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22 SEP 2011 08:06Report run on: Page 1VAERS Line List Report

Vax Type: HPV4 Status Date: 01-JAN-11 - 30-APR-11 All comb. w/AND

FDA Freedom of Informat ion Distri bution

MedDRA PT

Age

F

Gender

29-Sep-2009

Vaccine Date

29-Sep-2009

Onset Date

0

Days

11-Apr-2011

Status Date

US

State

201002320

Mfr Report Id

Initial report received from another manufacturer on 20 April 2010, under reference number WAES 1004USA00917 (VAERS number 370371). Thefollowing narrative is verbatim from that 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 mother reported that she brought her 16 year old daughter to hospital for "immunizations". It was reported that her 16year old daughter with allergies to red dye and codeine who was given the first dose of GARDASIL (lot number 663451/0216Y) into right arm, the firstdose of MENACTRA (lot number U3015AA, MFR. Sanofi Pasteur) and the first dose of HAVRIX (lot number AHAVB312AA, MFR. GSK) into her left armat about 5 pm on Tuesday 29-SEP-2009. The mother commented "they talked to me to getting the meningitis one". She said that the daughter got"dizzy" right away and had commented that she felt the meningitis shot "in elbow". The mom reported that her daughter said her knees hurt on the wayhome and was rubbing her knees and legs in the car. The mother took her daughter to the emergency room at around 9pm. She said that her daughterwas "delirious", she "couldn't walk or talk", and her "eyes were rolling back in her head". The mom denied fever, respiratory distress or seizure activity inher daughter at that time. The patient was admitted to hospital on 29-SEP-2009 and kept for 24 hours while "tests" were run. The mother stated thatthe doctor was called in "consult" and that her daughter's MRI showed "fluid in the brain". Her symptomology resolved spontaneously according to hermother, "going backwards" with the last symptoms resolving first and finally the pain in legs, knees, and her arm resolving. The mother said that thedoctor told her this could only happen if the meningitis had been given "directIV". At this time the mother was mainly concerned because her daughter's

arm bled and she didn't know if that meant the shot went into her vein or not. It was reassured that the bleeding from the injection site after animmunization was not uncommon and did not mean that the vaccine accessed the vein. The listing indicated that one or more of the events requiredhospitalization. No further information is available". "This was originally reported by the patient's mother. The VAER ID number is 370371". 05 January2011: A corrective version has been created in order to change the case to "not medically confirmed", as the event was originally reported by the patient'sparent, who was not a health care professional. No new relevant medical information has been added to the case.

Symptom Text:

Other Meds:

Lab Data:

History:

Prex Illness:

Patient had a history of allergies to red dye and codeine.

Vaers Id:

Type Manufacturer Lot Prev Doses Site Route

16.0

370371-2 (S)

11-Apr-2011

VAX Detail:

Last Edit Date

Seriousness:

Abasia, Aphasia, Arthralgia, Delirium, Dizziness, Gaze palsy, Hydrocephalus, Immediate post-injection reaction, Injection site haemorrhage, Pain inextremity

HOSPITALIZED, SERIOUS

Related reports 370371-1

Other Vaccine

10-Mar-2011

Received Date

Prex Vax Illns:

HEPA

HPV4

MNQ

GLAXOSMITHKLINEBIOLOGICALSMERCK & CO. INC.

SANOFI PASTEUR

AHAVB312AA

0216Y

U3015A

0

0

0

Right arm

Right arm

Unknown

Unknown

Unknown

Unknown

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MedDRA PT

Age

F

Gender

26-Jun-2007

Vaccine Date

12-Feb-2010

Onset Date

962

Days

14-Mar-2011

Status Date

US

State

201001159

Mfr Report Id

Initial report received on 19 February 2010 from a health care professional. A 16 year old female patient with an unknown medical history tested positivefor Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007(route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing

in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay ofthe brain for detection of Neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an

autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. Nofurther information was provided. Follow-up information received on 08 November 2010 from another manufacture (manufacturer report number WAES1010USA03110) who had received the report from a FDA line listing (VAERS identification number 381305). The following is verbatim from the othermanufactures report. "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of InformationAct. A 13 year old female who on 26-JUN-2007 was vaccinated with GARDASIL IM with the first dose. Second suspect therapy included MENACTRA(lot number U2324AA) IM into the left arm with the first dose. Concomitant therapy possibly included lithium. In the evening of 12-FEB-2010, the patientexperienced headache, nausea, vomiting. In the morning of 13-FEB-2010 the patient was found dead. Autopsy performed 14-FEB-2010 -meningococcal disease determined to be cause of death, Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist.Neisseria meningitidis serogroup C confirmed by polymerase chain reaction (PCR) on brain stem tissue on 14-FEB-2010. The listing indicated that oneor more of the events resulted in death was considered to be immediately life-threatening. No further information is available. The original reportingsource was not provided. The VAERS identification number is 381305." It is noted the subject's correct age is 16 years old as calculated from birth date toonset of events. The age of 13 years old as reported in the other manufacturer's report was the subject's age at the time of the vaccination. List of

Documents held by Sender: lab results.

Symptom Text:

LithiumOther Meds:

Lab Data:

History:

Prex Illness:

Autopsy spinal tap revealed gram negative rods, meningococcal type C. 14/Feb/2010: Neisseria Meningitidis PCR and Neisseria Meningitidis SerogroupPCR of the brain : Neisseria Meningitidis serogroup C DNA detected.

No illness at the time of vaccination. Medical history was unknown.

Vaers Id:


13.0

381305-3 (D)

14-Mar-2011

VAX Detail:

Last Edit Date

Seriousness:

Bacterial infection, Death, Headache, Joint sprain, Meningitis, Meningococcal infection, Nausea, Petechiae, Vomiting

DIED, LIFE THREATENING, SERIOUS

Related reports 381305-1; 381305-2

Other Vaccine

10-Mar-2011

Received Date

Prex Vax Illns:

HPV4

MNQ

MERCK & CO. INC.

SANOFI PASTEUR

NULL

U2324AA

0

0

Unknown

Left arm

Intramuscular

Intramuscular

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MedDRA PT

Age

F

Gender

26-Dec-2008

Vaccine Date

26-Dec-2008

Onset Date

0

Days

12-Apr-2011

Status Date

US

State

201003238

Mfr Report Id

Initial report received on 07 June 2010 from another manufacturer, report# WAES 1005USA04222. The initial reporter to this manufacturer had been ahealth care professional. Verbatim from the 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 14 year old female with conversion disorder and had an allergy of rash to red food dyes and a history of centralauditory processing defect who on 31-DEC-2008 was vaccinated in right arm with a dose of GARDASIL (LOT# 660616/0570X). Secondary suspectedvaccination included a dose of MENACTRA. A 14 year old female experienced activities of daily living impaired, alopecia, amnesia, ataxia, burningsensation, conversion disorder, deafness, dizziness, dyspnoea, eating disorder, erythema, fatigue, feeling cold, gait disturbance, headache,hyperhidrosis, hypersomnia, hypoaesthesia, menstruation irregular, migraine, muscle spasms, muscular weakness, nausea, nervous system disorder,neurological examination abnormal, pain, pallor, palpitations, paraesthesia, phonophobia, pyrexia, rash, rhinorrhoea, screaming, skin warm, stress,swelling, tremor, upper respiratory tract infection, vision blurred and wrong drug administered. On 26-DEC-2008, the patient was given a wrong shot(another meningitis shot given, instead of the third dose of GARDASIL. On 06-JAN-2009, the patient experienced upper respiratory infection, headache.On 14-JAN-2009 headaches worsen. Respiratory cleared up with antibiotics/looked like pneumonia. On 15-JAN-2009, the patient experienceddizziness. On 28-JAN-2009, headaches spike to levels 5-7 out of 10, 100% of the time. Ibuprofen did not work (800 mg). In the middle of February: thepatient saw doctor. Augmentin was given for possible sinus infection. Headaches worsen, nasal fluid leakage continued. Augmentin did nothing. CAT

scan MRI to be ordered within 5 days of Augmentin. Headaches spike to 7-8 100% of the time. Dizzy, no focus, loss of memory. The patient thenremoved from school. Saw chiropractor - no one could touch the back of her head (meninga area) without her screaming. Said her head felt swollen andnumb. Spine started to bum. On 15-FEB-2009 at 8:00 pm, headaches go to 10/10, patient screaming. Considered possibility of brain tumor and takenher to ER. She had trouble walking in straight line. CAT scan ordered by ER. Doctor sent her home and told her to take TYLENOL and 3 Ibuprofen's. CATscan was normal. On 17-FEB-2009 saw pediatrician again. Full blood work ordered: tests vitamin D, thyroid function, regular blood-work, and wasreferred to neurologist. 19-FEB-2009 Doctor agreed problem could have been caused by cross reactions of GARDASIL and MENACTRA: given herTOPAMAX at 50 mg/day and ordered MRI. On 20-FEB-2009: MRI looks normal. There was spine still burning, back of head untouchable, having moretrouble walking in a straight line. On 23-FEB-2009 second day of [Due to memory limitations, the remainder of this text could not be compared.] ofTOPAMAX, can only walk in 45 degree angles... cannot walk to bathroom. Went to ER, where she was seen by a team on neurologists and admitted tohospital for next 3 days. Ibuprofen administered via IV. No response. Second day: dihydroerogotamine mesylate (DHE) administered, which took effectand after third day she was released. March and April 2009: patient can get through 2-4 hours of school each day and in the midst of that, needed a 1hour rest on couch in office at school. Most days the parent picked her up at lunch. She was pale and very dizzy, with headaches reoccurring daily.Typically levels 4-5, with 7-8 spikes. She lose. The labs included CAT scan, MRI, thyroid testing, blood-work, heart monitoring... 26-APR-2010 and 05-MAY-2010 PCP records December 2008, MR, for 23-FEB-2009 to 25-FEB-2009, Neurologist consulted 03-APR-2009, diagnosed as Migraines. Labs:

BHCG negative Dx studies: Echo, CT Head and MRI. The listing indi

Symptom Text:

Vaers Id:


14.0

385808-3 (S)

12-Apr-2011

VAX Detail:

Last Edit Date

Seriousness:

Activities of daily living impaired, Alopecia, Amnesia, Ataxia, Burning sensation, Condition aggravated, Conversion disorder, Deafness, Dizziness,Dyspnoea, Eating disorder, Erythema, Fatigue, Feeling cold, Gait disturbance, Headache, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Menstruationirregular, Migraine, Muscle spasms, Muscular weakness, Nausea, Nervous system disorder, Pain, Pallor, Palpitations, Paraesthesia, Phonophobia,Pyrexia, Rash, Rhinorrhoea, Screaming, Skin warm, Stress, Swelling, Tremor, Upper respiratory tract infection, Vision blurred, Wrong drug administered

HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS

Related reports 385808-1; 385808-2

Other Vaccine

10-Mar-2011

Received Date

HPV4

MNQ

MERCK & CO. INC.

SANOFI PASTEUR

0570X

NULL

Right arm

Unknown

Unknown

Unknown

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AUGMENTIN; IBUPROFEN; Acetaminophen; Topamax;Other Meds:

Lab Data:

History:

Prex Illness:

15/Feb/2009: Computed axial tomography (CAT) scan was normal. 17/Feb/2009: Full blood work order: vitamin D, thyroid function, regular blood work.20/Feb/2009: Magnetic resonance imaging (MRI) was normal; Labs: BHOG negative; Dx studies: Ec

The patient has a history of conversion disorder and had an allergy of rash to red food dyes and a history of central auditory processing defect. Thepatient has a history of migraines. The patients concomitant medications was reported as unknown.

Vaers Id: 385808-3 (S)

Prex Vax Illns:

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MedDRA PT

Age

F

Gender

14-Aug-2010

Vaccine Date

14-Aug-2010

Onset Date

0

Days

14-Feb-2011

Status Date

US

State

201100458

Mfr Report Id

Initial report received on 31 January 2011 via another manufacturer (reference number WAES 1009USA00016) who had received the original report froma physician. The following is verbatim from report: "Information has been received from a physician concerning a 15 year old female with no pertinentmedical history who on 14-AUG-2010 was vaccinated intramuscularly with a dose of GARDASIL. (Lot Number is 665547/1318Y). It was part of theadolescent regime; she had gotten other shots that day. On 14-AUG-2010 the patient had a jerky reaction, headache and weakness in her arms aftervaccination. The patient was rushed to the emergency room and was hospitalized. The patient had neurological testing done with normal results, she wason medicine but her mom did not know the name of it, she experienced tremors on 30-AUG-2010 and the family physician prescribed gabapentin. At thetime of this report, the outcomes were unknown. Follow up information was received from the registered nurse (R.N.) who reported that the patient was14 year old and had no known drug allergies (NKDA). On 14-AUG-2010, the patient was vaccinated with a dose of GARDASIL and a dose ofMENACTRA in the right deltoid and a dose of VARIVAX (Merck) (MSD) (lot # 666761/0093Z) and a dose of Tdap in the left deltoid. There was no otherconcomitant medication. The nurse provided the name of the ER and indicated that there was "no admission". The nurse considered the events to be notdisabling or life-threatening. She reported that she "had not seen the patient since the day the vaccines were given, but had heard that hand splints were

needed two weeks after the event for flaccid arms, current status unknown". Additional information was reported by a medical assistant in theneurologist's office. It was reported that "the patient was seen twice - once on 16-AUG-2010 and then again on 31-AUG-2010. Follow up informationwas received from the Certified Medical Assistant (C.M.A.) who reported that the patient was seen on 16-AUG-2010 for jerking movement (described astetany; not seizure). The patient was unable to straighten her right arm and she was prescribed SKELAXIN for muscle spasms. When she referred toNeurologist, neurology consult showed that Electroencephalography and other testing were normal, no seizure activity, and "etiology unknown". The

patient was seen again on 30-AUG-2010, her exam presented normal and she was considered as recovered. She was prescribed Gabapentin 3 timesdaily as needed. The patient could go to school but to be abstained from sports for two weeks. Follow-up information was received from a physician anda medical record. The 14 year old, right-handed female with no allergies on 14-AUG-2010 was vaccinated with GARDASIL, VARIVAX (Merck),MENACTRA, "chickenpox", and Tdap in a car van. On the same date, the patient began jerking, uncontrollably. She went to ER and was given musclerelaxer which helped, but jerking unchanged when medicine wore off. The patient then saw neurology and MRI/EEG were normal. The patient also hadright upper extremity jerking, tetany (for 3 weeks), weakness, headache (2 days), fever/chills (for 2 days), numbness (2 days), having vital space, nowintermittent. On 16-AUG-2010, the patient was in the physician's office, presenting complaints of severe pain in her right arm and constant jerking thatstarted on 14-AUG-2010 after she received shots. The mother stated that about three hours after vaccine the patient developed twitching in her rightarm, intermittently. She was able to still use her arm but only with restrains. She described some tingling in both her hands. She denied any neck pain.

Symptom Text:

Vaers Id:


14.0

396141-4 (S)

15-Feb-2011

VAX Detail:

Last Edit Date

Seriousness:

Activities of daily living impaired, Anxiety, Chills, Convulsion, Demyelination, Dizziness, Dyskinesia, Encephalomyelitis, Fall, Feeling abnormal,

Gastrooesophageal reflux disease, Headache, Hyperreflexia, Hypoaesthesia, Hypotonia, Injected limb mobility decreased, Injection site reaction, Malaise,Migraine without aura, Muscle contracture, Muscle spasms, Muscle twitching, Muscular weakness, Musculoskeletal stiffness, Myoclonus, Nausea, Pain,Pain in extremity, Paraesthesia, Personality change, Phonophobia, Photophobia, Pyrexia, Somnolence, Splint application, Stress, Tearfulness, Tension

headache, Tetany, Tremor, Vision blurred

ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS

Related reports 396141-1; 396141-2; 396141-3

Other Vaccine

11-Feb-2011

Received Date

HPV4

TDAP

VARCEL

MNQ

MERCK & CO. INC.

UNKNOWN MANUFACTURER

MERCK & CO. INC.

SANOFI PASTEUR

1318Y

NULL

0093Z

NULL

Right arm

Left arm

Left arm

Right arm

Intramuscular

Unknown

Intramuscular

Intramuscular

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She did have headaches that particular day, and then the headaches were mild. She did go to emergency room twice and once she was given ATIVAN.

CT scan of her head and blood work were unremarkable. She was discharged. The patient was prescribed lorazepam which she tried but it made her sickso she was taking FLEXERIL 5 mg as needed. The

Other Meds:

Lab Data:

History:

Prex Illness:

neurological testing (MRI / EEG) were normal. CT scan of head and blood work were unremarkable. Electroencephalography and other testing were

normal. MRI of cervical spine and brain to evaluate for acute disseminated encephalomyelitis (ADEM

Right handed with no known drug allergies (NKDA). No concomitant medications at time of vaccinations.

Vaers Id: 396141-4 (S)

Prex Vax Illns:

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MedDRA PT

Age

F

Gender

25-Aug-2010

Vaccine Date

25-Aug-2010

Onset Date

0

Days

12-Apr-2011

Status Date

US

State

201006408

Mfr Report Id

Initial report received from another manufacturer on 08 November 2010 (manufacturer report number WAES 1010USA03170) who received the reportfrom the FDA (VAERS identification number 400679). The following is verbatim from report: "This report was identified from a line listing obtained onrequest by the Company from the FDA under the Freedom of Information Act. A 12 year old female who on 25-Aug-2010 was vaccinated intramuscularlywith the fourth dose of GARDASIL (Lot number 666162/0565z) in her left arm. Secondary suspect included the first dose of MENACTRA (Lot numberU3511AA) given intramuscularly in to the left arm, and the second dose of Varicella (Merck) (MSD) (Lot number 668080/0721z) given subcutaneously intothe left arm. Concomitant therapy included ADACEL (Lot number U3083CA). On 25-AUG-2010, the patient returned with left upper arm extremity (LUE)erythema, pain, and swelling from axilla to elbow. Rapidly enlarging. Admitted for intravenous antibiotics septic work-up. Monitored for possible abscess,

compartment syndrome. Given intravenously BENADRYL no pain medications. Resolved after 2 days inpatient. All culture (CX) results were negative.Lab diagnostics included blood culture (CX): negative; serum C-reactive protein test (CRP): 41 to less than 29.8; complete blood cell count (CBC); withinnormal limit (WNL); ultrasound (LUE U/S); negative and erythrocyte sedimentation rate (ESR); 28. No further information is available. The originalreporting source was not provided. The VAERS ID number is 400679." It was noted that the date of vaccination for the GARDASIL (Lot number666162/0565z), and Varicella was also reported as being on 23 August 2010. Documents held by sender: None.

Symptom Text:

Other Meds:

Lab Data:

History:

Prex Illness:

All culture results were negative, Ultrasound (LUE) - negative, Serum C-reactive protein (CRP) 41 to less than 29.8, complete blood cell count withinnormal, erythrocyte sedimentation rate 28, blood culture negative.

Unknown

Vaers Id:


12.0

400679-2 (S)

12-Apr-2011

VAX Detail:

Last Edit Date

Seriousness:

Injection site erythema, Injection site pain, Injection site swelling



Other Vaccine

10-Mar-2011

Received Date

Prex Vax Illns:

HPV4

VARCEL

TDAP

MNQ

MERCK & CO. INC.

MERCK & CO. INC.

SANOFI PASTEUR

SANOFI PASTEUR

0565Z

0721Z

U3083CA

U3511AA

3

1

0

Left arm

Left arm

Unknown

Left arm

Intramuscular

Subcutaneously

Unknown

Intramuscular

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MedDRA PT

Age

F

Gender

30-Apr-2010

Vaccine Date

01-May-2010

Onset Date

1

Days

24-Jan-2011

Status Date

NJ

State

WAES1010USA02469

Mfr Report Id

Information has been received from a consumer concerning her 15 year old daughter with spring-time allergies and no pertinent medical history who on30-APR-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL. There was no concomitant medication. The consumer reported that "around thebeginning of May 2010" on approximately 01-MAY-2010, her daughter had been experiencing heavy menstrual bleeding, headaches, quivering of thelimbs, bone-crushing, fatigue and a series of black-outs since receiving a dose of GARDASIL. The consumer said that her daughter experienced thesesymptoms mainly on the second day of her period. The consumer said they had gone to see many specialists, including neurologist and cardiologist. Onan unspecified date EEG, MRI and annual check-ups tests were performed (results not provided). At the time of the report, the patient had not recovered.

Follow up information has been received from a physician. It was reported that the patient with acid reflux and congenital stridor was vaccinated IM in theleft arm with the first dose of GARDASIL (lot number 663559/1178Y) on 30-APR-2010 at 16:45. The physician reported that the patient was seen on 31-AUG-2010 due to a second menstrual bleeding for 3 days (second time in that month). The patient experienced dizziness, shaking and near fainting. Thephysician reported that a similar episode had happened last month. Some dizziness was reported to take place daily and some was "present today." Thepatient was referred to the gynecologist, cardiologist, ear nose and throat (ENT) and neurology. At the time of the report the patient's outcome was

unknown. Patient had a second menstrual bleeding for three days (second time in a month), dizziness, shaking and near fainting were considered to beother important medical events by the physician. Additional information has been requested.

Symptom Text:

NoneOther Meds:

Lab Data:

History:

Seasonal allergy; Congenital stridor; Oesophageal acid refluxPrex Illness:

Unknown

Vaers Id:


15.0

404482-2 (O)

24-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Bone pain, Dizziness, Fatigue, Headache, Loss of consciousness, Menorrhagia, Polymenorrhoea, Presyncope, Tremor

ER VISIT, NOT SERIOUS


Other Vaccine

21-Jan-2011

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. 1178Y 0 Left arm Intramuscular

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MedDRA PT

Age

F

Gender

21-Mar-2008

Vaccine Date

23-Jul-2008

Onset Date

124

Days

19-Jan-2011

Status Date

US

State

WAES1012USA01665

Mfr Report Id

This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year oldfemale with mole of skin who on 22-JUN-2007 was intramuscularly vaccinated with the first dose of GARDASIL (lot # 654272/0319U) in right arm.Secondary suspect therapy included hepatitis A vaccine (manufacturer unknown) and varicella virus vaccine live (manufacturer unknown). Concomitanttherapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient had strange itchy rash

months before diagnosis, doctor recommended her taking CARITAN, did not diagnose. The patient also had DM (diabetes mellitus) Type 1 symptomsmonths before diagnosis. The following information was obtained through follow-up and/or provided by the government. On 29-OCT-2010 PCP (PrimaryCare Physician) records received for DOS (Date of Service) from 22-JUN-2007 to 12-AUG-2010. The patient returned on 12-SEP-2007 for additionalvaccinations (reported to be second dose of GARDASIL, hepatitis A and varicella). PE (Physical exam) was WNL (Within Normal Limits). The third doseof GARDASIL and MENACTRA were administered on 21-MAR-2008. There was rash on feet and legs for 1 week which was noted on 23-JUL-2008.Food allergy was questioned and the patient was sent for RAST (radioallergosorbent test). On 13-FEB-2009 the patient went to OV (office visit), MD(Doctor of Medicine) noted DM Type 1 dx (Diagnosis) was made in OCT-2008. The patient complained of headache (H/A). Rash was noted again on 12-AUG-2010. On 1-NOV-2010 ER (emergency room) records were received for DOS 10-SEP-2009. Final impression was as follow: InfectiousMononucleosis. Patient "c/c ST", running nose, vomiting, diarrhea, fatigue and HA for 1 week. Physical exam (PE) was positive for necklymphadenopathy, abdominal tenderness, tender palpable spleen. D/c to f/u (Follow up) with PCP. On 8-NOV-2010 hospital records were received forDOS from 2-DEC-2009 to 6-SEP-2010 when patient presented at the ER after syncopal episode. Final impression was as follow: hypoglycemia,

syncope. PE(+) was tenderness on upper extremities, abrasions on hands. On 6-SEP-2010 patient presented at ER with c/c abdominal pain, nausea,bloating, weakness. Patient left ER w/o (without) being discharged. A lot check has been initiated. One or more of the events required hospitalization, wasconsidered to be disabling, was considered to be immediately life-threatening. This was originally reported by a consumer. A standard lot checkinvestigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, and expanded lot checkinvestigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Centerfor Biologics Evaluation and Research and was released. No further information is available.

Symptom Text:

Other Meds:

Lab Data:

History:

Mole of skinPrex Illness:

Diagnostic laboratory, diabetes type 1; Physical examination, 09/12/07, within normal limits; Physical examination, 11/01/10, positive for necklymphadenopathy, abdominal tenderness, tender palpable spleen; Physical examination, 11/08/10, p

Vaers Id:


15.0

405873-2 (S)

19-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Abdominal distension, Abdominal pain, Abdominal tenderness, Asthenia, Diarrhoea, Excoriation, Fatigue, Headache, Hypoglycaemia, Infectiousmononucleosis, Lymphadenopathy, Nausea, Rash, Rash pruritic, Rhinorrhoea, Spleen palpable, Syncope, Type 1 diabetes mellitus, Vomiting

ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS


Other Vaccine

14-Jan-2011

Received Date

Prex Vax Illns:

MNQ

HPV4

SANOFI PASTEUR

MERCK & CO. INC.

NULL

NULL 2

Unknown

Unknown

Unknown

Unknown

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History:

Prex Illness:

Colic; Ear infection; upper respiratory tract infection; Dermatitis atopic; Eczema; Attention deficit/hyperactivity disorder; Attention deficit disorder; Vitamin

B12 deficiency

Vaers Id: 406578-2 (S)

Prex Vax Illns:

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MedDRA PT

Age

F

Gender

13-Jun-2007

Vaccine Date

22-Nov-2007

Onset Date

162

Days

16-Feb-2011

Status Date

US

State

WAES1101USA00740

Mfr Report Id

This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year oldfemale patient with a medical history of premature birth, cisterna magna, intracranial calcifications, periventricular hyperdensities and calcifications,hyoglycoracchia, and educational assistance since 2nd grade (verbal tasks were superior to ability to read), and no illness at time of vaccination, received

a third dose of GARDASIL (Lot # 653937/0637F) IM, on the right arm, on 13-JUN-2007. First and second doses of GARDASIL were administered on 13-DEC-2006 and 15-FEB-2007 respectively (Lot # not provided). The patient's speech was slurring. At this date patient could not talk, or move her

muscles. Patient has eating through a feeding tube. The following information was obtained through follow-up and/or provided by the government. On22-NOV-2010 hospital records were received for date of service 04 and 10-APR-2008 with a discharge diagnoses of leukoencephalopathy of unknownetiology. Secondary diagnoses: history of prematurity, question of neonatal Toxoplasma, Other viruses, Rubella, Cytomegalovirus, Herpes virus (TORCH)infection with residual ventriculomegaly, absent septum pellucidum, cerebellar hypoplasia and some gray matter heterotopia. The patient complained ofprogressively increasing dysarthria with word finding difficulties, loss of coordination, and more easily fatigued. Examination: slow hypophonic dysarthricspeech, mild weakness in upper extremities deltoids and triceps, MRI consistent with vasculitic picture with multiple strokes or autoimmune demyelinatingdisorder, or possibly toxic or infectious cause. The patient was discharged home in stable condition with speech therapy. On 29-NOV-2010 Neurologyconsultant records received for date of service on 29-APR-2008 with diagnostic of 1) progressive neurological deficits marked predominantly bydysarthria, spasticity, and upper motor neuron findings; 2) apraxia; 3) cortical sensory deficits; 4) pseudobulbar affect; 5) cognitive deficits, predominantlyattentional and learning; 6) abnormal MRI scan. The patient complained of slurred speech, midsentence hesitation, irregular rhythm and pitch - worsewith fatigue, inability to straighten right knee and move right leg, balance difficulty, weight loss, difficulty concentrating, unable to close mouth on resultingin drooling, laughs and cries easily, leg weakness. Examination: cognitive deficits in attention and learning, apraxia, cortical sensory deficits, CN VII deficitwith result on facial droop. Difficulty controlling tongue movements, hyperreflexia, spasticity, and difficulty heel walking. The patient was referred fortesting. On 29-NOV-2010 speech pathology consultant records received for date of service on 30-APR-2008 with diagnostic of spastic/ataxic dysarthria.The patient seen for symptoms as noted. Additionally reported previous difficulty swallowing - [Due to memory limitations, the remainder of this textcould not be compared.] lowing - controlled by eating slower and taking smaller bites. On 29-NOV-2010 neurology consultant records received for date

of service 03-MAY-2008 and 25-JUN-2008 with diagnostic of progressive neurologic syndrome with imaging changes. Follow up visit revealedadditional complaints of increasing difficulty swallowing. Other symptoms ongoing. Additional testing performed. The patient had performed severallaboratories, MRIs, and brain biopsies without any results available. The patient presented to ER and was hospitalized. The reporter considered theadverse events to be life threatening, required hospitalization and permanent disabling. A lot check has been initiated. The original reporting source wasnot provided. The VAERS ID # is 407172. No further information is available. A standard lot check investigation has been finalized. All in-process qualitychecks for the lot number in question were satisfactory. In addition, an expan

Symptom Text:

UnknownOther Meds:

Lab Data: Magnetic resonance, abnormal, see narrative; Brain biopsy, see narrative

Vaers Id:


23.0

407172-2 (S)

17-Feb-2011

VAX Detail:

Last Edit Date

Seriousness:

Affect lability, Aphasia, Apraxia, Arthropathy, Balance disorder, Cerebrovascular accident, Cognitive disorder, Coordination abnormal, Cranial nervedisorder, Demyelination, Disturbance in attention, Drooling, Dysarthria, Dyskinesia, Dysphagia, Dysphonia, Emotional disorder, Fatigue, Feeding disorder,Gait disturbance, Gastrointestinal tube insertion, Hyperreflexia, Leukoencephalopathy, Motor neurone disease, Movement disorder, Muscle spasticity,Muscular weakness, Nervous system disorder, Sensory loss, Speech disorder, Tongue paralysis, VIIth nerve paralysis, Vasculitis, Weight decreased

ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS


Other Vaccine

15-Feb-2011

Received Date

HPV4 MERCK & CO. INC. 0637F 2 Right arm Intramuscular

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13/602




History:

Prex Illness:

Premature birth; cerebrospinal fluid retention; cerebral calcification; educational problem

Vaers Id: 407172-2 (S)

Prex Vax Illns:

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MedDRA PT

Age

F

Gender

01-Apr-2010

Vaccine Date

25-Aug-2010

Onset Date

146

Days

27-Jan-2011

Status Date

FR

State

WAES1010USA02969

Mfr Report Id

Information has been received from the Health Authorities on 25-OCT-2010 under the reference numbers TS20100410 and 10 408. Case medicallyconfirmed. A 15-year-old female patient had received the first dose of GARDASIL (batch number not reported) in April 2010 and the second doseGARDASIL (batch number not reported( via intramuscular route on 01-JUN-2010. On 25-AUG-2010, a funduscopy was performed in the context of asystemic medical supervision of eye glasses wearer with accommodation disorder. It revealed an asymptomatic bilateral papilledema. The previousexamination had been performed (without funduscopy) in June 2010 by an orthoptist. The results were normal. The patient was hospitalized for a work-up. There was no ophthalmologic or neurologic or function sign. The cerebral angio scan performed in emergency showed no sign of intra-cranial blood

pressure, no ventricles dilatation, nor thrombophlebitis. Lyme disease was suspected and treated with ROCEPHIN in spite of the absence of a notion oftick's bite, but with a serology initially positive although not confirmed on a subsequent check-up, nor on the PCR in the cerebrospinal fluid. No otheretiology was found. There was no inflammatory, protein electrophoreses were normal, thyroidal work-up and lactic dehydrogenase were normal. Thefollowing serologies were negative or in favour of a former infection: toxoplasmosis, Cytomegalovirus, Epstein-Barr virus, Herpes simplex virus 1 and 2,VZV, rickettsial disease, leptospirosis, and toxocariasis. Immunologic work-up was negative (antinuclear antibodies SSA, SSB, SM, NRP, SL 70, Jo-1,

centromere, rheumatoid factor, C3, C4 and CH 50 complements, angiotensin-converting enzyme, anticardiolipin antibodies, beta 2-GP1,antiphospholipid antibodies. Lumbar punction showed: cerebrospinal fluid protein level at 0.2 g/l, glycorrhachia at 3.34 1mol/l, chlorides at 121 mol/l,leukocytes at 1/mm3, erythrocytes at 25/mm3. MRI performed en 17-SEP-2010 was normal. In the beginning of October 2010, the patient went to anOphthalmologic consultation which showed that the papilledema was regressing. The possible role of the GARDASIL vaccine was questioned as no otheretiology was found. Outcome was considered as recovering. The Health authorities assessed the causal relationship between the reported reaction andvaccinations as "possible" (C2 S2 I2) according to the foreign method of assessment. Other business partner numbers include E2010-06366. Additionalinformation has been requested.

Symptom Text:

UnknownOther Meds:Lab Data:

History:

Accommodation disorder; eyeglasses wearerPrex Illness:

ophthalmoscopy, 25Aug10, an asymptomatic bilateral papilledema; cerebral angiography, no sign of intra-cranial blood pressure, no ventricles dilatation,nor thrombophlebitis; Epstein-Barr virus antibodies, negative; HSV type 1 and/or 2 iden

Unknown

Vaers Id:


15.0

407699-1 (S)

27-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Lyme disease, Papilloedema


Other Vaccine

02-Nov-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. NULL 1 Unknown Intramuscular

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MedDRA PT

Age

F

Gender

12-Oct-2010

Vaccine Date

21-Oct-2010

Onset Date

9

Days

01-Feb-2011

Status Date

US

State

WAES1101USA01056

Mfr Report Id

This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year oldfemale with a history of dyslexia, amblyopia, vomiting and abdominal pain (after milk or ice cream) and penicillin allergy and no known pre-existing illnesson 12-OCT-2010 was vaccinated with the second dose of GARDASIL (Lot # 666595/0096Z) IM into the right arm. Concomitant vaccine therapy includedlive intranasal (cold adapted Ann Arbor master strain) FLUMIST (Lot # 501051P), the first dose of ADACEL (Lot # U3486AA) IM into the left arm and the

second dose of MENACTRA (Lot # U3511AA) IM into the left arm. On 21-OCT-2010 the patient experienced dizziness, syncope, disorientation.Seizures and syncope with loss of function on left side started on 28-OCT-2010 with hospitalization, headaches, migraines, nausea, vomiting, rash,

acne, fatigue, abnormal blood pressure. The following information was obtained through follow-up and/or provided by the government. 16-NOV-2010PCP office record and vaccination record received for DOS on 12-OCT-2010 and office visit rec received for DOS on 13-NOV-2010 to 15-NOV-2010.Assessment: Pseudoseizures. Patient was seen on 12-OCT-2010. Assessment: well child. Plan: screen for celiac disease. Visit on 03-NOV-2010 forfollow up post hospitalization. Patient reported to have continued episodes involving loss of consciousness, convulsing, hyperventilating, and staring offinto space and memory lapses. Patient also complaint of chest pain and headaches. Patient reported stressors (some picking on her at school, troublewith best friend). Neurological exam noted as normal. Assessment: Pseudoseizures, conversion disorder. Patient was seen on 15-NOV-2010 withcontinued complaint of episodes of seizure-like activity and "passing out". Neurological exam noted as normal. On 17-NOV-2010 discharge summary,in patient record and ER record received for DOS from 28-OCT-2010 to 29-OCT-2010. Diagnosis: Pseudoseizure/conversion disorder. Patientpresented with complaint of near syncopal episode at school. Patient reported similar episode 2 weeks earlier. CT head ordered and IV started. Inemergency room, patient had episode with eyes closed, non-responsive, entire body shaking side to side, hang grasping sheets, breathing quickly.Episode stopped when dad tickled her knee which made her smile. Record noted CT, blood and urine tests normal. Patient admitted and evaluated byneurology, psychology and physical therapy. Patient had continued periodic pseudoseizures and family educated as to origin (stressors). Patientdischarged home and to follow up with PCP. Laboratory results included: CT scan, video EEG, EKG, blood tests, vitals, therapy. The followinginformation was obtained through follow-up and/or provided by the government. On 17-NOV-2010 and 18-NOV-2010 records received. CT head/brain:normal, EEG: normal (normal awake). The listing indicated that one or more of the events required hospitalization, was considered to be immediatelylife-threatening. The events were serious. The original reporting source was not provided. The VAERS ID # is 408723. No further information is

available. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, anexpanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met therequirements of the Research Center and was released.

Symptom Text:

Other Meds:

Lab Data:

History:

Dyslexia; Amblyopia; Vomiting; Abdominal pain; Penicillin allergyPrex Illness:

Computed axial, head/brain: normal; Diagnostic laboratory, blood tests normal; Electrocardiogram, normal; urinalysis, normal

Vaers Id:


11.0

408723-2 (S)

01-Feb-2011

VAX Detail:

Last Edit Date

Seriousness:

Acne, Amnesia, Blood pressure abnormal, Chest pain, Conversion disorder, Convulsion, Disorientation, Dizziness, Emotional distress, Fatigue,Headache, Hyperventilation, Loss of consciousness, Migraine, Motor dysfunction, Movement disorder, Nausea, Presyncope, Rash, Respiratory rateincreased, Staring, Syncope, Tremor, Unresponsive to stimuli, Vomiting

ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS


Other Vaccine

31-Jan-2011

Received Date

HPV4 MERCK & CO. INC. 0096Z 1 Right arm Intramuscular

8/3/2019 vaers-010111-043011

16/602




Vaers Id: 408723-2 (S)

Prex Vax Illns:

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MedDRA PT

Age

F

Gender

30-Sep-2010

Vaccine Date

28-Oct-2010

Onset Date

28

Days

03-Jan-2011

Status Date

FR

State

WAES1011USA02975

Mfr Report Id

This case was received from the Health Authority on 19-NOV-2010 under the reference number 2010-000588. This case is medically confirmed. A 12year old female patient with unreported risk factors and concomitant medication received the first dose of GARDASIL, (batch number NM25090, lotnumber NK10770), intramuscularly, site not reported and experienced headache, asthenia, malaise, pain in head, somnolence and diarrhoea. One weekpost vaccination, the patient experienced a mild headache, followed by a violent headache two weeks post vaccination when the patient felt weak andsick. The site of the pain was at the back of the head. On 28-OCT-2010, 28 days post vaccination, the patient experienced the same again but also feltsleepy and had diarrhoea. The patient outcome has not been reported. Both the reporter and the agency considered the events to be serious for the other

medically important condition requiring intervention. Other business partner numbers include E2010-07181. No further information is available.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

Unknown

Unknown

Vaers Id:


12.0

411219-1 (O)

03-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Asthenia, Diarrhoea, Headache, Malaise, Somnolence

NO CONDITIONS, NOT SERIOUS

Other Vaccine

02-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. NK10770 0 Unknown Intramuscular

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MedDRA PT

Age

F

Gender

Unknown

Vaccine Date

Unknown

Onset Date Days

03-Jan-2011

Status Date

US

State

WAES1011USA03313

Mfr Report Id

Information has been received from a consumer who posted her granddaughter's experience on internet on 13-NOV-2009. It was reported that thepatient received one dose of GARDASIL (lot# not reported) and hadn't been right since. She had been in doctor's office 3 times since shot and diagnosedwith flu, virus...-yet 6 weeks later she was still ill. She had stomach upset, headache, very tired (she even looked tired...dark circles under her eyes, pale,listless). She broke out in shingles 3 weeks after shot. Her joints/muscles ached. But, most alarming was the partial paralysis in fingers and toes (worse intoes). Her toes literally cramp up and curl under towards her foot. Most recently she has a vaginal infection and possible urinary tract infections (UTI)

(going to get that checked tomorrow). At the time of this report, the patient's outcome was not reported for the patient's shingles. Upon internal review,partial paralysis in fingers and toes was considered to be an other important medical event. Additional information has been requested.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

Unknown

Unknown

Vaers Id:


12.0

411220-1 (O)

03-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Abdominal discomfort, Arthralgia, Dark circles under eyes, Fatigue, Headache, Herpes zoster, Influenza, Listless, Malaise, Muscle spasms, Myalgia,Pallor, Paralysis, Vaginal infection, Viral infection

ER VISIT, NOT SERIOUS

Other Vaccine

02-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. NULL 0 Unknown Unknown

FDA F d f I f i Di i b i

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MedDRA PT

Age

F

Gender

01-Mar-2007

Vaccine Date

Unknown

Onset Date Days

05-Jan-2011

Status Date

US

State

WAES1011USA03314

Mfr Report Id

Information has been received from a female consumer who posted her daughter's experience on internet. She reported that her healthy 13 year olddaughter started having her first of several seizures after she had received her second dose of GARDASIL (lot# not reported) in March 2007. She wasnow 15 year old and still having random seizures. On 21-OCT-2010, the patient had a seizure and she fell to the ground and had minimal injuries. Theoutcome was not reported. Upon internal review, seizures was considered to be an other important medical event. No further information is available.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

Unknown

Unknown

Vaers Id:


13.0

411221-1 (O)

05-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Convulsion, Fall, Injury


Other Vaccine

02-Dec-2010

Received Date

Prex Vax Illns:


8/3/2019 vaers-010111-043011

20/602

8/3/2019 vaers-010111-043011

21/602

8/3/2019 vaers-010111-043011

22/602


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23/602




MedDRA PT

Age

F

Gender

05-Nov-2010

Vaccine Date

05-Nov-2010

Onset Date

0

Days

03-Jan-2011

Status Date

FR

State

WAES1011USA03487

Mfr Report Id

Information has been received from the Health Authorities on 22-NOV-2010 under the reference number ES-AGEMED-622809341. Case medicallyconfirmed. A 14 year old female patient received a dose of GARDASIL, batch number not reported, by intramuscular route on 05-NOV-2010 and on thesame day, she experienced convulsions that lasted for 30 seconds with loss of consciousness. The patient recovered slowly, when she got up sheexperienced another loss of consciousness, this time without convulsions. Oxygen saturation readings at 99% (reported twice, with no dates reported),blood pressure levels (date not reported) 90/50mmHg and 120/70mmHg (date not reported). The patient completely recovered. Case reported as seriousby the health authorities with other medically important condition as criteria. No further information reported. Case is closed. Other business partner

numbers include: E2010-07247.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

blood pressure measurement, ??Nov10, 90/50 mmHg; blood pressure measurement, ??Nov10, 120/70 mmHg; arterial blood O2 saturation, ??Nov10,99%

Unknown

Vaers Id:


14.0

411656-1 (O)

03-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Convulsion, Loss of consciousness


Other Vaccine

06-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. NULL Unknown Intramuscular


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24/602




MedDRA PT

Age

F

Gender

17-Nov-2010

Vaccine Date

17-Nov-2010

Onset Date

0

Days

12-Jan-2011

Status Date

FR

State

WAES1012USA00325

Mfr Report Id

Information has been received from a Health Authority under the reference number ES-AGEMED-822846241 concerning a 14 year old female who on17-NOV-2010 was vaccinated intramuscularly with a dose of GARDASIL (LOT# not reported). On 17-NOV-2010 the patient experienced convulsions,muscle rigidity and faint. The patient recovered from convulsions, muscle rigidity and faint on the same day. Case reported serious by the HA with othermedically important condition as criteria. Other business partner numbers included: E2010-07434. No further information was reported. Case medicallyconfirmed.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

Unknown

Unknown

Vaers Id:


14.0

411657-1 (O)

12-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Convulsion, Muscle rigidity, Syncope


Other Vaccine

06-Dec-2010

Received Date

Prex Vax Illns:



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MedDRA PT

Age

F

Gender

Unknown

Vaccine Date

Unknown

Onset Date Days

04-Jan-2011

Status Date

NJ

State Mfr Report Id

10 cm by 7 cm swollen redness on left upper arm.Symptom Text:

Other Meds:

Lab Data:

History:

Prex Illness:

Vaers Id:


11.0

411994-1

20-May-2011

VAX Detail:

Last Edit Date

Seriousness:

Injection site erythema, Injection site swelling


Other Vaccine

07-Dec-2010

Received Date

Prex Vax Illns:

HEPA

TDAP

MNQ

HPV4

GLAXOSMITHKLINEBIOLOGICALSSANOFI PASTEUR

SANOFI PASTEUR

MERCK & CO. INC.

AHAVB462AA

C3476AA

U3507AA

0766Z

1

0

0

0

Right arm

Left arm

Left arm

Right arm

Unknown

Unknown

Unknown

Unknown


8/3/2019 vaers-010111-043011

26/602




MedDRA PT

Age

F

Gender

29-Oct-2010

Vaccine Date

05-Nov-2010

Onset Date

7

Days

05-Jan-2011

Status Date

OR

State Mfr Report Id

11/5 -> present sharp spreading pain when lifting arm; tender/painful to touch at specific point on arm/shoulder on day of vaccine & following 3-5 days -spreading pain in arm.

Symptom Text:

NUVARING; MVI; ProbioticsOther Meds:

Lab Data:

History:

NoPrex Illness:

None

No

Vaers Id:


24.0

412269-1

25-May-2011

VAX Detail:

Last Edit Date

Seriousness:

Pain, Pain in extremity, Tenderness


Other Vaccine

08-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. 1539Y 1 Left arm Unknown


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27/602




MedDRA PT

Age

F

Gender

05-Aug-2010

Vaccine Date

06-Aug-2010

Onset Date

1

Days

06-Jan-2011

Status Date

OH

State Mfr Report Id

First occurrence of heavy menses 24 hours post HPV. Patient normally not menstrual yet.Symptom Text:

Other Meds:

Lab Data:

History:

None - well visitPrex Illness:

None

Hematuria; proteinuria; acne

Vaers Id:


13.0

412303-1

26-May-2011

VAX Detail:

Last Edit Date

Seriousness:

Menorrhagia



Other Vaccine

09-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. 0318Z 0 Left arm Intramuscular


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28/602




MedDRA PT

Age

F

Gender

02-Nov-2010

Vaccine Date

02-Nov-2010

Onset Date

0

Days

24-Feb-2011

Status Date

GA

State

GA10066

Mfr Report Id

Administer vaccines below, client became groggy, not responding and fainted. Client placed supine with feet elevated, compressed to face, stimuli,monitored VS. Called for assistance from MD & nurses when client fainted. Alert, oriented & talkative. Left with mom in good condition. Provided withcola.

Symptom Text:

NoneOther Meds:

Lab Data:

History:

NonePrex Illness:

Blood glucose, 10:20, 79

None

Vaers Id:


13.0

412325-1

08-Mar-2011

VAX Detail:

Last Edit Date

Seriousness:

Somnolence, Syncope, Unresponsive to stimuli


Other Vaccine

09-Dec-2010

Received Date

Prex Vax Illns:

MEN

HPV4

MMR

HEPA

VARCEL

TDAP

SANOFI PASTEUR

MERCK & CO. INC.

MERCK & CO. INC.


GLAXOSMITHKLINEBIOLOGICALS

U3431AA

0766Z

0229Z

AHAVB427AA

0244Z

AC52B061CA

0

0

1

0

1

0

Right arm

Right arm

Left arm

Left arm

Right arm

Left arm

Intramuscular

Intramuscular

Subcutaneously

Intramuscular

Subcutaneously

Intramuscular


8/3/2019 vaers-010111-043011

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MedDRA PT

Age

F

Gender

11-Nov-2009

Vaccine Date

Unknown

Onset Date Days

05-Jan-2011

Status Date

FR

State

WAES1002USA00067

Mfr Report Id

Case received from a consumer in a foreign country through the Sanofi Pasteur GARDASIL Pregnancy Registry on 20-JAN-2010: Initial information hasbeen received from a female consumer, for GARDASIL, a Pregnancy Registry product, concerning herself (age unspecified) who on 11-JAN-2010 wasvaccinated with the second dose of GARDASIL (batch number not reported) as she was pregnant. On the day of reporting, she was in her 12th week ofpregnancy. The pregnancy was spontaneous. The first dose of GARDASIL had been well tolerated. Additional information received from a health careprofessional on 21 and 25-JAN-2009: The patient was 16 years old. She had no relevant medical history. She was taking oral contraceptive, but hadforgotten one pill. She was primipara and had no history of spontaneous abortion. The pregnancy was spontaneous. She had received the first dose of

GARDASIL approximately two months before this report. There was no reaction after the first dose, nor after the second dose. The patient had beenvaccinated at 7.5 weeks of amenorrhea. On 21-JAN-2010, the patient had told the reporter that she wanted to keep the baby. But on 25-JAN-2010, thereporter informed that finally the patient asked for a voluntary termination of pregnancy which was planned for the following Friday, i.e. on 29-JAN-2010.Follow up information received on 02-DEC-2010, according to the initial pregnancy questionnaire, the patient underwent an elective abortion on anunspecified date. The patient's outcome was unknown. Other business partner numbers included: E201000379. Additional information has been

requested.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Pregnancy NOS (LMP = 27Oct09)Prex Illness:

Unknown

Vaers Id:


16.0

412428-1 (O)

05-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Abortion induced, Amenorrhoea, Drug exposure during pregnancy, Oral contraception, Primiparous


Other Vaccine

10-Dec-2010

Received Date

Prex Vax Illns:



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30/602



MedDRA PT

Age

F

Gender

30-Apr-2010

Vaccine Date

30-Apr-2010

Onset Date

0

Days

06-Jan-2011

Status Date

FL

State

A0871483A

Mfr Report Id

This case was reported by a healthcare professional and described the occurrence of increase in thyroid levels in a 25-year-old female subject who wasvaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included hypothyroidism. Concurrent vaccination included GARDASIL (non-gsk); Merck; unknown; unknown given on 30 April 2010. Concurrent medications included LOESTRIN. On 30 April 2010 the subject received 1st dose ofTWINRIX (unknown route, right arm). On 30 April 2010, immediately after vaccination with TWINRIX, the subject experienced increase in thyroid levels.Relevant test results included thyroid levels over 100. At the time of reporting the outcome of the event was unspecified. The vaccination course withTWINRIX was discontinued. The subject was consulting with thyroid specialist. Follow-up information received on 03 August 2010 reported that followingadministration of TWINRIX and GARDASIL (given at the same time in the subject's left arm on 30 April 2010) the subject's thyroid levels immediatelyincreased. GARDASIL was also reported to be suspect. It was noted that further vaccinations with TWINRIX were discontinued at the present time.

Symptom Text:

LOESTRINOther Meds:

Lab Data:

History:

UnknownPrex Illness:

Thyroid function test abnormal, 30Apr2010, over 100

Hypothyroidism; It was unknown whether the subject had experienced adverse events following previous vaccinations. Follow-up reported that thesubject does not use alcohol and uses a half pack of tobacco a day.

Vaers Id:


25.0

412597-1

26-May-2011

VAX Detail:

Last Edit Date

Seriousness:

Immediate post-injection reaction


Other Vaccine

23-Nov-2010

Received Date

Prex Vax Illns:

HEPAB

HPV4


AHABB174AA

0672Y

0 Right arm

Left arm

Unknown

Unknown


8/3/2019 vaers-010111-043011

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MedDRA PT

Age

M

Gender

10-Dec-2010

Vaccine Date

10-Dec-2010

Onset Date

0

Days

22-Mar-2011

Status Date

US

State

WAES1103USA00580

Mfr Report Id

This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 10-DEC-2010an 18 year old male with no pre-existing illness was vaccinated IM into left arm with the third dose of GARDASIL (lot # 666597/0768Z). Concomitantmedication included intranasal FLUMIST. The patient's physical examination was within normal limits before vaccination. The patient experienced

dizziness, uneasiness within minutes of receiving shot. The patient was found to have pallor, cold clammy skin, thin thready pulse. After immunizations,patient's skin color changed and patient's hands became cold and clammy. He was given BENADRYL and epinephrine and free flow oxygen. It took 15-

20 minutes for recovery of good pulse volume and blood pressure. The patient recovered within a few minutes. On 11-DEC-2010 patient was feeling OKper patient's mother who was contacted by a follow-up call. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 412652. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 666597/0768Z, were satisfactory. In addition, an expanded lot check investigation was performed. The testingperformed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Researchand was released. No further information is available.

Symptom Text:

Other Meds:

Lab Data:

History:

Prex Illness:

Unknown

Unknown

Vaers Id:


18.0

412652-2 (S)

22-Mar-2011

VAX Detail:

Last Edit Date

Seriousness:

Anxiety, Cold sweat, Dizziness, Pallor, Peripheral coldness, Pulse abnormal, Skin discolouration

LIFE THREATENING, SERIOUS


Other Vaccine

21-Mar-2011

Received Date

Prex Vax Illns:

FLUN

HPV4

MEDIMMUNE VACCINES, INC.

MERCK & CO. INC.

501049P

0768Z

1

2

Unknown

Left arm

Unknown

Intramuscular


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MedDRA PT

Age

F

Gender

28-Sep-2010

Vaccine Date

28-Sep-2010

Onset Date

0

Days

04-Jan-2011

Status Date

FR

State

WAES1012USA01341

Mfr Report Id

This case was initially received from a health authority on 02-DEC-"2012" ref 2010-000931. This is one of two linked cases concerning the same patientand different vaccines. This case is medically confirmed. A 12 year old female patient with no concomitant medication reported received an injection ofGARDASIL (Batch number NM31130; lot number NK25010) on 28-SEP-2010. On 28-SEP-2010 approximately two hours post vaccination, the patientexperienced paraesthesia of the arm and a swinging pyrexia. The patient had received MMR II (manufacturer and batch number not reported) aged fiveyears and had patches with blisters in her arm. No risk factors were available. The patient missed three days of school and received NUROFEN ascorrective treatment. The paraesthesia lasted three days. The patient recovered on an unreported date. The patient's mother withdrew consent for further

doses of vaccine. The events were considered medically significant as they required intervention. Other business partner numbers include E2010-07575.No further information is available.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

Unknown

Immunisation; Blister

Vaers Id:


12.0

412755-1 (O)

04-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Paraesthesia, Pyrexia


Other Vaccine

14-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. NK25010 Unknown Intramuscular


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MedDRA PT

Age

F

Gender

15-Nov-2007

Vaccine Date

Unknown

Onset Date Days

11-Jan-2011

Status Date

KY

State

WAES1010USA01752

Mfr Report Id

Information has been received from a physician concerning a 11 year old female patient with no known drug reactions/allergies who in 2008 at 12 yearsold, was vaccinated IM with all three doses of GARDASIL (lot # not reported). The patient "had a normal eye exam before GARDASIL treatment and afterstarting GARDASIL treatment a later eye exam within the same year reported optic neuritis" in 2008. The patient sought unknown medical attention. Labdiagnostics test magnetic resonance imaging performed, no results provided. At the time of reporting the patient's optic neuritis did not improve. Follow-up information has been received from the physician concerning the 11 year old female student with exercise induced asthma who was vaccinated IM intothe left arm with the first dose of GARDASIL (lot number 658558/1061U) on 25-AUG-2007, the second dose (lot number 658563/1063U) on 15-NOV-

2007, and the third dose (lot number 660387/1967U) on 27-MAY-2008. In spring 2008, the patient wanted to opthamologist as could not see at school,bilat, dead spots seen on each optic nerve. Patient had had a normal eye exam in 2005. In 2008, the 11 year old patient experienced optic neuritis afterGARDASIL 1 to 3 dose. At the time of this report, the patient's adverse events did not recover. The patient's "could not see at school" and bilat, deadspots seen on each optic nerve were considered to be disabling and other important medical events by the physician. Additional information has beenrequested.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Asthma exercise inducedPrex Illness:

ophthalmological exam, ?/?05, normal; ophthalmological exam, ?/?08, optic neuritis

Vaers Id:


11.0

412903-1 (S)

11-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Blindness, Optic nerve disorder, Optic neuritis

PERMANENT DISABILITY, SERIOUS

Other Vaccine

15-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. 1063U 1 Unknown Intramuscular


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MedDRA PT

Age

F

Gender

29-Oct-2010

Vaccine Date

29-Oct-2010

Onset Date

0

Days

12-Jan-2011

Status Date

FR

State

WAES1012USA01011

Mfr Report Id

Information has been received from the Health Authorities (HA) under the reference number DK-DKMA-20103489. Case medically confirmed. A 21year old female patient had received an injection of GARDASIL (batch number not reported, IM) on 29-OCT-2010. HA coded urticaria and angioedemawith onset on 29-OCT-2010. The patient received corrective treatment with antihistamines and prednisolone, she was not hospitalized. The patientvisited the emergency ward and afterwards her own doctor. The HA considered angioedema as serious. Upon medical review the company upgradedthe case to serious due to other medically important condition. At the time of reporting, the outcome was recovering. Other business partner numbersinclude: E2010-07472. No further information is expected.

Symptom Text:

UnknownOther Meds:Lab Data:

History:

Prex Illness:

Unknown

None

Vaers Id:


21.0

412904-1 (O)

12-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Angioedema, Urticaria


Other Vaccine

15-Dec-2010

Received Date

Prex Vax Illns:



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MedDRA PT

Age

F

Gender

01-Jun-2007

Vaccine Date

01-Jun-2007

Onset Date

0

Days

05-Jan-2011

Status Date

US

State

WAES1012USA01992

Mfr Report Id

Information has been received via the internet from a 24 year old female consumer with no history of seizures who was vaccinated with the third dose ofGARDASIL in June 2007. In August 2007 the patient was hospitalized due to back problems. It was reported that "the following day", the patientexperienced seizures (it was also reported that the onset date of back pain and seizures was in June 2007). The patient stated she experienced thefollowing "preliminary symptoms: left eye weakens, strong pain in left side of the head, tremors and no feeling in face etc." After several days of seizuresthey disappear for several months and then reoccur. The patient stated that she had referred to a neurologist who did not know how to help her. Thepatient visited an epilepsy clinic where she was told that it was all in her mind because all the tests came positive. The outcome of the back pain was

unknown and at the time of this report the patient had not recovered from the seizures. The reporter felt that the seizures were related to therapy withGARDASIL. Upon internal review seizures were considered to be an Other Medical Event. Additional information is not expected.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

diagnostic laboratory, positive

Unknown

Vaers Id:


24.0

412905-1 (S)

05-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Back disorder, Back pain, Convulsion, Extraocular muscle paresis, Headache, Hypoaesthesia facial, Tremor

ER VISIT, HOSPITALIZED, SERIOUS

Other Vaccine

15-Dec-2010

Received Date

Prex Vax Illns:


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MedDRA PT

Age

F

Gender

Unknown

Vaccine Date

Unknown

Onset Date Days

13-Jan-2011

Status Date

FR

State

WAES1012USA02250

Mfr Report Id

This case was reported by a Health Care Professional on 09-DEC-2010. This case is linked to E2010-07789, same reporter and similar events, differentbatch numbers. This case is medically confirmed. A female patient of unreported age who had received dose 1 of GARDASIL, batch not reported, on anunreported date, received dose 2 of GARDASIL, batch not reported on an unreported date. One hour post vaccination the patient developed cyanosis ofboth hands. The patient's outcome was not reported. Other business partner numbers include E2010-07762.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

UnknownPrex Illness:

Unknown

Unknown

Vaers Id:


Unknown

413045-1 (O)

13-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Cyanosis


Other Vaccine

17-Dec-2010

Received Date

Prex Vax Illns:


S


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MedDRA PT

Age

F

Gender

17-Sep-2010

Vaccine Date

17-Sep-2010

Onset Date

0

Days

12-Jan-2011

Status Date

FR

State

WAES1012USA02252

Mfr Report Id

This case was received from the Health Authority on 09-DEC-2010 under the reference number 2010-001131. This case is medically confirmed. A 14year old female patient with no medical history and no concomitant medications received a dose of GARDASIL (lot# NK25010, batch# NM31130) 0.5 mlintramuscularly, site not reported on 17-SEP-2010 and on 17-SEP-2010, following the vaccination, the patient experienced peripheral cyanosis of bothhands and the hands felt very cold. The events lasted for two days. There was no central cyanosis and the patient's feet were evidently not affected. Thepatient had no previous similar episodes. The patient received no corrective treatment. At the time of reporting, the patient was recovered. The reporterconsidered the events to be serious due to other medically important condition which required intervention. Other business partner numbers include

E2010-07786.

Symptom Text:

NoneOther Meds:

Lab Data:

History:

Prex Illness:

Unknown

None

Vaers Id:


14.0

413046-1 (O)

12-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Cyanosis, Peripheral coldness


Other Vaccine

17-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. NK25010 Unknown Intramuscular

VAERS Li Li R


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MedDRA PT

Age

F

Gender

24-Nov-2010

Vaccine Date

24-Nov-2010

Onset Date

0

Days

12-Jan-2011

Status Date

FR

State

WAES1012USA02281

Mfr Report Id

Case received from a Health Authority on 09-DEC-2010 under the reference number 2010-03560. Case medically confirmed. A 15 year old femalepatient received a dose of GARDASIL (lot# 1334X, batch# NL20290, site of administration not reported), 0.5 ml, via intramuscular route on 24-NOV-2010. About 10 minutes after the administration of the vaccination, the patient developed syncope with loss of consciousness lasting several seconds.The patient then got up, but suffered another episode of syncope with loss of consciousness lasting several seconds 5 minutes later. During the episodeof syncopes her blood pressure could not be measured, but it returned to normal in the course of 5 minutes. She was put in the shock position. Thepatient was not given any medication. The patient was hospitalized. The patient completely recovered. The attending doctor considered the cause of the

syncope to be vasovagal. In the present case there was a chronological relationship between GARDASIL injection and the onset of two successiveepisodes of syncope at an interval of 5 minutes. The patient was admitted to hospital, and the cause of syncopes was given as vasovagal. Theinformation for Health Care Professional mentions the onset of syncopes after vaccination with GARDASIL. No non-drug cause for the syncope wasidentified. In the overall view of the findings, therefore, the causality of GARDASIL for the suspected undesirable effects according to the guidelines isclassified as probable. Syncope with loss of consciousness was considered to be an other important medical event. Other business partner numbers

include E2010-07745.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Prex Illness:

Unknown

Unknown

Vaers Id:


15.0

413047-1 (O)

12-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Loss of consciousness, Syncope


Other Vaccine

17-Dec-2010

Received Date

Prex Vax Illns:

HPV4 MERCK & CO. INC. 1334X 0 Unknown Intramuscular

VAERS Li Li t R t


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MedDRA PT

Age

F

Gender

01-Sep-2009

Vaccine Date

19-Apr-2010

Onset Date

230

Days

06-Jan-2011

Status Date

NY

State

WAES1003USA00488

Mfr Report Id

Information has been received from a 25 year old female with no known drug reactions/allergies and with a history of caesarean section for firstpregnancy who in approximately September 2009, "about six months ago" was vaccinated with the first dose of GARDASIL. Concomitant therapyincluded SUBOXONE. The patient reported that she received the third dose of GARDASIL the same day she had a positive pregnancy test. The patientreported to be about 1 month pregnant. The last menstrual period was estimated happened in January 2010 and the estimated delivery date is 08-OCT-2010. The patient sought medical attention visiting the physician. Follow up information has been received from a physician from a pregnancyquestionnaire who reported that the patient had an elective termination of pregnancy on 19-APR-2010, 11 weeks from last menstrual period. It was

unknown if the products of conception were examined. It was unknown if the fetus was normal. The patient's last menstrual period was on 01-JAN-2010.Upon internal review elective termination was considered to be an other important medical event. No further information is available.

Symptom Text:

SUBOXONEOther Meds:

Lab Data:

History:

Prex Illness:

beta-human chorionic, positive

Caesarean section

Vaers Id:


24.0

413259-1 (O)

06-Jan-2011

VAX Detail:

Last Edit Date

Seriousness:

Abortion induced, Drug exposure during pregnancy


Other Vaccine

20-Dec-2010

Received Date

Prex Vax Illns:


VAERS Li Li t R t


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MedDRA PT

Age

M

Gender

17-Nov-2010

Vaccine Date

04-Dec-2010

Onset Date

17

Days

06-Jan-2011

Status Date

US

State

WAES1012USA01611

Mfr Report Id

Information has been received from a nurse practitioner concerning a 15 year old male patient with Stevens-Johnson syndrome and no drugreaction/allergies, who on approximately on 17-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported) (4 days ago, reported dateas 08-DEC-2010). The nurse reported that on 04-DEC-2010 about three weeks after vaccination, the patient had a flare up of Stevens-Johnsonsyndrome. The patient had a fever, high white cell count, blisters on his mouth, lips and genitals and was diagnosed with a bacterial infection. He also hadcardiac arrhythmias and required a cardiac monitor and evaluation of his cardiac enzymes. He was hospitalized on 05-DEC-2010 and released on 07-DEC-2010. He was prescribed with antibiotics and steroids for 6 months. At the time of the report, the patient was recovering. Flare up of Stevens-Johnson syndrome, cardiac arrhythmia and bacterial infection were considered to be immediately life-threatening by the reporter. Upon internal review

flare up of Stevens-Johnson syndrome and hospitalization were considered to be an other important medical events. Additional information has beenrequested.

Symptom Text:

UnknownOther Meds:

Lab Data:

History:

Stevens-Johnson syndromePrex Illness:

WBC count, hig

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