vaers Id: 284999-1

15.0 F 18-Jul-2007 18-Jul-2007 0 18-Jul-2007 27-Jul-2007 WI 30-Jul-2007
DTAP SANOFI PASTEUR C2688AA 0 Left arm Intramuscular
MedDRA PT Cold sweat, Dizziness, Pallor, Syncope, Wrong drug administered
Symptom Text: PATIENT GIVEN tDAP AND MENACTRA IN LEFT DELTOID, HPV IN RIGHT DELTOID. C/O DIZZINESS, PUT HEAD DOWN. WITHIN MINUTES, PATIENT
GREEN IN COLOR AND VERY CLAMMY. HEAD PUT FURTHER DOWN. AFTER SEVERAL MINUTES TRIED TO MOVE CLIENT TO NEXT ROOM TO
REST WHEN SHE FAINTED IN HALLWAY. LOWERED TO GROUND AND FEET PUT UP ON CHAIR. PULSE AND BLOOD PRESSURE TAKEN. 911
CALLED. PATIENT SLOWLY OPENED EYES. STILL CLAMMY AND PALE. RESCUE ARRIVED, DENIED NEED FOR OXYGEN. COOL, WET COMPRESS
PUT ON FOREHEAD. PULSE OX 98%, PULSE 60 AND BLOOD PRESSURE 100/60. SLOWLY ABLE TO GET PATIENT TO SITTING POSITION. BLOOD
PRESSURE TAKEN AGAIN AND PATIENT HELPED INTO CHAIR. GIVEN WATER TO DRINK. MOM PRESENT THROUGHOUT INCIDENT. DENIED NEED
FOR TRANSPORT TO ER. PATIENT REMAINED ON PREMISES FOR ANOTHER 15 MINUTES DRINKING WATER. NURSE ASSISTED OUT TO HER
CAR. MOM DRIVING, AND MOM WILL BE HOME WITH PATIENT ALL DAY TO OBSERVE.
Other Meds: NONE KNOWN
Lab Data: NONE
History: NONE KNOWN
Prex Illness: NONE
Prex Vax Illns: NONE~ ()~NULL~~In Patient

Vaers Id: 285001-1

VARCEL UNKNOWN MANUFACTURER NULL Unknown Unknown
MedDRA PT Body temperature increased, Chest pain, Cough, Dyspnoea, Headache, Heart rate increased, Myalgia
Symptom Text: Came to ER at 10:09 7/18/07 with complaints of chest pain of severity of 5 on a scale of 0-5 (5 being worst pain) Stated it started at 9 a.m. 7/18/07. VS 100.9 -
111-18 109/73 room air sat was 94%. Other complaints were cough, headache, and trouble breathing. EKG was normal - tachy. Diagnosis by ER physician -
mylagia, possible reaction to vaccine. Given 1 gram tylenol. Instructed to return if wheezing or rash.
Other Meds: loratadine 10 mg. daily
Lab Data: EKG - normal, tachy; RA Po2 was 94%
Prex Illness:
Prex Vax Illns:

Vaers Id: 285002-1

13.0 F 18-Jul-2007 18-Jul-2007 0 18-Jul-2007 19-Jul-2007 RI 19-Jul-2007
TDAP GLAXOSMITHKLINE AC52B00BAA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Asthenia, Hyperhidrosis, Pallor, Syncope
Symptom Text: five minutes after vaccine given, patient fainted. Patient pale , diaphoretic, weak. Placed in supine position, cold cloth to head, vital signs done, sugar
containing drink given. Patient recovered back to normal conditon in twenty minutes and was able to walk out of clinic.
Other Meds:
Lab Data:
History: OCD, Tourette"s Syndrome
Prex Illness:
Prex Vax Illns:

Vaers Id: 285004-1

18.0 F 12-Jul-2007 13-Jul-2007 1 18-Jul-2007 27-Jul-2007 WI 08-Aug-2007
MNQ SANOFI PASTEUR U2236AA/PUBLI 0 Left arm Intramuscular
C
HPV4 MERCK & CO. INC. 0181U/PUBLIC 0 Right arm Intramuscular
MedDRA PT Arthralgia, Fatigue, Feeling abnormal, Headache, Injection site pain, Malaise, Musculoskeletal stiffness, Nausea, Pyrexia, Vision blurred
Symptom Text: Healthy client received Menactra 0.5 cc IM L Deltoid at 4PM on 07/12/07 without incident. Mother of client reported the following information at 4PM on
07/17/07. Onset of symptoms during the night of 07/12/07- fever of 100-101 degrees F, nausea, stiff neck, blurred vision, sore L arm, generalized joint aching
severe headache,malaise, sl. mental "fogginess," without seizure paralysis, generalized rash or vomiting. Parents gave client tylenol as needed to reduce
aching and fever symptoms over the course of next 3 days, during which time client was not able to go to work due to symptoms, but was able to lay on the
couch and eat some foods and liquids. At 4PM on 7/17/07 mother reports client is "Slowly getting better-she was able to go to work today, but she's still tired
and the L arm is still tender. The headache is going away, too. Interestingly, my sister's son had the Menactra vaccine last summer, and she just told me that
her son had three days of fever and aching when he had it, too." I encouraged mother to call Dr. to report the adverse symptoms and any symptoms that may
occur in the future related to the vaccination. Mother agreed to contact Dr. as follow up to incident.
Other Meds: none
Lab Data:
History: Mother reports client is allergic to sulfa, unknown if allery is physician diagnosed
Prex Illness: none
Prex Vax Illns:

Vaers Id: 285010-1 (S)

13.0 F 27-Feb-2007 28-Feb-2007 1 18-Jul-2007 23-Jul-2007 OK 24-Jul-2007

Abdominal pain upper, Blood test, Body temperature increased, Chest pain, Computerised tomogram abnormal, Dehydration, Dizziness, Enzyme abnormality,
MedDRA PT Gastrointestinal tube insertion, Injection site pain, Lipase increased, Nausea, Pain, Pancreatic cyst, Pancreatic pseudocyst drainage, Pseudocyst, Surgery,
Swelling, Vomiting
Symptom Text: (PER MOTHERS WRITTEN STATEMENT SUBMITTED TO HEALTH DEPARTMENT ON JULY 18, 2007) ON FEBRUARY 27 AT APPROXIMATELY 1:30 PM
PATIENT RECEIVED THE HPV VACCINE, GARDISIL. THAT EVENING SHE RAN A LOW GRADE TEMPERATURE AND COMPLAINED OF PAIN AT THE
INJECTION SITE. THE FOLLOWING AFTERNOON AT APPROXIMATELY 2:30PM SHE BEGAN TO EXPERIENCE PAIN IN HER CHEST AND UPPER
ABDOMEN AND CONTINUED TO RUN A LOW GRADE FEVER. ON 2/29/07 SHE BEGAN EXPERIENCING NAUSEA AND VOMITING CONTINUING
THROUGH THE WEEK. ON 03/02/2007 SHE WENT TO OUR FAMILY DR., WHO FELT THAT IT WAS A VIRUS AND PRESCRIBED SOME PRESCRIPTION
NAUSEA MEDICATION AND SOMETHING FOR HER STOMACH. SHE CONTINUED TO THROW UP AND RUN A LOW GRADE FEVER THAT RARELY
WENT OVER 101F.. ON MARCH 13TH I BEGAN CALLING OTHER DOCTORS WHO WOULD ACCEPT OUR INSURANCE AND FOUND DR. HE DID NOT
HAVE ANY APPOINTMENTS AVAILABLE THAT DAY SO I TOOK PATIENT TO THE EMERGENCY ROOM. THERE I ASKED THE DOCTOR TO RUN BLOOD
TESTS BECAUSE SHE HAD BEEN SICK FOR A LONG TIME, AND I FELT SHE WAS DEHYDRATED AND SOMETHING OTHER THAN A VIRUS WAS
GOING ON WITH HER. THE ER DOCTOR CHECKED HER ENZYME LEVELS AND HER LIPASE WAS OVER 1000. SHE WAS HOSPITALIZED FOR 11
DAYS AND HER ENZYMES CONTINUED TO FLUCTUATE. HOSPITAL WAS CALLED AND THEY DID NOT HAVE ANY BEDS AVAILABLE AT THAT TIME. A
CATSCAN REVEALED A SMALL PSEUDOCYST ON HER PANCREAS AND IT WAS EXPECTED TO RESOLVE ON ITS OWN. SHE WAS RELEASED ON
THE 23RD. ON MARCH 30TH SHE WAS TAKEN TO HOSPITAL AND ADMITTED. THEY FOUND THE SPUEDOCYST HAD GROWN AND SHE HAD
DEVELOPED ANOTHER CYST ON HER PANCREAS AS WELL. SHE WAS HOSPITALIZED UNTIL THE 2ND OF APRIL AND THEN RELEASED. ON APRIL
5TH SHE WENT TO THE DOCTOR AND HER ENZYMES WERE BACK UP OVER 700. ON APRIL 24TH THEY HAD COME DOWN TO 435. ON MAY 3RD
HER PAIN GOT EVEN WORSE AND SHE WAS TAKEN BACK TO HOSPITAL AND RELEASED AS SHE WAS TO HAVE SURGERY ON THE 14TH. ON MAY
14TH SHE HAD SURGERY AND THEY DRAINED HER PSUEDOCYST. SHE WAS RELEASED ON MAY 20TH. ON JUNE 9TH SHE WAS TAKEN BACK TO
THE ER AND HER ENZYMES WERE UP AGAIN. ON JUNE 12TH
Other Meds: none
Lab Data:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 285011-1


Symptom Text: Patient reportedly had a seizure within 12 hours of recieving Gardisil Vaccine. This was her first dose. It is undetermined how long the seizure lasted as the
patient and her mother are poor historians.
Other Meds:
Lab Data: None Available
Prex Illness:
Prex Vax Illns:

Vaers Id: 285016-1

7.0 F 09-Mar-2007 01-Jun-2007 84 18-Jul-2007 30-Jul-2007 FL 30-Jul-2007
HPV4 MERCK & CO. INC. N/A 1 Unknown Intramuscular

MedDRA PT Anaemia, Arthralgia, Juvenile arthritis
Symptom Text: Gardasil adverse reaction resembling RA pauciarticular joint pain elevated sed rate, elevated RF, anemia
Other Meds:
Lab Data: RF 343sed rate 110hgb 11hct 33other labs pending
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 285041-1


MedDRA PT Fatigue
Symptom Text: Information has been received from a health professional concerning her 15 year old daughter who was vaccinated with a third dose of Gardasil. Subsequently
the patient developed extreme fatigue after receiving the third dose of Gardasil. The event resolved after three days without any treatment. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285042-1

15.0 F 23-May-2007 01-Jun-2007 9 13-Jul-2007 13-Aug-2007 CA WAES0706USA01097 13-Aug-2007

MedDRA PT Drug exposure during pregnancy, Rash
Symptom Text: Information has been received through the Merck pregnancy registry from a physician concerning a 15 year old female with anaemia and scabies infestation
who on 23-MAR-2007 was vaccinated IM in the right deltoid with a 0.5 ml with a first dose of Gardasil (lot# 654702/0011U) patient reported last menstrual
period was 25-FEB-2007. On 23-MAY-2007 was vaccinated IM in the right deltoid with a 0.5 ml with a second dose of Gardasil (LOT # 654702/0011U) patient
reported LMP as 23-APR-2007. Concomitant therapy included Elimite cream. On 01-JUN-2007 the patient was seen in the office for a rash. When asked her
LMP, she refused to answer. The patient had a positive pregnancy test and it was discovered that the patient was 24 - 26 weeks pregnant. Other laboratory
tests included complete blood cell count, enzyme immunoassay HIV antibody screen, cervix Chlamydia trachomatis and Neisseria gonorrhoeae screen, and
food allergy test (results not reported). Additional information has been requested.
Other Meds: ELIMITE CREAM
Lab Data: allergy test, beta-human chorionic - positive, complete blood cell, HIV antibody screen, cervix C. trachomatis/N.
History:
Prex Illness: Pregnancy NOS (LMP = Unknown); Anaemia; Scabies infestation
Prex Vax Illns:

Vaers Id: 285043-1


Symptom Text: Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated (date unspecified) with
the first dose of Gardasil. Following the vaccination (duration of time not specified), the patient developed swollen lymph nodes in her neck. At the time of this
report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285044-1

20.0 F 05-Jun-2007 05-Jun-2007 0 13-Jul-2007 13-Aug-2007 MD WAES0706USA01133 13-Aug-2007

MedDRA PT Chills, Muscular weakness, Pyrexia
Symptom Text: Information has been received from a registered nurse, concerning a 20 year old female patient, with oligomenorrhoea, who on 05-JUN-2007, at 11:30am, was
vaccinated with the third dose, 0.5ml, IM, of Gardasil (Lot #657622/0388U). There was no concomitant medication. On 05-JUN-2007, at 8:00pm, the patient
developed a fever of 101F, with chills and muscular weakness. On 06-JUN-2007, the patient visited her physician, and stated the physician "thinks that it's a
natural virus infection." At the time of this report, the patient had not recovered. Additional information has been requested.
Other Meds: None
Lab Data: temperature measurement 06/05/07 101 degre
History:
Prex Illness: Oligomenorrhoea
Prex Vax Illns:

Vaers Id: 285045-1

23.0 F Unknown Unknown 13-Jul-2007 13-Aug-2007 TX WAES0706USA01138 13-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, Oedema peripheral, Rash
Symptom Text: Information has been received from a registered nurse, concerning a 23 year old female patient, with no known allergies and no significant medical history, who
was vaccinated (date unspecified) with the third dose, 0.5ml, IM, of Gardasil, two months after the second dose. There was no concomitant medication.
Following the vaccination (duration of time not specified), she developed hand swelling, and a rash that developed on her arms. At the time of this report, the
patient had recovered (date unspecified). Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285046-1

23.0 F 06-Mar-2007 06-Mar-2007 0 13-Jul-2007 13-Aug-2007 -- WAES0706USA01149 13-Aug-2007

MedDRA PT Urticaria
Symptom Text: Information has been received from a physician's assistant, concerning a 23 year old female patient, who on approximately 06-MAR-2007 ("three months ago"),
was vaccinated with the third dose, 0.5ml, of Gardasil. Following the vaccination (duration not specified), the patient developed raised hives on all of her
extremities, but not her trunk. Treatment included prednisone (manufacturer not specified). At the time of this report, the PA indicated the patient had not
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285047-1


MedDRA PT Menstrual disorder, Metrorrhagia
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female who was vaccinated on 01-JUN-2007 with a third dose of Gardasil.
Subsequently on 05-JUN-2007, the patient experienced abnormal bleeding and spotting. Unspecified medical attention was sought. The patient's abnormal
bleeding and spotting persisted.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285048-1

14.0 F 21-Mar-2007 Unknown 13-Jul-2007 13-Aug-2007 ME WAES0706USA01160 13-Aug-2007

Symptom Text: Information has been received from a nurse practitioner concerning a 14 year old female who on 21-MAR-2007 was vaccinated with a third dose of Gardasil.
Subsequently the patient experienced a skipped menstrual period in April and May (but had slight spotting in May). Unspecified medical attention was sought. A
pregnancy test was not given to the patient. This is one of two reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285049-1

Unknown F 05-Jun-2007 05-Jun-2007 0 13-Jul-2007 13-Aug-2007 -- WAES0706USA01166 13-Aug-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a certified medical assistant concerning a female who was vaccinated on 05-JUN-2007 with Gardasil. On 05-JUN-2007 the
patient experienced dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered from dizziness the same day. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285050-1


MedDRA PT Vomiting
Symptom Text: Information has been received from a physicians assistant concerning a 9 year old female who was vaccinated with Gardasil. Subsequently 6 hours after the
vaccination the patient experienced vomiting. Unspecified medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285051-1


Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female who on 04-JUN-2007 was vaccinated IM with a 0.5 ml first dose of
Gardasil. Five minutes later the patient experienced dizziness and fainted while sitting in a chair. Unspecified medical attention was sought. Subsequently, the
patient recovered from dizziness and fainting. This is one of several reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285052-1

Unknown F 06-Jun-2007 07-Jun-2007 1 13-Jul-2007 13-Aug-2007 NY WAES0706USA01191 13-Aug-2007

MedDRA PT Dizziness, Rash erythematous, Rash pruritic, Syncope
Symptom Text: Information has been received from a physician concerning a female patient with a penicillin allergy and no medical history who on 06-JUN-2007 was
vaccinated IM with a dose of Gardasil. There was no concomitant medication. On the morning of 07-JUN-2007, the patient developed a rash that was red,
erythematous, and itchy. It was on her trunk, neck and arms. She also felt faint or dizzy as the rash began. The treatment was Benadryl. No diagnostic
laboratory studies were performed. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information
has been requested.
Other Meds: None
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 285053-1

26.0 F 12-Apr-2007 15-Apr-2007 3 13-Jul-2007 13-Aug-2007 NY WAES0706USA01197 13-Aug-2007

Symptom Text: Information has been received from a physician concerning a 26 year old female with no medical history or drug allergies, who on 12-APR-2007 was
vaccinated with a first dose of Gardasil. There was no concomitant medication. Three days after vaccination, the patient developed a severe generalized rash
all over her body. The patient was referred to a dermatologist who treated the rash with hydrocortisone (Cotizone). No laboratory diagnostic studies were
performed. Subsequently, the patient recovered after a couple days. No product quality complaint was involved. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285054-1

12.0 F 01-Apr-2007 01-Apr-2007 0 13-Jul-2007 13-Aug-2007 TN WAES0706USA01198 13-Aug-2007
MedDRA PT Asthenia, Nausea
Symptom Text: Information has been received from a physician concerning a female between the age of 12 and 16, who, a "couple months ago" was vaccinated with a 0.5mL
dose of Gardasil. Concomitant therapy included Menactra. Twenty-four hours after being vaccinated with Gardasil the patient experienced nausea and
weakness. The patient sought unspecified medical attention. Subsequently, the patient recovered. No product quality complaint was involved. Additional
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285055-1


Symptom Text: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.
After the patient received one dose of Gardasil she experienced numbness in her arm. Patient received vaccination from her primary care physician and not the
reporting physician. The patient did seek unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285056-1

Unknown F Unknown Unknown 13-Jul-2007 13-Aug-2007 MI WAES0706USA01227 13-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (Lot Number
unknown) injection. The physician reported that the patient fainted after receiving Gardasil. Medical attention was sought. At the time of reporting the outcome
was unknown. No further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285057-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot number
unknown) injection. The physician reported that the patient fainted after receiving Gardasil. Medical attention was sought. No further information was provided.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285058-1


MedDRA PT Inappropriate schedule of drug administration, Nausea, Off label use
Symptom Text: Information has been received from a 41 year old with no pertinent medical history or drug reactions/allergies who on 01-JUN-2007 was vaccinated with her
first dose of Gardasil (lot number unknown) 0.5 mL. There was no concomitant medication used. On 01-JUN-2007 the consumer reported that she experienced
nausea following the first dose of Gardasil. The consumer recovered from the nausea on 02-JUN-2007. She did not seek medical attention. No additional
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285059-1

Unknown U Unknown Unknown 13-Jul-2007 13-Aug-2007 NC WAES0706USA01244 13-Aug-2007

MedDRA PT Pain
Symptom Text: Information has been received from a certified medical assistant concerning multiple patients' (unknown number) who were vaccinated with a dose of Gardasil.
Subsequently the patients' complained of pain while and after receiving vaccinations of Gardasil. It was reported that all of their patients' complain of the pain. It
was also reported that vaccinations are given via intramuscular route using two inch needles. The needles do not completely penetrate nor do the staff want to
"force it." It was also reported that for all patients' the symptoms resolved. No product quality complaint was involved. Attempts are being made to obtain
additional identifying to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285060-1

21.0 F 20-Feb-2007 20-Feb-2007 0 13-Jul-2007 13-Aug-2007 TX WAES0706USA01254 13-Aug-2007

MedDRA PT Fall, Head injury
Symptom Text: Information has been received from a physician's office manager concerning a 21 year old female who on 20-FEB-2007 received her first dose of Gardasil.
After receiving the vaccination, on 20-FEB-2007, the patient fell backwards and hit the back of her head in the physician's office. She was taken to the
emergency room for treatment. The patient was not admitted to the hospital. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285061-1

16.0 F 22-May-2007 22-May-2007 0 13-Jul-2007 13-Aug-2007 WA WAES0706USA01261 13-Aug-2007
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who on 22-MAY-2007 was vaccinated IM with a first dose of Gardasil
(Lot# "0170U"). Concomitant therapy included a dose of Menactra. Within fifteen minutes, the patient "passed out cold." Unspecified medical attention was
sought. Subsequently, the patient recovered and was fine. No product quality complaint was involved. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285062-1


Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female who on 04-JUN-2007 was vaccinated IM with a 0.5 ml first dose
Gardasil. On 04-JUN-2007 the patient fainted and hit her head. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting.
This is one of several reports received from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285063-1

17.0 U 05-Jun-2007 05-Jun-2007 0 13-Jul-2007 13-Aug-2007 -- WAES0706USA01271 13-Aug-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old patient who was hysterical prior to receiving the vaccine and on 05-JUN-2007
was vaccinated IM with a 0.5 ml dose of Gardasil. On 05-JUN-2007 after the vaccination, the patient felt light headed. Unspecified medical attention was
sought. Subsequently, the patient recovered from light headedness. This is one of several reports from the same source. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Hysteria
Prex Vax Illns:

Vaers Id: 285064-1


MedDRA PT Dizziness
Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female patient who on 06-JUN-2007 was vaccinated IM with a 0.5 ml second
dose of Gardasil. On 06-JUN-2007 the patient felt dizzy. Unspecified medical attention was sought. Subsequently, the patient recovered from dizziness. This is
one of several reports from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285065-1

20.0 F Unknown Unknown 13-Jul-2007 13-Aug-2007 MI WAES0706USA01318 13-Aug-2007

MedDRA PT Malaise, Menstruation irregular
Symptom Text: Information has been received from a licensed practical nurse, concerning herself, a female in her 20's, who was vaccinated on an unspecified date, with the
first dose of Gardasil. The day following the vaccination, the nurse reported that her period came early, and she felt sick. The nurse recovered after an unknown
duration of time. The nurse sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285066-1

Unknown F 23-Apr-2007 Unknown 13-Jul-2007 13-Aug-2007 NY WAES0706USA01336 13-Aug-2007

MedDRA PT Headache
Symptom Text: Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil
(Lot Number unknown). The nurse reported that on 23-APR-2007 the female was vaccinated with her second dose of Gardasil (Lot Number 655324/0089U)
0.5mL. On an unspecified date, the patient experienced violent headaches. There was no concomitant medication. Medical attention was sought. Additional
information was not provided. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285067-1

16.0 F Unknown Unknown 13-Jul-2007 13-Aug-2007 TN WAES0706USA01337 14-Aug-2007

MedDRA PT Syncope, Urinary incontinence
Symptom Text: Information has been received from a physician, via a company representative, concerning a 16 year old female patient, who "in the last couple of months,"
was vaccinated with the first dose, 0.5 ml, of Gardasil. The physician reported the patient fainted after receiving the injection, and urinated on herself when she
fainted. The patient recovered from the events after an unknown duration of time. The patient was later vaccinated (unspecified date) with the second dose of
Gardasil, with no problems reported. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285068-1


MedDRA PT Drug exposure during pregnancy, Injection site pain
Symptom Text: Information has been received from the Merck Pregnancy Registry via a consumer concerning her 17 year old daughter with a food allergy to pineapples who
on 05-APR-2007 received her first dose of Gardasil. Concomitant therapy included Phenergan. On 05-APR-2007, the patient experienced pain at the injection
site for several hours. The patient sought unspecified medical attention. The patient recovered on 06-APR-2007. Subsequently, the patient was informed that
she was pregnant by a physician at the hospital ER. Pregnancy was confirmed via pregnancy test. The date of her last menstrual period was approximately 15-
MAR-2007 and her estimated delivery date is 20-DEC-2007. The patient was not admitted. Additional information has been requested.
Other Meds: PHENERGAN (PROMETHAZINE
Lab Data: beta-human chorionic - pregnant
History:
Prex Illness: Pregnancy NOS (LMP = 3/15/2007); Food allergy
Prex Vax Illns:

Vaers Id: 285069-1


MedDRA PT Oral herpes, Stomatitis
Symptom Text: Information has been received from a health professional concerning a 13 year old female who on 26-FEB-2006 was vaccinated with a dose of Gardasil.
Concomitant therapy included Abreva. On 27-FEB-2007, 24 hours after vaccination the patient experienced redness around mouth. On 28-FEB-2007, 48 hours
after vaccination the patient cold sore around mouth. According to the nurse, the lesions resolved but returned again 3 weeks after the vaccination. Medical
attention was sought. No product quality complaint was involved. Additional information has been requested.
Other Meds: ABREVA
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285070-1

12.0 F 01-Mar-2007 01-May-2007 61 13-Jul-2007 13-Aug-2007 -- WAES0703USA01446 14-Aug-2007

MedDRA PT Abasia, Pain in extremity
Symptom Text: Information has been received from a immunization Coordinator at the physician's office concerning a 12 year old female who sometime in March 2007, was
vaccinated with Gardasil. About two months post vaccination sometime in May 2007, the patient could not walk and was complaining of leg pain. The patient
sought medical attention. Patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285071-1

Unknown F 01-May-2007 01-May-2007 0 13-Jul-2007 13-Aug-2007 MO WAES0706USA01462 14-Aug-2007

MedDRA PT Injection site pain, Injection site reaction
Symptom Text: Information has been received from a physician concerning a female who in approximately May 2007, was vaccinated with the third dose of Gardasil and had a
reaction at the injection site and pain on her arm right after receiving the injection. As of 08-JUN- 2007, the patient's experiences had improved. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285072-1


MedDRA PT Headache
Symptom Text: Information has received from a nurse practitioner concerning a 21 year old female with an allergy to nonsteroidal anti-inflammatory drugs who on 26-MAR-
2007 was vaccinated with a dose of Gardasil. Concomitant therapy included Yaz and Zyrtec. On 26-MAR-2007 the patient experienced worst headache ever.
The vaccination was given in the morning and the patient had a headache until she went to bed. The patient was better the next morning. Additional information
has been requested.
Other Meds: ZYRTEC, YAZ
Lab Data: Unknown
History:
Prex Illness: Nonsteroidal anti-inflammatory analgesic supportive therapy
Prex Vax Illns:

Vaers Id: 285073-1


Symptom Text: Information has been received from a Registered Nurse concerning a female who was vaccinated with Gardasil (date and dose unknown). Subsequently the
patient "passed out"after receiving Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered from passing out. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285074-1


MedDRA PT Headache, Nausea, Vomiting
Symptom Text: Information has been received from a Registered Nurse concerning a female with a history of migraines who on 07-JUN-2007 was vaccinated with the first
dose of Gardasil. On 07-JUN-2007 the patient experienced nausea, vomiting and a bad headache perhaps a migraine after receiving the vaccination.
Subsequently, the patient recovered from nausea, vomiting and bad headache/migraine. The patient sought unspecified medical attention. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Migraine
Prex Illness:
Prex Vax Illns:

Vaers Id: 285075-1


Symptom Text: Information has been received from a nurse concerning a 19 year old female with an allergic reaction to septra (hives) and a history of passing out with
injections who on 08-JUN-2007 was vaccinated with Gardasil (lot# 657736/0389U). On 08-JUN-2007 the patient passed out. Medical attention was sought, The
patient stayed in the office for about half hour and during that time the patient was laying down. The patient's vitals were rechecked and patient was okay and
sent home. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Passed out
Prex Vax Illns:

Vaers Id: 285076-1

Unknown F Unknown Unknown 13-Jul-2007 13-Aug-2007 AZ WAES0706USA01668 14-Aug-2007

Symptom Text: Information has been received from other source concerning a female (age not reported) who was vaccinated on unspecified date with Gardasil (lot number
unknown). On the same date, the patient also was vaccinated with 2 other vaccines. On an unspecified date when administered Gardasil, the patient passed
out. The patient recovered from the adverse event. Additional information has been requested.
Other Meds: (therapy unspecified), (therapy unspecified)
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285077-1

24.0 F 07-Jun-2007 08-Jun-2007 1 13-Jul-2007 08-Aug-2007 WI WAES0706USA01675 08-Aug-2007

MedDRA PT Pain
Symptom Text: Information has been received from a registered nurse concerning a 24 year old female with no pertinent medical history, drug reactions or allergies who on 27-
JUN-2007 was vaccinated with the first dose of Gardasil (653735/0688F) 0.5 mL IM. There was no concomitant medication used. The patient experienced a
dull ache in her wrist, neck and back on 08-JUN-2007 the day after the first dose of Gardasil (653735/0688F) was administered. Medical attention was sought.
No further information is available. At the time of reporting, the patient was recovering. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285078-1

16.0 F Unknown Unknown 13-Jul-2007 08-Aug-2007 CA WAES0706USA01741 08-Aug-2007

MedDRA PT Fall, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 16 year old healthy female who was vaccinated on an unspecified date with Gardasil (lot number
unknown). Concomitant therapy included Menactra. On an unspecified date the patient slumped over and fell to the floor after the physician administered
Menactra vaccine first then Gardasil. They called 911 and the patient was taken to the hospital and released. She was not hospitalized. The patient outcome
was not reported. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285079-1

Unknown F 26-Mar-2007 26-Mar-2007 0 13-Jul-2007 08-Aug-2007 -- WAES0706USA01949 08-Aug-2007

MedDRA PT Pain
Symptom Text: Information has been received from a nurse practitioner concerning a female patient who on 26-MAR-2007 was vaccinated with a dose of Gardasil. On 26-
MAR-2007 the patient experienced generalized body aches, which made her go to bed to sleep it off. Medical attention was sought. The felt better the next day.
No product quality complaint was involved. Additional information has been requested.
Other Meds: Zyrtec, Yaz
Lab Data: Unknown
History: Nonsteroidal anti-inflammatory analgesic supportive therapy
Prex Illness:
Prex Vax Illns:

Vaers Id: 285080-1

Unknown F 01-May-2007 01-May-2007 0 13-Jul-2007 08-Aug-2007 -- WAES0706USA01967 08-Aug-2007

Symptom Text: Information has been received from a physician concerning a female who in May 2007, received her third dose of Gardasil. In approximately May 2007, the
patient had an abnormal pap smear. The physician reported that the result of the pap smear came out positive for high risk HPV. The patient sought
unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: cervical smear abnormal; positive for high risk HPV
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285081-1

DTPIPV SANOFI PASTEUR NULL Unknown Unknown
Symptom Text: Information has been received from the physician office manager concerning a healthy 17 year old female who on an unspecified date was vaccinated with
Gardasil (lot number unknown). Concomitant therapy included DTAP-IPV (Sanofi Pasteur). On an unspecified date the patient was sitting and fell to the floor
after receiving a dose of DTAP-IPV (Sanofi Pasteur) followed by a dose of Gardasil. The patient came to approximately a minute after she fainted. Medical
attention was sought in the physician's office and "left the office smiling". Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285082-1


MedDRA PT Incorrect route of drug administration, Pain, Pruritus
Symptom Text: Information has been received from a physician concerning a 19 year old female who was vaccinated with Gardasil. It was reported that the patient received
her first dose of Gardasil (from an other physician than the one who reported it) in her right lower back. As a result of this incorrect administration, the patient
experienced painful itching in the lymph nodes and in the groin area 1-2 days after the vaccination. Medical attention was sought. Patient's outcome was
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285083-1

TDAP GLAXOSMITHKLINE NULL Unknown Intramuscular
BIOLOGICALS
MedDRA PT Abdominal pain lower
Symptom Text: Information has been received from a physician concerning an 18 year old female who on 18-MAY-2007 was vaccinated IM in her left arm with Vaqta.
Concomitant therapy included Gardasil and Boostrix. On 19-MAY-2007 the patient experienced severe lower right abdominal pain. he patient sought medical
attention at the hospital and had a CT Scan performed. It was reported the CT Scan was normal and the patient was not admitted to the hospital.
Subsequently, the patient recovered from severe lower right abdominal pain. Additional information has been requested.
Other Meds:
Lab Data: computed axial 05/19/07
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285084-1


MedDRA PT Syncope
Symptom Text: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil. It was reported that the patient had received
one dose of Gardasil and fainted. It was not reported, if she was one of the patient's that had not eaten that day prior to her vaccination or if she was one of the
patients that had received another vaccine at the same time. The patient was observed at the office for an unspecified period and then was allowed to leave. It
was reported that the patient recovered. This is one of two patients. Attempts are being made to obtain additional identifying information to distinguish the
individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285085-1

Unknown F Unknown Unknown 13-Jul-2007 08-Aug-2007 NC WAES0706USA04423 08-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning a female patient (the exact age of the patient is unknown) who was vaccinated with a dose of Gardasil
and fainted after being given the injection. Unspecified medical attention was sought by the patient. The outcome was unknown. The reporter reported that they
had two other patients (ranged from 9 to 11 years) who fainted after being given Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285086-1

Unknown F Unknown Unknown 13-Jul-2007 08-Aug-2007 NC WAES0706USA04424 08-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning a female patient (the exact age of the patient is unknown) who was vaccinated with a dose of Gardasil
and fainted after being given the injection. Unspecified medical attention was sought by the patient. The outcome was unknown. The reporter reported that they
had two other patients (ranged from 9 to 11 years) who fainted after being given Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285087-1

Unknown F Unknown Unknown 13-Jul-2007 08-Aug-2007 NM WAES0706USA04609 08-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. It was reported that the patient had fainted
after vaccination. The patient sought unspecified medical attention. The patient's outcome was unknown. This is one of two reports received from the same
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285147-1


MedDRA PT Grand mal convulsion, Syncope, Syncope, Syncope vasovagal
vaccinated with one of the following batches - J0798, J0799, J0800 or J1021. Subsequently the patient experienced syncope. Follow-up information was
received from the Department of Health via a line listing. The patient was a 15 year old female student who on 15-May-2007 was vaccinated with Gardasil (Lot
No. 655742/0138U, Batch No. J0799, Expiry date 07-AUG-2009). Immediately after the vaccination the patient fainted. Tonic Clonic seizure was noted during
vasovagal episode. The patient recovered with no injury (also the outcome reported as ongoing in the line listing). The patient was followed up with blood tests
which results were nothing abnormal detected. A CT scan is to be performed later in June 2007. The reporter considered that syncope was possibly related to
therapy with Gardasil. The original reporting source was not provided. Information/Follow-up information received on 04-JUL-2007 contained the following
adverse experiences" tonic clonic seizure (15-MAY-2007). Upon internal medical review, clonic tonic seizure is considered to be Other Important Medical Event.
Other Meds: Unknown
Lab Data: diagnostic laboratory test ??May07 NAD
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285148-1 (S)

16.0 F 04-Jul-2007 04-Jul-2007 0 19-Jul-2007 20-Jul-2007 FR WAES0707USA01866 23-Jul-2007

MedDRA PT Convulsion, Grand mal convulsion
Symptom Text: Information has been received from a pediatrician, concerning a 16 year old female patient with genuine grand mal epilepsy, who on 04-JUL-2007 was
vaccinated IM in the arm, with the first dose of Gardasil (Lot # not provided). Concomitant therapy included lamotrigine (LAMICTAL). On 04-JUL-2007, in the
evening following the vaccination, and while working on the computer, she had a grand mal seizure. She was immediately taken to the hospital and was
admitted; she recovered, and was discharged the following day; 05-JUL-2007. The reporter noted that for many years the patient had experienced no seizures,
but in the last two years, she had been having seizures up to 3 times a year. The last seizure also happened while she was working with the computer, however
she had had shown a response to photogenic triggers during examination. The file is closed. Other business partner numbers include: E2007-04428.
Other Meds: LAMICTAL Unk - Unk
Lab Data: Unknown
History:
Prex Illness: Grand Mal convulsion; Epilepsy
Prex Vax Illns:

Vaers Id: 285149-1 (S)


MedDRA PT Contusion, Dizziness, Fall, Head injury, Somnolence
Symptom Text: Information has been received from a physician concerning a 13 year old female with no medical history, who on 09-JUL-2007 was vaccinated IM into the
deltoid muscle with first dose of Gardasil (lot# 654948/0903F; batch# NE 38100). About five to ten minutes after vaccination, the patient felt dizzy, and fell down
and bruised her head. Afterwards she was very sleepy. The reporter considered the event to be syncope. The patient was hospitalized because of the head
injury, although pulse and blood pressure were normal. The patient was kept in the hospital for at least until the next day. At the time of this report, the patient's
outcome was unknown. Other business partner numbers include: E200704448. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285150-1

HPV4 MERCK & CO. INC. NF23310 Unknown Intramuscular

MedDRA PT Face injury, Facial bones fracture, Fall, Mouth injury, Surgery, Syncope
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 26-JUN-2007 was vaccinated intramuscularly in the left upper arm
with the first dose of Gardasil. Subsequently, 30 seconds post vaccination the patient experienced syncope. She fell down, broke her nose and injured her lips.
The physician reported that she recovered from the syncope within 2 to 3 minutes. The duration and outcome of the other events was not reported. The
reporting physician felt that since the nose fracture needed surgical intervention it was a serious other medical event. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285168-1

13.0 F 09-Feb-2007 15-Feb-2007 6 19-Jul-2007 30-Jul-2007 GA 31-Jul-2007
VARCEL MERCK & CO. INC. 0948R 1 Right arm Unknown
MedDRA PT Skin hypopigmentation, Skin lesion
Symptom Text: Within 1 week of receiving vaccines, pt developed a raised, pale line from ankle to knee, was tender initially and grad. became non tender
Other Meds:
Lab Data: Lesion seen 3-7-7. By then appeared to follow the saphenous vein. No palpable anomaly, but hypopigmented
History: Dust mite, Septra, Pollens
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285169-1

11.0 F 11-Jul-2007 13-Jul-2007 2 19-Jul-2007 30-Jul-2007 NE 30-Jul-2007
MedDRA PT Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Symptom Text: (R) upper arm 1 inch area of induration/warmth 2 inch area redness/warmth-tenderness to palpitation Tx-Ibuprofen/Benadryl
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285172-1

17.0 F 27-Jun-2007 27-Jun-2007 0 19-Jul-2007 30-Jul-2007 WI 31-Jul-2007

MedDRA PT Syncope
Symptom Text: Pt received Gardasil injection. 10 minutes later proceeded to reception area to schedule next appointment and fainted.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285179-1

17.0 F 11-Jul-2007 11-Jul-2007 0 19-Jul-2007 30-Jul-2007 NJ 31-Jul-2007
MedDRA PT Dizziness, Fall, Loss of consciousness, Syncope
Symptom Text: Following the administration of Hep A vaccine (second) and 1st Gardasil, pt became lightheaded and fainted, falling from sitting positive on table to floor. Pt
awakened after few seconds Hr-2, BP 98/58 Rested in office 30 minutes, given fluids p.o. Hr 62, BP 118/10
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285182-1

13.0 F 10-Jul-2007 11-Jul-2007 1 19-Jul-2007 30-Jul-2007 SC 06-Aug-2007
MedDRA PT Injection site erythema, Injection site pruritus, Injection site swelling
Symptom Text: Swelling and redness noted at area of injection after 24 hr. After 72 hr pt c/o itching at site. Pt fully recovered.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285185-1

14.0 F 12-Jul-2007 12-Jul-2007 0 19-Jul-2007 30-Jul-2007 TX 31-Jul-2007

MedDRA PT Syncope
Symptom Text: child fainted after receiving Gardasil #2

Other Meds: Doxycycline (Acne Rx)
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 285189-1

16.0 F 26-Jun-2007 26-Jun-2007 0 19-Jul-2007 08-Aug-2007 AZ 08-Aug-2007

MedDRA PT Dyspnoea, Swelling, Swelling face
Symptom Text: Injection was administer at Pediatrics and went home before any symptom started. The child's mom notice swelling to face, arms, neck, SOB child was rushed
to ER where she received treatment.
Other Meds:
Lab Data: None
History: Nephrolithiasis (allergic to Penicillin, Codeine)
Prex Illness:
Prex Vax Illns:

Vaers Id: 285192-1

Unknown F 20-Jun-2007 Unknown 19-Jul-2007 08-Aug-2007 WI 08-Aug-2007

MedDRA PT Muscle fatigue
Symptom Text: Patient reports muscle fatigue one hour after vaccine.
Other Meds: Tums, ibuprofen, Claritin, Nortripylene, Miralax, Propranolol, Zantac
Lab Data:
History: Aretazolamide, Divalproex, Topiramate, Verapamil, Migraine headaches
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285194-1

TDAP SANOFI PASTEUR C2758AA Right arm Unknown
MedDRA PT Dizziness, Hypotonia, Tremor
Symptom Text: Patient became limp, dizzy. Body tremors approximately 45 seconds after Gardasil injected to left deltoid, while TDaP was given to right deltoid. Body tremors
lasted a few seconds. Patient was placed on recumbent position, had no complaint of GI symptoms, no shortness of breath. Patient was observed for 45-60
minutes after incident.
Other Meds:
Lab Data: Pulse ox 100%, heart rate 70s but dropped to 50s after 5-10 minutes after injection, but normalized to 70s-80s. She had normal vital signs when sent home.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285198-1

16.0 F 05-Jul-2007 05-Jul-2007 0 19-Jul-2007 08-Aug-2007 WI 08-Aug-2007
MedDRA PT Loss of consciousness, Unresponsive to stimuli
Symptom Text: Received HPV and Tdap at which time patient passed out and was non responsive for about 10 minutes. Patient did not come to several seconds after passed
out before passing out again. She was transported to hospital per ambulance after IV started and blood work done.
Other Meds:
Lab Data:
History: None
Prex Illness: Patient fainted out for 5-10 minutes
Prex Vax Illns:

Vaers Id: 285253-1

Unknown F 09-Jul-2007 09-Jul-2007 0 19-Jul-2007 10-Aug-2007 -- 10-Aug-2007
MedDRA PT Pain, Pruritus
Symptom Text: Itchy and painful 6 cm x 4 cm

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns: ~Varicella (no brand name)~2~0~In Patient

Vaers Id: 285264-1

66.0 F 18-Jul-2007 18-Jul-2007 0 19-Jul-2007 27-Jul-2007 MA 30-Jul-2007
VARZOS MERCK & CO. INC. 0585U MERCK 0 Right arm Subcutaneously
HPV4 MERCK & CO. INC. UNKNOWN - 0 Right arm Subcutaneously
MERCK
DT UNKNOWN MANUFACTURER U1952DA Left arm Intramuscular
MedDRA PT Wrong drug administered
Symptom Text: Zostavax vaccine given SC was mistakenly diluted by nurse with Gardisil vaccine instead of sterile diluent.Given 7/18/2007 at about 2 pm. Patient notified. Has
had no problems resulting from this.
Other Meds: Flonase (FLUTICASONE NASAL SPRAY) 1-2 inhaled by mouth every day Fosamax (ALENDRONATE) 70MG take Tablet(s) by mouth every week
Pantoprazole 40MG take 1 40 MG by mouth every day Pravastatin 20MG take 1 20 MG by mouth every
Lab Data: none
History: Penicillins Unknown reaction Codeine Unknown reaction
Prex Illness: no
Prex Vax Illns:

Vaers Id: 285268-1

17.0 F 03-Jul-2007 13-Jul-2007 10 19-Jul-2007 30-Jul-2007 IL 30-Jul-2007

Symptom Text: high fever and severe sternum pain

Other Meds: none
Lab Data: CHEST X RAY LAB TESTS
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 285270-1 (S)

12.0 F 16-Jul-2007 17-Jul-2007 1 19-Jul-2007 24-Jul-2007 MN 08-Aug-2007

MedDRA PT Abdominal pain, Abdominal pain upper, Appendicitis, Asthenia, Constipation, Vomiting
Symptom Text: patient presented with stomach pains, vomiting and weakness. 8/8/07-records received, DX: acute appendicitis. Seen in ER on 7/17/07-four day history
abdominal pain, followed by vomiting two and three days ago. Pain on right side of abdomen. No stool at all in past 3 days.
Other Meds: Concerta 27mg daily
Lab Data: none records received 8/8/07-WBC 29.6.
History: none records received 8/8/07-PMH: ADHD.
Prex Illness: stomach ache, vomiting, weak
Prex Vax Illns:

Vaers Id: 285291-1

15.0 F 01-Nov-2006 Unknown 20-Jul-2007 23-Jul-2007 CO WAES0707USA01041 23-Jul-2007

Symptom Text: Information has been received from a medical assistant through the Merck pregnancy registry concerning an approximately 15 year old female patient with no
pertinent medical history or drug reactions/allergies, who in November 2006, was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml). There was
no concomitant medication. It was reported that the patient did not receive her second vaccination due to pregnancy. The patient subsequently had a
miscarriage. The date of miscarriage was not known. Upon internal review, the miscarriage was felt to be an other important medical event. Additional
Other Meds: None
Lab Data: None
History:
Prex Illness: Pregnancy NOS (LMP=Unknown)
Prex Vax Illns:

Vaers Id: 285292-1

20.0 F 15-Dec-2006 15-Dec-2006 0 20-Jul-2007 23-Jul-2007 FL WAES0707USA01628 23-Jul-2007

MedDRA PT Blood pressure decreased, Convulsion, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Symptom Text: Information has been received from a licensed practical nurse concerning a 20 year old female with a sulfonamide allergy and no pertinent medical history who
on 15-DEC-2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) 0.5mL IM in the arm. Concomitant therapy included birth control pills
(unspecified). On 15-DEC-2006 the patient fainted immediately after the needle was withdrawn from her arm after receiving Gardasil. The patient experienced a
brief loss of consciousness and possible mild seizure activity. Medical attention was sought. Her symptoms resolved in 5 minutes after smelling salts were
administered. The patient was very pale and her blood pressure measurement was 60/40 mmHg post vaccination. Prior to vaccination the patient's blood
pressure was 110/78mm Hg. The patient has not received her second dose of Gardasil. No further information was available. At the time of reporting the
patient recovered from syncope, brief loss of consciousness, decreased blood pressure, possible mild seizure activity and looking pale. Upon internal review,
mild seizure activity was determined to be an other important medical event. Additional information has been requested.
Lab Data: blood pressure 12/15/06 60/40 mm/H after vaccination; blood pressure 12/15/06 110/7 mm/H before vaccination
History:
Prex Illness: Sulfonamide allergy; Contraception
Prex Vax Illns:

Vaers Id: 285293-1

17.0 F 10-Jul-2007 10-Jul-2007 0 20-Jul-2007 23-Jul-2007 MO WAES0707USA01812 02-Aug-2007
MedDRA PT Fall, Head injury, Inappropriate schedule of drug administration, Syncope
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 10-JUL-2007 was vaccinated with a first dose of Gardasil.
Concomitant therapy on 10-JUL-2007 included DTaP, tetanus toxoid and Vaqta. On 10-JUL-2007 after the vaccination, the patient was seated for several
minutes. When the patient got up to make an appointment, the patient fainted, hit the floor and had a knot on her head. The physician referred the patient to the
hospital for the skull X-Rays, results were reported as negative. At the time of the report the patient was recovering. The physician considered fainting, hitting
the floor and had a knot on her head to be an other important medical event. Additional information has been requested.
Other Meds:
Lab Data: skull X-ray 07/10/07 - negative
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285294-1

15.0 F Unknown 11-Jul-2007 20-Jul-2007 23-Jul-2007 OK WAES0707USA02070 23-Jul-2007

MedDRA PT Convulsion, Syncope, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot
number unknown). The physician also mentioned that the patient fainted after receiving a first dose of Gardasil but did not have a seizure. On 11-JUL-2007 the
patient was vaccinated with a second dose of Gardasil injection and fainted. The physician believes that the patient might have had a seizure as well. Medical
attention was sought. The patient was watched for a while after the vaccination and was okay to leave. At the time of reporting the patient is was recovering
with therapy (unspecified). No further adverse event information was available. Upon internal review, seizure was determined to be an other important medical
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285295-1

Unknown F Unknown 01-Jan-2007 20-Jul-2007 23-Jul-2007 -- WAES0707USA02214 23-Jul-2007

MedDRA PT Stevens-Johnson syndrome
Symptom Text: Information has been received from a physician's assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of
Gardasil. Subsequently, in January 2007, the patient developed "Stevens-Johnson syndrome". The patient sought unspecified medical attention. At the time of
the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285296-1 (S)

16.0 F 12-Jul-2007 12-Jul-2007 0 20-Jul-2007 23-Jul-2007 VA WAES0707USA02290 23-Jul-2007

MedDRA PT Convulsion, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 16 year old female, who on 12-JUL-2007 was vaccinated with a 0.5mL first dose of Gardasil.
Concomitant vaccinations included Menactra and DTaP (+) tetanus toxoid. On 12-JUL-2007 after receiving the vaccination, the patient "stood and passed out",
experienced a small seizure, regained consciousness and experienced another seizure. The patient went to the emergency room and was admitted to the
hospital. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285302-1

18.0 F 18-Jul-2007 18-Jul-2007 0 20-Jul-2007 30-Jul-2007 NV 30-Jul-2007
BIOLOGICALS
HPV4 MERCK & CO. INC. AHABB080AA 0 Right arm Intramuscular
HEPAB GLAXOSMITHKLINE 1426F 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Eye rolling, Moaning, Syncope, Tonic convulsion, Unresponsive to stimuli
Symptom Text: After receiving 3 of 4 forecasted vaccines, client stated, "I'm going to faint". She then fainted and had tonic like seizure activity during which time her eyes
rolled back and she had periods of moaning. The seizure like activity lasted approximately 2 minutes during which time she was non-responsive to verbal
commands. She was breathing and had a pulse during the entire episode. After she regained consciousness she was asked about previous seizure history
and said she had two seizures in the past. One was related to a hand injury and the other I am unclear about. She was placed in a supine position during the
incident and allowed to remain there for about 10 minutes after regaining consciuosness. Client then stayed in a sitting position in 'clinic area' for approximately
20 minutes. She declined transport to an emergency room. She left the area with her boyfriend.
Other Meds: none per client
Lab Data: none
History: none known
Prex Illness: stated she had a sore throat but denied any other symptoms
Prex Vax Illns:

Vaers Id: 285303-1

MNQ SANOFI PASTEUR U2233CH Unknown Intramuscular
MedDRA PT Abdominal pain, Dizziness, Dizziness, Fatigue, Flushing, Pyrexia
Symptom Text: LIGHT HEADED, FLUSH,DIZZY,FEVER'TIRED,ABD.PAIN

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 285328-1

20.0 F 15-May-2007 16-May-2007 1 20-Jul-2007 30-Jul-2007 MO 30-Jul-2007

MedDRA PT Back pain, Chest pain, Influenza like illness
Symptom Text: Flu like symptoms, back pain, chest pain x 1 day
Other Meds: Levien
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 285331-1

17.0 F 20-Jul-2007 20-Jul-2007 0 20-Jul-2007 10-Aug-2007 IL 10-Aug-2007
MedDRA PT Dyskinesia, Gaze palsy, Heart rate decreased, Loss of consciousness, Nausea, Pallor
Symptom Text: Within 1-2 minutes after HPV, turned pale, eyes rolled up in head, head jerked forward once or twice, then lost consciousness. Breathing OK (RR 16-20, POX
99-100%) BP 98/63. HR 52-57. Alert within 5 minutes. Monitored carefully x 35-40 minutes - on attempt to stand, same thing (nausea, pallor, decreased HR,
loss of consciousness) happened. Received Pedialyte and crackers, and monitored another 40 minutes (HR increased to normal 98-100). Able to stand, walk,
D/C home.
Other Meds: Albuterol MDI 2p q 4-6 prn, Zyrtec 10mg po daily
Lab Data: EKG normal, Glucose 132 (postprandial), Hgb 14.0
History: Asthma; Allergy to Pediazole
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285363-1

16.0 F 26-Oct-2006 07-May-2007 193 18-Jul-2007 15-Aug-2007 MO WAES0611USA01347 16-Aug-2007

MedDRA PT Chorioamnionitis, Drug exposure during pregnancy, Pregnancy, Premature labour
Symptom Text: Information has been received from the Merck pregnancy registry via a physician concerning a 16 year old female with attention deficit/hyperactivity disorder
with a history of 0 pregnancies and 0 live births who on 17-AUG-2006 was vaccinated with a first dose of Gardasil (lot # 653937/0637F). On 26-OCT-2006, the
patient was vaccination with a second dose of Gardasil (lot #653938/0954F). Concomitant therapy included CONCERTA. Subsequently, she became pregnant.
Last menstrual period was 24-AUG-2006 and estimated date of delivery was 29-MAY-2007. On 09-NOV-2006 and ultrasound reported that the patient was 11
weeks and 3 days. On approximately 07-MAY-2007 the patient developed pre-term labor and chorioamnionitis. On 07-MAY-2007, the patient gave birth to a
normal male. Other medications used during this pregnancy included KEFLEX. On 18-JUN-2007, the patient was vaccinated with a third dose of Gardasil (lot
#657736/0389U). No further information is available.
Other Meds: CONCERTA
Lab Data: ultrasound 11/09/06 - 11 weeks 3 days
History:
Prex Illness: Pregnancy (LMP = 8/24/2006); Attention deficit/hyperactivity disorder
Prex Vax Illns:

Vaers Id: 285364-1

24.0 F 11-Dec-2006 01-May-2007 141 18-Jul-2007 15-Aug-2007 -- WAES0702USA03600 16-Aug-2007

Symptom Text: Information has been received for the pregnancy registry for Gardasil from a 24 year old female healthcare worker with a childhood history of anaemia who on
11-DEC-2006 was vaccinated IM with a first dose Gardasil. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR).
Subsequently the patient found out she was about 5 weeks pregnant (estimated LMP 10-JAN-2007, EDD 17-OCT-2007). The patient was scheduled to see her
physician on 26-FEB-2007. On 22-JUN-2007 follow up information was received from a physician concerning the hispanic patient with a history of low grade
squamous intraepithelial lesion (August 2004) and cryosurgery to cervix (September 2004) and 0 previous pregnancies. The patient underwent amniocentesis
on 09-MAY-2007 (negative) and ultrasound on 23-MAY-2007 (19 weeks). Maternal serum alpha-fetoprotein (MSAFP) was 4; the patient also had an increased
random glucose of 239. She was put on a 2000 kcl ADA diet. Her outcome was not reported. Additional information has been requested.
Other Meds: Advair
Lab Data: ultrasound 05/23/07 19 weeks, amniocentesis 05/09/07 negative, serum alpha-fetoprotein, blood glucose 05/07 239
History: Anaemia; Low grade squamous intraepithelial lesion; Cryocautery of cervix
Prex Illness:
Prex Vax Illns:

Vaers Id: 285365-1


MedDRA PT Anxiety, Poor quality drug administered, Syncope
Symptom Text: Information has been received from a medical assistant concerning a white female (age not reported) who on an unspecified date was vaccinated with Gardasil
(lot number unknown) IM that was stored at 10 degree C for 12-14 hours. Follow-up information was received from a nurse practitioner. The patient fainted for 2
to 3 minutes after the injection was given. The nurse practitioner stated that this may have been "fear of needles". The nurse practitioner does not know if it was
related to Gardasil but it has occurred with other immunization too. The patient recovered. Additional information was not provided. Further information is not
available.
Other Meds: None
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285366-1

21.0 F 02-May-2007 02-May-2007 0 18-Jul-2007 15-Aug-2007 MO WAES0706USA00917 15-Aug-2007

MedDRA PT Drug exposure during pregnancy, Pregnancy
Symptom Text: Information has been received from a physician concerning a 21 year old female patient who on 02-MAY-2007 was vaccinated with a dose of Gardasil.
Concomitant therapy included AMITRIPTYLIN (manufacturer unspecified, start date unspecified, but prior to vaccination with Gardasil). Post vaccination client
had a Home pregnancy test and it was found out that the client was pregnant. Patient also had an x-ray of the lumbar spine on or about 07-MAY-2007. No other
information reported. The outcome was unknown. Additional information has been requested.
Other Meds: AMITRIPTYLIN 25mg
Lab Data: spinal x-ray 05/07?/07 - no problems; beta-human chorionic 05/22/07 - Client is pregnant
History:
Prex Vax Illns:

Vaers Id: 285367-1


MedDRA PT Medical device complication, No adverse effect
Symptom Text: Initial and follow up information has been received from a Nurse Practitioner (N.P.), who reported when she went to administered a dose of Gardasil (Lot #
0469U) from a prefilled syringe, it "shot off across the room" and hit the wall. The syringe fell apart. The NP confirmed that no patients were involved, and no
one was injured. No further information is expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285368-1

17.0 F 08-Jun-2007 Unknown 18-Jul-2007 15-Aug-2007 NY WAES0706USA01483 15-Aug-2007

Symptom Text: Information has been received concerning a 17 year old female who on 08-JUN-2007 was vaccinated with a dose of Gardasil. Subsequently, the patient
experienced pain at the injection site. At the time of the report, the patient was recovered by 10-JUN-2007. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285369-1

27.0 F Unknown Unknown 18-Jul-2007 15-Aug-2007 NY WAES0706USA01830 15-Aug-2007

MedDRA PT Arthralgia, Inappropriate schedule of drug administration, Myalgia
Symptom Text: Information has been received from a physician concerning a 27 year old female who was vaccinated IM with Gardasil. Subsequently the patient had pain
syndrome described as myalgia and arthralgia. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285370-1

20.0 F 08-Jun-2007 08-Jun-2007 0 18-Jul-2007 15-Aug-2007 NJ WAES0706USA01841 15-Aug-2007

MedDRA PT Diarrhoea, Influenza like illness, Vomiting
Symptom Text: Information has been received from a health professional concerning a 20 year old female with no known drug allergies and flu-like symptoms who on 12-JAN-
2007 was vaccinated IM with her first dose of Gardasil (Lot # 653650/0696F). There was no concomitant medication. On 08-JUN-2007 the patient was
vaccinated with a second dose of Gardasil (Lot # 0210U). The patient had no problems after she received her first dose of Gardasil. Immediately following her
second vaccination, she vomited (unknown to the office staff). The patient continued to vomit and had diarrhea throughout the weekend. The patient noted that
her whole family was sick with flu-like symptoms. At the time of this report, it is unknown if the patient recovered from the vomiting and diarrhea. Additional
Other Meds: None
Lab Data:
History: Flu-like symptoms
Prex Illness:
Prex Vax Illns:

Vaers Id: 285371-1


MedDRA PT Chills, Influenza like illness, Pyrexia
Symptom Text: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced flu-like
symptoms such as a high fever and chills which lasted for a few hours. Subsequently, the patient recovered from flu-like symptoms. No further details were
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285372-1

25.0 F 21-May-2007 21-May-2007 0 18-Jul-2007 15-Aug-2007 IN WAES0706USA01871 15-Aug-2007

MedDRA PT Incorrect route of drug administration, Injection site irritation
Symptom Text: Information has been received from a medical assistant concerning a 25 year old female with an allergy to Ketek and a history of hypoglycaemia, anxiety, panic
attacks and a syncopal attack who on 21-MAY-2007 was vaccinated IM with her first dose of 0.5 ml of Gardasil (Lot # 655617/1447F). Concomitant therapy
included LEXAPRO, hormonal contraceptives (unspecified) and NASACORT AQ. On 21-MAY-2007 the patient received her first dose of Gardasil in the left
upper outer buttocks. After she received the vaccination, she experienced burning at the injection site. Subsequently, the burning resolved on its own.
Other Meds: LEXAPRO; hormonal contraceptives; NASACORT AQ
Lab Data:
History: Hypoglycaemia; Anxiety; Panic attack; Syncopal attack
Prex Vax Illns:

Vaers Id: 285373-1


MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a female who on 28-MAY-2007 was vaccinated with Gardasil. On 30-MAY-2007 the patient
experienced rash. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from rash. No further details were
Other Meds: Unknown
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285374-1


MedDRA PT Abdominal pain
Symptom Text: Information has been received from a radiology technician concerning an 11 year old female who was vaccinated with Gardasil. Subsequently the patient
experienced severe abdominal cramping. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from
severe abdominal cramping. No further details were provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285375-1

17.0 F 11-May-2007 12-May-2007 1 18-Jul-2007 15-Aug-2007 NY WAES0706USA01918 17-Aug-2007
MedDRA PT Lip swelling
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 11-MAY-2007 was vaccinated with first dose of Gardasil. Concomitant
therapy included meningococcal vaccine (unspecified). On 12-MAY-2007 the patient developed swelling of her lips. She did go to the emergency room,
however she was not admitted to the hospital. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been
requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285376-1

19.0 F 08-Jun-2007 08-Jun-2007 0 18-Jul-2007 15-Aug-2007 FL WAES0706USA01926 24-Aug-2007

Symptom Text: Information has been received from a nurse concerning a 19 year old female who on 08-JUN2007 was vaccinated Intramuscularly with a first dose of Gardasil.
On 9-JUN-2007, the patient called the office to report that her lymph nodes was swollen on her neck. The patient read the information that mentions swollen
lymph nodes as one of the side effects of the vaccine but called the doctor's office to confirm. The patient did not see the doctor but was advised to call back if
the symptoms worsened and no laboratory diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No product quality
complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285377-1

16.0 F 11-Jun-2007 11-Jun-2007 0 18-Jul-2007 15-Aug-2007 CA WAES0706USA01928 15-Aug-2007

Symptom Text: Information has been received from a physician concerning a 16 year old female with no medical history or allergies, who on 11-JUN-2007 was vaccinated with
a 0.5mL first dose of Gardasil. There was no concomitant medication. After receiving the vaccination the patient passed out for about five minutes and when
she "came to", she began to vomit. The patient did go to the emergency room. At the time of the report, the patient's outcome was unknown. No product quality
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285378-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 NJ WAES0706USA01930 16-Aug-2007

Symptom Text: Information has been received from a nurse concerning a female (age unknown) who, on an unspecified date, was vaccinated with a 0.5mL dose of Gardasil.
Subsequently the patient experienced injection site pain that had persisted for over a month after receiving the vaccination. The patient sought unspecified
medical attention. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285379-1

15.0 F 06-Apr-2007 06-Apr-2007 0 18-Jul-2007 15-Aug-2007 AZ WAES0706USA01946 15-Aug-2007

MedDRA PT Cold sweat, Dizziness, Pallor
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 06-APR-2007, at 16:00, was vaccinated IM with the first dose of
Gardasil (lot#654272/0319U). There was no concomitant medication. On 06-APR-2007, at 16:05, the patient experienced dizziness, became pale and clammy,
and her blood pressure decreased to 80/52 from 110/68. On 06-APR-2007, the patient recovered. Additional information is not expected.
Other Meds: None
Lab Data: blood pressure 04/06/07 110/6 pre-vaccination; blood pressure 04/06/07 80/52 post-vaccination
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285380-1

28.0 F 23-Feb-2007 25-May-2007 91 18-Jul-2007 15-Aug-2007 -- WAES0706USA01984 29-Aug-2007

Symptom Text: Information has been received from a 29 year old female drug representative with no medical history or drug allergies, who in "November or December" of 2006
was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included LO/OVRAL. On 23-FEB-2007 she received a second dose of Gardasil. On 25-
MAY-2007, the patient had a pap smear test which was reported to be positive for high risk HPV. On 11-JUN-2007, she received the results. At the time of this
report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Lab Data: Cervical smear 05/25/07 - positive for high risk hpv
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285382-1

16.0 F 05-Jun-2007 Unknown 18-Jul-2007 15-Aug-2007 TN WAES0706USA02048 16-Aug-2007

MedDRA PT Injection site erythema, Injection site nodule, Injection site reaction
Symptom Text: Initial and follow-up information has been received from a certified medical assistant concerning a mother who reported her 16 year old daughter with no
pertinent medical history, who on 05-JUN-2007 was vaccinated IM with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included ADVIL
and CLARITIN. Subsequently the patient developed an injection site reaction. She developed a red "knot" on her deltoid arm, "not even big as a penny".
Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient's recovered from the red "knot". It was reported
that the patient had no reaction to the first injection and that the third dose will be given in the future. Additional information has been requested.
Other Meds: ADVIL; CLARITIN
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285383-1

25.0 F 24-May-2007 11-Jun-2007 18 18-Jul-2007 15-Aug-2007 NY WAES0706USA02060 16-Aug-2007

MedDRA PT Erythema, Rash
Symptom Text: Initial and follow-up information has been received from a health professional and a physician concerning a 25 year old white female graphic designer with
acne who on 24-MAY-2007 received the first dose of the Gardasil (lot # 657737/0522U), 0.5 ml, intramuscularly in the left deltoid. Concomitant therapy include
minocycline. On 11-JUN-2007, the patient developed a mild pink rash on her chest, per patient and dermatologist. The patient sought unspecified medical
attention. It was reported that the patient recovered "soon after". The physician reported that the rash may or may not be related to the vaccine injection.
Other Meds: Minocycline
Lab Data: None
History:
Prex Illness: Acne
Prex Vax Illns:

Vaers Id: 285384-1


Symptom Text: Information has been received from a registered nurse, concerning a 16 year old female patient, who on 11-JUN-2007 was vaccinated with a dose of Gardasil
(Lot # not provided). On 11-JUN-2007, following the vaccination, the patient turned pale white, and then fainted. At the time of this report, the patient was
recovering from the events. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285385-1

17.0 F 07-Mar-2007 07-Mar-2007 0 18-Jul-2007 15-Aug-2007 KS WAES0706USA02064 16-Aug-2007

MedDRA PT Anxiety, Dizziness, Hyperhidrosis, Nausea, Pharyngeal oedema, Vaccine positive rechallenge
Symptom Text: Information has been received from a licensed practical nurse concerning a 17 year old white, female student, with penicillin allergy, whose reported weight
was 132 pounds and whose reported height was 65 inches with no illness at the time of vaccination who on 07-MAR-2007 at 4:00 p.m., the patient was
vaccinated, intramuscularly into the left deltoid muscle with the first dose of Gardasil (Lot # 654389/0961F). It was reported that on 07-MAR-2007 the patient
became nauseated, lightheaded, sweaty with anxiety and felt like her throat was swelling shut. It was reported that the patient had no respiratory distress. She
was treated with a cool rag applied to her head and was laid down, given water to drink and within 5 minutes, she was fine. The patient recovered that day. On
23-MAY-2007, at 4:30 p.m., the patient was vaccinated, intramuscularly into the right deltoid muscle with the second dose of Gardasil (Lot # "616867/0243D").
It was reported that on 23-MAY-2007, the patient became nauseated, lightheaded, and sweaty with anxiety and felt like her throat was swelling shut. It was
reported that the patient had no respiratory distress. She was treated with a cool rag applied to her head and was laid down, given water to drink and within 5
minutes, she was fine. The patient recovered that day. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 285386-1

20.0 F 11-Jan-2007 11-Jan-2007 0 18-Jul-2007 15-Aug-2007 -- WAES0706USA02065 16-Aug-2007

MedDRA PT Erythema, Injection site atrophy, Pain
Symptom Text: Information has been received from a physician concerning a 20 year old female who on 11-JAN-2007 received the first dose of the Gardasil (lot #
655619/1427F) intramuscularly at the right hip. On 11-JAN-2007, the patient developed subcutaneous fat atrophy, a 2 cm x 1 cm atrophic "dimpled" site in the
right hip. On an unspecified date, the patient returned for the second injection and wished to proceed. The patient reported redness and pain with the injection,
but did not return for follow-up exam. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285387-1

Unknown F 05-Jun-2007 05-Jun-2007 0 18-Jul-2007 15-Aug-2007 MA WAES0706USA02093 16-Aug-2007

MedDRA PT Thrombosis
Symptom Text: Information has been received from a physician concerning a female patient with a history of an unspecified arm operation who on approximately 05-Jun-2007
"about a week ago", was vaccinated IM with a first dose of Gardasil. On approximately 05-JUN-2007, the patient experienced a blood clot. It was unknown
where the blood clot occurred. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Arm operation
Prex Illness:
Prex Vax Illns:

Vaers Id: 285388-1

18.0 F 27-Mar-2007 27-Mar-2007 0 18-Jul-2007 15-Aug-2007 NY WAES0706USA02106 16-Aug-2007

MedDRA PT Asthenia, Dyspnoea, Injection site pain, Pyrexia
Symptom Text: Information has been received from an other health professional concerning an 18 year old white female patient with allergies to aspirin and ibuprofen who on
27-MAR-2007, at 15:00 was vaccinated IM into the left deltoid with a first dose of Gardasil (Lot# 656051/0244U). Concomitant therapy included ORTHO EVRA.
That evening, the patient experienced fever, weakness, trouble breathing and pain at injection site. The patient stated that she was in bed for about two days. It
was reported that the patient did not report these reactions until she came in for her second injection which was not given. Unspecified medical attention was
sought. On 29-MAR-2007, it was reported that the patient recovered. No product quality complaint was involved. Additional information is not expected.
Other Meds: ORTHO EVRA
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 285389-1


MedDRA PT Confusional state, Heart rate decreased, Syncope vasovagal, Tremor
Symptom Text: Information has been received from a nurse concerning a 20 year old female with no pertinent medical history who on 08-JUN-2007 received her first dose of
Gardasil (lot #657868/0523U), 0.5 ml, intramuscularly. Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). After the receiving the
vaccination, the patient began shaking and was confused. Her vital signs were assessed and the pulse rate was noted as low (48-52). The patient was
transported to the emergency room and diagnosed with a vasovagal response. It was reported that she was discharged from the emergency room and
experienced no further symptoms. Additional information has been requested.
Lab Data: total heartbeat count 06/08/07 48-52
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285390-1


MedDRA PT Asthenia, Chills, Headache, Hypoaesthesia, Injection site pain, Pyrexia
Symptom Text: FEVER,FEELING WEAK,HEADACHE,CHILLS. INJECTION SITE TO LEFT ARM FEELS SOREAND HAD EPISODE OF NUMBNESS TO LEFT ARM PER RN
07/17/07 AT 1256
Other Meds: NYSTATIN,IBUPROFEN
Lab Data: PER RN PT VERBALIZED A/A AND WELL AMBULATORY, NO SOB
History:
Prex Illness: WELL PHYSICAL
Prex Vax Illns:

Vaers Id: 285397-1

14.0 F 02-Jul-2007 05-Jul-2007 3 20-Jul-2007 30-Jul-2007 FL 30-Jul-2007

MedDRA PT Rash
Symptom Text: My daughter had a server out break of rash on the arms, legs and face. As of 07/20/2007 she is still marked. This happened 3days after the shots. The
appointment was for her yearly check up. She was NOT sick. I also took took my 17year daughter and she had the shots as well no reaction. But i will not
contiune the series.
Other Meds:
Lab Data: Blood test and other laboratory test where done.
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 285409-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 IL WAES0706USA02129 16-Aug-2007

MedDRA PT Oral herpes
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with the Gardasil, 0.5 ml. Subsequently, the patient developed a
fever sore on her mouth after receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285410-1

17.0 F 11-Jun-2007 11-Jun-2007 0 18-Jul-2007 15-Aug-2007 PA WAES0706USA02135 15-Aug-2007

MedDRA PT Headache
Symptom Text: Information has been received from a nurse concerning a 17 year old female who on 11-JUN-2007 was vaccinated with Gardasil. On 11-JUN-2007,
immediately following the injection, the patient developed a headache. The patient sought unspecified medical attention. It was reported that the patient said
that she felt better before leaving the office. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285411-1

12.0 F Unknown Unknown 18-Jul-2007 15-Aug-2007 FL WAES0706USA02139 16-Aug-2007

Symptom Text: Information has been received from a physician concerning a 12 year old female who was vaccinated with the first dose of Gardasil. The patient experienced
redness and swelling behind the injection site of the lower part of her tricep, closer to the elbow, after receiving the injection. Medical attention was sought.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285412-1

26.0 F 21-May-2007 21-May-2007 0 18-Jul-2007 15-Aug-2007 NC WAES0706USA02144 16-Aug-2007

MedDRA PT Injection site abscess sterile
Symptom Text: Information has been received concerning a 26 year old female who on 22-NOV-2006 was vaccinated with the first dose of Gardasil. Concomitant therapy
included LEXAPRO. The patient was vaccinated with the second dose of Gardasil (Lot #653937/0637F) on 22-JAN-2007 and the third dose (Lot
#657622/0388U) on 21-MAY-2007. On 21-MAY-2007, the patient was vaccinated and developed a quarter-sized knot around the injection site which was
diagnosed as a sterile abscess which was being treated with antibiotics. As of 14-JUN-2007, the patient had not recovered. Additional information has been
requested.
Other Meds: LEXAPRO 10 mg
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285413-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 NY WAES0706USA02148 15-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient was at the
front desk to make another appointment when she fainted. Medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285414-1

Unknown U Unknown Unknown 18-Jul-2007 15-Aug-2007 NC WAES0706USA02156 16-Aug-2007
MedDRA PT Syncope
Symptom Text: Information has been received from a registered nurse concerning a patient who was vaccinated with Gardasil in one arm and then fainted while receiving a
tetanus vaccine (manufacturer unknown) in the other arm. Medical attention was sought. No further information is available.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285415-1

21.0 F 09-Apr-2007 23-Apr-2007 14 18-Jul-2007 15-Aug-2007 CA WAES0706USA02163 15-Aug-2007

Symptom Text: Information has been received from a nurse concerning a female who on 09-APR-2007 was vaccinated with the first dose of Gardasil (Lot #655165/1425F). On
approximately 23-APR-2007 the patient experienced bruising at the injection site. Medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285416-1

17.0 F 04-Apr-2007 04-Apr-2007 0 18-Jul-2007 15-Aug-2007 CT WAES0706USA02173 16-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a 17 year old female with sulfonamide allergy who on 04-APR-2007 was vaccinated IM with the first
dose of Gardasil. Concomitant therapy included allergy medicines. On 04-APR-2007 the patient was vaccinated and two hours later broke out in a rash. The
rash looked like the type of rash from a sulfa allergy rather than hives. The physician gave the patient Benadryl and the patient recovered on 08-APR-2007.
Medical attention was sought. Additional information has been requested.
Other Meds: Allergy medicine
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 285417-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse practitioner concerning an 4 approximately 18 year old females who in approximately May 2007, were vaccinated
with Gardasil. There was no concomitant medication. The all fainted after receiving the vaccine. After a while they all came to. Medical attention was sought.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285419-1


MedDRA PT Oedema mouth
Symptom Text: Information has been received from a nurse concerning a 22 year old female with no medical history or allergies, who on 28-MAR-2007 was vaccinated
intramuscularly with a first 0.5mL dose of Gardasil (lot#656049/0187U). There was no concomitant medication. The patient reported that on 28-MAR-2007 the
roof of her mouth felt swollen for about 24 hours after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient
had recovered. No product quality complaint was involved. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285420-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 CA WAES0706USA02281 16-Aug-2007

MedDRA PT Fatigue, Gastrointestinal disorder
Symptom Text: Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of Gardasil. After being vaccinated the
patient had "GI problems and fatigue." The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285421-1


Symptom Text: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Gardasil. It was reported that the dose
the patient received was unspecified. On an unspecified date, the patient developed genital warts after receiving the vaccine. Unspecified medical attention
was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285422-1

32.0 F 24-Apr-2007 24-Apr-2007 0 18-Jul-2007 15-Aug-2007 TX WAES0706USA02293 16-Aug-2007

MedDRA PT Choking, Inappropriate schedule of drug administration, Pharyngeal oedema
Symptom Text: Information has been received from a health professional concerning a 32 year old female patient with no medical history or allergies who on 24-APR-2007,
was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 654535/0136U). There was no concomitant medication. On 24-APR-2007, the patient developed
swelling in her throat and it caused her to choke. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. Subsequently,
the patient recovered. No product quality complaint was involved. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285423-1

Unknown F 06-Jun-2007 06-Jun-2007 0 18-Jul-2007 15-Aug-2007 OR WAES0706USA02299 16-Aug-2007

Symptom Text: Information has been received from a physician concerning a female who on 06-JUN-2007 intramuscularly with a 0.5 ml dose of Gardasil. On 06-JUN-2007, the
patient experienced significant pain and swelling at the injection site. The patient sought unspecified medical attention. At the time of the report, the patient was
recovering. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285424-1

16.0 F Unknown Unknown 18-Jul-2007 15-Aug-2007 DE WAES0706USA02307 16-Aug-2007

MedDRA PT Injection site rash
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who was vaccinated with a first dose of Gardasil. Subsequently, the
patient developed a local rash around the injection site. The rash was about 3 inches in diameter. Unspecified medical attention was sought. At the time of this
report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285425-1

23.0 F 12-Jun-2007 12-Jun-2007 0 18-Jul-2007 15-Aug-2007 AL WAES0706USA02309 16-Aug-2007

MedDRA PT Face injury, Fall, Malaise, Tooth injury
Symptom Text: Information has been received from a nurse practitioner concerning a 23 year old female who on 12-JUN-2007 received the first dose of Gardasil. Immediately
upon injection, the patient complained of not feeling well and collapsed as the nurse was removing the needle from her arm. The patient fell on the side of her
face and was rushed to the emergency room of a local hospital where she received 20 stitches in her face and mouth. Also, two of her front teeth were knocked
loose. An unspecified blood test was performed (results not provided). It was also reported that the patient did not have anything to eat all day and the dose
was given at 2:00 pm. The patient recovered on 12-JUN-2007. Additional information has been requested.
Other Meds: Unknown
Lab Data: Diagnostic laboratory 06/12/07 - results not provided
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285426-1


MedDRA PT Body temperature increased, Rash
Symptom Text: Information has been received from a nurse concerning an 18 year old female who on 11-JAN-2007 received the first dose of Gardasil. Subsequently, the
patient developed a rash on her arm and "had a temperature". On 15-MAR-2007, the patient received the second dose of the Gardasil. On 15-MAR-2007, the
patient developed a rash on her arm and legs and "had a temperature". The patient sought unspecified medical attention. The patient recovered. It was also
reported that the patient will not receive her "3rd dose" of the vaccine. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285427-1

21.0 F 22-Nov-2006 29-Nov-2006 7 18-Jul-2007 15-Aug-2007 MI WAES0706USA02337 16-Aug-2007

MedDRA PT Tonsillitis, Vaccine positive rechallenge
Symptom Text: Information has been received from a nurse concerning her 21 year old daughter with no pertinent medical history who, on approximately 22-NOV-2006,
received the first dose of Gardasil. There was no concomitant medication. On approximately 29-NOV-2006, the patient developed tonsillitis. The patient was
treated with penicillin. Subsequently, the patient recovered. On 22-Jan-2007, the patient received the second dose of Gardasil. On approximately 01-FEB-2007,
"ten to fourteen days later", the patient developed tonsillitis. She was treated with ZITHROMAX and recovered "a couple of days after starting ZITHROMAX".
On 22-MAY-2007, the patient received the third dose of Gardasil. On approximately 01-JUN-2007, the patient developed tonsillitis. She was treated with
AMOXIL. Diagnostic studies performed after the third occurrence of the tonsillitis in June 2007 included a "strep screen" and a "mononucleosis spot", both of
which were negative. The patient recovered on 11-JUN-2007. The reporter indicated that for all three occurrences, the patient's tonsils were coated with "white
stuff". Additional information has been requested.
Other Meds: None
Lab Data: throat culture - negative; serum Epstein-Barr 06/??/07 - negative
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285428-1


MedDRA PT Rash generalised, Streptococcal identification test negative
Symptom Text: Information has been received from a nurse practitioner concerning a 14 year old female who was vaccinated with a second dose of Gardasil. Subsequently
"about a day or two" after receiving the vaccination the patient developed rash all over her body. The patient returned to the office and they confirmed the rash
was everywhere. A Streptococcus oralis culture came back negative. The patient was advised to take diphenhydramine
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285429-1


MedDRA PT Syncope
Symptom Text: Information has been received from a health professional concerning a 16 year old female patient who on 13-MAY-2007 was vaccinated with a dose of
Gardasil. On 13-MAY-2007 the patient fainted. The reporter mentioned that 2 weeks later the patient fainted again while sitting down. Subsequently, the patient
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285430-1


MedDRA PT Pain
Symptom Text: Information has been received from a nurse concerning her 11 year old daughter with a history of fibromyalgia who on 10-APR-2007 was vaccinated with a first
dose of Gardasil (lot number unknown) injection. On 10-APR-2007 the nurse reported that "2 and a half weeks" after her daughter was administered with
Gardasil, her daughter experienced pain all over her body. Medical attention was sought. The patient was prescribed VICODIN for the pain. At the time of the
reporting, patient has not recovered. No further information was provided. Additional information has been requested.
Other Meds: None
Lab Data: Unknown
History: Fibromyalgia
Prex Illness:
Prex Vax Illns:

Vaers Id: 285431-1

18.0 F 13-Jun-2007 13-Jun-2007 0 18-Jul-2007 15-Aug-2007 IN WAES0706USA02364 15-Aug-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on 13-JUN-
2007 was vaccinated with Gardasil (Lot number unknown) 0.5 mL injection. There was no concomitant medication used. On 13-JUN-2007 the patient
experienced dizziness. Medical attention was sought. The patient recovered on 13-JUN-2007. Additional information was not provided. Additional information
has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285433-1

16.0 F 01-Apr-2007 01-Apr-2007 0 18-Jul-2007 15-Aug-2007 MD WAES0706USA02380 15-Aug-2007

Symptom Text: Information has been received from a Medical Assistant concerning a 16 year old female patient who in approximately April 2007, was vaccinated with her first
dose of Gardasil. Concomitant therapy included ALLEGRA. The reporter indicated that the patient "has not had regular menstrual cycles since receiving her
first dose of GARDASIL". The patient was not pregnant. Medical attention was sought. At the time of reporting the event was ongoing. Additional information
has been requested.
Other Meds: ALLEGRA
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285434-1


MedDRA PT Vomiting
Symptom Text: Information has been received from a physician, via a company representative, concerning a 23 year old female patient, with a sulfonamide allergy, who on 13-
JUN-2007, was vaccinated with the second dose of Gardasil (Lot #0212U). Concomitant therapy included YASMIN and AMBIEN. Forty five minutes after the
vaccine had been administered, the mother of the patient called the office to report her daughter was "violently vomiting." At the time of this report, the patient
was recovering from the event. Additional information has been requested.
Other Meds: YASMIN; AMBIEN
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 285435-1


MedDRA PT Arthralgia, Influenza like illness, Pharyngolaryngeal pain, Pyrexia
Symptom Text: Information has been received from a physician concerning her 18 year old daughter who on approximately 24-MAY-2007 was vaccinated IM with a first dose of
Gardasil. Concomitant therapy included appetite depressant (unspecified). On approximately 25-MAY-2007 the patient experienced flu like symptoms of joint
aches, high fever, and sore throat. Unspecified medical attention was sought. Subsequently, the patient recovered from the flu like symptoms. Additional
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285436-1


Symptom Text: Information has been received from a nurse concerning her 18 year old daughter who, on an unspecified date, was vaccinated intramuscularly with a first dose
of Gardasil. The patient had arm pain five days after receiving the vaccination. The patient did not seek medical attention. At the time of the report, the patient
outcome was unspecified. No product quality complaint was involved. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285437-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse concerning a 15 year old female, who, on an unspecified date, was vaccinated intramuscularly with a first dose of
Gardasil. The patient fainted after receiving the vaccination. The patient regained consciousness and was sent home. The patient did not seek medical
attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285438-1

16.0 F Unknown Unknown 18-Jul-2007 15-Aug-2007 MN WAES0706USA02520 16-Aug-2007

MedDRA PT Abscess
Symptom Text: Information has been received from a physician concerning a 16 year old female on an unspecified date who was vaccinated with her first dose of Gardasil (lot
number unknown). The physician reported that on an unspecified date the patient developed an abscess on her left breast two weeks after her first dose of
Gardasil. Medical attention was sought. Additional information was not provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285439-1

Unknown F 07-Jun-2007 07-Jun-2007 0 18-Jul-2007 15-Aug-2007 KS WAES0706USA02521 16-Aug-2007

MedDRA PT Immediate post-injection reaction, Vaccination complication
Symptom Text: Information has been received from a physician concerning a female who on approximately 07-JUN-2007 received her first dose of Gardasil, 0.5 ml. The
patient experienced an "acute immediate reaction" after receiving the vaccination. She was rushed to the hospital. No further information was provided.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285440-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 NE WAES706USA02523 16-Aug-2007

MedDRA PT Skin warm, Urticaria
Symptom Text: Information has been received from an office worker concerning a female (age not reported) who was vaccinated on unspecified dates with her first and second
dose of Gardasil (lot number unknown) 0.5 mL injection. The office worker reported that on an unspecified date the patient developed a large, hot welt, size of a
baseball on her right deltoid 24 hours after receiving her third dose of Gardasil (lot number unknown) 0.5 mL injection. Medical attention was sought. On 24-
APR-2007 the patient recovered from the adverse which lasted about four days. No additional information was provided. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285441-1

Unknown F 01-Mar-2007 Unknown 18-Jul-2007 15-Aug-2007 FL WAES0706USA02542 16-Aug-2007

MedDRA PT Body temperature increased
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of
Gardasil (Lot number unknown). The registered nurse reported that the patient received her second dose of Gardasil (Lot number unknown) approximately in
MARCH of 2007 at the college health clinic and experienced a temperature of 103 degrees. Medical attention was sought. At the time of reporting the patient
recovered from the temperature of 103 degrees. The nurse reported that they are unsure about giving the patient her third dose of Gardasil due to the patient's
experience with the second dose. No further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: temperature measurement 03/??/07 103 degrees
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285442-1


MedDRA PT Joint swelling, Serum sickness
Symptom Text: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (Lot
number unknown). On an unspecified date the patient developed serum sickness after the first dose of Gardasil. The physician also reported that the patient
had swelling of the joints and was put on therapy with prednisone (PROMIFEN). At the time of reporting, the outcome was unknown. No additional information
was available. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285443-1


MedDRA PT Pyrexia
Symptom Text: Information has been received from a nurse concerning a 25 year old female, who, on an unspecified date, was vaccinated intramuscularly with a dose of
Gardasil. Subsequently, on an unspecified date the patient developed a low grade fever after being vaccinated. The patient did not seek medical attention. At
the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285444-1

11.0 F 12-Jun-2007 12-Jun-2007 0 18-Jul-2007 15-Aug-2007 OH WAES0706USA02569 16-Aug-2007

MedDRA PT Breast swelling, Breast tenderness
Symptom Text: Initial and follow-up information has been received from a medical assistant concerning an 11 year old white female with no pertinent medical history who on
12-JUN-2007 at 3:15 pm, received her first dose of Gardasil (lot # 656049/0187U), 0.5 ml, intramuscularly into the left arm. There was no concomitant
medication. Subsequently, the patient experienced swelling of her left breast. At the time of the report, the patient had not recovered. She was seen at the
doctor's office on 14-JUN-2007. It was reported that the patient will receive her second dose of Gardasil on schedule. The medical assistant reported that the
patient had no reaction to the vaccine. Her breast tenderness was linked to another issue. Additional information is not expected.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285445-1


MedDRA PT Urticaria
Symptom Text: Information has been received from a registered nurse, concerning a 20 year old female patient, with a penicillin allergy involving a rash, who on 12-JUN-2007
was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # 657737/0522U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+)
norethindrone acetate (LOESTRIN FE). On 14-JUN-2007 when the patient woke up in the morning, she had hives all over her body. At the time of this report,
the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Loestrin Fe
Lab Data: Unknown
History: Drug rash
Prex Vax Illns:

Vaers Id: 285446-1

18.0 F Unknown Unknown 18-Jul-2007 15-Aug-2007 FL WAES0706USA02586 16-Aug-2007

MedDRA PT Dyspnoea, Malaise, Pyrexia
Symptom Text: Information has been received from the office manager in a doctor's office concerning an 18 year old female patient with penicillin allergy who was vaccinated
with a first dose of Gardasil and a second dose of Gardasil. The patient developed fever of 103 F after 8 hours of getting the second injection. She also did not
feel well and had "problem breathing". She had no reaction after the first injection with Gardasil. Unspecified medical attention was sought by the patient. The
patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 285447-1


MedDRA PT Chlamydial infection, Drug exposure during pregnancy
Symptom Text: Initial and follow up information has been received from Pregnancy Registry and a Nurse Practitioner (N.P.) concerning an 18 year old female client who on an
unspecified day was vaccinated with a first dose of Gardasil and at the end of February 2007, was vaccinated with a second dose of Gardasil. The reporter was
unsure of the last menstrual period (LMP) provided by the patient. On 07-JUN-2007 Ultrasound was performed and the estimated date of conception (EDC)
was mentioned as 19-DEC-2006. On 14-JUN-2007 patient went to clinic and was prescribed ZITHROMAX for Chlamydia. The outcome was unknown.
Other Meds: Unknown
Lab Data: Ultrasound 06/07/07 - (confirmed pregnancy)
History:
Prex Vax Illns:

Vaers Id: 285448-1

Unknown F 26-Mar-2007 27-Mar-2007 1 18-Jul-2007 15-Aug-2007 AR WAES0706USA02601 16-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a female patient who on 26-MAR-2007 was vaccinated IM in left deltoid with her first dose of
Gardasil. On 27-MAR-2007 she developed a rash on the left side of her body. Unspecified medical attention was sought. The patient recovered two weeks after
the event occurred. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285449-1

21.0 F 22-May-2007 Unknown 18-Jul-2007 16-Aug-2007 NJ WAES0706USA02606 17-Aug-2007

MedDRA PT Weight increased
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female with no relevant medical history reported who on 04-JAN-2007 was
vaccinated with a first dose of Gardasil. On 22-May-2007, the patient was vaccinated Intramuscularly with a 0.5 mL second dose of Gardasil. Concomitant
therapy included YASMIN, RITALIN and BENTYL. The nurse reported that the patient's mother called the office stating that the patient gained weight after
receiving dose 2 of Gardasil. The patient did not have weight gain with dose one. The patient received dose two of Gardasil on 22-MAY-2007 and was a size
two. The patient then went to college and returned as a size 6. The only weight measurements that the office had were that the patient weighed 115 lbs in
August 2005 and weighed 122 lbs when she received dose one on 04-JAN-2007. The present weight of the patient was unknown The patient sought
unspecified medical attention. At the time of this report, the patient's weight gain persisted. Additional information has been requested.
Other Meds: BENTYL; YASMIN; RITALIN
Lab Data: body weight measurement 08/??/05 115 lbs.; body weight measurement 01/04/07 122 lbs.
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285450-1


MedDRA PT Erythema, Oedema peripheral, Pain in extremity, Pruritus
Symptom Text: Information has been received from a physician concerning a 11 year old female who on 13-JUN-2007 was vaccinated with a dose of Gardasil in the left upper
arm. Concomitant medication was not reported. on 13-JUN-2007, later in the evening, the patient's left hand became swollen, itchy, red and painful." The
patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285451-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician's assistant concerning a female (age unknown) who on an unspecified date was vaccinated intramuscularly
with a 0.5 ml first dose of Gardasil. Subsequently the patient fainted. At the time of this report, the outcome was unknown. No product quality complaint was
involved. This is one of two reports from the same source. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285452-1

11.0 F 04-May-2007 04-May-2007 0 18-Jul-2007 16-Aug-2007 UT WAES0706USA02627 16-Aug-2007
MedDRA PT Lymphadenopathy, Skin ulcer
Symptom Text: Information has been received from a physician concerning an 11 yr old female who on 04-MAY-2007 was vaccinated with a first dose of Gardasil. On the
same day, the patient also received Vaqta and hepatitis A virus vaccine (unspecified) ("HEP A") in the other arm. On 04-MAY-2007 the patient developed a
large ulcer on her arm. The ulcer was on the arm where the patient received Gardasil. The patient also developed swollen lymph nodes under her jaw. At the
time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285453-1


MedDRA PT Erythema, Skin warm
Symptom Text: Information has been received from a registered school nurse concerning an approximately 11 year old female who, on an unspecified date during her sixth
grade physical, was vaccinated with Gardasil. Subsequently the patient developed a "red, hot to touch area about the size of a baseball". The patient was taken
out of school and taken to her physician. The patient's mother reported that the area was "bigger than it had been the night before". At the time of this report,
the outcome of the event was unknown. NO further information is expected. This is one of two reports from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285454-1

12.0 F Unknown 22-Nov-2006 18-Jul-2007 16-Aug-2007 NY WAES0706USA02699 17-Aug-2007

MedDRA PT Dizziness, Vomiting
Symptom Text: Information has been received from a health professional concerning a 12 year old female who on 22-NOV-2006 was vaccinated with the first dose of Gardasil
(Lot # not reported). On approximately 22-NOV-2006 the patient experienced feeling light headed. on 24-JAN-2007 the patient received the second dose of
Gardasil (lot # not reported). on approximately 24-JAN-2007 the patient experienced feeling light headed. on 06-JUN-2007 the patient received the third dose of
Gardasil (Lot# not reported). On approximately 06-JUN-2007 the patient experienced feeling light headed and vomited. Additional information has been
requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285455-1


MedDRA PT Dizziness, Inappropriate schedule of drug administration, Presyncope
Symptom Text: Information has been received from a 30 year old female with no medical history or allergies, who on 14-JUN-2007 was vaccinated with 0.5 mL first dose of
Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient became very dizzy and stated that she almost
fainted. The consumer also stated that the "nurse did not shake the liquid in the syringe before administering the vaccine." The patient sought unspecified
medical attention. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285456-1


MedDRA PT Throat tightness, Tremor
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female who on unspecified dates was vaccinated with a first and second dose
of Gardasil (lot number unknown). In June 2007, the patient received her third dose of Gardasil (Lot # 653650/0702F) IM. The patient was observed for about
15 minutes and she seemed fine, but soon after the patient started complaining of her throat tightening and the patient started trembling. The nurse checked
her blood pressure (148/85) and heart rate (97) both of which were elevated. The office did not believe it was an anaphylactic reaction since there was no
respiratory distress. The patient was given diphenhydramine hydrochloride 25mg (BENADRYL) and ibuprofen (MOTRIN). The patient recovered from throat
tightening, elevated blood pressure and elevated heart rate within 20 minutes and was sent home. Medical attention was sought. The patient called the next
day and said she was feeling fine. She felt fine after the first two doses. Additional information has been requested.
Other Meds: Unknown
Lab Data: blood pressure 148/8, respiratory rate 97
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285457-1


MedDRA PT Musculoskeletal pain, Neck pain
Symptom Text: Information has been received from a nurse concerning her 19 year old daughter with no medical history or allergies, who in January 2007, was vaccinated with
a first dose of Gardasil. She was vaccinated with a second dose in approximately March 2007 or early April 2007. Concomitant therapy included YASMIN. The
patient experienced neck pain after vaccination with the second dose of Gardasil. The symptoms began at least 24 hours after the vaccination and resolved
after 72 hours. The pain radiated from the shoulder of the arm (arm unspecified) up to her neck. The patient sought unspecified medical attention. Ibuprofen
(Motrin) was taken for the symptoms. At the time of the report, the patient had recovered. No product quality complaint was involved. No laboratory diagnostic
studies were performed. Additional information has been requested.
Other Meds: YASMIN
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285458-1


Symptom Text: Information has been received from a nurse practitioner concerning a 24 year old female who on an unspecified date was vaccinated with the first dose of
Gardasil (lot number unknown). On an unspecified date, the patient was vaccinated with her second dose of Gardasil and developed genital warts. Medical
attention was sought. At the time of reporting the patient was recovering. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285459-1


MedDRA PT Inappropriate schedule of drug administration, Nausea, Vomiting
Symptom Text: Information has been received from an office manager concerning a 28 year old female with no medical history or allergies, who on 12-JUN-2007 was
vaccinated intramuscular with a third 0.5mL dose of Gardasil (lot #657005/0314U). There was no concomitant medication. Subsequently several hours after
being vaccinated the patient experienced nausea and vomiting. No laboratory diagnostic studies were performed. The symptoms improved within 24 hours. The
patient sought unspecified medical attention. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285460-1


MedDRA PT Syncope vasovagal
Symptom Text: Information ahs been received from a physician concerning a 16 year old female patient who on 15-JUN-2007 was vaccinated with a first dose of Gardasil. On
15-JUN-2007, the patient experienced a vasovagal reaction. Unspecified medical attention was sought. On 15-JUN-2007, the patient recovered. No product
quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285461-1


MedDRA PT Nausea
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female who was vaccinated with a first dose of Gardasil. Concomitant
therapy included hormonal contraceptives (unspecified). The next morning, the patient experienced extreme nausea. Unspecified medical attention was sought.
On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285462-1


MedDRA PT Pyrexia
Symptom Text: Information has been received from a nurse concerning a 17 year old female, who, on an unspecified date, was vaccinated intramuscularly with a dose of
Gardasil. Subsequently, on an unspecified date the patient developed a low grade fever after being vaccinated. At the time of the report, the patient's outcome
was unknown. No product quality complaint was involved. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285463-1


MedDRA PT Dehydration, Influenza like illness, Vaccine positive rechallenge
Symptom Text: Information has been received from a nurse concerning a 25 year old female who received 0.5 ml of the first dose of Gardasil on an unspecified date.
Concomitant therapy included DEPO-PROVERA. It was reported that the patient experienced dehydration and flu-like symptoms one week after receiving the
vaccination. She went to the emergency room (ER). On an unspecified date, the patient was vaccinated with a second dose of Gardasil. Two weeks after
receiving her second dose of Gardasil, she ad the same symptoms, but they were not as severe. The patient's outcome was unknown. Additional information
has been requested.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285464-1

20.0 F 22-Feb-2007 23-Feb-2007 1 18-Jul-2007 16-Aug-2007 VT WAES0706USA02842 17-Aug-2007

MedDRA PT Chemotherapy, Dyspnoea, Oedema peripheral, Urticaria
Symptom Text: Information has been received from a registered nurse concerning a 20 year old female with acute lymphocytic leukaemia treated with chemotherapy (2989)
and a drug allergy to BENADRYL (hives, trouble breathing) who on 22-FEB-2007, was vaccinated IM into the left arm with a first dose of Gardasil (Lot#
654741/0013U). Concomitant therapy included DEPO-PROVERA. "Within a day or two later," the patient's left forearm swelled from the injection site to the
upper arm after lifting weights of 20 to 40 pounds. It was reported that the patient denied any erythema or itching. Unspecified medical attention was sought. No
laboratory diagnostic studies were performed. After 2 to 3 days, the swelling resolved. It was also reported the patient has not yet received the second dose of
the vaccine. No product quality complaint was involved. Additional information has been requested.
Lab Data: None
History: Chemotherapy; Hives; Breathing difficult
Prex Illness: Drug hypersensitivity; Acute lymphocytic leukaemia
Prex Vax Illns:

Vaers Id: 285465-1


MedDRA PT Asthma, Condition aggravated, Urticaria
Symptom Text: Information has been received from a physician concerning a 25 year old hispanic female with a history of asthma who on 02-APR-2007 was vaccinated with a
first dose of Gardasil (lot number 657617/0384U) IM in her left upper arm. Concomitant medication included ZYRTEC, MSD, and PAXIL. The physician
reported that the patient was in the office for her second dose of Gardasil on 15-JUN-2007 and reported that on 2-APR-2007 she developed hives on her legs
and her asthma started bothering her after receiving the first dose of Gardasil. Medical attention was sought. The patient recovered on an unspecified date from
asthma and the hives on her legs. At the time of reporting it was stated that the "patient" is fine now". The office did not administer the second dose after finding
out about the patient's experience from the first dose of Gardasil. Additional information is not expected.
Other Meds: ZYRTEC; SINGULAIR; PAXIL
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 285466-1

27.0 F 12-Mar-2007 26-Mar-2007 14 18-Jul-2007 16-Aug-2007 FL WAES0706USA02857 17-Aug-2007

MedDRA PT Discomfort, Fungal infection, No reaction on previous exposure to drug, Pruritus, Skin burning sensation
Symptom Text: Information has been received from a 27 year old female consumer with a history of yeast infection (after taking antibiotics) and allergic reaction to antibiotics
telithromycin KETER and levofloxacin LEVAQUIN, who on 12-MAR-2007 was vaccinated with a third dose of Gardasil. There was no concomitant medication.
On 26-MAR-2007, the consumer developed a yeast infection two weeks later. It was reported that the consumer was initially treated with antibiotics (name not
known) for treatment of what they thought was a urinary tract infection. She was then given fluconazole (DIFLUCAN) which did not resolve the yeast infection,
and metronidazole (FLAGYL) which still has not resolved the yeast infection. It was reported that the consumer continues to experienced burning, itching and
discomfort. Her symptoms have not changed in intensity. On 07-JUN-2007, a culture was taken that showed a yeast infection. It was reported that the
consumer did not experience any difficulties after the last two vaccinations. At the time of this report, the consumer was reported to be recovering. It was
reported that on 26-AUG-2006, the patient was vaccinated IM with a 0.5ml dose of Gardasil (Lot # 654540/0800F). No product quality complaint was involved.
Other Meds: None
Lab Data: vaginal culture 06/07/07 yeast infection
History: Yeast infection; Endometriosis
Prex Vax Illns:

Vaers Id: 285468-1

23.0 F Unknown Unknown 18-Jul-2007 16-Aug-2007 NJ WAES0706USA03013 17-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from a registered nurse concerning a 23 year old female patient who on an unspecified date was vaccinated with Gardasil (lot
number unknown). The nurse reported that after receiving Gardasil on an unspecified date the patient developed a rash all over the abdomen. Further
information was not provided. The outcome was not reported. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285469-1


MedDRA PT Syncope
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot
number unknown). The registered nurse reported that after receiving the HPV the patient walked down the hall and fainted. The nurse was behind her and she
fainted into the physician's arms. Medical attention was sought. The patient was placed on the chair and she was fine. At the time of reporting patient had
recovered. Further information was not provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285470-1

Unknown F Unknown Unknown 18-Jul-2007 16-Aug-2007 PA WAES0706USA03039 17-Aug-2007

MedDRA PT Abdominal pain, Vaccine positive rechallenge
Symptom Text: Information has been received from a immunization coordinator concerning a female who was vaccinated with a first dose of Gardasil. Subsequently after the
first dose the patient experienced abdominal cramping similar to menstrual cramps. Unspecified medical attention was sought. Subsequently, the patient
recovered from the abdominal cramping similar to menstrual cramps. The patient was vaccinated with a second dose of Gardasil. Subsequently after the
second dose the patient experienced abdominal cramping similar to menstrual cramps. Unspecified medical attention was sought. Subsequently, the patient
recovered from the abdominal cramping similar to menstrual cramps. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285471-1

MedDRA PT Lip swelling, Oedema peripheral, Oedema peripheral, Pyrexia, Syncope, Urticaria
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female with a history of spinal fusion who on 12-JUN-2007 was vaccinated
with a first dose of Gardasil (Lot # 657868/0523U) 0.5mL IM. Concomitant therapy included MENACTRA. On 12-JUN-2007 within a few minutes after receiving
Gardasil the patient experienced syncope. Medical attention was sought. Within a few minutes the patient was awake and able to leave on her own. Later that
evening the patient experienced swelling of her lip. Approximately 22 hours later, on approximately 13-JUN-2007 the patient experienced swelling of her hands
and feet and hives that would come and go. Approximately 48 hours later, on approximately 15-JUN-2007 the patient developed a fever of 101 degrees F. At
the time of reporting the patient recovered from syncope. The outcome of lip swelling edema peripheral, pyrexia and hives was unknown. No further information
is available. Additional information has been requested.
Other Meds:
Lab Data: temperature measurement 101 F
History: Spinal fusion
Prex Illness:
Prex Vax Illns:

Vaers Id: 285472-1

19.0 F 14-Jun-2007 15-Jun-2007 1 18-Jul-2007 16-Aug-2007 TX WAES0706USA03108 16-Aug-2007

MedDRA PT Labia enlarged, Local swelling
Symptom Text: Information has been received from a licensed vocational nurse concerning a 19 year old female who on 14-JUN-2007 was vaccinated intramuscularly into the
right deltoid with the first dose of Gardasil (lot # 0211U). On 15-JUN-2007, the patient experienced "swelling in the groin area and the labia". The patient sought
unspecified medical attention. The patient was advised to use miconazole nitrate (MONISTAT) and go to the emergency room if symptoms did not improve.
The patient outcome was unknown at the time of the report. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285473-1

21.0 F 27-Mar-2007 23-Apr-2007 27 18-Jul-2007 16-Aug-2007 -- WAES0706USA03111 17-Aug-2007

MedDRA PT Abdominal pain, Drug exposure during pregnancy
Symptom Text: Information has been received from a physician's assistant, for the Pregnancy Registry for Gardasil concerning a 21 year old white female with pelvic
inflammatory disease and a history of gastrooesophageal reflux disease and penicillin allergy. On 04-DEC-2006 the patient was vaccinated with the first dose
of Gardasil (Lot # 653736/0868F) 0.5 mL IM in the left arm and on 23-MAR-2007 with the second dose of Gardasil (Lot # 657006/0188U) 0.5 mL IM.
Concomitant therapy included PREVACID and NESTABS FA TABLETS. The patient developed abdominal cramps on 23-APR-2007 and presented to the
doctor's office. Medical attention was sought. Serum beta-human chorionic gonadotropin and urine beta-human chorionic gonadotropin tests were performed to
confirm pregnancy. The patient was referred to a Ob/Gyn for follow-up care. No additional information was given. The date of the last menstrual period was 14-
MAR-2007, the estimated conception date is 28-MAR-2007 and the estimated delivery date is 20-DEC-2007. Additional information has been requested.
Other Meds: PREVACID 15 mg; NESTABS FA TABLETS
Lab Data: urine beta-human 04/23/07 - positive; serum beta-human 04/23/07 - positive
History: Gastrooesophageal reflux disease
Prex Illness: Pregnancy NOS (LMP = 3/14/2007); Pelvic inflammatory disease; Penicillin allergy
Prex Vax Illns:

Vaers Id: 285474-1


MedDRA PT Rash vesicular
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 07-MAY-2007 was vaccinated with a 0.5 ml dose of Gardasil. On
approximately 21-MAY-2007, two weeks after getting the vaccination, the patient developed a "besicular" rash. The patient was seen by her physician again on
14-JUN-2007 and the rash had continued to spread. The course of treatment for the rash included prednisone and ZYRTEC. The "besicular" rash persisted.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285475-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse practitioner concerning a female (age not reported) who in approximately May 2007, "about a month ago" was
vaccinated with a first dose of Gardasil (lot number unknown) IM. Almost immediately after receiving Gardasil, the patient fainted. Medical attention was sought.
The nurse practitioner had made the patient sit in the waiting room until she felt better. Patient seemed to have recovered momentarily after sitting in the
waiting room. Further information was not provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285476-1

23.0 F 22-Jan-2007 22-Jan-2007 0 18-Jul-2007 16-Aug-2007 MD WAES0706USA03134 17-Aug-2007

MedDRA PT Cervical dysplasia, Drug exposure during pregnancy
Symptom Text: Information has been received for the Merck Pregnancy Registry for Gardasil via a registered nurse concerning a 23 year old female with a sulfonamide allergy
and drug hypersensitivity to erythromycin, BACTRIM and ZITHROMAX who on 22-JAN-2007 was vaccinated with the first dose of Gardasil (lot #
655619/1427F). Concomitant therapy included pre-natal vitamins. It was reported that the patient may have been pregnant when she received the vaccination
on 22-JAN-2007. The patient reported the date of her last menstrual period as approximately 20-JAN-2007. The patient's estimated date of delivery is 27-OCT-
2007. The patient sought unspecified medical attention. In February 2007, a "pap smear" revealed cervical intraepithelial neoplasia 3 and the patient underwent
colposcopy (results not provided). The reporter indicated that the pregnancy has been normal to date. Additional information has been requested.
Other Meds: Vitamins (unspecified)
Lab Data: cervical smear 02/??/07 - cervical intra-eithelial neoplasia 3; colposcopy 02/??/07 - results not provided.
History:
Prex Illness: Pregnancy NOS (LMP = 1/20/2007); Sulfonamide allergy; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 285477-1

Unknown F Unknown Unknown 18-Jul-2007 16-Aug-2007 GA WAES0706USA03138 17-Aug-2007

Symptom Text: Information has been received from a certified medical assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose
of Gardasil. Subsequently, the patient experienced a "high-grade" positive HPV on a PAP smear. The patient sought unspecified medical attention. At the time
of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: cervical smear - high grade positive HPV
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285478-1

17.0 F 15-May-2007 15-May-2007 0 18-Jul-2007 16-Aug-2007 WA WAES0706USA03151 17-Aug-2007

MedDRA PT Headache
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 15-MAY-2007 was vaccinated with a 0.5 ml first dose of Gardasil. On
15-MAY-2007 the patient experienced off and on headaches. The patient sought unspecified medical attention. On 17-MAY-2007, the patient recovered from
off and on headaches. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285479-1


Symptom Text: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil, on an unspecified date. Two days after
receiving the first injection, she experienced swelling in her lymph nodes (under her arm and in her neck). She sought unspecified medical attention. There
were no diagnostic or laboratory tests performed. Subsequently the patient recovered. On an unspecified date, the patient vaccinated with the second dose of
Gardasil. She did not have any adverse reactions to the second dose. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285481-1


MedDRA PT Lymphadenopathy, Vaccine positive rechallenge
Symptom Text: Information has been received from a 20 year old female who on 07-MAR-2007 was vaccinated intramuscularly with 0.5 ml dose of Gardasil. Concomitant
therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). On 09-MAR-2007, the patient's right lymph node swelled to the size of a marble. She
sought unspecified medical attention. The patient reported that she recovered 1 1/2 weeks after the swelling began. On an unspecified date, the patient was
vaccinated intramuscularly with 0.5 ml of the second dose of Gardasil. Two days after the vaccination, the patient's left lymph node swelled to the size of a
marble. The patient sought unspecified medical attention. Additional information is not expected.
Other Meds: Ortho-Cyclen
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285482-1

18.0 F 05-Jun-2007 07-Jun-2007 2 18-Jul-2007 16-Aug-2007 AZ WAES0706USA03179 17-Aug-2007
VARCEL MERCK & CO. INC. 0114U Unknown Subcutaneously
MedDRA PT Erythema, Skin warm, Tenderness
Symptom Text: Information has been received from a health professional concerning a 17 year old female who on 05-JUN-2007 was vaccinated IM into the right deltoid with a
dose of Gardasil (lot# 654885/1424F). Concomitant therapy included a SC dose given into the left arm of Varivax (lot4 656569/0114U), an IM dose into the left
deltoid of Menactra (batch# U2115AA) and hormonal contraceptives (unspecified). On 07-JUN-2007 within 36 hours, the patient experienced a "10 x 8
centimeter of left arm redness, warmth and tender." No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285483-1

17.0 F Unknown Unknown 18-Jul-2007 16-Aug-2007 TN WAES0706USA03180 17-Aug-2007

Symptom Text: Information has been received from a physician concerning a 17 year old female with a kidney condition for which she is being treated who on an unspecified
date was vaccinated with Gardasil (lot number unknown) injection. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). About an
hour after being vaccinated with Gardasil the patient developed a rash all over her body. Medical attention was sought. The physician advised the patient to
take diphenhydramine hydrochloride (BENADRYL) and to follow up with the office if the problem persisted. The patient has not contacted the office yet. The
physician reported that it was not an anaphylactic type of reaction. No additional information is provided. Additional information has been requested.
Other Meds: Benadryl
Lab Data: None
History:
Prex Illness: Renal disorder; Hypersensitivity reaction
Prex Vax Illns:

Vaers Id: 285484-1


Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil. Subsequently the patient developed
"swollen lymph nodes". Unspecified medical attention was sought. The outcome was unknown. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285485-1


Symptom Text: Initial and follow up information has been received from a Nurse Practitioner (N.P.) concerning a 17 year old female student who on 18-JUN-2007 was
vaccinated with a first dose of Gardasil. On 18-JUN-2007, after "her first injection the patient developed 3 1/2-4 centimeter red spot at injection site and it was
swollen and itchy." The nurse practitioner then applied diphenhydramine hydrochloride (BENADRYL) and the patient was fine after that. Additional information
is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285486-1

Unknown F 08-Jun-2007 08-Jun-2007 0 18-Jul-2007 16-Aug-2007 PA WAES0706USA03196 17-Aug-2007

MedDRA PT Dizziness, Stomach discomfort, Syncope
Symptom Text: Information has been received from a physician concerning a female patient who on 08-JUN-2007 "ten days ago", was vaccinated with a first dose of Gardasil.
On 08-JUN-2007, the patient fainted after getting injection site Gardasil. The physician also reported that the patient felt dizzy and was sick to the stomach after
the injection. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285487-1

18.0 F 27-Feb-2007 27-Feb-2007 0 18-Jul-2007 16-Aug-2007 MI WAES0706USA03199 17-Aug-2007

MedDRA PT Nausea, Syncope, Vaccine positive rechallenge, Vomiting
Symptom Text: Information has been received from a certified medical assistant concerning an 18 year old white female with no medical history or allergies, who on 27-FEB-
2007 at 16:30 was vaccinated IM into the right arm with a first dose of Gardasil (lot # 656372/0243U). About 5 minutes later the patient was on the floor
because she had fainted and nauseous. It was reported that she sat for a few minutes and "felt fine" and was sent home. On 30-APR-2007 at 13:30, the patient
was vaccinated IM into the left arm with a second dose of Gardasil (lot# 657622/0388U). Immediately, the patient experienced the same symptoms and
became nauseous and vomited. The patient did not faint. It was reported that afterward she was better. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285488-1


Symptom Text: Information has been received from a nurse practitioner concerning a 22 year old female who on an unspecified date was vaccinated with a first dose Gardasil
(lot number unknown). Subsequently the patient developed genital warts. At the time of reporting it is unknown if the patient has recovered. Additional
information was unavailable. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285489-1


MedDRA PT Pharyngolaryngeal pain, Pyrexia, Vaccine positive rechallenge
Symptom Text: Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of Gardasil. Subsequently the patient
experienced sore throat and fever after the first and second dose. No medical attention was sought. At the time of this report, the patient's outcome was
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285497-1 (S)

17.0 F 15-Sep-2006 11-Oct-2006 26 23-Jul-2007 24-Jul-2007 KS WAES0612USA01320 24-Jul-2007

MedDRA PT Caesarean section, Chorioamnionitis, Drug exposure during pregnancy, Pain
Symptom Text: Information has been received from a health professional through a Merck pregnancy registry concerning a 17 year old female with no known allergies who on
15-SEP-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot#653735/0688F). Concomitant therapy included hormonal
contraceptives (unspecified). On 11-OCT-2006 the patient had a positive urine pregnancy test. It was reported that the patient had previously had a negative
serum pregnancy test on 17-JUL-2006. The patients last menstrual period was on 15-AUG-2006. The patient sought unspecified medical attention. At the time
of this report the outcome of the event was unknown. Follow up information was received from a registered nurse stating that on an unspecified date prior to
delivery the patient developed an increased white blood cell count (actual values not provided) and was diagnosed with suspected occult chorioamnionitis. The
nurse did not know if the patient received any treatment for the condition, if any other testing was done, or when and what the results of follow up white blood
cell count were. The nurse also reported that on 04-JUN-2007 the patient delivered a normal healthy baby girl with no congenital anomalies by cesarean
section. The nurse reported that the reason for the cesarean section was "unrelieved pain". The mother and baby were both discharged on 11-JUN-2007. The
nurse did not know the reason for the extended hospitalization. Additional information has been requested.
Lab Data: serum beta-human 07/17/06 - negative; urine beta-human 10/11/06 - positive; WBC count - increased
History:
Prex Vax Illns:

Vaers Id: 285498-1 (S)

Unknown F Unknown Unknown 23-Jul-2007 24-Jul-2007 FL WAES0707USA01767 24-Jul-2007
MedDRA PT Muscle twitching, Syncope
Symptom Text: Information has been received from a physician concerning a female patient with a history of syncope who was vaccinated with the first dose of Gardasil.
Concomitant therapy included hepatitis A vaccine (inactive) (MSD). Subsequently, the patient experienced syncope and twitching and was hospitalized to rule
out seizures. The length of the hospital stay was not specified. On an unspecified date, the patient recovered from syncope and twitching. It was also reported
that the patient did not have this experience with the second dose of Gardasil. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Syncope
Prex Illness:
Prex Vax Illns:

Vaers Id: 285499-1

Unknown F Unknown Unknown 23-Jul-2007 24-Jul-2007 PA WAES0707USA02207 24-Jul-2007

Symptom Text: Information has been received from a physician concerning a female patient with a history of convulsion who was vaccinated with a first dose of Gardasil (lot #
"unavailable"). Concomitant therapy included unspecified therapy. The physician reported that the patient developed "seizures after receiving her first dose of
Gardasil." It was reported that the patient had "been having seizures before Gardasil was administered." Unspecified medical attention was sought by the
patient. The outcome was unknown. Upon internal review, seizure was considered to be an other important medical event. Additional information has been
requested.
Lab Data: Unknown
History: Convulsion
Prex Illness:
Prex Vax Illns:

Vaers Id: 285516-1

17.0 F 11-Jul-2007 11-Jul-2007 0 23-Jul-2007 31-Jul-2007 CT 31-Jul-2007
MedDRA PT Syncope
Symptom Text: Patient felt faint after receiving Gardasil injection, was observed for 15 minutes until faintness passed then discharged to family member.
Other Meds: Align (OTC)
Lab Data:
History:
Prex Illness: Weight loss, Bloating, digestive system symptoms
Prex Vax Illns:

Vaers Id: 285518-1

24.0 F 18-Jul-2007 18-Jul-2007 0 23-Jul-2007 31-Jul-2007 VA 31-Jul-2007

MedDRA PT Syncope
Symptom Text: After 3rd injection of Gardasil vaccine, pt fainted. There had not been any problems with 2 prior injections.
Other Meds:
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 285525-1

18.0 F 12-Jul-2007 13-Jul-2007 1 23-Jul-2007 31-Jul-2007 MA 31-Jul-2007
TDAP GLAXOSMITHKLINE AC52B015AA 0 Left arm Unknown
BIOLOGICALS
MNQ SANOFI PASTEUR U22330A 0 Right arm Unknown
MedDRA PT Chills, Delirium, Dizziness, Myalgia, Paraesthesia, Pyrexia, Speech disorder, Throat tightness
Symptom Text: Received Gardasil, Menactra and Tdap 7/12/07 at 9am - patient felt dizzy in parking lot - was fine then the evening. Woke at 4am with chills, not able to speak
a full sentence, fever 104, mom felt she was delirious, c/o tingling of her fingers and muscle aches. Patient later told mom she felt as of her throat was closing
in the am. Patient was fine according to mom.
Other Meds: None Known
Lab Data: None
History: None Known
Prex Vax Illns:

Vaers Id: 285527-1

17.0 F 08-Jun-2007 09-Jun-2007 1 23-Jul-2007 31-Jul-2007 -- 31-Jul-2007
VARCEL MERCK & CO. INC. 05920 0 Right arm Subcutaneously
MedDRA PT Injection site erythema, Injection site pain
Symptom Text: Moderate severe pain at site and erythema 4" diameter resolved after 48 hours.
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285529-1


MedDRA PT Hypokinesia, Musculoskeletal pain
Symptom Text: After 9 days left shoulder a lot of pain. Hurts to move shoulder. Hard to put pull over shirts on. No fever. No redness reported can only move left arm up 10
inches from waist then very painful.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285531-1


MedDRA PT Erythema, Swelling face
Symptom Text: Erythema and swelling of face, trunk and extremities - woke with symptoms day after vaccine.
Other Meds: Using new sunscreen
Lab Data: Clinical exam only
History: Erythromycin
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285544-1

17.0 F 17-Jul-2007 18-Jul-2007 1 23-Jul-2007 31-Jul-2007 GA 01-Aug-2007
HPV4 MERCK & CO. INC. 0802U 1 Left arm Intramuscular HPV4

MedDRA PT Asthenia, Pyrexia
Symptom Text: Mother called two days after vaccine; pt. had weakness and fever the day after the injection. Was well at the time I spoke with mother.
Other Meds:
Lab Data:
History: As written on systems review sheet per pt. and mother-asthma/bronchitis, dizziness/fainting, chest pains.
Prex Illness:
Prex Vax Illns:

Vaers Id: 285564-1

17.0 F 14-Jul-2007 22-Jul-2007 8 23-Jul-2007 31-Jul-2007 NE 01-Aug-2007

MedDRA PT Herpes zoster
Symptom Text: Mother states re-occurrence of "shingles" lesions below Rt eye 8 days after Gardasil #1 given. Child had not had outbreak in 2 yrs.
Other Meds: Zoloft, Zyrtec
Lab Data:
History: facial injury 6-8-07 contusion of TMJ
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285565-1

24.0 F 23-Jul-2007 23-Jul-2007 0 23-Jul-2007 31-Jul-2007 NM 01-Aug-2007

MedDRA PT Asthenia, Dizziness, Hypersensitivity, Hypotonia, Paraesthesia, Visual disturbance
Symptom Text: Pt seen in am and describes what appeared like an allergic response after 1st inj. anyway. Pt was given Betamethasone 6 mg IM at approx 1000 this am, Pt
returned at 1340 and was given Gardasil. 5 ml IM to (L) deltoid. Within one minute pt c/o tingling to bilat. arms and fingers and dizziness. Pt was laying down
and became weak with decreased muscle tone. c/o visual disturbance. Maintained BP + O2 Sat + Pulse all WNL. (1350) No improvement, Pt was given
Benadryl 50 mg IM at 1410. Took 20 minutes for slight improvement. Approx 35 min after Benadryl, pt was improving. Pt. had bee recommended not to receive
further doses and will take Benadryl 50mg P.O. daily x 2-3 days per Dr. Pt. d/c'd to home with boyfriend.
Other Meds:
Lab Data: None
History: Celiac disease, allergy to gluten
Prex Illness: None
Prex Vax Illns: ~HPV (Gardasil)~1~0~In Patient

Vaers Id: 285567-1

16.0 F 18-Jul-2007 21-Jul-2007 3 23-Jul-2007 31-Jul-2007 MA 01-Aug-2007

Symptom Text: Phone call 7/21/07. c/o red area sz of half dollar. Warm to touch. Advised Tylenol. Call if sx. persist condition resolved itself.
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285611-1

27.0 F 19-Jul-2007 20-Jul-2007 1 23-Jul-2007 31-Jul-2007 CA 01-Aug-2007

MedDRA PT Abdominal pain, Back pain, Blister, Erythema, Headache, Neck pain, Off label use, Pruritus, Urticaria
Symptom Text: I received the Gardasil/Gardisil vaccine 7/19. 7/20 I started experiencing itchiness in my scalp and felt the appearance of some hives on my scalp. 7/21 at
night I started feeling itchiness all over my body but very few red marks appeared. When I woke up 7/22 I had over 60 red spots (hives) all over my body, 6 on
my face and neck, and the majority on my back, chest and legs. Through out the course of that day abot 10 more appeared including a big, hard one on the
back of my neck that is causing me severe headaches and back/neck pain. 7/23 I woke up with over 30 new marks (apparently the majority of the new marks
come out at night). The older marks grew in size to the approx size of a 5cent coin, and in the center small blisters have formed. The area around the blister is
very irritated (red). A couple of them have popped, exposing a deep red dot underneath. I went to the doctor and they have put me on benadryl for the
moment, I might have to go back for a cortisone shot if the benadryl doesn't calm my symptoms. I am experience rushes of itchiness through out, and pain in
some areas (right side of my abdomen and back/neck).
Other Meds: None
Lab Data: No tests were performed.
History: Allergic to dust, dander and grass (apparently also gardasil starting now)
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285631-1


MedDRA PT Urticaria
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female with no drug reactions or allergies with hypertension and asthma who
on 13-APR-2007 was vaccinated intramuscularly with the first dose of Gardasil, (Lot # 656050/0245U). Concomitant therapy included ethinyl
estradiol/norgestimate (ORTHO TRI-CYCLEN LO), fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA-D), hydrochlorothiazide
(manufacturer unknown), albuterol, bupropion HCl (WELLBUTRIN), atomoxetine hydrochloride (STRATTERA) and venlafaxine HCl (EFFEXOR). On 13-APR-
2007 the patient developed hives after receiving her first dose of Gardasil. The hives were mostly on her vaccinated arm. The patient sought unspecified
medical attention. The hives disappeared the next day, 14-APR-2007. No further information was available. Additional information has been requested.
Other Meds: albuterol, Strattera, Wellbutrin, Ortho Tri-Cyclen Lo, Allegra-D, Hydrodiuril, Effexor
Lab Data: Unknown
History:
Prex Illness: Hypertension; Asthma
Prex Vax Illns:

Vaers Id: 285632-1


MedDRA PT Injection site erythema, Injection site rash
Symptom Text: Information has been received from a licensed practical nurse concerning a 24 year old female who on approximately 18-JUN-2007 was vaccinated IM with a
third 0.5 ml dose of Gardasil (lot# 657868/0523U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On 18-JUN-2007, the
patient experienced redness and a rash at the injection site. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On
18-JUN-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285633-1


MedDRA PT Injection site erythema, Injection site rash, No reaction on previous exposure to drug
Symptom Text: Information has been received from a licensed practical nurse concerning a 22 year old female who on 24-APR-2007 and on approximately 18-JUN-2007 was
IM vaccinated with a first and second 0.5 ml dose of Gardasil (lot# 657868/0523U), respectively. Concomitant therapy included drospirenone (+) ethinyl
estradiol (YASMIN). On 18-JUN-2007,the patient experienced redness and a rash at the injection site. Unspecified medical attention was sought. No diagnostic
laboratory studies were performed. On 18-JUN-2007, the patient recovered. It was reported that there were no problems after she received the first dose. No
Other Meds: Yasmin
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285634-1


Symptom Text: Information has been released from a physician, via a company representative, concerning a 26 year old female patient, who on 18-JUN-2007 was vaccinated
with the second of Gardasil (Lot #657736/0389U). On 18-JUN-2007, two hours after the vaccine was administered, the patient experienced ongoing numbness
and tingling in her legs. At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285635-1


MedDRA PT Concussion, Head injury, Loss of consciousness
Symptom Text: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with Gardasil. After receiving Gardasil, the patient
passed out, hit her head on the tablet resulting in a concussion. Therapy with Gardasil was discontinued. As of 19-JUN-2007, the patient had improved after
stopping therapy. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285636-1

Unknown F Unknown Unknown 18-Jul-2007 16-Aug-2007 OH WAES0706USA03259 17-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated on an unknown day with a third dose of Gardasil. The patient
fainted after her third injection. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285637-1

22.0 F 15-Jun-2007 15-Jun-2007 0 18-Jul-2007 16-Aug-2007 MO WAES0706USA03262 17-Aug-2007

MedDRA PT Hyperhidrosis, Nausea, Pain
Symptom Text: Information has been received from a physician concerning a 22 year old female patient who on 15-JUN-2007, was vaccinated IM with a first dose of Gardasil.
A few minutes later the patient started sweating profusely and became nauseous. The patient also complained that the injection hurt when she was getting it.
No medical attention was sought. No laboratory diagnostic studies were performed. Within 5 minutes, the patient recovered. No product quality complaint was
Other Meds: Unknown
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285638-1

24.0 F 05-Jun-2007 18-Jun-2007 13 18-Jul-2007 16-Aug-2007 OR WAES0706USA03289 17-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a 24 year old female who on 05-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose
of Gardasil (lot # 657617/0384U). Concomitant therapy included sertraline HCl (ZOLOFT) and amoxicillin. On 18-JUN-2007, the patient developed a red rash
on her chest and back. The patient sought unspecified medical attention. No other symptoms were noted. At the time of the report, the patient was recovering.
There were no laboratory or diagnostic tests performed. Additional information has been requested.
Other Meds: Amoxicillin, Zoloft
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285639-1

Unknown F Unknown Unknown 18-Jul-2007 17-Aug-2007 NJ WAES0706USA03297 20-Aug-2007

MedDRA PT Fungal infection, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. One week later, the patient developed
a yeast infection and she sought unspecified medical attention. Subsequently she recovered from the yeast infection. On an unspecified date, the patient was
vaccinated with the second dose of Gardasil and developed a yeast infection one week later. She sought unspecified medical attention and subsequently
recovered. On an unspecified date, the patient was vaccinated with the third dose of Gardasil. With the third dose, the physician gave the patient unspecified
medication along with the dose and no yeast infection occurred. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285640-1

20.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 OR WAES0706USA03300 20-Aug-2007

Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female who was vaccinated with Gardasil. Subsequently, the patient
experienced "stinging pain at the injection site". The patient sought unspecified medical attention. She recovered on an unspecified date. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285641-1

16.0 F 18-Jun-2007 18-Jun-2007 0 18-Jul-2007 17-Aug-2007 VA WAES0706USA03304 20-Aug-2007

MedDRA PT Dizziness
Symptom Text: Information has been received from a physician concerning a 16 year old female who on 18-JUN-2007 was vaccinated intramuscularly with the second dose of
Gardasil (lot # 655618/0186U). On 18-JUN-2007, ten minutes after receiving the vaccination, the patient became "light-headed". It was reported that after the
physician gave her water and she sat down for a while, she felt fine. The patient recovered after "a few minutes". Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285642-1


MedDRA PT Urticaria
Symptom Text: Information has been received from a physician concerning a 12 year old female who on 16-JUN-2007 was vaccinated with a first dose of Gardasil (Lot
#658100/0525U). There was no concomitant medication. Subsequently, later that night the patient broke out in hives all over her body. She called the office
and the physician advised her to take BENADRYL and "everything was fine." At the time of the report, the patient had recovered. No product quality complaint
was involved. Additional information has been requested.
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285643-1


Symptom Text: Information has been received from a physician, via a company representative, concerning a female patient (age unspecified), who was vaccinated (date
unspecified), with the second dose of Gardasil. The patient indicated that the shot "was very painful," and the physician reported that her arm was "still hurting"
two weeks later. At the time of this report, the patient had not recovered from the arm pain. The patient sought unspecified medical attention. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285644-1

Unknown F Unknown Unknown 18-Jul-2007 17-Aug-2007 IN WAES0706USA03405 20-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female (age unknown) was vaccinated with a dose of Gardasil. Subsequently, after receiving the
vaccination the patient fainted. The patient sought unspecified medical attention. At the time of the report, the patient had recovered on unspecified therapy. No
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285645-1


MedDRA PT Immediate post-injection reaction, Reaction to previous exposure to any vaccine, Syncope vasovagal
Symptom Text: Information has been received from a nurse concerning a female (age unknown) with an history of vasovagal reactions after vaccinations and no allergies, who
on 17-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot#0210U). There was no concomitant medication. The patient
experienced a vagal reaction immediately after the injection. The patient sought unspecified medical attention. The patient had recovered on 17-MAY-2007. No
Other Meds: None
Lab Data: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285646-1

Unknown F Unknown Unknown 18-Jul-2007 17-Aug-2007 -- WAES070603411 20-Aug-2007

MedDRA PT Pain
Symptom Text: Information has been received from a registered nurse concerning "many patients" who were vaccinated with a dose of Gardasil. Subsequently, the patients
reported that the vaccination was painful. At the time of the report, the outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285647-1

MedDRA PT Dizziness, Dizziness, Headache, Nausea, Syncope
Symptom Text: Information has been received from a physician concerning a 15 year old female, who on 17-APR-2007 was vaccinated with a first dose of Gardasil
(lot#656051/0224U). Concomitant suspect vaccinations received on 17-APR-2007 included Varivax and Vaqta (manufacturer unknown). Other concomitant
therapy included DTaP (unspecified) (+) tetanus toxoid. Subsequently, after being vaccinated with a first dose of Gardasil (lot#656051/0224U) the patient
fainted a few minutes after administration. It was also reported that when the patient was vaccinated with a second dose of Gardasil (lot#657868/0523U), 15
minutes later the patient experienced light headedness, nausea, and a headache. The physician reported that "the patient got well" on the same day that she
received the first and second dose. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information has
been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285648-1


Symptom Text: Information has been received from a certified medical assistant concerning a 26 year old female with no medical history or allergies, who on 18-JUN-2007 was
vaccinated intramuscularly into the right arm with a 0.5mL second dose of Gardasil (lot#657736/0389U). Subsequently, on 18-JUN-2007 the patient
experienced numbness and tingling in both legs. The patient called the office on 19-JUN-2007 and stated that the symptoms had not resolved. She stated that
it's "a weird kind of sensation." The patient had a follow up appointment. She is able to walk and is at work. No lab or diagnostic studies were performed. At the
time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285649-1

15.0 F 08-Sep-2006 10-Sep-2006 2 18-Jul-2007 17-Aug-2007 IL WAES0706USA03455 20-Aug-2007

MedDRA PT Hypersensitivity, Urticaria
Symptom Text: Information has been received from a physician concerning a 15 year old female with Asthma, Allergic Rhinitis, and no drug allergies, who on 08-SEP-2006
was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included ZYRTEC and ADVAIR. About 48 hours after vaccination on
approximately 10-SEP-2006 the patient experienced hives mainly on her face and neck. She was treated with BENADRYL and ZYRTEC. In approximately
November 2006, a test dose was given intradermally which resulted in a positive allergic reaction. The second dose of Gardasil was not administered due to
the patient's suspected allergy to the vaccine. The patient sought unspecified medical attention. No lab diagnostic studies were performed. At the time of the
report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Other Meds: ZYRTEC; ADVAIR
Lab Data: None
History: Asthma; Allergic Rhinitis
Prex Illness:
Prex Vax Illns:

Vaers Id: 285650-1


MedDRA PT Anxiety, Immediate post-injection reaction, Syncope
Symptom Text: Information has been received from a physician concerning a 13 year old female, who did not eat anything and was very anxious before the vaccine, who on
19-JUN-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. The patient fainted immediately following the injection.
Unspecified medical attention was sought. there were no laboratory or diagnostic tests performed. At the time of the report the patient was recovering. The
physician reported that the patient will continue the series of vaccines. Additional information has been requested.
Other Meds: None
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285651-1

MedDRA PT Dizziness, Hyperhidrosis, Pallor
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female who on 18-JUN-2007 was vaccinated with a 0.5ml first dose of
Gardasil. Concomitant therapy included meningococcal vaccine (unspecified) and DTaP (+) tetanus toxoid. On 18-JUN-2007 the patient became pale, woozy
and began sweating. The patients blood pressure measurement was low. She laid down and had some orange juice and crackers. On 18-JUN-2007, the
patient recovered from becoming pale, woozy and sweating, and low blood pressure Additional information has been requested.
Other Meds:
Lab Data: blood pressure 6/18/07 low
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285652-1

26.0 F 17-May-2007 19-May-2007 2 18-Jul-2007 17-Aug-2007 TN WAES0706USA03476 20-Aug-2007

MedDRA PT Rash erythematous, Rash pruritic
Symptom Text: Information has been received from a nurse practitioner concerning a 26 year old female with chronic vaginitis who on 17-MAY-2007 was vaccinated with a first
dose of Gardasil (lot # 57736/0389U). There was no concomitant medication. On 19-MAY-2007 the patient developed a rash on her interior and posterior trunk
and a little bit on her arms. The rash was described as kind of flat and raised, and was itchy and red. The patient went to the urgent care emergency room and
was administered steroids which helped the rash. At the time of the report, the patient was recovering. Additional information has been requested.
Other Meds: None
Lab Data: Unknown
History:
Prex Illness: Vaginitis
Prex Vax Illns:

Vaers Id: 285653-1


MedDRA PT Dizziness, Dizziness
Symptom Text: Information has been received from a registered nurse concerning a 26 year old female with a history of colitis who on 16-ARPR-2007 was vaccinated IM with
the first dose of Gardasil (lot # 657621/0387U). On 19-JUN-2007 was vaccinated IM with the second dose of Gardasil (lot # 0211U). Concomitant therapy
included FEMCON FE. Immediately after the second dose the patient experienced "extreme lightheadedness and dizziness". Unspecified medical attention was
sought. The registered nurse reported the symptoms lasted "within 10 minutes or so". On 19-JUN-2007, the patient recovered from "extreme lightheadedness
and dizziness". There were no laboratory or diagnostic tests performed. It was reported that the patient did not experience any symptoms after receipt of the
first dose. Additional information has been requested.
Other Meds: FEMCOM FE
Lab Data: None
History: Colitis
Prex Illness:
Prex Vax Illns:

Vaers Id: 285654-1

23.0 F 11-Jun-2007 11-Jun-2007 0 18-Jul-2007 17-Aug-2007 TN WAES0706USA03494 20-Aug-2007

MedDRA PT Arthralgia, Arthralgia, Lip blister, Musculoskeletal stiffness, Pyrexia, Skin exfoliation, Swelling
Symptom Text: Information has been received from a office assistant concerning a 23 year old female with drug hypersensitivity to aspirin who on 11-JUN-2007 was
vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 657868/0523U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) Norethindrone
acetate (LOESTRIN 24 FE). On 11-JUN-2007 in the evening, the patient experienced fever 100-101F, stiff limbs, joint aches and pains, and swollen, sore,
blistery, and peeling lips. Unspecified medical attention was sought. The patient's fever 100-101F and stiff limbs, joint aches and pains, and swollen, sore,
blistery, and peeling lips persisted. There were no laboratory or diagnostic tests performed. Additional information has been requested.
Other Meds: Loestrin 24 FE
Lab Data: body temp 100-101F
History:
Prex Illness: Drug hypersensivity
Prex Vax Illns:

Vaers Id: 285655-1


MedDRA PT Dizziness, Nausea, No reaction on previous exposure to drug
Symptom Text: Information has been received from a certified medical assistant concerning a 23 year old female, with no pertinent medical history, who on 20-APR-2007 was
vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 0210U). On 18-JUN-2007 was vaccinated IM with a 0.5 ml second dose of Gardasil (lot # 0210U). There
was no concomitant medication. Later that evening, the patient experienced dizziness and nausea. Unspecified medical attention was sought. The patient's
dizziness and nausea persisted. The certified medical assistant reported that the patient did not experience any difficulties with the 20-APR-2007 first dose.
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285656-1


MedDRA PT Vaccination complication
Symptom Text: Information has been received from a mother concerning her daughter who on unspecified dates was vaccinated with first and second doses of Gardasil. Her
daughter only took 2 doses of the vaccine and had to stop. Subsequently, it was reported that the patient's body had rejected the vaccine. Unspecified medical
attention was sought. The patient was seen by a neurologist. The patient's outcome was unknown. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285657-1

MedDRA PT Syncope
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female who on 18-JUN-2007 was vaccinated with Gardasil. Concomitant
therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, tuberculin purified protein derivative and MENACTRA. On 18-
JUN-2007 the patient experienced syncope. Subsequently, the patient recovered from syncope. Medical attention was sought. Additional information has been
requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285658-1


MedDRA PT Syncope
Symptom Text: Information has been received from a nurse practitioner concerning a female who on 18-JUN-2007 was vaccinated IM with Gardasil and fainted after receiving
the injection. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285659-1

17.0 F 16-Jun-2007 19-Jun-2007 3 18-Jul-2007 16-Aug-2007 VA WAES0706USA03834 17-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 19-JUN-2007 was vaccinated with the first dose of Gardasil (Lot #
655618/0186U) and immediately fainted. It was reported that the patient "came back on her own" 15 seconds later. Concomitant therapy included hepatitis A
virus vaccine (unspecified). The patient sought unspecified medical attention. It was also reported that the patient was menstruating at the time. Additional
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285660-1


MedDRA PT Injection site erythema, Injection site irritation, Injection site pain
Symptom Text: Information has been received concerning a "below 20" year old female (age estimated) who on an unspecified date was vaccinated with Gardasil (Lot number
unknown). Concomitant medication was not reported. On an unspecified date the patient experienced burning, redness and a little bit of pain at the injection
site after receiving a dose of Gardasil. At the time of reporting, the outcome causality were not reported. No further information was available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285661-1

11.0 F 01-May-2007 01-May-2007 0 18-Jul-2007 17-Aug-2007 TN WAES0706USA03844 20-Aug-2007

MedDRA PT Cyst, Pain in extremity
Symptom Text: Information has been received from a physician concerning an approximately 11 year old female or older who in approximately May 2007, was vaccinated with
Gardasil (lot number unknown) 0.5 mL IM. In approximately May 2007, the patient complained of pain in the arm where she received the injection for over a
month. Medical attention was sought. An MRI was performed on an unspecified date and the results showed a "8mm fluid sac". It was reported that it was not
known if the fluid sac was the injection site. At the time of reporting the patient has not recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: magnetic resonance - 8mm fluid sac
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285662-1

Unknown F Unknown Unknown 18-Jul-2007 17-Aug-2007 MO WAES0706USA03845 20-Aug-2007

MedDRA PT Headache
Symptom Text: Information has been received from a nurse in an OB/GYN office concerning a female (age not reported) who on an unspecified date was vaccinated with
Gardasil. Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On an unspecified date the patient experienced headaches that
lasted for 30 days unspecified. Medical attention was sought. The nurse reported that when the patient called into the OB/GYN office, there were no documents
stating that the patient had received the Gardasil and that the last patient visit was August 2006. The nurse believed that the patient may have received the
vaccination for her primary care physician. The nurse was unsure the patient had received the vaccine in their OB/GYN office. At the time of reporting, it was
unknown if the patient had recovered. Additional information has been requested available. Further information is not available.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285663-1

19.0 F 24-Mar-2007 24-Mar-2007 0 18-Jul-2007 17-Aug-2007 NJ WAES0706USA03856 20-Aug-2007

MedDRA PT Abdominal pain upper, Drug exposure during pregnancy, Metrorrhagia
Symptom Text: Information has been received from a consumer concerning her 19 year old daughter with an allergy to Zithromax who on 17-JAN-2007 was vaccinated IM with
a 0.5 mL of the first dose of Gardasil. Concomitant therapy included acetaminophen/codeine phosphate (TYLENOL WITH CODEINE) and albuterol. On 24-
MAR-2007 the patient was vaccinated with the second dose of Gardasil and is now pregnant. Her LMP is 13-APR-2007. On 18-JUN-2007 the patient
experienced light spotting and stomach cramps. The patient's outcome was not reported. Additional information has been requested.
Other Meds: Tylenol with codeine, albuterol
Lab Data: None
History:
Prex Illness: Pregnancy NOS (LMP=4/13/2007) Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 285664-1

Unknown F Unknown Unknown 18-Jul-2007 17-Aug-2007 LA WAES0706USA03882 20-Aug-2007

MedDRA PT Dysgeusia, Immediate post-injection reaction
Symptom Text: Information has been received from a physician concerning 3 females who were vaccinated with the first dose of Gardasil (Lot # 656372/0243U). Subsequently
the patients experienced metal taste in their mouths five minutes after receiving the vaccine. Medical attention was sought. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285665-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 19 year old female with no pertinent medical history and seasonal allergies who on 04-JUN-2007
was vaccinated with a first dose of Gardasil (Lot # "0524U") 0.5 mL IM. Concomitant therapy included YASMIN and CLARITIN. The physician reported that after
receiving the Gardasil the patient experienced a syncope episode for 45 seconds. Medical attention was sought. The patient was back to normal within 2
minutes. The doctor feels the patient was not accustomed to receiving injections. At the time of reporting the patient recovered. No additional information at this
this time. Additional information has been requested.
Other Meds: YASMIN; CLARITIN
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 285666-1

Unknown F 18-Jun-2007 19-Jun-2007 1 18-Jul-2007 17-Aug-2007 AZ WAES0706USA03897 20-Aug-2007

Symptom Text: Information has been received from a consumer concerning his niece who on 18-JUN-2007 was vaccinated with the first dose of Gardasil. On 19-JUN-2007,
the patient experienced severe abdominal cramping "in the stomach area." The patient sought unspecified medical attention. Subsequently, the patient
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285667-1

16.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 PA WAES0706USA03899 20-Aug-2007

Symptom Text: Information has been received from a physician concerning a 16 year old female who was vaccinated with a dose of Gardasil. The physician reported that the
patient passed out in the parking lot, which was a half hour after vaccination. The physician also reported that "it was a hot day outside." The patient sought
unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285668-1


MedDRA PT Injection site urticaria
Symptom Text: Information has been received from a physician concerning a 14 year old female who was vaccinated with the third dose of Gardasil. Subsequently, during the
evening after vaccination, the patient developed a half-dollar, raised welt at the injection site. The patient sought unspecified medical attention. It was reported
that the welt lasted for two days. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285669-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 16 year old female who was vaccinated with Gardasil. It was reported that the patient sat in the
room for 10 minutes after receiving the vaccination and when she went to stand up she fainted. They took her to the waiting room to sit for a bit and when she
went to stand up and leave she fainted again. The patient sought unspecified medical attention. No other information was available. Additional information has
been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285670-1

15.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 CT WAES0706USA03955 20-Aug-2007

MedDRA PT Injection site pain, Pain, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 15 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil.
Subsequently, the patient experienced significant arm pain at the injection site and then full body pain. The patient was taken to the emergency room of the
local hospital. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285671-1


MedDRA PT Hypersensitivity
Symptom Text: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of Gardasil.
Subsequently, the patient experienced an acute allergic reaction and had to go to the emergency room. At the time of the report, the patient's outcome was
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285672-1

10.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 OH WAES0706USA03959 20-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 10 year old female who was vaccinated with Gardasil. It was reported that the patient fainted
shortly after receiving Gardasil. The patient sought unspecified medical attention. No further information was available. Additional information has been
requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285673-1


MedDRA PT Nausea
Symptom Text: Information has been received from a pharmacist concerning his daughter (age unknown), who, on an unspecified date, was vaccinated with a dose of
Gardasil. Subsequently, the patient experienced nausea for two days. At the time of the report, the patient's outcome was unknown. No product quality
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285674-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female (age unknown) was vaccinated with a dose of Gardasil. Subsequently, after receiving the
vaccination the patient fainted. The patient sought unspecified medical attention. At the time of the report, the patient had recovered on an unspecified therapy.
No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285675-1

Unknown F 01-Apr-2007 01-Apr-2007 0 18-Jul-2007 17-Aug-2007 MN WAES0706USA04016 20-Aug-2007

MedDRA PT Lip swelling, Swelling face
Symptom Text: Information has been received from a physician concerning a female who in approximately April 2007, was vaccinated IM with the first dose of Gardasil. The
day after vaccination, the patient experienced swelling of her lips and a member of the patient's family thought that her face was a little puffy too. The patient's
outcome was not reported. Medical attention was sought. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285676-1


MedDRA PT Presyncope, Syncope
Symptom Text: Information has been received from an office manager concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of
Gardasil. Subsequently, the patient experienced syncope. The patient did not pass out but felt like she was going to. The patient sought unspecified medical
attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports received from the
same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285677-1


MedDRA PT Asthenia, Heart rate increased, Nausea
Symptom Text: Information has been received from a female health professional who on 19-JUN-2007 was vaccinated IM with a second dose of Gardasil. The registered nurse
immediately was nauseous, weak and developed an elevated heart rate. The symptoms lasted a few minutes and the registered nurse recovered from feeling
nauseous, weak and the elevated heart rate. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285678-1

Unknown F Unknown Unknown 18-Jul-2007 17-Aug-2007 VA WAES0706USA04025 20-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female who was vaccinated IM with a second dose of Gardasil. Shortly after being vaccinated the
patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285679-1


MedDRA PT Back pain, Diarrhoea, Inappropriate schedule of drug administration, Nausea, Pyrexia, Vomiting
Symptom Text: Initial and follow-up information has been received from a nurse practitioner concerning an approximately 27 year old female who was vaccinated with a 0.5 ml
second dose of Gardasil. During the next 24 hours, the patient experienced fever, nausea, diarrhea, low back pain, and vomiting. Unspecified medical attention
was sought. The patient then recovered within 24 hours from the fever, nausea, diarrhea, low back pain, and vomiting. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285680-1

21.0 F 02-Apr-2007 18-Jun-2007 77 18-Jul-2007 17-Aug-2007 -- WAES0706USA04044 20-Aug-2007

MedDRA PT Cervix haemorrhage uterine
Symptom Text: Information has been received from the mother of a 21 year old female with allergy to corn flour who in August 2006, was vaccinated with her first dose of
Gardasil. The patient's second dose was in approximately November 2006 and her third dose was on 02-APR-2007. Concomitant therapy included ethinyl
estradiol (+) norelgestromin (ORTHO EVRA). On 18-JUN-2007 the patient experienced cervix bleeding. The patient sought medical attention and no laboratory
or diagnostic studies were performed. As of 20-JUN-2007, the patient's cervix bleeding persisted. Additional information is not expected.
Other Meds: Ortho Evra
Lab Data:
History:
Prex Illness: Flour sensitivity
Prex Vax Illns:

Vaers Id: 285681-1

16.0 F 24-May-2007 25-May-2007 1 18-Jul-2007 17-Aug-2007 CA WAES0706USA04049 20-Aug-2007

MedDRA PT Asthenia, Dizziness, Fatigue, Nausea
Symptom Text: Information has been received from a physician concerning a 16 year old Hispanic female who on 24-MAY-2007 was vaccinated with her first dose of Gardasil.
There was no concomitant medication. On 25-MAY-2007 the patient developed nausea, dizziness, weakness and was tired.
Other Meds: None
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285682-1


Symptom Text: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Gardasil. It was reported that the dose
the patient received was unspecified. On an unspecified date, the patient developed genital wart after receiving the vaccine. Unspecified medical attention was
sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285690-1

21.0 F 10-Jul-2007 12-Jul-2007 2 24-Jul-2007 25-Jul-2007 PA WAES0707USA02591 25-Jul-2007

MedDRA PT Palpitations, Palpitations, Pyrexia, Tremor
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female patient who on 10-JUL-2007, was vaccinated with a first dose of
Gardasil. There was no concomitant medication. On 12-JUL-2007 (more than 48 hours after her first vaccination), the patient became shaky, feverish and had
heart palpitations and her heart was racing. It was reported that she called the paramedics but did not go to the hospital. Subsequently, the patient recovered.
No product quality complaint was involved. The registered nurse considered the had heart palpitations, heart racing and being shaky to be considered other
important medical events. Additional information has been requested.
Other Meds: none
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285691-1 (S)

Unknown F Unknown Unknown 24-Jul-2007 25-Jul-2007 IL WAES0707USA02973 25-Jul-2007

Symptom Text: Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of Gardasil. Subsequently, four days
after the vaccination the patient experienced tingling in her legs and was admitted to the hospital. At the time of the report, the patient was recovering. No
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285692-1 (S)

21.0 F 15-May-2007 01-Jun-2007 17 24-Jul-2007 25-Jul-2007 FL WAES0707USA03092 25-Jul-2007

MedDRA PT Arthralgia, Joint range of motion decreased, Joint swelling, Mobility decreased
Symptom Text: Information has been received from a physician, concerning a 21 year old female patient, who on 15-MAY-2007 was vaccinated IM, with the second dose,
0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication. On 01-JUN-2007, the patient began to experience prolonged swelling and
tenderness of all her joints, as well as, a decreased mobility of her joints. Diagnostic labs included a complete blood count (CBC) with differential,
sedimentation rate, rheumatoid factor C3 and C4, and an autoimmune workup (results were not provided). Treatment included meloxicam (MOBIC), and the
patient was referred to a rheumatologist for further evaluation. At the time of this report, the patient had not recovered from the events. The reporting physician
considered one or more of the events to be serious, as disabling/incapacitating. Additional information has been requested.
Other Meds: None
Lab Data: complete blood cell; erythrocyte; serum rheumatoid factor
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285693-1 (S)

17.0 F 29-Jun-2007 30-Jun-2007 1 24-Jul-2007 30-Jul-2007 NJ 31-Jul-2007
MNQ SANOFI PASTEUR U2233CA 0 Unknown Intramuscular
MedDRA PT Confusional state, Psychiatric symptom, Speech disorder, Thinking abnormal
Symptom Text: Within one day of dose, pt developed psychiatric symptoms (disorganized thoughts, speech, etc.) and ended up admitted 5 days after dose to psychiatric
inpatient facility for 12 days.
Other Meds: None
Lab Data: MRI Pending; Neurology eval pending
History: None
Prex Illness: Malaise
Prex Vax Illns:

Vaers Id: 285695-1

18.0 F 17-Jul-2007 17-Jul-2007 0 24-Jul-2007 01-Aug-2007 OR 01-Aug-2007

MedDRA PT Headache, Injection site swelling, Oedema peripheral
Symptom Text: Swollen arm at injection site and headache.

Other Meds: None
Lab Data: None
History: Common migraines
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285700-1

14.0 F 18-Jul-2007 18-Jul-2007 0 24-Jul-2007 01-Aug-2007 NC 02-Aug-2007
MedDRA PT Convulsion, Dizziness, Fall, Pallor, Tremor
Symptom Text: I administered the vaccine Gardasil in (L) arm IM pt was ok at this point within 1 min after vaccine was administered pt. started getting dizzy, turned very pale
and fell over to (R) side, her body then started shaking almost like a seizure, Dr enter the room pt was coming to herself we gave her a drink of soda her pulse
Ox was 99% and she started feeling better.
Other Meds:
Lab Data: Pulse Ox=98-99
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285711-1

10.0 F 20-Jul-2007 20-Jul-2007 0 24-Jul-2007 02-Aug-2007 PA 02-Aug-2007
HPV4 MERCK & CO. INC. 0524U 0 Left arm Intramuscular MNQ
TDAP
VARCEL
MedDRA PT Cold sweat, Dizziness, Dizziness, Hyperhidrosis, Pallor, Syncope
Symptom Text: Within 15 minutes after vaccine - pt became dizzy, clammy, sweaty, lightheaded, loss of color, fainted in exam room.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285712-1

17.0 F 09-Apr-2007 13-Jul-2007 95 24-Jul-2007 02-Aug-2007 MI 02-Aug-2007

MedDRA PT Drug exposure during pregnancy, Intra-uterine death
Symptom Text: Patient was pregnant - which she did not inform and then had fetal demise - the cord was wrapped around fetus arm and shoulder 4 times.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 285713-1

11.0 F 16-Jul-2007 18-Jul-2007 2 24-Jul-2007 02-Aug-2007 KY 02-Aug-2007
HPV4 MERCK & CO. INC. 0524U 1 Right arm Intramuscular MNQ

MedDRA PT Rash papular, Skin hyperpigmentation
Symptom Text: Rash, flesh colored papules to shoulder with surrounding hyperpigmentation also with flesh colored papules to chest.
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285736-1

13.0 F 19-Jul-2007 20-Jul-2007 1 24-Jul-2007 02-Aug-2007 FL 02-Aug-2007
HPV4 MERCK & CO. INC. 0245U 1 Right leg Intramuscular

MedDRA PT Cough, Dysphonia, Wheezing
Symptom Text: Received vaccine approximately 7/19/07 - (cough x 3 days prior) hoarseness 7/19 PM and wheezing next AM went to ER seen at medical center ER told
"possible reaction to HPV shot".
Other Meds: None
Lab Data: CXR - "negative"
History: None, no history asthma per parent
Prex Illness: Cough x >24 hours
Prex Vax Illns:

Vaers Id: 285737-1

21.0 F 17-Jul-2007 18-Jul-2007 1 24-Jul-2007 02-Aug-2007 NY 02-Aug-2007

MedDRA PT Pain, Pain of skin, Pyrexia
Symptom Text: Pt awoke on 7/18/07 with symptoms of generalized body aches, low grade fever, and skin tenderness lasting throughout the day. Patient took Advil 400mg in
the A.M. and Advil 400mg in the afternoon with some relief from symptoms. 7/19/07 symptoms were resolved.
Other Meds: BCP
Lab Data:
History: Red food dye allergy
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285745-1

15.0 F 25-Jun-2007 25-Jun-2007 0 24-Jul-2007 01-Aug-2007 MN 01-Aug-2007

MedDRA PT Headache, Musculoskeletal stiffness, Vomiting
Symptom Text: Stiff hands. Headache. Vomiting. One month before. Tylenol. Lasted about two hours. HEADACHE: Started two hours after vaccination with HPV.
Recurrent HA this AM one month later. Associated with vomiting.
Other Meds: None
Lab Data: none
History: No history of miagrane headaches.
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285747-1

20.0 F 19-Jul-2007 21-Jul-2007 2 24-Jul-2007 01-Aug-2007 GA 01-Aug-2007
TYP BERNA BIOTECH, LTD NULL Unknown Unknown
MedDRA PT Abdominal pain, Abdominal pain upper, Diarrhoea, Disorientation, Dizziness, Gastrointestinal disorder, Nausea, Pyrexia
Symptom Text: Nausea, diarrhea, fever, acute GI illness, abdominal cramping, dizziness, and disorientation from time of second pill administration. Slight symptoms of
stomach ache were noted about 36 hours after first pill was taken. Pills were taken two hours after dinner, exactly 48 hours apart. Patient felt so bad that she
was taken to a physician on Monday 7/23. Physician recommended immediate fluids and bed rest. Physician said to discontinue use of Loperamide
Hydrochloride tablets and let bowels empty. Physician considered hospital admission and IV fluids.
Other Meds: Allegra 180 mg daily, Yasmin birth control pill daily
Lab Data: Physician ran blood test, took vital signs, blood pressure, and took stool sample. Results of stool sample are not back yet. Physician believes the side effects
are the result of the live oral Typhoid vaccine, not the other three immuniza
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 285760-1

25.0 F 23-Jul-2007 23-Jul-2007 0 24-Jul-2007 01-Aug-2007 CA 01-Aug-2007

MedDRA PT Dizziness, Immediate post-injection reaction, Injection site reaction, Nausea, Paraesthesia
Symptom Text: Immediately following vaccinatin, patient felt tingling at injection site. She stated that she felt light headed and nauseous. She felt better after lying down for
around 5 minutes. We observed patient for over 30 minutes and she left in stable condition.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 285791-1


Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female, who, on an unspecified date, was vaccinated intramuscularly with a
second dose of Gardasil. Subsequently, the patient passed out in the car about 15 minutes post vaccination. The nurse practitioner reported that the patient
mentioned that she had cleaned her backroom that morning with Tilex and really had nothing substantial to eat besides popcorn and pineapple that day. The
patient ended up going to the emergency room. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285792-1

Symptom Text: Information has been received from an office manager (also reported as a nurse) concerning a 15 year old female with no medical history or allergies, who on
21-JUN-2007 was vaccinated intramuscularly with a first 0.5mL dose of Gardasil (Lot #357736/0389U). Concomitant vaccinations on 21-JUN-2007 included
Menactra and Tdap
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285793-1

Unknown U Unknown Unknown 18-Jul-2007 17-Aug-2007 IN WAES0706USA04348 20-Aug-2007

Symptom Text: Information has been received from a registered nurse, concerning two patients (gender and age not specified), who were vaccinated (date unspecified) with a
dose of Gardasil (Lot # not specified). Following vaccination (duration of time not specified), the patient experienced fatigue, flu-like symptoms, dizziness and
musculoskeletal aches. At the time of this report, it was unknown if the patients had recovered from the events. The patient sought unspecified medical
attention. The nurse reported that another patient experienced similar symptoms following vaccination with Gardasil (WAES #0706USA04089). Attempts are
being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if
available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285794-1

21.0 F 19-Mar-2007 Unknown 18-Jul-2007 17-Aug-2007 FL WAES0706USA04335 20-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a health professional concerning a 21 year old white female with no medical history or allergies, who on 19-MAR-2007 was
vaccinated intramuscularly in the right deltoid with a first dose of Gardasil (Lot # 655503/0012U). Concomitant therapy included YAZ and ALLEGRA.
Subsequently, the patient experienced syncope. The patient had no illness at the time of the vaccination. It was noted that the patient had not eaten that
morning. The patient had recovered on 19-MAR-2007. Additional information has been requested.
Other Meds: YAZ; ALLEGRA
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285795-1


Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed a bump at an
injection site after receiving the vaccine. This is one of several reports from the same source.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285796-1


Symptom Text: Information has been received from a physician concerning a female patients between 20 - 25 years old who was vaccinated IM with Gardasil. Subsequently all
the patient experienced abdominal cramping "like premenstrual related symptoms". Subsequently, all the patient recovered from abdominal cramping "like
premenstrual related symptoms". The patient did not seek medical attention. Additional information has been requested. This is one of several reports from the
same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285797-1


MedDRA PT Chest pain, Dyspnoea
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient
experienced chest pains and shortness of breath. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285798-1

18.0 F 01-Apr-2007 07-Apr-2007 6 18-Jul-2007 17-Aug-2007 FL WAES0706USA04185 20-Aug-2007

MedDRA PT Nausea, Pruritus generalised, Urticaria
Symptom Text: Information has been received from a physician concerning an 18 year old female with "unremarkable" medical history who in April 2007, was vaccinated with a
first dose of Gardasil. Subsequently, the patient experienced welts, itching all over body, and nausea. The patient sought unspecified medical attention. The
patient recovered from welts, itching all over body and nausea approximately 3 days after initial injection. The physician did plan on administering further doses
of Gardasil to this patient. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285799-1

13.0 F 14-Jun-2007 15-Jun-2007 1 18-Jul-2007 17-Aug-2007 DE WAES0706USA04065 20-Aug-2007

MedDRA PT Erythema, Rash generalised, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 13 year old female patient, with no known drug or food allergies, who on 14-JUN-2007 was
vaccinated with the first dose of Gardasil (Lot # 657617/0384U). There was no concomitant medication. On 15-JUN-2007, the patient developed a generalized,
red, raised, pruritic rash. Treatment included BENADRYL. Subsequently, the patient recovered from the rash (date of recovery unspecified). Additional
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285800-1


MedDRA PT Erythema, Injection site erythema, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 19 year old female patient with no known allergies who on 19-JUN-2007, was vaccinated with a
first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On the 20-JUN-2007 at the "end of the day," she developed
redness on the injection site forearm. By the next day, the redness developed into a clustered pin-pricked - but not raised - red, itchy rash. It has now spread to
both arms, neck and upper chest area. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285801-1

16.0 F 21-Feb-2007 23-May-2007 91 18-Jul-2007 17-Aug-2007 TN WAES0706USA04075 20-Aug-2007

MedDRA PT Hypersensitivity, Infectious mononucleosis, Staphylococcal infection
Symptom Text: Information has been received from a certified medical assistant concerning a 16 year old female patient who on 21-DEC-2006 was vaccinated IM into the arm
with a first 0.5ml dose of Gardasil. On 21-FEB-2007 and 21-JUN-2007 the patient was vaccinated into the arm with a second and third dose, respectively.
There was no concomitant medications. On 23-MAY-2007, the patient was diagnosed with mononucleosis and a staph infection on her leg. It was reported that
the patient was treated with an unnamed sulfa antibiotic and experienced an "allergic reaction." She was then treated with an unnamed steroid. Laboratory
diagnostic studies performed included "unknown lab tests." Subsequently, the patient recovered from staph infection on her leg and the allergic reaction. At the
time of this report, the patient was recovering from the mononucleosis. No product quality complaint was involved. Additional information has been requested.
Other Meds: None
Lab Data: Diagnostic laboratory
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285802-1


Symptom Text: information has been received from a consumer concerning her 19 year old female daughter who was vaccinated with a first and second dose of Gardasil. It
was reported that prior to getting the scheduled third dose of the vaccine, her daughter was diagnosed with mononucleosis. At the time of this report, the
patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285803-1


Symptom Text: Information has been received from a physician concerning an approximately 11 year old female patient who was vaccinated with a first dose of Gardasil. Right
after administration, the patient experienced tingling in her fingers. Unspecified medical attention was sought. Subsequently, the patient recovered. No product
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285804-1

25.0 F 21-May-2007 22-May-2007 1 18-Jul-2007 17-Aug-2007 IN WAES0706USA04089 20-Aug-2007

Symptom Text: Information has been received from a registered nurse, concerning a 25 year old female patient, with migraines and no known allergies, who on 21-MAY-2007
was vaccinated IM with the first dose, 0.5ml, of Gardasil (Lot #657737/0522U). Concomitant therapy included unspecified therapy for migraines and
multivitamins (manufacturer unspecified). 22-MAY-2007, the day following vaccination, the patient experienced fatigue, flu-like symptoms, dizziness and
musculoskeletal aches. Subsequently, the patient recovered from the events (date of recovery not specified). The patient sought unspecified medical attention.
The nurse reported that 2 other patients experienced similar symptoms following vaccination with Gardasil (WAES 0706USA04348). Additional information has
been requested.
Other Meds: [therapy unspecified], vitamins (unspecified)
Lab Data: None
History:
Prex Illness: Migraine
Prex Vax Illns:

Vaers Id: 285805-1


MedDRA PT Asthenia, Headache, Hypotension, Nausea, Pallor
Symptom Text: Information has been received from a registered nurse herself and via a company representative concerning a 17 year old female patient who on 20-JUN-2007
was vaccinated with the first dose of Gardasil (Lot # 0212U). On 21-JUN-2007, the morning following vaccination, the patient called the office and reported that
she was pale, had low blood pressure (value not specified), had nausea, was weak and had a headache. On 22-JUN-2007, the patient had recovered from the
events. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285806-1

23.0 F 16-Nov-2006 Unknown 18-Jul-2007 17-Aug-2007 TX WAES0706USA04092 20-Aug-2007

MedDRA PT Drug exposure during pregnancy, Headache, Menstruation irregular, Vaccine positive rechallenge
Symptom Text: Information has been received, via the Merck pregnancy registry, from a registered nurse, concerning her 23 daughter with depression, who on 16-NOV-2006
was vaccinated with the first dose of Gardasil (Lot #654540/0800F), and following vaccination (onset date not specified), experienced a slight headache.
Concomitant therapy included LOESTRIN 24 FE and WELLBUTRIN. On 16-JAN-2007, she was vaccinated with the second dose of Gardasil (Lot
#657005/0314U), and again following vaccination she experienced a slight headache. The nurse indicated her daughter had unknowingly become pregnant on
approximately 04-APR-2007, and on 16-MAY-2007, was administered the third dose of Gardasil (Lot #657005/0314U). Again, following the vaccination, she
experienced a headache, though this headache was "stronger." The patient sought treatment for the headache with her primary physician, and a urine
pregnancy test at that time (date unspecified) indicated she was pregnant. The nurse confirmed that her daughter had been taking the birth control pills
(specified above), and had experienced a light menstrual cycle throughout his time period. On 30-MAY-2007, the patient had an ultrasound that confirmed she
was approximately 8 weeks pregnant, and "all looked fine." The estimated date of delivery was 09-JAN-2008. At the time of this report, the outcome of
headache was unknown. Additional information has been requested.
Other Meds: WELLBUTRIN; LOESTRIN 24 FE
Lab Data: Ultrasound 05/30/07 - approximately 8 weeks pregnant; Urine beta-human 05/??/07 - positive
History:
Prex Illness: Pregnancy NOS (LMP = 4/4/07); Depression; Contraception
Prex Vax Illns:

Vaers Id: 285807-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 26 year old female who on 31-MAY-2007 was vaccinated with a first dose of Gardasil (Lot number
0210U) expiry date 22-NOV-2009 injection in the right deltoid. Concomitant therapy was reported as none. The physician reported that within 10 minutes of
receiving the first dose the patient fainted. It was also reported that, the patient "snapped out of it (time unspecified)" recovered. Medical attention was sought
and at the time of reporting additional information was not provided. Follow-up information was received from the physician. The patient is not pregnant, was
not hospitalized and medications were not given. The patient was given juice. Additional information is not available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285808-1

19.0 F 03-May-2007 30-May-2007 27 18-Jul-2007 17-Aug-2007 KY WAES0706USA04098 20-Aug-2007

MedDRA PT Cold compress therapy, Injection site mass, Injection site swelling
Symptom Text: Information has been received from a physician concerning a 19 year old female who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot #
657622/0388U) IM in the right arm. Concomitant therapy was not reported. On approximately 04-MAY-2007 or 05-MAY-2007 about 24 to 48 hours after the
shot he patient developed an orange sized knot at the injection site. Medical attention was sought. At the time of reporting the patient recovered from the
orange sized knot at the injection site and no further adverse event information was available. Follow-up information was received on 27-JUN-2007 via
telephone. The physician reported that on 03-MAY-2007 the patient developed a softball-size swelling and a knot at the injection site. The physician advised
the patient to use cold compresses and to take ibuprofen (MOTRIN). On approximately 05-MAY-2007 the patient recovered from the softball size swelling and a
knot at the injection site but the physician is not sure whether or not to continue with the Gardasil dosing schedule due to the patient's experience. The patient
has been previously sensitive to other vaccines. No further information was available.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 285809-1

Unknown F 01-Jun-2007 01-Jun-2007 0 18-Jul-2007 17-Aug-2007 FL WAES0706USA04099 20-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning two female patients (age not reported) who on approximately 01-JUN-2007 were vaccinated with a
first dose of Gardasil (lot number unknown). The females may have been siblings. The one patient may have fainted after watching her sister receive Gardasil.
It is unspecified whether patient two received the dose. No additional information was provided. Follow-up information was received via telephone. The clinical
manager stated that when the first girl received her shot the sister fainted. Both patient were fine. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285810-1

13.0 F 11-Jun-2007 12-Jun-2007 1 18-Jul-2007 17-Aug-2007 KY WAES0706USA04102 20-Aug-2007
Symptom Text: Information has been received from a physician concerning an 13 year old female who on 11-JUN-2007 was vaccinated with a first dose of Gardasil (lot
number unknown) injection in the right arm and received concomitant suspect therapy which included Vaqta, injection in the left arm. Concomitant therapy
included Menactra on the left arm. The physician reported that patient had a low grade fever on 10-JUN-2007 before receiving Gardasil. On 12-JUN-2007 the
patient experienced vomiting. Medical attention was sought. The patient was given a medication to control the vomiting. On an unspecified date the patient had
recovered. At the time no further adverse event information is available. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History:
Prex Illness: Slight fever
Prex Vax Illns:

Vaers Id: 285811-1

17.0 F 21-Jun-2007 21-Jun-2007 0 18-Jul-2007 17-Aug-2007 MI WAES0706USA04108 20-Aug-2007

MedDRA PT Hyperhidrosis, Nausea
Symptom Text: Information has been received from a nurse concerning a 17 year old female who on 21-JUN-2007 was vaccinated intramuscularly with the first dose of
Gardasil. Concomitant therapy included sertraline HCl (ZOLOFT). After the vaccine was administered, the patient said that she felt nauseous and wanted to lay
down. The reporter stated that the patient had not been sweating and was given crackers and soda. After about twenty minutes, the patient said that she felt
better and was sent home. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Zoloft
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285812-1

Unknown F 20-Jun-2007 20-Jun-2007 0 18-Jul-2007 17-Aug-2007 NC WAES0706USA04113 20-Aug-2007
MedDRA PT Inappropriate schedule of drug administration, Syncope
Symptom Text: Information has been received from a physician concerning a female who the patient reported to the nurse that she faints whenever she gets any shots, on 20-
JUN-2007 was vaccinated with a second dose of Gardasil. Concomitant therapy included a vaccination (unspecified). In the doctors office the patient fainted.
Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. It was reported that the patient was over the three month window
between the first and second dose. No further information is available.
Other Meds:
Lab Data: Unknown
History: Syncope
Prex Illness:
Prex Vax Illns:

Vaers Id: 285813-1

Unknown F 01-Dec-2006 Unknown 18-Jul-2007 17-Aug-2007 -- WAES0706USA04136 20-Aug-2007

Symptom Text: Information has been received from a nurse practitioner concerning a female who on approximately December 2006, was vaccinated IM with a first dose of
Gardasil. On an unspecified date, the patient was vaccinated with a second dose of Gardasil. "About 2 weeks after the second vaccination" the patient
developed "big bump on her upper arm". Unspecified medical attention was sought. Subsequently, after a few days the patient recovered from "big bump on
her upper arm". 20-JUN-2007 when the patient came into the office for her third dose. It was at this visit that she notified the doctor of the "big bump on her
upper arm" that was felt after receiving her second vaccination. On 20-JUN-2007, the patient was vaccinated with a third dose of Gardasil. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285814-1

21.0 F 02-Apr-2007 03-Apr-2007 1 18-Jul-2007 17-Aug-2007 OR WAES0706USA04138 20-Aug-2007

MedDRA PT Burning sensation, Oedema peripheral, Pruritus, Rash macular, Skin warm, Swelling, Vaccine positive rechallenge
Symptom Text: Information has been received from an LPN concerning a 21 year old female patient with allergies to sulfa and AMOXIL who on 02-APR-2007 and 12-JUN-
2007 was vaccinated IM in upper arm with her first and second doses of Gardasil, lot #653736/0014U for both doses. No other medications or vaccines were
administered on these days. After both doses the next morning both hands were hot and itchy, slightly swollen, burning sensation of palms, sensitive to heat,
blotchy rash from wrist to middle of the forearm (not hives). This lasted approximately one day and resolved with no treatment on either occasion, however the
reporter indicated that medical attention was sought. It was also noted that the blotchy rash resolved within 24 hours. The patient requested the third dose. The
HCP will probably pre-medicate with BENADRYL and observe. Additional information has been requested.
Other Meds: None
Lab Data: Unknown
History:
Prex Illness: Sulfonamide allergy; Allergic reaction to antibiotics
Prex Vax Illns:

Vaers Id: 285815-1

22.0 F 13-Jun-2007 13-Jun-2007 0 18-Jul-2007 17-Aug-2007 TN WAES0706USA04143 20-Aug-2007

MedDRA PT Injection site haematoma, Injection site pain
Symptom Text: Information has been received from a 22 year old female physician's receptionist, who on approximately 13-JUN-2007 was vaccinated IM with her first dose of
Gardasil. On approximately 13-JUN-2007 the patient experienced pain at the injection and a hematoma at injection site (lump). The pain at the injection lasted
about 4 to 5 days. The patient's hematoma at injection site (lump) persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285816-1

12.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 OK WAES0706USA04177 20-Aug-2007
MedDRA PT Cold compress therapy, Head injury, Syncope
Symptom Text: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of Gardasil (lot
#658094/0524U). Concomitant vaccination that day included Menactra. It was reported that following vaccination, the patient sat down for a few minutes. When
she went up to the check out window, she fainted and hit her head. The office staff sat her back down and gave her some ice for her head. Subsequently, the
patient recovered. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285817-1

44.0 F 01-Apr-2007 25-May-2007 54 18-Jul-2007 17-Aug-2007 NY WAES0706USA04919 29-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, Pruritus, Urticaria
Symptom Text: Information has been received from a physician concerning a 44 year old female patient with latex allergy who in March 2007, was vaccinated IM with a first
dose of Gardasil and in April 2007, got her second dose of Gardasil. On 25-MAY-2007 the patient developed itching and hives all over her body. The physician
referred the patient to allergist. The patient has not recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Latex allergy
Prex Vax Illns:

Vaers Id: 285818-1

Unknown U 22-Jun-2007 22-Jun-2007 0 18-Jul-2007 17-Aug-2007 KY WAES0706USA04366 20-Aug-2007

Symptom Text: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown), who on 22-JUN-2007 was vaccinated by, a
medical assistant in the office, intramuscularly with a 0.5ml dose of Gardasil. A pre-filled syringe was used to vaccinate the patient. It was noted that the needle
shield bruised the patient's arm at the injection site, when it deployed. The nurse stated that it may have been user error. The full dose was administered to the
patient. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285819-1


MedDRA PT Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth, No reaction on previous exposure to drug
Symptom Text: Information has been received from a registered nurse concerning her daughter, with possible allergy to aluminum. The patient subsequently experienced a
knot in arm around injection site and pruritus while on therapy with hepatitis B virus vaccine (manufacturer unknown) (WAES # 0706USA05089). The patient
was vaccinated IM with a 0.5 ml second dose of Gardasil. Subsequently the patient experienced "knot in her arm around the injection site." The area was
swollen and warm th the touch. Unspecified medical attention was sought. It was reported that the patient had an ultrasound that revealed a knot in muscle. It
was reported it took 1 month before her symptoms resolved. Subsequently, the patient recovered from "knot in her arm around the injection site", swollen and
warm to the touch. It was reported that the patient did not experience any adverse event after the first dose of the vaccine. Additional information has been
requested.
Other Meds: Unknown
Lab Data: ultrasound knot in muscle
History: Injection site induration; Pruritus
Prex Vax Illns:

Vaers Id: 285820-1

18.0 F 22-Jun-2007 22-Jun-2007 0 18-Jul-2007 17-Aug-2007 CT WAES0706USA04386 20-Aug-2007

Symptom Text: Information has been received from a physician concerning an 18 year old female who on 22-JUN-2007 was vaccinated with a first dose of Gardasil.
Immediately following the vaccine, the patient fainted. The patient was laid down and watched for ten to fifteen minutes. After that time, the patient was fine and
had recovered from fainting. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285821-1


Symptom Text: Information has been received from an 18 year old female certified medical assistant, who was vaccinated with her first dose of Gardasil. Subsequently she
started getting her menstrual period every two weeks for about a month and a half. Additional information has been requested. This is one of two reports from
the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285822-1


MedDRA PT Pain in extremity, Paraesthesia, Vaccine positive rechallenge
Symptom Text: Information has been received from a 16 year old female with a history of migraines who on approximately February 2007 was vaccinated with a first dose of
Gardasil. Subsequently, the patient experienced tingling in her leg and pain in her leg. Subsequently the patient recovered. on an unspecified day in 2007, the
patient received a second dose of Gardasil. Subsequently the patient experienced tingling in her leg and pain in her leg. At the time of the report, the patient
was recovering. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Migraine
Prex Vax Illns:

Vaers Id: 285823-1


MedDRA PT Rash vesicular
Symptom Text: Information has been received from a registered nurse concerning a 23 year old female patient with a penicillin allergy and no medical history who on 20-APR-
2007, was vaccinated IM into the left arm with a first 0.5ml dose of Gardasil. On 16-JUN-2007, the patient was vaccinated with a second dose of Gardasil (Lot#
657736/0389U). There was no concomitant medication. On 20-JUN-2007, the patient developed a vesicular rash which was described as spreading from the
lower lip to surrounding both lips and spreading to cheek and around a naris. The patient showed the rash to the psychiatrist. No medical attention was sought.
No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved.
Other Meds: None
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 285824-1

22.0 F 30-May-2007 12-Jun-2007 13 18-Jul-2007 17-Aug-2007 -- WAES0706USA04403 20-Aug-2007

Symptom Text: Information has been received from a 22 year old female consumer with a history of mild dysplasia and no drug allergies who on 30-MAY-2007, was vaccinated
with a dose of Gardasil. There was no concomitant medication. On 12-JUN-2007, her menstrual cycle was about 11 days late. The consumer stated there was
the possibility of being pregnant but it has not been confirmed. No medical attention was sought. No laboratory diagnostic studies were performed. At the time
of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Other Meds: None
Lab Data: None
History: Dysplasia
Prex Illness:
Prex Vax Illns:

Vaers Id: 285825-1


MedDRA PT Syncope
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning an "approximately 20 year old" female patient who was vaccinated with a dose of
Gardasil. The patient fainted after receiving the Gardasil. The patient recovered. The nurse reported that two other patient experienced fainting after receiving
the dose of Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285826-1

17.0 F 11-Jun-2007 11-Jun-2007 0 18-Jul-2007 30-Jul-2007 PA WAES0706USA04434 30-Jul-2007

MedDRA PT Inflammation, Pain, Tenderness
Symptom Text: Information has been received from a physician concerning a 17 year old female who on approximately 11-JUN-2007 (2 weeks ago), was vaccinated with a
dose of Gardasil (lot number unknown). The physician reported that the patient developed pain to arm, tenderness and inflammation (3 cm) since being
vaccinated with Gardasil. The outcome of the events were not reported. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285827-1

16.0 F 22-Jun-2007 22-Jun-2007 0 18-Jul-2007 30-Jul-2007 NM WAES0706USA04447 30-Jul-2007

Symptom Text: Information has been received from a health professional concerning a 16 year old female patient who on 22-JUN-2007 was vaccinated IM with a first dose of
Gardasil lot #654535/0960F. The patient while sitting passed out for one minute. She appeared fine and an electrocardiogram and blood pressure were normal.
She was observed in the office for an hour. No additional information at this time. The patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: electrocardiogram Normal blood pressure Normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285828-1

Unknown F Unknown Unknown 18-Jul-2007 30-Jul-2007 AZ WAES0706USA04458 30-Jul-2007

MedDRA PT Immunosuppression
Symptom Text: Information has been received from a physician concerning a female patient with oral cancer who was vaccinated with a dose of Gardasil. It was reported that
the patient may have been immunocompromised because she had oral cancer. At the time of this report, the patient's outcome was unknown. No product
Other Meds: Unknown
Lab Data: Unknown
History: Mouth cancer
Prex Illness:
Prex Vax Illns:

Vaers Id: 285829-1

29.0 F 01-Dec-2006 01-Dec-2006 0 18-Jul-2007 30-Jul-2007 PA WAES0706USA04478 06-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, Myositis, Nodule, Off label use
Symptom Text: Information has been received from a registered nurse concerning a 29 year old female with no pertinent medical history or drug reactions/allergies who in
October 2006, was vaccinated with a first dose of Gardasil (lot number unknown) and in December 2006 with the second dose of Gardasil. On unspecified date
the nodules developed in 2006 "late fall", after vaccination. Both vaccines were administered at another office. Concomitant therapy included naproxen sodium
(ALEVE), ethinyl estradiol/norethindrone (OVCON) and vitamins (unspecified). The nurse reported that on 27-APR-2007 the patient was examined in their
office and on an unspecified date after receiving the third dose of Gardasil in March 2007 at another office she developed myositis described as nodules that
developed on the knucles of both hands. Medical attention was sought. The serum creatine kinase (CPK) test and serum aldolase test were elevated and have
continued to climb to present 22-JUN-2007. Complete work up for rheumatology was performed and the results were negative. Hematology laboratory tests
unspecified were also performed. At the time of reporting the patient has not recovered and no further information was reported. Additional information has
been requested.
Other Meds: Ovcon, Aleve, vitamins (unspecified)
Lab Data: serum creatine kinase 06/22/07 elevated, serum aldolase 06/22/07 elevated, hematology
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285830-1

19.0 M Unknown Unknown 18-Jul-2007 30-Jul-2007 UT WAES0706USA04497 30-Jul-2007

MedDRA PT Lymphadenopathy, Medication error
Symptom Text: Information has been received from a nurse practitioner (NP), with a company representative, concerning a 19 year old male patient, with no pertinent medical
history, who was vaccinated on an unspecified date, with a dose, 0.5ml. of Gardasil (Lot # not provided). There was no concomitant medication. Subsequently
the patient was diagnosed with an infraclavicular swollen lymph nodes. The NP added that no treatment was required, and the event resolved on it's own (date
and duration not specified). No further information is expected.
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285831-1

16.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 ME WAES0706USA04504 20-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician, via a company representative, concerning a 16 year old female patient, who was vaccinated (date not
specified) with the first dose of Gardasil, and following vaccination (time duration not specified), she fainted. The physician confirmed that the patient recovered
within a period of 10 minutes. The physician reported that the patient later received both the second and third doses of Gardasil, and was fine after each dose.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285832-1

15.0 U Unknown Unknown 18-Jul-2007 17-Aug-2007 ME WAES0706USA04505 20-Aug-2007

MedDRA PT Familial risk factor, Syncope
Symptom Text: Information has been received from a physician, via a company representative, concerning a 15 year old patient (gender not specified), with a family history of
fainting post vaccination, who was vaccinated (date not specified) with the first dose of Gardasil, and fainted following the vaccination. At the time of this report,
the outcome of the event was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285833-1

24.0 F 01-Jan-2007 01-Jan-2007 0 18-Jul-2007 17-Aug-2007 NY WAES0706USA04517 20-Aug-2007

MedDRA PT Myalgia, Vaccine positive rechallenge
Symptom Text: Information has been received from a 25 year old female consumer with no pertinent medical history or drug reactions/allergies who in January 2007, was
vaccinated with a first dose of Gardasil (lot number unknown) and in March 2007 was vaccinated with a second dose of Gardasil (lot number unknown).
Concomitant therapy included hormonal contraceptives (unspecified). The consumer reported that the next day after she received her first and second dose of
the vaccinations she had a sharp muscle pain that ran through the left arm all the way up and through her "next" on the left side. The pain lasted for about a
month after the injection. The patient recovered about a month after each injection. Medical attention was sought. Additional information has been requested.
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 285834-1


MedDRA PT Arthropathy
Symptom Text: Information has been received from a registered nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a
dose of Gardasil (lot number unknown), injection. Concomitant medication not reported. The nurse reported that on an unspecified date the patient developed
arthritic symptoms after receiving Gardasil. At the time of reporting it is unknown if the patient had recovered from the arthritic symptoms. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285835-1


MedDRA PT Presyncope, Syncope
Symptom Text: Information has been received from an office manager concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a
second dose of Gardasil. Subsequently, the patient experienced syncope. The patient did not pass out but felt like she was going to. At the time of the report,
the patient's outcome was unknown. N product quality complaint was involved. This is one of two reports received from the same source. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285836-1

Unknown F 25-May-2007 25-May-2007 0 18-Jul-2007 17-Aug-2007 TN WAES0706USA04664 20-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a female (age unknown), who was vaccinated on 25-MAY-2007 with a 0.5 mL dose of Gardasil.
Shortly post-vaccination the patient developed a rash on her arms and legs. The physician reported that the client did not report the rash away, but presented,
with the rash to the office. A steroid dose pack was the treatment prescribed. At the time of the report, the patient had not recovered. No product quality
complaint was involved.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285837-1


MedDRA PT Haemorrhage
Symptom Text: Information has been received from a certified medical assistant concerning a 21 year old female who was vaccinated with a dose of Gardasil. Subsequently
two of three days after the vaccine the patient experienced "bleeding". Additional information has been requested. This is one of two reports from the same
source.
Other Meds:
Lab Data: Unknown
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 285838-1

9.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 OK WAES0706USA04689 20-Aug-2007

MedDRA PT Dizziness, No reaction on previous exposure to drug
Symptom Text: Information has been received from a physician concerning a 9 year old female patient who on an unspecified date, was vaccinated IM with a second dose of
Gardasil (Lot # 655205/1426F). Subsequently, the patient was feeling dizzy. Unspecified medical attention was sought. On 11-JUN-2007, the patient
recovered. It was reported that the patient experienced no adverse effects after the first dose. No product quality complaint was involved. Additional information
has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285839-1

Unknown F 04-Jun-2007 25-Jun-2007 21 18-Jul-2007 17-Aug-2007 TX WAES0706USA04695 20-Aug-2007

Symptom Text: Information has been received from a medical assistant concerning a female patient who on approximately 04-JUN-2007 "three weeks ago", was vaccinated
with a dose of Gardasil. On approximately 25-JUN-2007, the patient came into the office and complained of pain at the injection site. Unspecified medical
attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285840-1

18.0 F 23-Jun-2007 23-Jun-2007 0 18-Jul-2007 17-Aug-2007 IL WAES0706USA04697 20-Aug-2007
Symptom Text: Information has been received from a certified medical assistant (CMA), concerning an 18 year old female who on 23-JUN-2007 was vaccinated IM in the right
deltoid with the first dose, 0.5ml, of Gardasil (Lot #655503/0012U). Concomitant therapy included Menactra and Varivax (manufacturer unspecified). On 23-
JUN-2007, three minutes after vaccination with Gardasil, the patient had an episode of syncope while sitting in the office. The patient was attended to in the
office (treatment not specified), and felt better after 10-15 minutes had passes. At the time of this report, the CMA stated the patient was recovering from the
event. The CMA reported a similar events of syncope for 2 additional female patients following vaccination with Gardasil (WAES #0706USA04707 and
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285841-1

Unknown F 30-May-2007 30-May-2007 0 18-Jul-2007 17-Aug-2007 OK WAES0706USA04699 20-Aug-2007

MedDRA PT Dizziness, Fall, Injury, Syncope
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on 30-MAY-2007 was vaccinated with her first dose of Gardasil (lot
number 654741/1208F) IM. The physician reported that the patient fainted after receiving her first dose of Gardasil IM. Patient also fell down and hit her nose
and felt woozy for about 10 minutes. Medical attention was sought. The patient did not eat anything prior to getting a vaccine. At the time of reporting the
patient recovered from the adverse events and no further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285842-1

14.0 F 17-May-2007 17-May-2007 0 18-Jul-2007 17-Aug-2007 OK WAES0706USA04705 20-Aug-2007

MedDRA PT Dizziness, Immediate post-injection reaction
Symptom Text: Information has been received from a physician concerning a 14 year old female who on 17-MAY-2007 was vaccinated with her first dose of Gardasil IM. The
physician reported that the patient felt dizzy right after receiving the first dose of Gardasil IM. At the time of reporting the patient recovered from feeling dizzy
and no further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285843-1

16.0 F 01-Feb-2007 Unknown 18-Jul-2007 17-Aug-2007 OH WAES0706USA04713 20-Aug-2007

MedDRA PT Exfoliative rash, Rash generalised
Symptom Text: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and a drug reaction to minocycline who near
the end of February 2007, was vaccinated with Gardasil (lot number unknown). On an unspecified date, about two weeks post vaccination the patient
developed a scaly purplish rash over her entire body that was mostly on her extremities. Medical attention was sought. The patient was treated with ammonium
Lac-Hydrin and at the time of reporting the patient is still recovering. Further information was not available. Additional information has been requested.
Other Meds:
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 285844-1


Symptom Text: Information has been received from a certified medical assistant concerning a 10 year old female with a history of seizures and an amoxicillin allergy who on
04-APR-2007 was vaccinated with a first dose of Gardasil (lot# 655503/0012U) IM in the left deltoid. There was no concomitant medication used. On 20-JUN-
2007 the patient was administered with a second dose of Gardasil IM in the right deltoid. Three minutes after the administration of the vaccine the patient
developed syncope while sitting in the office. Medical attention was sought at the office. The patient better after 10-15 minutes of the adverse experience. The
CMA reported that two additional female patients also experienced syncope after vaccination with Gardasil (Lot#655503/0012U) (WAES #0706USA04697.
Other Meds: None
Lab Data: serum cholesterol 04/??/07
History: Convulsion
Prex Illness: Drug Hypersensitivity
Prex Vax Illns:

Vaers Id: 285845-1

Unknown F 18-Jun-2007 18-Jun-2007 0 18-Jul-2007 17-Aug-2007 MI WAES0706USA04728 20-Aug-2007

MedDRA PT Syncope, Vomiting
Symptom Text: Information has been received from a physician concerning a female who on approximately 18-JUN-2007 was vaccinated with a 0.5 ml dose of the Gardasil.
After receiving the vaccine, the patient vomited and fainted. The patient sought unspecified medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285846-1


MedDRA PT Accidental needle stick, Haemorrhage
Symptom Text: Information has been received from a female registered nurse who administered the Gardasil to a patient. It was reported that after the vaccine was given to
the patient, the needle guard device did not work properly to fully cover and protect the needle. Subsequently, the nurse accidentally stuck her hand with the
exposed needle which caused bleeding. She sought unspecified medical attention. A number of blood tests were performed, including a test for human
immunodeficiency virus (HIV) (results not provided). The HIV test will be repeated in six months. Additional information has been requested.
Other Meds: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285847-1


MedDRA PT Syncope, Vaccine positive rechallenge
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated with the first 0.5 ml dose of the Gardasil.
Concomitant therapy included Yaz. Subsequently, the patient fainted. She recovered on an unspecified date. On an unspecified date, the patient was
vaccinated with the second 0.5 ml dose of the Gardasil. Subsequently, the patient fainted. She recovered on an unspecified date. Additional information has
been requested.
Other Meds: Yaz
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285848-1

19.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 NH WAES0706USA04744 20-Aug-2007

Symptom Text: Information ha been received from a registered nurse concerning a 19 year old female who vaccinated intramuscularly with the third dose of the Gardasil on an
unspecified date. Subsequently, the patient almost fainted and became extremely light-headed while at the physician's office. Subsequently, the patient
recovered on the same day after receiving in the office. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285849-1


MedDRA PT Pyrexia
Symptom Text: Information has been received from a pharmacist concerning her 18 year old daughter with no pertinent medical history who on 21-JUN-2007 was vaccinated
intramuscularly with the first dose of the Gardasil. There were no concomitant medications. On the evening of 24-JUN-2007, the patient developed a fever of an
unknown temperature. Medical attention was sought and the patient was treated with Motrin. The patient's fever persisted. There were no laboratory or
diagnostic tests performed. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285850-1

Unknown F 23-Jun-2007 23-Jun-2007 0 18-Jul-2007 17-Aug-2007 IL WAES0706USA04759 20-Aug-2007

Symptom Text: Information has been received from a physician concerning a female who on 23-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil.
Concomitant therapy included 'other vaccines". A couple of minutes after the injection, in the waiting room, the patient fainted. The patient was given "smelling
salts and it didn't help, and then she was given epinephrine and the patient didn't react to that either." About about fifteen minutes, the patient "finally came to."
Unspecified medical attention was sought. It was reported that the patient recovered on an unknown date. No further information is available.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285851-1


Symptom Text: Information has been received from a healthcare worker concerning a female who on an unspecified date was vaccinated with the first dose of Gardasil. The
patient subsequently experienced an abnormal PAP smear. Unspecified medical attention was sought. No further details were provided. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Pap smear - abnormal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285852-1

Unknown F Unknown Unknown 18-Jul-2007 17-Aug-2007 PA WAES0706USA04773 20-Aug-2007

Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently the
patient developed small bumps all over her body about a week after vaccination. Unspecified medical attention was sought. At the time of this report, the
outcome of the event was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285853-1

19.0 F 08-May-2007 08-May-2007 0 18-Jul-2007 17-Aug-2007 NH WAES0706USA04783 20-Aug-2007

Symptom Text: Information has been received from a nurse concerning a 19 year old female with no drug allergies, who on 08-MAY-2007 was vaccinated intramuscularly with
a second dose of Gardasil. Concomitant therapy included Loestrin. Almost immediately after receiving the vaccination the patient fainted in the office. It was
reported that the patient was not hospitalized and the patient had recovered before leaving the office. No product quality complaint was involved. Additional
Other Meds: LOESTRIN
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285854-1


MedDRA PT Injection site discolouration, Injection site mass, Injection site pain, No reaction on previous exposure to drug
Symptom Text: Information has been received from a certified medical assistant (also reported as a nurse) concerning her 16 year old daughter, who was vaccinated with a
second dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a painful, raised, brown square on her arm where the
injection was given. The patient did not have any adverse experiences with the first dose. The patient did not seek medical attention. At the time of the report,
the patient was recovering. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has
been requested.
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285855-1


MedDRA PT Injection site discolouration, Injection site mass, Injection site pain, No reaction on previous exposure to drug
Symptom Text: Information has been received from a certified medical assistant (also reported as a nurse) concerning her 15 year old daughter, who was vaccinated with a
second dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a painful, raised, brown square on her arm where the
injection was given. The patient did not have any adverse experiences with the first dose. The patient did not seek medical attention. At the time of the report,
the patient was recovering. No product quality complain was involved. This is one of two reports from the same source. Additional information has been
requested.
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285856-1

Unknown F 18-Jun-2007 18-Jun-2007 0 18-Jul-2007 17-Aug-2007 VA WAES0706USA04810 20-Aug-2007

Symptom Text: Information has been received from a physician concerning a female (age unknown) with a history of orthostatic hypertension, who on approximately 18-JUN-
2007 was vaccinated with Gardasil. Subsequently, after receiving the vaccination the patient fainted, but it took a while to revive her. The patient sought
unspecified medical attention. At the time of the report, the patient recovered. No product quality complaint was involved. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Orthostatic hypertension
Prex Illness:
Prex Vax Illns:

Vaers Id: 285857-1


MedDRA PT Incorrect route of drug administration, Pain in extremity
Symptom Text: Information has been received from a physician's office concerning a 20 year old female, who on 14-MAY-2007 was vaccinated with a dose of Gardasil.
Subsequently. on the same day as the vaccination the patient experienced pain in her arm. It was noted that the injection was given to the patient in the wrong
position of the arm said to be too interiorly. The patient sought unspecified medical attention. At the time of the report, the patients outcome was unknown. No
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285858-1


Symptom Text: information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated IM with a first dose of Gardasil. Concomitant
therapy included meningococcal vaccine (unspecified). Subsequently the patient fainted and was unconscious for about 15 seconds and then came to.
Subsequently, the patient recovered from fainting. Additional information has been requested.
Other Meds: meningococcal vaccine
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285859-1


Symptom Text: Information has been received from a physician concerning a female patients between 20 - 25 years old who was vaccinated with Gardasil. Subsequently all
the patient experienced abdominal cramping "like premenstrual related symptoms". Subsequently, all the patient recovered from abdominal cramping "like
premenstrual related symptoms". The patient did not seek medical attention. Additional information has been requested. This is one of several from the same
source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285860-1


Symptom Text: Information has been received from a physician concerning a female patients between 20 - 25 years old was vaccinated IM with Gardasil. Subsequently all the
patient experienced abdominal cramping "like premenstrual related symptoms". The patient did not seek medical attention. Additional information has been
requested. This is one of several reports from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285861-1


MedDRA PT Abdominal pain, Fatigue, Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a health professional concerning a 12 year old female patient who on 06-APR-2007, at 03:30 PM was vaccinated with a
first dose of Gardasil lot #657621/0387U. On 07-APR-2007 the patient developed fever 102, nausea and abdominal cramping x 4 days. On 09-APR-2007 the
patient had vomiting and fatigue. It was not known if patient sought medical advice. The outcome was unknown. Additional information has not been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285862-1


MedDRA PT Rash
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female assistant director of admissions, who on 19-JUN-2007 was vaccinated
with a second dose of Gardasil. On 20-JUN-2007 the patient reported that she woke up with a rash on her back with no itch. At the time of the report, the rash
still persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285863-1


MedDRA PT Human papilloma virus test positive
Symptom Text: Information has been received from a physician concerning a 19 year old female with no pertinent medical history who was vaccinated with two doses of the
Gardasil (dates not specified). Concomitant therapy included Yasmin. Subsequently, the patient testes positive for human papilloma virus (HPV) with the HPV
DNA test. The patient had not experienced any known symptoms. Patient outcome was unknown. Additional information has been requested.
Other Meds: YASMIN
Lab Data: cervix HPV DNA assay - positive for HPV
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285864-1


MedDRA PT Dizziness, Inappropriate schedule of drug administration, Pain in extremity, Vaccine positive rechallenge
Symptom Text: Information has been received from an 18 year old female with no pertinent medical history and a penicillin allergy who on 17-JAN-2007 was vaccinated with a
first dose of Gardasil (lot number unknown) injection who developed light headedness. On 19-MAR-2007 the patient was vaccinated with a second dose of
Gardasil and experienced soreness in her arms. On 25-JUN-2007 the patient received a third dose of Gardasil and experienced soreness in her arms which
was given 22 days earlier than scheduled. On 25-JUN-2007 concomitant suspect therapy included hepatitis A vaccine (unspecified) was given. Medical
attention was sought. At the time of reporting it is unknown if the patient had recovered. No further information was provided. No further information is available.
Other Meds:
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 285865-1


MedDRA PT Urticaria
Symptom Text: Information has been received from a physician, via a company representative , concerning a 15 year old female patient, who on unspecified date was
vaccinated with the first dose of Gardasil (Lot # not provided). After an unspecified duration of time following the vaccination, the patient developed hives.
Treatment included unspecified steroids. At the time of this report, the outcome of the event was unknown.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285866-1

Symptom Text: Information has been received from a physician concerning a 14 year old female who on 21-JUN-2007 was vaccinated with the first dose of the Gardasil.
Concomitant therapy included Menactra, DTaP (unspecified) and Varivax (manufacturer unknown), which were also administered on 21-JUN-2007. After
receiving the Gardasil, the patient became woozy and slumped in her chair as if she was about to faint. Unspecified medical attention was sought. The reporter
noted that the patient had not eaten lunch the day she received the vaccinations. The patient recovered within an hour. Additional information has been
requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285867-1


Symptom Text: Information has been received from a physician concerning a 14 or 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil
(lot number unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil 0.5ml injection and passed-out on the elevator.
Medical attention was sought. At the time of reporting it is unknown if the patient recovered. No additional information was provided. Additional information has
been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285868-1


MedDRA PT Immediate post-injection reaction, Pain, Syncope
Symptom Text: Information has been received from a licensed practical nurse concerning an 18 year old female with no pertinent medical history who on 22-JUN-2007 was
vaccinated intramuscularly into the left arm with 0.5 ml of the first dose of the Gardasil (Lot 3 653735/0688F). There was no concomitant medication.
Immediately after receiving the vaccination, the patient felt pain and fainted. Unspecified medical attention was sought by the patient. No laboratory or
diagnostic tests were performed. The patient was observed for 1/2 hours and then was recovered and sent home. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285869-1


Symptom Text: Information has been received via a company representative, from a health professional (HCP) concerning her daughter (age unspecified), who was vaccinated
on an unspecified date, with the second dose, 0.5ml, of Gardasil (Lot # not provided). The HCP reported that her daughter developed pain and swelling at the
injection site, that lasted for '3-4 days" and then resolved. No further information is expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285870-1


MedDRA PT Immediate post-injection reaction, Paraesthesia
Symptom Text: Information has been received from a physician concerning an approximately 13 year old female patient who was vaccinated with a first dose of Gardasil. Right
after administration, the patient experienced tingling in her fingers. Unspecified medical attention was sought. Subsequently, the patient recovered. No product
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285871-1


MedDRA PT Fatigue, Swelling face, Swollen tongue
Symptom Text: Information has been received from a physician concerning a 22 year old female with a history of an unspecified hypersensitivity and hives who on 02-JAN-
2007 was vaccinated with the first dose of Gardasil (Lot # not specified). On 02-MAR-2007 the patient received the second dose of Gardasil (Lot
3656049/0187U). The physician reported that the same day at an unspecified time the patient reported that she felt tired and that her tongue and face had
swelled. The patient sought unspecified medical attention. Subsequently, on an unspecified date the patient recovered from the events. Additional information
has been requested.
Other Meds: Unknown
Lab Data:
History: Hives; Hypersensitivity
Prex Illness:
Prex Vax Illns:

Vaers Id: 285872-1

23.0 F Unknown Unknown 18-Jul-2007 17-Aug-2007 -- WASES0706USA04943 20-Aug-2007

Symptom Text: Information has been received from consumer her 23 year old daughter who on unspecified date was vaccinated with a second dose of Gardasil. Two weeks
post vaccination with the second dose of Gardasil. Two weeks post vaccination with the second dose of Gardasil, the patient developed "bells palsy, which
freezes one side of the face" as reported by the patient's mother. The patient sought unspecified medical attention. Subsequently, the patient recovered from
bells palsy on an unspecified date. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285873-1

21.0 F 21-Jun-2007 22-Jun-2007 1 18-Jul-2007 17-Aug-2007 IA WAES0706USA04954 21-Aug-2007

MedDRA PT Diarrhoea, Nausea
Symptom Text: Information has been received from a physician concerning a 21 year old female who on 21-JUN-2007 was vaccinated with a second dose of Gardasil (lot #
657737/0522U). On 22-JUN-2007 the patient experienced nausea and diarrhea. Unspecified medical attention was sought. On 25-JUN-2007, the patient
recovered from nausea and diarrhea. It was reported that the physician suggested to the patient that she can receive the third dose of the vaccine. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285874-1

MedDRA PT Asthenia, Body temperature increased, Gait disturbance, Immediate post-injection reaction, Presyncope
Symptom Text: Information has been received via company representative, from a health professional (HCP) concerning her 16 year old daughter, with restless legs syndrome,
who on 20-JUN-2007 was vaccinated IM with the first dose of Gardasil (Lot # invalid). Concomitant therapy included Menactra and tuberculin purified protein
derivative (manufacturer unspecified). On 20-JUN-2007, "within 5 minutes of being vaccinated," the patient experienced weakness, elevated temperature,
difficulty walking and she felt like she was going to faint. The HCP confirmed that her daughter had recovered (date unspecified), and "is fine now." The HCP
stated she had concerns about continuing with the Gardasil series. The patient sought unspecified medical attention. Additional information has been
requested.
Other Meds: tuberculin purified protein
Lab Data: Unknown
History:
Prex Illness: Restless legs syndrome
Prex Vax Illns:

Vaers Id: 285875-1


MedDRA PT Arthralgia, Oedema peripheral, Pain, Pain
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female patient with no medical history or drug allergies who on 15-JUN-2007,
was vaccinated with a first dose of Gardasil (Lot 3 658094/0524U). There was no concomitant medication. On 20-JUN-2007, the patient experienced arm
swelling, joint pain, soreness and achiness. It was reported that after the pain continued for about 5 days, she decided to contact her physician's office.
Unspecified medical attention was sought. No laboratory diagnostic studies were performed. "About a week later," the patient recovered from joint pain,
soreness and achiness and the outcome of her swelled arm was unknown. No product quality complaint was involved. Additional information has been
requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285876-1

Unknown F Unknown Unknown 18-Jul-2007 16-Aug-2007 TX WAES0706USA05009 16-Aug-2007

MedDRA PT No adverse effect, Wrong drug administered
Symptom Text: Information has been received from a licensed visiting nurse concerning three female patient' who were supposed to be vaccinated with a dose of Gardasil. It
was reported that when the nurse removed the vaccine from the refrigerator, she picked up 2 doses of Gardasil and one dose of Pitocin. The nurse stated the
error was due to the cap colors of Gardasil and Pitocin being similar. No symptoms were noted in any woman. At the time of this report, the patient's outcome
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285877-1


Concomitant therapy included "other vaccines". On 23-JUN-2007, the patient fainted. The patient was "unconscious for about 15 minutes". Unspecified medical
attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285878-1


Concomitant therapy include "other vaccines". On 23-JUN-2007, the patient fainted. The patient was "unconscious for about 15 minutes". Unspecified medical
attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285879-1

17.0 F 22-Jun-2007 22-Jun-2007 0 18-Jul-2007 16-Aug-2007 NC WAES0706USA05048 16-Aug-2007
HPV4 MERCK & CO. INC. NULL 0 Unknown By Mouth

MedDRA PT Dizziness, Dizziness, Immediate post-injection reaction, Incorrect route of drug administration
Symptom Text: Information has been received from a nurse concerning a 17 year old female patient who on 22-JUN-2007, was vaccinated with a first dose of Gardasil.
Immediately, the patient was dizzy and light-headed. Unspecified medical attention was sought. After several minutes the patient recovered. No product quality
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285880-1

Unknown F 17-Jun-2007 23-Jun-2007 6 18-Jul-2007 16-Aug-2007 FL WAES0706USA05052 16-Aug-2007

Symptom Text: Information has been received from a physician concerning a female patient who during the week of 17-JUN-2007 to 22-JUN-2007, was vaccinated with a first
dose of Gardasil. On 23-JUN-2007, the patient experienced abdominal pain. Unspecified medical attention was sought. At the time of this report, the patient's
outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285881-1


MedDRA PT Ovarian cyst
Symptom Text: Information has been received from a consumer, concerning her female friend (age unspecified), who was vaccinated on unspecified dates, with a first and
second dose of Gardasil and subsequently developed ovarian cysts. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285882-1


Symptom Text: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who was vaccinated IM, on an
unspecified date with the third dose of Gardasil, and subsequently felt dizzy when going to the parking lot. The patient called the nurse, who brought her back
to the office, and the patient then fainted. The patient's mother was called to get her, as she was unable to drive. The physician sought unspecified medical
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285883-1


MedDRA PT Dizziness, Myalgia, Nausea, Pyrexia
Symptom Text: Information has been received from a registered nurse, concerning a 19 year old female patient, who on 21-JUN-2007 was vaccinated IM, with the first dose,
0.5ml, of Gardasil (Lot #0469U). Concomitant therapy included Yasmin. On 22-JUN-2007, the day following vaccination, she developed a fever of 102F, and
had dizziness, nausea and muscle aches. On 25-JUN-2007, the patient's symptoms were improving, though her temperature was then 100 F. The patient
sought unspecified medical attention. Additional information has been requested.
Other Meds: YASMIN
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285884-1


MedDRA PT Injection site streaking
Symptom Text: Information has been received from a nurse concerning a 23 year old female who in April 2007, was vaccinated with a first dose of Gardasil. On 22-JUN-2007,
the patient received her second dose of Gardasil (Lot# 656371/0181U). On 25-JUN-2007, the patient developed red streaks moving away from the injection site
area. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285885-1


MedDRA PT Papilloma viral infection
Symptom Text: Information has been received from a female (age not reported) who on unspecified dates was vaccinated with first and second doses of Gardasil (lot number
unknown). The patient is not having any symptoms from the Gardasil who has been diagnosed with another type of human papilloma virus (HPV) infection
(type unspecified) since vaccinated. The patient also reports that as of 27-JUN-2007 the patient is 2 weeks late for her third vaccination. No further information
is expected. No additional information is expected.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Human papilloma virus infection
Prex Vax Illns:

Vaers Id: 285886-1


MedDRA PT Rash
Symptom Text: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a first dose of Gardasil (lot number unknown)
IM. On an unspecified medical dates, the patient developed diffuse rashes and continued to get them. Medical attention was sought. The family physician
treated the patient with steroids and was planning to give a work-up of blood test. The physician advised the patient to discontinue therapy with Gardasil. At the
time of reporting the patient was recovering. No further information was provided. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285887-1

Unknown F Unknown Unknown 18-Jul-2007 16-Aug-2007 CA WAES0706USA05119 16-Aug-2007

Symptom Text: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of the Gardasil. Subsequently, the patient
experienced "diffused joint pain". Unspecified medical attention was sought. The patient outcome was unknown. The reporting physician was concerned that
this could be related to the Gardasil and was worried it could have caused a "problem with the patient's immune response." Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285888-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 15-JUN-2007 was vaccinated with
the first dose of the Gardasil (Lot # "03894"). There was no concomitant medication. On 15-JUN-2007, the patient fainted within a half hour of receiving the
Gardasil. The patient sought unspecified medical attention, "was given ammonia salts and came to immediately." Laboratory tests performed on 15-JUN-2007
included a thyroid function test, hemoglobin urinalysis, and cholesterol test (results not provided). Subsequently, the patient recovered. No further information is
available.
Other Meds: None
Lab Data: thyroid function test 06/15/07 - results not provided, urine hemoglobin 06/15/07 - results not provided, serum cholesterol 06/15/07 - results not provided
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285889-1

19.0 F Unknown Unknown 18-Jul-2007 16-Aug-2007 NC WAES0706USA05135 16-Aug-2007

MedDRA PT Malaise
Symptom Text: Information has been received from a physician concerning a 19 year old female who was vaccinated with the first dose of the Gardasil. Subsequently, the
patient developed malaise all over the body, which lasted for about a month. Unspecified medical attention was sought. Subsequently, the patient recovered
from malaise all over the body. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285890-1


MedDRA PT Dizziness
Symptom Text: Information has been received from a physician concerning a 17 year old female who was vaccinated with the first dose of the Gardasil on an unspecified date.
The patient started to feel lightheaded immediately after receiving the Gardasil. At the time of the report, the patient was recovering. The patient did not wish to
continue the vaccination series. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285891-1


MedDRA PT Ear pain, Herpes zoster, Rash
Symptom Text: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2007 was vaccinated with a 0.5 ml dose of the Gardasil.
Concomitant therapy included Menactra. On 25-JUN-2007, the patient developed a rash on her forehead. Unspecified medical attention was sought. The rash
was diagnosed with shingles which further progresses into the eyes and the patient developed pain in ear. The patient's shingles in the ear persisted at the time
of the report. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285892-1


MedDRA PT Arthralgia, Joint swelling, Splenectomy
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil. Subsequently, two weeks after
vaccination, the patient developed swollen and painful joints and an enlarged spleen. Unspecified medical attention was sought. The patient's outcome was
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285893-1

15.0 F 21-Jun-2007 21-Jun-2007 0 18-Jul-2007 16-Aug-2007 MI WAES0706USA05148 16-Aug-2007

MedDRA PT Dizziness, Lymphadenopathy, Pain, Tenderness
Symptom Text: Information has been received from a physician concerning a 15 year old female with no pertinent medical history who on 21-JUN-2007 was vaccinated
intramuscularly with a 0.5 ml first dose of Gardasil. There was no concomitant medication. On 21-JUN-2007 the patient experienced dizziness for about 30
minutes. On 27-JUN-2007, she developed lymphadenopathy on the left side of her groin. It was reported that she had two swollen lymph nodes in her groin
closer to her femur. The area is sore and tender. Unspecified medical attention was sought. The patient's lymphadenopathy and tender and sore area
Other Meds: None
Lab Data: diagnostic laboratory - results not reported, urinalysis - results not reported
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285894-1

Unknown F Unknown Unknown 18-Jul-2007 16-Aug-2007 FL WAES0706USA05150 16-Aug-2007

Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated on an unknown day with a first dose of Gardasil. The
physician reported that the patient received her first dose of Gardasil and "claimed it affected her menstrual cycle". She said her cycle went from being every
four weeks to being every six weeks. The patient reused to go on to get the second and third doses. The physician did not believe the adverse experience was
related to Gardasil. The outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285895-1


MedDRA PT Fatigue, Hyperhidrosis, Hyperhidrosis, Pallor, Paraesthesia, Syncope vasovagal, Vision blurred, Vomiting
Symptom Text: Information has been received from a physician concerning a 12 year old female patient who on 25-JUN-2007 was vaccinated IM in to left arm with a dose of
Gardasil lot #654510/0962F. Concomitant therapy included Havrix. On 25-JUN-2007, after receiving the Gardasil, the patient experienced tingling of her left
arm and a reaction which appeared as "vagal". She became diaphoretic, pale, sweaty, her eyes were blurry, and she vomited. The physician mentioned that
the recovered during the same visit. On 24-JUN-2007, during a follow-up call the patient's mother mentioned that the patient was "tired today". The physician
reported that this symptom was "not specific". Unspecified medical attention was sought by the patient. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285896-1


Symptom Text: Information has been received from a physician concerning a 12 year old female patient who on 22-JUN-2007 was vaccinated with a second dose of Gardasil
lot #655849/0263U. On 22-JUN-2007 the patient experienced "syncope within one minute of vaccination." Unspecified medical attention was sought by the
patient. The patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285897-1

15.0 F Unknown Unknown 18-Jul-2007 16-Aug-2007 KS WAES0706USA05166 16-Aug-2007

MedDRA PT Dizziness, Throat tightness
Symptom Text: Information has been received from a physician concerning a 15 year old female patient who on an unknown day was vaccinated with a second dose of
Gardasil. The physician reported that patient after getting second dose of Gardasil "felt dizzy and felt like throat was closing." Unspecified medical attention was
sought by the patient. The patient recovered 'an hour after the dose". Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285905-1


MedDRA PT Crying, Head injury, Syncope
Symptom Text: Pt had syncope episode approx. 15 minutes after receiving Gardasil injection. Pt verbalized fear of needles before receiving the injection. Crying after the
injection and nurse sat with her in exam room for approx 10 min. Pt had syncope while on her way out to waiting room and hit her head on the edge of a door.
No visible injury but went to hospital via ambulance. Her guardian decided at that time that she did not need to be seen and took her home.
Other Meds: None
Lab Data: None
History: Allergy-Motrin
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285909-1

39.0 F 02-May-2007 06-Jul-2007 65 25-Jul-2007 03-Aug-2007 IA 14-Aug-2007

MedDRA PT Facial palsy, Inappropriate schedule of drug administration, Off label use
Symptom Text: Diagnosed with Bells Palsy (paralysis on left side of face) Acyclovir 400 mg-1 tab 5 times a day Prednisone 20mg-2 tabs for 3 days 1.5 3 days, 1.0 3 days, 0.5
3 day
Other Meds:
Lab Data:
History: Allergic rhinitis, overactive bladder
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285915-1 (S)


MedDRA PT No reaction on previous exposure to drug, Pyrexia, Ulcer, Vulvitis
Symptom Text: Information has been received from a gynecologist concerning a 13 year old female who on 02-JUL-2007 was vaccinated IM into the upper arm with a second
dose of Gardasil. On 02-JUL-2007 in the evening, the patient developed a fever up to 39 C. On 04-JUL-2007 the gynecologist diagnosed severe painful
ulcerative vulvitis and the patient was hospitalized. The patient was treated with analgesic (unspecified) and sitz bath. A Herpes simplex infection was ruled out.
The patient improved and was discharged on 08-JUL-2007. On 09-JUL-2007 the patient was seen by her gynecologist. At this time the patient showed one
ulcer of 1 cm diameter. It was reported that the first vaccination with Gardasil was well tolerated. Additional information is not expected. Other business partner
numbers included E2007-04570.
Other Meds: Unknown
Lab Data: Unknown
History: Immunisation
Prex Illness:
Prex Vax Illns:

Vaers Id: 285916-1

16.0 F 31-May-2007 31-May-2007 0 25-Jul-2007 26-Jul-2007 FR WAES0707USA03077 26-Jul-2007

MedDRA PT Myositis, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 16 year old female with a history of right shoulder amyotrophy of unknown etiology who on 31-
MAY-2007 was vaccinated IM in the left deltoid with a first dose of Gardasil. On 15-JUN-2007 the mother of the patient called the reporter and told her that her
daughter experienced pain of the left arm down to the elbow especially while stretching the arm since the vaccination. On 19-JUN-2007 a blood sample was
taken, serum creatine kinase test reported 1036. Myositis was diagnosed. The patient was treated with ibuprofen and resting. On an unknown date another
blood sample was taken and the serum creatine kinase test reported 260. At the time of the report, the patient had improved. The reporting physician
considered myositis to be another important medical event. Additional information is not expected. Other business partner numbers include E2007-04641.
Other Meds: Unknown
Lab Data: serum creatine kinase 19Jun07 1036; serum creatine kinase 260
History: Amyotrophy
Prex Illness:
Prex Vax Illns:

Vaers Id: 285917-1


Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient develop a bump at an
injection site after receiving the vaccine. This is one of several reports from the same source. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285918-1


MedDRA PT Syncope
Symptom Text: Information has been received from a registered nurse concerning a female patient between "14 and 16 years old" who in February 2007, was vaccinated into
the left arm with a first dose of Gardasil. Concomitant therapy included an unknown vaccination into the right arm. Subsequently, the patient fainted after
receiving the vaccinations. It was reported that the patient was fine after sitting for a bit. Unspecified medical attention was sought. On an unspecified date, the
patient recovered. No product quality complaint was involved. Additional information has been requested.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285919-1

11.0 F Unknown Unknown 18-Jul-2007 16-Aug-2007 MN WAES0706USA05215 16-Aug-2007

Symptom Text: Information has been received from a physician concerning an 11 year old female who was vaccinated with a dose of the Gardasil. Concomitant therapy
included hepatitis B vaccine, recomb (MSD), meningococcal vaccine (unspecified) and DTAP-IPV. Subsequently, the patient 'kept walking right into the wall".
"got dizzy" and "thought she was going to pass out". The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285920-1


MedDRA PT Migraine, No reaction on previous exposure to drug, Pain, Pyrexia
Symptom Text: Information has been received from a medical assistant concerning a 16 year old female patient who on 26-JUN-2007, was vaccinated IM with a third dose of
Gardasil. On 27-JUN-2007, the patient experienced migraine, fever and a whole body ache. No medical attention was sought. At the time of this report, the
patient's outcome was unknown. It was reported that the patient was fine after receiving the first two doses. No product quality complaint was involved.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285921-1

12.0 F 01-Jan-2007 Unknown 18-Jul-2007 16-Aug-2007 OH WAES0706USA05218 16-Aug-2007

MedDRA PT Arthralgia, Familial risk factor, Joint stiffness, Muscular weakness, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 12 year old female patient with no medical history who in January 2007, was vaccinated IM with a
0.5ml dose of Gardasil. One to two days after receiving her first and second dose, the patient developed pain and weakness to both upper limbs. Then 10 to 14
days later, she developed soreness and stiffness to both elbows. It was reported that this discomfort lasts for about 4 days and then resolves. It was also
reported that the patient's mother has multiple sclerosis. Unspecified medical attention was sought. At the time of this report, the patient was recovering from
pain and weakness to both upper limbs. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: None
Prex Illness: n
Prex Vax Illns:

Vaers Id: 285922-1


MedDRA PT Injection site pain, Mobility decreased, Myalgia, Neck pain, Pain
Symptom Text: Information has been received from a physician and the father of a consumer concerning a 19 year old female patient with drug hypersensitivity, seasonal
allergy hay fever and allergic to codeine who on 27-JUN-2007 was vaccinated IM with a first dose of Gardasil lot #657621/0387U. Concomitant therapy
included unspecified birth control pill. The physician reported that on 27-JUN-2007 the patient developed muscle pain in her neck and the patient experienced
neck muscle pain on the left side of her neck. The reporter mentioned that on 27-JUN-2007 his daughter experienced injection site pain at neck. On 28-JUN-
2007 the patient awakened with pain on her left side of her body, with difficulty moving left arm and leg, and she could not throw her neck and head. Her doctor
was notified and said to take her to the Emergency Room. The patient has not recovered. Additional information has been requested.
Lab Data: Unknown
History:
Prex Illness: Hay fever; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 285923-1

16.0 F 26-Jun-2007 26-Jun-2007 0 18-Jul-2007 16-Aug-2007 OH WAES0706USA05225 16-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who on 26-JUN-2007 was vaccinated with a first dose of Gardasil.
Concomitant therapy included hepatitis virus vaccine (unspecified). On 26-JUN-2007 the reporter that "the patient fainted immediately after receiving her first
dose of Gardasil. She recovered completely quickly. Patient's mother reported that she had a similar episode when she received hepatitis injection a few years
ago." Unspecified medical attention was sought by patient. The patient recovered. Additional information has been requested.
Other Meds: hepatitis virus vaccine
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285924-1

20.0 F Unknown 26-Jun-2007 18-Jul-2007 16-Aug-2007 MO WAES0706USA05234 16-Aug-2007

MedDRA PT Injection site erythema, Injection site pruritus, Injection site rash
Symptom Text: Information has been received from a physician concerning a 20 year old female patient who was vaccinated with a third dose of Gardasil. Concomitant therapy
included hormonal contraceptives (unspecified). On 26-JUN-2007, the patient developed a rash, itching and redness at the injection site. Unspecified medical
attention was sought, At the time of this report, the patient's outcome was unknown. It was reported that the patient did not have this experience with the first
and second dose. No product quality complaint was involved. Additional information has been requested.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285925-1

Unknown F Unknown Unknown 18-Jul-2007 16-Aug-2007 WI WAES0706USA05244 16-Aug-2007

MedDRA PT Hypersensitivity
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The physician reported that
patient had a serious allergic reaction after the first injection. Patient sought unspecified medical attention. The outcome was unknown. Additional information
has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285926-1

VARCEL MERCK & CO. INC. NULL Unknown Subcutaneously
MedDRA PT Cyanosis, Heart rate decreased, Musculoskeletal stiffness, Nausea, Pallor, Syncope, Vomiting
Symptom Text: Information has been received from a physician concerning a 11 year old female student who on 21-JUN-2007 in AM was vaccinated IM in left arm with a first
dose of Gardasil. Concomitant suspect therapy included Varivax, (MSD) and Vaqta (inactive), (MSD). Other concomitant therapy included Adacel and
Menactra. On 21-JUN-2007, after receiving the Gardasil injection and two other vaccines the patient fainted, very pale, arms stiffened, blue in face and her
heart rate became 50. She took smelling salt. She vomited x1 and felt nausea rest of the day. She was in the office for 5 minutes and her legs were lifted. She
recovered without any problems. She tool 24 hours to recover. It was indicated that patient did not eat prior to vaccine administration. Additional information is
not expected.
Other Meds:
Lab Data: vital sign 06/21/07 50 - Heart rate
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285927-1


Symptom Text: Information has been received from a nurse concerning a number of patients' who were vaccinated with a dose of Gardasil. Subsequently, the patients
developed redness and swelling around injection site area. At the time of this report, the patients' outcome was unknown. No product quality complaint was
involved. Additional information has been requested. Attempts are being made to obtain additional identifying information to distinguish the individual patients
mentioned in this report. Additional information will be provided if available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285928-1

18.0 F 01-Mar-2007 31-May-2007 91 18-Jul-2007 16-Aug-2007 TX WAES0706USA05281 16-Aug-2007
HPV4 MERCK & CO. INC. NULL 0 Gluteous maxima Intramuscular

MedDRA PT Drug administered at inappropriate site, Pain
Symptom Text: Information has been received from a consumer concerning her 18 year old daughter with exercise induced asthma who in March 2007, was vaccinated with
the first 0.5 ml dose of the Gardasil. On approximately 31-MAY-2007, at the end of May 2007, the patient was vaccinated in the buttocks with the second 0.5 ml
dose of the Gardasil. Concomitant therapy included montelukast sodium (MSD) and albuterol. On approximately 31-MAY-2007, after the vaccination, the
patient reported that "it was one of the most painful shots she ever had." The pain lasted for 3 days and the patient treated herself with Motrin during that time.
No laboratory or diagnostic tests were performed. Subsequently, the patient recovered from the pain. Additional information has been requested.
Lab Data: None
History:
Prex Illness: Asthma exercise induced
Prex Vax Illns:

Vaers Id: 285929-1


MedDRA PT Malaise, Pyrexia, Vomiting
Symptom Text: Information has been received from a physician concerning a 19 year old female who was vaccinated with a first dose of the Gardasil on an unspecified date.
Subsequently, the patient developed a fever of 102 degrees, was vomiting for 24 hours and did not feel well for three days. At the time of the report, the patient
had recovered. It was also reported that the patient received the second dose of the Gardasil on an unspecified date, and "she was feeling fine after receiving
the" vaccination. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285930-1


MedDRA PT Urticaria
Symptom Text: Information has been received from a licensed practical nurse concerning a 16 year old female patient with no medical history or drug allergies who on 25-JUN-
2007, was vaccinated IM with a first 0.5ml dose of Gardasil. Concomitant therapy included Alesse. On 28-JUN-2007, the patient developed hives. Unspecified
medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product
Other Meds: ALESSE
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285931-1

19.0 F 01-Mar-2007 01-Mar-2007 0 18-Jul-2007 16-Aug-2007 NH WAES0706USA05300 16-Aug-2007

MedDRA PT Laceration, Syncope
Symptom Text: Information has been received from a physician concerning an approximately 19 year old female patient who in March 2007, was vaccinated with a first 0.5ml
dose of Gardasil. Concomitant therapy included oral contraceptives. Subsequently, the patient fainted at the check out counter in the doctor's office and cut her
lip on the edge of the counter. It was reported that the patient had to go to the emergency room for stitches. On an unspecified date, the patient recovered. No
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285932-1


Symptom Text: Information has been received from a physician concerning an approximately 17 year old female who on 04-JUN-2007 was vaccinated with a 0.5 ml second
dose of Gardasil (lot# 655205/1426F). Concomitant therapy included Cymbalta, Lamicatal, Synthroid, Ortho-Novum, Claritin and "500 fiber therapy". On 19-
JUN-2007 the patient went into the office with redness, swelling and itching "beyond normal" around the injection site. The physician did not administer the first
dose and was not aware of a previous similar reaction. At the time of the report the patient was recovering from redness, swelling and itching around the
injection site. There were no diagnostic or laboratory test performed. Additional information has been requested.
Other Meds: CYMBALTA mg, ORTHO-NOVUM 7/7/7, gastrointestinal preparations, LAMICTAL, SYNTHROID, CLARITIN mg
Lab Data: None
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285933-1

25.0 F 29-Jan-2007 29-Jan-2007 0 18-Jul-2007 15-Aug-2007 TX WAES0706USA05317 15-Aug-2007
HPV4 MERCK & CO. INC. 0522U 0 Unknown Subcutaneously

MedDRA PT Incorrect route of drug administration, Injection site erythema, Injection site irritation, Injection site irritation, Oedema peripheral, Paraesthesia
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female, with drug hypersensitivity to Vistaril and no pertinent medical history,
who on 29-JAN-2007 was vaccinated subcutaneously with a 0.5 ml first dose of Gardasil (lot # 657737/0522U). Concomitant therapy included vitamins
(unspecified). On an unspecified date the patient was vaccinated subcutaneously with a second dose of Gardasil. On 27-JUN-2007 the patient experienced
irritation, burning and redness at injection site. The burning traveled down her arm and there was tingling in her fingers. Medical attention was sought ON 28-
JUN-2007 there was still swelling and redness at the arm. The patient was instructed by the office to put ice on affected area. The AE's improved and the
patient's irritation, burning and redness at injection site, tingling in her fingers, and swelling and redness at the arm persisted at the time of reporting. Additional
Lab Data: None
History:
Prex Vax Illns:

Vaers Id: 285934-1


MedDRA PT Pain, Urticaria
Symptom Text: Information has been received concerning a 14 year old female who on 26-JUN-2007 was vaccinated with a 0.5 ml first dose of Gardasil. On 27-JUN-2007 was
vaccinated with a 0.5 ml first dose of Gardasil. On 27-JUN-2007 the patient called the office complaining that her left lung was hurting. On 28-JUN-2007 the
patient called the office reporting that she had hives. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285935-1


MedDRA PT Syncope
Symptom Text: Information has been received from a laboratory technician concerning a 15 year old female who on 28-JUN-2007 was vaccinated with a 0.5 ml first dose of
Gardasil. On 28-JUN-2007, while still in the physician's office the patient fainted. Unspecified medical attention was sought. There were no laboratory or
diagnostic tests performed. Additional information has been requested. This is one of two reports from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285936-1

25.0 F 01-Apr-2007 01-Apr-2007 0 18-Jul-2007 15-Aug-2007 VT WAES0706USA05340 15-Aug-2007

MedDRA PT Injection site pain, Syncope
Symptom Text: Information has been received from a 25 year old female who in April 2007, was vaccinated with a 0.5 ml second dose of Gardasil. Subsequently in April 2007
the patient fainted and had a moderate amount of injection site pain. Unspecified medical attention. Subsequently that same day, the patient recovered from
the fainting and moderate amount of injection site pain. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285937-1


MedDRA PT Chest pain, Neck pain, Urticaria
Symptom Text: Information has been received from a physician (a pediatrician), concerning a 14 year old female patient, who on 27-JUN-2007, was vaccinated IM in the left
arm, with the first dose of Gardasil (lot #657736/0389U). There was no concomitant medication. On approximately 28-JUN-2007 ("less than 24 hours after'), the
patient experienced left sided pain from her neck, that radiated "down to her chest into the base of the lung." Treatment involved Motrin, which relieved the
pain. Shortly after the pain had subsided, she experienced urticaria ("within 24 hours" of the injection). Treatment involved Benadryl. The physician confirmed
the patient had recovered from the events on 28-JUN-2007. Additional information has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285938-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 OH WAES0706USA05358 15-Aug-2007

MedDRA PT Heart rate increased
Symptom Text: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with the second dose of the Gardasil on an
unspecified date. Subsequently, the patient experienced " a really fast heartbeat". The patient sought unspecified medical attention. At the time of the report,
the patient had recovered from the increased heartbeat. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285939-1

17.0 F 25-Jun-2007 25-Jun-2007 0 18-Jul-2007 15-Aug-2007 NH WAES0706USA05369 15-Aug-2007

MedDRA PT Dizziness, Fall, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 25-JUN-2007 at 11:00 A.M. was vaccinated in the right deltoid with the
first dose of Gardasil (lot # 658094/0524U) which was tolerated well. After two to three minutes, the patient stated that she felt dizzy and then lasted
approximately 30-45 seconds. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285940-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 KS WAES0706USA05377 15-Aug-2007

MedDRA PT Eye swelling, Tenderness
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with her first dose of Gardasil, and within 24 hours experienced
tenderness and swelling around her eyes. The patient saw an eye doctor, however the result of that visit is unknown. The patient's outcome was unknown.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285941-1

18.0 F 26-Mar-2007 26-Mar-2007 0 18-Jul-2007 15-Aug-2007 KY WAES0706USA05382 15-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning an 18 year old female student who on 26-MAR-2007 was vaccinated IM with her first dose of
Gardasil, lot #657622/0388U. Five minutes after the injection, the patient had an episode of syncope. She had normal vitals and improved after lying flat for
approximately 15-20 minutes. The patient recovered and received a second dose of Gardasil on an unspecified date. It was reported that "we made her lie flat
after the injection. No syncope on 2nd injection. Additional information is not expected.
Other Meds: Unknown
Lab Data: vital sign 03/26/07 - normal
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285942-1


MedDRA PT Syncope vasovagal, Tremor
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who on 28-JUN-2007 was vaccinated with a dose of Gardasil. There
was no concomitant medication. As the injection was being administered, the patient had a syncopal episode and appeared to be shaking. It was also reported
that she had a vasovagal reaction immediately upon removal of needle following administration of Gardasil. She recovered immediately with no treatment of
medication. The patient was reported to be fine, totally asymptomatic. The reporter believed the patient had a vasovagal reaction to the actual injection, not to
product, and had no suspicions other than a young, nervous adolescent. No further information is available.
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285943-1


Symptom Text: Information has been received from a Physician's Assistant concerning a female patient who on 26-JUN-2007 was vaccinated IM with her third dose of
Gardasil. After the third dose, the patient developed enlarged lymphnodes. The patient had no reaction to the first and second doses. Unspecified medical
attention was sought. Her outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285950-1

TDAP GLAXOSMITHKLINE AC52B018AB 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Eye swelling, Pruritus, Rash
Symptom Text: Pt developed skin rash, eye swelling last night (07/24/07) at 10pm. Pt received Boostrix and HPV at 5 pm, no difficulty with breathing, no abd. pain, no vomiting,
+ itching. Took Benadryl at 7am today (07/25/07).
Other Meds:
Lab Data:
History: Monistat 1 combo pack kit
Prex Illness:
Prex Vax Illns:

Vaers Id: 285963-1

MedDRA PT Cold compress therapy, Dizziness, Hyperhidrosis, Loss of consciousness, Nausea
Symptom Text: after injection given-patient reported feeling faint-sl. diaphoretic c/o nausea-passed out for approx 1"- supine position-legs elevated cool compress/fluid given.
Other Meds: PPD
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285964-1

16.0 F 24-Jul-2007 24-Jul-2007 0 25-Jul-2007 03-Aug-2007 MI 06-Aug-2007
VARCEL MERCK & CO. INC. 0780U 0 Unknown Subcutaneously HEPA
TDAP GLAXOSMITHKLINE C2734AA 0 Left arm Intramuscular MNQ
BIOLOGICALS
MMR MERCK & CO. INC. 1468F 0 Right arm Subcutaneously
HEP GLAXOSMITHKLINE AHBVB340AA 0 Right arm Intramuscular
BIOLOGICALS
IPV SANOFI PASTEUR Y0824 0 Left arm Subcutaneously
MedDRA PT Anaphylactic reaction, Bronchospasm, Cough, Flushing, Ocular hyperaemia, Throat tightness, Urticaria
Symptom Text: Client developed anaphylactic rxn within 10 min. of receiving vaccines-AEB hives, flushed skin, blood shot eyes, bronchospasm, cough and tightness in throat.
ER protocols initiated per health dept policy as well as doctor and immunization supervisor notified. At 11:30 AM 0-8 ml of Benadryl given at 11:45 am 0.4 ml of
Epi given by RN. CT discharged to hosp in good condition for further follow-up. 8L of O2 per NC was initiated at 11:35 am. Vitals monitored throughout.
Other Meds: Possible malaria medication
Lab Data: vitals
History: possible spleen enlargement per overseas physical , chronic malaria
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285969-1

18.0 F 18-Jul-2007 20-Jul-2007 2 25-Jul-2007 03-Aug-2007 WI 06-Aug-2007
MedDRA PT Lymphadenopathy, Musculoskeletal stiffness
Symptom Text: 2 Days after vaccine developed occipital adenopathy and stiff neck.
Other Meds: ZYRTEC D, TRICYCLEN, GLUCOPHAGE
Lab Data: WBC = 8.5
History: Allergy syndrome/ PCOS
Prex Illness: None
Prex Vax Illns:

Vaers Id: 285977-1


Symptom Text: Information has been received from a physician concerning a 16 year old female patient who on 24-APR-2007 was vaccinated with her first dose of Gardasil,
lot # 657006/0188U. After receiving the first dose, she experienced amenorrhea. Unspecified medical attention was sought. Her outcome was unknown.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285978-1


MedDRA PT Rash
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with the Gardasil on an unspecified date. Subsequently, the
patient developed a rash. The patient unspecified medical attention. The patient's outcome was unknown. This report is one of two reports from the same
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285979-1

11.0 F 21-Jun-2007 28-Jun-2007 7 18-Jul-2007 15-Aug-2007 KY WAES0707USA00029 15-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from the grandmother of an 11 year old female who on 21-JUN-2007, was vaccinated with a first dose of Gardasil. On 28-JUN-
2007, the patient developed a rash on her arm and stomach area. On 29-JUN-2007, the patient sought medical attention at the Health Department in which she
received the vaccine. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285980-1


MedDRA PT Headache, Hyperhidrosis, Loss of consciousness, Loss of consciousness
Symptom Text: Information has been received from a physical therapist concerning his 12 year daughter with an allergy to ant bites who on approximately 04-JUN-2007 was
vaccinated intramuscularly with the first dose of the Gardasil. There was no concomitant medication. On approximately 04-JUN-2007, post-vaccination, the
patient experienced a "headache, became diaphoretic and passed out". Unspecified medical attention was sought. No laboratory or diagnostic tests were
performed. The patient recovered from the headache, diaphoresis and loss of consciousness. Additional information is not expected.
Other Meds: None
Lab Data: None
History:
Prex Illness: Insect bite allergy
Prex Vax Illns:

Vaers Id: 285981-1

18.0 F 29-Mar-2007 29-Mar-2007 0 18-Jul-2007 15-Aug-2007 KY WAES0707USA00035 15-Aug-2007

MedDRA PT Syncope
Symptom Text: Information has been received from a physician, concerning an 18 year old female student, with no known allergies or medical conditions, who on 29-MAR-
2007, at 11:00am, was vaccinated IM in the right deltoid, with the first dose of Gardasil (Lot #656371/0181U). There was no illness at the time of vaccination.
On 29-MAR-2007, within 5 minutes of receiving the vaccination, the patient had an episode of syncope. She was helped to lie down flat, and was monitored for
15 minutes; she recovered on her own. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285982-1


MedDRA PT Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Symptom Text: Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml
dose of the Gardasil. Subsequently, the patient had an "abnormal Pap test and was HPV positive." It was reported that the patient had a normal pap result prior
to receiving the Gardasil. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: cervical smear - normal, cervical smear - abnormal; HPV positive
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285983-1

Unknown F 27-Jun-2007 27-Jun-2007 0 18-Jul-2007 15-Aug-2007 CT WAES0707USA00052 15-Aug-2007

MedDRA PT Paraesthesia oral, Rash
Symptom Text: Information has been received from a nurse, via a company representative, concerning a female patient (age unspecified), who on 27-JUN-2007 was
vaccinated with the first dose, 0.5ml, of Gardasil (invalid lot # provided). On 27-JUN-2007 the patient experienced a rash on her chest and arms, as well as a
"tingly tongue sensation." Subsequently, the patient recovered from the events (date and duration not specified). Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285984-1

Unknown F 27-Jun-2007 27-Jun-2007 0 18-Jul-2007 15-Aug-2007 OR WAES0707USA00055 15-Aug-2007

MedDRA PT Pharyngolaryngeal pain, Rash generalised
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a female patient who on 27-JUN-2007 was vaccinated with a second dose of
Gardasil. Concomitant therapy included Menactra. The patient developed a sore throat and generalized rash, after her second injection. Unspecified medical
attention was sought by the patient. The outcome was unknown. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285985-1

17.0 F 29-Nov-2006 06-Dec-2006 7 18-Jul-2007 15-Aug-2007 NY WAES0707USA00081 15-Aug-2007

MedDRA PT Erythema, Facial pain, Inappropriate schedule of drug administration, Similar reaction on previous exposure to drug
Symptom Text: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 17 year old female patient who on 29-NOV-2006 was vaccinated IM with
a first dose of Gardasil lot # 653736/0868F and on 10-MAR-2007 with a second dose of Gardasil lot #654702/0011U. Concomitant therapy included
Benzamycin Topical Gel and Nuvaring. On 05-DEC-2006 the patient developed painful redness to her face one week after her first injection and on 13-MAR-
2007 she also developed painful redness to her face one week after her second injection. The redness and pain lasted about a week and a half in both cases.
The patient sought unspecified medical attention. The patient recovered. Additional information has been requested.
Other Meds: BENZAMYCIN TOPICAL GEL, NUVARING
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285986-1

23.0 F 19-Jan-2007 26-Jan-2007 7 18-Jul-2007 15-Aug-2007 MA WAES0707USA00101 16-Aug-2007

MedDRA PT Dizziness, Hypoaesthesia
Symptom Text: Information has been received from a licensed practical nurse concerning a 23 year old female patient with a history of panic attacks who on 19-JAN-2007, was
vaccinated into the left deltoid with a first dose of Gardasil (Lot# 658094/0524U). Concomitant therapy included hormonal contraceptives (unspecified). On 26-
JAN-2007, the patient experienced dizziness and numbness on the left side of her body. Unspecified medical attention was sought. At the time of this report,
the patient has not recovered. No product complaint was involved. Additional information has been requested.
Lab Data: Unknown
History: Panic attack
Prex Illness:
Prex Vax Illns:

Vaers Id: 285987-1


MedDRA PT Dizziness, Hyperhidrosis, Nausea
Symptom Text: Information has been received from a registered nurse concerning female patient with no pertinent medical history who on approximately 22-JUN-2007 was
vaccinated with a dose of the Gardasil. There was no concomitant medication. Five minutes after receiving the vaccination, the patient became dizzy, nauseous
and diaphoretic. The symptoms lasted for 10 minutes. Unspecified medical attention was sought. The patient recovered from the dizziness, nausea and
diaphoresis on the same day she received the Gardasil. This report is one of several reports received from the same source. Additional information has been
requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 285988-1


MedDRA PT Dyspnoea, Oxygen saturation decreased
Symptom Text: Information has been received from a nurse practitioner concerning a 21 year old female patient with asthma and allergies to Advil, aspirin, and penicillin who
on 20-JUN-2007, was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included Imitrex and albuterol. Subsequently, the patient had
difficulty breathing and a low oxygen level. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint
was involved. Additional information has been requested.
Other Meds: albuterol, IMITREX (SUMATRIPTAN
Lab Data: pulse oximetry 06/20/07 - low
History:
Prex Illness: Asthma; Drug hypersensitivity; Penicillin allergy
Prex Vax Illns:

Vaers Id: 285989-1

Unknown F 19-Jun-2007 01-Dec-2006 -200 18-Jul-2007 15-Aug-2007 -- WAES0707USA00148 15-Aug-2007

MedDRA PT Metrorrhagia, Metrorrhagia
Symptom Text: Information has been received from a Physician's Assistant (P.A.) concerning a female patient who roughly on 29-DEC-2006 was vaccinated with a first dose of
Gardasil and on an unknown day was vaccinated with a second dose of Gardasil and on 19-JUN-2007 was vaccinated with a third dose of Gardasil.
Concomitant therapy included hormonal contraceptives (unspecified). The reporter reported that the patient developed "breakthrough bleeding and spotting"
after both the first and second injection. The patient mentioned this information on 19-JUN-2007 when she came to the office. Unspecified medical attention
was sought by the patient. The patient recovered. Additional information has been requested.
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285990-1

Unknown F Unknown Unknown 18-Jul-2007 15-Aug-2007 NH WAES0707USA00149 15-Aug-2007

MedDRA PT Injection site induration, Pain in extremity
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated IM with a dose of Gardasil. The physician reported that the
patient developed an "extremely sore arm and that the injection site was very hard". He also mentioned that the patient reported that she was having "great
difficulty with her arm". The patient was in the physician's office at time of the events. The outcome was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285991-1

12.0 F Unknown Unknown 18-Jul-2007 15-Aug-2007 WA WAES0707USA00153 15-Aug-2007

MedDRA PT Influenza like illness, Nausea, Vomiting
Symptom Text: Information has been received from a nurse concerning 5 to 8 female "12 year old" patients who on unspecified dates, were vaccinated with first doses of
Gardasil. Subsequently, on unspecified dates, the patients experienced flu-like symptoms such as nausea and vomiting. Subsequently, the patients recovered
("symptoms passed quickly"). No product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinguish the
individual patients mentioned in this report. Additional information will be provided if available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285992-1


MedDRA PT Oedema peripheral
Symptom Text: Information has been received from a registered nurse concerning her daughter (age unknown) who on unspecified dates was vaccinated with first, second and
third doses of Gardasil. Subsequently the patient developed swelling of the arm after all three doses of Gardasil. At the time of this report, the outcome was
unknown. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285993-1

MedDRA PT Dizziness, Feeling hot, Inappropriate schedule of drug administration, Syncope, Throat tightness
Symptom Text: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on an unknown date was
vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included Menactra and M-M-R II (MSD). Following vaccination with Gardasil, the
patient felt dizzy, had tightness in her throat, felt warm, and "fainted for a second." Subsequently, the patient recovered from the events (duration not specified).
The patient sought unspecified medical attention. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285994-1

16.0 U 14-Jun-2007 14-Jun-2007 0 18-Jul-2007 14-Aug-2007 -- WAES0707USA0059 14-Aug-2007

MedDRA PT Syncope, Vomiting
Symptom Text: Information has been received from a laboratory technician concerning a 16 year old patient who on approximately 14-JUN-2007 was vaccinated with a dose of
Gardasil. On approximately 14-JUN-2007, while still in the physician's office the patient fainted and vomited. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285995-1


MedDRA PT Dizziness, Migraine, Nausea, Vomiting
Symptom Text: Information has been received from a physician concerning a 22 year old female who on 21-JUN-2007 was vaccinated with Gardasil (lot # not reported) 0.5 ml
injection. There was no concomitant medication. On 21-JUN- 2007, the patient experienced severe dizziness, nausea, vomiting which resulted in a migraine.
Medical attention was sought. The experience lasted approximately 12 hours. On 22-JUN-2007, the patient recovered. Additional information has been
requested.
Other Meds: None
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285996-1

Unknown U Unknown Unknown 18-Jul-2007 14-Aug-2007 AZ WAES0707USA01204 14-Aug-2007
MedDRA PT Erythema, Skin warm, Tenderness
Symptom Text: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Varivax. Subsequently, the patient
experienced a "10 x 8 centimeter of left arm redness, warmth and tender," No medical attention was sought. At the time of this report, the patient's outcome
Other Meds:
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285997-1


MedDRA PT Rash
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with the Gardasil on an unspecified date. Subsequently, the
patient developed a rash. The patient sought unspecified medical attention. The patient's outcome was unknown. This report is one of two reports from the
same source. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285998-1


Symptom Text: Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml
dose of the Gardasil. Subsequently, the patient had an "abnormal Pap test and was HOV positive." It was reported that the patient had a normal pap result prior
to receiving the Gardasil. Unspecified medical attention was sought. The patient's outcome was unknown. This is one of two reports from the same source.
Other Meds: Unknown
Lab Data: cervical smear - normal, cervical smear - abnormal, HPV positive
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 285999-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician's assistant concerning a female (age unknown) who on an unspecified date was vaccinated intramuscularly
with a 0.5 ml first dose of Gardasil. Subsequently the patient fainted. At the time of this report, the outcome was unknown. No product quality complaint was
involved. This is one of two reports from the same source. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286000-1


Symptom Text: Information has been received from a registered nurse concerning female patient with no medical history who on approximately 22-JUN-2007 was vaccinated
with a dose of the Gardasil. There was no concomitant medication. Five minutes after receiving the vaccination, the patient became dizzy, nauseous and
diaphoretic. The symptoms lasted for 10 minutes. Unspecified medical attention was sought. The patient recovered from the dizziness, nausea, and
diaphoresis on the same day she received the Gardasil. This report is one of several reports received from the same source. Additional information has been
requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 286001-1


Symptom Text: Information has been received from a registered nurse concerning female patient with no pertinent medical history who on approximately 22-JUN-2007 was
vaccinated with a dose of the Gardasil. There was no concomitant medication. Five minutes after receiving the vaccination, the patient became dizzy, nauseous
and diaphoretic. The symptoms lasted for 10 minutes. Unspecified medical attention was sought. The patient recovered from the
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 286002-1


Symptom Text: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently the
patient had a "terrible reaction to the vaccine". It was reported that the patient had such a bad reaction that she was not allowed to get the next two vaccines.
No further information was provided. Additional information is not expected. This is one of two reports from the same source.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286003-1


MedDRA PT Syncope
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning around an 18 year old female who was vaccinated with a dose of Gardasil. The
patient fainted after receiving the Gardasil. Unspecified medical attention was sought by the patient, the patient recovered. The reporter reported that two other
patient experienced fainting after receiving the dose of Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286004-1


MedDRA PT Syncope
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a female patient (age unknown) who was vaccinated with a dose of Gardasil. The
patient fainted after receiving the Gardasil. Unspecified medical attention was sought, the patient recovered. The reporter reported that two other patient
experienced fainting after receiving the dose of Gardasil. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286005-1


MedDRA PT Cold compress therapy, Syncope
Symptom Text: Information has been received from a health professional concerning a 11 year old female who on 08-JUN-2007 was vaccinated with the second dose (date of
first dose not provided) of Gardasil (Lot # not provided). Concomitant therapy included Menactra. On 08-JUN-2007 the patient experienced syncope after being
vaccinated with the three vaccines. It was reported that the episode of syncope last 10 to 15 minutes. The patient was treated with a cold compress, put her
head between her legs and was "fine after that". The health professional reported that the patient will be scheduled to receive the third dose of Gardasil on an
unspecified date. Additional information has been requested.
Other Meds:
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286006-1


MedDRA PT Syncope
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil (Lot# not provided). It was reported that
the patient fainted at the check out. The patient was treated with smelling salts of ammonia and drank a Mountain Dew soda. Her parents picked her up at the
physicians office. Subsequently, the patient recovered. Additional information has been requested.
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286011-1

14.0 F Unknown Unknown 26-Jul-2007 27-Jul-2007 CA WAES0707USA02908 27-Jul-2007
VARCEL MERCK & CO. INC. 1260F Unknown Unknown
MedDRA PT Convulsion, Injection site irritation, Syncope
Symptom Text: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with Gardasil (lot # Unknown).
Concomitant secondary suspect therapy included Varivax (Lot # 654811/1260F) for prophylaxis (duration and dose not reported). On an unspecified date post-
vaccination the patient fainted and had seizures. The patient also complained of burning at the injection site. Medical attention was sought. The outcome was
not reported. No other information was available. The reported felt that the events required intervention to prevent serious criteria (other important medical
event). Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286012-1 (S)

18.0 F 25-Jun-2007 30-Jun-2007 5 26-Jul-2007 27-Jul-2007 RI WAES0707USA03181 27-Jul-2007

MedDRA PT Throat tightness, Urticaria
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female patient with no medical history or allergies who on 25-JUN-2007, was
vaccinated IM into the left deltoid with a first 0.5ml dose of Gardasil (Lot # 658100/0525U). There was no concomitant medication. On 30-JUN-2007 5 days
later, the patient developed hives all over the body and her throat felt like it was closing. It was reported that the patient went to the emergency room and was
given in IV and unspecified steroids. The patient was discharged on steroids and BENADRYL. Subsequently, the patient recovered. No product quality
complaint was involved. The reporter felt that the hives all over the body and throat closing were considered to be immediately life-threatening and other
Other Meds: None
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 286018-1

12.0 F 20-Jul-2007 20-Jul-2007 0 26-Jul-2007 06-Aug-2007 CT 06-Aug-2007
VARCEL MERCK & CO. INC. 0722U 1 Right arm Intramuscular
MedDRA PT Fall, Pallor, Syncope
Symptom Text: Patient received 3 vaccines, MCV4, Varivax, and HPV and after 115 min she fainted (fell to the floor) became pale and awoke within seconds. Brought to an
examining table, apple juice given observed for 20 min, she was well then.
Other Meds: None
Lab Data: N/A
History: No
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286021-1

21.0 F 06-Jul-2007 07-Jul-2007 1 26-Jul-2007 03-Aug-2007 AZ 06-Aug-2007
HEPA GLAXOSMITHKLINE AHAVB139AA 1 Unknown Unknown
BIOLOGICALS
MedDRA PT Cell death, Musculoskeletal pain
Symptom Text: Severe shoulder pain lasting 2 weeks after shot. Doctor believes it may be cell death.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286032-1

16.0 F 19-Jul-2007 Unknown 26-Jul-2007 06-Aug-2007 -- 06-Aug-2007
MNQ SANOFI PASTEUR U2233CA 0 Right arm Unknown
Symptom Text: Patient received first Gardasil vaccination at 430 PM 7/19/07. Five minutes after injection experienced syncope and again experienced syncopy 10 minutes
after vaccination.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286033-1

16.0 F 17-Jul-2007 18-Jul-2007 1 26-Jul-2007 06-Aug-2007 WA 06-Aug-2007
HEPA MERCK & CO. INC. O0014 0 Right arm Unknown
MedDRA PT Headache, Nausea, Pain in extremity, Photophobia
Symptom Text: Sore arm then severe headache with nausea and light sensitivity. Pain medication PRN headache.
Other Meds: None
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286057-1


MedDRA PT Rash generalised, Urticaria
Symptom Text: Pt states on 7/25/07 she developed hives/rash all over body. On 7/26/07 it worsened all over body. Referred to Primary MD for treatment.
Other Meds:
Lab Data:
History: Mycin Abx, Morphine allergies
Prex Illness:
Prex Vax Illns:

Vaers Id: 286062-1

14.0 F 23-Jul-2007 23-Jul-2007 0 26-Jul-2007 06-Aug-2007 MI 06-Aug-2007
BIOLOGICALS
MNQ SANOFI PASTEUR V2339AA 0 Right arm Intramuscular
MedDRA PT Head injury, Immediate post-injection reaction, Syncope
Symptom Text: Event occurred within 5 minutes of receiving vaccines. Patient was standing next to her mother, tapped her mother's shoulder, and fell backward to the floor.
She was responsive after hitting her head, but does not remember the fall. Patient was observed and had no further difficulty.
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286064-1


Symptom Text: After receiving Gardasil vaccine pt felt dizzy/faint - placed in supine position. B/P and pulse monitored and doctor examined pt. Sent home after B/P ok and pt.
improved
Other Meds:
Lab Data:
History: Hx of fainting from needles
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286082-1

16.0 F 26-Jul-2007 26-Jul-2007 0 26-Jul-2007 02-Aug-2007 KY 02-Aug-2007
HPV UNKNOWN MANUFACTURER UNK 0 Left arm Intramuscular

MedDRA PT Eye rolling, Grunting, Loss of consciousness
Symptom Text: Received a Gardasil shot. Was talking for about 20 secs, said she was going down and she was out. Nurse ran to get ammonia capsule. Eyes rolled back in
her head, arms drew up, making grunting sounds, was out around 45 secs. Took about 20 secs to get her back with the ammonia.
Other Meds: none
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns: syncope~Hep A (no brand name)~1~16~In Patient

Vaers Id: 286091-1

11.0 F 26-Feb-2007 27-Feb-2007 1 27-Jul-2007 06-Aug-2007 CO 06-Aug-2007
VARCEL MERCK & CO. INC. 1308F 1 Right leg Unknown
HPV4 MERCK & CO. INC. 0187U 0 Left leg Unknown
HEPA MERCK & CO. INC. 1280F 0 Left leg Unknown
MedDRA PT Erythema, Swelling
Symptom Text: 2"x2" spot - solid red, swollen, tender right thigh
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286093-1

12.0 F 20-Jun-2007 21-Jun-2007 1 27-Jul-2007 06-Aug-2007 CO 06-Aug-2007
VARCEL MERCK & CO. INC. 0516U 1 Left leg Unknown
TDAP SANOFI PASTEUR C734AA 1 Left leg Unknown
HPV4 MERCK & CO. INC. 0522G 1 Left leg Unknown
MedDRA PT Erythema, Tenderness
Symptom Text: 8.5cmx4.5cm area of erythema - tenderness. Rx Augmentin.

Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286149-1


MedDRA PT Dizziness, Fall, Syncope
Symptom Text: Patient had syncopal episode approx 5-7 mins after vaccination. Fell down bed face forward, no head injury. pt was awake and aware within <1 min and stated
that she felt dizzy
Other Meds: None
Lab Data: O2 given, stable vital signs, BPs 100/57 & 108/52, declined BS
History: Patient did not have any meals and no proper meals x 3 days
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286151-1

10.0 F 26-Jul-2007 20-Jul-2007 -6 27-Jul-2007 03-Aug-2007 MI 06-Aug-2007

Symptom Text: Seizure like episode 2-3 minutes after immuniz. sister has epilepsy
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286154-1

16.0 F 30-May-2007 30-May-2007 0 27-Jul-2007 03-Aug-2007 IN 06-Aug-2007

MedDRA PT Haemorrhage
Symptom Text: On 7-25-07 after receiving 2nd Gardasil, patients mom reported that on last Gardasil given on 5-30-07, patient started spotting blood that same evening. Mom
stated patient spotted blood off and on for approx. 1 week. Mom stated patient had never done that prior to Gardasil. No treatment did not see physician.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286173-1

15.0 F 26-Jul-2007 26-Jul-2007 0 27-Jul-2007 02-Aug-2007 MO 02-Aug-2007
MedDRA PT Abdominal pain, Anorexia, Body temperature decreased, Chills, Chills, Myalgia, Nausea, Vomiting
Symptom Text: low temperature, chills/rigors, nausea, vomiting, myalgias, severe abdominal pain, anorexia. started within 12 hours of vaccination, much worse by 24 hours.
Seen in E.D. received IV fluids and NSAIDS with improvement.
Other Meds: None
Lab Data: CO2=18, comp. metabolic panel and lipase normal, WBC of 12 with 90% neutrophils, CT abdomen (due to pain) normal
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286174-1


MedDRA PT Abdominal pain, Anorexia, Body temperature decreased, Chills, Chills, Myalgia, Nausea, Vomiting
Symptom Text: low temperature, chills/rigors, nausea, vomiting, myalgias, severe abdominal pain, anorexia. started within 12 hours of vaccination, much worse by 24 hours.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286186-1

25.0 F 06-Jul-2007 06-Jul-2007 0 30-Jul-2007 31-Jul-2007 FR WAES707POL00019 31-Jul-2007

MedDRA PT Bradycardia, Convulsion, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 25 year old female who on 06-JUL-2007 was vaccinated with Gardasil. On 06-JUL-2007 after
administration of whole dose of Gardasil the patient experienced loss of consciousness, bradycardia and convulsion. Lost of consciousness and convulsion
lasted several seconds. Bradycardia lasted about half an hour. Electrocardiogram performed on 06-JUL-2007 showed bradycardia. The reporter marked life
threatening as unknown for lost of consciousness. Therapy with human papillomavirus vaccine was discontinued (the reporter decided not to administer in the
future the second and the third dose of Gardasil). The patient recovered from loss of consciousness, bradycardia and convulsion. The reporter felt that loss of
consciousness, bradycardia and convulsion were related to therapy with Gardasil. Upon internal review, convulsion was considered to be an other important
medical event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Electrocardiogram 06Jul07 Comment: Bradycardia
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286205-1

16.0 F 25-Jul-2007 25-Jul-2007 0 30-Jul-2007 06-Aug-2007 MA 07-Aug-2007
Symptom Text: Patient felt lightheaded and dizzy approx 15-20 min after injection. Blood also drawn after injections.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286207-1

MedDRA PT Blood pressure decreased, Dizziness, Dizziness, Pallor
Symptom Text: Pt. received HPV shot and felt lightheaded and dizzy. This very thin girl then almost past out. Pt became pale with BP of 63/34 and 57/26. Recovered with BP
97/64 and left.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286214-1

MedDRA PT Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Symptom Text: 3cm area of swelling, erythema, warmth and pain to palpation developed at site of immunization one day after administration
Other Meds: None
Lab Data: None
History: Adverse reaction to rabies immunoglobulin in 6/06 (Rash on face)
Prex Illness: None
Prex Vax Illns: Rash on face~Rabies (no brand name)~UN~14~In Patient

Vaers Id: 286231-1

VARCEL MERCK & CO. INC. 0127U 1 Right arm Intramuscular
TDAP GLAXOSMITHKLINE AC52B013AA 4 Right arm Subcutaneously
BIOLOGICALS
MedDRA PT Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: ROA OF R-ARM, VZA ADMINISTERED 7/25/2007 IN THE AM. BY EVENING PT C/O DISCOMFORT, MOM BROUGHT PT TO HEALTH DEPT 7/27/2007
W/ROA OF R-ARM SLIGHTLY SWOLLEN AND RED TO 50MM.
Other Meds: NONE
Lab Data: NONE
History: N/A
Prex Illness: N/A
Prex Vax Illns: NONE~ ()~NULL~~In Patient

Vaers Id: 286235-1

18.0 F 20-Jul-2007 20-Jul-2007 0 30-Jul-2007 02-Aug-2007 MA 02-Aug-2007
MNQ SANOFI PASTEUR U2222A 0 Right arm Intramuscular
MedDRA PT Cold compress therapy, Dizziness, Haemorrhagic ovarian cyst, Immediate post-injection reaction, Nausea, Ovarian cyst, Pelvic pain
Symptom Text: Patient had c/o nausea and lightheadedness approximately one minute after administration of Gardasil. Pt laid down and applied cold compress to neck and
forehead. Symptoms persisted for approximately 15 minutes and began to improve. Of note, patient also presented back to office on 07-25-07, 5 days after
injection with severe LLQ pain and diagnosed with hemorrhagic ovarian cyst. Patient also received Menactra that day but not until after all s/s had cleared.
Gardasil was given first.
Other Meds: Valtrex, Albuterol MDI
Lab Data:
History: allergy to Ceclor (rash), seasonal allergies, RAD, trigeminal neuralgia in 2003
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286244-1


MedDRA PT Musculoskeletal pain
Symptom Text: Pain left shoulder region 2 hours after vaccine given.
Other Meds:
Lab Data: None
History: No
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286246-1

17.0 F 08-Jun-2007 17-Jul-2007 39 30-Jul-2007 07-Aug-2007 FL 07-Aug-2007

MedDRA PT Abortion spontaneous, Pregnancy test positive
Symptom Text: Pt was give Gardasil shot June 8-Had positive preg. test June 21. U/S 2 months baby heart beating 2nd U/S no heart beat (7/17 d/c to remove deceased baby)
at medical center
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286247-1

TDAP GLAXOSMITHKLINE AC52B0155A 6 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Confusional state, Dizziness, Headache, Malaise, Nausea, Paraesthesia, Rash
Symptom Text: 7/26/07 Within a few hours of receiving vaccine c/o tingling in her feet, awoke 7/27/07 - felt very sick, lightheaded - confused went to work, headaches,
nauseous - took a nap after work and Sat/Sun rash on hands, feet and body.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286249-1

22.0 F 23-Jul-2007 29-Jul-2007 6 30-Jul-2007 07-Aug-2007 NJ 07-Aug-2007

MedDRA PT Convulsion, Gaze palsy, Musculoskeletal stiffness, Unresponsive to stimuli
Symptom Text: Had seizure on 7/29/07 - unresponsive, no loss of tone, stiffening upper arms, eyes deviated to left lasted about 1 min, no post-ictal symptoms. Seizure free
since 1/2001.
Other Meds: Tegretol; Diamox
Lab Data:
History: Hx of Seizure Disorder - controlled
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286250-1

16.0 F 20-Jul-2007 21-Jul-2007 1 30-Jul-2007 07-Aug-2007 MD 07-Aug-2007
VARCEL MERCK & CO. INC. 0776U 1 Left arm Intramuscular
MedDRA PT Headache
Symptom Text: Daily headaches for at least 1 week following administration of vaccines
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286269-1 (S)

17.0 F 17-May-2007 17-May-2007 0 31-Jul-2007 01-Aug-2007 FR WAES0707AUS00221 01-Aug-2007

MedDRA PT Flushing, Headache, Paraesthesia
Symptom Text: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 17 year old female
with severe allergies to antibiotics, arthritis, asthma, gastric reflux and delayed emptying who on 17-MAY-2007 was vaccinated with Gardasil (Lot #
655742/0138U, Batch # J0800, Expiry Date 07-AUG-2009). On 17-MAY-2007 after vaccination with Gardasil the patient experienced tingling in fingers and
toes, flushing and headache and was hospitalised and was treated with adrenaline. On 17-MAY-2007, the patient recovered from tingling in fingers and toes,
flushing and headache. The agency considered that tingling in fingers and toes, flushing and headache were possibly related to therapy with Gardasil. The
original reporting source was not provided. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Allergic reaction to antibiotics; Arthritis; Asthma; Gastrooesophageal reflux; Delayed gastric emptying
Prex Vax Illns:

Vaers Id: 286270-1 (S)

24.0 F 05-Jul-2007 05-Jul-2007 0 31-Jul-2007 01-Aug-2007 FR WAES0707AUS00223 01-Aug-2007

MedDRA PT Pruritus, Rash maculo-papular
who on 05-JUL-2007 was vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date, 08-AUG-2009). On 05-JUL-2007 after vaccination
with Gardasil the patient developed pruritus over trunk and arms and rash maculo-papular over trunk and arms. On 11-JUL-2007, the patient recovered from
pruritus over trunk and arms and rash maculo-papular over trunk and arms. The agency considered that pruritus over trunk and arms and rash maculo-papular
over trunk and arms were related to therapy with Gardasil. The original reporting source was not provided. Pruritus over trunk and arms and rash maculo-
papular over trunk and arms were considered to be disabling by the agency. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286271-1

Unknown F 23-May-2007 23-May-2007 0 31-Jul-2007 01-Aug-2007 FR WAES0707AUS00224 01-Aug-2007

MedDRA PT Deafness, Dizziness, Nausea, Vision blurred
Symptom Text: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail form. The patient was a female who on
23-MAY-2007 was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0799, Expiry date, 07-AUG-2009). On 23-MAY-2007 the patient experienced
nausea, dizziness, blurred vision and loss of hearing post vaccination. The agency considered that nausea, dizziness, deafness and blurred vision were
possibly related to therapy with Gardasil. The original reporting source was not provided. Upon internal review, deafness was considered to be an other
important medical event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286272-1 (S)

17.0 F 08-May-2007 08-May-2007 0 31-Jul-2007 01-Aug-2007 FR WAES0707AUS00226 01-Aug-2007

MedDRA PT Fatigue, Feeling hot and cold, Headache, Nausea, Unresponsive to stimuli
who on 08-MAY-2007 was vaccinated with Gardasil (Lot # 655742/0138U, Batch # J0798, Expiry Date 07-AUG-2009). Concomitant therapy included amoxicillin
(AMOXIL). On 08-MAY-2007 one minute post vaccination, the patient felt drained, felt hot and cold and experienced headache, nausea and was unresponsive
to stimuli. At the time of reporting to the agency on 11-MAY-2007, the patient's felt drained, feeling hot and cold, headache, nausea and unresponsive to stimuli
persisted. The agency considered that felt drained, feeling hot and cold, headache, nausea and unresponsive to stimuli were possibly related to therapy with
Gardasil. The original reporting source was not provided. Felt drained 1 minute post vaccination, feeling hot and cold, headache, nausea and unresponsive to
stimuli were considered to be disabling by the agency. Additional information is not expected.
Other Meds: amoxicillin 04May07 - 10May07
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286273-1

17.0 F 29-May-2007 15-Jun-2007 17 31-Jul-2007 01-Aug-2007 -- WAES0707USA02094 01-Aug-2007

MedDRA PT Abortion, Drug exposure during pregnancy, Foetal heart rate abnormal, Papilloma viral infection
Symptom Text: Initial and follow-up information has been received via the Merck pregnancy registry, from a nurse practitioner (NP) and a mother concerning her daughter, a 17
year old female, who on 29-MAY-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #0211U). On approximately 15-JUN-2007 ("2 1/2 weeks
later"), the patient became pregnant. An ultrasound test (date not reported), confirmed the pregnancy duration as 6 weeks and 4 days, and provided an
estimated date of delivery of 01-MAR-2008. On 19-JUL-2007 the patient went for an ultrasound that reported the baby's heart beat had stopped. On an
unspecified date the patient tested for positive for human papilloma virus. Upon internal review, abortion was considered to be other important medical event.
Conflicting information has been received from the patients mother. In was reported that the patient was vaccinated with the first dose of Gardasil on 18-JUN-
2007 and the patient was two and a half months pregnant at the time of the vaccination. Additional information has been requested.
Other Meds: Unknown
Lab Data: ultrasound 06/15?/07 - 6 weeks 4 days pregnant, diagnostic laboratory - + HPV, ultrasound 07/19/07 - heart beat had stopped
History:
Prex Vax Illns:

Vaers Id: 286274-1 (S)

16.0 F 20-Jul-2007 20-Jul-2007 0 31-Jul-2007 01-Aug-2007 IL WAES0707USA03652 01-Aug-2007
MNQ SANOFI PASTEUR NULL Left arm Intramuscular
MedDRA PT Bradycardia, Cold sweat, Loss of consciousness, Nausea, Pallor, Syncope
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female with asthma and drug hypersensitivity to erythromycin ethylsuccinate
(+) sulfisoxazole acetyl (PEDIAZOLE) who on 20-JUL-2007 was vaccinated intramuscularly, into the right deltoid with a first dose of Gardasil (lot
#657868/0523U) concomitantly with a dose of Menactra into the left deltoid. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and albuterol. On
20-JUL-2007, within minutes of the vaccinations, the patient experienced bradycardia and fainting. Her total heartbeat count was 52-57, blood pressure
measurement was 98/53 and her pulse oximetry was 99-100 percent. She was unconscious for 3 to 5 minutes and was clammy and pale. She was "better"
within 10 minutes. The patient was observes for 30-40 minutes. When she stool up she became nauseated, pale and fainted again. She regained
consciousness within 5 minutes. It was reported that she did not eat breakfast and used albuterol before arriving at the appointment. The patient was given
crackers and dextrose (+) electrolytes (unspecified) (PEDIALYTE) to drink. Her glucose was 134 and hemoglobin was 14.0. She was sent to the hospital for an
electrocardiogram showed normal sinus rhythm and a normal echocardiography. Subsequently, the patient recovered.
Other Meds: albuterol, ZYRTEC
Lab Data: blood pressure 07/20/07 98/53, pulse oximetry 07/20/07 99-perc, echocardiography 07/20?/07 - normal, electrocardiogram 07/20?/07 - normal sinus rhythm,
total heartbeat count 07/20/07 - 52-57, serum glucose 07/20/07 134, hemoglobin 07/20/07
History:
Prex Illness: Asthma; Drug hypersensitivity
Prex Vax Illns:

Vaers Id: 286275-1 (S)

20.0 F Unknown Unknown 31-Jul-2007 01-Aug-2007 LA WAES0707USA03793 01-Aug-2007

MedDRA PT Injection site pain, Muscle spasms, Pain, Pain
Symptom Text: Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergies rash only, who, on an unspecified date,
was vaccinated in the right arm with a dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Both parents of the patient
reported that she was vaccinated very high up in the deltoid area, almost right at the joint at the top of the arm, almost posterior. The father who is an
anesthetist nurse is concerned that this may have been an intraarticular injection. Subsequently, three weeks after the vaccination the patient has experienced
increased pain at the injection site, throbbing pain down the arm, and her fingers of the right hand cramp. She is being treated with Motrin over the counter
600mg three times daily. The patient was seen at the doctor's office who states that it may be tissue necrosis, but is unsure. The patient was also seen by the
orthopedic office and an A-P Plane X Ray was performed, nothing conclusive. The patient is scheduled for an MRI. The reporter indicated, the patient
experienced significant disability or incapacity. At the time of the report, the patient had not recovered. Additional information has been requested.
Lab Data: X-ray - nothing conclusive
History: Sulfonamide allergy; Rash
Prex Illness:
Prex Vax Illns:


18.0 F 13-Jul-2007 14-Jul-2007 1 31-Jul-2007 01-Aug-2007 MO WAES0707USA04022 01-Aug-2007
MedDRA PT Grand mal convulsion, Headache
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose of Gardasil (lot#
unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (duration and dose not reported) and Menactra. Other concomitant
therapy included cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D). On 14-JUL-2007 at 11:30 PM the patient experienced a generalized
tonic-clonic seizure at which time she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed
axial tomography (CT) test and drug test which were negative. An electroencephalography (EEG) test was also performed which showed minimal
abnormalities. There was no family history of seizures and the patient herself had never had a seizure. The patient also had a headache that rated 7 out of 10 .
The patient was treated with lorazepam (ATIVAN), which they believe aborted another possible seizure. It was also reported that the patient was on vacation
one week before vaccination on a cruise in the Caribbean. At the time of reporting the patient was recovering. Upon internal review generalized clonic-tonic
seizure is considered to be an other important medical event. Additional information has been requested.
Other Meds: ZYRTEC-D
Lab Data: magnetic resonance 07/14/07 - negative, computed axial 07/14/2007 - negative, electroencephalography 07/14/07 - minimal abnormalities, blood drug screen
07/14/07 - negative
History: None
Prex Illness:
Prex Vax Illns:


18.0 F 13-Jul-2007 14-Jul-2007 1 13-Aug-2007 14-Aug-2007 -- 200702729 22-Aug-2007
MedDRA PT Computerised tomogram normal, Electroencephalogram abnormal, Grand mal convulsion, Headache, Nuclear magnetic resonance imaging normal
Symptom Text: This case was reported by another manufacturer on 06 August 2007 under the reference number WAES 0707USA04022. The following narrative is verbatim
from the report: "Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose
of Gardasil (lot # unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (MSD) (duration and dose not reported) and
Menactra. Other concomitant therapy included Zyrtec-D. On 14-JUL-2007 at 11:30 PM the patient experienced a generalized tonic-clonic seizure at which time
she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed axial tomography (CT) test and drug
test which were negative. An electroencephalography (EEG) test was also performed which showed minimal abnormalities. There was no family history of
seizures and the patient was treated with Ativan, which they believe aborted another possible seizure. It was also reported that the patient was on vacation one
week before vaccination on a cruise. At the time of reporting the patient was recovering. Upon internal review generalized tonic-clonic seizure is considered to
be an other important medical event. Additional information has been requested."
Other Meds: ZYRTEC-D
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286295-1

19.0 F 12-Jul-2007 Unknown 31-Jul-2007 07-Aug-2007 NY 08-Aug-2007

MedDRA PT Chills, Headache, Pyrexia
Symptom Text: Fever 102, chills, HA's

Other Meds: Oral Contra
Lab Data: N/A
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286297-1

12.0 F 21-Jul-2007 21-Jul-2007 0 31-Jul-2007 07-Aug-2007 CO 08-Aug-2007
VARCEL MERCK & CO. INC. 0600U 1 Left arm Unknown TDAP
MedDRA PT Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Symptom Text: Varivax site - red, swollen - 6"x8" area, tender to touch, hard, blistery, itchy. Resolved about 6 days. Zyrtec given.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286318-1

19.5 F 24-Jul-2007 24-Jul-2007 0 31-Jul-2007 07-Aug-2007 DE 08-Aug-2007

MedDRA PT Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Pain in extremity, Paraesthesia
Symptom Text: Pt called office on 7/25/07 c/o pain between shoulder blades, neck, pain shooting down both legs and arms, tingling in fingers and toes.
Other Meds:
Lab Data: E.R. Dr. felt related to back strain. Pt released.
History: N/A
Prex Illness: N/A
Prex Vax Illns:

Vaers Id: 286369-1

17.0 F 30-May-2007 30-May-2007 0 31-Jul-2007 07-Aug-2007 TN 07-Aug-2007

MedDRA PT Convulsion, Diarrhoea, Hypotension, Vomiting
Symptom Text: Vomiting, diarrhea, low blood pressure. Someone "said this was a seizure" family did not take her to ER.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286373-1

20.0 F 26-Jun-2007 26-Jun-2007 0 30-Jul-2007 02-Aug-2007 MA 02-Aug-2007
BIOLOGICALS
Symptom Text: pt with c/o lightheadedness/dizziness approximately one minute after injection of Gardasil #1. Pt laid down and stated symptoms resolved after about 10
minutes. Pt also recieved TDAP that day. TDAP given first, then Gardasil. Symptoms occurred after Gardasil given.
Other Meds: orthotricyclen lo
Lab Data:
History: NKDA, hx cholinergic urticaria, hx fainting with trauma,pain,fear,etc, exercise-induced anaphylaxis, heart murmur
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286374-1

21.0 F 09-Mar-2007 19-Mar-2007 10 30-Jul-2007 02-Aug-2007 MA 02-Aug-2007

MedDRA PT Headache, Hot flush, Tremor
Symptom Text: Patient received Gardasil #1 on 3-09-07. No c/o at time of injection. patient called office on 3-19-07 with c/o feeling shaky, hot flashes,and headache. No other
s/s of illness, s/s resolved that day.
Other Meds: Zoloft 75mg
Lab Data:
History: Allergy to Ceclor and PCN resulting in hives. Anaphylaxis to potatos at age 5yrs. Hx anxiety and depression.
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286377-1

16.0 F 14-Jun-2007 14-Jun-2007 0 30-Jul-2007 02-Aug-2007 MA 02-Aug-2007
MedDRA PT Cold sweat, Dizziness, Loss of consciousness, No reaction on previous exposure to drug, Pallor, Pulse pressure decreased, Skin discolouration, Unresponsive
to stimuli
Symptom Text: Pt received first two Gardasil without incident. Gardasil #3 given 6-14-07. Following administration pt lost consciousness and was assisted to laying position on
exam table by nurse. Pt was non-responsive, clammy, and had weak thready pulse. LOC resolved after 35-45 seconds. Pt had persisting dizziness and
discoloration. Pt was unable to come to standing position after approximately 45 minutes lying. Pt was transported to ER via stretcher (we're located in the
hospital) due to persisting dizziness and circumoral pallor. Was given Zofran IV in ER and released home.
Other Meds: Advair Diskus, Singulair
Lab Data:
History: asthma, hx near-syncope, allergy to PCN which resulted in hives
Prex Illness: had headache and intermittent dizziness for two days prior. S/s were resolved with Motrin. c/o slight non-productive cough days
Prex Vax Illns:

Vaers Id: 286379-1

Unknown U 29-Jul-2007 29-Jul-2007 0 30-Jul-2007 02-Aug-2007 NY 02-Aug-2007

MedDRA PT Asthenia, Dizziness, Dizziness, Dyspnoea, Hyperhidrosis, Nausea, No reaction on previous exposure to drug, Paralysis, Syncope, Thirst
Symptom Text: I fainted right after receiving the second dose of the vacine. Started sweating, couldnt breathe, my arms and legs were temporarily paralyzed. I became
instantly thirsty and was terribly dizzy and nautios. It was the most terrifyng experience of my life. It happened this morning and I have been feeling
lightheaded all day, extremely thirsty and weak. I deeply regret taking the advice of my doctor to get it. The vacine should be withdrawn and absotelutely not
administered to anyone!
Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286384-1

18.0 F 27-Jul-2007 27-Jul-2007 0 31-Jul-2007 02-Aug-2007 MN 02-Aug-2007

MedDRA PT Dysgeusia, Dysphagia, Dyspnoea, Headache, Similar reaction on previous exposure to drug, Vaccine positive rechallenge
Symptom Text: When the first shot was given to my daughter on 11/22/06, she started feeling short of breath, had a hard time swallowing & had an iron taste in her mouth.
They Doctor was notified & they monitored her for 30 minutes to see if the symptoms would worsen. The symptoms slowly went away & they noted the reaction
in her chart. When she had the 2nd shot on 2/16/07 she had the same symptoms but not as severe, her biggest complaint was the iron taste in her mouth.
Again she was monitored for 20 minutes until the symptoms went away. She had the last of the shots on 7/27/07 & again had the iron taste in her mouth & the
trouble swallowing but no shortness of breath. She was monitored for 20 minutes until the symptoms went away. Also on all 3 occasions about 10 to 15
minutes after the shot was administered she came down with a headache. The last shot's headache was the worst one, the headache lasted her most of the
rest of that day & was more severe.
Other Meds: Zoloft ..... Trazadon ..... Yaz
Lab Data:
History: depression
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286401-1


Symptom Text: syncope likely w/ carpal spasm approx. 10 minutes following administration, 30 seconds duration; r/o seizure
Other Meds: None known
Lab Data: none ordered
History: none known
Prex Vax Illns: none known~ ()~NULL~~In Patient|none known~ ()~NULL~~In Sibling1|none known~ ()~NULL~~In Sibling2

Vaers Id: 286413-1 (S)

23.0 F 24-Jul-2007 25-Jul-2007 1 01-Aug-2007 02-Aug-2007 FR WAES0707AUS00222 02-Aug-2007

MedDRA PT Erythema, Erythema, Hypersensitivity, Oedema peripheral
Symptom Text: Information was obtained on request by the Company from the agency via a Public Case Detail form and a Case Line Listing concerning a 23 year old female
who on 24-JUL-2007 was vaccinated with Gardasil. On 25-JUL-2007 the patient experienced erythema - fingers to wrist and swollen red and sensitive hands
from the tips of fingers to wrist, bilaterally. At the time of reporting to the agency on 25-JUL2007 the outcome of erythema - fingers to wrist and swollen red and
sensitive hands from the tips of fingers to wrist, bilaterally were unknown. The agency considered that erythema - fingers to wrist and swollen red and sensitive
hands from the tips of fingers to wrist, bilaterally were possibly related to therapy with Gardasil. The original reporting source was not provided. Erythema -
fingers to wrist and swollen red and sensitive hands from the tips of fingers to wrist, bilaterally were3 considered to be disabling by the agency. Additional
information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286414-1 (S)

15.0 F 15-May-2007 17-May-2007 2 01-Aug-2007 02-Aug-2007 FR WAES0707AUS00225 02-Aug-2007

MedDRA PT Bedridden, Muscle spasms, Neck pain
Symptom Text: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail form. The patient was a 15 year old
female who on 15-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included sertraline HCl. On 17-MAY2007 the patient experienced painful
muscle spasm in neck which was diagnosed as "acute wry neck" by a physician. The patient was bedridden for 2 days. On 23-MAY-2007, it was reported to the
agency that the patient still had a sore neck but no where near as severe as before. The agency considered that painful muscle spasm in possibly were related
to therapy with Gardasil. Painful muscle spasm in neck was considered to be disabling by the agency. Additional information is not expected.
Other Meds: sertraline HCl Unk - Unk
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286415-1 (S)


MedDRA PT Flushing, Hypersensitivity, Hypersensitivity, Nausea, Pruritus, Pruritus generalised, Rash, Stomach discomfort, Syncope
Symptom Text: Information was obtained on request by the Company from the agency via a Public Case Detail form and a Case Line Listing concerning a 14 year old female
who on 01-MAY-2007 was vaccinated with Gardasil (Lot # 655742/0138U, Batch # J0798, Expiry Date 07-AUG2009). On 01-MAY-2007 after vaccination with
Gardasil the patient experienced nausea, hypersensitivity, pruritus and rash. It was described by the agency that the patient felt sick in the stomach and itchy
all over her body. Her face was flushed and she developed a rash over parts of her body and she felt faint when she stood up. The patient was treated with
phenergan and was taken to the hospital for observation. Physicians assessed it as an allergic reaction to the vaccine. At the time of reporting to the agency on
01-JUN-2007 the outcome of nausea, hypersensitivity, pruritus and rash were unknown. The agency considered that nausea, hypersensitivity, pruritus and rash
were related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286416-1

17.0 F 30-May-2007 31-May-2007 1 01-Aug-2007 02-Aug-2007 FR WAES0707USA03667 02-Aug-2007

MedDRA PT Headache, Lymph node pain, Lymphadenopathy, Malaise, Pyrexia
Symptom Text: Information has been received from a health professional and the Health Authority concerning a 17 year old female who on 30-MAY-2007 was vaccinated with
a first dose of Gardasil (lot # 655376/0572F; batch # NE47600) IM in the left arm. The next day, patient was feeling unwell with headache and fever sensation.
These symptoms lasted for 3 days. On 04-JUN-2007, the patient developed enlarged lymph nodes and lymph nodes tenderness. No infection was suspected.
At the time of the report, on 13-JUL-2007, the lymph nodes were still enlarged, but no tenderness. On an unspecified date the patient recovered from feeling
unwell. Case is closed. The reporter felt that the events were serious (other important medical events). No further information is expected. Other business
partners included are: E2007-04614.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 286417-1 (S)

15.0 F 11-Jul-2007 11-Jul-2007 0 01-Aug-2007 02-Aug-2007 FR WAES0707USA03810 02-Aug-2007
HPV4 MERCK & CO. INC. NF22900 Unknown Unknown

MedDRA PT Dyspnoea, Headache, Laboratory test, Nausea, Neck pain
Symptom Text: Initial and follow up information has been received from a health professional concerning a 15 year old female patient who on 11-JUL-2007 was vaccinated with
a dose of Gardasil. On the same day (11-JUL-2007) about four hours after vaccination she presented with cervicalgia, headache, marked nausea and dyspnea.
She was taken to the Emergency Room (E.R.) where she underwent neurological and eye evaluation. Routine lab work was performed and resulted within
range. She was not admitted to the hospital The symptoms resolved after 8 hours. In follow-up report on 19-JUL-2007, the case was entered as serious (no
explanation) into the National Pharmaco Vigilance (NPV) Network. On 20-JUL-07 a phone call was received from the Local Health Unit explaining they agreed
with the agency to upgrade the case to serious because of ER visit (considered like an admission). The patient was not admitted to the hospital. The reporting
physician did not consider this case as serious. The case was closed. Additional information is not expected.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 286418-1 (S)

16.0 F Unknown Unknown 01-Aug-2007 02-Aug-2007 FR WAES0705AUS00121 02-Aug-2007

MedDRA PT Asthma, Dyspnoea, Dyspnoea, Malaise, Malaise, Rash, Rash macular, Rash pruritic, Urticaria, Wheezing
Symptom Text: Information has been received from a health professional via an other company as part of a business agreement with follow-up from the physician concerning a
16 year old female with a history of asthma precipitated by exercise who was vaccinated with Gardasil. Concomitant therapy included ERICANYL and
SERETIDE. Subsequently after vaccination with Gardasil, the patient experienced severe asthma attack and rash (also reported as wheeze, shortness of
breath and urticaria in follow-up information). It was described that 5 hours after vaccination the patient became unwell and over 6 - 10 hours after vaccination
developed an itchy, blotchy rash (also reported as urticaria in follow-up information), with shortness of breath and wheeze. The patient was taken to the
accident and emergency department where she was treated with adrenaline and steroids. The patient returned home but had another asthma attack (also
reported in follow-up as recurrence of itch and wheeze) 2 days later. The physician felt that asthma attack and urticaria were related to therapy with Gardasil.
Asthma attack and urticaria were considered to other important medical events by the reporting physician. Information was obtained on request by the
Company from the agency via a Case Line Listing and Public Case Detail form. The patient was vaccinated with Gardasil, intramuscularly, for prophylactic
inoculation and vaccination. The agency considered that asthma, dyspnoea, malaise, urticaria and wheezing were immediately life-threatening and possibly
related to therapy with Gardasil. At the time of reporting to the agency on 03-JUL-2007, the patient had recovered from asthma, dyspnoea, malaise, urticaria
and wheezing. The original reporting source was not provided. Additional information is not expected.
Other Meds: fluticasone propionate (+) salmeterol xi Unk - Unk, terbutaline sulfate Unk - Unk
Lab Data: Unknown
History: Asthma exercise induced
Prex Illness:
Prex Vax Illns:

Vaers Id: 286419-1 (S)

17.0 F Unknown Unknown 01-Aug-2007 02-Aug-2007 NJ WAES0707USA03569 02-Aug-2007

MedDRA PT Abnormal behaviour, Psychotic disorder
Symptom Text: Information has been received from a physician concerning a 17 year old female who was vaccinated with a first dose of Gardasil dose and date not reported.
Subsequently the patient experienced strange behavior and was diagnosed with a "psychotic outbreak" and was hospitalized in the "psychiatric ward". An
unspecified therapy was initiated. The physician reported the patient was at camp prior to the administration of Gardasil and was unsure if the event was due to
something she may have experienced at camp. At the time of the report the patient was recovering. The reporting physician considered the "psychotic
outbreak" to be a disabling event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286420-1

12.0 F 06-Jun-2007 06-Jun-2007 0 01-Aug-2007 02-Aug-2007 -- WAES0707USA04417 29-Aug-2007
MedDRA PT Convulsion, Eye rolling, Inappropriate schedule of drug administration, Muscle rigidity
Symptom Text: Information has been received from a consumer concerning her 12 year old daughter with no drug allergies and no medical history, who on 06-JUN-2007 was
vaccinated with a first dose of Gardasil. Concomitant suspect therapy on 06-JUN-2007 included "a hepatitis shot" (manufacturer unknown). Concomitant
therapy on 06-JUN-2007 included "a tetanus shot" (manufacturer unknown). Subsequently, the patient began to have convulsions. Her body became rigid and
her eyes "rolled backward." The entire episode lasted approximately thirty seconds. No laboratory diagnostics were performed. The patient recovered on an
unspecified date "and is fine." No product quality complaint was involved. Additional information is not available.
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 286438-1

20.0 F 31-Jul-2007 31-Jul-2007 0 01-Aug-2007 03-Aug-2007 WA 03-Aug-2007

Symptom Text: Pt called back to clinic reporting Nausea, Dizziness, and "my head doesn't feel right" within 60 minutes of vaccination.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286442-1

13.0 F 31-Jul-2007 01-Aug-2007 1 01-Aug-2007 03-Aug-2007 VT 03-Aug-2007

MedDRA PT Erythema, Eye swelling, Rash pruritic
Symptom Text: Patient awoke day after receiving HPV with eyes swollen shut, red itchy periorbital rash. Seen early afternoon approximately 24 hrs after injection. Eyes open,
rash represent with residual swelling. Rx: Applications of cold, benedryl or claritin, motrin for inflammation. Photo taken of pt.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286452-1

18.0 F 23-Jul-2007 23-Jul-2007 0 01-Aug-2007 08-Aug-2007 GA 08-Aug-2007

Symptom Text: Pt felt dizzy and light headed about 5 minutes after vaccine - BP/HR WNL - no LOC - No syncope. Pt rested about 10 minutes and then left with mother in
stable condition.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286456-1

13.0 F 31-Jul-2007 31-Jul-2007 0 01-Aug-2007 08-Aug-2007 NM 08-Aug-2007
Symptom Text: Light-headed and dizzy about 30 minutes after immunizations. No treatment needed. Patient felt better the next day.
Other Meds: None
Lab Data: None
History: Scoliosis
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286459-1

26.0 F 30-Jul-2007 30-Jul-2007 0 01-Aug-2007 08-Aug-2007 NY 08-Aug-2007

MedDRA PT Dizziness, Dizziness, Dyspnoea, Fear, Nausea, Paraesthesia
Symptom Text: Lightheaded nausea dizzy, tingling face down arms and legs. Approx time till pt could safely sit up 25 minutes. HR 60-80, - SOB, pt scared, + diff breathing
Other Meds:
Lab Data: None
History: NKDA
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286460-1

15.0 F Unknown Unknown 01-Aug-2007 08-Aug-2007 NY 08-Aug-2007
MedDRA PT Urticaria
Symptom Text: Hives after expose to cold plasting 24 hours after vaccine given.
Other Meds:
Lab Data:
History: None, ? environmental
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286464-1

Unknown F 31-Jul-2007 31-Jul-2007 0 01-Aug-2007 08-Aug-2007 CA 08-Aug-2007

MedDRA PT Pyrexia
Symptom Text: Pt had fever and went to ER night after received 3rd Gardasil injection - fever = 103 F. Given in ER - Acetominophen 1gm, Ibuprofen 600mg.
Other Meds: OCP's - Loestrin
Lab Data: CBC / U/A
History: NKDA - No medical conditions
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286474-1

16.0 F 23-Jul-2007 23-Jul-2007 0 01-Aug-2007 03-Aug-2007 PA 03-Aug-2007
TDAP GLAXOSMITHKLINE AC52B018CA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Immediate post-injection reaction, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Symptom Text: Patient reports that her right arm became sore immediately after HPV injection. It remains sore from shoulder to elbow 10 days later. It hurts to lift arm.
Patient reports it was swollen also.
Other Meds: Alesse birth control pills
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286478-1

17.0 F 31-Jul-2007 31-Jul-2007 0 01-Aug-2007 08-Aug-2007 NJ 08-Aug-2007

MedDRA PT Erythema, Insomnia, Nodule, Pain, Pruritus, Rash, Sensation of heaviness
Symptom Text: Shortly after Gardasil (HPV) vaccine was given in the right shoulder, she developed heaviness in that arm. At work she could only work with her left arm. About
an hour later she started to develop large "bumps" al over her right arm which became itchy and painful. She later bought Benadryl but said she still could
hardly sleep. She was seen in the office the next day. She had large erythematous nodules all over her right arm and forearm only. Not anywhere else. They
were pruritic. She was given an Epinephrine injection subcutaneously immediately and prescribed hydroxyzine orally and triamcinolone 0.1% cream topically.
She was instructed to go to the Emergency room if she developed signs of respiratory difficulty or if any of the symptoms worsened.
Other Meds: None
Lab Data:
History: None
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286481-1

Unknown F Unknown Unknown 02-Aug-2007 03-Aug-2007 MA WAES0707USA04510 16-Aug-2007

MedDRA PT Granuloma, Injection site nodule, Injection site pain
Symptom Text: Information has been received from a pathologist concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.
The patient had received the vaccination and developed a tender nodule at the injection site. Subsequently, the patient died. The nodule was excised and the
pathologist was researching possible granulomatosis with Gardasil. No product quality complaint was involved. Additional information has been requested.
08/03/07 Email to FDA/CDC: Spoke w/the reporter on this case who is quite upset that it has been mistakenly reported as a Death. The reporter is a
pathologist who had received a biopsy of the nodule. She stated she called Merck just to ask a question as to whether granulomas at the injection site had
occurred during clinical trials. She emphatically stated that this patient did not die & she will not provide name/dob or any additional information. Since Merck
reported this case & discusses death in box 7 & in box 8, how would you like to handle this report? Would someone at CDC/FDA want to contact Merck & ask
for clarification on this report? 8/3/07 FDA will contact Merck to discuss case. 8/3/07 Email from Merck to FDA: We spoke to the pathologist who now states
that the patient is alive and well. This followup will be sent via normal procedures on Monday but I wanted to send you this draft copy today. 8/6/07 Email from
FDA to VAERS: Merck has confirmed that the pt is alive. 8/6/07 Status of report changed from death to serious. Case closed as incomplete as no further
information provided. Case will be reopened should additional information become available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286482-1

20.0 F 19-Jul-2007 20-Jul-2007 1 02-Aug-2007 03-Aug-2007 MO WAES0707USA04128 03-Aug-2007

MedDRA PT Dyspnoea, Dyspnoea, Lip swelling, Swelling face
Symptom Text: Information has been received from a medical assistant concerning a 20 year old female with hypothyroidism who on 19-JUL-2007 was vaccinated with a 0.5
ml intramuscularly with a first dose of Gardasil (Lot # 658222/0927U). Concomitant therapy included SYNTHROID. On 20-JUL-2007 the patient developed
swelling to her face and lips, shortness of breath, and difficulty breathing. The patient was treated in the emergency room with BENADRYL and Prednisone.
Subsequently, the patient recovered. The reporting medical assistant considered swelling of the face and lips, shortness of breath, and difficulty breathing to be
another important medical events. Additional information has been requested.
Lab Data: Unknown
History:
Prex Illness: Hypothyroidism
Prex Vax Illns:

Vaers Id: 286485-1 (S)

HPV4 MERCK & CO. INC. NULL Left arm Intramuscular

MedDRA PT Hypoaesthesia, Hyporeflexia, Injected limb mobility decreased, Injection site anaesthesia, Injection site irritation, Injection site reaction, Neuralgia, Paralysis
Symptom Text: Information was obtained on request by the Company from the agency via a Case Line Listing and Public Case Detail Form concerning a 16 year old female
who on 22-May-2007 was vaccinated with Gardasil. Concomitant therapy included LOETTE. On 27-MAY-2007 (also reported as 22-MAY-2007), 5 days after
vaccination with Gardasil, the patient developed numbness and burning on the injection site, left arm. The patient was then unable to move the left arm and leg
and developed numbness and was hospitalized. The patient underwent nerve conduction study as well as a brain MRI, both of which revealed a normal result.
The patient was treated with carbamazepine and amitriptyline for neuropathic pain. The patient was also given methylprednisolone and underwent
physiotherapy. At the time of reporting to the agency on 22-JUN-2007, the patient had recovered from the paralysis of the left leg but the patient's hyporeflexia,
injection site reaction and paralysis of left arm persisted. The agency considered that hyporeflexia, injection site reaction and paralysis were certainly related to
therapy with Gardasil. The original reporting source was not provided. Additional information is not expected.
Other Meds: ethinyl estradiol (+) levonorgestrel
Lab Data: Nerve conduction study 05Jun07 Comment: normal; Magnetic resonance imaging 05Jun07 Comment: normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286486-1 (S)

25.0 F 24-May-2007 25-May-2007 1 02-Aug-2007 03-Aug-2007 NJ WAES0707USA03736 15-Aug-2007

MedDRA PT Cardiac failure, Chest pain, Dyspnoea, Hypotension, Intensive care, Palpitations, Pulmonary embolism, Shock
Symptom Text: Information has been received from a 25 year old female with a penicillin allergy with a history of appendicitis (age five) and shingles (2005) who on 24-MAY-
2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included LO/OVRAL. On 25-MAY2007 the patient experienced shortness of breath and
was hospitalized. The patient spent four days in the intensive care unit out of the nine days she was hospitalized. On 29-MAY-2007 the patient was diagnosed
with a pulmonary embolism and was placed on COUMADIN. It was reported that the patient also developed heart failure "because of the pulmonary embolism".
Laboratory data revealed all proteins low. The genetic tests yielded positive results for 2 genetic traits (specific names of the traits are unknown). At the time of
report the patient was recovering. No further information is available. 8/15/07-records received DC Summary for DOS 7/23-7/24/07- DC DX: Chest pain not
otherwise specified. Palpitations. Hypercoagulable state. Recent pulmonary embolus.VQ Scan low probability for pulmonary embolus. Pain was similar to
previous event. Massive pulmonary embolus requiring use of TPA about two months prior. Now on chronic coumadin therapy. DC Summary for DOS 5/29-
6/9/07-DC DX Pulmonary embolism with shock, hypotension, syncope and history of oral contraceptive use.
Other Meds: Lo/Ovral
Lab Data: Deoxyribonucleic acid 05/25/07 - tested positive for 2 genetic traits. Specific name unknown; Total serum protein 05/25/2007 - low 8/15/07-records received-
EKG sinus tachycardia, bilatrial abnormality and an S1, Q3, T3 pattern, non specif
History: Appendicitis; Shingles
Prex Vax Illns:

Vaers Id: 286487-1

Unknown F Unknown Unknown 02-Aug-2007 03-Aug-2007 -- WAES0707USA02980 03-Aug-2007

MedDRA PT Guillain-Barre syndrome, Paraesthesia
Symptom Text: Information has been received from a physician "who heard from a colleague" that a female (age unknown), who was vaccinated with a dose of Gardasil.
Subsequently, a few days after receiving the vaccination the patient experienced a tingling in her leg and she had Guillian Barre Syndrome. The patient may
have had other vaccines that day (unsure of which vaccines). At the time of the report, the patient's outcome was unknown. No product quality complaint was
involved. Upon internal review Guillian Barre Syndrome was considered an important medical event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:


14.0 F 20-Jul-2007 20-Jul-2007 0 02-Aug-2007 03-Aug-2007 NJ WAES0707USA03973 03-Aug-2007
MedDRA PT Aggression, Amnesia, Delirium, Headache, Intensive care, Loss of consciousness, Syncope
Symptom Text: Information has been received from a physician concerning a 14 year old female with no pertinent past medical history who on 20-JUL-2007 was vaccinated
with 0.5 ml intramuscularly with a first dose of Gardasil (Lot # 658100/0525U). Concomitant therapy included ADACEL. On 20-JUL-2007 within minutes of
receiving the injection the patient fainted onto the floor and was unconscious for a few seconds. The patient was sent to the emergency room. The patient
developed a severe headache and amnesia and was hospitalized in the intensive care unit. The patient became combative and delirious and was given two
unspecified sedatives and IV ZOFRAN. She was discharged from the hospital within a day or two. On 23-JUL-2007 the patient was seen in the physician's
office and was fully recovered. She was referred to a neurologist. The physician considered the patient's fainting, unconsciousness, severe headache,
amnesia, combativeness, and delirium to be life threatening and other important medical events. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:


TDAP SANOFI PASTEUR C2769AA 0 Unknown Intramuscular
MedDRA PT Aggression, Amnesia, Delirium, Dizziness, Headache, Syncope
Symptom Text: Pt felt dizzy immed after vaccine. Then fainted a few minutes later. Recovered w/in 5 sec. layed down flat, complained of severe headache then reported
memory loss. Sent to ED. Noted to become extremely combative & delirious
Other Meds: No
Lab Data: Electrolytes - NL, - Cat scan of head, drug screen -, metabolic screen -
History: NKA; healthy child
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286501-1

15.0 F 27-Jul-2007 27-Jul-2007 0 02-Aug-2007 08-Aug-2007 MI 08-Aug-2007
BIOLOGICALS
MedDRA PT Heart rate increased, Malaise, Pyrexia
Symptom Text: Evening of shot wasn't feeling well. Early AM woke with 102 fever and rapid heart rate 160's. Taken to ER, fluids given, took a few hours to get heart rate down.
Other Meds: Mircette
Lab Data:
History: PCN, Polytrim, Zithromax, Cucumbers
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286504-1

11.0 F 17-Jul-2007 17-Jul-2007 0 02-Aug-2007 08-Aug-2007 AZ 08-Aug-2007
VARCEL MERCK & CO. INC. 07314 1 Unknown Subcutaneously
MedDRA PT Dizziness, Injection site erythema, Injection site induration, Nausea
Symptom Text: Pt. received Varivax #2 (RSQ), HPV #1 (RD) & Tdap #1 (LD) 7/17/07. Developed nausea and dizziness within 24 hours, lasting >48 hr after imm. Also
developed erythema and induration at Varivax site 48 hours after injection (3 1/2 x 4 cm diam.)
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286507-1

16.0 F 25-Jul-2007 26-Jul-2007 1 02-Aug-2007 08-Aug-2007 TX 08-Aug-2007
MedDRA PT Pruritus, Rash, Skin warm
Symptom Text: Rash no redness around the area of vaccine about 2 cm diameter. As per pt felt itchy and warm.
Other Meds: None
Lab Data:
History: None
Prex Illness: Foot Pain/Refractive Error
Prex Vax Illns:

Vaers Id: 286528-1

24.0 F 26-Jul-2007 26-Jul-2007 0 02-Aug-2007 08-Aug-2007 CA 08-Aug-2007

MedDRA PT Pruritus
Symptom Text: 2-3 hrs after given vaccine, pt began itching-chest, abdomen, buttocks, thighs, feet. No dyspnea or swelling at time of examination (4 hrs after vaccinated). No
hives developed no cyanosis. bump clear. Started Benadryl 50 mg po
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286532-1

15.0 F 01-Aug-2007 01-Aug-2007 0 02-Aug-2007 08-Aug-2007 MD 09-Aug-2007
HEPA GLAXOSMITHKLINE AHAVB163AB 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Erythema, Injection site swelling, Pruritus
Symptom Text: Erythema feet and hands with itching. Local swelling at injection site left arm sub Q
Other Meds: Duac, Concentra 54 mg, Focalin 2.5 mg PRN
Lab Data: N/A
History: Sulfa
Prex Illness: Healthy
Prex Vax Illns:

Vaers Id: 286534-1

13.0 F 31-Jul-2007 01-Aug-2007 1 02-Aug-2007 08-Aug-2007 AR 08-Aug-2007
MedDRA PT Urticaria, Urticaria
Symptom Text: Broke out in welts/hives - spread over body.

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286541-1


Symptom Text: Pt passed out - a few seconds

Other Meds:
Lab Data:
History:
Prex Illness: N/A
Prex Vax Illns:

Vaers Id: 286542-1

BIOLOGICALS
MedDRA PT Rash morbilliform, Rash pruritic
Symptom Text: Pt had 4 vaccines administered 7/05/07 on 7/28/07 developed pruritic, morbilliform rash over entire body
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286543-1

18.0 F 02-Aug-2007 02-Aug-2007 0 02-Aug-2007 08-Aug-2007 TX 09-Aug-2007
MedDRA PT Syncope, Yellow skin
Symptom Text: Fainted for about 10 sec., looking yellowish. Gave her alcohol to breathe. Water and juice were provided. *Pt had not eaten anything before vaccinated.
Other Meds: None
Lab Data:
History: Unknown
Prex Vax Illns:

Vaers Id: 286561-1 (S)

19.0 F 14-Sep-2006 15-Sep-2006 1 02-Aug-2007 07-Aug-2007 DE 30-Aug-2007

MedDRA PT Lymphadenopathy, Pain
Symptom Text: Lymphnode in Left side of neck swelled up. Sought care at Health Services, but none could be provided. Painful for a time. Went away after about three
months. Came back with third dose of HPV vaccine. Has not yet gone back to normal completely. It has been three months. 8/15/07-records received from
clinic. Diagnoses for DOS 10/10/06-2/8/07- include pelvic pain with C/O menstrual type cramps. Abdominal pain with C/O abdominal cramping. Enlarged lymph
node left neck. Painful. HX of mono. Neck hurts less but has some nasal congestion. Bilateral rib pain. Lymphadenopathy. Lump in neck first appeared around
10/28/06-Lymphadenitis. Cold few days prior to first vaccine
Other Meds: none
Lab Data: blood tests for various imbalances
History: allergic to ceclor, some adhesives, some sun-tan lotions...no medical conditions
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286564-1 (S)

Seriousness: ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS
MedDRA PT Diabetes mellitus insulin-dependent
Symptom Text: Came to office 1 week after immunizations were given with New onset Type 1 DM with sugar of 977.
Other Meds:
Lab Data: glucose - 977
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286565-1

14.0 F 31-Jul-2007 31-Jul-2007 0 02-Aug-2007 10-Aug-2007 CO 13-Aug-2007
MedDRA PT Crying, Dyskinesia, Dyspnoea, Gaze palsy, Headache, Hypotonia, Joint stiffness, Loss of consciousness, Musculoskeletal stiffness, Paraesthesia, Pyrexia,
Syncope, Syncope vasovagal, Tremor
Symptom Text: Patient received the 2nd Gardasil vaccination at 11:20 a.m. on July 31, 2007. She did not seem anxious, namely because the first shot went fine. But,
approximately four minutes later, she fainted from a standing position, totally went limp, eyes fell back into her head. The nurse gave her ammonia under her
nose and patient came to. We got her to a sitting position and two minutes later, she passed out again for about 10 seconds. The second time she came to,
she was laid out on the floor, very scared and complaining of tingling in her right arm (she received the shot in her left), and had two very stiff hands, claw-like
esp. the right and her jaw was tight, hard for her to talk. Her legs were also tingling and her feet pointed inward, but it was her arms and hands that were worse.
She was breathing heavily and still very scared, crying. We couldn't seem to regulate her breathing, even with a paper sac and decided to call the EMTs,
namely due to the stiff hands that were bent toward her wrists and her very low blood pressure. The EMTs came and talked her through this, calming her down
and regulating her breathing well enough. Her hands were still stiff. The EMTs called it a syncable episode with a vasovagal response. As a mother, I
transported her to the hospital emergency to have a doctor look at her before I took her home 30 mins away. On the way to the hospital, I was holding her hand
which was not as tight, but the muscles were consistently jerking in her fingers. At the hospital, she seemed better and was released to go home and rest. At
home, she developed a low grade fever, under 100. She was quiet and subdued the rest of the day with a slight headache. The next day, she was fine but I
could still feel minor tremors in her hands when I held them. I am seriously debating whether or not she should have the third gardasil shot.
Other Meds: None
Lab Data: Syncable episode, vasovagal response.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286571-1

14.0 F 02-Jul-2007 02-Jul-2007 0 02-Aug-2007 08-Aug-2007 FL 08-Aug-2007
MedDRA PT Convulsion, Dyskinesia, Fall, Head injury, Muscle twitching, Postictal state, Unresponsive to stimuli
Symptom Text: Several minutes after receiving vaccine patient went from standing at checkout desk to falling and hitting head on the floor as a several second seizure insued
(head jerking, arm twitching and unresponsiveness). Pt was postictal for several seconds until returning to normal state. Because of possible head injury, pt.
was transferred via ambulance to Emergency Dept.
Other Meds:
Lab Data: Labs and Head CT
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286575-1

VARCEL UNKNOWN MANUFACTURER NULL 1 Left arm Intramuscular
HPV UNKNOWN MANUFACTURER NULL 0 Left arm Intramuscular
DTAP SANOFI PASTEUR AC52B0012AA 5 Right arm Intramuscular
HEPA UNKNOWN MANUFACTURER NULL 0 Left arm Intramuscular
MedDRA PT Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Symptom Text: Shot site very swollen and painfull. Size of a small egg. Surrounding skin (6 - 7 inches in diameter) very red and itchy. Swelling susideded after 48- 72 hours.
Redness remained for 5 days.
Other Meds: none
Lab Data: normal
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286580-1

11.0 F 31-Jul-2007 01-Aug-2007 1 02-Aug-2007 08-Aug-2007 GA 08-Aug-2007
MedDRA PT Erythema, Induration, Skin warm
Symptom Text: pt received vaccines on 7/31/2007 at 2pm. By next am 1/2 dollar sized reddened area was visible. By today 8/2/07, tennis-ball sized reddened area is visible.
Area is firm and hot to touch. Pt feels fine; no fever or other sx.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 286582-1

18.0 F 01-Aug-2007 02-Aug-2007 1 02-Aug-2007 08-Aug-2007 WA 08-Aug-2007
MedDRA PT Erythema, Hypokinesia, Oedema peripheral, Pain
Symptom Text: Awoke morning after vaccinations (one in each deltoid) with symmetrically swollen, red hands. Difficult to move fingers because of swelling, but no joint pain.
No skin changes other than diffuse redness. No itchiness. A few body aches, but no other systemic symptoms. No respiratory distress. Improved over course
of day.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286584-1

13.0 F 31-Jul-2007 31-Jul-2007 0 02-Aug-2007 08-Aug-2007 MA 08-Aug-2007

MedDRA PT Dizziness, Malaise
Symptom Text: Pt presented for HPV #3 on 07-31-07. Approximately 15 seconds after injection pt stated she "did not feel good", complained of dizziness. Pt was assisted to
lying position and symptoms resolved after about two minutes. She had not had any problems with first two shots of series.
Other Meds: Adderol XR 20mg
Lab Data:
History: ADHD, Tourette's, PDD/Asperger's, anxiety
Prex Illness: none, T98.6
Prex Vax Illns:

Vaers Id: 286586-1 (S)

27.0 F 15-Jun-2007 26-Jun-2007 11 02-Aug-2007 07-Aug-2007 MA 07-Aug-2007
HPV4 MERCK & CO. INC. UPON 2 Right arm Intramuscular
REQUEST
Seriousness: ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS
MedDRA PT Anorectal disorder, Demyelination, Hypoaesthesia, Multiple sclerosis, Muscular weakness, Nervous system disorder, Nuclear magnetic resonance imaging
brain abnormal
Symptom Text: Onset of what was later diagnosed as Multiple Sclerosis or another demylinating disorder. Began with numbness and muscle weakness on lower left side of
body, including left buttock, leg, and foot. Onset was 06/26/2007. Rectum, tailbone area, and toes of right foot also went numb within 10 days after initial
symptoms. Patient presented in mid-July with *no rectal tone* and was unable to defecate normally for nearly 2 weeks. Following an MRI of the brain (on
07/20/2007), which showed several lesions, was formally diagnosed with Multiple Sclerosis "or another demylinating disorder."
Other Meds: Clonazepam (1mg 2x daily)
Lab Data: MRI of brain and spine, lumbar puncture, standard neurological tests.
History: Allergy to Bactrim
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286707-1

17.0 F Unknown Unknown 03-Aug-2007 06-Aug-2007 MI WAES0707USA03886 29-Aug-2007

MedDRA PT Drug exposure during pregnancy, Intra-uterine death
Symptom Text: Information has been received from the Merck Pregnancy Registry via a medical assistant concerning a 17 Year old female with no pertinent past medical
history who on 18-JAN-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot #655619/1427F). On an unspecified date the patient was
vaccinated intramuscularly with the second dose of Gardasil (657005/0188U). There were no concomitant therapies. It was reported by the medical assistant
that the patient did not let the staff know she was pregnant and the first and second doses of Gardasil were administered respectively. The patient's last
menstrual period was 26-SEP-2006. Estimated the patient's pregnancy to be at least 37 weeks gestation. Subsequently the patient's pregnancy ended in a fetal
demise. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Other Meds: None
Lab Data: ultrasound 07/13/07 - 37 weeks gestation; cervical smear - unknown; beta-human chorionic - positive
History:
Prex Vax Illns:

Vaers Id: 286708-1

26.0 F 07-Jun-2007 07-Jun-2007 0 03-Aug-2007 06-Aug-2007 CT WAES0707USA01570 06-Aug-2007

MedDRA PT Abortion missed, Drug exposure during pregnancy, Uterine dilation and curettage
Symptom Text: Initial and follow-up information has been received for the Merck Pregnancy Registry from a nurse and a certified nurse midwife concerning a 26 year old
female who on 12-DEC-2006 was vaccinated with a first dose of Gardasil (Lot # 654389/0961F). On 07-FEB-2007, the patient vaccinated with a second dose of
Gardasil (Lot #653736/0014U). Subsequently the patient became pregnant. The estimated date of conception was 02-JUN-2007. On 07-JUN-2007 the patient
was vaccinated IM with a third dose of Gardasil (Lot #657737/0522U). Concomitant therapy included Percocet. Unspecified medical attention was sought. All
"prenatal labs" were normal. The date of the patient's last menstrual period was 18-MAY-2007. The estimated date of delivery was 22-FEB-2008. On 23-JUL-
2007 the patient underwent an ultrasound for viability which revealed missed abortion. On 24-JUL-2007, the patient underwent a uterine dilation and curettage.
Other medications used during this pregnancy included prenatal vitamins. Upon internal review, the missed abortion was considered to be an other important
Other Meds: PERCOCET
Lab Data: diagnostic laboratory - "prenatal labs": all normal , ultrasound - "MAB"
History:
Prex Vax Illns:

Vaers Id: 286709-1 (S)

Unknown F 09-Jan-2007 16-Jul-2007 188 03-Aug-2007 06-Aug-2007 NJ WAES0707USA03832 06-Aug-2007

MedDRA PT Tachycardia
Symptom Text: Information has been received from a certified medical assistant concerning a female patient with a penicillin allergy who on 09-JAN-2007, was vaccinated with
a dose of Gardasil. On 16-JUL-2007, the patient experienced tachycardia and was hospitalized. On 20-JUL-2007, it was reported that the patient was released
from the hospital. On an unspecified date, the patient recovered. No product quality complaint was involved. The reporter considered tachycardia to be life
threatening and an other important medical event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 286710-1

16.0 F 11-Jul-2007 11-Jul-2007 0 03-Aug-2007 06-Aug-2007 TX WAES0707USA04064 06-Aug-2007

MedDRA PT Convulsion, Fall, Immediate post-injection reaction, Syncope, Tremor
Symptom Text: Information has been received from a certified medical assistant concerning a 16 year old female patient with no history of seizures or fainting in the past and
an allergy to cefixme (SUPRAX) who on 01-MAY-2007, was vaccinated with a first dose of Gardasil (Lot# 658094/0524U). On 11-JUL-2007, the patient was
very afraid to receive the second dose. There was no concomitant medication. It was reported that 30 seconds after the vaccine was given the patient fainted.
The patient was standing and fell to the floor and did not hit her head. She fell to her knees and her upper body went backwards, head did not hit the floor. The
nurse guided the patient to the floor. The patient's entire body shook like she was having a seizure for 5 to 10 seconds. Unspecified medical attention was
sought. It was reported that the patient became conscious and rested. On 11-JUL-2007, the patient recovered. No product quality complaint was involved.
Upon internal review, entire body shaking like she was having a seizure was considered to be an other important medical event. Additional information has
been requested.
Other Meds: None
Lab Data: Unknown
History:
Prex Illness: Allergic reaction to antibiotics; Fear
Prex Vax Illns:

Vaers Id: 286711-1

24.0 F 01-May-2007 01-May-2007 0 03-Aug-2007 06-Aug-2007 SC WAES0707usa04531 06-Aug-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Ectopic pregnancy
Symptom Text: Information has been received from a Registered Nurse, through the Merck pregnancy registry, concerning a 24 year old female patient who in March 2007,
was vaccinated with a first dose of Gardasil and in May 2007 received the second dose of Gardasil. On 25-JUN-2007 Methotrexate was given for treatment of
the ectopic pregnancy. Pregnancy was confirmed 1 week before 25-JUN-2007. No further information was available. Upon internal review, ectopic pregnancy,
spontaneous abortion was determined to be an other Important Medical Event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Serum alpha-human - Quantitative HCG
History:
Prex Vax Illns:

Vaers Id: 286759-1

12.0 F 02-Aug-2007 02-Aug-2007 0 03-Aug-2007 10-Aug-2007 AZ 13-Aug-2007
TDAP GLAXOSMITHKLINE AC52B013AA Left arm Intramuscular
BIOLOGICALS
MedDRA PT Pallor, Tachycardia, Unresponsive to stimuli, Urinary incontinence
Symptom Text: Mother states, `On way home from (shot clinic) daughter started "growling" and did not respond to verbal stimuli- approx. 20-30 seconds in duration. Within 1
minute, daughter was answering all questions appropriately'. She returned to (shot clinic) where daughter was evaluated by a paramedic. She was found to be
pale in color; incontinent to urine; but was awake, alert, and appropriately oriented. Patient was placed supine and local EMS was summoned. Mother denies
any other altered mental state. EMS arrival found patient's condition to be as described above. Patient was tachycardic at 130 bpm with steady pulse. All other
vital signs were within normal parameters. Blood sugar was 100 mg/dL. Pulse on departure of EMS was 108 strong and regular. EMS advised mother to allow
ambulance transportation to local ER. Both ambulance and ER treatment were refused. Mother stated that `she would "keep an eye on her tonight". Mother
also advised to monitor daughter for any unusual color, complaints, or changes in behavior. Phoenix Fire Department Immunization Coordinator subsequently
contacted parents at approximately 2030 that same night. Father stated, "Oh, she's fine. She ate some dinner; had a shower; and is now playing on the
Internet." Father was advised by Coordinator, of the same precautions, as was the mother.
Other Meds: None
Lab Data:
History: Mother Denies
Prex Illness: Mother Denies
Prex Vax Illns:

Vaers Id: 286766-1 (S)

17.0 F 27-Jul-2007 29-Jul-2007 2 04-Aug-2007 08-Aug-2007 WI 08-Aug-2007
HPV4 MERCK & CO. INC. UKNOWN 0 Unknown Unknown

MedDRA PT Lymphadenopathy, Parotid gland enlargement, Skin nodule, Swelling, Swelling face
Symptom Text: Please understand that I have no idea as to whether patient's illness is a result of the vaccine but I feel that I should at least report the experience. Patient was
given the shot at 9 on Friday morning, July 27 in Dr. office. Sunday evening, July 29, she developed a sore pea sized swelling under the skin where her jaw is
attached. She woke us at 3:30 am on Monday with a completely swollen side of her face-- she was given an x-ray and CAT scan and oral antibiotics at the
Hospital emergency room and released with an appointment with a local ENT at mid-day. He placed patient in Hospital for one round of IV antibotics, gave her
a blood test and wanted to see her the following day. The tests came back with a slightly elevated WBC,SEGS, and LYMPH count. After seeing that her face
continued to swell, he referred us to Dr. at Hospital. Patient was hospitalized under his care from Tuesday through Friday on IV antibiotics and had an
additional contrast CAT which revealed no stones, tumors, but did show an enlarged parotid gland and jugular lymph node. The swelling is down to just a bit
puffy now and Patient was released on oral antibiotics. There is no known reason for this situation at this time.
Other Meds: Asthma medication if needed (last used approximately 4 weeks ago)
Lab Data: Contrast and non contrast CAT scan; blood and urine tests
History: Asthma, surgery on ACL May 23
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286780-1

PNC WYETH PHARMACEUTICALS, INC B08675C 0 Right arm Unknown
MedDRA PT Rash
Symptom Text: Rash on face and legs after vaccination on 07/30/07 at 6:00 pm. Symptoms start on 7/30/07 at 11:00 pm Rx=Claritin 10 mg once qd x 10.
Other Meds: Ferrous Sulfate 325 mg qd
Lab Data: Dermatitis r/o vaccine reaction
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286782-1

19.0 F 30-Jul-2007 31-Jul-2007 1 03-Aug-2007 09-Aug-2007 ND 10-Aug-2007
MNQ SANOFI PASTEUR U2155CA 0 Right arm Unknown
MedDRA PT Heart rate increased, Nausea, Pain
Symptom Text: Rapid pulse, body aches, nausea

Other Meds:
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286787-1

HPV4 MERCK & CO. INC. 0930U Left arm Unknown

MedDRA PT Syncope vasovagal
Symptom Text: Vagal response

Other Meds: Proair HFA - (Inhaler), Cymbalta, Ritalin
Lab Data:
History: Asthma, ADD, Depression
Prex Illness: Asthma, ADD, Depression
Prex Vax Illns:

Vaers Id: 286789-1

Unknown F 01-Aug-2007 02-Aug-2007 1 03-Aug-2007 09-Aug-2007 WV 10-Aug-2007
MedDRA PT Cellulitis, Oedema peripheral
Symptom Text: Local swelling with cellulitis to right arm.

Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286841-1 (S)


MedDRA PT Dizziness, Lethargy, Malaise, Nausea
Symptom Text: Information was obtained on request by the Company from the agency via a Public Case Details Form and a Case Line Listing concerning a 16 year old female
who on 17-MAY-2007 was vaccinated with Gardasil. On 17-MAY-2007 after vaccination with Gardasil, the patient experienced dizziness, malaise, lethargy and
acute nausea which persisted more than 12 hours later. At the time of reporting to the agency on 17-MAY-2007, the outcome of dizziness, malaise, lethargy
and acute nausea were unknown. The agency considered that dizziness, malaise, lethargy and acute nausea were possibly related to therapy with Gardasil.
The original reporting source was not provided. Dizziness, malaise, lethargy and acute nausea were considered to be disabling by the agency. Additional
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286842-1

17.0 F 18-Jul-2007 21-Jul-2007 3 06-Aug-2007 07-Aug-2007 CO WAES0707USA04589 07-Aug-2007

MedDRA PT Dehydration, Eye pain, Headache, Nausea, Pyrexia, Sinusitis
Symptom Text: Information has been received from a registered nurse concerning her 17 year old daughter with a sulfonamide therapy, migraines and "2 months of periods"
who on 18-JUL-2007 was vaccinated with a dose of 0.5 ml intramuscularly in the deltoid with Gardasil. Concomitant therapy included ibuprofen, acetaminophen
(TYLENOL) and sumatriptan succinate (IMITREX (sumatriptan succinate). On 21-JUL-2007 the patient developed a headache that hurt behind her eyes and on
22-JUL-2007 the patient developed a fever lasting 3 1/2 days. On approximately 25-JUL-2007 the patient developed nausea and dehydration. On 25-JUL-2007
the patient visited her physician where she was given IV saline for dehydration, ketorolac tromethamine (TORADOL) for the headache, 1 GM IV of ceftriaxone
sodium (ROCEPHIN), promethazine hydrochloride (PHEERGAN) for nausea, and amoxicillin (+) clavulanate potassium (AUGMENTIN). The physician thought
that the patient might also have had a sinus infection. A complete blood count (CBC) and thyroid panel were completed, but the results were not reported. At
the time of the report the patient had not recovered from nausea, dehydration, eye pain, headache, and the sinus infection. The physician considered
headache, fever, sinus infection, nausea, and dehydration to be other important medical events. Additional information has been requested.
Other Meds: TYLENOL, ibuprofen, IMITREX (SUMATRIPTAN)
Lab Data: complete blood cell - Results not reported, thyroid function test - Results not reported
History:
Prex Illness: Migraine; Prolonged periods; Sulfonamide allergy
Prex Vax Illns:

Vaers Id: 286843-1

16.0 F 01-Jan-2007 01-Jan-2007 0 06-Aug-2007 07-Aug-2007 FR WAES0707USA05017 07-Aug-2007

MedDRA PT Condition aggravated, Petit mal epilepsy
Symptom Text: Information has been received from a gynecologist concerning a 16 year old female with absence seizure since early childhood but was symptom free under
therapy, who in 2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included ERGENYL. In 2007, the day after the vaccination, the patient
experienced an episode of an absence seizure (duration not reported). At the time of the report, the outcome of the patient was unknown. The patient's twin
sister, who has the same history and concomitant medication, was vaccinated with Gardasil the same day, but showed no adverse effect. The reporting
gynecologist, absence seizure was considered to be an other important medical event. Additional information is not available. Other business partner numbers
included E2007-04861.
Other Meds: Ergenyl
Lab Data: Unknown
History:
Prex Illness: Absence seizure
Prex Vax Illns:

Vaers Id: 286844-1 (S)

HPV4 MERCK & CO. INC. NF42170 0 Unknown Unknown

MedDRA PT Abdominal pain, Headache, Leukocytosis, Malaise, Pyrexia
Symptom Text: Information has been received from a pediatrician concerning a 15 year old female, with no pertinent medical history reported, who on 25-JUL-2007 was
vaccinated with a dose of Gardasil (batch # NF42170). Later that evening at approximately 10:00 pm,. the patient developed a fever up to 39 C, complained
about a headache, abdominal pain, and feeling sick. On 26-JUL-2007 the lab tests reported white blood count was 29.2 and serum C-reactive protein test was
78. On an unspecified date the patient was admitted to the hospital to rule out meningitis, this suspected diagnosis was not confirmed. The leukocytosis and
elevated serum C-reactive protein were still present. At the time of the report, the symptoms were ongoing. Additional information has been requested. Other
business partner numbers included E2007-04865.
Other Meds: Unknown
Lab Data: Body temp 25Jul07 39 C; WBC count 26Jul07 29.2; Serum C-reactive protein 26Jul07 78 mg/dl
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 286851-1

16.0 F 31-Jul-2007 31-Jul-2007 0 06-Aug-2007 09-Aug-2007 MN 15-Aug-2007
MedDRA PT Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Symptom Text: Itchy and redness about 2 inches below injection site started 1 hour after injections were given. Redness continued to worsen as time went by, swelling, warm
to touch.
Other Meds: Loestrin qd; Albuterol PRN
Lab Data: No testing done.
History: Asthma
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286855-1

17.0 F 15-Mar-2007 29-Mar-2007 14 06-Aug-2007 09-Aug-2007 DE 10-Aug-2007

Symptom Text: Patients mother reported to doctor that pt developed shingles (2 weeks)after Gardasil injection
Other Meds: Is taking HCTZ, Allegra, Concerta, Maxalt, Lexapro, Albuterol, Singulair, Flonase, Zantac
Lab Data: Unknown
History: Allergy: Mirooxydone, Keflex; Pt has ADD, IBS, GERD, nephrolithiasis, Migraine, William's syndrome
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286857-1

14.0 F 07-Jun-2007 12-Jun-2007 5 06-Aug-2007 09-Aug-2007 AZ 10-Aug-2007

MedDRA PT Hypoaesthesia, Hypoaesthesia, Neuralgia, Paraesthesia
Symptom Text: Left UE neuralgia: pain, tingling, numbness fingers to arm. Pain to active motion. Referred to ped. neurology
Other Meds: None
Lab Data:
History: Myopia
Prex Illness: None
Prex Vax Illns:


BIOLOGICALS
MedDRA PT Asthenia, Blood pressure increased, Hyperhidrosis, Nausea, Pallor, Vomiting
Symptom Text: After Gardasil vaccination client became pale, c/o weakness, diaproic, N/V. BP 120/60. Symptoms abated - BP 102/58. Client was to have Tdap, Gardasil -
MCV4 held.
Other Meds:
Lab Data: None
History: Biaxin and Almonds
Prex Illness: None
Prex Vax Illns:


15.0 F 01-Aug-2007 01-Aug-2007 0 13-Aug-2007 23-Aug-2007 AZ AZ0713 28-Aug-2007
BIOLOGICALS
MedDRA PT Asthenia, Hyperhidrosis, Pallor
Symptom Text: After Gardasil vaccination client became pale, c/o weakness, diaphoretic, N/VBP 120/60, symptoms abated BP 102/58
Other Meds:
Lab Data: none
History: Biaxin, Almonds
Prex Illness:
Prex Vax Illns:

Vaers Id: 286867-1

13.0 F 01-Aug-2007 01-Aug-2007 0 06-Aug-2007 10-Aug-2007 WI 10-Aug-2007
HPV4 MERCK & CO. INC. 1426F 0 Left arm Intramuscular MNQ
HEP GLAXOSMITHKLINE AHVBV263CA 1 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Depressed level of consciousness, Gait disturbance
Symptom Text: Client received 2 vaccines at the health dept. Staff member observed wavering gait. Walked back to chambers for 15 min observation period. Was observed by
RN who assisted immediately. Client was lowered to the floor, eyes closed, non-verbal for a few seconds. Responsive to name. Assisted to chair, cool cloth/ice
to forehead, back of neck.
Other Meds:
Lab Data: N/A
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286871-1

22.0 F 25-Jul-2007 25-Jul-2007 0 06-Aug-2007 14-Aug-2007 AZ 14-Aug-2007
UNK UNKNOWN MANUFACTURER C2670AA 0 Right arm Unknown
MedDRA PT Erythema, Pain, Swelling
Symptom Text: 7/25/07 Given in morning started in PM red, swollen, painful.

Other Meds: None
Lab Data: None
History: Allergic to EES
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286873-1

13.0 F 20-Jul-2007 22-Jul-2007 2 06-Aug-2007 10-Aug-2007 NY 10-Aug-2007
MNQ SANOFI PASTEUR UL367AA 0 Left arm Unknown
MedDRA PT Angioedema, Eye pruritus, Eyelid oedema, Urticaria
Symptom Text: Two days after vaccines given pt had itchy eyes. Next AM upper and lower eyelids swollen and hives on face. This continued for 3 days. Pt seen in office
7/25/07 with angioedema of face. No trouble breathing. No relief with Loratadine or Benadryl. Trial Atarax.
Other Meds: Loratadine 10mg
Lab Data: N/A
History: Allergies to sulfa, ibuprofen, Lorabid, Biaxin, Bactrim, and Augmentin
Prex Illness: Headache
Prex Vax Illns:

Vaers Id: 286874-1

14.0 F 30-Jul-2007 30-Jul-2007 0 06-Aug-2007 10-Aug-2007 NM 10-Aug-2007
MedDRA PT Anxiety, Anxiety, Asthenia, Disorientation, Dizziness
Symptom Text: Pt was given vaccines. After vaccines given, she started feeling anxious, weak, then disoriented. Felt dizzy nearly passing out. Pt was given 50mg of Benadryl
injection. Blood
Other Meds: Naprosyn in a.m.
Lab Data:
History:
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286875-1

16.0 F 23-Mar-2007 Unknown 06-Aug-2007 10-Aug-2007 NM 10-Aug-2007

MedDRA PT Dizziness
Symptom Text: Patient felt dizzy had to sit for like 5 min. Felt better.
Other Meds: None
Lab Data: N/A
History: No
Prex Illness: No
Prex Vax Illns:

Vaers Id: 286880-1

13.0 F 31-Jul-2007 31-Jul-2007 0 06-Aug-2007 10-Aug-2007 OH 13-Aug-2007
MedDRA PT Fall, Immediate post-injection reaction, Pain in extremity, Unresponsive to stimuli
Symptom Text: Pt received the Menactra vaccine (left arm) then the Gardasil vaccine (right arm). Immediately following the Gardasil vaccine she said her arm hurt but was
feeling fine. She then immediately fell off the exam table, hit the wall and was unresponsive for about 2-3 seconds.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286884-1

12.0 F 31-Jul-2007 31-Jul-2007 0 06-Aug-2007 10-Aug-2007 OH 13-Aug-2007
BIOLOGICALS
MedDRA PT Eye rolling, Fall, Head injury
Symptom Text: After receiving vaccines, pt and her grandmother walked to the check-out area. At 11:18 AM, pt was witnessed "eyes rolled back in head" and fell to the floor
striking the back of head on the floor. Pt regained consciousness immediately and vital signs were WNL.
Lab Data: N/A
History: Hypothyroidism
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286885-1


Symptom Text: No noted difficulty after injection. Pt stayed in the clinic for 5 min. after inject. - pt. was in her car, passenger seat. A friend came into clinic saying pt passed out
and was having a seizure - nurse checked pt. - pt was awake, alert, pallor, vital signs stable. Pt stated she always faints/seizures when any type of inject given -
pt brought into the clinic - given a Coke, laid down for approx. 20 min. Pt left with partner without problem.
Other Meds:
Lab Data:
History: Unknown
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286888-1

12.0 F 30-Jul-2007 30-Jul-2007 0 06-Aug-2007 10-Aug-2007 OK 13-Aug-2007
BIOLOGICALS
MedDRA PT Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in
extremity
Symptom Text: 7/30/07 (Info. per Mom) Child c/o lt. arm sore, red at shot site. No fever. No comfort measures done. Then next day 7/31 child c/o lt. up. arm hurts, red, hot to
touch, temp. 101 by mouth, Tylenol given by Mom. On 8/1/07 Mom took child to see her doctor. On 8/1/07 at 1:20 PM rec'd a call from clinic that child
presented and treated for increased lt deltoid red, swollen, hot to touch at inj. site only. Child sent home w/ Mom. Rx Claritin 10mg/d PO until sx subside,
alternate Tylenol and Motrin po every 4 hr. until sx subside. Cool pack to upper lt. arm area prn. No fever noted at clinic visit. F/U as need. No other S/Sxs
noted.
Other Meds: None
Lab Data: None performed
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 286895-1

22.8 F 31-Jul-2007 31-Jul-2007 0 06-Aug-2007 10-Aug-2007 MD 13-Aug-2007

MedDRA PT Injection site streaking
Symptom Text: 8cm green line inferior to injection site left arm. Appeared like superficial thrombophlebitis but not red, palpable or warm.
Other Meds: None
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 286935-1

16.0 F 06-Aug-2007 Unknown 06-Aug-2007 10-Aug-2007 CA 10-Aug-2007
MNQ SANOFI PASTEUR U2338A 1 Left arm Intramuscular
MedDRA PT Incorrect dose administered, Wrong drug administered
Symptom Text: PT. INADVERTANTLY GIVEN A SECOND DOSE OF MCV4. SANOFI PASTEUR AND CDC INFO LINE CONTACTED RE: POSSIBLE ADVERSE
REACTIONS, PT. GIVEN VIS AND MANUFACTURER INSERT WITH ADVERSE REACTIONS HIGHLIGHTED AND EXPLAINED TO BOTH PT. AND
MOTHER. MOTHER ALSO GIVEN INSTRUCTIONS TO MONITOR FOR ANY ADVERSE REACTIONS AND UPDATED WITH INFO THAT TO DATE,
ACCORDING TO THE CDC, THRE HAVE NOT BEEN ANY SERIOUS ADVERSE REACTIONS OR EVENTS RELATED TO RECEIPT OF A SECOND DOSE
OF MCV4.
Other Meds:
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 287111-1

MedDRA PT Chills, Dyspnoea, Hyperventilation, Pyrexia
Symptom Text: 8 hrs. after immunization woke at midnight with a fever, gave Motrin but continued to shiver and felt SOB/hyperventilating. Mom called 911 and paramedics
came and cleared her, normal vital signs. Once Motrin kicked in she felt much better.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287150-1

12.0 F 10-Apr-2007 10-Apr-2007 0 07-Aug-2007 10-Aug-2007 MA MA0711 10-Aug-2007
TDAP GLAXOSMITHKLINE AC526015AA 0 Left arm Intramuscular
BIOLOGICALS
HPV4 MERCK & CO. INC. 0244V 0 Right arm Intramuscular
MedDRA PT Injection site pruritus
Symptom Text: Itching at site of HPV injected. No other symptoms. No erythema or swelling. Lasted 30-90 minutes. Treated with Benedryl 25mg po
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 287328-1

11.0 F 06-Aug-2007 06-Aug-2007 0 08-Aug-2007 10-Aug-2007 FL 15-Aug-2007
TD UNKNOWN MANUFACTURER 0 Right arm Unknown
MNQ SANOFI PASTEUR 0 Right arm Unknown
MedDRA PT Abdominal pain upper, Convulsion, Headache
Symptom Text: Within 5 minutes of recieving the Gardasil vaccine, my daughter had a seizure in the car leaving the parking lot of the doctors office. She complained of a
stomach ache and a headache just before the seizure began. It lasted only a few minutes. I took her immediately back into the office, where Dr had a nurse
check her blood pressure, and gave her some water and sent us home.
Other Meds: N/A
Lab Data:
History: N/A
Prex Illness: N/A
Prex Vax Illns:

Vaers Id: 287332-1


MedDRA PT Circulatory collapse, Gaze palsy, Tremor
Symptom Text: my daughter was given her first Guardisil vaccine. within 2 minutes of injection she began to ask me if it was normal....when she collapsed and fainted. her
eyes rolled back into her head and she began to shake almose as if she were on the edge of a seizure. within 45 seconds to one minute she awoke wondering
what had happened to her. we are very concerned about the safety of this vacccine and do not intend to continue treatment
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 287339-1

MNQ SANOFI PASTEUR 2324AA 0 Right arm Unknown
HEPA GLAXOSMITHKLINE AHAVB172AA 0 Left arm Unknown
BIOLOGICALS
MedDRA PT Confusional state, Convulsion, Cyanosis, Dizziness, Dizziness, Dyskinesia, Loss of consciousness, Pain, Pain in extremity, Pallor
Symptom Text: My daughter reported severe pain (for someone who has a very high tolerance for pain) as soon as immunization was administered. She then felt
dizziness/light-headed, stepping down from the examining table. While exiting the clinic through the triage area, her lips turned pale, then her face. My daughter
then sat down on a chair while I went to get help; a nurse came. Patient (my daughter) had her eyes closed and almost slid from chair, she briefly open her
eyes and sat up on chair again, closing her eyes. Nurse asked her to open her eyes, she responded "I can't." Patient lost consciousness and slid from chair. I
tried to get closer to catch her when she suddenly began to have some jerking movements, like a seizure. I ran to the hallway, screaming for more help, and
immediately returned to my daughter whom I found on the floor, still having some jerking movements. After a few seconds she stopped moving, as if she went
to sleep. Nurse checked her vital signs and blood sugar level. Patient woke up, confused, wondering what she was doing on the floor and where one of her
shoes was (she had kicked it off while having jerking movements). A doctor then asked her name and date of birth; she responded appropriately. She was
given a pillow for the head, and a popsicle to eat, then was moved to a seated position (on the floor still). Another doctor gave her a vegetable sandwich, she
ate it, reported feeling better, waited a few minutes sitting down and slowly stood up and left in stable condition, but still hurting from immunization. No
complains up until today, except for pain on upper right arm where vaccine was administered.
Other Meds:
Lab Data: Blood sugar (finger-stick) 83.
History: SULFA drug, and environmental allergies.
Prex Illness: NO.
Prex Vax Illns:

Vaers Id: 287340-1

18.0 F 30-Jul-2007 Unknown 08-Aug-2007 10-Aug-2007 MN 10-Aug-2007
MNC UNKNOWN MANUFACTURER NULL 1 Unknown Unknown
MedDRA PT Anxiety, Chest discomfort, Dyspnoea, Throat tightness
Symptom Text: Shortness of breathe, anxiety, throat tightening, chest tightening. Came back to clinic 7/31/07 with these complaints. Was given prednisone rx for 20mg po bid
for 5 days, benadryl 25 mg q4-6h and albuterol
Other Meds: NONE
Lab Data: NONE
History: none
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 287347-1

13.0 F 01-Aug-2007 02-Aug-2007 1 08-Aug-2007 10-Aug-2007 NY 10-Aug-2007
HPV4 MERCK & CO. INC. ? 1 Right arm Unknown

MedDRA PT Abdominal pain upper, Dizziness, Dyspnoea, Fatigue, Headache, Nausea, Tachycardia
Symptom Text: DIFFICULTY BREATHING, NAUSEA,VERY RAPID HEART BEATS(157BPM) DIZZYNESS,FATIGUE, HEADACHE AND STOMACH ACHE. TOOK HER TO
EMERGENCY ROOM THEY GAVE HER AN IV AND SENT US HOME BECAUSE HER EKG WAS FINE EXCEPT FOR HER RAPID HEARTBEAT. THE NEXT
NIGHT I HAD TO TAKE HER AGAIN FOR THE SAME SYMPTOMS, HER HEARTBEAT WAS 128BPM THEY SENT US HOME AGAIN. SHE DIDNT FEEL
BETTER UNTIL TODAY 08/08/07. SHE STILL DOESNT FEEL 100% BACK TO NORMAL.
Other Meds: NONE
Lab Data: 1. EKG 157BMP ON 08/02/07. 2.EKG 117BPM(SAME DAY) 3.EKG 128BPM ON 08/03/07
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 287369-1 (S)

23.0 F 27-Apr-2007 01-Jun-2007 35 08-Aug-2007 09-Aug-2007 VA WAES0707USA04986 09-Aug-2007

MedDRA PT Contusion, Epistaxis, Idiopathic thrombocytopenic purpura, Immunoglobulins
Symptom Text: Information has been received from a physician concerning a 23 year old female patient who during the last week of April 2007 was vaccinated IM with a first
dose of Gardasil. Concomitant therapy included tetanus toxoid, tetracycline and hormonal contraceptives (unspecified brand). In June 2007, the patient
developed nose bleed and bruising of her body. The patient's platelet count reached 2000 and was hospitalized for ITP (Idiopathic Thrombocytopenic Purpura).
The patient was treated with intravenous immunoglobulin and high dose corticosteroids (unspecified). The patient responded to the corticosteroids
(unspecified) but became intolerant to the side effects. There have been more than one attempts to taper the patient off the corticosteroid but the platelets
decreased each time. As of 26-JUL-2007, the patient's platelet count was 8000. No other details were provided. Physician did not provide specifics on
corticosteroid side effects that the patient developed. The patient had not recovered. The events nose bleeds, bruising of patient's body, and Idiopathic
Thrombocytopenic Purpura (ITP) were considered to be life-threatening. Additional information has been requested.
Other Meds: Hormonal contraceptives; Tetracycline
Lab Data: Platelet count 06/??/07 - 2000; Platelet count 07/26/07 - 8000
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 287370-1

Unknown F Unknown Unknown 08-Aug-2007 09-Aug-2007 -- WAES0707USA04917 09-Aug-2007

Symptom Text: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a first dose of Gardasil. After receiving the
vaccine, the patient had a seizure for 5 minutes. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No
product quality complaint was involved. Upon internal review, seizure was considered to be an other important medical event. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 287371-1 (S)

25.0 F 29-Mar-2007 11-Apr-2007 13 08-Aug-2007 09-Aug-2007 -- WAES0707USA04654 24-Aug-2007

MedDRA PT Deafness unilateral, Tinnitus, Viral infection
Symptom Text: Information has been received from a nurse practitioner concerning a female nurse (age not reported) who on an unspecified date was vaccinated with a first
dose of Gardasil. On 29-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # not reported) IM. On the morning of 11-APR-2007, the
patient was non-symptomatic. Later that day, she woke up from a nap and she could hear nothing in her ear, except ringing. The patient sought the medical
attention of primary care, ear, nose and throat (ENT) and surgical ENT services. It was determined that the patient had a "92% hearing loss". A magnetic
resonance imaging was performed, result not reported. She was treated with antibiotics, steroids, and steroids injected into her ear without any improvement.
The diagnosis was sudden, unilateral hearing loss due to a viral attack on the nerve. The surgical ENT had no idea of the etiology except that this was a rare
experience. The patient had no idea of the etiology except that this was a rare experience. The patient had 8% word recognition in the left ear with the ability to
hear one tonal frequency. It was reported that the permanent hearing loss was disabling. At the time of reporting, the unilateral hearing loss persisted.
Other Meds: Unknown
Lab Data: magnetic resonance - no result reported
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 287372-1 (S)

17.0 F Unknown 07-Jul-2007 08-Aug-2007 09-Aug-2007 IN WAES0707USA04247 09-Aug-2007

MedDRA PT Herpes zoster, Infectious mononucleosis
Symptom Text: Information has been received from a licensed practical nurse (LPN) concerning a 17 year old female with pertinent medical history and drug reactions/allergies
reported as none who in 2007 was vaccinated with the first dose of Gardasil. The LPN was unable to provide the lot number. Concomitant medication was
reported as none. The nurse stated that the patient was close to the time that she should receive the second dose. ON 07-JUL-2007, the patient experienced
mononucleosis and was hospitalized. Before the patient was discharged from the hospital she developed shingles. The patient sought unspecified medical
attention. On an unspecified date, the patient was discharged from the hospital and she was recovering from the mononucleosis and shingles. Additional
Other Meds: Unknown
Lab Data:
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 287373-1 (S)


MedDRA PT Abdominal pain, Dysmenorrhoea, Syncope
Symptom Text: Information has been received from a gynecologist concerning a 20 year old female with abdominal pain for 2-3 days prior to vaccination, who on 26-JUL-2007
was vaccinated intramuscularly with a first dose of Gardasil (lot #1537F; batch NF37110). Concomitant therapy included VALETTE. On 26-JUL-2007, during
the vaccination, the patient experienced syncope from which she recovered after an unspecified infusion. About 3 minutes post vaccination the patient
complained about abdominal cramps and therefore was admitted to the hospital. The patient was discharged from the hospital on 27-JUL-2007. The diagnosis
established was period pains. The reporting gynecologist considered the reaction as not related to the vaccine. Other business partner numbers included
E2007-04873. No further information is available.
Other Meds: VALETTE Unk - Unk
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 287374-1

18.0 F 26-Jul-2007 26-Jul-2007 0 08-Aug-2007 09-Aug-2007 -- WAES0708USA00505 09-Aug-2007

MedDRA PT Convulsion, Loss of consciousness, Mydriasis
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female, who on 26-JUL-2007 was vaccinated with a first dose of Gardasil. On
26-JUL-2007 the patient passed out. It was reported that her pupils were dilated and she experienced a 10 second seizure. The patient sought unspecified
medical attention. On 26-JUL-2007 the patient recovered. No product quality complaint was involved. Upon internal review, seizure was considered to be an
other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 287383-1

21.0 F 07-Aug-2007 07-Aug-2007 0 08-Aug-2007 20-Aug-2007 NJ 20-Aug-2007

MedDRA PT Convulsion, Syncope, Tremor
Symptom Text: Fainted with "shaking" "seizure" activity 2 hrs after injection
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287384-1

20.0 F 09-Jul-2007 10-Jul-2007 1 08-Aug-2007 20-Aug-2007 SD 20-Aug-2007

MedDRA PT Injection site erythema, Injection site pain, Injection site rash
Symptom Text: 8-6-07 Patient phones to report pain to the injection site shortly after receiving vaccine and continues to have the pain. Also reports a raised red rash developed
to the injection site area approximately 2 weeks ago. Will check with MD before she receives last vaccination.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287390-1

HEPA MERCK & CO. INC. 04950 1 Right arm Unknown
MedDRA PT Eye rolling, Immediate post-injection reaction, Syncope
Symptom Text: Child was given Vaqta, then Gardasil vaccine. She immediately felt faint-slumped over (was helped to lay down on exam table) and "eyes rolled back". Child
became responsive quickly
Other Meds: None
Lab Data:
History: Scoliosis, Dorsal Ganglion cyst, Short Frenulum
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287394-1

11.0 F 23-Jul-2007 26-Jul-2007 3 08-Aug-2007 20-Aug-2007 LA 20-Aug-2007
MNQ SANOFI PASTEUR AC52B018 0 Right leg Intramuscular
Symptom Text: Shingles to dermatomes L2, L3 to left leg beginning 3 days after administration of Gardasil (L leg), Menactra (R leg)
Other Meds: None
Lab Data: Viral culture
History: Eczema
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287561-1

15.0 F 25-Jun-2007 25-Jun-2007 0 09-Aug-2007 10-Aug-2007 PA WAES0708USA00221 10-Aug-2007

MedDRA PT Confusional state, Convulsion
Symptom Text: Information has been received from a Doctor of Pharmacy concerning a 15 year old female who on 25-JUN-2007 was vaccinated with a second dose of
Gardasil. On 25-JUN-2007 the patient developed seizure like activity shortly after the injection. The physician was summoned to the room, but upon arrival the
patient's symptoms stopped. The patient looked confused but her color remained good. Her blood pressure was 104/60 mm/Hg. She stayed at the office for 35
minutes for observation. Her blood pressure was taken again was 110/60 m/Hg. The patient recovered and was sent home. Upon internal review, the patient's
seizure like activity was considered an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: blood pressure 06/26/07 110/6 mm/H, blood pressure 06/26/07 104/6 mm/H
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 287570-1

16.0 F 30-Jul-2007 30-Jul-2007 0 09-Aug-2007 20-Aug-2007 DE 21-Aug-2007

MedDRA PT Dizziness, Head injury, Syncope, Visual disturbance
Symptom Text: While pt was leaving the office, pt fainted and fell back into the wall, hitting her head. Within a minute, pt came to/alert but distraught. Pt described seeing black
stops and dizziness before fainting episode.
Other Meds: N/A
Lab Data: N/A
History: N/A
Prex Illness: N/A
Prex Vax Illns:

Vaers Id: 287577-1

17.0 F 09-May-2007 12-May-2007 3 09-Aug-2007 20-Aug-2007 MA 21-Aug-2007
TDAP GLAXOSMITHKLINE C2720H 0 Left arm Unknown
BIOLOGICALS
HPV4 MERCK & CO. INC. C1884 0 Left arm Unknown
MedDRA PT Dyspnoea, Rash pruritic, Urticaria
Symptom Text: Given 2 vac-> HPV #1 Tdap on 5/9/07 on 5/13/07 at ER-diffuse rash-itchy "hive like" rash. Breathing difficulty Dx "urticarial rash". 2 hr vac. -> Rx'd Decadron,
Benadryl, Pepcid- Prednisone x 50 mg
Other Meds:
Lab Data: None
History: Anxious/OCD
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287579-1

VARCEL UNKNOWN MANUFACTURER NULL 0 Unknown Unknown
TD UNKNOWN MANUFACTURER NULL 0 Unknown Unknown
HPV UNKNOWN MANUFACTURER NULL 0 Unknown Unknown
MedDRA PT Hyperhidrosis, Nausea, Pallor, Presyncope
Symptom Text: Patient turned pale. felt nauseous, and broke out in a sweat for approximately 5 minutes. Patient almost passed out. *As her mother, I believe the long-term
benefits of this drug far outweigh the risks.
Other Meds: Tylenol 1000mg
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287580-1

19.0 F 30-Jul-2007 30-Jul-2007 0 09-Aug-2007 21-Aug-2007 GA 21-Aug-2007

MedDRA PT Chills, Dyspnoea, Feeling hot, Hypoaesthesia, Muscle spasms, Vision blurred
Symptom Text: 30 min after injection - pt became hot - had difficulty breathing - chills- muscle spasms. Went to E.R. Pt was numb feeling - blurred vision - pt not sure what in
ER - will send for report.
Other Meds:
Lab Data: Will get records from E.R.
History: NKA at that time
Prex Illness: No illness
Prex Vax Illns:

Vaers Id: 287602-1

MedDRA PT Burning sensation, Convulsion, Pain, Pain in extremity
Symptom Text: Patient received Gardasil vaccine IM in right arm and Tdap in left arm. She complained of burning and pain in that arm and then stated she felt achy. Patient
was lowered into supine position where she started to seizure. Patient was given cold compress to injection site and Benadryl when she came to. Benadryl
given at 2:20 pm. BP and Pulse taken and within normal limits. Lungs and heart assessed by nurse practitioner and reported normal.
Other Meds: None
Lab Data:
History: Penicillin, "-cillin family" allergy
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287603-1

12.0 F 07-Aug-2007 08-Aug-2007 1 09-Aug-2007 21-Aug-2007 CT 21-Aug-2007
MedDRA PT Injection site erythema, Injection site warmth, Nausea, Pain
Symptom Text: Had redness site of Varivax 2 1/2 " diam-& heat Body ahces, nausea
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287607-1

20.0 F 01-Aug-2007 01-Aug-2007 0 09-Aug-2007 21-Aug-2007 DE 21-Aug-2007

MedDRA PT Headache, Pain, Pain in extremity
Symptom Text: Patient states a few hours after 3rd Gardasil had leg aches. Now aches/headache.
Other Meds: No
Lab Data: CBC with diff, Lyme titers
History: Amoxicillin/PCN
Prex Illness: No
Prex Vax Illns: Same as pt~HPV (Gardasil)~3~0~In Sibling

Vaers Id: 287620-1

14.0 F 16-Jul-2007 17-Jul-2007 1 09-Aug-2007 10-Aug-2007 NC 17-Aug-2007
MNQ SANOFI PASTEUR 02524AA 0 Left arm Intramuscular
HEPA UNKNOWN MANUFACTURER NA 0 Left arm Intramuscular
HPV4 MERCK & CO. INC. NA 0 Right arm Intramuscular
MedDRA PT Dizziness, Migraine, Nausea, Visual disturbance
Symptom Text: Severe nausea lasting more than two weeks. Severe migrane headaches and vision disturbances. Dizziness. All of these have lasted more than two weeks
and are currently ongoing.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 287636-1

14.0 F 07-Aug-2007 07-Aug-2007 0 09-Aug-2007 10-Aug-2007 CA 10-Aug-2007
BIOLOGICALS
MedDRA PT Hyperhidrosis, Pallor, Syncope, Vomiting
Symptom Text: Fainted, remained pale and diaphoretic for 1 1/4 hours after vaccines given. Vomited 4 - 5 times.
Other Meds:
Lab Data: none
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 287642-1


MedDRA PT Urticaria
Symptom Text: mom called and pt broke out in hives after getting the second dose of HPV.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 287646-1

14.0 F 07-Aug-2007 07-Aug-2007 0 10-Aug-2007 10-Aug-2007 MO 10-Aug-2007
MNQ SANOFI PASTEUR ? 0 Left arm Intramuscular
HPV4 MERCK & CO. INC. ? 0 Left arm Intramuscular
MedDRA PT Cold sweat, Dizziness, Fall, Head injury, Hyperhidrosis, Hypotonia, Loss of consciousness, Loss of consciousness, Loss of consciousness, Musculoskeletal
stiffness, Pallor, Somnolence, Visual disturbance
Symptom Text: My daughter was standing behind me while I was at the front desk paying our insurance co-pay. I heard her quietly start to say, "Mom, Mom, Mom..." and
turned around just in time to watch her crumble to the floor, but too late to catch her. She fell forward onto a carpeted floor. She was completely unconscious
for approximately 5-10 seconds, but continued to be groggy after regaining consciousness. We got her into a sitting position at which point 2 nurses came over,
asked if she had hit her head, and attempted to help her walk to a room where she could lay down. While walking, she lost consciousness a second time. Her
legs were dragging behind her and she went limp. I was following right behind them when this happened and observed her arms move back in a stiff position
with her fingers in an odd, stiff shape. I was terrified she was having a seizure, but the nurses insisted she wasn't. However, they were at her sides and did not
see what her arms and hands were doing. They stopped and sat her on the floor leaning against the wall and she regained consciousness again. I estimate
she was unconscious the second time for approx 10 seconds. She was then moved to a room where she very quickly recovered while sitting in a chair. She
was given water and a wet washcloth. She did not want to lay down and had no trouble drinking water, controlling her arms, legs, etc and her speech was
normal. She was very pale, sweaty, cold and clammy to the touch. When asked to describe what she experienced before she passed out, she said she became
very dizzy, started to see spots, and then her vision started to go black. She also stated that she knew what was about to happen the second time right before
she fainted again. She remembered everything before and after, but had no sense of what was said or going on around her while unconscious. She stayed in
the examine room for about 15 minutes and insisted she felt fine and was ready to leave. She has not experienced any other symptoms since.
Other Meds: Takes Claritin for seasonal allergies.
Lab Data: None were given.
History: Mild strabismis and amblioplia in right eye.
Prex Illness: None - was there for a routine physical and was found healthy.
Prex Vax Illns:

Vaers Id: 287759-1

25.0 F 19-Mar-2007 24-Jun-2007 97 10-Aug-2007 13-Aug-2007 PA WAES0708USA00038 13-Aug-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Muscle spasms, Vaginal haemorrhage
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 29-
JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F) injection 0.5mL IM left deltoid. On 19-MAR-2007, the patient was vaccinated with a
second dose of Gardasil (lot # 656372/0243U) injection 0.5mL IM left deltoid. Concomitant medication included ZYRTEC and PREVACID. The date of the
patient's last menstrual period was 24-JUN-2007. On 23-JUL-2007, the patient reported that she tested positive for pregnancy. On 29-JUL-2007, the patient
sought medical attention for a miscarriage (the estimated date of delivery was 30-MAR-2008). On 29-JUL-2007, the patient arrived at the emergency room with
complaints of bleeding and cramping. An ultrasound performed showed no fetus/pregnancy. Additional information was received from the registered nurse via
telephone. It was originally reported that the miscarriage was life-threatening. The nurse clarified that it was not life-threatening to the mother but was unknown
to the fetus as it was very early on in the pregnancy. The relationship of the miscarriage to Gardasil was unknown. Upon internal review, spontaneous abortion
was considered to be an Other Important Medical Event. No additional information is expected.
Other Meds: ZYRTEC; PREVACID
Lab Data: ultrasound 07/29/07 - no fetus/pregnancy; beta-human chorionic 07/23/07 - positive
History:
Prex Vax Illns:

Vaers Id: 287777-1

17.0 F 03-Aug-2007 03-Aug-2007 0 10-Aug-2007 21-Aug-2007 MA 21-Aug-2007

MedDRA PT Eye rolling, Muscle spasms, Mydriasis, Nausea, Pallor, Unresponsive to stimuli
Symptom Text: Temp 97.7. Eyes rolling, arm spasm, non-responsive to talking x < 30 seconds. When episode were over there were dilated pupils, pallor and nausea. Vitals
stable - transmitted by EMS to hospital
Other Meds: Nasonex; Albuterol inh; Singulair; Zyrtec; Lutera
Lab Data: Labs from 2006, all NL
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287780-1

14.0 F 21-Jun-2007 21-Jun-2007 0 10-Aug-2007 21-Aug-2007 SD 21-Aug-2007

MedDRA PT Flushing
Symptom Text: Patient complained of face feeling hot. No shortness of breath. No reaction at injection site. Vital signs normal. Note: Patient does not like needles.
Other Meds: None
Lab Data: N/A
History: Allergy - Sulfa
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287794-1

11.0 F 08-Aug-2007 08-Aug-2007 0 10-Aug-2007 21-Aug-2007 KY 21-Aug-2007
VARCEL MERCK & CO. INC. AC2B004BA 1 Right arm Intramuscular
TDAP GLAXOSMITHKLINE AC52B004AB 0 Right arm Intramuscular
BIOLOGICALS
Symptom Text: Rash on entire body, onset 8-8-07 5 pm. Treated by pediatrician with Benadryl
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287800-1


MedDRA PT Dizziness, Loss of consciousness, Syncope
Symptom Text: Pt received Gardasil #1. 10 minutes after receiving shot patient fainted. Regained consciousness within seconds. Dizzy for another 10 minutes. Blood pressure
100/70, pulse steady and regular. Pt recovered and left office 1/2 hour after fainting
Other Meds:
Lab Data: None
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287801-1

18.0 F 26-Jul-2007 26-Jul-2007 0 10-Aug-2007 21-Aug-2007 NH NH0732 21-Aug-2007

Symptom Text: After Gardasil #2, pt c/o nausea x 12 days, vomited x 4, comes and goes. Pt had office visit with doctor on 8/7/07 - given Rx for Phenergan/follow up as
needed. Pt had some nausea after Gardasil #1 for a few days.
Other Meds: Alesse PO qd; Metrogel; Promethazine
Lab Data: None; given Rx for Phenergan 25mg T PO q 6 hours prn
History: This patient has no known allergies.
Prex Illness: None noted
Prex Vax Illns: Nausea~HPV (Gardasil)~1~18~In Patient

Vaers Id: 287803-1

15.0 F 09-Aug-2007 09-Aug-2007 0 10-Aug-2007 21-Aug-2007 NV 31-Aug-2007
MNQ SANOFI PASTEUR U2182AA Unknown Unknown
HPV4 MERCK & CO. INC. 01A1U Unknown Unknown
MedDRA PT Pruritus, Swelling face
Symptom Text: She started itchy and swells of face immediately after leaving the clinic. The symptoms persist for 24 hours
Other Meds:
Lab Data: None
History: She has mental retardation and tuberous sclerosis
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287804-1

TDAP GLAXOSMITHKLINE AC521B018CA 4 Unknown Intramuscular
BIOLOGICALS
HPV4 MERCK & CO. INC. 04950 Unknown Intramuscular
HEPA MERCK & CO. INC. 0380 Unknown Intramuscular
MedDRA PT Syncope
Symptom Text: Pt fainted when leaving exam room, lasted few seconds, recovered after 15 min-juice and snack provided.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287805-1

TDAP GLAXOSMITHKLINE AC52B018CA 5 Unknown Intramuscular
BIOLOGICALS
HEPA MERCK & CO. INC. 0495U 0 Unknown Intramuscular
MMR MERCK & CO. INC. 0412U 1 Unknown Subcutaneously
MedDRA PT Syncope
Symptom Text: After receiving HPV #1 - pt felt faint, put head between legs - fainted, lasted 2-3 sec then ok
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287806-1

15.0 F 03-Aug-2007 Unknown 10-Aug-2007 21-Aug-2007 TX 21-Aug-2007
Symptom Text: redness and swelling of lt upper arm

Other Meds:
Lab Data:
History: PCN, Sulfa
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287807-1

TDAP GLAXOSMITHKLINE AC52B006BA Unknown Unknown
BIOLOGICALS
MedDRA PT Syncope
Symptom Text: Gave Tdap and soon after Gardasil close to the Tdap site. Was injecting PPD in same arm, patient developed syncope within 2-3 minutes.
Other Meds: None
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 287821-1

VARCEL MERCK & CO. INC. 07794 1 Right arm Intramuscular
MedDRA PT Asthenia, Convulsion, Gaze palsy, Loss of consciousness, Pallor, Somnolence, Tremor
Symptom Text: GARDASIL vaccine was administered (IM) to my daughter, left arm. Prior to Gardasil, Patient had been given the Chicken Pox booster and the meningitis
(Menactra) vaccine in her right arm. Gardasil was administered and then wuickly her eyes roolled back, she passed out, and her limbs (legs and arms) started
shaking(Like a mild seizure). The nurse said she thought patient mught be seizing and went to get Dr. Suddenly the shaking stopped and patient sat up and
frightfully grabbed me and asked what happened. Patient felt weak and drained. She was pale and eventually regained some color. Patient drank some water,
rested and then came home. She has been sleeping all day. I am not sure how she will be when she wakes up.
Other Meds:
Lab Data:
History: Sulphur medication allergy
Prex Illness: none
Prex Vax Illns:

Vaers Id: 287825-1

17.0 F 11-Jun-2007 12-Jun-2007 1 10-Aug-2007 15-Aug-2007 SD 15-Aug-2007
MedDRA PT Candidiasis, Diet refusal, Dizziness, Feeling hot, Oral soft tissue disorder, Pharyngeal oedema, Pharyngolaryngeal pain, Pyrexia, Skin warm, Speech disorder,
Stomatitis, Swollen tongue, Weight decreased
Symptom Text: On the day of the vaccination later that evening, she noticed she was dizzy and she felt warm like she had a fever. On June 12th, she woke up, went to brush
her teeth and found 4-5 white sore spots/lesions on the inside of her lower lip. She went to a doctor appointment right away that day. Throughout the day and
over the next few days the spots got worse and spread to the all over the inside of her mouth, tongue and on the outside of her lips. She said this lasted for 1
week. She went to the doctor that day on June 12th. Doctor diagnosed her with stomatitis and thrush. She said her tongue and throat were very sore and
swollen. She could barely talk and could not eat for 1 week. She said that she lost 11lbs in that week. Her doctor gave her Valtrex and that cleared up the
sore spots/lesions. She was also given a 'cocktail' to rinse her mouth.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 287830-1

MedDRA PT Injection site erythema, Injection site induration, Injection site urticaria, Rash macular
Symptom Text: Patient is a 16 year old female brought by mother with a blotchy, raised and red rash on her left arm around her varicella vaccine, given 8/9/2007 in this office.
The rash occurred today. Parents observations of the patient at home are normal activity, normal appetite and normal fluid intake. There is no fever, vomiting,
or diarrhea. No breathing difficulty, no fainting. 1 cm raised, round induration and 3 cm x 1 cm erythematous wheal located on right arm extending from varicella
injection
Other Meds: Wellbutrin XL 300mg qd, OrthoTricylcin 28 qd
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 287841-1

9.0 F Unknown Unknown 12-Aug-2007 21-Aug-2007 VA 22-Aug-2007

Symptom Text: Patient has developed spots on her legs that are bothering her , itching and red and not clearing up since she has recieved the Gardasil shots , she is also a
heart patient with Truncusaterious Aterious type 1 1/2 with complications & also in remission for Antiphospholipid syndrom.. i dont know if any of these mixed
with the Gardasil has made it possible for her to have a reaction but i would appricatiate if you could look into this matter , she does not have the spots
anywhere but on her legs and they are getting worse , her doctor as listed above does not seem to be able to find solution to this
Other Meds: at this time she is on no other medications only over the counter flinstone vitimans with iron
Lab Data: Patient has had blood work done and other tests with no help
History: Truncusaterious Type 1 1/2 with complications & Antiphosphilipid Syndrom ( wich in in remission at the moment )
Prex Illness:
Prex Vax Illns:

Vaers Id: 287851-1

16.0 F 06-Aug-2007 06-Aug-2007 0 10-Aug-2007 21-Aug-2007 PA 22-Aug-2007
MNQ SANOFI PASTEUR U2386BA 0 Right arm Unknown
Symptom Text: Pt passed out 5-10 minutes after getting vaccines

Other Meds:
Lab Data: checked blood pressure
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287885-1 (S)

11.0 F 08-Jun-2007 13-Jul-2007 35 13-Aug-2007 14-Aug-2007 TX WAES0708USA00750 14-Aug-2007
MedDRA PT Diabetes mellitus insulin-dependent, Lethargy, Pollakiuria, Weight decreased
Symptom Text: Information has been received from a physician concerning an 11 year old female who on 08-JUN-2007 was vaccinated with a dose of Gardasil (lot #
unknown). Concomitant secondary therapy also given on 08-JUN-2007 included VAQTA and Varivax. On 13-JUL-2007 the patient was diagnosed with "new
onset type 1 diabetes" Medical attention was sought. On an unspecified date, at a follow-up visit, it was reported that after receiving Gardasil the physician
determined this diagnosis. It was reported that at the follow-up visit the patient lost 12 pounds, was lethargic and was urinating frequently. On an unspecified
date the patient had a blood glucose test performed and the results had a sugar reading of 977. At the time of reporting the patient had not recovered. Diabetic
was considered to be disabling. Additional information has been requested.
Other Meds: Unknown
Lab Data: blood glucose - 977
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 287886-1

16.0 F 01-Nov-2006 01-Nov-2006 0 13-Aug-2007 14-Aug-2007 CA WAES0708USA00707 14-Aug-2007
FLU UNKNOWN MANUFACTURER NULL Unknown Unknown
Symptom Text: Information has been received from a physician's wife concerning a 16 year old female who in November 2006, was vaccinated with a first dose of Gardasil.
Concomitant therapy included influenza virus vaccine (unspecified). Ten minutes after receiving the vaccination, the patient experienced a one minute seizure.
The patient was sent to the emergency room and diagnosed with seizure disorder. Subsequently, the patient recovered from the seizure. She has since had a
second and third dose of Gardasil and did not experience any seizure activities after those doses. Upon internal review, seizure disorder was considered to be
an other important medical event. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 287887-1 (S)

18.0 F 16-Apr-2007 16-Apr-2007 0 13-Aug-2007 14-Aug-2007 TX WAES0708USA00643 14-Aug-2007

MedDRA PT Anaphylactic reaction, Loss of consciousness, Urticaria
Symptom Text: Information has been received from a registered nurse, via a company representative, concerning a non-pregnant, 18 year old female patient, who on 16-APR-
2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not provided). On 16-APR-2007, "shortly after being administered the vaccine" the patient
had an anaphylactic reaction, described as, she developed hives down both arms but did not have difficulty breathing; she also passed out. Treatment included
Benadryl, and oxygen, and the patient was observed in the office for a "short time" and then went home. The patient then fully recovered (duration not
reported). The nurse considered anaphylactic reaction and "passing out" to be serious, as life-threatening and as an important medical event. No further
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 287888-1 (D)

22.0 F 21-May-2007 23-May-2007 2 13-Aug-2007 14-Aug-2007 -- WAES0708USA00407 14-Aug-2007

MedDRA PT Death
Symptom Text: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history or drug allergies who on 21-
MAY-2007, was vaccinated IM with a 0.5ml dose of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified)
("MERCET"). On 23-MAY-2007, the patient died suddenly. The cause of death was unknown. Unspecified medical attention was sought. Laboratory diagnostic
studies included an autopsy which showed no findings. No product quality complaint was involved. The reporter stated that Gardasil did not cause the patient's
death. Additional information is not expected.
Lab Data: autopsy - no findings
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 287889-1 (S)

24.0 F 09-Mar-2007 09-Apr-2007 31 13-Aug-2007 14-Aug-2007 -- WAES0708USA00308 14-Aug-2007

MedDRA PT Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage
Symptom Text: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old
female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term
pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil.
Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and
amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-
2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was
considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no
abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused
by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous
abortion and subsequent study administration discontinued. No further information is available.
Other Meds: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Lab Data: beta-human chorionic 04/09/07 posit
History: Early onset of delivery
Prex Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidi
Prex Vax Illns:

Vaers Id: 287890-1

20.0 F 01-Jul-2007 01-Jul-2007 0 13-Aug-2007 14-Aug-2007 FR WAES0708AUS00032 14-Aug-2007

MedDRA PT Anaphylactic shock, Injection site induration, Injection site reaction, Lymphadenopathy
Symptom Text: Information has been received from a physician via CSL as part of a business agreement (manufacturer's report number: GARD 2007 07 31 002) concerning a
20 year old female with drug hypersensitivity to salicylates and a history of respiratory arrest following codeine and morphine, and urticaria following Fentanyl.
In July 2007 the patient was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0801, Expiry date 07-AUG-2009). In July 2007 ("last week" of 19 - 25
in July 2007), after administration of Gardasil, she developed anaphylactic shock requiring 0.6 mg of adrenaline and hydrocortisone intravenously. An
ambulance was called and she was administered oxygen and given further 0.5 mg of adrenaline on the way to the hospital. The patient stayed in the accident
and emergency department for approximately 6 hours and was discharged. She consulted a physician and was on therapy with prednisone 50 mg for 2 days.
At the time of reporting on 31-JUL-2007, the patient had enormous glands on the side of Gardasil administration and the muscle at the injection site felt firm
and tight. Upon internal review, anaphylactic shock was considered to be an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Respiratory arrest; Urticaria
Prex Vax Illns:

Vaers Id: 287918-1

11.0 F 06-Aug-2007 07-Aug-2007 1 13-Aug-2007 22-Aug-2007 IN 22-Aug-2007

MedDRA PT Urticaria
Symptom Text: Reported by mother - patient not seen. Hives all over a little more than 24 hours after vaccine given. Treated with Benadryl.
Other Meds: Albuterol inhaler PRN; Singulair 10mg daily
Lab Data: None
History: None (Asthma)
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287920-1


MedDRA PT Acne, Pruritus, Rash
Symptom Text: Afebrile. "Pimple" on face 2 days after Gardasil vaccine. "Pimply" rash all over back 2 days after Gardasil vaccine. Itchy mostly at night, rash lasted 3 days. Pt
not seen here. Reported verbally by mom.
Other Meds:
Lab Data: N/A
History: NKDA or NKA
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287923-1

26.0 F 18-Jul-2007 18-Jul-2007 0 13-Aug-2007 21-Aug-2007 VA 22-Aug-2007

MedDRA PT Abdominal pain, Back pain, Body temperature fluctuation, Diarrhoea, Fatigue, Headache, Insomnia, Myalgia, Nausea, Neck pain, Pyrexia, Vertigo
Symptom Text: Pyrexia - headache, temperature flux - persisted approximately 36 hours - Ibuprofen, fatigue and insomnia - persisted approximately 20 hours. Neck and back
pain - persisted 48 + hours, myalgia - persisted approximately 40 hours. Abdominal and pelvic cramping, diarrhea, nausea w/o emesis - persisted
approximately 12 hrs - treated with pepto Bismol, vertigo - persisted approximately 6 hours.
Other Meds: Ortho Tri-Cyclen Lo, multivitamin
Lab Data: None
History: Allergy to Cefaclor
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287929-1

HPV4 MERCK & CO. INC. 0930Y 0 Left arm Intramuscular

MedDRA PT Throat irritation, Throat tightness
Symptom Text: About 5 minutes after receiving vaccine, pt complained on itchy throat and tig of throat. Benadryl 50mg liquid given.
Other Meds:
Lab Data: None
History: Food allergies
Prex Illness: None
Prex Vax Illns:


13.0 U 31-Jul-2007 31-Jul-2007 0 13-Aug-2007 21-Aug-2007 -- 22-Aug-2007

MedDRA PT Crying, Malaise, Muscle rigidity, Syncope, Tremor, Unresponsive to stimuli
Symptom Text: Within 2 minutes of administration patient c/o being "sick" and collapsed was unresponsive x app. 1 minute and had rigidity of extremities, shook and cried out
as she regained consciousness. Will follow up with cardiologist and neuro eval.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


MNQ SANOFI PASTEUR 92378BA 0 Right arm Unknown
MedDRA PT Cold sweat, Pain in extremity, Pallor, Syncope, Tonic clonic movements
Symptom Text: Was given Menactra and Gardasil. Said she felt a lot of pain after the vaccinations in her arm. On the way out of the office (about 5-10 min after vaccination) pt
fainted and had tonic clonic movements that lasted a few seconds. Upon wakening she was cool, clammy, pale. Vital signs were stable, O2 sat 98% RA. After
resting for about 15 minutes, the pt was sent home.
Other Meds:
Lab Data: N/A
History: None; parent reports that one tends to faint with intense pain.
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287933-1

11.0 F 31-Jul-2007 31-Jul-2007 0 13-Aug-2007 22-Aug-2007 LA 22-Aug-2007

MedDRA PT Head injury, Injury, Syncope
Symptom Text: Syncope following vaccine administration. Sustained head injury, broken teeth
Other Meds:
Lab Data: Head CT
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287934-1

15.0 F 06-Aug-2007 06-Aug-2007 0 13-Aug-2007 22-Aug-2007 NC 22-Aug-2007
MedDRA PT Convulsion, Gaze palsy, Muscle spasms
Symptom Text: After 2nd shot - patient slumped to side, eyes rolled back - and after laying her back on table had seizure-like spasm < 5 sec. Called doctor - patient was
laughing and left shortly after that. Checked vitals and was ok.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 287936-1

VARCEL MERCK & CO. INC. 0523U 1 Left leg Intramuscular
HPV4 MERCK & CO. INC. 0779U 2 Right arm Subcutaneously
MedDRA PT Asthenia, Pallor, Syncope vasovagal
Symptom Text: Looked like a vasovagal reaction last 10 minutes was pale, weak. No loc, no sz.
Other Meds:
Lab Data: BS 96 BP 1201/90 HR 90
History: Sulfur
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287941-1


MedDRA PT Loss of consciousness, Pain, Pallor, Posturing, Somnolence, Unresponsive to stimuli
Symptom Text: 3 vaccines to give: Tdap given left deltoid - no problems; HPV given right deltoid - complained of pain; Menactra needle inserted no given patient immediately
passed out, posturing behavior, pale, unable to wake up patient for about 5 seconds. Pt seemed groggy but stable.
Other Meds:
Lab Data:
History: Duane syndrome; Seizures in park
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287943-1

15.0 F 18-Jun-2007 19-Jun-2007 1 13-Aug-2007 23-Aug-2007 CA 23-Aug-2007
MedDRA PT Erythema, Mass, Skin warm
Symptom Text: Inj given 6/18/07. 6/19/07, at school pt noted large hot, red lump on back of right arm. Saw MD, gave Benadryl cream and ice. Resolved completely in 1 week.
Other Meds: Claritin
Lab Data: None
History: Hay fever, cat allergy, metal (nickel) allergy
Prex Illness: None
Prex Vax Illns: Increased fever~DTaP (no brand name)~3~1~In Sibling

Vaers Id: 287946-1

16.0 F 31-Jul-2007 31-Jul-2007 0 13-Aug-2007 23-Aug-2007 CT 23-Aug-2007
MedDRA PT Lethargy, Syncope, Vomiting
Symptom Text: Stated by mother child fainted in office was lethargic and vomited at home x 1 x 24 hours.
Other Meds:
Lab Data: None
History: Faints easily noted on chart
Prex Illness: None
Prex Vax Illns:

Vaers Id: 287950-1

18.0 F 08-Aug-2007 08-Aug-2007 0 13-Aug-2007 23-Aug-2007 NC 23-Aug-2007
HEPA GLAXOSMITHKLINE AHAVB163AB 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Cold compress therapy, Injection site erythema, Injection site swelling, Injection site warmth
Symptom Text: PT RECEIVED HEPATITIS A, MENACTRA, GARDISIL, AND VARIVAX VACCINES ON 8/8/07. PT SEEN IN OFFICE ON 8/10/07 FOR REACTION ON LEFT
ARM. GARDISIL AND VARIVAX WERE GIVEN IN THE LEFT ARM. AREA OF VARIVAX INJECTION WARM, RED, AND SWOLLEN. NO VESICLES, NO
FEVER. LATERAL SURFACE OF LEFT ARM WITH 4CM X 3CM AREA OF ERYTHEMA, WHICH WAS RESOLVING AFTER APPLICATION OF COLD PACK
X10 MINUTES. PT RXED ZYRTEC 10MG PO QHS X5-7 DAYS AND LOCOID LIPOCREAM TO BE APPLIED BID UNTIL AREA OF ERYTHEMA RESOLVED,
TO USE ICE PACKS PRN.
Other Meds: YAZ ORAL CONTRACEPTIVES STARTED 8/8/07
Lab Data: NONE
History: PRIMARY DYSMENORRHEA
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 287954-1

17.0 F 15-May-2007 16-May-2007 1 13-Aug-2007 23-Aug-2007 AZ AZ0710 23-Aug-2007
BIOLOGICALS
Symptom Text: Nausea and Dizziness today (next day after shots)
Other Meds: none
Lab Data:
History: No
Prex Illness: No
Prex Vax Illns:

Vaers Id: 287962-1

15.0 F 25-Jun-2007 27-Jun-2007 2 13-Aug-2007 23-Aug-2007 IN 23-Aug-2007
TDAP GLAXOSMITHKLINE AC 52B014BA 0 Right arm Intramuscular
BIOLOGICALS
HEPA GLAXOSMITHKLINE 172AA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Abdominal pain upper, Blister, Hot flush, Pyrexia, Rash
Symptom Text: Client started with blister in vaginal area which developed into 4 blisters x 2 days. developed fever 101.07 stomachache rash on trunk looked blistery behind
ears and knees. Client given Valtrex symptoms lasted 5-7 days sores dried up scabbed over. hot flashes noted.
Other Meds: Clarinex
Lab Data: Vaginal Cultures- HSV Negative Result
History: Env Allergies
Prex Illness: No
Prex Vax Illns:

Vaers Id: 287970-1 (S)

17.0 F 27-Feb-2007 05-Mar-2007 6 13-Aug-2007 15-Aug-2007 CA 15-Aug-2007
MedDRA PT Activities of daily living impaired, Anhedonia, Anxiety, Apathy, Crying, Depressed mood, Depression, Fatigue, Screaming, Self esteem decreased, Suicidal
ideation
Symptom Text: Within one week she became very depressed. By April her depression weas so severe she missed about 10 days of school. She had sadness, anhedonia, no
motivation, fatigue, low self esteem, hopelessn, helpless, overwhelmed and some suicidal ideation without plan. She began therapy with psychologist and
symptoms improved significantly. She received a 2nd injection of Gardasil onMay 25, 2007. On the very same night she began crying, yelling, became very
depressed and had recurrence of suicidal ideation. She denies ever having an actual plan or intention but did have fantasies of dying. All her other symptoms
of depression also returned.. She also developed a lot of anxiety and concerns and worries about her future. She was evaluated by me, her psychiatrist on
07/19/07. She started Lexapro 5mg and her symptoms significantly improved.
Other Meds: none
Lab Data: 07/21/07 CBC, complete metabolic panel, thyroid function tests, aluminum levels all within normal levels.
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288024-1 (S)

Unknown F 15-Feb-2007 09-May-2007 83 14-Aug-2007 15-Aug-2007 MA WAES0708USA00964 15-Aug-2007

MedDRA PT Muscular weakness, Myelitis transverse, Paraesthesia
Symptom Text: Information has been received from a physician concerning a female who on 15-FEB-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (lot #
653736/0868F). On 09-MAY-2007 the patient developed weakness and paresthesia of the upper and lower extremities. The patient was hospitalized from 09-
MAY-2007 to 14-MAY-2007. The diagnosis was determined to be transverse myelitis. Details of the hospitalization and treatment were not available. The
physician reported that the patient had required additional hospitalization but the details were not available. At the time of the report, the patient's transverse
myelitis persisted. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288025-1

24.0 F 24-Jul-2007 24-Jul-2007 0 14-Aug-2007 15-Aug-2007 MD WAES0708USA01340 15-Aug-2007

MedDRA PT Hypoaesthesia facial, Throat tightness
Symptom Text: Information has been received from a registered nurse, concerning a 24 year old female patient, who on 22-MAY-2007 was vaccinated IM, with the first dose,
0.5ml, of Gardasil (Lot # 657621/0387U), and on 24-JUL-2007 was vaccinated IM, with the second dose, 0.5ml, of Gardasil (Lot # 658094/0524U). There was
no concomitant medication. On 24-JUL-2007, about two hours after the vaccination, the patient experienced numbness in her left cheek and "slight tightening
of her throat." She was instructed to take Benadryl, 50mg, and the symptoms resolved (duration not specified). The reporting nurse considered one or both of
the events to be serious as an other important medical event, as intervention to prevent serious criteria was required. Additional information has been
requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288026-1 (S)


MedDRA PT Optic neuritis retrobulbar
Symptom Text: Information has been received from a health authority concerning a 22 year old female, with no pertinent medical history, who on 05-JUL-2007 was vaccinated
with a first dose of Gardasil. On 07-JUL-2007 the patient experienced retrobulbar neuritis and was hospitalized on an unspecified date. As of 13-JUL-2007, the
patient had not recovered. No further information is available. File is closed. Other business partner numbers include E2007-05171 and PEI2007007376.
Other Meds: Unknown
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288027-1 (S)

13.0 F 05-Dec-2006 05-Dec-2006 0 14-Aug-2007 15-Aug-2007 NY WAES0704USA05856 15-Aug-2007
Seriousness: ER VISIT, EXTENDED HOSPITAL STAY, SERIOUS
MedDRA PT Abdominal distension, Abscess, Constipation, Drug exposure during pregnancy, Furuncle, Jaundice, Rash vesicular, Seborrhoeic dermatitis, Staphylococcal
skin infection, Weight decreased
Symptom Text: Information has been received from a registered nurse for the Pregnancy Registry for Gardasil concerning a 13 year old female with no pertinent medical
history and no previous pregnancies. There is a family history of asthma and eczema on the mothers side and adult onset diabetes on the maternal
grandmother's side. On 05-DEC-2006, the patient was vaccinated with first dose of Gardasil (lot # 654540/1262F) 0.5 ml IM. There was no concomitant
medication. After the first dose of vaccine, it was determined that the patient was pregnant. She had a physical exam on 05-DEC-2006 and was diagnosed with
abdominal fullness. She told the physician at the time of the examination that she currently had her menses. The patient was examined again in January 2007
for a sick visit and was sent for an abdominal ultrasound which showed she was 28 weeks pregnant and all structures within normal limits. Estimated last
menstrual period was on approximately 30-JUN-2006 and her estimated date of delivery was 08-MAR-2007. On 30-MAR-2007, the patient gave birth to a
healthy baby normal vaginal delivery without any complications. The baby was examined for 1 month check up and was healthy. On 24-APR-2007, the patient
was administered her second dose of Gardasil (lot # not reported). No further information was available at the time of reporting. Follow-up information was
received from the registered nurse. Information from medical records revealed: A female full term normal infant was born on 30-MAR-2007. Weight 6 pounds
and 14 ounces, length 20.5 inches. No congenital anomalies or other complications. Bilirubin 5.4 prior to discharge. Passed the hearing test. Discharge weight
6 pounds 9 ounces. The infant was seen on 03-APR-2007 for new born evaluation. Baby is breast feeding. Has mild jaundice, slight decrease in weight since
discharge. Having yellow seedy bowel movements. Coombs test negative. Plan breastfeed more. Evaluated on 04-APR-2007 as follow-up. Excellent weight
gain (7 pounds, gained 8 ounces), excellent breast feeding, and less j
Other Meds:
Lab Data: abdominal ultrasound 01/12/07 - 28 weeks pregnant, Apgar score 03/30/07 8 - baby: at 1 minute and 5 minutes, direct antiglobulin 03/30/07 - baby: negative,
Rapid plasma reagin 03/30/07 - mother: non-reactive, serum rubella IgG 03/30/07 - mo
History:
Prex Vax Illns:

Vaers Id: 288050-1

MedDRA PT Dizziness, Immediate post-injection reaction, Syncope vasovagal
Symptom Text: Pt. received varicella iz first then Gardasil in other arm . immediately said "feel dizzy" then laid pt. down on table. Pt. has a vasovagal event. No true syncope.
Other Meds:
Lab Data: BP 80/54, 90/56; HR 40s; and P to 60s
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288053-1

MedDRA PT Syncope, Syncope
Symptom Text: Syncopy. Fainting attack after 5-10 min of Menactra and Gardasil vaccination
Other Meds:
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288054-1

12.0 F 20-Jul-2007 20-Jul-2007 0 14-Aug-2007 23-Aug-2007 KS 23-Aug-2007
MedDRA PT Dizziness, Loss of consciousness, Pallor, Pruritus
Symptom Text: After receiving vaccinations, pt. left exam room and had a momentary LOC noted. Became pale and pruritic. Taken to exam room to rest with a cook rag. O2
sats 98% on RA, P 66, BP 84/60, BS 103. Did have lunch, but stated felt lightheaded after shots. After eval. her color returned and she was feeling much
better. After several minutes was able to sit up with feet dangling. Left with Mom, ambulating on own.
Other Meds: Albuterol inj. PRN
Lab Data: Vital signs
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288056-1

18.0 F 30-Jul-2007 30-Jul-2007 0 14-Aug-2007 23-Aug-2007 KS 23-Aug-2007

MedDRA PT Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Symptom Text: After patient received Gardasil vaccine, she proceeded out to the waiting area. She then became lightheaded and LOC. Instantly she regained consciousness
and was diaphoretic and pale. She was able to get up and sit in a chair. Then walked back to a exam room, where she laid down. Given water and cool rag.
After physician eval., she had received her color back. Vitals WNL. Able to dangle legs w/o probs. Able to ambulate out of office.
Other Meds: Ortho Tri-Cyclen LO
Lab Data:
History: N/A
Prex Illness: N/A
Prex Vax Illns: Syncope~Tdap (Boostrix)~6~12~In Sibling

Vaers Id: 288061-1


MedDRA PT Pyrexia, Skin nodule
Symptom Text: Knot, fever in left arm

Other Meds:
Lab Data: CBC
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288062-1

13.0 F 06-Aug-2007 07-Aug-2007 1 14-Aug-2007 23-Aug-2007 MN 23-Aug-2007
MNQ SANOFI PASTEUR 62370AA 0 Right arm Intramuscular
TDAP GLAXOSMITHKLINE A052B016BA 5 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Hypersensitivity, Injection site erythema, Injection site pain
Symptom Text: Left arm at site of injection red/tender. Most c/w allergic rx., not infection. No systemic symptoms.
Other Meds:
Lab Data: N/A
History:
Prex Illness: No
Prex Vax Illns:

Vaers Id: 288064-1

43.0 F 09-Aug-2007 09-Aug-2007 0 14-Aug-2007 23-Aug-2007 MI 29-Aug-2007
MedDRA PT Deafness, Loss of consciousness, Pain in extremity, Skin warm, Syncope
Symptom Text: Client reports pain in arm then loss of hearing, then became hot and faint. Brief loss of consciousness. Client was given ice and told to lie down. Given orange
juice to drink. Client recovered with time.
Other Meds:
Lab Data: None
History: None known
Prex Illness: None known
Prex Vax Illns:

Vaers Id: 288068-1

HPV4 MERCK & CO. INC. 1426E 2 Left arm Unknown

MedDRA PT Immediate post-injection reaction, Loss of consciousness, Vomiting
Symptom Text: Patient had brief LOC for about 15 seconds within 1-2 minutes after receiving vaccine. Obtain vitals - normal. On way home, pt. vomited x1, per mom. Later in
day doing well, back to normal.
Other Meds: None
Lab Data: None
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288073-1

HPV4 MERCK & CO. INC. U2383BA 0 Left arm Intramuscular
MedDRA PT Face injury, Laceration, Syncope
Symptom Text: Shortly after having received the vaccines, the patient fainted face down in my office and struck her chin and sustained a laceration on her chin which required
sutures.
Other Meds:
Lab Data: Dextrostick in ED was normal
History: allergic to penicillin-hives
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288082-1

MedDRA PT Dizziness, Lethargy, Pain, Pyrexia, Tenderness
Symptom Text: Pt experienced lethargy, dizzines on day of vaccine administration then fever of 102, then generalized body aches, Right axillary tenderness, continued lethargy
for 4 days
Other Meds: Orthtricyclin
Lab Data: none
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288093-1

HPV4 MERCK & CO. INC. INFO N/A 1 Left arm Subcutaneously

Symptom Text: Nausea and Vomiting and Diarrhea within one hour of vaccine administration. >5 episodes of vomiting and 6-7 episodes of diarrhea.
Other Meds: Birth Control Pill
Lab Data: CBC with WBC 15.1 and electrolytes normal.
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288146-1

MedDRA PT Hypoaesthesia, Oedema peripheral
Symptom Text: Swelling and numbness 3rd and 4th fingers - ipsilateral to injection site. Occurred 12-17 hrs after injection and progressing
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288149-1

13.0 F 23-Jul-2007 26-Jul-2007 3 15-Aug-2007 24-Aug-2007 CT 27-Aug-2007
VARCEL MERCK & CO. INC. 07224 1 Unknown Unknown
MedDRA PT Injection site induration
Symptom Text: 2 1/2 cm tender induration on left arm at Varivax site 2 days after administration. No Rx required, resolved spontaneously. No systemic symptoms.
Other Meds:
Lab Data: None
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288150-1

17.0 F 15-Aug-2007 15-Aug-2007 0 15-Aug-2007 24-Aug-2007 VT 27-Aug-2007
MedDRA PT Dizziness, Immediate post-injection reaction, Musculoskeletal stiffness, Syncope
Symptom Text: I gave HPV first in LA and patient was standing and appeared fine. I then gave the Menactra vaccine in the RA and patient immediately fainted and body
stiffened for less than one minute. She then quickly reoriented and stood up and she was fine. Had two dizzy spells while sitting down, but they resolved w/ her
head b/w legs. Monitored pt x2: 1st laying then sitting, then standing.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288164-1

13.0 F 14-Aug-2007 15-Aug-2007 1 15-Aug-2007 24-Aug-2007 VI 24-Aug-2007
BIOLOGICALS
MedDRA PT Abdominal pain, Nausea, Vomiting
Symptom Text: mother called morning after vaccines. child c/o abdominal pain, nausea and vomiting. no fever. no diarrhea. no other symptoms.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288168-1

14.0 F 09-Aug-2007 09-Aug-2007 0 15-Aug-2007 24-Aug-2007 ID 24-Aug-2007

MedDRA PT Muscle rigidity, Mydriasis, Syncope
Symptom Text: Patient was given HPV vaccine and within 30 seconds had a syncopal episode lasting 30 secinds. Her arms and legs became rigid and eyed dilated.
Recovered quickly. Treatment was application of cool compresses to forehead and neck. Patient had not eaten much that day. B/P was94/66 prior to
administration
Other Meds: none
Lab Data:
History:
Prex Vax Illns:

Vaers Id: 288173-1 (S)

21.0 F 06-Jul-2007 11-Jul-2007 5 15-Aug-2007 20-Aug-2007 TN 20-Aug-2007
HPV4 MERCK & CO. INC. UNKNOWN 1 Unknown Unknown

MedDRA PT Angioedema, Arthralgia, Pain, Serum sickness, Urticaria
Symptom Text: developed serum sickness with arthralgias, urticaria, and angioedema of eyes and lips, high CRP during hospitalization (CRP = 7.9). Received Gardasil on
7/6/07, 5 days before her symptoms began. Hospitalization lasted 5 days for refractory pain from arthralgias. Did not have fever. Urticaria were refractory and
lasted for several days after her hospitalization. Of potential confouding interest, she had also recently received keflex (finished a few days prior to when her
symptoms began)
Other Meds: 1. recently completed course of keflex for parotitis (Mumps IgM titers were negative, amitriptyline 25 mg QHS (IBS symptoms), seasonale (OCP)
Lab Data: Labs from the above hospitalization included CBC (WBC 12.8, hct 39.7, plt 281), BMP (Na 138, K 3.9, Cl 108, HCO3 26, BUN 8, Cr 0.7), LFT's(essentially
normal), ESR 16, and CRP 7.9, and UA (normal). Blood cultures normal x 2.
History: history of idiopathic chronic urticaria
Prex Illness: had already recovered from episode of parotitis
Prex Vax Illns:

Vaers Id: 288210-1 (S)

15.0 F 04-Jun-2007 04-Jun-2007 0 16-Aug-2007 17-Aug-2007 FR WAES0708USA00836 17-Aug-2007

MedDRA PT Headache, Incorrect route of drug administration, Injection site pain
Symptom Text: Information has been received from a physician concerning a 15 year old female patient with no medical history who on 04-JUN-2007, was vaccinated IM into
the upper arm with a first dose of Gardasil (Lot# 654884/0902F; Batch# NE24240). During the injection, the patient complained of pain at the injection site. It
was reported that the doctor who already administered almost the full dose, aspirated once more and at this time, she saw blood in the syringe. She was not
sure whether the vaccine possibly was administered intravenously. The injection was stopped and the patient was fine again. A few days later, the patient
experienced a therapy resistant headache. As the symptom persisted, a lumbar puncture was done (probably the patient was hospitalized overnight). The
result of the procedure showed that protein was slightly increased in the cerebral spinal fluid (CSF). This finding didn't lead to further exploration as the patient
recovered from the headache (exact duration not reported). Pain at the injection site, headache and protein slightly increased in the CSF were considered to be
other important medical events. Other business partners numbers include: E200705081. No further information is available.
Other Meds: Unknown
Lab Data: spinal tap protein slightly increased in the cerebral spinal fluid (CSF)
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288211-1

Unknown F 08-Aug-2007 08-Aug-2007 0 16-Aug-2007 17-Aug-2007 CA WAES0708USA02091 17-Aug-2007

MedDRA PT Convulsion, Dizziness, Head injury, Syncope
Symptom Text: Information has been received from a Physician's Assistant concerning a female patient who on 08-AUG-2007 was vaccinated with her first dose of Gardasil. A
couple of minutes later, the patient became dizzy, fainted and hit her head against something in the office, and had seizures. The office then had paramedics
come and take the patient to the hospital. The amount of time the patient stayed at the hospital was unknown. Her outcome was unknown. Upon internal
review, seizure was considered an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288215-1 (S)

16.0 F 13-Jul-2007 13-Jul-2007 0 16-Aug-2007 21-Aug-2007 VA 21-Aug-2007
MedDRA PT Fall, Head injury, Loss of consciousness, Tonic clonic movements
Symptom Text: Patient fell to floor and hit her head, developed LOC and tonic-clonic movements of arms for about 30 secs and recovered with full orientation for a few minutes
then fell again and had a second similar episode. She was taken to the hospital ER when she had a 3rd episode hours later. Recovered without any further
problems.
Other Meds: None
Lab Data: Head CT scan normal, Blood test normal
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288219-1

TDAP GLAXOSMITHKLINE AC52B018CA 0 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Syncope
Symptom Text: Patient fainted after receiving immunizations-recovered rapidly-pulse 62 BP 100/70 evaluated by physician.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288220-1

12.0 F 01-Aug-2007 05-Aug-2007 4 16-Aug-2007 27-Aug-2007 AL 27-Aug-2007
MedDRA PT Erythema, Oedema
Symptom Text: 4 days after immunization redness and edema noted on (R) shoulder
Other Meds: Claritin PRN Advair PRN
Lab Data: None
History: asthma
Prex Illness: None
Prex Vax Illns: redness, swelling~Tdap (no brand name)~5~11~In Sibling

Vaers Id: 288225-1

16.0 F 29-Aug-2006 11-Jun-2007 286 16-Aug-2007 27-Aug-2007 VA 27-Aug-2007

MedDRA PT Arthralgia, Pain
Symptom Text: Joint pains- hands and feet noted 6/11/07. Workup showed (+) ANA of 1:160. Patient read article from "National Vaccine Information Center" and would like
this to be reported as a possible adverse event following Gardasil to VAERS
Other Meds: None
Lab Data: ANA (+) 1:160
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288226-1


MedDRA PT Injection site pain, Neck pain
Symptom Text: Pain radiating from (L) delt IM site, to (L) shoulder, to (L) neck since im on 8/4/07 through today 8/10/07
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288227-1

MNQ SANOFI PASTEUR U2324AA 0 Left arm Intramuscular VARCEL
MedDRA PT Syncope, Throat tightness
Symptom Text: syncope-recovered quickly when layed down c/o throat tightness-did not progress to allergic reaction
Other Meds:
Lab Data: None
History: Sulfa Penicillin Ceclor allergy
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288230-1

17.0 F 18-May-2007 18-May-2007 0 16-Aug-2007 27-Aug-2007 TX 27-Aug-2007
MedDRA PT Laceration, Syncope
Symptom Text: Teen fainted, sustained a laceration that required repair

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288231-1


Symptom Text: Pt started feeling queasy and nauseous the day after having HPV. Vomited x 1
Other Meds:
Lab Data:
History: allergic - amoxicillin
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288250-1

14.0 F 14-Aug-2007 14-Aug-2007 0 16-Aug-2007 27-Aug-2007 IL 27-Aug-2007

MedDRA PT Blood pressure, Headache, Syncope
Symptom Text: Patient received shot, walked to waiting room and fainted. Brought back into exam room. HA and ST occurred at time of feeling faint. No SOB, BP 115/50
Other Meds: None
Lab Data:
History: Sickle cell trait
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288252-1

12.0 F 16-Aug-2007 11-Sep-2007 26 16-Aug-2007 27-Aug-2007 MN 27-Aug-2007
HEPA GLAXOSMITHKLINE AHAVB163AB Unknown Intramuscular
BIOLOGICALS
MedDRA PT Dizziness, Nausea, Nausea, Pyrexia
Symptom Text: dose #1-Nausea, fever one day after shot same day-lightheaded, queasy Dose #2 severe queasiness, lightheaded, nausea
Other Meds:
Lab Data: Normal EKG
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288253-1

HEPA GLAXOSMITHKLINE AHAVB186BA 0 Right arm Unknown
BIOLOGICALS
MedDRA PT Loss of consciousness, Pallor, Syncope
Symptom Text: After receiving HPV and HepA vaccines patient became pale and "everything looked black." Patient had a syncopal episode for a few seconds.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:


13.0 F 01-Aug-2007 15-Aug-2007 14 16-Aug-2007 27-Aug-2007 ID 27-Aug-2007
Symptom Text: left sided facial nerve paralysis (Bell's palsy)

Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:


13.0 F 01-Aug-2007 15-Aug-2007 14 27-Aug-2007 28-Aug-2007 ID 200702816 28-Aug-2007
Symptom Text: Initial report received from a health care professional in the United States on 16 August 2007. A 13-year-old female had received a left deltoid injection of
Menactra, lot number U2278AA, expiration date 09 May 2008, and a left deltoid injection of Gardasil, lot number 0515U on 01 August 2007 and 14 days later
developed left sided facial nerve paralysis (Bell's Palsy). The route of administration of both vaccines had not been reported. The patient had no illness at the
time of vaccination, no reported medical history and they had not received any concomitant medications. The patient had received a prior dose of Menactra and
no prior events had been reported at this time. The date and route/site of administration for Menactra previously received had not been reported. The patient's
status had been listed as not recovered at the time of this report.
Other Meds:
Lab Data: None reported
History: The patient had no illness at the time of vaccination and no reported medical history.
Prex Illness:
Prex Vax Illns:

Vaers Id: 288279-1

23.0 F 15-Aug-2007 15-Aug-2007 0 16-Aug-2007 24-Aug-2007 MO 24-Aug-2007

MedDRA PT Syncope
Symptom Text: After receiving vaccine, patient fainted as needle was being removed. Patient responded within seconds of fainting. B/P 90/60
Other Meds: none
Lab Data: none
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288284-1

25.0 U 15-Aug-2007 15-Aug-2007 0 16-Aug-2007 24-Aug-2007 DE 24-Aug-2007
HEP MERCK & CO. INC. 0762U 1 Right arm Intramuscular
MedDRA PT Abdominal pain, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Symptom Text: Approximately 10 minutes after receving #1 Gardisil and 15 mintues after receiving #2 Hep , client suddenly lost consciousness while seated in the waitng area
of the clinic. This lasted for about 1 minute. She slowly returned to consciousness, but was very diaphoretic and pale. Ammonia capsule used and client's color
improved and diphoresis subsided. Within 20-30 minutes of initially losing consciousness she was able to walk out of clinic with family, fully alert and with no
complaints. Principal complaint when able to speak about incident was that she felt very nauseated, had sudden abdominal cramping and then everything went
black.
Other Meds: Ortho-Evra Patches
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288342-1

22.0 F 30-Jul-2007 30-Jul-2007 0 17-Aug-2007 20-Aug-2007 FL WAES0708USA01634 20-Aug-2007

Symptom Text: Information has been received from a health professional concerning a 22 year old white female student who on 30-JUL-2007 at 3:30 pm, was vaccinated IM,
in the left deltoid with a second dose of Gardasil (lot # 657868/0523U). On 30-JUL-2007 the patient "appeared to have a seizure." Unspecified medical
attention was sought. On 30-JUL-2007, the patient recovered from seizure. Upon internal review, a seizure was considered to be an other important medical
event. Additional information is not expected.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288343-1 (S)


MedDRA PT Dizziness, Dyspnoea, Familial risk factor, Pyrexia
Symptom Text: Information has been received from a health professional concerning a 21 year old female, with no history and a paternal history of sarcoidosis, who on 20-
JUN-2007 was vaccinated with a first dose of Gardasil (lot #655376/0572F), batch # NE47600). On 25-JUN-2007 the patient experienced dizziness, dyspnoea
and fever 39-40 C of unknown origin. On 26-JUN-2007 the patient was hospitalized. There was no apparent focus for infection and no conclusive diagnosis. On
27-JUN-2007 the patient was discharged from the hospital for ambulatory follow-up. The patient was continued experiencing fever episodes (39-40 C) for three
to four hours duration every three to four days. Additional information has been requested. Other business partner numbers include E2007-05199.
Other Meds: Unknown
Lab Data: body temp 25Jul07 39-40C
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288353-1

19.0 F 15-Aug-2007 Unknown 17-Aug-2007 27-Aug-2007 MI 27-Aug-2007
HEPA GLAXOSMITHKLINE AHAVB186CA 0 Left arm Intramuscular
BIOLOGICALS
MedDRA PT Incorrect dose administered, Wrong drug administered
Symptom Text: Pt received Hep A pediatric dose instead of adult dose: under-immunized.
Other Meds: Benzoyl Peroxide - Erythromycin
Lab Data: None
History: Acne
Prex Illness: Physical
Prex Vax Illns:

Vaers Id: 288356-1


MedDRA PT Blood pressure decreased, Dizziness, Dizziness, Heart rate decreased, Loss of consciousness, Malaise, Pain in extremity, Pallor
Symptom Text: Within 1 min of receiving Gardasil, pt was having finger aches and stated that she felt dizzy. Pt started to lay down then passed out, became pale. VS - HR 42,
BP 80/38, O2 Sat 100%. Regained conscious, felt "sick lightheaded". IV started by MD. Pt sent to ER for further evaluation.
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288360-1

11.0 F 02-Aug-2007 02-Aug-2007 0 17-Aug-2007 27-Aug-2007 WA WAES072168 27-Aug-2007
BIOLOGICALS
MedDRA PT Dizziness, Pallor
Symptom Text: Rcvd Gardasil #1 at routine annual exam, as well as Tdap, and Hep A #1. After leaving the office, child got to end of hallway and became pale and light-
headed. Brought back to office in wheelchair - seen by MD.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288362-1

23.0 F 10-Aug-2007 10-Aug-2007 0 17-Aug-2007 27-Aug-2007 OH 27-Aug-2007

MedDRA PT Feeling abnormal, Pharyngeal oedema, Swollen tongue
Symptom Text: I received the first shot of the Gardasil vaccine series on Friday, August 10 at 12:30pm. The nurse asked me to stay five minutes to see if I had any reaction to
the vaccine, but I chose not to and left after I scheduled my second shot for October 5, 2007. A few minutes after I got in my car to leave, I started to feel
strange and it felt as if my throat and tongue were swelling. It was not severe, but enough to make me question what was happening. I waited to see if it would
subside, it did not, and 15 minutes later I took a Benadryl and that helped. After an hour of sleep, I felt fine. I just wanted to let you know about this experienced
and I have called your office this morning to discuss with the nurse if I should proceed with the next two shots. I am waiting on a call back from the nurse.
Other Meds: Junel
Lab Data: None
History: NKDA - denies others
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288380-1

HPV4 MERCK & CO. INC. O9300 1 Unknown Intramuscular

MedDRA PT Chest discomfort, Dyspnoea, Injection site pain, Neck pain
Symptom Text: Within minutes - neck pain/injection site pain 1 hr dyspnea/chest tightness. Sent to ED for monitoring
Other Meds:
Lab Data:
History:
Prex Illness: No illness/well visit
Prex Vax Illns:

Vaers Id: 288381-1


MedDRA PT Vulvovaginal pruritus
Symptom Text: Pt began to have vaginal pruritus same day received the Gardasil vaccine. No discharge or redness or swelling. No fever. Pruritus improved by time seen 2
days later.
Other Meds:
Lab Data:
History: Ovarian cyst on hormonal therapy
Prex Illness: Ovarian Cyst
Prex Vax Illns:

Vaers Id: 288414-1


MedDRA PT Erythema, Paraesthesia, Pruritus, Rash
Symptom Text: VAERS submitted since HPV vaccine not included on Table of Reportable Events......Pt resides in another state (school). Gardasil administered in deltoid on
8/14/07 during office visit. Phone call received on 8/17 from pt, now returned back home. Pt reports that 6 hours after administration of Gardasil, pt
experienced "prickly, itchy" sensation on back, arms, & underneath breasts accompanied by "splotchy redness", not raised. Pt denies SOB. Pt relates sx have
been improving since initial onset & will start trial of OTC Benadryl for residual sx. Pt was not seen at local facility. Approximately 90 mintues after taking
Benadryl, pt reported resolution of sx. Then pt also reported that she had smoked marijuana within the 6 hours between the injection & onset of rash.
Other Meds: Yasmin
Lab Data: None
History: Denied by pt
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288419-1

MedDRA PT Body temperature increased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Symptom Text: REDNESS,SWELLING,WARMTH,PAIN WITH MILD ITCH AT THE INJECTION SITE ON THE LEFT UPPER ARM (LATERAL)SINCE 09:00PM ON 08/16/07.
BODY TEMP WAS 100.0F(A) AT 09:00PM, WHICH RESOLVED BY ONE DOSE OF TYLENOL(160MG/5ML)1TSP. Possible cellulitis vs. vaccine reaction.
Treatment: Augmentin
Other Meds:
Lab Data:
History: none
Prex Illness: Dental caries (Started Amoxicillin after vax).
Prex Vax Illns:

Vaers Id: 288453-1 (S)

16.0 F 26-Jun-2007 09-Jul-2007 13 20-Aug-2007 21-Aug-2007 CT WAES0708USA02045 28-Aug-2007
HPV4 MERCK & CO. INC. 0011U 1 Left arm Unknown HPV4

MedDRA PT Blindness unilateral, Multiple sclerosis
Symptom Text: Information has been received from a physician concerning a 16 year old female who on 24-APR-2007 was vaccinated with the first dose of Gardasil (lot #
654510/0962F). On 24-APR-2007, the patient was vaccinated with the second dose of Gardasil (lot # 654702/0011U). The patient sought medical attention and
was hospitalized on 09-JUL-2007 after experiencing blindness in her left eye. The patient was diagnosed with multiple sclerosis while hospitalized. The
physician noted the blindness had been experienced for approximately 6-8 weeks prior to the hospitalization. At the time of reporting, the outcome was
unspecified. Upon internal review, multiple sclerosis was considered to be an Other Important Medical Event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288454-1

17.0 F Unknown Unknown 20-Aug-2007 21-Aug-2007 FL WAES0708USA01976 21-Aug-2007
Symptom Text: Information has been received from a physician concerning a 17 year old female patient with a history of passing out and convulsion who was vaccinated with a
first dose of Gardasil (date not specified). Concomitant therapy included other unspecified vaccines. The physician reported that the patient passed out and
then had a seizure after getting the first dose of Gardasil. The patient sought unspecified medical attention. The outcome was unknown. Upon internal review,
seizure was considered to be an other important medical event. Additional information has been requested.
Other Meds:
Lab Data: Unknown
History: Passed out; Convulsion
Prex Illness:
Prex Vax Illns:

Vaers Id: 288455-1 (S)


MedDRA PT Neck pain
intramuscularly in the upper arm with a dose of Gardasil. On 08-JUN-2007 the patient experienced severe neck pain and was hospitalized to rule out
meningitis. Laboratory and diagnostic tests performed included, a lumbar puncture, electrocardiogram (ECG), and unspecified laboratory tests, findings were
normal. On 09-JUN-2007 the patient's symptoms had remarkably improved and she was discharged. Muscular tension was assumed to be the cause of the
patients complaints. At the time of the report the patient recovered completely. Additional information is not expected. This case is closed. Other business
partner numbers included E2007-05241.
Other Meds: Unknown
Lab Data: spinal tap 08Jun07 normal results, electrocardiogram normal, blood chemistry 08Jun07 normal
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288456-1

17.0 F 12-Jul-2007 Unknown 20-Aug-2007 21-Aug-2007 TX WAES0708USA01821 21-Aug-2007

Symptom Text: Information has been received from a health professional concerning a 17 year old female, who on 12-JUL-2007 was vaccinated with a first 0.5mL dose of
Gardasil. At the time of the first vaccination the patient was unaware that she was three weeks pregnant. In August 2007 the patient was vaccinated with a
second dose of Gardasil. The patient miscarried sometime between the first dose and the second dose. The patient sought unspecified medical attention. At
the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Vax Illns:

Vaers Id: 288457-1 (S)

20.0 F 19-Jun-2007 18-Jul-2007 29 20-Aug-2007 21-Aug-2007 FR WAES0708USA01696 21-Aug-2007

MedDRA PT Autoimmune thyroiditis, Diarrhoea, Malaise, Sinus tachycardia, Tremor
intramuscularly in the upper arm with a first dose of Gardasil (Lot # 1339F, batch # NF23310). On 18-JUL-2007 the patient developed sinus tachycardia,
malaise, and a slight resting tremor and was hospitalized. The patient reported on admission that she had been having diarrhea for a while, but had not lost
weight. Laboratory findings showed a hyperthyrosis. Ultrasound of the thyroid showed no nodules and radioisotope scanning showed diffuse autonomia. Chest
x-ray, echocardiography, and electrocardiogram (ECG) were normal except tachycardia. Free serum thyroxine index was 2.00 and free serum triiodothyronine
test was 5.83. On 20-Jul-2007 the white blood cell count was 5,600 microL. Results for MAK, TAK, and TRAX were not available. The patient was treated with
Favistan and Dociton and symptoms improved. On 23-JUL-07 the patient was discharged from the hospital and an examination in an endocrinologic surgery
was planned. On 07-AUG-2007 it was learned from the vaccinating physician that the patient was diagnosed with Hashimoto's thyroiditis. At the time of the
report the patient's symptoms had improved. Additional information is not available. Other business partner number included E2007-05231. Additional
Other Meds: Unknown
Lab Data: ultrasound No nodules, thyroid radionuclear scan Diffuse autonomia, chest X-ray normal except tachycardia, echocardiography normal except tachycardia,
electrocardiogram normal except tachycardia, diagnostic laboratory test MAK, TAK and TRAK
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288458-1 (S)

19.0 F 06-Aug-2007 06-Aug-2007 0 20-Aug-2007 21-Aug-2007 TX WAES0708USA01429 21-Aug-2007

MedDRA PT Abdominal pain, Diarrhoea, Nausea, Vomiting
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female patient with a history of cholecystectomy (FEBRUARY 2005) and no
allergies who on 06-AUG-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot # 658282/0929U). Concomitant therapy included ethinyl
estradiol/norethidrone (OVCON). About 2 hours after receiving the vaccine, the patient experienced severe abdominal pain, nausea, vomiting and diarrhea. The
patient stated that the area that hurts was about 2 inches from her belly button. The patient was prescribed atropine sulfate (+) diphenoxylate hydrochloride
(LOMOTRIL) and promethazine hydrochloride (PHENERGAN). It was reported that the next day the patient called the office and her stomach pain had gotten
worse. On a scale of 1 to 10 the patient felt her pain was a six. Laboratory diagnostic studies given on 07-AUG-2007 included a CBC and a thyroid study. Both
were reported as normal. The patient no longer has diarrhea but was still experiencing nausea and vomiting. The outcome of severe abdominal pain was
unknown. No product quality complaint was involved. Severe abdominal pain, nausea, vomiting and diarrhea were considered to be disabling. Additional
Other Meds: OVCON
Lab Data: complete blood cell 08/07/07 normal, serum TSH 08/07/07 normal
History: Cholecystectomy
Prex Illness:
Prex Vax Illns:

Vaers Id: 288459-1

17.0 F 02-Jul-2007 02-Jul-2007 0 20-Aug-2007 21-Aug-2007 WV WAES0707USA00550 21-Aug-2007

Symptom Text: Initial and follow-up information has been received through the Merck Pregnancy registry from a registered nurse a 17 year old white female with bipolar
disorder, headache, and no previous pregnancies, who on 02-JUL-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 655617/1447F).
Concomitant therapy included XANAX. On 02-JUL-2007, after the vaccination, a urine beta-human chorionic gonadotropin test was reported positive for
pregnancy. The patients last menstrual period was 24-MAY-2007. The estimated date of delivery was 02-MAR-2008. On 19-JUL-2007, at 8 weeks from the last
menstrual period, the patient had an elective termination of the pregnancy. The patient was scheduled to return for her second dose of Gardasil on 10-SEP-
2007. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not expected.
Other Meds: XANAX
Lab Data: urine beta-human 07/02/07 posit
History:
Prex Illness: Pregnancy NOS (LMP = 5/24/2007); Bipolar disorder; Headache
Prex Vax Illns:

Vaers Id: 288474-1


MedDRA PT Syncope, Tremor, Unresponsive to stimuli
Symptom Text: Patient received vaccine left exam room, walked to check out window, states she is feeling well, becomes faint placed in chair becomes unresponsive and 2x
shaking movements of upper body. Cold cloth applied to face and forehead, Ammonia salts given after approx 1-2 minutes Pt seems responsive Pt assisted to
exam table rested approx 5 min states was feeling better.
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288476-1

13.0 F 06-Aug-2007 06-Aug-2007 0 20-Aug-2007 28-Aug-2007 VA 28-Aug-2007
MedDRA PT Pallor, Syncope vasovagal, Vomiting
Symptom Text: Pt had vasovagal response with vomiting. Pt sat with head in between legs/knees. Color returned to normal within 10 minutes.
Other Meds:
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288486-1

VARCEL MERCK & CO. INC. 08424 1 Right arm Unknown
MedDRA PT Erythema, Induration, Local reaction, Pain
Symptom Text: 24 hrs after Varivax injection developed painful local reaction. Induration, Erythema 6x 8 cm Rx with ice and Benadryl
Other Meds: Nasonex, Loratadine
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288493-1

14.0 F 26-May-2007 10-Jun-2007 15 20-Aug-2007 28-Aug-2007 TX TX07069 28-Aug-2007

MedDRA PT Arthralgia, Erythema, Myalgia, Swelling
Symptom Text: Patient came in 6/11/07 complaining of pain right wrist going to antebrachial area, then left wrist join antebrachial area, start in 6/10/07 pain and swelling right
and left wrist, tenderness muscle of bottom arms join to the shoulder small redness on right wrist looks mosquito or insect bite.
Other Meds:
Lab Data: Refer to orthopedics and neurologist
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288495-1

MedDRA PT Injection site erythema, Injection site warmth
Symptom Text: Area red and hot to touch at site of Varivax injection right back arm. Treatment: ice, Benadryl, elevation, Motrin
Other Meds: Orthotricyclen
Lab Data: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288515-1

13.0 F 16-Aug-2007 16-Aug-2007 0 20-Aug-2007 24-Aug-2007 WV 24-Aug-2007
VARCEL MERCK & CO. INC. M0174U 1 Left arm Unknown
HPV4 MERCK & CO. INC. M0181U 0 Right arm Unknown
Symptom Text: Hives noted in the evening on date of vaccine administration, waxing and waning over the next 4 days, last noted the evening prior to filing this report. Benadryl
2+ doses given for itching. No vomiting, shortness of breath, or wheezing.
Other Meds: Benzaclin
Lab Data: none performed
History: exercise-induced asthma, acne
Prex Illness:
Prex Vax Illns:

Vaers Id: 288516-1

MedDRA PT Injection site erythema, Injection site swelling, Rash
Symptom Text: Red and swollen area on R upper arm where immunizations were given on 8/14/07. She also developed some red, raised areas on L arm and fingers. She took
Benedryl and it helped to lessen the degree of redness and puffiness to the bumps.
Other Meds: Cymbalta, Lamictal
Lab Data: None
History: Migranes, Ligament laxity, Dysthymic disorder
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288528-1

Unknown F Unknown Unknown 21-Aug-2007 22-Aug-2007 LA WAES0707USA04078 22-Aug-2007

MedDRA PT Abortion induced, Drug exposure during pregnancy, Pregnancy
Symptom Text: Information has been received from the Pregnancy Registry for Gardasil from a physician concerning a female who was vaccinated with the first dose of
Gardasil (lot # unknown) 0.5 mL. The physician recently found out the patient was pregnant. The physician did not know if the patient would terminate the
pregnancy. No adverse experience was reported. Medical attention was sought. Follow-up information was received from the physician. The physician reported
that the patient had an elective termination of her pregnancy not due to the use of Gardasil. Upon internal review elective abortion is considered to be an other
Other Meds: Unknown
Lab Data: urine beta-human positive
History:
Prex Illness: Pregnancy NOS (LMP=Unknown)
Prex Vax Illns:

Vaers Id: 288529-1

Unknown F Unknown Unknown 21-Aug-2007 22-Aug-2007 FR WAES0708AUS00184 22-Aug-2007

MedDRA PT Condition aggravated, Grand mal convulsion
Symptom Text: Information has been received from a female patient's mother who contacted the Population Health Unit as part of a business agreement concerning her
daughter who has severe uncontrolled epilepsy and was vaccinated with Gardasil. Following both the first and second doses of Gardasil administration, the
patient experienced grand mal seizures. The nurse from the Population Health Unit stated that although seizures were experienced following administration of
Gardasil, she believed the seizures may have been related to the patient's pre-existing condition. Upon internal review, grand mal seizures were considered to
be other important medical events. No further information is available.
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Epilepsy
Prex Vax Illns:

Vaers Id: 288543-1

MedDRA PT Skin laceration, Syncope
Symptom Text: Syncope - laceration head requiring sutures

Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288546-1

11.0 F 16-Aug-2007 Unknown 21-Aug-2007 29-Aug-2007 MN 29-Aug-2007
TTOX MASS. PUB HLTH BIOL LAB TD160 Left arm Intramuscular
HEPAB GLAXOSMITHKLINE NULL Left arm Intramuscular
BIOLOGICALS
MedDRA PT Wrong drug administered
Symptom Text: Was given Twinrix Hep A/Hep B to early, not 18 yrs old yet. No reaction stayed at clinic for 20 min.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288559-1

13.0 F 13-Aug-2007 16-Aug-2007 3 21-Aug-2007 29-Aug-2007 OR 29-Aug-2007

MedDRA PT Headache, Stomach discomfort, Vomiting
Symptom Text: 9-16-07 Headache, vomiting all day. 9-17-07 Headache, upset stomach.
Other Meds: N/A
Lab Data:
History: N/A
Prex Illness: N/A
Prex Vax Illns:

Vaers Id: 288564-1

MedDRA PT Blood pressure, Pallor, Syncope
Symptom Text: I applied PPD test to left forearm and then gave Varivax, Menactra, and Gardasil, Patient wanted band-aid on PPD site because she didn't want to look at it.
She became very pale and fainted onto exam table. She got up after a few second and took BP 130/30. Waited in office 30 min, BP 100/64. Stated she felt fine
and went home.
Other Meds: None
Lab Data: PPD TB test applied 7/31/07
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288568-1


Symptom Text: Pt stated arm was dead and heavy, continued, was able to move it, no numbness or tingling. pt called next day arm felt fine.
Other Meds:
Lab Data: None
History: Allergy to dogs.
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288569-1

MedDRA PT Rash, Varicella
Symptom Text: Left arm with "varicella rash"

Other Meds: Advair; Albuterol inhaler
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288579-1

18.0 F 16-Aug-2007 Unknown 21-Aug-2007 24-Aug-2007 IN 27-Aug-2007
Symptom Text: Patient discovered that she is pregnant approximately 4 days after the administration of Gardasil, Ttdap (Adacel), and Menactra.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288580-1

32.0 F 03-Jul-2007 Unknown 21-Aug-2007 24-Aug-2007 MI 27-Aug-2007
HEP MERCK & CO. INC. 0010U 0 Right arm Intramuscular
Symptom Text: HPV administered on 7-3-07, pt is 32 years of age at time of receiving vaccine
Other Meds:
Lab Data:
History: Office visit for annual exam
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288582-1

32.0 F 14-May-2007 14-May-2007 0 21-Aug-2007 24-Aug-2007 MI 27-Aug-2007

Symptom Text: Received HPV vaccine at age 32 years on 5-14-2007 and 7-17-2007. No adverse event.
Other Meds:
Lab Data: none
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288583-1

27.0 F 26-Apr-2007 26-Apr-2007 0 21-Aug-2007 24-Aug-2007 MI 27-Aug-2007
HEP SANOFI PASTEUR C2572AA 0 Right arm Intramuscular
Symptom Text: VAERS report submitted due to pt receiving the HPV vaccines on 4-26-07 (lot # 0962F) and 5-29-07 (lot # 0384U), at age 27 years (beyond the recommended
age recommendations).
Other Meds:
Lab Data: none
History:
Prex Illness: None, annual exam
Prex Vax Illns:

Vaers Id: 288586-1

28.0 F 22-May-2007 22-May-2007 0 21-Aug-2007 24-Aug-2007 MI 27-Aug-2007

MedDRA PT Inappropriate schedule of drug administration, No adverse effect
Symptom Text: Pt received HPV vaccine on 5-22-07 (lot # 0387U) and 7-17-2007 (lot # 0387U. VAERS report submitted due to pt receiving HPV vaccines beyond the
recommended age range of 26 years. No adverse events occured.
Other Meds:
Lab Data: none
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288590-1

DTAPH UNKNOWN MANUFACTURER U1965AB 5 Unknown Intramuscular
BIOLOGICALS
MedDRA PT Hyperhidrosis, Hypokinesia, Immediate post-injection reaction, Inappropriate schedule of drug administration, Nausea, Pallor, Wrong drug administered
Symptom Text: Patient immediately became pale, nauseated, and diaphoretic. She was momentarily non responsive. Remained nauseated for the remainder of the day
Other Meds: Birth Control
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288592-1

TDAP SANOFI PASTEUR U1965AB 1 Left leg Intramuscular
MedDRA PT Erythema, Local reaction, Pruritus, Swelling
Symptom Text: Approximately 12 hours after receiving injections patient developed localized reaction 4 inches of redness, swelling, and itching
Other Meds: NONE
Lab Data:
History: Asthma
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 288593-1


MedDRA PT Dyspnoea, Lip swelling, Pyrexia
Symptom Text: lip swelling, fever, transient shortness of breath day after 2nd gardasil vaccination was given
Other Meds: depo-provera
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288594-1

Symptom Text: On 8/16/07 during routine vaccination screening, Public Health Nurse questioned client and clients mother to see if she was possibly pregnant, and client
stated no. Nurse Administered HPV & MCV 4 to Client. Client then presented to Clinic on 8/21/07 with mother for pregnancy test and was positive. Public
Health Nurse phoned CDC information line and was encouraged to complete VAERS form and have Client to register with HPV Pregnancy Registry. Client not
to receive the followup doses of HPV vaccine until completion of pregnancy.
Other Meds: none
Lab Data: Positive Pregnancy test 5 days post vaccination with HPV & MCV 4. Client is estimated to be about 5-6 wks gestation.
History: none
Prex Illness: none
Prex Vax Illns: none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2

Vaers Id: 288595-1

17.0 F 20-Aug-2007 Unknown 21-Aug-2007 24-Aug-2007 NC 31-Aug-2007
TDAP UNKNOWN MANUFACTURER NULL 0 Left arm Intramuscular HEP
HPV UNKNOWN MANUFACTURER NULL 0 Right arm Intramuscular
MedDRA PT Abdominal pain upper, Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Symptom Text: pain at the injection site.redness and swelling at the injection site. moderate fever(102 F). headache. stomach ache.
Other Meds: seroquel, 50mg
Lab Data: none
History: none
Prex Illness: pain at the injection site.
Prex Vax Illns:

Vaers Id: 288596-1


Symptom Text: Pt woke up day after vaccine administration (received only gardasil) with head itching, sides, bottom itching - elbows with rash - roundish red bumps. Pt denied
throat symptoms, SOB. Clinician recommended claritin or benadrl until rash is gone plus 1% hydrocortisone to rash bid.
Other Meds: advil
Lab Data: none
History: s/p Left hip tumor removed 2002
Prex Illness: muscle soreness
Prex Vax Illns:

Vaers Id: 288597-1


MedDRA PT Cough, Headache, Lymphadenopathy, Rash, Rash
Symptom Text: Pt's grandmother called. Rash started on ankles, also noted rash on face and arms. Throat glands got swollen. Non painful - 'felt funny'. Also developed
headache. Came in to see practitioner 4 days after immunization - had 2-3d history of cough, negative rapid strep, but culture grew moderate amt Beta Strep,
not group A or group B.
Other Meds: none
Lab Data: Rapid Strep - negative. Throat culture positive for moderate amount Beta Strep, not group A or group B. Moderate amount normal respiratory flora.
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288603-1

MedDRA PT Erythema, Pruritus, Rash, Varicella
Symptom Text: Vaccine given on Thursday Aug 1, 2007. Broke into rashes immediately after shower on Saturday, Aug 3, 2007 around 2 pm. Itiching, redness, chicken pox
marks of different color levels spread all over the body within 10 to 15 minutes. Called 24 hour line, and gave Benedryl -normal dosage at 6 hrly interval.
Other Meds: None
Lab Data: None. Confirmed adverse reaction to chicken pox vaccine and that the break out too is a chicken pox rash from second appointment with Dr. on Aug 5, 2007.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288628-1 (S)

20.0 F 26-Apr-2007 26-Apr-2007 0 22-Aug-2007 23-Aug-2007 FR WAES0708POL00011 23-Aug-2007

MedDRA PT Body temperature increased, Injection site pain, Injection site pain, Night sweats, Polycythaemia
Symptom Text: Information has been received from a physician concerning a 20 year old female who on 26-APR-2007 was vaccinated with the first dose of Gardasil. On 26-
APR-2007 the patient experienced temperature elevation to 37 grades of Celsius with increase to 38 grades of Celsius, polycythaemia, nocturnal drenching
sweat and injection site pain. The patient was hospitalized. According to the recommendation of the haematologist the therapy with Gardasil was discontinued.
The patient's temperature elevation and polycythaemia persisted. Outcome of nocturnal drenching sweat and injection site is unknown. The reporter felt that
temperature elevation, polycythaemia, nocturnal drenching sweat and injection site tenderness were related to therapy with Gardasil. Additional information has
been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288629-1

18.0 F 11-Aug-2007 11-Aug-2007 0 22-Aug-2007 23-Aug-2007 FR WAES0708PHL00003 23-Aug-2007

MedDRA PT Dizziness, Loss of consciousness, Muscle spasms
Symptom Text: Information has been received from a physician concerning an 18 year old female who on 11-AUG-2007 was vaccinated with Gardasil. On 11-AUG-2007,
approximately 10 minutes after vaccination, the patient experienced dizziness followed by loss of consciousness and spasms of the limbs. A few seconds after,
the patient recovered from dizziness, loss of consciousness and spasms of the limbs. She was brought to the emergency room for observation. Her vital signs
were normal. Sodium, potassium and chloride levels were normal. Calcium was found to be low. The reporter felt that dizziness, loss of consciousness and
spasms of the limbs were related to therapy with Gardasil. The reporting physician considered dizziness, loss of consciousness and spasms of the limbs as
other important medical events and serious. Low serum calcium level is an abstracted event. No further information is available.
Other Meds: Unknown
Lab Data: serum calcium 11Aug07 low, serum chloride 11Aug07 normal, serum potassium 11Aug07 normal, serum sodium 11Aug07 normal
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288630-1

17.0 F 30-Jan-2007 27-Nov-2006 -64 22-Aug-2007 23-Aug-2007 -- WAES0705USA05442 23-Aug-2007

MedDRA PT Caesarean section, Drug exposure during pregnancy, Pre-eclampsia, Pregnancy, Premature labour
Symptom Text: Initial and follow up information has been received as part of a pregnancy registry from a nurse practitioner concerning a 17 year old black female with asthma,
who in January 2007, was vaccinated with a 0.5mL dose of Gardasil (Lot# 653938/0954F). Concomitant medications included albuterol inhaler ("last used
winter during allergy season") and Qvar. On 27-NOV-2006 the patient became pregnant. On 23-MAY-2007, the patient underwent a lab test that was positive
and revealed that she was 23 weeks and 5 days pregnant. The patient's last menstrual period was 27-NOV-2006 and her estimated date of delivery was 03-
SEP-2007. The patient had two previous births resulting in elective abortions. On 11-APR-2007 an alpha-fetalprotein test was taken and the results were
negative. On 02-MAY-2007 an ultrasound was taken and the results were negative. The patient experienced pre-eclampsia resulting in a premature delivery by
caeserian section on 12-JUL-2007. The infant was born normal and no congenital anomalies. The infant was a male with a low birthweight of 1510 grams, a
length of 43.5cm, a head circumference of 31cm and an Apgar score of 8/9. At the time of the report, the patient's outcome was unknown. The pre-eclampsia
and premature delivery were considered to be other important medical events. Additional information has been requested.
Other Meds: albuterol, QVAR 80 microgm
Lab Data: ultrasound 05/02/07 - negative; beta-human chorionic 05/23/07 - positive; serum alpha-fetoprotein 04/11/07 - negative
History: Termination of Pregnancy - elective
Prex Illness: Pregnancy NOS (LMP = 11/27/2006); Asthma
Prex Vax Illns:

Vaers Id: 288637-1

19.0 F Unknown Unknown 22-Aug-2007 29-Aug-2007 PA 29-Aug-2007
HPV UNKNOWN MANUFACTURER NULL Unknown Subcutaneously

MedDRA PT White blood cell count decreased
Symptom Text: Decreased WBC (2.1) now resolved (4 wks)

Other Meds: None
Lab Data: CBC; HIV
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288640-1

17.0 F Unknown Unknown 22-Aug-2007 29-Aug-2007 CA 29-Aug-2007
MedDRA PT Asthenia, Dizziness, Dizziness, Fatigue, Headache, Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Syncope
Symptom Text: Dizziness, blacked out - fainted (out for 1 min.), nausea, paleness, sweating, weakness, tired, weak, dizzy and headache for several hours after (still has
symptoms 24 hours later)
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288660-1


MedDRA PT Eye pruritus, Eyelid oedema
Symptom Text: Swelling and pruritus of eyelids bilaterally within 12-18 hours of receiving first Gardasil vaccine.
Other Meds:
Lab Data:
History: Allergy to cats, asthma
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288664-1

HPV4 MERCK & CO. INC. 0802U Right leg Intramuscular
MedDRA PT Dizziness, Tremor, Visual disturbance
Symptom Text: Dizziness began 21 min after vaccines given. Pt lay down on exam table, B/P 110/76, color good, not cyanotic, pt. shaky, claimed to see "spots". All sx gone
after 30 min.
Other Meds: Miralax; Allegra
Lab Data:
History: ADD
Prex Illness: Constipation
Prex Vax Illns:

Vaers Id: 288676-1

23.0 F 13-Aug-2007 13-Aug-2007 0 22-Aug-2007 28-Aug-2007 GA 29-Aug-2007
HPV4 MERCK & CO. INC. 0928U 2 Left arm Subcutaneously

MedDRA PT Dizziness, Hypotension
Symptom Text: Dizziness after injection. Bp 80/60. Rechecked after 5 minutes-94/62.

Other Meds:
Lab Data:
History: tb-1994
Prex Illness:
Prex Vax Illns:

Vaers Id: 288681-1


MedDRA PT Blood pressure decreased, Hyperhidrosis, Pallor, Wheezing
Symptom Text: client recieved Gardasil vaccine and then became diaphroetic pale and began to wheeze. 911 called We checked her vitals, bp 80/60 pulse 56-64. Ice applied
to arm and forhead and she was placed on a mat. Juice and crackers recieved. Ems arrived and vitals were reevaluated. Stable at this time.Mother refused
further EMS treatment but was instructed to call if further problems. We will call in a.m. for follow up.
Other Meds:
Lab Data:
History: skin irritation at site of PPd
Prex Illness: Non
Prex Vax Illns:

Vaers Id: 288685-1

11.0 F 20-Aug-2007 23-Aug-2007 3 22-Aug-2007 28-Aug-2007 VA 28-Aug-2007
TDAP SANOFI PASTEUR C2631AA 0 Left leg Intramuscular
MNQ SANOFI PASTEUR U2141AA 0 Left leg Intramuscular
HPV4 MERCK & CO. INC. 1060U 0 Right leg Intramuscular
MedDRA PT Erythema, Skin nodule, Skin warm
Symptom Text: LARGE RED AREA THAT IS HOT TO THE TOUCH AND SLIGHT LUMP 2 DAYS POST VACCINATION LOCATED ON LEFT FRONT THIGH.
Other Meds:
Lab Data: NONE
History: NONE
Prex Illness: OTALGIA
Prex Vax Illns:

Vaers Id: 288686-1

17.0 F 20-Jun-2007 06-Aug-2007 47 22-Aug-2007 28-Aug-2007 NC 28-Aug-2007
MedDRA PT Abortion spontaneous
Symptom Text: 8-6-07 Miscarriage

Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288697-1

12.0 F 17-Aug-2007 Unknown 22-Aug-2007 28-Aug-2007 MN 28-Aug-2007
DTAP GLAXOSMITHKLINE AC14B036CA 2 Left arm Intramuscular
BIOLOGICALS
Symptom Text: unable to reach patient at this time

Other Meds:
Lab Data:
History: allergic to ceclor,systolic heart mumur
Prex Illness: no
Prex Vax Illns:

Vaers Id: 288703-1

MEN UNKNOWN MANUFACTURER NULL Left leg Unknown
HEP UNKNOWN MANUFACTURER NULL Left arm Unknown
HPV4 MERCK & CO. INC. NULL 0 Right arm Unknown
MedDRA PT Anorexia, Asthenia, Dizziness, Dizziness, Pallor, Somnolence, Vision blurred
Symptom Text: Shot was received on Friday, August 17, 2007 at approx. 3:30 p.m. On Monday, August 20, 2007 while at school, my daughter developed sudden blurred
vision, dizziness, suddenly turned very pale and almost passed out at school. The nurse called me (her mother) at work and advised that she (Paige) be
checked out of school. Upon arriving home, she immediately went to bed and slept for about 4 hours. When she woke, she was still very pale, and felt
extremely weak. She had no appetite and went back to sleep and slept through the night. I kept her home from school on Tuesday August 21, and she
continued to sleep for most of the day, only waking twice and ate very little. She awoke at about 7 pm and stated that she felt a little better and was able to eat
a little dinner. She went back to bed again and slept throughout the night. When she awoke today, Wednesday August 22, she finally felt well enough to go to
school and managed to stay there throughout the day. Her appetite has improved, her skin is more flush and she is a little more energetic.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288761-1 (S)

24.0 F 29-May-2007 29-May-2007 0 23-Aug-2007 24-Aug-2007 VA WAES0708USA01863 24-Aug-2007
HPV4 MERCK & CO. INC. NULL Left arm Unknown

MedDRA PT Drug administered at inappropriate site, Incorrect dose administered, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 24 year old female with obesity, hypersensitivity and asthma and a history of headaches who on
29-MAY-2007 was vaccinated in the left arm with a 65 ml confirmed dose of Gardasil. Concomitant therapy included albuterol, phentermine HCL, antimicrobial
(unspecified) and Yasmin. On 29-MAY-2007 the needle accidentally hit a "vursar sac" in the patient's left arm. Subsequently, the patient developed arm pain.
The patient was going to physical therapy and is seeing an orthopedic doctor. At the time of the report the patient had not recovered. The reporting physician
considered arm pain to be disabling. Additional information has been requested.
Other Meds: albuterol; antimicrobial (unspecified); YASMIN; phentermine hydrochloride 37.5 mL
Lab Data: Unknown
History: Headache
Prex Illness: Obesity; Hypersensitivity; Asthma
Prex Vax Illns:

Vaers Id: 288762-1 (S)

15.0 F 06-Aug-2007 06-Aug-2007 0 23-Aug-2007 24-Aug-2007 IA WAES0708USA03472 04-Sep-2007
MedDRA PT Fall, Head injury, Inappropriate schedule of drug administration
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 06-AUG-2007 was vaccinated with first dose of Gardasil (lot #
655619/1427F) injection. Concomitant therapy also given on 06-AUG-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus
toxoid (manufacturer unknown). On 06-AUG-2007, the patient was sitting on the exam table and was administered the 2 vaccines. The patient fell off the exam
table and hit the left side of her head and face. Medical attention was sought (doctor's office and emergency room). The physician admitted the patient into the
hospital for a 23 hour observation. The patient had neurology and cardiology consultations and they performed some tests which are unspecified. On an
unspecified date, the patient recovered. Additional information has been requested.
Other Meds:
Lab Data: neurological 08/06/07 - result not reported; physical examination 08/06/07 - cardiology: result not reported
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288771-1

17.0 F 09-Apr-2007 09-Apr-2007 0 23-Aug-2007 30-Aug-2007 MO 30-Aug-2007

Symptom Text: Had nausea and dizziness with 2nd Gardasil-given Singulair 10 mg prior to 3rd injection Consulted Dr at medical center
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288775-1

MedDRA PT Syncope
Symptom Text: Syncope post vaccination

Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288776-1


MedDRA PT Dizziness, Feeling hot
Symptom Text: Patient became warm and dizzy

Other Meds: None
Lab Data: None
History: None-healthy patient
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288793-1

MNQ SANOFI PASTEUR 42393BA 0 Right arm Intramuscular
MedDRA PT Blood pressure, Contusion, Eye rolling, Fall
Symptom Text: 2 minutes after Gardasil administered, pt leaned forward and tumbled to floor. Eyes rolled back. Immediately refocused and speaking. BP 104/56. Monitored pt
for 20 minutes no further adverse effects. Bruise to right hip where landed on floor.
Other Meds: None
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288797-1


MedDRA PT Urticaria
Symptom Text: hives occurring on legs, arms and trunk 24 hr. past immune
Other Meds: PPD
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288799-1

MedDRA PT Asthenia, Cyanosis, Dyskinesia, Pallor
Symptom Text: as vaccine being injected, pt leaned forward, pale, almost cyanotic, holding breath, (+) jerky movement all lasting 30 seconds. Pt. rested for few minutes -> felt
weak, couldn't wake. After 15 min -> pt recovered
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288802-1

Unknown F 21-Aug-2007 22-Aug-2007 1 23-Aug-2007 30-Aug-2007 IN 30-Aug-2007
Symptom Text: Puffy, red at injection site left arm. Varivax, Adacel given at this site.
Other Meds:
Lab Data:
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288804-1

TDAP SANOFI PASTEUR U2290BA 0 Right arm Unknown
MedDRA PT Erythema, Induration, Swelling
Symptom Text: Vaccine given 8-2-07. Same day swelling, induration redness.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288813-1

25.0 F 17-Jul-2007 17-Jul-2007 0 23-Aug-2007 30-Aug-2007 GA GA07036 30-Aug-2007

MedDRA PT Injection site pain, Neck pain, Pain in extremity
Symptom Text: Pt phoned at 8:30 AM on 7/19/07 stating approx. 2 h after immunization, she experienced pain at injection site which radiated to her neck and (L) arm that
evening. Denies edema, erythema or exudate.
Other Meds:
Lab Data: None
History: None - has breast implants
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288815-1

19.0 F 31-Jul-2007 Unknown 23-Aug-2007 30-Aug-2007 GA GA07034 30-Aug-2007
Symptom Text: 8-1-07 Tdap given 12-29-06. Client in for immun 7-31-07 and was given Tdap again. No adverse events at this time. 8-7-07 No adverse events reported to Hth
Dept.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288818-1

17.0 F 21-Jun-2007 22-Jun-2007 1 23-Aug-2007 30-Aug-2007 NJ 30-Aug-2007
MedDRA PT Chills, Pain in extremity, Pyrexia
Symptom Text: Fever to 102, chills and arm pain lasting 24+ hours.
Other Meds:
Lab Data: N/A
History: None
Prex Illness: No
Prex Vax Illns:

Vaers Id: 288830-1

HEPA GLAXOSMITHKLINE AHAVB175AA Unknown Intramuscular
BIOLOGICALS
Symptom Text: TWO DAYS AFTER IMMUNIZATION, PATIENT COMPLAINED OF ITCHING, REDNESS AND BUMPS TO BOTH HANDS.
Other Meds: NONE KNOWN
Lab Data: NONE
History: NONE ACCORDING TO MOTHER
Prex Illness: NONE ACCORDING TO MOTHER
Prex Vax Illns:

Vaers Id: 288833-1


MedDRA PT Headache, Pyrexia
Symptom Text: Headache and fever > 102.0 F for 48 hours after injection
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288901-1 (S)

Unknown F 04-Aug-2007 04-Aug-2007 0 24-Aug-2007 27-Aug-2007 FL WAES0708USA02529 27-Aug-2007

MedDRA PT Arthralgia, Arthralgia, Arthralgia, Asthenia, Pruritus, Pyrexia, Urticaria
Symptom Text: Information has been received from a physician assistant concerning a female patient who in June 2007, was vaccinated with a first dose of Gardasil. On 04-
AUG-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 658100/0525U). Illness at the time included a sore throat (viral syndrome). On 07-
AUG-2007 three days later, the patient developed hives, joint pain, was itchy, tenderness in joints, arthralgia, fever and weakness. On 09-AUG-2007, the
patient came in to see the physician. The physician put the patient on steroids and loratadine (CLARITIN) (manufacturer unknown). No laboratory diagnostic
studies were performed. At the time of this report, the patient was recovering. The nurse practitioner wasn't sure if the patient's symptoms were related to the
viral syndrome or the vaccine. No product quality complaint was involved. Hives, joint pain, was itchy, tenderness in joints, arthralgia, fever and weakness were
considered to be disabling. Additional information has been requested.
Other Meds: Unknown
Lab Data: None
History: Unknown
Prex Illness: Viral sore throat
Prex Vax Illns:

Vaers Id: 288902-1 (S)

16.0 F 03-Aug-2007 03-Aug-2007 0 24-Aug-2007 27-Aug-2007 AZ WAES0708USA03128 27-Aug-2007
MedDRA PT Crying, Head injury, Loss of consciousness, Screaming, Skull fracture, Syncope
Symptom Text: Information has been received from a physician and certified medical assistant concerning a 16 year old female, who on 03-AUG-2007 was vaccinated
intramuscularly with a 0.5mL dose of Gardasil (Lot# 655620/0171U). Concomitant suspect vaccinations included hepatitis A vaccine (inactive) (duration and
dose not reported) and varicella virus vaccine live (duration and dose not reported). Other concomitant therapy included MENACTRA. On 03-AUG-2007
following the vaccinations, the patient fainted at the front desk when she went to make the next appointment. The patient hit the back of her head and lost
consciousness for 1 to 2 minutes. When the patient regained consciousness, the patient was screaming and crying. When the paramedics arrived and tried to
get the patient into the ambulance, the patient was fighting with the paramedics. The patient was taken to the emergency room at a hospital then was
transported to a pediatric hospital where she saw a pediatric neurologist. The patient was found to have a small fracture at the back of her head. The medical
assistant mentioned to the nurse that the patient was cold, clammy, and had high anxiety prior to all the vaccines. The father mentioned that the patient has
been having anxiety attacks. The office had offered to give 2 vaccinations at one visit and the other 2 at another time but the patient had refused. The patient
recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Other Meds:
Lab Data: Unknown
History:
Prex Illness: Clamminess; Cold; Anxiety Attack
Prex Vax Illns:

Vaers Id: 288903-1 (S)


MedDRA PT Breast pain, Chest pain, Injection site pain
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female who on 24-JUL-2007 was vaccinated with the first dose of Gardasil. On
24-JUL-2007 the patient experienced pain at the injection site. The pain has persisted for a month now and has traveled into her breast and chest area. The
patient's pain at injection site and pain in breast and chest area persisted. Pain at injection site and pain in breast and chest area were considered to be
disabling. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288904-1 (S)

Unknown F 04-Jun-2007 04-Jun-2007 0 24-Aug-2007 27-Aug-2007 PA WAES0708USA02491 27-Aug-2007

MedDRA PT Headache, Immediate post-injection reaction, Influenza like illness, Malaise, Nausea, Pain, Pain in extremity, Pulmonary embolism, Vasculitis
Symptom Text: Information has been received from a female pharmacist who is also the patient with Sjogren's syndrome and "other health issues" who on 04-JUN-2007 was
vaccinated with a first dose of Gardasil. On 04-JUN-2007 immediately post vaccination the patient did not feel good and developed pain in her left arm, nausea,
and headache. On an unspecified date the symptoms resolved. On 09-JUN-2007 and 10-JUN-2007 the patient felt sick, had pains in her legs and whole body,
resembling "flu like symptoms." On 18-JUL-2007 the patient developed vasculitis in her right leg. On 04-AUG-2007 the patient was hospitalized with a
diagnosis of, bilateral pulmonary embolism. She was treated with 5 mg of COUMADIN daily and 81 mg of Aspirin daily. On 10-AUG-2007 the patient was
discharged from the hospital. At the time of the report the patient's outcome was unknown. The reporting pharmacist considered the events to be other
Other Meds: Unknown
Lab Data: Unknown
History:
Prex Illness: Sjogren's syndrome; General symptom
Prex Vax Illns:

Vaers Id: 288905-1

Unknown F Unknown Unknown 24-Aug-2007 27-Aug-2007 NJ WAES0708USA02827 27-Aug-2007

Symptom Text: Information has been received from a physician concerning a female (age not reported) with a history of past seizures who on an unspecified date was
vaccinated with a first dose of Gardasil (lot # unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot # unknown)
0.5mL injection. On an unspecified date several weeks after receiving her second dose of Gardasil the patient had a seizure. Medical attention was sought. On
an unspecified date the patient had recovered from the seizure. No further information was provided. Upon internal review seizure was considered to be an
other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Convulsion
Prex Illness:
Prex Vax Illns:

Vaers Id: 288906-1

25.0 F 09-Aug-2007 10-Aug-2007 1 24-Aug-2007 27-Aug-2007 FL WAES0708USA02975 27-Aug-2007

MedDRA PT Condition aggravated, Convulsion, Dizziness postural, Loss of consciousness
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female with a history of seizures who on 15-JAN-2007 was vaccinated
intramuscularly with a 0.5 ml first dose of Gardasil. On 04-APR-2007 the patient was vaccinated with a second dose of Gardasil. On 10-AUG-2007 the patient
was vaccinated third dose of Gardasil (lot #0211U). Concomitant therapy included hormonal contraceptives (unspecified). On 10-AUG-2007 the patient stood
up and became "really dizzy", passed out, and had a seizure. The patient reported her boyfriend "slapped her and it helped her come out of the seizure". There
were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had recovered. Upon internal
review, seizures was considered to be an other important medical event. Additional information has been requested.
Lab Data: None
History: Convulsion
Prex Illness:
Prex Vax Illns:

Vaers Id: 288907-1

18.0 F 07-Jul-2007 08-Aug-2007 32 24-Aug-2007 27-Aug-2007 TN WAES0708USA03011 27-Aug-2007

Symptom Text: Information has been received from a licensed practical nurse concerning an 18 year old female with an allergy to penicillin and no medical history, who in June
2007, was vaccinated intramuscularly with a first dose of Gardasil and a second dose in July 2007. There was no concomitant medication. The patient had
become pregnant sometime between the two doses. Her last menstrual period was 11-JUL-2007 and her estimated delivery date was 16-APR-2008. On
approximately 08-AUG-2007 the patient had a miscarriage. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention.
The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review spontaneous abortion was considered an other
Other Meds: None
Lab Data: None
History:
Prex Illness: Pregnancy NOS (LMP = 7/11/2007); Penicillin allergy
Prex Vax Illns:

Vaers Id: 288908-1

Unknown F Unknown Unknown 24-Aug-2007 27-Aug-2007 NY WAES0708USA03025 27-Aug-2007

MedDRA PT Thrombocytopenia
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil
(lot# unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil injection and experienced thrombocytopenia. Medical
attention was sought. The physician sent the patient to the hospital. At the time of reporting it was unknown if the patient had recovered. No additional
information was provided. Upon internal review thrombocytopenia was considered to be an other important medical event. Additional information has been
requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 288909-1 (S)

16.0 F 06-Aug-2007 13-Aug-2007 7 24-Aug-2007 27-Aug-2007 FR WAES0708USA03527 27-Aug-2007

MedDRA PT Petechiae, Rash
Symptom Text: Information has been received from a health professional concerning a 16 year old female with no medical history, who on 06-AUG-2007 was vaccinated with a
first dose of Gardasil (Lot# 1518F; Batch# NF23330). On 13-AUG-2007 the patient experienced exanthema, and on 15-AUG-2007 she additionally developed
petechiae. She was admitted to the hospital by the family physician on 15-AUG-2007 for diagnostics. At the time of the report no examination results were
available and the patient's outcome was unknown. Other business partner numbers include: E2007-05416. Further information is not available.
Other Meds: Unknown
Lab Data: Unknown
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288910-1

26.0 F 31-Jan-2007 01-Feb-2007 1 24-Aug-2007 27-Aug-2007 FR WAES0708USA03951 27-Aug-2007

Symptom Text: Information has been received from a physician concerning a 26 year old female who on 31-JAN-2007 was vaccinated intramuscularly with Gardasil. In
February 2007, the patient experienced vaccine exposure during pregnancy (date of last menstrual period was 12-FEB-2007/urine pregnancy test positive on
30-MAR-2007). The patient had two previous pregnancies with two live births. The second dose of Gardasil was interrupted. It was reported that the patient was
in good condition. On 17-APR-2007 the patient experienced a spontaneous abortion. The reporter felt that the vaccine exposure during pregnancy was not
related to therapy with Gardasil and the spontaneous abortion was probably not related to therapy with Gardasil. Upon internal review, the spontaneous
abortion was felt to be an other important medical event. No further information is available.
Other Meds: Unknown
Lab Data: urine beta-human chorionic gonadotropin 30Mar07 Comment: positive
History:
Prex Illness: Pregnancy NOS (LMP = 12Feb07)
Prex Vax Illns:

Vaers Id: 288923-1

14.0 F 15-Jun-2007 15-Jun-2007 0 24-Aug-2007 30-Aug-2007 PA 30-Aug-2007
VARCEL MERCK & CO. INC. 05940 1 Right arm Subcutaneously
TDAP GLAXOSMITHKLINE AC152B014BA Left arm Intramuscular
BIOLOGICALS
HPV4 MERCK & CO. INC. 0523U Right arm Subcutaneously
MedDRA PT Syncope
Symptom Text: after vaccines given pt appears to be fine 5 to 10 minutes after when had left office and waited for elevator, fainted and was brought back into office by m/c
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288925-1

MedDRA PT Blood glucose normal, Dyskinesia, Hyperhidrosis, Pallor, Syncope
Symptom Text: Two minutes after receiving injection , child became very pale, slightly diaphoretic, fainted but arms were jerking in movement. Doctors examined child. Alert
and talking, wanting to sit up. V/S taken. Child remained in office x 35 minutes. Doctor examined child, all V/S were normal, color pink A+O x 3. Released home
with mother.
Other Meds:
Lab Data: Fingerstick glucose 87 at 9:25A, B/P 130/65, HR 70. 9:40A BP 118/74, PR 72, RR 16. 9:50A BP 110/70, PR 70, RR 16.
History: Hypothyroid (hx graves); Congenital absence right ear
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288929-1

13.0 F 13-Apr-2007 Unknown 24-Aug-2007 30-Aug-2007 DC 30-Aug-2007

Symptom Text: Amenorrhea x 3 months

Other Meds: Motrin
Lab Data: FSH; TSH
History: Dysmenorrhea
Prex Illness: N/A
Prex Vax Illns:

Vaers Id: 288930-1

MedDRA PT Dry skin, Pruritus, Rash papular, Swelling face
Symptom Text: Dry rough facial skin, itching and slight facial puffiness. Red papules on arms and legs. Began about 6 hrs after vaccines.
Other Meds:
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288932-1


MedDRA PT Abdominal pain upper, Headache, Malaise, Nausea
Symptom Text: Pt called from a pharmacy - states she received Gardasil vaccine this AM at our office - she is now experiencing nausea, stomach cramps, headache and
generalized malaise - advised to call parent to take her home from mall - Benadryl 25mg - if SOB, chest pain or other severe symptoms, pt to go to ER.
Other Meds: Nuva Ring
Lab Data:
History: Pt with Hx Crohn's disease - no recent flare ups
Prex Illness: Denies
Prex Vax Illns:

Vaers Id: 288938-1

HPV4 MERCK & CO. INC. NULL Left arm Intramuscular
MedDRA PT Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Symptom Text: 4 x 2 1/2 redness/swelling/ hardness around injection site. Itch and pain present.
Other Meds: None
Lab Data: Augmentin 75 BID x 7 days
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288949-1

13.0 F 21-Aug-2007 21-Aug-2007 0 24-Aug-2007 31-Aug-2007 PA 04-Sep-2007
HEPA UNKNOWN MANUFACTURER UNKNOWN 0 Right arm Intramuscular
MedDRA PT Convulsion, Eye rolling, Syncope
Symptom Text: My daughter received Meningitis, Hepatitis A, and HPV vaccines. [First injection for each of these for her...I know HPV and one of the others requires
booster(s).] Less than a minute after receiving injections and while still sitting on exam table, my daughter fainted and had short episode of seizure-type
activity...shaking and her eyes rolled. Vital signs monitored and oxygen was administered.
Other Meds:
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288951-1

11.0 F 20-Aug-2007 21-Aug-2007 1 24-Aug-2007 29-Aug-2007 WY 29-Aug-2007

MedDRA PT Headache, Pyrexia
Symptom Text: During early morning hours after vaccine given, client had fever of 102 degrees. Also had complaint of headache. Symptoms lasted about 24 hours. Given
Ibuprofen by her mother for fever and headache.
Other Meds:
Lab Data:
History:
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288955-1 (S)


MedDRA PT Anaphylactic reaction, Face oedema, Swelling face, Urticaria generalised
Symptom Text: Anaphylactic/ type I/ reaction within 12 hours of vaccine Gardasil generalized urticaria, facial oedema
Other Meds: no
Lab Data:
History: no
Prex Illness: no
Prex Vax Illns:

Vaers Id: 288962-1


MedDRA PT Migraine
Symptom Text: Migraine headache 2 hours after Gardasil #2 given

Other Meds:
Lab Data: 2nd Gardasil dose
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 288964-1

MedDRA PT Dizziness, Immediate post-injection reaction, Syncope, Throat tightness
Symptom Text: Client experienced post immunization syncope approximately 3 minutes after vaccines were given. States her threat felt tight and she was dizzy". This
appeared to last approximately a few minutes and client returned to pre-vaccine state within 10 - 15 minutes total. VSS B/P 100/60, Pulse ox 99%, No
intercostal retractions. EMT called at request of mother. Mother declined taking child to hospital.
Other Meds:
Lab Data:
History:
Prex Illness: No current illness
Prex Vax Illns:

Vaers Id: 288965-1

MedDRA PT Rash
Symptom Text: Woke up the am following administration of Gardasil and Menactra with rash on left side of torso, no itching, no swelling, no heat, no SOB. Vaccines given at
11am on 8/23/07. Rash appeared a.m. of 8/27 Calamine/ Caladryl lotion applied.
Other Meds: None
Lab Data:
History: e mycin
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288966-1

14.0 F 21-Aug-2007 21-Aug-2007 0 24-Aug-2007 30-Aug-2007 UT 30-Aug-2007
HEP GLAXOSMITHKLINE AHBVB428AA 1 Right arm Intramuscular
BIOLOGICALS
HEPA GLAXOSMITHKLINE AHBVB428AA 1 Right arm Intramuscular
BIOLOGICALS
MedDRA PT Fall, Head injury, Syncope
Symptom Text: Patient was given immunizations while patient was standing up. Shortly afterwards patient fainted and hit her head on the immunization floor. After patient fell,
she started to fling her arms around for about 10 seconds. Patient claimed she remembers leaning against the frig and then blacked out. Patient seen by doctor
sent to ER.
Other Meds:
Lab Data: EKG, CT of head
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 288967-1

MNQ SANOFI PASTEUR U2386BA 0 Left arm Unknown
MedDRA PT Immediate post-injection reaction, Nausea, Syncope
Symptom Text: Injection given (MCV4) one arm < 1 minute Gardasil other arm. In 5 seconds fainted few seconds - eyelids fluttered and then regained consciousness - c/o
nausea ++
Other Meds:
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 288992-1

17.0 F 23-Aug-2007 24-Aug-2007 1 25-Aug-2007 31-Aug-2007 WA 31-Aug-2007
TDAP UNKNOWN MANUFACTURER NULL 0 Unknown Unknown
HPV UNKNOWN MANUFACTURER NULL 0 Unknown Unknown
HEPA UNKNOWN MANUFACTURER NULL 0 Unknown Unknown
MEN UNKNOWN MANUFACTURER NULL 0 Unknown Unknown
MedDRA PT Chills, Dizziness, Dyspnoea, Fatigue, Headache, Hypoaesthesia, Malaise, Pain, Pyrexia
Symptom Text: The day after receiving the meningococcal vaccine (she also received HPV,Hep A & Tdap at the same time)she woke up not feeling well. As the day
progressed she got a 102.5 fever, chills, headache, whole body ache, difficulty breathing and her hands felt numb at times. This lasted until the next day. She
felt better the next day but still felt tired, some what achy and dizzy at times. By the next day she felt normal again. I gave her ibuprofen, which brought the
fever down some and somewhat helped with the aches. I did not take her in to the doctors office. She received two shots in the left arm and two in the right
(which ones in each, I do not know). I clicked unkown manufacturer below, because I do not know what was used.
Other Meds: none
Lab Data:
History: none
Prex Illness: none
Prex Vax Illns:

Vaers Id: 288998-1

18.0 F 30-May-2007 04-Jul-2007 35 26-Aug-2007 31-Aug-2007 OK 31-Aug-2007

MedDRA PT Skin papilloma
Symptom Text: My daughter began to have facial(flat) warts on her face and chest after the 2nd dose of Gardasil. There are many warts on her face and chest at least 20 or
more. She has never had this problem before receiving the vaccine. She was treated for warts by her Doctor and now has been referred to Dermatology. She
has not recovered yet. She will not receive the 3rd dose.
Other Meds: none
Lab Data:
History: none
Prex Illness: no
Prex Vax Illns:

Vaers Id: 289024-1


MedDRA PT Blood pressure increased, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 12 year old female who in July 2007, was vaccinated with a first dose of Gardasil. In July 2007,
the patient passed out and experienced elevated blood pressure after receiving Gardasil. Subsequently, the patient recovered from passing out and elevated
blood pressure. The physician considered passing out and elevated blood pressure as other important medical events due to intervention with intravenous and
oxygen administration (not further specified). The patient sought medical attention. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289025-1 (S)

25.0 F 01-Mar-2007 15-Jun-2007 106 27-Aug-2007 28-Aug-2007 FR WAES0708BRA00041 28-Aug-2007

MedDRA PT Blindness, Encephalitis post immunisation, Multiple sclerosis
Symptom Text: Information has been received from a physician concerning a 25 year old female who in March 2007, was vaccinated with the first dose of Gardasil. In May
2007 the patient received the second dose of Gardasil. On approximately 15-JUN-2007 the patient experienced adverse reactions (not specified), including
visual loss. The patient looked for physician who asked for laboratory exams (not specified). Then, multiple sclerosis was diagnosed. The patient was treated
with corticosteroids (pulse therapy; 1 g corticosteroid). The patients parents looked for another physician who saw the results of the exams (not reported) and
ADEN (auto immune demyelating encephalitis) was diagnosed and related to Gardasil. Auto immune demyelating encephalitis was considered to be disabling.
According to the reporter, the patient is recovering from ADEN (auto immune demyelating encephalitis). No further information is available.
Other Meds: Unknown
Lab Data: diagnostic laboratory test 15?Jun07 Comment: multiple sclerosis
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289026-1 (S)

16.0 F 01-Aug-2007 01-Aug-2007 0 27-Aug-2007 28-Aug-2007 -- WAES0708USA03395 28-Aug-2007

MedDRA PT Grand mal convulsion, Head injury, Heart rate, Hyperhidrosis, Syncope vasovagal, Tonic clonic movements
Symptom Text: Information has been received from a physician concerning a 16 year old female with no known allergies who on 01-AUG-2007 was vaccinated with the first
dose of Gardasil (Lot# not provided). No concomitant therapies were reported. The physician reported that within 60 seconds post vaccination the patient had a
vasal vagal response, experienced a Tonic clonic Grand mal seizure and hit her head on the office wall. The physician reported that at that time the patient was
sweating and her pulse was 43 BPM. The patient laid down and oxygen was administered. The physician reported that the patient was monitored and with 20
minutes her pulse was 68 BPM and she had recovered from the event. The physician considered the event to be disabling and an other important medical
Other Meds: Unknown
Lab Data: total heartbeat count 08/01/07 43 BPM - PV; total heartbeat 08/01/07 68 BPM - 20 min PV
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289027-1 (S)

13.0 F Unknown Unknown 27-Aug-2007 28-Aug-2007 KY WAES0708USA02942 28-Aug-2007

MedDRA PT Myelitis transverse, Neuromyelitis optica, Paralysis
Symptom Text: Initial and follow-up information has been received from a physician concerning an "otherwise healthy" 13 year old female who was vaccinated with her first and
second doses of Gardasil. Subsequently the patient experienced what was thought to be transverse myelitis and was hospitalized. She experienced paralysis
from the chest down, lesions of the optic nerve, and was diagnosed with "Neuromyelitis Optica (NMO)". The patient was treated with high dose corticosteroids
(unspecified) and did not respond. A course of Cytoxan was planned. Duration of hospitalization was not reported. At the time of the report the patient had not
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289028-1 (S)

26.0 F 14-Aug-2007 14-Aug-2007 0 27-Aug-2007 28-Aug-2007 PA WAES0708USA02610 28-Aug-2007

MedDRA PT Dizziness, Haematoma, Injection site pain, Loss of consciousness, Musculoskeletal stiffness, Musculoskeletal stiffness, Nausea, Syncope vasovagal, Vomiting
Symptom Text: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 26 year old female patient who on 14-AUG-2007 was
vaccinated with a first dose of Gardasil lot #658222/0927U. Concomitant therapy included ethinyl estradiol (+) Levonorgestrel (SEASONALE). On 14-AUG-
2007, within one month of vaccination patient developed injection site soreness, and then passed out for about one minute. She was dizzy and nauseated. She
was transported to the Emergency Room via ambulance. In follow up the nurse reported that after patient received her Gardasil injection she turned her back
and about 30 seconds later she turned around and the patient's head had dropped down and she was very stiff, not limp but stiff. She passed out. She was
taken to the emergency room (ER) where she vomited. She had a computed axial tomography (CAT) scan which was normal, although she had a hematoma
on her head. The nurse said that she did not fall while in the office or anytime before hand that she knew about so she was not sure where that came from. She
had an electrocardiogram (EKG) which was borderline abnormal, and she was recommended to follow up with her primary care physician about the EKG. The
primary care physician was aware of the patient's cardiology problem. The patient's glucose was 126, prothrombin time (PT) 13.0, red blood cell count (RBC)
4.05, everything else was right on the normal border. She was discharged from the ER that same day. Her discharge diagnosis was vasovagal syncope. The
nurse's office was not able to contact the patient since then and was not sure if patient had recovered. The nurse reported that she did not know whether the
event was from her Gardasil vaccination, since the event occurred about 30 seconds after her vaccination. The reporter indicated that the patient's adverse
events injection site soreness, passing out, being dizzy and nauseated were disabling. She also believed transporting patient to the emergency room (ER) via
ambulance was an intervention to prevent a serious crite
Other Meds: SEASONALE
Lab Data: computed axial 08/14/07 Normal, electrocardiogram Borderline abnormal, red blood cell count 4.05, serum glucose 126, prothrombin time 13.0
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289046-1

MNQ SANOFI PASTEUR 0387U 0 Right arm Unknown
HPV4 MERCK & CO. INC. U2183AA 0 Left arm Unknown
MedDRA PT Anxiety, Crying, Dyspnoea, Headache, Loss of consciousness, Tremor, Unresponsive to stimuli
Symptom Text: Client's mother reports that when they arrived home, client "passed out" in back seat of car. This was about "10 minutes after the shot was administered. She
was unresponsive for about 30 seconds 9or so). Mom says that client started "shaking" and she thought client was going into a seizure, but "she did not." The
mother went to her immediately, taking to her and pulled her up from the lying position. Client then was responsive. They live close to a EMS worker who came
and checked her vital signs - mom states they were fine. Also, after the client 'came to' she complained of a headache and difficulty breathing. Mom had her lie
down to rest for awhile. During this time she again complained of difficulty which lasted only a few seconds, then she again felt fine. The remainder of the day,
client had no symptoms and even went to facility a few hours later. We were notified of this incident on 8/23/07. The client was not seen by a medical
professional. When the client was at the clinic for her shots, she was very nervous/anxious and was crying while the shots were being given.
Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289049-1

12.0 F 27-Aug-2007 27-Aug-2007 0 27-Aug-2007 31-Aug-2007 MN 04-Sep-2007

MedDRA PT Sensation of foreign body, Throat irritation
Symptom Text: Within 15 secs of 2nd vaccine developed a burning in throat and then a feeling of a lump in throat.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289055-1

14.0 F 21-Jun-2007 21-Jun-2007 0 27-Aug-2007 31-Aug-2007 MI 04-Sep-2007

Symptom Text: None stated.

Other Meds: None
Lab Data:
History: N/A
Prex Illness: Vomiting, Syncope
Prex Vax Illns:

Vaers Id: 289056-1

15.0 F 22-Aug-2007 25-Aug-2007 3 27-Aug-2007 31-Aug-2007 MA 04-Sep-2007
Symptom Text: Cellulitis (R) arm diagnosed by covering provider on 8/25/07. Treated with Keflex 1000mg PO BID x 7 days
Other Meds:
Lab Data:
History: Ureteral Reimplantation
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289057-1

13.0 F 22-Aug-2007 Unknown 27-Aug-2007 31-Aug-2007 VT 04-Sep-2007
VARCEL MERCK & CO. INC. 0535U 1 Right arm Subcutaneously MMR
MedDRA PT Cold compress therapy, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Symptom Text: Redness, warmth, swelling and tenderness at injection site. Advised cold compresses, ibuprofen, Benadryl and monitor.
Other Meds:
Lab Data:
History:
Prex Illness: No
Prex Vax Illns:

Vaers Id: 289058-1

15.0 F 07-Aug-2007 07-Aug-2007 0 27-Aug-2007 31-Aug-2007 SD 04-Sep-2007
MedDRA PT Dizziness, Hypoaesthesia, Hypoaesthesia, Oxygen supplementation
Symptom Text: Complained of dizziness, numbness to arms/legs within 10 min of getting the vaccine. Had her lie down, legs elevated, gave O2 - resolved after 10-15 min.
Other Meds:
Lab Data:
History: No
Prex Illness: No
Prex Vax Illns:

Vaers Id: 289059-1

14.0 F 07-Aug-2007 07-Aug-2007 0 27-Aug-2007 31-Aug-2007 SD 04-Sep-2007

MedDRA PT Dizziness
Symptom Text: Dizziness within 10 minutes of getting the vaccine. Had her lie down, elevated legs - resolved after 10-15 minutes.
Other Meds:
Lab Data:
History: No
Prex Illness: No
Prex Vax Illns:

Vaers Id: 289063-1

18.0 F 17-Aug-2007 17-Aug-2007 0 27-Aug-2007 31-Aug-2007 MI 04-Sep-2007
MedDRA PT Headache, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Symptom Text: Fever, Rt arm pain, neck stiffness, severe headache

Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289071-1

20.0 F 17-Aug-2007 17-Aug-2007 0 27-Aug-2007 31-Aug-2007 OH 04-Sep-2007

MedDRA PT Pain, Pharyngeal oedema, Pyrexia, Swollen tongue
Symptom Text: Rec'd 2nd Gardasil vaccine 8/17/07 at approximately 815 AM. Client noticed swollen throat and tongue at approx 3 PM the same day along with overall body
aches and low-grade fever. Client did not seek treatment. Mother of client notified H.D. 8/20/07 at 1140 AM. Symptoms still persist but client went to classes.
Other Meds: Singulair 10 mg QD
Lab Data: None
History: Seasonal allergies; Allergic to Doryx; Mono 6/05.
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289074-1

MedDRA PT Syncope
Symptom Text: ?? Syncope

Other Meds: None
Lab Data:
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289077-1

14.0 F 20-Aug-2007 20-Aug-2007 0 27-Aug-2007 31-Aug-2007 IA 04-Sep-2007
TDAP SANOFI PASTEUR AC52B013AA 0 Left arm Intramuscular
MNQ SANOFI PASTEUR U2342CA 0 Right arm Intramuscular
MedDRA PT Pallor, Syncope, Visual disturbance
Symptom Text: After injections, client pale - then reports "things are going black". Eyes remained open but not alert. Observed for 30-40 minutes. BP range 92/60 - 80/60, P.
62-80 - thready. Becomes more alert, responsive - taking sips of H20 and juice. Report no breakfast or fluids this AM and swam for 2 hours. Client becomes
faint again - recommend ambulance - parent refuses. At 1515 - color returning, responsive - no further occurrence of fainting events. Parents have arranged
appt at doctor. 8/21/07 - PC to parents - no further problems - did not see doctor - as were advised by doctor office to keep client cool and hydrate.
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289079-1

17.0 F 01-Aug-2007 Unknown 27-Aug-2007 31-Aug-2007 TN 04-Sep-2007

MedDRA PT Pyrexia
Symptom Text: Pt developed a fever of 104 one hour after injection

Other Meds:
Lab Data:
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 289082-1

PPV MERCK & CO. INC. NULL Unknown Unknown
MedDRA PT Injection site erythema, Injection site induration
Symptom Text: 1x2 inch erythema, indurated oval at site of injection (Pneumovax)
Other Meds:
Lab Data:
History: Dermatomyositis, Allergic to Bactroban
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289086-1

10.0 F 25-Jul-2007 27-Jul-2007 2 27-Aug-2007 31-Aug-2007 TX TX07075 04-Sep-2007
BIOLOGICALS
Symptom Text: Pt received Varicella vaccine 7-25-07. Mother states area became red 24 hours after receiving vaccine. Mother returned to clinic 7-31-07. Area some redness
measured 10mm x 12mm. Warm to touch.
Other Meds: None
Lab Data: Child seen for well exam
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289087-1

12.0 F 26-Jul-2007 27-Jul-2007 1 27-Aug-2007 31-Aug-2007 TX TX07074 04-Sep-2007
Symptom Text: 24 hrs after varicella mom called stated pt has quarter size reddened area to (L) upper arm where varicella was given
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289091-1

MedDRA PT Cyanosis, Immediate post-injection reaction, Loss of consciousness, Nausea
Symptom Text: Pt recieved 4 immunizations. After the 3rd vaccine she complained of nausea and passed out in the nurse's arms immediately after the 4th injection. She was
moved to the floor and legs were raised. Blueing of the lips was noted, but she was breathing on her own. Pt awake within 5 min and asking what happened.
Her BP was stable and 02 was not needed. Pt said she had missed breakfast that morning.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 289149-1

15.0 F Unknown Unknown 28-Aug-2007 29-Aug-2007 FL WAES0708USA04183 29-Aug-2007

Symptom Text: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a second dose of Gardasil.
Subsequently the patient experienced a seizure. The physician reported the patient had a seizure not immediately after the second dose but within a few weeks
of being vaccinated with Gardasil. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Upon internal review,
the patient's seizure was considered an other important medical event. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289150-1

15.0 F 21-Aug-2007 21-Aug-2007 0 28-Aug-2007 29-Aug-2007 -- WAES0708USA04165 29-Aug-2007

MedDRA PT Convulsion, Crying, Dyskinesia, Gaze palsy, Glossodynia, Injection site irritation, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 15 year old female with no known drug allergies or medical history who on 21-AUG-2007 was
vaccinated with her first dose of Gardasil (Lot # 655620/0171U). There was no concomitant medication. After vaccination on 21-AUG-2007 the patient
experienced burning at the injection site. About 1-2 minutes after the vaccination, while in the physician's office, the patient experienced a seizure as she
passed out and had jerking movements of her upper torso. Her eyes rolled back while she was passed out. She woke up crying hysterically and reported
burning of her tongue. The patient had received vaccinations in the past without incident. On 21-AUG-2007, the patient recovered from seizure, burning at the
injection site, burning of her tongue and crying. Upon internal review, seizure was determined to be an other important medical event. Additional information
has been requested.
Other Meds: None
Lab Data: None
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 289177-1 (S)

MedDRA PT Blood pressure, Chills, Condition aggravated, Dyspnoea, Dyspnoea, Headache, Lumbar puncture, Pain, Photophobia, Pyrexia, Tremor
Symptom Text: severe headache at night time after vaccination; exacerbated in the next morning, photophobia, entire body ache, chills, trouble breathing, low grade fever
100.3. On exam BP 150/78 shaking but nonconvulsive, transferred to hospital via ambulance. 1 day admission, spinal tap has r/o meningitis done-normal.
Persistent headache few days after discharge
Other Meds: None
Lab Data: None
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289238-1

15.0 F 14-Aug-2007 15-Aug-2007 1 28-Aug-2007 31-Aug-2007 KS 31-Aug-2007
HEP GLAXOSMITHKLINE AHBVB301AA 1 Left arm Intramuscular
BIOLOGICALS
Symptom Text: Facial nerve paralysis left began 24-36 hours after receiving Gardisial vaccine #1 and Heptatis B vaccine #2. There were no lesions, fever, pain, decrease in
salivation, taste decrease, or vision loss. She did not report any problems with her first Hep B vaccine. Treated with valcyclovir and prednisone. Saw her back
in the office 10 days later. She had made a nearly complete recovery.
Other Meds: none
Lab Data: CBC, Chem 13, HIV, LYME titer, and MRI of brain all negative
History: history of varicella in early childhood
Prex Illness: no
Prex Vax Illns:

Vaers Id: 289243-1

HPV4 MERCK & CO. INC. MSD 0012U 0 Left arm Intramuscular

MedDRA PT Haematoma, Muscle twitching, Syncope, Tooth injury
Symptom Text: 3 to 5 second Syncopal episode after HPV vaccine given. Twitching of right arm noted, recovered alertness quickly after postictel. Hematoma left brow/temple
and chipped left lower incisor. NV intact. Observed patient for 1 hour. Had not had a meal in 15 hours(skipped breakfast).
Other Meds:
Lab Data: None
History: Asthma
Prex Illness: none
Prex Vax Illns:

Vaers Id: 289244-1

MedDRA PT Injection site erythema, Injection site induration, Injection site swelling
Symptom Text: 11 year old female brought by both parents with mild redness and swelling at the site of Varicella vaccination in the right upper arm 2 days ago. No fever or
breathing difficulty. No pus at the punctum.Skin: 7 x 6 cm area of redness with a 2.5 x 2 cm area of induration at the site of injection in the posterolateral aspect
of the right upper arm, no pus in the punctum; no streaking
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 289265-1

16.0 F 10-Apr-2007 02-May-2007 22 29-Aug-2007 30-Aug-2007 FR WAES0708USA04247 30-Aug-2007

MedDRA PT Immunoglobulins, No reaction on previous exposure to drug, Thrombocytopenia
Symptom Text: Information has been received from a health authority via a hospital pediatrician concerning a 16 year old female with Hashimoto's thyroiditis who on 10-APR-
2007 was vaccinated intramuscularly with a second dose of Gardasil. On 02-MAY-2007 the patient experienced thrombocytopenia. Thrombocytes minimum
value was 10 microl. She was treated with immunoglobulins but the thrombocytes only raised for short times. It was unknown if the patient was treated as an
inpatient or outpatient. As of 04-JUN-2007 the patient had not yet recovered. The previous dose of Gardasil was well tolerated. The health authority considered
thrombocytopenia to be an other important medical event. Additional information is not expected. Other business partner numbers included E2007-05483 and
2007007675
Other Meds: Unknown
Lab Data: platelet count 10 microL
History:
Prex Illness: Hashimoto's thyroiditis
Prex Vax Illns:

Vaers Id: 289333-1

15.0 F 27-Aug-2007 27-Aug-2007 0 29-Aug-2007 31-Aug-2007 MI 04-Sep-2007
VARCEL UNKNOWN MANUFACTURER UNKNOWN 1 Right arm Intramuscular
MNC UNKNOWN MANUFACTURER UNKNOWN 0 Unknown Intramuscular
HPV UNKNOWN MANUFACTURER UNKNOWN 0 Unknown Intramuscular
HEPA UNKNOWN MANUFACTURER UNKNOWN 0 Unknown Intramuscular
MedDRA PT Headache, Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pain in extremity
Symptom Text: At injection site there was immediate swelling, redness and skin/muscle was hot to touch. Patient experienced a fairly intense headache, her entire arm was
quite painful and she was not feeling well ingeneral. This lasted for several days. PLEASE NOTE: HEP A IMMUNIZATION WAS ADMINISTERED ON THE
SAME DATE AT A DIFFERENT LOCATION (PUBLIC HEALTH CLINIC).
Other Meds: None
Lab Data: N/A
History: IBD
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289342-1

MedDRA PT Injection site pain, Muscular weakness
Symptom Text: Patient has had continued pain at injection site and now is having increasing weakness in right arm.
Other Meds: Depo-Provera; Amoxicillin
Lab Data:
History: Bactrim allergy; Thoracic-dectroscoliosis
Prex Illness: Sinusitis
Prex Vax Illns:

Vaers Id: 289343-1


MedDRA PT Dizziness, Influenza like illness, Pain
Symptom Text: Dizziness, and body aches (flu like) were experienced.
Other Meds: albuterol as needed
Lab Data:
History: asthma
Prex Illness: Injection sight stung as needle went in.
Prex Vax Illns: redness and itchiness ~HPV (Gardasil)~2~17~In Patient

Vaers Id: 289351-1

13.0 F 28-Jul-2007 11-Aug-2007 14 29-Aug-2007 31-Aug-2007 IN 31-Aug-2007
MNC UNKNOWN MANUFACTURER U2331A 0 Left arm Intramuscular
MedDRA PT Neuralgia, Pain, Pain in jaw
Symptom Text: This patient developed neuralgias with lancinating pain in the left deltoid starting ~8/11/07 and lancinating pains in left jaw, left temple, left forehead starting
~8/18/07. This continues to cause her pain.
Other Meds:
Lab Data: MRI of brain with and without contrast 8/28/07 normal. MRI of spine to be done.
History: None
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289352-1


MedDRA PT Abdominal pain, Back pain
Symptom Text: Patient complained of back & abdominal pain. Catscan was done in ER.
Other Meds:
Lab Data: kidney stones
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 289356-1 (S)

Unknown F 01-Jul-2007 01-Jul-2007 0 30-Aug-2007 31-Aug-2007 NJ WAES0708USA04723 31-Aug-2007

MedDRA PT Rash
Symptom Text: Information has been received from a nurse, via a company representative, concerning a female patient (age unspecified), who in approximately July 2007
("about a month ago"), was vaccinated with the first dose of Gardasil (Lot # not provided). Within 48 hours of the vaccination, she developed a rash which
"started on her arms and moved down to the legs, then back up to her arms again." She was hospitalized for "a day and a half." Treatment included
intravenous therapy (unspecified). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289378-1

MNQ SANOFI PASTEUR U2234 0 Unknown Intramuscular
MedDRA PT Abdominal pain, Dizziness, Nausea
Symptom Text: patient complained of dizzyness, nausea and mild lower abdominal pain without fever for 2 days after vaccination.
Other Meds: None
Lab Data: none
History:
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289382-1

DTAP SANOFI PASTEUR C2491AA 0 Right arm Intramuscular
MedDRA PT Erythema, Oedema
Symptom Text: PT NOTICED LOCALIZED EDEMA AND ERYTHEMIA ONE DAY AFTER INOCULATION (PT VISIT WAS 2 DAYS AFTER INOCULATION). NO PAIN OR
TENDERNESS TO AREA. PT WAS AFEBRILE. INPECTION REVEALED LOCAL AREA TO BE 14.5 CM. NO ASSOCIATED SXS. PT WAS TREATED WITH
CEPHALEXIN 500MG, TID, F10D. WILL RETURN TO CLINIC IS SXS ARE DO NOT RESOLVE.
Other Meds: MULTIVITAMIN
Lab Data: NONE
History: ALLERGIES: AMOXICILLIN, ZINC
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 289408-1

26.0 F 01-Aug-2007 Unknown 30-Aug-2007 31-Aug-2007 MA 31-Aug-2007

MedDRA PT Injection site mass, Injection site pain, Local reaction, Nodule, Swelling
Symptom Text: PT. RECEIVED #1GARDASIL VACCINE ON 5/31/07 AND HAD A SMALL LOCAL REACTION AND A SMALL NODULE THAT SHE IGNORED AND DID NOT
REPORT TO US. #2 GARDASIL GIVE ON 8/1/07. SHE DEVELOPED SIGNIFICANT SWELLING 3 DAYS AFTERWARDS WITHOUT BRUISING OR
REDNESS. THE SWELLING HAS DECREASED OVER THE PAST 4 WEEKS BUT TODAY THERE WAS A PALPABLE 3.5 X 2.5 CM. MASS AT THE
INJECTION SITE. NO EVIDENCE OF CELLULITIS. NO REDNESS. THE AREA IS SLIGHTLY TENDER
Other Meds: NONE
Lab Data: NONE
History: NO
Prex Illness: NO
Prex Vax Illns:

Vaers Id: 289426-1

12.0 F 30-Jul-2007 30-Jul-2007 0 30-Aug-2007 31-Aug-2007 OK 04-Sep-2007
BIOLOGICALS
MedDRA PT Body temperature increased, Injection site erythema, Injection site warmth, Pain in extremity
Symptom Text: 07-30-07 Call from Mother stated child c/o lt. arm sore, red at shot sight. No fever. No comfort measures done. Then next day 7/31 child c/o lt. upper arm hurts,
red, hot to touch, temp. 101 by mouth, gave Tylenol. On 08/01/07 mom took child to see her doctor. On 08/01/07 @ 1:20 pm PHN did recieve call from Med.
Cl. that child presented and treated for Increased lt. deltoid red, swollen,hot to touch at inj. site only. Child sent home with mom given Rx. for Claritin 10mg/d po
until s/sxs subside, to alternate tylenol and Motrin po q 4 hr until sx's subside. Cool pk. to up. lt. arm area p.r.n. No fever noted @ cl. visit. F/up as need. No
other signs, symptoms noted.
Other Meds: none
Lab Data: none performed
History: None
Prex Illness: None
Prex Vax Illns: None~ ()~~0~In Patient|Nonex2 sisters~ ()~~0~In Sibling

Vaers Id: 289428-1

13.0 F 23-Aug-2007 23-Aug-2007 0 30-Aug-2007 31-Aug-2007 CA 04-Sep-2007
HPV4 MERCK & CO. INC. 093OU 1 Right arm Intramuscular

MedDRA PT Arthralgia, Asthenia, Hypokinesia
Symptom Text: 6 hours after Gardasil immunization (second dose) was given, patient had an episode where she felt weak and she felt that she could not move her arms or
legs secondary to weakness. This was transient. She then developed severe joint pain in bilateral elbows, hips and knees, severe enough to go to the Hospital
ER the following day for it. Pain improved after patient was given ibuprofen 400mg, and then resolved completely, and has not returned.
Other Meds: None
Lab Data: None
History: Tree Nut allergies
Prex Illness: None
Prex Vax Illns:

Vaers Id: 289429-1

18.0 F 24-Jul-2007 13-Aug-2007 20 30-Aug-2007 31-Aug-2007 WA 31-Aug-2007

Symptom Text: left hand numbness, question Gullian Barre Syndrome

Other Meds: NONE
Lab Data:
History: NONE
Prex Illness: NONE
Prex Vax Illns:

Vaers Id: 289435-1

12.0 F 16-Aug-2007 16-Aug-2007 0 30-Aug-2007 31-Aug-2007 VA 04-Sep-2007
MedDRA PT Dizziness, Dyskinesia, Eye rolling, Feeling cold, Hyperhidrosis, Nausea, Pallor
Symptom Text: After aproximately 5 minutes of the shoots she felt nauseated and started to jerk her body around almost falling down, her eyes rolled back this lasted about 45
seconds. She was pale and sweating cold and felt dizzy. She was taken to a different room to lie down where her vital sign were checked. her blood pressure
was higher than at the time of examination.She was given apple juice to raise her blood sugar level according to the nurse.
Other Meds:
Lab Data:
History:
Prex Illness:
Prex Vax Illns:

Vaers Id: 289545-1

19.0 F 20-Aug-2007 20-Aug-2007 0 31-Aug-2007 04-Sep-2007 NY WAES0708USA04346 04-Sep-2007
MedDRA PT Arthralgia, Concussion, Convulsion, Dizziness, Excoriation, Fall, Foaming at mouth, Gaze palsy, Head injury, Swelling, Swelling face
Symptom Text: Information has been received from a physician concerning a 19 year old female with no known drug allergies, who on 20-AUG-2007 was vaccinated with
Gardasil (lot # 658282/0929U). Prior to administration of Gardasil, the patient was given a TB test, blood was drawn and ADACEL was given in the right arm.
The patient received Gardasil and became light headed, fell forward off the exam table and hit her head on the floor. The patient's eyes rolled back and there
was brief seizure activity and foaming at the mouth. The patient had an abrasion on the nose from the fall and a bump/swelling on the top of the head. The
patient complained of pain in the left wrist. The patient was taken to the emergency room and a CAT scan was found to be "okay" and no bloodwork was done.
The patient was diagnosed with a mild concussion and was released from the emergency room. The patient was seen in the office on 22-AUG-2007 and the
swelling on the forehead improved and the patient was recovered (also reported as recovered on the night of 20-AUG-2007. Upon internal review, brief seizure
activity was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been
requested.
Other Meds: tuberculin purified protein
Lab Data: computed axial 08/20?/07 - okay
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 289546-1 (S)

25.0 F 29-Jun-2007 13-Jul-2007 14 31-Aug-2007 04-Sep-2007 FR WAES0708USA04248 04-Sep-2007

MedDRA PT Bacterial infection, Necrosis, Pain, Surgery, Vulvitis
Symptom Text: Information has been received from a gynecologist concerning a 25-year old female patient with a history of genital herpes in 1999 and who was vaccinated
I.M. into the deltoid muscle with the first dose of Gardasil (lot # 654884/0902F) on 29-JUN-2007. On 13-JUN-2007 she experienced herpes genitalis and
necrotising vulvitis. On 15-JUL-2007 she was admitted to the hospital because of unbearable pain and suspected bacterial infection in the vulva area. She was
treated with I.V. antivirals, antibiotics (Unacid=sulbactam/ampicilline) and analgesics. On 20-JUL-2007, surgical intervention for ablation of the necrotic material
was necessary. Histology showed no malignancy. The patient was discharged on 27-JUL-2007 and meanwhile has recovered completely. This was originally
reported by a gynecologist. Other business partner numbers included E2007-05510(0). Additional information has been requested.
Other Meds: Unknown
Lab Data: diagnostic pathological examination 20Jul07 Comment: no malignancy
History: Genital herpes
Prex Illness:
Prex Vax Illns:

Vaers Id: 289547-1

17.0 F Unknown Unknown 31-Aug-2007 04-Sep-2007 PA WAES0708USA04161 04-Sep-2007

MedDRA PT Dizziness, Grand mal convulsion, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 17 year old female with a positive family history of seizure within the family and who was
vaccinated with Gardasil on her right arm. There was no concomitant medication. After being vaccinated with Gardasil, the patient was dizzy, passed out and
had a tonic clonic seizure. The seizure lasted 2-3 minutes long and had urinary continence afterward. Unspecified medical attention was sought and the
patient's blood pressure was 100/70, her pulse was 120 and the physician did a respiratory rate, which was 25. The patient was also sent for an
electroencephalography (EEG) (results not provided). As of 22-AUG-2007, the patient was recovering from dizziness, increased heart rate, passing out and her
tonic clonic seizure. Product Quality Complaints (PQC) were not involved. Upon internal review, tonic clonic seizure was determined to be an other important
Other Meds: None
Lab Data: The patient's blood pressure was 100/70, her pulse was 120 and the physician did a respiratory rate, which was 25. The patient was also sent for an
electroencephalography (EEG) (results not provided).
History: Unknown
Prex Illness:
Prex Vax Illns:

Vaers Id: 289548-1 (S)

13.0 F 27-Feb-2007 28-Feb-2007 1 31-Aug-2007 04-Sep-2007 -- WAES0708USA02039 04-Sep-2007
Seriousness: EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, SERIOUS
MedDRA PT Abdominal pain, Body temperature increased, Chest pain, Dehydration, Dizziness, Enzyme abnormality, Gastrointestinal tube insertion, Injection site pain,
Nausea, Pain, Pancreatic cyst, Pseudocyst, Pseudolymphoma, Surgery, Swelling, Vomiting
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female with
seasonal allergies and no pre-existing illnesses who on 27-FEB-2007 was vaccinated, intramuscularly into the left arm with the first dose of Gardasil, (lot #
654741/1208F). It was reported that the patient experienced abdominal pain, upper, blood test, body temperature increased, chest pain, computerized
tomogram abnormal, dizziness, dehydration, enzyme abnormality, gastrointestinal tube insertion, injection site pain, lipase increased, nausea, pain, pancreatic
cyst, pancreatic pseudocyst drainage, pseudocyst, surgery, swelling, vomiting and nausea. The listing indicated that one or more of the events required
hospitalization, was considered to be immediately life-threatening. (Per the mother's written statement submitted to the Health department on 18-JUL-2007) on
27-FEB-2007, at approximately 1:30 p.m. the patient received Gardasil. That evening she ran a low grade temperature and complained of pain at the injection
site. The following afternoon at approximately 2:30 p.m., she began to experience pain in her chest and upper abdomen and continued to run a low grade fever.
On 29-FEB-2007, she began experiencing nausea and vomiting which continued through the week. On 02-MAR-2007, she went to the family physician who felt
that it was a virus and prescribed some prescription nausea medication and something for her stomach. She continued to throw up and run a low grade fever
that rarely went over 101 degrees Fahrenheit. On 13-MAR-2007, the patient was taken to the Emergency Room (ER). The patient's mother requested that
blood tests be done because the patient had been sick a long time. The mother thought the patient was dehydrated and she thought that something other than
a virus was going on with the patient. The ER physician checked the patient's enzyme levels and her lipase was over 1000. The patient was hospitalized for 11
days and her enzymes continued to
Other Meds: None
Lab Data: computed axial 03/13?/07 - see narrative; diagnostic laboratory 04/24/07 435 - enzymes; diagnostic laboratory 04/05/07 700 - enzymes; serum lipase test
03/13/07 >1000; body temp 03/02?07 - rarely over 101 degrees Fahrenheit
History:
Prex Vax Illns:

Vaers Id: 289549-1 (S)

21.0 F 09-Jan-2007 06-Mar-2007 56 31-Aug-2007 04-Sep-2007 -- WAES0708USA02035 04-Sep-2007

MedDRA PT Back pain, Chest pain, Dyspnoea, Dyspnoea, Flank pain, Musculoskeletal pain, Pain in extremity, Pain in extremity, Pulmonary embolism, Pulmonary infarction
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 21 year old female on
09-JAN-2007, was vaccinated with the second dose of Gardasil (lot # 654389/0961F). She had started taking hormonal contraceptives (unspecified) birth
control pills (BCP) for the first time in February 2007. On 06-MAR-2007, the patient experienced back pain, chest pain, dyspnoea, flank pain, musculoskeletal
pain, pain in extremity, pulmonary embolism and pulmonary infarction. The listing indicated that one or more of the events required hospitalization, was
considered to be immediately life-threatening. It was reported that the patient traveled from 03-MAR-2007 to 10-MAR-2007. It was reported that the patient had
calf pain that traveled to the thigh on 06-MAR-2007. On 19-MAR-2007, the patient went to the Medical Center Emergency Room (ER) for severe pain in the
lower back. Two large clots were found in the lung (Pulmonary embulus). The patient was admitted to the hospital for heparin treatment for a few days. The
patient was discharged on COUMADIN for 6 months. The patient had lingering pain in the lower back and damage to the lung. She had genetic testing done
after the pulmonary embolus which showed that she had a prothrombin genetic mutation, elevated lipoprotein and hemocystine line. Initially presented to the
Emergency Department (ED) on 19-MAR-2007 with complaints of c/o right back pain which was worse upon lying down, as well as pain in the chest which was
worse with deep breathing. The pain radiated to the right shoulder. She had been having some right leg discomfort while traveling prior to the ED visit. On 19-
MAR-2007 a computed axial tomography (CT) scan revealed bilateral pulmonary emboli and consolidation in the right lower lobe of the lung with possible
necrosis in the middle of the right lower lobe. A chest x-ray on 20-MAR-2007 revealed some improvement. A complete blood count (CBC) revealed white blood
cell count (WBC) of 14.7 with Internationa
Lab Data: computed axial 03/19/07 - see narrative; chest x-ray 03/20/07 - see narrative; complete blood cell 03/20/07 - see narrative; WBC count 03/20/07 14.7 - se
narrative; INR 03/20/07 1.01 - see narrative
History: None
Prex Illness:
Prex Vax Illns:

Vaers Id: 289550-1

Unknown F Unknown Unknown 31-Aug-2007 04-Sep-2007 FR WAES0708CAN00131 04-Sep-2007

MedDRA PT Hypoaesthesia, Insomnia
Symptom Text: Information has been received from a pharmacist concerning a female who was vaccinated with Gardasil, first dose, lot # not available. Subsequently the
patient experienced numbness over body and difficulty sleeping. The reporter was uncertain if numbness over body and difficulty sleeping were related to
therapy with Gardasil. Numbness over body was determined to be an important medical event based on foreign agency requirements. No further information is
available.
Other Meds: Unknown
Lab Data: Unknown
History: Unknown
Prex Illness:
Prex Vax Illns:
Total Non Serious 1638 90%
Total Serious Non Fatal: 176 10%
Total Death: 10 1%
Total All Reports: 1824

Gardasil VAERS Adverse Reactions

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Gardasil VAERS Adverse Reactions

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FDA Freedom of Information Distribution

Report run on: 07 SEP 2007 12:15

Vaers Id: 262735-1 (S) Related reports: 262735-2; 262735-3; 262735-4

Report run on: 07 SEP 2007 12:15

Vaers Id: 262735-2 (S) Related reports: 262735-1; 262735-3; 262735-4

Report run on: 07 SEP 2007 12:15

Vaers Id: 262735-3 (S) Related reports: 262735-1; 262735-2; 262735-4

Report run on: 07 SEP 2007 12:15

Vaers Id: 262735-4 (S) Related reports: 262735-1; 262735-2; 262735-3

Report run on: 07 SEP 2007 12:15

Vaers Id: 263204-1 Related reports: 263204-2

Seriousness: ER VISIT, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 263204-2 (S) Related reports: 263204-1

Seriousness: PERMANENT DISABILITY, SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 266889-1 (S) Related reports: 266889-2

Report run on: 07 SEP 2007 12:15

Vaers Id: 266889-2 (S) Related reports: 266889-1

Report run on: 07 SEP 2007 12:15

Vaers Id: 271541-1 Related reports: 271541-2

Seriousness: NO CONDITIONS, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 271541-2 Related reports: 271541-1

Seriousness: NO CONDITIONS, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 273472-1 Related reports: 273472-2

Seriousness: NO CONDITIONS, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 273472-2 Related reports: 273472-1

Seriousness: ER VISIT, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 273918-1 Related reports: 273918-2

Seriousness: NO CONDITIONS, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 273918-2 Related reports: 273918-1

Seriousness: ER VISIT, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 274361-1 Related reports: 274361-2

Seriousness: ER VISIT, NOT SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 274361-2 Related reports: 274361-1

Report run on: 07 SEP 2007 12:15

Vaers Id: 274461-1 Related reports: 274461-2

Report run on: 07 SEP 2007 12:15

Vaers Id: 274461-2 Related reports: 274461-1

Symptom Text: Broke out with hives

Report run on: 07 SEP 2007 12:15

Vaers Id: 274953-1 (S) Related reports: 274953-2

Report run on: 07 SEP 2007 12:15

Vaers Id: 274953-2 (S) Related reports: 274953-1

Report run on: 07 SEP 2007 12:15

Vaers Id: 275428-1 (D) Related reports: 275428-2

Report run on: 07 SEP 2007 12:15

Vaers Id: 275428-2 (D) Related reports: 275428-1

Report run on: 07 SEP 2007 12:15

Vaers Id: 275438-1 (D) Related reports: 275438-2

Seriousness: DIED, SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 275438-2 (D) Related reports: 275438-1

Seriousness: DIED, ER VISIT, SERIOUS

Report run on: 07 SEP 2007 12:15

Vaers Id: 275712-1 (S) Related reports: 275712-2; 275712-3; 275712-4