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Judicial Watch • 2011 vaers-010111-043011

2011 vaers-010111-043011

2011 vaers-010111-043011

Page 1: 2011 vaers-010111-043011

Category:Obtained Document

Number of Pages:603

Date Created:September 22, 2011

Date Uploaded to the Library:July 30, 2013

Tags:History, Follow, visit, patient, status, received, number, Freedom, health, information, reported, State, EPA, IRS, ICE, CIA


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FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Vaers Id: 370371-2 (S)  Related reports:  370371-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
16.0  29-Sep-2009  29-Sep-2009  10-Mar-2011  11-Apr-2011  201002320  11-Apr-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HEPA  GLAXOSMITHKLINE  AHAVB312AA  Right arm  Unknown  
BIOLOGICALS  
HPV4  MERCK CO. INC.  0216Y  Right arm  Unknown  
MNQ  SANOFI PASTEUR  U3015A  Unknown  Unknown  
Seriousness:  HOSPITALIZED, SERIOUS  

Abasia, Aphasia, Arthralgia, Delirium, Dizziness, Gaze palsy, Hydrocephalus, Immediate post-injection reaction, Injection site haemorrhage, Pain
MedDRA 
extremity
Symptom Text: 	Initial report received from another manufacturer April 2010, under reference number WAES 1004USA00917 (VAERS number 370371). The following narrative verbatim from that report: "This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. mother reported that she brought her year old daughter hospital for "immunizations". was reported that her year old daughter with allergies red dye and codeine who was given the first dose GARDASIL (lot number 663451/0216Y) into right arm, the first dose MENACTRA (lot number U3015AA, MFR. Sanofi Pasteur) and the first dose HAVRIX (lot number AHAVB312AA, MFR. GSK) into her left arm about Tuesday 29-SEP-2009. The mother commented "they talked 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 the way home and was rubbing her knees and legs the car. The mother took her daughter the emergency room around 9pm. She said that her daughter was "delirious", she "couldn't walk talk", and her "eyes were rolling back her head". The mom denied fever, respiratory distress seizure activity her daughter that time. The patient was admitted hospital 29-SEP-2009 and kept for hours while "tests" were run. The mother stated that the doctor was called "consult" and that her daughter's MRI showed "fluid the brain". Her symptomology resolved spontaneously according her mother, "going backwards" with the last symptoms resolving first and finally the pain legs, knees, and her arm resolving. The mother said that the doctor told her this could only happen the meningitis had been given "directIV". this time the mother was mainly concerned because her daughter's arm bled and she didn't know that meant the shot went into her vein not. was reassured that the bleeding from the injection site after immunization was not uncommon and did not mean that the vaccine accessed the vein. The listing indicated that one more the events required hospitalization. further information available". "This was originally reported the patient's mother. The VAER number 370371". January 2011: corrective version has been created order change the case "not medically confirmed", the event was originally reported the patient's parent, who was not health care professional. new relevant medical information has been added the case. 
Other Meds: 

Lab Data: 
History: 	Patient had history allergies red dye and codeine. 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11 All comb. w/AND  

Age Gender 26-Jun-2007 Vaccine Date 12-Feb-2010 Onset Date 962 Days Vaers Id: 13.0 381305-3 (D) Related reports: 381305-1; 381305-2  10-Mar-2011 Received Date  14-Mar-2011 Status Date State  201001159 Mfr Report  14-Mar-2011 Last Edit Date  
VAX Detail:  Type HPV4  Manufacturer MERCK CO. INC.  Lot NULL  Prev Doses  Site Unknown  Route Intramuscular  Other Vaccine  
MNQ  SANOFI PASTEUR  U2324AA  Left arm  Intramuscular  
Seriousness:  DIED, LIFE THREATENING, SERIOUS  

MedDRA 	Bacterial infection, Death, Headache, Joint sprain, Meningitis, Meningococcal infection, Nausea, Petechiae, Vomiting
Symptom Text: 	Initial report received February 2010 from health care professional. year old female patient with unknown medical history tested positive for Neisseria Meningitidis years, months, days (963 days) after she received first dose MENACTRA (lot number U2324AA) June 2007 (route and site were unknown). The patient was seen physician February 2010 after emergency room visit for sprained ankle after playing the snow. February 2010 10:30 AM, the patient was found dead her home. February 2010 the patient had real-time PCR assay the brain for detection Neisseria meningitidis performed which detected Neisseria Meningitidis serogroup DNA. spinal tap was done during autopsy which revealed gram negative rods Meningitis Type DNA. The physician stated that the patient did not have any symptoms meningitis. further information was provided. Follow-up information received November 2010 from another manufacture (manufacturer report number WAES 1010USA03110) who had received the report from FDA line listing (VAERS identification number 381305). The following verbatim from the other manufactures report. "This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. year old female who 26-JUN-2007 was vaccinated with GARDASIL with the first dose. Second suspect therapy included MENACTRA (lot number U2324AA) into the left arm with the first dose. Concomitant therapy possibly included lithium. the evening 12-FEB-2010, the patient experienced headache, nausea, vomiting. the morning 13-FEB-2010 the patient was found dead. Autopsy performed 14-FEB-2010 -meningococcal disease determined cause death, Gram negative diplococci observed brain stem area, petechial rash observed pathologist. Neisseria meningitidis serogroup confirmed polymerase chain reaction (PCR) brain stem tissue 14-FEB-2010. The listing indicated that one more the events resulted death was considered immediately life-threatening. further information available. The original reporting source was not provided. The VAERS identification number 381305." noted the subject's correct age years old calculated from birth date onset events. The age years old reported the other manufacturer's report was the subject's age the time the vaccination. List Documents held Sender: lab results. 
Other Meds: 	Lithium 
Lab Data: 	Autopsy spinal tap revealed gram negative rods, meningococcal type 14/Feb/2010: Neisseria Meningitidis PCR and Neisseria Meningitidis Serogroup 
PCR the brain Neisseria Meningitidis serogroup DNA detected. History: illness the time vaccination. Medical history was unknown. Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Vaers Id:  385808-3 (S)  Related reports:  385808-1; 385808-2  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
14.0  26-Dec-2008  26-Dec-2008  10-Mar-2011  12-Apr-2011  201003238  12-Apr-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0570X  Right arm  Unknown  
MNQ  SANOFI PASTEUR  NULL  Unknown  Unknown  

Seriousness:	 HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS 
Activities 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, Menstruation

MedDRA 
irregular, 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
Symptom Text: 	Initial report received June 2010 from another manufacturer, report# WAES 1005USA04222. The initial reporter this manufacturer had been health care professional. Verbatim from the report: "This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. year old female with conversion disorder and had allergy rash red food dyes and history central auditory processing defect who 31-DEC-2008 was vaccinated right arm with dose GARDASIL (LOT# 660616/0570X). Secondary suspected vaccination included dose MENACTRA. year old female experienced activities daily living impaired, alopecia, amnesia, ataxia, burning sensation, 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. 26-DEC-2008, the patient was given wrong shot (another meningitis shot given, instead the third dose GARDASIL. 06-JAN-2009, the patient experienced upper respiratory infection, headache. 14-JAN-2009 headaches worsen. Respiratory cleared with antibiotics/looked like pneumonia. 15-JAN-2009, the patient experienced dizziness. 28-JAN-2009, headaches spike levels 5-7 out 10, 100% the time. Ibuprofen did not work (800 mg). the middle February: the patient saw doctor. Augmentin was given for possible sinus infection. Headaches worsen, nasal fluid leakage continued. Augmentin did nothing. CAT scan MRI ordered within days Augmentin. Headaches spike 7-8 100% the time. Dizzy, focus, loss memory. The patient then removed from school. Saw chiropractor one could touch the back her head (meninga area) without her screaming. Said her head felt swollen and numb. Spine started bum. 15-FEB-2009 8:00 pm, headaches 10/10, patient screaming. Considered possibility brain tumor and taken her ER. She had trouble walking straight line. CAT scan ordered ER. Doctor sent her home and told her take TYLENOL and Ibuprofen's. CAT scan was normal. 17-FEB-2009 saw pediatrician again. Full blood work ordered: tests vitamin thyroid function, regular blood-work, and was referred neurologist. 19-FEB-2009 Doctor agreed problem could have been caused cross reactions GARDASIL and MENACTRA: given her TOPAMAX mg/day and ordered MRI. 20-FEB-2009: MRI looks normal. There was spine still burning, back head untouchable, having more trouble walking straight line. 23-FEB-2009 second day [Due memory limitations, the remainder this text could not compared.] TOPAMAX, can only walk degree angles... cannot walk bathroom. Went ER, where she was seen team neurologists and admitted hospital for next days. Ibuprofen administered via IV. response. Second day: dihydroerogotamine mesylate (DHE) administered, which took effect and after third day she was released. March and April 2009: patient can get through 2-4 hours school each day and the midst that, needed hour rest couch office school. Most days the parent picked her 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 05MAY-2010 PCP records December 2008, MR, for 23-FEB-2009 25-FEB-2009, Neurologist consulted 03-APR-2009, diagnosed Migraines. Labs: BHCG negative studies: Echo, Head and MRI. The listing indi 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Other Meds:  AUGMENTIN; IBUPROFEN; Acetaminophen; Topamax;  
Lab Data:  15/Feb/2009: Computed axial tomography (CAT) scan was normal. 17/Feb/2009: Full blood work order: vitamin thyroid function, regular blood work.  
20/Feb/2009: Magnetic resonance imaging (MRI) was normal; Labs: BHOG negative; studies:  
History:  The patient has history conversion disorder and had allergy rash red food dyes and history central auditory processing defect. The  
patient has history migraines. The patients concomitant medications was reported unknown.  
Prex Illness:  
Prex Vax Illns:  

FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Vaers Id:  396141-4 (S)  Related reports:  396141-1; 396141-2; 396141-3  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
14.0  14-Aug-2010  14-Aug-2010  11-Feb-2011  14-Feb-2011  201100458  15-Feb-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1318Y  Right arm  Intramuscular  
TDAP  UNKNOWN MANUFACTURER  NULL  Left arm  Unknown  
VARCEL  MERCK CO. INC.  0093Z  Left arm  Intramuscular  
MNQ  SANOFI PASTEUR  NULL  Right arm  Intramuscular  

Seriousness: VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS 
Activities 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,

MedDRA 
Migraine without aura, Muscle contracture, Muscle spasms, Muscle twitching, Muscular weakness, Musculoskeletal stiffness, Myoclonus, Nausea, Pain, Pain extremity, Paraesthesia, Personality change, Phonophobia, Photophobia, Pyrexia, Somnolence, Splint application, Stress, Tearfulness, Tension headache, Tetany, Tremor, Vision blurred
Symptom Text: 	Initial report received January 2011 via another manufacturer (reference number WAES 1009USA00016) who had received the original report from physician. The following verbatim from report: "Information has been received from physician concerning year old female with pertinent medical history who 14-AUG-2010 was vaccinated intramuscularly with dose GARDASIL. (Lot Number 665547/1318Y). was part the adolescent regime; she had gotten other shots that day. 14-AUG-2010 the patient had jerky reaction, headache and weakness her arms after vaccination. The patient was rushed the emergency room and was hospitalized. The patient had neurological testing done with normal results, she was medicine but her mom did not know the name it, she experienced tremors 30-AUG-2010 and the family physician prescribed gabapentin. the time this report, the outcomes were unknown. Follow information was received from the registered nurse (R.N.) who reported that the patient was year old and had known drug allergies (NKDA). 14-AUG-2010, the patient was vaccinated with dose GARDASIL and dose MENACTRA the right deltoid and dose VARIVAX (Merck) (MSD) (lot 666761/0093Z) and dose Tdap the left deltoid. There was other concomitant medication. The nurse provided the name the and indicated that there was "no admission". The nurse considered the events not disabling 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 medical assistant the neurologist's office. was reported that "the patient was seen twice once 16-AUG-2010 and then again 31-AUG-2010. Follow information was received from the Certified Medical Assistant (C.M.A.) who reported that the patient was seen 16-AUG-2010 for jerking movement (described tetany; not seizure). The patient was unable straighten her right arm and she was prescribed SKELAXIN for muscle spasms. When she referred Neurologist, neurology consult showed that Electroencephalography and other testing were normal, seizure activity, and "etiology unknown". The patient was seen again 30-AUG-2010, her exam presented normal and she was considered recovered. She was prescribed Gabapentin times daily needed. The patient could school but abstained from sports for two weeks. Follow-up information was received from physician and medical record. The year old, right-handed female with allergies 14-AUG-2010 was vaccinated with GARDASIL, VARIVAX (Merck), MENACTRA, "chickenpox", and Tdap car van. the same date, the patient began jerking, uncontrollably. She went and was given muscle relaxer which helped, but jerking unchanged when medicine wore off. The patient then saw neurology and MRI/EEG were normal. The patient also had right upper extremity jerking, tetany (for weeks), weakness, headache days), fever/chills (for days), numbness days), having vital space, now intermittent. 16-AUG-2010, the patient was the physician's office, presenting complaints severe pain her right arm and constant jerking that started 14-AUG-2010 after she received shots. The mother stated that about three hours after vaccine the patient developed twitching her right arm, intermittently. She was able still use her arm but only with restrains. She described some tingling both her hands. She denied any neck pain. 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

She did have headaches that particular day, and then the headaches were mild. She did emergency room twice and once she was given ATIVAN. scan her head and blood work were unremarkable. She was discharged. The patient was prescribed lorazepam which she tried but made her sick she was taking FLEXERIL needed. The 
Other Meds: 
Lab Data: neurological testing (MRI EEG) were normal. scan head and blood work were unremarkable. Electroencephalography and other testing were 
normal. MRI cervical spine and brain evaluate for acute disseminated encephalomyelitis (ADEM History: Right handed with known drug allergies (NKDA). concomitant medications time vaccinations. Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Vaers Id: 400679-2 (S)  Related reports:  400679-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  25-Aug-2010  25-Aug-2010  10-Mar-2011  12-Apr-2011  201006408  12-Apr-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0565Z  Left arm  Intramuscular  
VARCEL  MERCK CO. INC.  0721Z  Left arm  Subcutaneously  
TDAP  SANOFI PASTEUR  U3083CA  Unknown  Unknown  
MNQ  SANOFI PASTEUR  U3511AA  Left arm  Intramuscular  
Seriousness:  HOSPITALIZED, SERIOUS  

MedDRA 	Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: 	Initial report received from another manufacturer November 2010 (manufacturer report number WAES 1010USA03170) who received the report from the FDA (VAERS identification number 400679). The following verbatim from report: "This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. year old female who 25-Aug-2010 was vaccinated intramuscularly with the fourth dose GARDASIL (Lot number 666162/0565z) her left arm. Secondary suspect included the first dose MENACTRA (Lot number U3511AA) given intramuscularly the left arm, and the second dose Varicella (Merck) (MSD) (Lot number 668080/0721z) given subcutaneously into the left arm. Concomitant therapy included ADACEL (Lot number U3083CA). 25-AUG-2010, the patient returned with left upper arm extremity (LUE) erythema, pain, and swelling from axilla elbow. Rapidly enlarging. Admitted for intravenous antibiotics septic work-up. Monitored for possible abscess, compartment syndrome. Given intravenously BENADRYL pain medications. Resolved after days inpatient. All culture (CX) results were negative. Lab diagnostics included blood culture (CX): negative; serum C-reactive protein test (CRP): less than 29.8; complete blood cell count (CBC); within normal limit (WNL); ultrasound (LUE U/S); negative and erythrocyte sedimentation rate (ESR); 28. further information available. The original reporting source was not provided. The VAERS number 400679." was noted that the date vaccination for the GARDASIL (Lot number 666162/0565z), and Varicella was also reported being August 2010. Documents held sender: None. 
Other Meds: 
Lab Data: 	All culture results were negative, Ultrasound (LUE) negative, Serum C-reactive protein (CRP) less than 29.8, complete blood cell count within 
normal, erythrocyte sedimentation rate 28, blood culture negative. History: Unknown Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 30-Apr-2010 Vaccine Date 01-May-2010 Onset Date Vaers Id: Type Manufacturer 15.0 404482-2 (O) VAX Detail: Related reports: 404482-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 21-Jan-2011 Received Date 1178Y  24-Jan-2011 Status Date Left arm  Site State  WAES1010USA02469 Mfr Report Route Intramuscular  24-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Bone pain, Dizziness, Fatigue, Headache, Loss consciousness, Menorrhagia, Polymenorrhoea, Presyncope, Tremor
Symptom Text: 	Information has been received from consumer concerning her year old daughter with spring-time allergies and pertinent medical history who 30-APR-2010 was vaccinated with 0.5 dose GARDASIL. There was concomitant medication. The consumer reported that "around the beginning May 2010" approximately 01-MAY-2010, her daughter had been experiencing heavy menstrual bleeding, headaches, quivering the limbs, bone-crushing, fatigue and series black-outs since receiving dose GARDASIL. The consumer said that her daughter experienced these symptoms mainly the second day her period. The consumer said they had gone see many specialists, including neurologist and cardiologist. unspecified date EEG, MRI and annual check-ups tests were performed (results not provided). the time the report, the patient had not recovered. Follow information has been received from physician. was reported that the patient with acid reflux and congenital stridor was vaccinated the left arm with the first dose GARDASIL (lot number 663559/1178Y) 30-APR-2010 16:45. The physician reported that the patient was seen 31AUG-2010 due second menstrual bleeding for days (second time that month). The patient experienced dizziness, shaking and near fainting. The physician reported that similar episode had happened last month. Some dizziness was reported take place daily and some was "present today." The patient was referred the gynecologist, cardiologist, ear nose and throat (ENT) and neurology. the time the report the patient's outcome was unknown. Patient had second menstrual bleeding for three days (second time month), dizziness, shaking and near fainting were considered other important medical events the physician. Additional information has been requested. 
Other Meds: 	None 

Lab Data: 	Unknown 
History: 
Prex Illness: 	Seasonal allergy; Congenital stridor; Oesophageal acid reflux 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Vaers Id:  405873-2 (S)  Related reports:  405873-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  21-Mar-2008  23-Jul-2008  124  14-Jan-2011  19-Jan-2011  WAES1012USA01665  19-Jan-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
MNQ  SANOFI PASTEUR  NULL  Unknown  Unknown  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  

Seriousness: VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Abdominal distension, Abdominal pain, Abdominal tenderness, Asthenia, Diarrhoea, Excoriation, Fatigue, Headache, Hypoglycaemia, Infectious

MedDRA 
mononucleosis, Lymphadenopathy, Nausea, Rash, Rash pruritic, Rhinorrhoea, Spleen palpable, Syncope, Type diabetes mellitus, Vomiting
Symptom Text: 	This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. year old female with mole skin who 22-JUN-2007 was intramuscularly vaccinated with the first dose GARDASIL (lot 654272/0319U) right arm. Secondary suspect therapy included hepatitis vaccine (manufacturer unknown) and varicella virus vaccine live (manufacturer unknown). Concomitant therapy 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 (diabetes mellitus) Type symptoms months before diagnosis. The following information was obtained through follow-up and/or provided the government. 29-OCT-2010 PCP (Primary Care Physician) records received for DOS (Date Service) from 22-JUN-2007 12-AUG-2010. The patient returned 12-SEP-2007 for additional vaccinations (reported second dose GARDASIL, hepatitis and varicella). (Physical exam) was WNL (Within Normal Limits). The third dose GARDASIL and MENACTRA were administered 21-MAR-2008. There was rash feet and legs for week which was noted 23-JUL-2008. Food allergy was questioned and the patient was sent for RAST (radioallergosorbent test). 13-FEB-2009 the patient went (office visit), (Doctor Medicine) noted Type (Diagnosis) was made OCT-2008. The patient complained headache (H/A). Rash was noted again 12AUG-2010. 1-NOV-2010 (emergency room) records were received for DOS 10-SEP-2009. Final impression was follow: Infectious Mononucleosis. Patient "c/c ST", running nose, vomiting, diarrhea, fatigue and for week. Physical exam (PE) was positive for neck lymphadenopathy, abdominal tenderness, tender palpable spleen. D/c f/u (Follow up) with PCP. 8-NOV-2010 hospital records were received for DOS from 2-DEC-2009 6-SEP-2010 when patient presented the after syncopal episode. Final impression was follow: hypoglycemia, syncope. PE(+) was tenderness upper extremities, abrasions hands. 6-SEP-2010 patient presented with c/c abdominal pain, nausea, bloating, weakness. Patient left w/o (without) being discharged. lot check has been initiated. One more the events required hospitalization, was considered disabling, was considered immediately life-threatening. This was originally reported consumer. standard lot check investigation has been finalized. All in-process quality checks for the lot number question were satisfactory. addition, and expanded lot check investigation was performed. The testing performed the batch prior release met all release specifications. The lot met the requirements the Center for Biologics Evaluation and Research and was released. further information available. 
Other Meds: 
Lab Data: 	Diagnostic laboratory, diabetes type Physical examination, 09/12/07, within normal limits; Physical examination, 11/01/10, positive for neck lymphadenopathy, abdominal tenderness, tender palpable spleen; Physical examination, 11/08/10, 

History: 
Prex Illness: 	Mole skin 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Vaers Id:  406578-2 (S)  Related reports:  406578-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  12-May-2010  23-Sep-2010  134  28-Jan-2011  31-Jan-2011  WAES1101USA00723  18-Apr-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0969Y  Right arm  Intramuscular  
TDAP  SANOFI PASTEUR  U3052AA  Left arm  Intramuscular  
VARCEL  MERCK CO. INC.  1048S  Left arm  Subcutaneously  
HEPA  GLAXOSMITHKLINE  AHAVB365CA  Right arm  Intramuscular  
BIOLOGICALS  
MNQ  SANOFI PASTEUR  U3068AA  Right arm  Intramuscular  

Seriousness: LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Alopecia, Arthralgia, Arthritis, Autoimmune disorder, Cognitive disorder, Decreased eye contact, Disturbance attention, Dry eye, Educational problem,

MedDRA 
Epistaxis, Fatigue, Lethargy, Malaise, Memory impairment, Multiple sclerosis, Muscle spasms, Pain, Sjogrens syndrome, Systemic lupus erythematosus, Urinary tract infection
Symptom Text: 	This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act, concerning year old female patient. The patient's past medical history included: colic infant weeks old months old), ear infections, Upper Respiratory Tract Infection (URI), atopic dermatitis, eczema, Attention Deficit/Hyperactivity Disorder (ADHD), questionable Attention Deficit Disorder (ADD). 12-MAY2010 the patient received the first dose GARDASIL (lot 663573/0969Y) left arm and the second dose VARIVAX (lot reported "1048S") left arm. Concomitant vaccinations the same included the first dose MENACTRA (lot U3068AA) right arm, the first dose HAVRIX (lot AHAVB365CA) right arm, and the fifth dose ADACEL (lot U3052AA) left arm. 23-SEP-2010 (134 days after vaccination) the patient experienced memory and cognitive deficit. "May" present hair loss, nose bleeds, fatigue, lethargy, dry eyes, positive ANA (reported antiphospholipid antibodies test) for autoimmune diagnosis for either lupus, multiple sclerosis (MS), arthritis and Sjogren's. Patient went neurology hospital. Continued treatment. The following information was obtained through follow-up and/or provided the government. 19-NOV-2010, primary care physician (PCP) records was received for date service (DOS) 17-NOV-1997 18-NOV-2010 with assessment: multiple arthralgias uncertain etiology. 15-OCT-2010 patient complained poor concentration, poor memory, body aches, falling grades. Past Medical History included (vitamin) B12 deficiency (per mom, documentation), poor sleep, fatigue, and questionable Attention Deficit Disorder (ADD). The patient was provided flu vaccine and sent for labs. She was referred rheumatologist. 12-NOV-2010 the patient returned for labs results, complained not feeling well. She was diagnosed with urinary tract infection (UTI). The patient returned 18-NOV-2010 complained feeling "like crap". She was scheduled for magnetic resonance imaging (MRI) and electroencephalography (EEG). She had poor eye contact during visit. Provided copy lab results for rheumatology appointment. 18-OCT-2010 more lupus 1:320, positive ANA testing TBD (to determined). 19-NOV-2010 lab/diagnostic reports received for DOS 10-NOV-2010 "IgG IgM negative Anti-". Outcome the events was not reported. The report indicated one more the reported AEs were considered disabling and immediately life-threatening. The original reporting source was not provided. The VAERS 406578. standard lot check investigation has been finalized. All in-process quality checks for the lot number question were satisfactory. addition, expanded lot check investigation was performed. The testing performed the batch prior release met all release specifications. The lot met [Due memory limitations, the remainder this text could not compared.] the requirements the Research Center and was released. further information available. 

Other Meds: 
Lab Data: 	serum ANA, also reported antiphospholipid antibodies test positive; lupus anticoagulant, 1:320; serum immunoglobulin negative; serum immunoglobulin negative. 
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Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

History: Prex Illness:  Colic; Ear infection; upper respiratory tract infection; Dermatitis atopic; Eczema; Attention deficit/hyperactivity disorder; Attention deficit disorder; Vitamin B12 deficiency  
Prex Vax Illns:  

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Vaers Id:  407172-2 (S)  Related reports:  407172-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
23.0  13-Jun-2007  22-Nov-2007  162  15-Feb-2011  16-Feb-2011  WAES1101USA00740  17-Feb-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0637F  Right arm  Intramuscular  

Seriousness: VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS 
Affect lability, Aphasia, Apraxia, Arthropathy, Balance disorder, Cerebrovascular accident, Cognitive disorder, Coordination abnormal, Cranial nerve disorder, Demyelination, Disturbance attention, Drooling, Dysarthria, Dyskinesia, Dysphagia, Dysphonia, Emotional disorder, Fatigue, Feeding disorder,

MedDRA 
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
Symptom Text: 	This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. year old female patient with medical history premature birth, cisterna magna, intracranial calcifications, periventricular hyperdensities and calcifications, hyoglycoracchia, and educational assistance since 2nd grade (verbal tasks were superior ability read), and illness time vaccination, received third dose GARDASIL (Lot 653937/0637F) IM, the right arm, 13-JUN-2007. First and second doses GARDASIL were administered 13DEC-2006 and 15-FEB-2007 respectively (Lot not provided). The patient's speech was slurring. this date patient could not talk, move her muscles. Patient has eating through feeding tube. The following information was obtained through follow-up and/or provided the government. 22-NOV-2010 hospital records were received for date service and 10-APR-2008 with discharge diagnoses leukoencephalopathy unknown etiology. Secondary diagnoses: history prematurity, question 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 progressively increasing dysarthria with word finding difficulties, loss coordination, and more easily fatigued. Examination: slow hypophonic dysarthric speech, mild weakness upper extremities deltoids and triceps, MRI consistent with vasculitic picture with multiple strokes autoimmune demyelinating disorder, possibly toxic infectious cause. The patient was discharged home stable condition with speech therapy. 29-NOV-2010 Neurology consultant records received for date service 29-APR-2008 with diagnostic progressive neurological deficits marked predominantly dysarthria, spasticity, and upper motor neuron findings; apraxia; cortical sensory deficits; pseudobulbar affect; cognitive deficits, predominantly attentional and learning; abnormal MRI scan. The patient complained slurred speech, midsentence hesitation, irregular rhythm and pitch worse with fatigue, inability straighten right knee and move right leg, balance difficulty, weight loss, difficulty concentrating, unable close mouth resulting drooling, laughs and cries easily, leg weakness. Examination: cognitive deficits attention and learning, apraxia, cortical sensory deficits, VII deficit with result facial droop. Difficulty controlling tongue movements, hyperreflexia, spasticity, and difficulty heel walking. The patient was referred for testing. 29-NOV-2010 speech pathology consultant records received for date service 30-APR-2008 with diagnostic spastic/ataxic dysarthria. The patient seen for symptoms noted. Additionally reported previous difficulty swallowing -[Due memory limitations, the remainder this text could not compared.] lowing controlled eating slower and taking smaller bites. 29-NOV-2010 neurology consultant records received for date service 03-MAY-2008 and 25-JUN-2008 with diagnostic progressive neurologic syndrome with imaging changes. Follow visit revealed additional complaints increasing difficulty swallowing. Other symptoms ongoing. Additional testing performed. The patient had performed several laboratories, MRIs, and brain biopsies without any results available. The patient presented and was hospitalized. The reporter considered the adverse events life threatening, required hospitalization and permanent disabling. lot check has been initiated. The original reporting source was not provided. The VAERS 407172. further information available. standard lot check investigation has been finalized. All in-process quality checks for the lot number question were satisfactory. addition, expan 
Other Meds: Unknown Lab Data: Magnetic resonance, abnormal, see narrative; Brain biopsy, see narrative 
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History: Premature birth; cerebrospinal fluid retention; cerebral calcification; educational problem 
Prex Illness: 
Prex Vax Illns: 

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Age Gender 01-Apr-2010 Vaccine Date 25-Aug-2010 Onset Date Type Manufacturer 15.0 VAX Detail: HPV4 MERCK CO. INC.  146 Days  Lot Prev Doses 02-Nov-2010 Received Date NULL  27-Jan-2011 Status Date Site nknown State  WAES1010USA02969 Mfr Report Route Intramuscular  27-Jan-2011 Last Edit Date Other Vaccine  
Seriousness:  HOSPITALIZED, SERIOUS  
MedDRA  Lyme disease, Papilloedema 

Symptom Text: 	Information has been received from the Health Authorities 25-OCT-2010 under the reference numbers TS20100410 and 408. Case medically confirmed. 15-year-old female patient had received the first dose GARDASIL (batch number not reported) April 2010 and the second dose GARDASIL (batch number not reported( via intramuscular route 01-JUN-2010. 25-AUG-2010, funduscopy was performed the context systemic medical supervision eye glasses wearer with accommodation disorder. revealed asymptomatic bilateral papilledema. The previous examination had been performed (without funduscopy) June 2010 orthoptist. The results were normal. The patient was hospitalized for workup. There was ophthalmologic neurologic function sign. The cerebral angio scan performed emergency showed sign intra-cranial blood pressure, ventricles dilatation, nor thrombophlebitis. Lyme disease was suspected and treated with ROCEPHIN spite the absence notion tick's bite, but with serology initially positive although not confirmed subsequent check-up, nor the PCR the cerebrospinal fluid. other etiology was found. There was inflammatory, protein electrophoreses were normal, thyroidal work-up and lactic dehydrogenase were normal. The following serologies were negative favour former infection: toxoplasmosis, Cytomegalovirus, Epstein-Barr virus, Herpes simplex virus and VZV, rickettsial disease, leptospirosis, and toxocariasis. Immunologic work-up was negative (antinuclear antibodies SSA, SSB, SM, NRP, 70, Jo-1, centromere, rheumatoid factor, C3, and complements, angiotensin-converting enzyme, anticardiolipin antibodies, beta 2-GP1, antiphospholipid antibodies. Lumbar punction showed: cerebrospinal fluid protein level 0.2 g/l, glycorrhachia 3.34 1mol/l, chlorides 121 mol/l, leukocytes 1/mm3, erythrocytes 25/mm3. MRI performed 17-SEP-2010 was normal. the beginning October 2010, the patient went Ophthalmologic consultation which showed that the papilledema was regressing. The possible role the GARDASIL vaccine was questioned other etiology was found. Outcome was considered recovering. The Health authorities assessed the causal relationship between the reported reaction and vaccinations "possible" (C2 I2) according the foreign method assessment. Other business partner numbers include E2010-06366. Additional information has been requested. 
Other Meds: 	Unknown 
Lab Data: 	ophthalmoscopy, 25Aug10, asymptomatic bilateral papilledema; cerebral angiography, sign intra-cranial blood pressure, ventricles dilatation, 
nor thrombophlebitis; Epstein-Barr virus antibodies, negative; HSV type and/or iden History: Unknown Prex Illness: Accommodation disorder; eyeglasses wearer Prex Vax Illns: 
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Vaers Id:  408723-2 (S)  Related reports:  408723-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
11.0  12-Oct-2010  21-Oct-2010  31-Jan-2011  01-Feb-2011  WAES1101USA01056  01-Feb-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0096Z  Right arm  Intramuscular  

Seriousness: VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Acne, Amnesia, Blood pressure abnormal, Chest pain, Conversion disorder, Convulsion, Disorientation, Dizziness, Emotional distress, Fatigue,

MedDRA 
Headache, Hyperventilation, Loss consciousness, Migraine, Motor dysfunction, Movement disorder, Nausea, Presyncope, Rash, Respiratory rate increased, Staring, Syncope, Tremor, Unresponsive stimuli, Vomiting
Symptom Text: 	This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. year old female with history dyslexia, amblyopia, vomiting and abdominal pain (after milk ice cream) and penicillin allergy and known pre-existing illness 12-OCT-2010 was vaccinated with the second dose GARDASIL (Lot 666595/0096Z) into the right arm. Concomitant vaccine therapy included live intranasal (cold adapted Ann Arbor master strain) FLUMIST (Lot 501051P), the first dose ADACEL (Lot U3486AA) into the left arm and the second dose MENACTRA (Lot U3511AA) into the left arm. 21-OCT-2010 the patient experienced dizziness, syncope, disorientation. Seizures and syncope with loss function left side started 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 the government. 16-NOV-2010 PCP office record and vaccination record received for DOS 12-OCT-2010 and office visit rec received for DOS 13-NOV-2010 15-NOV-2010. Assessment: Pseudoseizures. Patient was seen 12-OCT-2010. Assessment: well child. Plan: screen for celiac disease. Visit 03-NOV-2010 for follow post hospitalization. Patient reported have continued episodes involving loss consciousness, convulsing, hyperventilating, and staring off into space and memory lapses. Patient also complaint chest pain and headaches. Patient reported stressors (some picking her school, trouble with best friend). Neurological exam noted normal. Assessment: Pseudoseizures, conversion disorder. Patient was seen 15-NOV-2010 with continued complaint episodes seizure-like activity and "passing out". Neurological exam noted normal. 17-NOV-2010 discharge summary, patient record and record received for DOS from 28-OCT-2010 29-OCT-2010. Diagnosis: Pseudoseizure/conversion disorder. Patient presented with complaint near syncopal episode school. Patient reported similar episode weeks earlier. head ordered and started. emergency room, patient had episode with eyes closed, non-responsive, entire body shaking side 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 neurology, psychology and physical therapy. Patient had continued periodic pseudoseizures and family educated origin (stressors). Patient discharged home and follow with PCP. Laboratory results included: scan, video EEG, EKG, blood tests, vitals, therapy. The following information was obtained through follow-up and/or provided the government. 17-NOV-2010 and 18-NOV-2010 records received. head/brain: normal, EEG: normal (normal awake). The listing indicated that one more the events required hospitalization, was considered immediately life-threatening. The events were serious. The original reporting source was not provided. The VAERS 408723. further information available. standard lot check has been finalized. All in-process quality checks for the lot number question were satisfactory. addition, expanded lot check investigation was performed. The testing performed the batch prior release met all release specifications. The lot met the requirements the Research Center and was released. 
Other Meds: 
Lab Data: 	Computed axial, head/brain: normal; Diagnostic laboratory, blood tests normal; Electrocardiogram, normal; urinalysis, normal 
History: 
Prex Illness: 	Dyslexia; Amblyopia; Vomiting; Abdominal pain; Penicillin allergy 
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Age Gender 30-Sep-2010 Vaccine Date 28-Oct-2010 Onset Date Type Manufacturer 12.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 02-Dec-2010 Received Date NK10770  03-Jan-2011 Status Date Site nknown State  WAES1011USA02975 Mfr Report Route Intramuscular  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Asthenia, Diarrhoea, Headache, Malaise, Somnolence
Symptom Text: 	This case was received from the Health Authority 19-NOV-2010 under the reference number 2010-000588. This case medically confirmed. year old female patient with unreported risk factors and concomitant medication received the first dose GARDASIL, (batch number NM25090, lot number NK10770), intramuscularly, site not reported and experienced headache, asthenia, malaise, pain head, somnolence and diarrhoea. One week post vaccination, the patient experienced mild headache, followed violent headache two weeks post vaccination when the patient felt weak and sick. The site the pain was the back the head. 28-OCT-2010, days post vaccination, the patient experienced the same again but also felt sleepy and had diarrhoea. The patient outcome has not been reported. Both the reporter and the agency considered the events serious for the other medically important condition requiring intervention. Other business partner numbers include E2010-07181. further information available. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
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Age Gender Unknown Vaccine Date Unknown Onset Date Type Manufacturer 12.0 VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 02-Dec-2010 Received Date NULL  03-Jan-2011 Status Date Site nknown State  WAES1011USA03313 Mfr Report Route Unknown  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

Abdominal discomfort, Arthralgia, Dark circles under eyes, Fatigue, Headache, Herpes zoster, Influenza, Listless, Malaise, Muscle spasms, Myalgia,

MedDRA 
Pallor, Paralysis, Vaginal infection, Viral infection
Symptom Text: 	Information has been received from consumer who posted her granddaughter's experience internet 13-NOV-2009. was reported that the patient received one dose GARDASIL (lot# not reported) and hadn't been right since. She had been doctor's office times since shot and diagnosed with flu, virus...-yet 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 shingles weeks after shot. Her joints/muscles ached. But, most alarming was the partial paralysis fingers and toes (worse toes). Her toes literally cramp and curl under towards her foot. Most recently she has vaginal infection and possible urinary tract infections (UTI) (going get that checked tomorrow). the time this report, the patient's outcome was not reported for the patient's shingles. Upon internal review, partial paralysis fingers and toes was considered other important medical event. Additional information has been requested. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

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

Age Gender 01-Mar-2007 Vaccine Date Unknown Onset Date Type Manufacturer 13.0 VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 02-Dec-2010 Received Date NULL  05-Jan-2011 Status Date Site nknown State  WAES1011USA03314 Mfr Report Route Unknown  05-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Convulsion, Fall, Injury 

Symptom Text: 	Information has been received from female consumer who posted her daughter's experience internet. She reported that her healthy year old daughter started having her first several seizures after she had received her second dose GARDASIL (lot# not reported) March 2007. She was now year old and still having random seizures. 21-OCT-2010, the patient had seizure and she fell the ground and had minimal injuries. The outcome was not reported. Upon internal review, seizures was considered other important medical event. further information available. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Type: HPV4  Status Date: 01-JAN-1 30-APR-11  All comb. w/AND  

Age Gender 04-Nov-2010 Vaccine Date 04-Nov-2010 Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 02-Dec-2010 Received Date NULL  03-Jan-2011 Status Date Site nknown State  WAES1011USA03334 Mfr Report Route Intramuscular  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Pain extremity, Paraesthesia 

Symptom Text: 	Case received from the health authorities 22-NOV-2010 (Reference number ES-AGEMED-022813441). Case medically confirmed. year old female patient with relevant medical history reported 04-NOV-2010 was vaccinated via intramuscular with dose GARDASIL (Lot and Batch# not reported). the same date, 04-NOV-2010, the patient presented with paresthesia lower limb and leg pain. According the narratives the health authorities report, 2-3 hours after vaccine administration, the patient developed pain from knee feet with intermittent paresthesia. The patient was sent the hospital her pediatrician, normal neurological examination was performed, the result was normal. the health authorities report was not reported whether the patient was hospital admitted not. The outcome for these adverse events was unknown. Only paresthesia lower limb and leg pain was coded the health authorities report. Case reported serious the health authorities with other medically important condition criteria. Case was closed. Other business partner numbers include: E2010-07228. further information available. 
Other Meds: 	Unknown 
Lab Data: 	neurological examination, normal 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
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Age Gender 05-Oct-2010 Vaccine Date 06-Oct-2010 Onset Date Type Manufacturer 13.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 06-Dec-2010 Received Date NULL  28-Jan-2011 Status Date Site nknown State  WAES1011USA03331 Mfr Report Route Unknown  28-Jan-2011 Last Edit Date Other Vaccine  
Seriousness:  HOSPITALIZED, SERIOUS  

MedDRA 	Abdominal pain, Condition aggravated, Eosinophilia, Leukocytosis, Lymphadenitis, Peritoneal disorder, Sleep disorder
Symptom Text: 	Serious case received from the health authorities 22-NOV-2010. Case medically confirmed. case reported serious the health authorities. The primary reporter had reported the case serious. 13-year-old female patient with medical history mentioned "correct" general condition (sic) and dependence. The patient had presented with nocturnal enuresis till year because overactive bladder. March 2010, she had had constipation due diet issue (no vegetables/fruit) and had presented with abdominal pain for which DICLOFENAC 2x25mg was given for days. Eosinophilia which was minimally present about months before. September 2010, she had had serous otitis and congested nose treated with DAFALGAN with without NUROFEN. The patient was frequently holiday another country. was also mentioned that the patient's mother had history hay fever. 05OCT-2010 she had received dose GARDASIL (Lot and batch# not reported). She experienced abdominal pain and increasing leukocytosis with clear eosinophilia and mesenteric lymph glands. 06-OCT-2010, the patient developed progressive "++" abdominal pain and had mild peritoneal irritation. She did not have fever. Her night sleep was disturbed pain. Menses were unclear. medication was prescribed. Laboratory test were performed included: 22-MAR-2010: white blood cells: 11.380 Eosinophiles 11%. 11-OCT-2010: white blood cells: 29.8 (eosinophiles: 37%). 13-OCT2010: white blood cells: 30.58 (eosinophiles: 53.2%). 14-OCT-2010, the patient was observation the hospital. toxemia, neningism, collapse was observed. Abdominal computed axial tomography showed increased mesenteric glands. Abdominal pain was found between navel and symphysis, not peritoneal. thorax and Echo abdomen were normal. Dermatological, urogenital and ophthalmological examinations were normal. Lungs were normal. Dentist examination found one small hole. Ears, nose, and throat examination was normal. Bone marrow examination and coproculture. These tests were mentioned without results. was specified that the adverse event was evolution. Treatment: expectatio armata. The health care professional wondered about the influence the vaccination eosinophilia which was minimally present about months before and escalated October such way that hospital admission was needed. Other business partner numbers include: E2010-07211. further information available. 
Other Meds: 	Unknown 
Lab Data: 	hospital observation; 14Oct10; toxemia, meningism, collapse; abdominal computed axial tomography; 14Oct10; normal; abdominal ultrasound; 
14Oct10; Echo abdominal: normal; X-ray; 14Oct10;Rx Thorax: normal; urological examination; 14O History: Nocturnal enuresis; Constipation; Abdominal pain; glue ear; Nasal congestion; Eosinophilia; Overactive bladder Prex Illness: Prex Vax Illns: 
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Age Gender 04-Nov-2010 Vaccine Date 04-Nov-2010 Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 06-Dec-2010 Received Date NULL  03-Jan-2011 Status Date Site nknown State  WAES1011USA03333 Mfr Report Route Intramuscular  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Formication, Myalgia, Tremor 

Symptom Text: 	Case received from the health authorities 22-NOV-2010 (Reference number ES-AGEMED-922812341). Case medically confirmed. year old female patient with relevant medical history reported 04-NOV-2010 was vaccinated via intramuscular with dose GARDASIL (Lot and batch# not reported). the same date, 04-NOV-2010, the patient presented with shakiness, formication and myalgia. The patient recovered from shakiness unspecified date. The outcome from formication and myalgia was unknown. Case reported serious the health authorities with other medically important condition criteria. Case was closed. Other business partner numbers include: E2010-07218. further information available. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
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Vax Type: HPV4  Status Date: 01-JAN-1 30-APR-11  All comb. w/AND  

Age Gender 05-Nov-2010 Vaccine Date 05-Nov-2010 Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 06-Dec-2010 Received Date NULL  03-Jan-2011 Status Date Site nknown State  WAES1011USA03487 Mfr Report Route Intramuscular  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Convulsion, Loss consciousness 

Symptom Text: 	Information has been received from the Health Authorities 22-NOV-2010 under the reference number ES-AGEMED-622809341. Case medically confirmed. year old female patient received dose GARDASIL, batch number not reported, intramuscular route 05-NOV-2010 and the same day, she experienced convulsions that lasted for seconds with loss consciousness. The patient recovered slowly, when she got she experienced another loss consciousness, this time without convulsions. Oxygen saturation readings 99% (reported twice, with dates reported), blood pressure levels (date not reported) 90/50mmHg and 120/70mmHg (date not reported). The patient completely recovered. Case reported serious the health authorities with other medically important condition criteria. further information reported. Case closed. Other business partner numbers include: E2010-07247. 

Other Meds: 	Unknown 
Lab Data: 	blood pressure measurement, ??Nov10, 90/50 mmHg; blood pressure measurement, ??Nov10, 120/70 mmHg; arterial blood saturation, ??Nov10, 
99% History: Unknown Prex Illness: Prex Vax Illns: 
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Age Gender 17-Nov-2010 Vaccine Date 17-Nov-2010 Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 06-Dec-2010 Received Date NULL  12-Jan-2011 Status Date Site nknown State  WAES1012USA00325 Mfr Report Route Intramuscular  12-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Convulsion, Muscle rigidity, Syncope 

Symptom Text: 	Information has been received from Health Authority under the reference number ES-AGEMED-822846241 concerning year old female who 17-NOV-2010 was vaccinated intramuscularly with dose GARDASIL (LOT# not reported). 17-NOV-2010 the patient experienced convulsions, muscle rigidity and faint. The patient recovered from convulsions, muscle rigidity and faint the same day. Case reported serious the with other medically important condition criteria. Other business partner numbers included: E2010-07434. further information was reported. Case medically confirmed. 

Other Meds: 	Unknown 
Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
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Vaers Id: 411994-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
11.0  Unknown  Unknown  07-Dec-2010  04-Jan-2011  20-May-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HEPA  GLAXOSMITHKLINE  AHAVB462AA  Right arm  Unknown  
BIOLOGICALS  
TDAP  SANOFI PASTEUR  C3476AA  Left arm  Unknown  
MNQ  SANOFI PASTEUR  U3507AA  Left arm  Unknown  
HPV4  MERCK CO. INC.  0766Z  Right arm  Unknown  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Injection site erythema, Injection site swelling 
Symptom Text: swollen redness left upper arm.  
Other Meds:  
Lab Data:  
History:  
Prex Illness:  
Prex Vax Illns:  

FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 29-Oct-2010 Vaccine Date 05-Nov-2010 Onset Date Type Manufacturer 24.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 08-Dec-2010 Received Date 1539Y  05-Jan-2011 Status Date Left arm  Site State  Mfr Report Route Unknown  25-May-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Pain, Pain extremity, Tenderness 

Symptom Text: 11/5 present sharp spreading pain when lifting arm; tender/painful touch specific point arm/shoulder day vaccine following 3-5 days -spreading pain arm. Other Meds: NUVARING; MVI; Probiotics Lab Data: None History: Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  
Vaers Id: 412303-1  Related reports:  412303-2  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
13.0  05-Aug-2010  06-Aug-2010  09-Dec-2010  06-Jan-2011  26-May-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0318Z  Left arm  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Menorrhagia 
Symptom Text: First occurrence heavy menses hours post HPV. Patient normally not menstrual yet.  
Other Meds:  
Lab Data:  None  
History:  Hematuria; proteinuria; acne  
Prex Illness:  None well visit  
Prex Vax Illns:  

FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
13.0  02-Nov-2010  02-Nov-2010  09-Dec-2010  24-Feb-2011  GA10066  08-Mar-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
MEN  SANOFI PASTEUR  U3431AA  Right arm  Intramuscular  
HPV4  MERCK CO. INC.  0766Z  Right arm  Intramuscular  
MMR  MERCK CO. INC.  0229Z  Left arm  Subcutaneously  
HEPA  GLAXOSMITHKLINE  AHAVB427AA  Left arm  Intramuscular  
BIOLOGICALS  
VARCEL  MERCK CO. INC.  0244Z  Right arm  Subcutaneously  
TDAP  GLAXOSMITHKLINE  AC52B061CA  Left arm  Intramuscular  
BIOLOGICALS  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA Somnolence, Syncope, Unresponsive stimuliSymptom Text: Administer vaccines below, client became groggy, not responding and fainted. Client placed supine with feet elevated, compressed face, stimuli, monitored VS. Called for assistance from nurses when client fainted. Alert, oriented talkative. Left with mom good condition. Provided with cola. Other Meds: None Lab Data: Blood glucose, 10:20, History: None Prex Illness: None Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 11-Nov-2009 Vaccine Date Unknown Onset Date Type Manufacturer 16.0 VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 10-Dec-2010 Received Date NULL  05-Jan-2011 Status Date Site nknown State  WAES1002USA00067 Mfr Report Route Unknown  05-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Abortion induced, Amenorrhoea, Drug exposure during pregnancy, Oral contraception, Primiparous
Symptom Text: 	Case received from consumer foreign country through the Sanofi Pasteur GARDASIL Pregnancy Registry 20-JAN-2010: Initial information has been received from female consumer, for GARDASIL, Pregnancy Registry product, concerning herself (age unspecified) who 11-JAN-2010 was vaccinated with the second dose GARDASIL (batch number not reported) she was pregnant. the day reporting, she was her 12th week pregnancy. The pregnancy was spontaneous. The first dose GARDASIL had been well tolerated. Additional information received from health care professional and 25-JAN-2009: The patient was years old. She had relevant medical history. She was taking oral contraceptive, but had forgotten one pill. She was primipara and had history spontaneous abortion. The pregnancy was spontaneous. She had received the first dose GARDASIL approximately two months before this report. There was reaction after the first dose, nor after the second dose. The patient had been vaccinated 7.5 weeks amenorrhea. 21-JAN-2010, the patient had told the reporter that she wanted keep the baby. But 25-JAN-2010, the reporter informed that finally the patient asked for voluntary termination pregnancy which was planned for the following Friday, i.e. 29-JAN-2010. Follow information received 02-DEC-2010, according the initial pregnancy questionnaire, the patient underwent elective abortion unspecified date. The patient's outcome was unknown. Other business partner numbers included: E201000379. Additional information has been requested. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 
Prex Illness: 	Pregnancy NOS (LMP 27Oct09) 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11 All comb. w/AND  

Age Gender 30-Apr-2010 Vaccine Date 30-Apr-2010 Onset Date Type Manufacturer 25.0 VAX Detail: HEPAB HPV4 GLAXOSMITHKLINE BIOLOGICALS MERCK CO. INC. Days  Lot Prev Doses 23-Nov-2010 Received Date AHABB174AA 0672Y  06-Jan-2011 Status Date State Site Right arm Left arm  A0871483A Mfr Report Route Unknown Unknown  26-May-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Immediate post-injection reaction 

Symptom Text: 	This case was reported healthcare professional and described the occurrence increase thyroid levels 25-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included hypothyroidism. Concurrent vaccination included GARDASIL (nongsk); Merck; unknown; unknown given April 2010. Concurrent medications included LOESTRIN. April 2010 the subject received 1st dose TWINRIX (unknown route, right arm). April 2010, immediately after vaccination with TWINRIX, the subject experienced increase thyroid levels. Relevant test results included thyroid levels over 100. the time reporting the outcome the event was unspecified. The vaccination course with TWINRIX was discontinued. The subject was consulting with thyroid specialist. Follow-up information received August 2010 reported that following administration TWINRIX and GARDASIL (given the same time the subject's left arm April 2010) the subject's thyroid levels immediately increased. GARDASIL was also reported suspect. was noted that further vaccinations with TWINRIX were discontinued the present time. 
Other Meds: 	LOESTRIN 
Lab Data: 	Thyroid function test abnormal, 30Apr2010, over 100 
History: 	Hypothyroidism; was unknown whether the subject had experienced adverse events following previous vaccinations. Follow-up reported that the subject does not use alcohol and uses half pack tobacco day. 
Prex Illness: 	Unknown 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11 All comb. w/AND  

Age Gender 10-Dec-2010 Vaccine Date 10-Dec-2010 Onset Date Vaers Id: 18.0 412652-2 (S) Related reports: 412652-1 Days  21-Mar-2011 Received Date  22-Mar-2011 Status Date State  WAES1103USA00580 Mfr Report  22-Mar-2011 Last Edit Date  
VAX Detail:  Type FLUN HPV4  Manufacturer MEDIMMUNE VACCINEMERCK CO. INC. INC.  Lot 501049P 0768Z  Prev Doses  Site Unknown Left arm  Route Unknown Intramuscular  Other Vaccine  
Seriousness:  LIFE THREATENING, SERIOUS  

MedDRA 	Anxiety, Cold sweat, Dizziness, Pallor, Peripheral coldness, Pulse abnormal, Skin discolouration
Symptom Text: 	This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. 10-DEC-2010 year old male with pre-existing illness was vaccinated into left arm with the third dose GARDASIL (lot 666597/0768Z). Concomitant medication included intranasal FLUMIST. The patient's physical examination was within normal limits before vaccination. The patient experienced dizziness, uneasiness within minutes receiving shot. The patient was found have pallor, cold clammy skin, thin thready pulse. After immunizations, patient's skin color changed and patient's hands became cold and clammy. was given BENADRYL and epinephrine and free flow oxygen. took 1520 minutes for recovery good pulse volume and blood pressure. The patient recovered within few minutes. 11-DEC-2010 patient was feeling per patient's mother who was contacted follow-up call. The listing indicated that one more the events was considered immediately life-threatening. The original reporting source was not provided. The VAERS 412652. standard lot check investigation has been finalized. All in-process quality checks for the lot number 666597/0768Z, were satisfactory. addition, expanded lot check investigation was performed. The testing performed the batch prior release met all release specifications. The lot met the requirements the Center for Biologics Evaluation and Research and was released. further information available. 

Other Meds: 
Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-1 30-APR-11  All comb. w/AND  

Age Gender 28-Sep-2010 Vaccine Date 28-Sep-2010 Onset Date Type Manufacturer 12.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 14-Dec-2010 Received Date NK25010  04-Jan-2011 Status Date Site nknown State  WAES1012USA01341 Mfr Report Route Intramuscular  04-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Paraesthesia, Pyrexia 

Symptom Text: 	This case was initially received from health authority 02-DEC-"2012" ref 2010-000931. This one two linked cases concerning the same patient and different vaccines. This case medically confirmed. year old female patient with concomitant medication reported received injection GARDASIL (Batch number NM31130; lot number NK25010) 28-SEP-2010. 28-SEP-2010 approximately two hours post vaccination, the patient experienced paraesthesia the arm and swinging pyrexia. The patient had received MMR (manufacturer and batch number not reported) aged five years and had patches with blisters her arm. risk factors were available. The patient missed three days school and received NUROFEN corrective treatment. The paraesthesia lasted three days. The patient recovered unreported date. The patient's mother withdrew consent for further doses vaccine. The events were considered medically significant they required intervention. Other business partner numbers include E2010-07575. further information available. 

Other Meds: 	Unknown 
Lab Data: 	Unknown 
History: 	Immunisation; Blister 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 15-Nov-2007 Vaccine Date Unknown Onset Date Days Type Manufacturer 11.0 VAX Detail: HPV4 MERCK CO. INC.  Lot Prev Doses 15-Dec-2010 Received Date 1063U  11-Jan-2011 Status Date Site nknown State  WAES1010USA01752 Mfr Report Route Intramuscular  11-Jan-2011 Last Edit Date Other Vaccine  
Seriousness:  PERMANENT DISABILITY, SERIOUS  
MedDRA  Blindness, Optic nerve disorder, Optic neuritis 

Symptom Text: 	Information has been received from physician concerning year old female patient with known drug reactions/allergies who 2008 years old, was vaccinated with all three doses GARDASIL (lot not reported). The patient "had normal eye exam before GARDASIL treatment and after starting GARDASIL treatment later eye exam within the same year reported optic neuritis" 2008. The patient sought unknown medical attention. Lab diagnostics test magnetic resonance imaging performed, results provided. the time reporting the patient's optic neuritis did not improve. Follow-up information has been received from the physician concerning the year old female student with exercise induced asthma who was vaccinated into the left arm with the first dose GARDASIL (lot number 658558/1061U) 25-AUG-2007, the second dose (lot number 658563/1063U) 15-NOV2007, and the third dose (lot number 660387/1967U) 27-MAY-2008. spring 2008, the patient wanted opthamologist could not see school, bilat, dead spots seen each optic nerve. Patient had had normal eye exam 2005. 2008, the year old patient experienced optic neuritis after GARDASIL dose. the time this report, the patient's adverse events did not recover. The patient's "could not see school" and bilat, dead spots seen each optic nerve were considered disabling and other important medical events the physician. Additional information has been requested. 
Other Meds: 	Unknown 
Lab Data: 	ophthalmological exam, ?/?05, normal; ophthalmological exam, ?/?08, optic neuritis 
History: 
Prex Illness: 	Asthma exercise induced 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-1 30-APR-11  All comb. w/AND  

Age Gender 29-Oct-2010 Vaccine Date 29-Oct-2010 Onset Date Type Manufacturer 21.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 15-Dec-2010 Received Date NULL  12-Jan-2011 Status Date Site nknown State  WAES1012USA01011 Mfr Report Route Intramuscular  12-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Angioedema, Urticaria 

Symptom Text: 	Information has been received from the Health Authorities (HA) under the reference number DK-DKMA-20103489. Case medically confirmed. year old female patient had received injection GARDASIL (batch number not reported, IM) 29-OCT-2010. coded urticaria and angioedema with onset 29-OCT-2010. The patient received corrective treatment with antihistamines and prednisolone, she was not hospitalized. The patient visited the emergency ward and afterwards her own doctor. The considered angioedema serious. Upon medical review the company upgraded the case serious due other medically important condition. the time reporting, the outcome was recovering. Other business partner numbers include: E2010-07472. further information expected. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	None 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 01-Jun-2007 Vaccine Date 01-Jun-2007 Onset Date Type Manufacturer 24.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 15-Dec-2010 Received Date NULL  05-Jan-2011 Status Date Site nknown State  WAES1012USA01992 Mfr Report Route Unknown  05-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, HOSPITALIZED, SERIOUS  

MedDRA 	Back disorder, Back pain, Convulsion, Extraocular muscle paresis, Headache, Hypoaesthesia facial, Tremor
Symptom Text: 	Information has been received via the internet from year old female consumer with history seizures who was vaccinated with the third dose GARDASIL June 2007. August 2007 the patient was hospitalized due back problems. was reported that "the following day", the patient experienced seizures (it was also reported that the onset date back pain and seizures was June 2007). The patient stated she experienced the following "preliminary symptoms: left eye weakens, strong pain left side the head, tremors and feeling face etc." After several days seizures they disappear for several months and then reoccur. The patient stated that she had referred neurologist who did not know how help her. The patient visited epilepsy clinic where she was told that was all her mind because all the tests came positive. The outcome the back pain was unknown and the time this report the patient had not recovered from the seizures. The reporter felt that the seizures were related therapy with GARDASIL. Upon internal review seizures were considered Other Medical Event. Additional information not expected. 
Other Meds: 	Unknown 
Lab Data: 	diagnostic laboratory, positive 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 21-Sep-2010 Vaccine Date 22-Sep-2010 Onset Date Type Manufacturer 13.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 17-Dec-2010 Received Date NK25010  13-Jan-2011 Status Date Site nknown State  WAES1012USA02096 Mfr Report Route Intramuscular  13-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Pruritus generalised, Urticaria 

Symptom Text: 	This case was received from health authority 09-DEC-2010 under the reference number 2010-001195. This case was medically confirmed. year old female patient with unreported medical history and non concomitant medication received the first dose GARDASIL (batch number NM11420, lot number NK25010) 21-SEP-2010 and 22-SEP-2010, hours later, the patient experienced urticarial rash and severe whole body itch. The patient received corrective treatment with ZIRTEK mg. The event lasted for two days. the time reporting, the patient has recovered. The agency considered the events were serious due other medically important condition which required intervention. Other business partner numbers include E2010-07723. further information available. 

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

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender Unknown Vaccine Date Unknown Onset Date Type Manufacturer Unknown VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 17-Dec-2010 Received Date NULL  13-Jan-2011 Status Date Site nknown State  WAES1012USA02250 Mfr Report Route Unknown  13-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Cyanosis 

Symptom Text: 	This case was reported Health Care Professional 09-DEC-2010. This case linked E2010-07789, same reporter and similar events, different batch numbers. This case medically confirmed. female patient unreported age who had received dose GARDASIL, batch not reported, unreported date, received dose GARDASIL, batch not reported unreported date. One hour post vaccination the patient developed cyanosis both hands. The patient's outcome was not reported. Other business partner numbers include E2010-07762. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Unknown Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-1 30-APR-11  All comb. w/AND  

Age Gender 17-Sep-2010 Vaccine Date 17-Sep-2010 Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 17-Dec-2010 Received Date NK25010  12-Jan-2011 Status Date Site nknown State  WAES1012USA02252 Mfr Report Route Intramuscular  12-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Cyanosis, Peripheral coldness 

Symptom Text: 	This case was received from the Health Authority 09-DEC-2010 under the reference number 2010-001131. This case medically confirmed. year old female patient with medical history and concomitant medications received dose GARDASIL (lot# NK25010, batch# NM31130) 0.5 intramuscularly, site not reported 17-SEP-2010 and 17-SEP-2010, following the vaccination, the patient experienced peripheral cyanosis both hands and the hands felt very cold. The events lasted for two days. There was central cyanosis and the patient's feet were evidently not affected. The patient had previous similar episodes. The patient received corrective treatment. the time reporting, the patient was recovered. The reporter considered the events serious due other medically important condition which required intervention. Other business partner numbers include E2010-07786. 

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

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 24-Nov-2010 Vaccine Date 24-Nov-2010 Onset Date Type Manufacturer 15.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 17-Dec-2010 Received Date 1334X  12-Jan-2011 Status Date Site nknown State  WAES1012USA02281 Mfr Report Route Intramuscular  12-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Loss consciousness, Syncope 

Symptom Text: 	Case received from Health Authority 09-DEC-2010 under the reference number 2010-03560. Case medically confirmed. year old female patient received dose GARDASIL (lot# 1334X, batch# NL20290, site administration not reported), 0.5 ml, via intramuscular route 24-NOV2010. About minutes after the administration the vaccination, the patient developed syncope with loss consciousness lasting several seconds. The patient then got up, but suffered another episode syncope with loss consciousness lasting several seconds minutes later. During the episode syncopes her blood pressure could not measured, but returned normal the course minutes. She was put the shock position. The patient was not given any medication. The patient was hospitalized. The patient completely recovered. The attending doctor considered the cause the syncope vasovagal. the present case there was chronological relationship between GARDASIL injection and the onset two successive episodes syncope interval minutes. The patient was admitted hospital, and the cause syncopes was given vasovagal. The information for Health Care Professional mentions the onset syncopes after vaccination with GARDASIL. non-drug cause for the syncope was identified. the overall view the findings, therefore, the causality GARDASIL for the suspected undesirable effects according the guidelines classified probable. Syncope with loss consciousness was considered other important medical event. Other business partner numbers include E2010-07745. 

Other Meds: 	Unknown 
Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 01-Sep-2009 Vaccine Date 19-Apr-2010 Onset Date 230 Days Type Manufacturer 24.0 VAX Detail: HPV4 MERCK CO. INC.  Lot Prev Doses 20-Dec-2010 Received Date NULL  06-Jan-2011 Status Date Site nknown State  WAES1003USA00488 Mfr Report Route Unknown  06-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Abortion induced, Drug exposure during pregnancy 

Symptom Text: 	Information has been received from year old female with known drug reactions/allergies and with history caesarean section for first pregnancy who approximately September 2009, "about six months ago" was vaccinated with the first dose GARDASIL. Concomitant therapy included SUBOXONE. The patient reported that she received the third dose GARDASIL the same day she had positive pregnancy test. The patient reported about month pregnant. The last menstrual period was estimated happened January 2010 and the estimated delivery date 08-OCT2010. The patient sought medical attention visiting the physician. Follow information has been received from physician from pregnancy questionnaire who reported that the patient had elective termination pregnancy 19-APR-2010, weeks from last menstrual period. was unknown the products conception were examined. was unknown the fetus was normal. The patient's last menstrual period was 01-JAN-2010. Upon internal review elective termination was considered other important medical event. further information available. 
Other Meds: 	SUBOXONE 
Lab Data: 	beta-human chorionic, positive 
History: 	Caesarean section 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 17-Nov-2010 Vaccine Date 04-Dec-2010 Onset Date Days Vaers Id: Type Manufacturer Lot Prev Doses 15.0 413260-1 (S) VAX Detail: 20-Dec-2010 Received Date HPV4 MERCK CO. INC. NULL  06-Jan-2011 Status Date Site nknown State  WAES1012USA01611 Mfr Report Route Unknown  06-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS  

Arrhythmia, Bacterial infection, Cardiac enzymes, Cardiac monitoring, Condition aggravated, Genital lesion, Lip blister, Oropharyngeal blistering, Pyrexia,

MedDRA 
Stevens-Johnson syndrome
Symptom Text: 	Information has been received from nurse practitioner concerning year old male patient with Stevens-Johnson syndrome and drug reaction/allergies, who approximately 17-NOV-2010 was vaccinated with first dose GARDASIL (Lot not reported) days ago, reported date 08-DEC-2010). The nurse reported that 04-DEC-2010 about three weeks after vaccination, the patient had flare Stevens-Johnson syndrome. The patient had fever, high white cell count, blisters his mouth, lips and genitals and was diagnosed with bacterial infection. also had cardiac arrhythmias and required cardiac monitor and evaluation his cardiac enzymes. was hospitalized 05-DEC-2010 and released 07DEC-2010. was prescribed with antibiotics and steroids for months. the time the report, the patient was recovering. Flare Stevens-Johnson syndrome, cardiac arrhythmia and bacterial infection were considered immediately life-threatening the reporter. Upon internal review flare Stevens-Johnson syndrome and hospitalization were considered other important medical events. Additional information has been requested. 
Other Meds: 	Unknown 
Lab Data: 	WBC count, high 
History: 
Prex Illness: 	Stevens-Johnson syndrome 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Vaers Id:  413440-1 (S)  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
17.0  08-Nov-2010  08-Nov-2010  22-Dec-2010  12-Jan-2011  WAES1012USA01863  12-Jan-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0768Z  Unknown  Intramuscular  

Seriousness: VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS Asthenia, Complex regional pain syndrome, Dysphagia, Dyspnoea, Joint effusion, Muscle atrophy, Pain extremity, Streptococcal infection, Walking aid

MedDRA 
user
Symptom Text: 	Information has been received from physician and from licensed practical nurse concerning year old female patient with pertinent medical history and drug reactions allergies who 08-NOV-2010, was vaccinated with the first 0.5 dose GARDASIL (Lot# 666597/0768Z, expire date 17-OCT-2012). Concomitant medication included NECON. The patient did not receive any concomitant vaccination that time. The nurse stated that 08-NOV-2010, sometime after the patient had received the GARDASIL, the patient complained difficulty breathing and was unable swallow. The patient was seen the emergency room. was reported that the patient was positive for strep infection (not specified). The patient's white blood cell (WBC) count was elevated. The patient was treated with penicillin shot and was sent home and was not admitted the hospital. Approximately twelve hours later 09-NOV-2010, the patient experienced left leg pain (also reported bilateral lower extremity pain) and weakness on. The patient was seen the hospital and was admitted. The patient was hospitalized 09-NOV-2010. The patient had magnetic resonance imaging (MRI), computed axial tomography (CT) scan and bone scan. The tests revealed fluid the patient's hip. The patient was diagnosed with chronic regional pain syndrome. The patient was treated with extensive physical therapy. The patient was discharged 14-NOV-2010 NEURONTIN, amitriptyline hydrochloride and hydrocodone. The patient was now recovering but still had persistent pain and required walker for ambulate due muscular atrophy. The GARDASIL series had been discontinued. Chronic regional pain syndrome and the patient require walker ambulate due muscular was considered physician disabling. Additional information has been requested. 
Other Meds: 	NECON 
Lab Data: 	magnetic resonance, 11/09?/10, Fluid the patient's hip; computed axial, 11/09?/10, Fluid the patient's hip; bone scan, 11/09?/10, Fluid the 
patient's hip; diagnostic laboratory, 11/08?/10, Positive for strep infection; WBC count, History: Unknown Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 28-Sep-2010 Vaccine Date 29-Sep-2010 Onset Date Type Manufacturer 13.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 22-Dec-2010 Received Date NK25010  12-Jan-2011 Status Date Site nknown State  WAES1012USA02095 Mfr Report Route Intramuscular  12-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Dermatitis allergic, Pruritus, Urticaria 

Symptom Text: 	This case was received the Health Authority 09-DEC-2010 under the reference number 2010-001211. This case medically confirmed. year old female patient with medical history and concomitant received the first dose GARDASIL (batch NM31130, lot NK25010) intramuscularly, site not reported 28-SEP-2010. hour later 29-SEP-2010, the patient experienced allergic type skin reaction with urticaria and was itchy. The patient received corrective treatment with cortrophin cream. The events persisted for six days. the time reporting, the patient has recovered 06-OCT-2010. The agency considered the events serious for other medically important condition which required intervention. The patient was due for second dose 30-NOV-2010 when the reaction was reported. The second dose was deferred whilst the reporter was awaiting guidelines. Other business partner numbers include E2010-07720. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	None 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender Unknown Vaccine Date Unknown Onset Date Type Manufacturer Unknown VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 22-Dec-2010 Received Date NULL  12-Jan-2011 Status Date Site nknown State  WAES1012USA02249 Mfr Report Route Unknown  12-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Cyanosis 

Symptom Text: 	This case was reported Health Care Professional (HCP) 09-DEC-2010, and linked E2010-07762 (WAES# 1012USA02250), same reporter and similar events. This case medically confirmed. female patient unreported age with unreported history received the first dose GARDASIL (batch not reported, route and site not reported) unreported date. unreported date, days post vaccination, the patient experienced cyanosis both hands plus the leg below the knee but not the foot. The events spontaneously resolved unreported date. Upon internal review this case was determined medically significant and serious. Other business partner numbers include E2010-07789. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Unknown Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 23-Nov-2010 Vaccine Date 24-Nov-2010 Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 22-Dec-2010 Received Date NK10770  12-Jan-2011 Status Date Site nknown State  WAES1012USA02392 Mfr Report Route Unknown  12-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Rash pruritic, Urticaria 

Symptom Text: 	Information has been received from the Health Authority (2010-001132). This case medically confirmed. year old female patient with risk factors available and history being prone tonsillitis, she was premature baby and had rash her neck age three months which the thought was due the washing powder "Persil", received the third dose GARDASIL (Lot NK10770 and Batch NM25090), expiry January 2012 23NOV-2010. 24-NOV-2010, hours post vaccination; the patient experienced urticarial rash legs, back and neck, itchy rash. 15-NOV2010 (prior vaccination) the patient saw the doctor with sore throat, runny nose, etc. The doctor who saw her indicated that her cervical glands were enlarged and that she had cough and sore throat. The patient was prescribed CLONAMOX. The course finished 21-NOV-2010. The patient had also experienced conjunctivitis one week earlier. The indicated possible association with streptococcal. The patient was given PIRITON corrective treatment. the time reporting the rash was persisting but was less obvious. The events were considered serious they were medically important and required intervention. Other business partner numbers include: E2010-07806. further information available. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Premature baby; Rash; Sore throat; Runny nose; Tonsillitis; Cough 
Prex Illness: 	Conjunctivitis 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 29-May-2008 Vaccine Date 02-Aug-2008 Onset Date Type Manufacturer 13.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 28-Dec-2010 Received Date 1062U  03-Jan-2011 Status Date Left arm  Site State  Mfr Report Route Intramuscular  18-May-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

Abdominal pain, Abdominal tenderness, Chills, Decreased appetite, Diplopia, Dizziness, Dyspnoea, Eyeglasses therapy, Eyelid ptosis, Fatigue,

MedDRA 
Headache, Myasthenia gravis, Nausea, Ophthalmoplegia, Pain, Palpitations, Paraesthesia, Pelvic pain, Strabismus, Syncope, Tinnitus, Vertigo
Symptom Text: 	Vertigo constant head pressure till this day. Tingling fingers, ringing ears, aches, shortness breath, fainting, EKG, MRI etc. Many school days missed. The following information was obtained through follow-up and/or provided the government. 1/6/2011 neuro/ophthamoloy consultant record received for DOS 12/20/2010 impression likely myasthenia gravis. presented month upper lid ptosis, ophthalmoplegia, vertical diplopia, headaches, dizziness. other MD's: large vertical deviation, ptosis, large hypertropia, fatigable ptosis upper lid. this visit normal. Suspect ocular myasthenia gravis. Sent for additional labs and will f/u months. 1/14/2011 PCP records received for DOS 3/26-11/12/2008 assessment: vertigo, palpitations. 11/12 presented day dizziness, palpitations, shortness breath. Dizziness improved shaking her leg moving around, spells caused her fall asleep class, afraid school. able run cross country track w/o difficulties. Got new glasses weeks prior, but not wearing consistently. 1/20/2011 record received for DOS 12/3/2008 impression: dizziness. c/o weeks dizziness. previousley seen PCP referred ENT. also c/o racing heartbeat. released instructions call ENT move appointment. 1/20/2011 records received for DOS 12/20/2009 impression: pelvic pain. c/o abdominal pain (cramping), chills, loss appetite, nausea, dizziness, light headaches. Abdomen tender palpation. d/c'd home stable condition. 
Other Meds: 
Lab Data: years labs 2008-2010 The following information was obtained through follow-up and/or provided the government. 1/6/2011 lab/diagnostic results per neuro consultant: Acetylcholine receptor binding antibodies (-). MRI brain and orbits: unremarkable. 1/20/2011 lab/diagnostic records received for DOS 11/4/2008-1/3/2011. ANA, Hep antibody, RPR, herpes virus, EBV negative. CPK, ESR WNL. Blood: 266 mcg/dL (H), CMV (H). Pelvic normal. EKG unremarkable.
History: The following information was obtained through follow-up and/or provided the government. PMH: VSD (resolved), varicella, enlarged lymph node 
below ear. Prex Illness: None Prex Vax Illns: ~HPV (no brand name)~2~14.00~Patient 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-11 30-APR-11 All comb. w/AND  

Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
9.0  17-Sep-2010  18-Sep-2010  28-Dec-2010  03-Jan-2011  TN10014  18-May-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HEPA  GLAXOSMITHKLINE  AHAVB427BA  Left arm  Intramuscular  
BIOLOGICALS  
HPV4  MERCK CO. INC.  1539Y  Right arm  Intramuscular  
VARCEL  MERCK CO. INC.  0610Z  Left arm  Subcutaneously  
Seriousness: VISIT, NOT SERIOUS  

MedDRA Injected limb mobility decreased, Myalgia, Pain extremitySymptom Text: states awoke next morning after 1st HPV injection and could not abduct (R) arm. States area sore had trouble lifting 1-1 1/2 wks then symptoms subsided. Pain difficulty lifting (R) arm recurred 10/27/10. states muscle soreness prevents full function. Other Meds: None Lab Data: None History: Penicillin Prex Illness: URI Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 23-Sep-2009 Vaccine Date 23-Sep-2009 Onset Date Type Manufacturer 25.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 30-Dec-2010 Received Date 0100Y  03-Jan-2011 Status Date Site nknown State  WAES0910USA01627 Mfr Report Route Intramuscular  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

MedDRA Abortion missed, Drug exposure during pregnancy, Uterine dilation and evacuationSymptom Text: Information has been received from nurse practitioner, for GARDASIL, Pregnancy Registry product, concerning year old female patient with depression, obesity, hypertension and known drug allergies who 23-SEP-2009 was vaccinated with first 0.5 dose GARDASIL (lot 662300/0100Y). Concomitant therapy included labetalol HCl. 12-OCT-2009 the patient had positive urine pregnancy test. The patient sought medical attention through office visit. Last menstrual period and gestational age were unknown the time the report. Follow information had been received from registered nurse and was reported that the patient had "missed abortion", and Dilation and evacuation 13-NOV2009. Upon internal review, the missed abortion was determined other important medical event. Additional information has been requested. Other Meds: labetalol hydrochloride Lab Data: urine beta-human, 10/12/09, positive History: Prex Illness: Pregnancy NOS (LMP Unknown); Hypertension; Depression; Obesity Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-JAN-1 30-APR-11  All comb. w/AND  

Age Gender 06-Dec-2010 Vaccine Date 06-Dec-2010 Onset Date Type Manufacturer 13.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 30-Dec-2010 Received Date NK44350  03-Jan-2011 Status Date Site nknown State  WAES1012USA02813 Mfr Report Route Intramuscular  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Oropharyngeal pain, Swollen tongue 

Symptom Text: 	Information has been received from the Health Authority (HA), reference 2010-001362. This case medically confirmed. year old female patient with medical history concomitant medications and available data risk factors, received GARDASIL batch number NN01990, lot number NK44350, 0.5 intramuscularly 06-DEC-2010. Fifteen thirteen minutes post vaccination, the patient experienced sore throat and swollen tongue that persisted for two three hours. Corrective treatment included chlorphenamine (G). The patient went home with her parents after three hours and went back school the next day, the patient was recovered the time reporting. The IMB considered the case serious and other important medically important condition because the event required intervention. Other business partner numbers include: E2010-07854. further information available. 

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

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 13-Oct-2010 Vaccine Date 14-Oct-2010 Onset Date Type Manufacturer 13.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 30-Dec-2010 Received Date MN39510  03-Jan-2011 Status Date Site nknown State  WAES1012USA03553 Mfr Report Route Intramuscular  03-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS