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Judicial Watch • 2011 vaers-050111-091511

2011 vaers-050111-091511

2011 vaers-050111-091511

Page 1: 2011 vaers-050111-091511

Category:Obtained Document

Number of Pages:1639

Date Created:September 22, 2011

Date Uploaded to the Library:July 30, 2013

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


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FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id:  292001-2 (S)  Related reports:  292001-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  26-Sep-2007  26-Sep-2007  08-Aug-2011  09-Aug-2011  WAES1107USA03578  09-Aug-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  

Seriousness: VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS Abasia, Back pain, Bladder catheterisation, Bladder disorder, Burning sensation, Crying, Gastrointestinal disorder, Headache, Hemiplegia, Paraesthesia,
MedDRA 
Paralysis, Syncope, Tremor, Walking aid user
Symptom Text: 	Information has been received from physician regarding year old female who 26-SEP-2007 was vaccinated with her second dose GARDASIL for prevention HPV (human papillomavirus). She was taking concomitant medications and had pertinent medical history drug reactions/allergies. Thirty minutes after the vaccination, the patient experienced headache and that night went home and slept until the next morning. The patient woke the next day and went school. The school nurse called the patient's mother and informed her that the patient felt tingling both hands. Later that day, the patient was again sent the nurse's office due shaking sensation all over. Later that evening, things became worse and the patient started crying from the pain and burning her back. The patient was taken the emergency room her parents. the emergency room, the patient collapsed and was not able walk; she was paralyzed from the waist down. was reported that the patient was hospitalized for two months. After several months therapy, the patient was able walk with the assistance walker (by November 2007) but the time the report, she remained paralyzed her left side. The patient also had have catheter for four months and the time the report had bladder and bowel problems. Many labs were performed (results not provided). Therapy with GARDASIL was discontinued. Additional information has been requested. 
Other Meds: 	None 

Lab Data: 
History: 	None 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11 All comb. w/AND  

Age Gender 13-Jun-2007 Vaccine Date 06-Oct-2007 Onset Date Vaers Id: Type Manufacturer 18.0 293388-2 (D) VAX Detail: Related reports: 293388-1 MEN UNKNOWN MANUFACT 115 Days URER  Lot Prev Doses 30-Aug-2011 Received Date U2049AA  31-Aug-2011 Status Date State Site Left arm  WAES0711USA00552 Mfr Report Route Unknown  31-Aug-2011 Last Edit Date Other Vaccine  
HPV4  MERCK CO. INC.  0389U  Right arm  Unknown  
Seriousness:  DIED, HOSPITALIZED, SERIOUS  

MedDRA 	Brain death, Brain herniation, Chills, Death, Encephalitis, Headache, Malaise, Meningitis, Meningococcal infection, Neck pain, Pyrexia
Symptom Text: 	Information has been received via line listing from the FDA under the Freedom Information Act from health care professional 10-OCT-2007. Additional information was received from newspaper article concerning year old female with medical history and was unknown the patient was ill the time vaccination who 10-MAY-2007 was vaccinated with GARDASIL (lot 657736/0389U) the right arm. unspecified date concomitant therapy included meningococcal ACYW conj vaccine (name, manufacturer, and lot U2048AA) the left arm. The patient who was college freshman travelled 05-OCT-2007 visit her family for the weekend. The patient reportedly felt "slightly ill" upon her arrival and subsequently took aspirin and went bed awakening 1:30 the following afternoon "appearing refreshed". The patient became feverish again that night and woke 1:00 the morning 07-OCT-2007 with chills and severe headache complaining that "my headache about explode". The patient was taken local hospital, where brain computed axial tomography (CAT) scan was performed and the brain revealed meningococcal disease her brain and brain stem. The patient was immediately transferred another hospital and died the evening 07-OCT-2007 due complications meningitis. The health department noted that the "lab tests have not yet confirmed the strain meningitis" but that was "likely the type not prevented the vaccination". The listing indicated that pyrexia, meningitis, malaise, headache and chills required hospitalization and resulted death. Follow-up information was received from the FDA under the Freedom Information Act. The lot numbers and site administration was updated. Additional information was obtained from agency who reported that year old female patient received meningococcal ACYW conj vaccine (name, manufacturer, and lot number not reported). unspecified date, the patient who was college freshman, travelled 05-OCT-2007, visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival and subsequently took aspirin and went bed, awakening 1:30pm. The following afternoon "appearing refreshed". She became feverish again that night, and awoke 1:00am the morning 07-OCT-2007 with chills and severe headache, complaining, that "my head was about explode". She was taken local hospital, where CAT scan the brain revealed meningococcal disease her brain and brain stem. She was immediately transferred another hospital and died that evening 07-OCT-2007 due complication meningitis. The health department noted that "lab test had not yet confirmed the strain meningitis" but that was "likely the type not prevented the vaccination". Past medical history and concomitant medication were unknown. was not known the patient was ill the time vaccination. [Due memory limitations, the remainder this text could not compared.] 18-OCT-2007, the patient name received from FDA. 18-OCT-2007, was received death certificate from funeral home which stated cause death brain death due cerebral herniation and meningoencephalitis. 26-OCT-2010, received vaccination record from the primary care physician which indicated that the patient received GARDASIL (lot# not reported) and MENACTRA 10-MAY-2007. VAERS database updated with the same vaccination record indicated that the patient also received the second dose GARDASIL (lot# 657868/0523U, left arm). 27-NOV-2007, reviewed hospital medical records which reveal patient experienced headache, fever and neck pain for day. preliminary lot check investigation was performed. date our investigation has found that the lot 657868/0523U and the lot 657736/0389U are conformed quality release parameters and the manufacturing was typical lot GARDASIL. Additional information will provided upo 
Other Meds: 
Lab Data: 	head computed axial, 10/07/07, (BRAIN SCAN) showed meningococcal disease; WBC count, 10/07/07, 14.9; neutrophil count, 10/07/07, 67.2; absolute lymphocyte, 10/07/07, 6.4; serum creatinine, 10/07/07, 1.2; serum alanine, 10/07/07, 27; CSF white cell count, 10/07/07, 4455; red blood cell count, 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

10/07/07, 171; absolute neutrophil, 10/07/07, 100% History: None Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id:  311785-2  Related reports:  311785-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
14.0  21-Jan-2008  22-Jan-2008  18-Jul-2011  19-Jul-2011  22-Jul-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0742U  Left arm  Unknown  TDAP  

Seriousness: VISIT, NOT SERIOUS Abdominal pain upper, Crying, Depression, Menstrual disorder, Menstruation irregular, Panic attack, Suicidal ideation, Thinking abnormal, Weight

MedDRA 
decreased
Symptom Text: 	The panic attacks began the very next day. She had never experienced anything like this before. Then came the suicidal thoughts, depression, stomach pains, weight loss, menstrual period disruption. Patient went from involved and happy child one that was withdrawn and cried constantly. She went from 107 lbs lbs about month. She couldn't eat cause she stomach hurt much. She talked about how she kept getting thoughts that she should kill herself but she didn't want to...so she had constantly fight the thoughts. Her periods went from some days days apart. She would lay her room and cry for reason. had sit with her the bathroom when she took showers because she would have panic attacks the shower. She was seen the Pediatrician and all blood work tests were normal. Checked for liver pancreas issues explain pain. Seen her neurologist multiple times help her with the panic attacks and suicidal thoughts. She still this day has some irrational thoughts but she has learned control them now and has returned the happy, involved girl she was back then. 
Other Meds: 
Lab Data: 	1/19/08 sleep deprevation EEG 2/7/08 complete blood work 3/4/08 neurologist visit 4/3/08 neurologist visit 7/22/08 Dr. visit 
History: 	Epilepsy 
Prex Illness: 	none 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 25-Jul-2007 Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer Lot Prev Doses 17.0 338247-4 (S) VAX Detail: Related reports: 338247-1; 338247-2; 338247-3 09-Aug-2011 Received Date HPV4 MERCK CO. INC. 0524U  12-Aug-2011 Status Date Site nknown State  WAES1011USA02422 Mfr Report Route Unknown  12-Aug-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, HOSPITALIZED, SERIOUS  

Alopecia, Anovulatory cycle, Dehydration, Diarrhoea, Dizziness, Dyslexia, Fatigue, Feeling abnormal, Increased upper airway secretion, Medical diet,

MedDRA 
Menorrhagia, Menstrual disorder, Migraine, Pneumonia, Polymenorrhoea, Postmenopause, Premature menopause, Premenstrual syndrome, Sinusitis, Vomiting, Weight increased
Symptom Text: 	Information has been received from mother concerning her daughter with pyruvate kinase deficiencies who unspecified date, was vaccinated with GARDASIL (lot not reported). The patient received GARDASIL and was recently diagnosed post-menopausal. This was after she lost hair, had severe pneumonia, dehydration (which she was sent the hospital twice for), migraines, etc. Currently, the patient was not ovulating, although she still had regular menses. The patient was being treated with vitamin complex, vitamin vitamin and NIACIN (after being very specific diet for several months). The patient's outcome was not reported. The reporter felt that these events were related therapy with GARDASIL. Additional information has been received from the mother who posted her daughter's event internet, concerning her year old daughter who 23-JAN2007 was vaccinated with the first dose GARDASIL (Lot 654389/0961F) together with hepatitis virus vaccine (manufacturer unspecified) and MENACTRA. The patient received single dose (the second dose) GARDASIL (Lot 657617/0384U) 25-JUL-2007, and her final vaccination (the third dose) with GARDASIL (Lot 658094/0524U) took place 25-JUL-2007 which she had along with shot hepatitis virus vaccine (manufacturer unspecified). The patient was first diagnosed with pneumonia July 2007 which resulted visit, and pneumonia was severe that the patient was oxygen and home. The patient's mother had continuously pound her back help break the mucous. Several months later (in 2007), the patient was continuously ill with migraines, sinus infections, and menstrual changes (she was starting menopause age getting heavy period every two weeks). The patient's symptoms included hair loss, chronic sinus infections, migraines, weight gain, dizziness and brain fog (complaints dyslexia) and severe PMS (premenstrual syndrome) symptoms. November 2007, the patient was experiencing changes her menstrual cycle. December 2008, the patient had admitted ER, with diarrhea and vomiting, and that re-occurred again August 2009 and the patient had back the treated. After hours upon hours research, the mother realized that GARDASIL was the culprit. The mother stated that "This vaccine has robbed daughter her best years college". The patient would often call her mother tears because the fatigue was overwhelming. The patient was now doing much better after getting help from doctor. Additional information has been requested. The patient was first diagnosed with pneumonia July 2007 which resulted visit Hospital. December 2008 and August 2009, the patient had admitted treated for diarrhea and vomiting. 
Other Meds: 

Lab Data: 	Unknown 
History: 
Prex Illness: 	Pyruvate kinase decreased 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 348807-4  Related reports:  348807-1; 348807-2; 348807-3  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
Unknown  23-Apr-2009  24-Apr-2009  09-Aug-2011  29-Aug-2011  WAES1012USA01334  15-Sep-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  

Abdominal pain, Arthralgia, Back pain, Chest pain, Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Gait disturbance, Headache, Heart rate increased,

MedDRA 
Hyperaesthesia, Hypoaesthesia, Muscular weakness, Nausea, Neuralgia, Neuropathy peripheral, Pain, Pain extremity, Paraesthesia, Visual impairment
Symptom Text: 	Information has been received from consumer via internet concerning her daughter. The patient was vaccinated with dose GARDASIL 23-APR2009. She was told the side effects were; pain and redness the injection site and possible fainting she would need stay the office for minutes following the injection. The next day, 24-APR-2009 she began having symptoms dizziness, nausea and abdominal pain. the 5th day symptoms, the parents called the pediatrician and she said that could not due the vaccine because was too long past the injection and she felt was viral. they waited. The longer the vaccine was her system, the sicker she became. They called the doctor again June because the symptoms had progressed include: numbness and tingling feet, joint pain, muscle weakness severe that she needed her parent support her walk, stabbing pain her back, headaches, stabbing pain her feet, skin sensitivity, brain fog, chest pain, shortness breath, racing pulse, extreme fatigue, visual disturbances and severe pain with movement. They saw the pediatrician 03-JUN-2009 and she referred them neurologist. 08-JUN2010 they saw him and diagnosed her extreme foot pain peripheral neuropathy which was result GARDASIL. She was started Prednisone treat the extreme inflammatory process going her body and the neuropathy. She was seen 16-JUN-2009 due severe chest pain, shortness breath and nerve pain feet and arms. EKG's, CXR, blood drawn. After hours ER, she was given acetaminophen (TYLENOL) and sent home. They did not know what was causing the problems because tests came back normal. Symptoms continued daily until 10-JUL-2009 when she had about good days. The symptoms slowly returned. They sought the help from several different doctors who had little else offer because they did not know how deal with GARDASIL side effects. They consulted chiropractor 30-JUL-2009 and treatment was begun. Once again, the patient has had about good days but slowly the symptoms were re-occurring. She was suffering from dizziness, foot pain and extreme fatigue. Additional information not expected. 
Other Meds: 	Unknown 
Lab Data: 	Electrocardiogram, 06/16/09, normal; chest X-ray, 06/16/09, normal; diagnostic laboratory, 06/16/09, blood drawn-normal 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 349322-2  Related reports:  349322-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
14.0  16-Aug-2007  07-Nov-2007  05-May-2011  06-May-2011  06-May-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Right arm  Unknown  FLU  
TTOX  UNKNOWN MANUFACTURER  NULL  Left arm  Unknown  HPV4  
MEN  UNKNOWN MANUFACTURER  NULL  Right arm  Unknown  
Seriousness: VISIT, NOT SERIOUS  

MedDRA Asthenia, Autoimmune disorder, Dizziness, Fatigue, Headache, Intracranial pressure increased, Nausea, Tremor
Symptom Text: Tremors, nausea, light-headed, severe headache, extreme fatigue, mental normalities. 
Other Meds: 

Lab Data: MRI, CAT Scan, Lumbar Puncture, Vertical MRI, Multiple numerous blood tests, vision examinations, Diagnosed with increased intercranial pressure, three positive ANA tests indicating autoimmune disorder. Debiltating fatigue and constant non-stoping headaches with relief. History: None Prex Illness: None Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 375693-2  Related reports:  375693-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  30-Jan-2008  05-May-2008  09-Aug-2011  29-Aug-2011  WAES1007USA01970  29-Aug-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1062U  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Abdominal pain, Arthralgia, Condition aggravated, Depression, Fibromyalgia, Headache, Myalgia
Symptom Text: 	Information has been received from physician concerning year old female with history arthralgia and allergies who 2008, years ago", was vaccinated with the first, second and third doses GARDASIL (lot number, injection site and route not reported). Concomitant therapy included unspecified birth control pill. Subsequently the patient experienced arthralgia, chronic abdominal pain, depression, myalgia and headaches. The patient had been referred for evaluation unspecified psychiatrist, gastroenterologist and rheumatologist. Laboratory diagnostic test included endoscopy gastroenterologist which was normal. The patient had been diagnosed with fibromyalgia and was prescribed, psychiatrist, medication for depression. The physician added that the patient had experienced arthralgia the past prior receiving GARDASIL. The patient's arthralgia and chronic abdominal pain and depression and headache and fibromyalgia persisted. Additional information has been received from female receptionist reported that two the GARDASIL was vaccinated 30-JAN-2008 (Lot# 658560/1062U and 30-MAY-2008 (lot# 659439/1267U). She was not able provide any other information. The health care professional contacted during telephone follow could not supply the following information: date event. Additional information has been received from the physician indicated that the patient's joint pain pre-existed the first dose GARDASIL. was thought that the joint pain was sports related. The physician confirmed there were only two doses GARDASIL given and there were concomitant vaccines. The physician gave the onset date 05-MAY-2008 and stated the fibromyalgia diagnosis was not made the rheumatologist until 24-OCT-2009. Additional information has been requested. 
Other Meds: 	Hormonal contraceptives 
Lab Data: 	Endoscopy, normal 
History: 	Arthralgia 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 23-Apr-2010 Vaccine Date 23-Apr-2010 Onset Date Vaers Id: Type Manufacturer 19.0 386095-2 VAX Detail: Related reports: 386095-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 29-Aug-2011 Received Date NULL  12-Sep-2011 Status Date Site nknown State  WAES1106USA00498 Mfr Report Route Unknown  12-Sep-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Blood pressure immeasurable, Syncope 

Symptom Text: 	Information has been received from physician's assistant (PA) concerning year old female patient with history fainting who 23-APR-2010, was vaccinated with the first 0.5 dose GARDASIL. The physician's assistant reported that the patient received her first dose GARDASIL and fainted. The stated that the patient was fasting because she wanted her blood work well and her blood pressure was 94/54 before receiving the vaccine. After she fainted, the office could not get read her blood pressure and her pulse was 40. Oxygen was 98. The also mentioned that minutes later she fainted again while she was laying down and after that they did EKG (read 38) and took blood pressure again and was 88/48. After that the patient went emergency room (ER), however she was released and all other lab work came back normal. The patient recovered the same day. The patient sought unspecified medical attention. Additional information has been requested. 
Other Meds: 	Unknown 
Lab Data: 	Electrocardiogram, 04/23/10, 38, after fainted second time; Blood pressure, 4/23/10, 88/48, After fainted second time; Oxygen supplementation, 04/23/10, 
98, after fainted first time; Pulse oximetry, 04/23/10, 40, after fainted first time; Blood pressure, 04/23/10, 94/54, before vaccination History: Syncope Prex Illness: Low blood pressure Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id:  387662-2 (S)  Related reports:  387662-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
22.0  12-Mar-2010  13-Mar-2010  09-Aug-2011  11-Aug-2011  WAES1006USA01640  11-Aug-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0249Y  Unknown  Unknown  

Seriousness: VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS 
MedDRA 	Guillain-Barre syndrome
Symptom Text: 	Information has been received from registered nurse concerning year old female who 12-MAR-2010 was vaccinated with dose (the nurse was not sure what dose the series this was) GARDASIL (Lot#663453/0249Y) and ended being diagnosed with Guillain-Barre. 13-MAR-2010 the patient went the emergency room and was hospitalized with symptoms (nurse did not know what symptoms the patient had). the time reporting, the patient recovered from Guillain-Barre. The nurse stated this case was already from the neurologist the hospital. lot check has been initiated. Guillain-Barre was considered immediately life-threatening the reporter. All telephone attempts obtain follow-up information have been unsuccessful. Additional information has been requested. 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 the requirements the Research Center and was released. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 07-Jun-2010 Vaccine Date 07-Jun-2010 Onset Date Vaers Id: Type Manufacturer 12.0 390355-2 VAX Detail: Related reports: 390355-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 09-Aug-2011 Received Date 1377Y  30-Aug-2011 Status Date Left arm  Site State  WAES1008USA03508 Mfr Report Route Intramuscular  31-Aug-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Vision blurred 

Symptom Text: 	Information has been received from registered nurse concerning year old female patient with pertinent medical history, drug reactions and known drug allergies, who 07-JUN-2010 was vaccinated with the first 0.5 dose GARDASIL (Lot and route not reported). There were concomitant medications. The nurse reported that the patient experienced blurry vision then minutes after receiving the first dose. Nurse stated that the patient was the office this time. The blurry vision resolved minutes after the onset, while the patient was still the office. Follow-up information has been received from certified medical assistant indicating the year old female with illness time vaccination and history thyromegaly, who 07-JUN-2010 09:10 a.m. was vaccinated with the first 0.5 dose GARDASIL (lot 666768/1377Y) intramuscularly into her left deltoid. 07-JUN-2010 about 09:15 a.m. the patient complained blurred vision about minutes after injection GARDASIL. The blurry vision improved and then resolved 25-40 minutes after injection. further information available. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Enlarged thyroid 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 27-Jul-2010 Vaccine Date 27-Jul-2010 Onset Date Vaers Id: Type Manufacturer 12.0 393712-2 VAX Detail: Related reports: 393712-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 09-Aug-2011 Received Date 1318Y  29-Aug-2011 Status Date Site nknown State  WAES1007USA03812 Mfr Report Route Intramuscular  14-Sep-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Tonic clonic movements 

Symptom Text: 	Information has been received from physician concerning year old female patient with drug reactions/allergies who 27-JUL-2010 was vaccinated with 0.5 first dose GARDASIL (lot number: 665547/1318Y). There was concomitant medication. 27-JUL-2010, five minutes "after getting GARDASIL", the patient was her way out and she experienced tonic clonic movement from about seconds without loss consciousness. The physician did not think the patient would back receive any other doses. the time the report the outcome the patient was recovered the same day (on 27-JUL-2010). The patient sought unspecified medical attention. lab diagnostic studies were performed. The physician considered the events non serious. Telephone followed 03-AUG-2010 from the medical assistant confirmed the lot 1318Y and the patient had pertinent medical history and received test concomitantly with the GARDASIL vaccine. further information available. 
Other Meds: 	tuberculin purified protein 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 394362-2  Related reports:  394362-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
Unknown  11-Dec-2009  20-Jul-2010  221  09-Aug-2011  29-Aug-2011  WAES1001USA03408B  14-Sep-2011  
VAX Detail:  Type HPV4  Manufacturer MERCK CO. INC.  Lot 0249Y  Prev Doses  Site Unknown RouteUnknown  Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Amniotic fluid volume decreased, Drug exposure during pregnancy, Foetal distress syndrome, Neonatal disorder
Symptom Text: 	Information has been received for GARDASIL, Pregnancy Registry product, concerning year old female with previous pregnancies births and known drug allergies who 14-NOV-2008, 12-AUG-2009 and 11-DEC-2009 was vaccinated intramuscularly with the first 0.5 mL, second 0.5 and third 0.5 dose GARDASIL (LOT# first dose 659180/1758U, second dose 659964/1975U and third dose 663453/0249Y), respectively. This female during entire pregnancy time period was taken prenatal vitamins, daily for prenatal care and SLOW FE, daily for anemia. The patient was found pregnant since the pregnancy urine test was positive. The date the last menstrual period was October 2009, the estimated date delivery July 2010. During pregnancy delivering, the patient had complication low amniotic fluid (had captured WAES 1001USA03408) and fetal distress. Obstetric labs, ultrasound and fetal stress test were performed and outcomes were unknown. 20-JUL-2010, LMP weeks the patient through C-section delivered normal male infant, weight pounds 1.6 ounce" and length 19.5 inches. Follow-up information was received from certified medical assistant who reported that the baby was normal and doing well. The baby's last weight was pounds and oz. The mother had recovered from the C-section. The baby's next well visit was scheduled for next month (September 2010). Follow information has been received the licensed practical nurse indicated that the baby was delivered via C-Section and was currently healthy happy baby boy who was meeting his age appropriate milestones. The baby did not received GARDASIL. The mother received GARDASIL very early pregnancy. Follow-up information has been received from the responsible physician and pediatric otolaryngologist via medical records. 06-OCT-2010, the now month and day old baby, who was about two and half weeks early, but had problems with abnormal Apgar any other feeding difficulties, was sent with his parents for evaluation lump under the tongue. The parents reported history small pea-sized area which they noted birth, the floor the mouth, underneath the tongue. They had watched that increased size the point where they now felt was interfering with his feeding. According the mother, the baby was gaining weight and overall thriving, but over the last two three weeks, she had noted some episodic gagging and vomiting. She believed was related the increase the size the mass underneath the tongue. Mom noted airway breathing issues this juncture. The physical examine was within normal limits. The physician's impression was, floor mouth mass; Cyst like appearance suggestive ranula/mucocele. surgical consultation with pediatric otolaryngologist was recommended. 02-DEC-2010, the now month old baby was seen pediatric otolaryngologist. had scan done. The otolaryngologist believed this was consistent with ranula. Mom said that recently the ranula disappeared. This happened overnight. There had been further problems. The baby was feeding well and growing well. had trouble breathing. examination 02-DEC-2010, the rightt eardrum was normal. the left side, had dull, opaque eardrum, which was consistent with persistent effusion. Tonsils were 1+. The floor mouth looked completely normal. Other examine was within normal limits. The otolaryngologist impression was that his ranula had resolved. The doctor told the mom that sometimes ranula would recur and sometimes would not. The doctor also told the mom that they would recheck the baby's left otitis media with effusion months. The mother's experience had captured WAES 1001USA03408. Additional information not expected. 
Other Meds: 	SLOW FE; vitamins (unspecified) 
Lab Data: 	computed axial, 12/02/10, consistent with ranula 
History: 
Prex Illness: 	Anaemia 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-1 15-SEP-11  All comb. w/AND  

Age Gender 12-Aug-2010 Vaccine Date 12-Aug-2010 Onset Date Days Vaers Id: Type Manufacturer Unknown 395074-2 (O) VAX Detail: Related reports: 395074-1 HPV4 MERCK CO. INC.  Lot Prev Doses 14-Jun-2011 Received Date NULL  15-Jun-2011 Status Date Site nknown tate  WAES1106USA00436 Mfr Report Route Unknown  15-Jun-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Movement disorder, Posture abnormal, Syncope 

Symptom Text: 	Initial and follow information has been received from registered nurse (RN) concerning female patient who 12-AUG-2010 was vaccinated with dose GARDASIL (dose, route and lot number not provided). The stated that following the vaccination, approximately 12-AUG-2010, the patient experienced syncope and seizure-like posturing. The stated that the patient was taken Ambulance the Emergency Room. The patient was not admitted the hospital. was reported that the patient recovered (date unspecified). The stated that the patient also had sibling that received GARDASIL prior the patient receiving it, but the patient's sibling did not have adverse event following the vaccination. Upon internal review, seizure-like posturing was considered other important medical event. This one two reports from the same source. Additional information has been requested. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 395833-2  Related reports:  395833-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
11.0  13-Aug-2009  13-Aug-2009  09-Aug-2011  29-Aug-2011  WAES1007USA03811  04-Sep-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1130X  Unknown  Intramuscular  
MNQ  SANOFI PASTEUR  NULL  Unknown  Unknown  
TDAP  UNKNOWN MANUFACTURER  NULL  Unknown  Unknown  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Hypoaesthesia 

Symptom Text: 	Information has been received from medical assistant concerning current year old female patient who 13-AUG-2009 the age year old was vaccinated with 0.5 dose GARDASIL (dose unspecified and lot number: 661953/1130X, expiration date: 13-MAR-2011). The Medical assistant reported that the patient had been experiencing numbness arms and legs after vaccination. The patient did not seek medical attention until 28-JUL-2010. the time the report the patient has not recovered. Follow information was received from the medical assistant concerning the female patient with illness time vaccination and pertinent medical history, drug reactions allergies who 13-AUG-2009, was vaccinated with first dose GARDASIL (Lot# 661953/1130X). Concomitant therapy included MENACTRA and Tdap (manufacturer unknown). The medical assistant reported that 13-AUG-2010, "fairly night after the patient had received the first dose GARDASIL, MENACTRA and Tdap (manufacturer unknown)", the patient started feel numbness the upper extremity which through one year went her legs and other arm. test was done because patient's parent did not notify them until one year later when the patient went another exam. The patient did not come for the second dose GARDASIL then info was disclosed. The outcome the patient was not reported. Additional information has been requested. 
Other Meds: 

Lab Data: 	None 
History: 	None 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 03-Aug-2010 Vaccine Date 03-Aug-2010 Onset Date Vaers Id: Type Manufacturer 18.0 396326-2 VAX Detail: Related reports: 396326-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 09-Aug-2011 Received Date 0664Z  29-Aug-2011 Status Date Right arm  Site State  WAES1008USA00486 Mfr Report Route Intramuscular  04-Sep-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Erythema, Rash 

Symptom Text: 	Information has been received from registered nurse concerning year old female with medical history allergies who 21-MAY-2010 and 03-AUG-2010 was vaccinated with the first and second doses GARDASIL (lot# 666163/0664Z), 0.5 into right arm, respectively. There was concomitant therapy. approximately 03-AUG-2010 the patient developed rash and large areas erythema, over upper extremities her body, left orbit, neck, abdomen and back. lab diagnostics studies were performed. The patient was being treated with prednisone. The patient's rash and erythema persisted. The patient sought unspecified medical attention. Additional information has been requested. 
Other Meds: 	None 

Lab Data: 	None 
History: 	None 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 396395-2  Related reports:  396395-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
16.0  17-Aug-2010  22-Aug-2010  09-Aug-2011  15-Sep-2011  WAES1010USA01742  16-Sep-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0672Y  Unknown  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Arthralgia, Asthenia, Diarrhoea, Dizziness, Fatigue, Groin pain, Headache, Lymphadenopathy, Malaise, Nausea, Pain extremity
Symptom Text: 	Information has been received from medical assistant concerning year old female patient with drug reaction allergies and pertinent medical history who 17-AUG-2010 was vaccinated with her first dose GARDASIL (lot 663454/0672Y). Concomitant therapy included YAZ, CELEXA, and SEROQUEL. 22-AUG-2010 (reported days after vaccination") the patient developed enlarged lymph node her groin. The patient complained increase pain and noticed 0.5 lump her left side the groin. lab diagnostics studies were performed. The patient recovered 05-SEP-2010. The patient sought unspecified medical attention. Follow-up information has been received from the physician indicating that the patient was vaccinated with second dose GARDASIL 12-NOV-2010 and 14-NOV-2010 had nausea, headache, tired, weak, and not feeling well. Patient was seen the doctor office 15-NOV-2010 with those complaints. Blood count profile labs were taken and were okay, except for white blood cell count was low. Patient was treated symptomatically. physician follow call 17-NOV-2010, patient was feeling better. However, another call physician 22-NOV-2010 and patient was weak and tired. Follow information has been received from the physician indicating that the patient with illness time vaccination who 12-NOV-2010 received the second dose GARDASIL (lot 666929/0331Z). other medications were included. 13-NOV-2010 (previously reported "on 14-NOV-2010") she had sore arm, nausea, headache, extreme weakness, diarrhoea, dizziness one day after the second dose vaccination. The patient was treated symptomatically. The patient felt better, but not normal after days. the time reporting, the patient's outcome was unknown. Additional information has been requested. 
Other Meds: 	CELEXA; YAZ; SEROQUEL 
Lab Data: 	complete blood cell, blood count profile: okay except for white blood cell count was low 
History: 	None 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 396747-2  Related reports:  396747-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
25.0  19-Aug-2010  21-Aug-2010  09-Aug-2011  29-Aug-2011  WAES1008USA03816  04-Sep-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0787Z  Right  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Symptom Text: 	Information has been received from physician concerning female who unspecified date was vaccinated with GARDASIL (lot not reported). Subsequently the patient experienced warmth, tenderness and swelling the local injection site. The outcome the events was not reported. The patient sought unspecified medical attention. Follow information has been received from medical assistant concerning year old female who 19-AUG-2010 2:46PM was vaccinated intramuscularly into right deltoid with GARDASIL (lot 0787Z). Concomitant therapy included ADACEL. 21AUG-2010 5:06PM the patient experienced warmth, tenderness, swelling and redness the local injection site. unknown date, the patient recovered from warmth, tenderness, swelling and redness the local injection site. The patient required emergency room/doctor visit. further information available. 

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

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 397602-2  Related reports:  397602-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
13.0  01-Sep-2010  01-Sep-2010  09-Aug-2011  30-Aug-2011  WAES1009USA00144  15-Sep-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0337Z  Unknown  Unknown  
HEPA  GLAXOSMITHKLINE  AHAVB453BA  Unknown  Unknown  
BIOLOGICALS  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Abdominal pain upper, Dyskinesia, Musculoskeletal stiffness, Posture abnormal, Syncope, Tonic clonic movements
Symptom Text: 	Information has been received from physician and licensed practical nurse concerning year old female patient with history fainting and had clean health history, who 01-SEP-2010 was vaccinated with first dose GARDASIL (lot 666931/0337Z) unspecified arm. Concomitant therapy included dose HAVRIX, (Lot number AHAVB453BA) the other arm the same day with GARDASIL vaccination The physician further stated that the patient fainted, and experienced movements described tonic-clonic. The patient was placed exam table allowed rest, and left the practice feeling fine. The nurse stated that about minutes following the last vaccination the patient stated that her stomach hurt. She slumped over her chair and she began having jerking movements, her body became stiff. The patient recovered approximately seconds. The patient was given some candy "sucker" and cold compresses were applied. The patient's blood pressure was 96/98. Prior receiving the GARDASIL vaccination, her blood pressure was 107/71. The patient waited the office for time (not specified) and had recovered. The patient went home with her mother and older sister. The patient's blood pressure leaving the physician's office was 103/68. Additional information not expected. This one several reports received from the same source. The patient's older sister's information was captured WAES#1009USA00636. 
Other Meds: 
Lab Data: 	Blood pressure, 09/01/10, 107/7, Prior GARDASIL vaccination; blood pressure, 09/01/10, 96/98; blood pressure, 09/01/10, 103/6, when leaving the 
physician's office History: None Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 12-Aug-2010 Vaccine Date Unknown Onset Date Vaers Id: Type Manufacturer 18.0 401366-2 VAX Detail: Related reports: 401366-1 HPV4 MERCK CO. INC.  Days  Lot Prev Doses 09-Aug-2011 Received Date 0331Z  01-Sep-2011 Status Date Site nknown State  WAES1010USA02740 Mfr Report Route Intramuscular  04-Sep-2011 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Contusion 

Symptom Text: 	Information has been received from representative concerning "about 20" years old female who unknown date was vaccinated with the first dose GARDASIL (lot not reported). The patient noticed bruising her lower extremities. The outcome bruising her lower extremities was not reported. The patient sought unspecified medical attention. follow-up, the physician indicated that the year old (reported "about 20" the first version) patient with iodine allergy and mild attention deficient disorder (ADD) who 12-AUG-2010 was vaccinated with the first dose GARDASIL (lot 666929/0331Z). August 2010, the patient experienced bruising her lower extremities. The outcome bruising her lower extremities was not reported. The patient visited the doctor. Additional information has been requested. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 
Prex Illness: 	Iodine allergy; Attention deficit disorder 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 403924-2  Related reports:  403924-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
13.0  11-Oct-2010  12-Oct-2010  09-Aug-2011  31-Aug-2011  WAES1010USA02171  05-Sep-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1016Z  Left arm  Intramuscular  
FLUN  MEDIMMUNE VACCINES, INC.  501036P  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  

Herpes zoster, Injection site pain, Injection site rash, Injection site reaction, Joint swelling, Muscular weakness, Musculoskeletal pain, Pain extremity,

MedDRA 
Paresis, Post herpetic neuralgia, Rash pustular, Scab, Skin lesion
Symptom Text: 	Information has been received from physician concerning year old male with hypothyroidism and drug reactions/allergies and history vaccination with VARIVAX (Merck) 09-SEP-1998 and 09-AUG-2007, who 11-OCT-2010 was vaccinated with second dose GARDASIL (Lot not reported). Concomitant therapy included SYNTHROID, clonidine and loratadine (MSD). The physician reported that the patient had developed shingles-like rash and muscle weakness the injection site after receiving dose GARDASIL (Lot not reported). The patient initially started having injection site pain 12-OCT-2010. 13-OCT-2010 the patient had developed rash the injection site which progressed the following days along with localized muscle weakness. was prescribed acyclovir his pediatrician's office. The physician referred the patient see the specialist infectious disease. The specialist had done direct antigen test and was waiting for the result. She reported that the older lesions the injection site had crusted but the new ones had formed 17-OCT-2010. The muscle weakness the injection site was starting away. the time the report, the patient was recovering. Follow-up information has been received from the physician. The patient had throbbing pain and almost complete paresis his arm within few days following the dose GARDASIL. was diagnosed with Zoster and had post-herpetic neuralgia. did not have natural varicella and had received doses VARIVAX (Merck). Dates VARIVAX (Merck) were unknown, but not known recent (previously reported 09-SEP-1999 and 09-AUG-2007). The patient was treated with VALTREX and symptoms pain and weakness were still persisting today (10NOV-2010). had physical therapy treat the weakness. The patient did not undergone any nerve conduction studies but that this would considered the symptoms persist for few more weeks. Follow-up information has been received from physician concerning the patient. The patient had illness time vaccination. 11-OCT-2010 the patient received second dose GARDASIL (Lot 666987/1016Z) the left deltoid, and dose FLUMIST (Lot 501036P) intranasally. 13-OCT-2010 the patient developed swelling and pain the shoulder area after immunization. also developed vesiculopapular rash left shoulder that had spread down the arm 12-OCT-2010 days post immunization). 15-OCT-2010 condition was discussed with Infectious Disease. Diagnosis: shingles. The patient has been seen neurology clinic for post herpetic paresis. the time reporting, the patient had not recovered from the events. Follow-up information has been received from the physician. The patient was male. Besides hypothyroidism, his medical conditions also included precocious puberty, growth failure and poor weight gain. further information available. 
Other Meds: 	Clonidine; SYNTHROID; CLARITIN 

Lab Data: 	Unknown 
History: 
Prex Illness: 	Hypothyroidism; Precocious puberty; Weight gain poor; Failure thrive 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 06-Aug-2010 Vaccine Date 06-Aug-2010 Onset Date Vaers Id: Type Manufacturer 13.0 412303-2 VAX Detail: Related reports: 412303-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 09-Aug-2011 Received Date 1231Z  29-Aug-2011 Status Date Left arm  Site State  WAES1012USA01869 Mfr Report Route Intramuscular  14-Sep-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Menorrhagia 

Symptom Text: 	Information has been received from registered nurse concerning year old female patient with incontinence, allergies who 05-AUG-2010 was vaccinated with first 0.5 dose GARDASIL (Lot# 0318Z), and 07-DEC-2010 was vaccinated with second 0.5ml dose GARDASIL (Lot# 1231Z), IM. There was concomitant medication. The nurse stated that 05-AUG-2010 and 07-DEC-2010 the patient experienced heavy bleeding hours after each dose GARDASIL. There were laboratories performed. the time the report the patient was recovering from these symptoms. The patient sought unspecified medical attention. This one several reports received from the same source. Follow-up information has been received from the registered nurse who reported that the female patient (GU) tanner (not yet normally menstruating) 06-AUG-2010 was vaccinated with first 0.5ml dose GARDASIL (Lot# 1231Z), IM, left deltoid 19:00, and 08-DEC-2010 was vaccinated with second 0.5ml dose GARDASIL (lot# 1231Z), IM, 11:00. The patient experienced hematuria the time vaccination and also was reported that the patient was well the child visits. The registered nurse stated that 06-AUG-2010 (also reported 05-AUG-2010 the registered nurse) the patient was menstruating and suddenly had onset heavy menstrual cycle (24 degrees post injection). 09-AUG-2010, the patient recovered and she did not require treatment. The nurse also stated that the patient 08-DEC-2010 (also reported 07-DEC-2010 the registered nurse) started menstrual cycle that included heavy bleeding. treatment was needed for these events. There were laboratories diagnostics performed. the time the report the patient had recovered 11-DEC-2010. The patient did not seek medical attention. further information available. 
Other Meds: 	None 

Lab Data: 	None 
History: 
Prex Illness: 	Haematuria; Incontinence 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 413814-2  Related reports:  413814-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
21.0  01-Aug-2007  01-Aug-2007  09-Aug-2011  29-Aug-2011  WAES1101USA00014  31-Aug-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Anxiety, Nervous system disorder, Panic attack, Social phobia, Syncope
Symptom Text: 	Information has been received from currently year old female consumer with drug allergies pertinent medical history who August 2007, was vaccinated with the second dose GARDASIL (lot number not provided). There was concurrent medication. The consumer reported that August 2007 (at the age years old) after receiving the second dose the vaccine, she fainted the physician's office. She also began experience "anxiety, social phobia, tremendous panic attacks and nervous system issues." The consumer reported that she was treated with anti-anxiety medication but that just made worse her doctor took her off it. Laboratory tests performed included "regular blood draw" with results provided. Therapy with GARDASIL was discontinued before receiving the third dose. The consumer reported that she was still experiencing the symptoms mentioned which she felt "ruined her life". The patient sought unspecified medical attention. Additional information has been requested. 
Other Meds: 	None 

Lab Data: 	None 
History: 	None 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11 All comb. w/AND  

Age Gender 04-Nov-2010 Vaccine Date Unknown Onset Date DVaers Id: Type Manufacturer 19.0 413955-2 (O) VAX Detail: Related reports: 413955-1 VARCEL TDAP MERCK CO. INC. SANOFI PASTEUR  ays Lot Prev Doses 14-Sep-2011 Received Date 0714Z 3281BA  15-Sep-2011 Status Date State Site Left arm Left arm  WAES1011USA03447 Mfr Report Route Subcutaneously Intramuscular  15-Sep-2011 Last Edit Date Other Vaccine  
HPV4  MERCK CO. INC. 1778Y  Right arm  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Caesarean section, Foetal disorder, Maternal exposure during pregnancy
Symptom Text: 	Information has been received from nurse, for VARIVAX (Merck) and GARDASIL, both Pregnancy Registry products, concerning year old female with drug allergies erythromycin, codeine, CECLOR and ampicillin and history kidney stones who 04-NOV-2010 was vaccinated subcutaneously with 0.5 VARIVAX (Merck) (lot 666850/0714Z, expiration date 14-MAR-2012) left arm and 0.5 dose GARDASIL (lot 666121/1778Y, expiration date 19-AUG-2012) intramuscularly the right arm. the same day the patient was also vaccinated with ADACEL. Concomitant therapy also included ORTHO TRI-CYCLEN birth control pills. Prior getting vaccines, the patient was given urine pregnancy test the health center 04-NOV-2010 which was negative. 23-NOV-2010 the patient came into the health center stating she felt like she was pregnant. Urine pregnancy test was positive. Her last menstrual period (LMP) was 15-OCT-2010, and estimated delivery date (EDD) was 22-JUL-2011. The patient was not experiencing any problems. adverse effect reported. Follow-up information has been received from the nurse via Initial Pregnancy Questionnaire, for VARIVAX (Merck) and GARDASIL, both Pregnancy Registry products, concerning the year old female with illness time vaccination, who 04-NOV-2010 was vaccinated with the third 0.5 dose VARIVAX (Merck) (lot 666850/0714Z, expiration date 14-MAR2012) subcutaneously left arm. Other suspect therapy included the second 0.5 dose GARDASIL (lot 666121/1778Y, expiration date 19-AUG2012) intramuscularly right deltoid the same day. Concomitant therapy included the second dose ADACEL (lot# 3281B/A) intramuscularly left deltoid the same day. The patient did not test for varicella antibodies before vaccination with varicella-zoster virus (VZV) contained vaccine. adverse effect reported. Follow-up information has been received from the nurse via Outcome Pregnancy Questionnaire, for VARIVAX (Merck) and GARDASIL, both Pregnancy Registry products, concerning the patient who delivered normal male baby 09-AUG-2011 via C-section since the baby had low heart rate. The neonate weighed lbs. oz. weeks gestation. There were congenital anomalies. The baby had respiratory problem and fluid lung, and was Intensive Care Unit (ICU) from 09-AUG-2011 12-AUG-2011. was reported that there was complication infections illness during pregnancy and concurrent medical conditions. There was other medication used during this pregnancy. Upon internal review, the C-section baby had low heart rate was determined other important medical event. The baby's experience has been captured WAES 1011USA03447B1. further information available. 
Other Meds: 	ORTHO TRI-CYCLEN 
Lab Data: 	Urine beta-human, 11/04/10, negative; Urine beta-human, 11/23/10, positive 
History: 	Kidney stone 
Prex Illness: 	Pregnancy NOS (LMP 10/15/2010); Drug hypersensitivity; Penicillin allergy 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Vaers Id: 414028-2  Related reports:  414028-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  03-Jan-2011  03-Jan-2011  09-Aug-2011  30-Aug-2011  WAES1101USA00108  15-Sep-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1178Y  Left arm  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Abasia, Activities daily living impaired, Arthralgia, Dizziness, Fall, Flushing, Head injury, Headache, Nausea, Pain, Pain extremity
Symptom Text: 	Information has been received from consumer concerning his year old daughter with pertinent medical history, drug reactions allergies who October 2010, was vaccinated with first dose GARDASIL (Lot# unknown). 03-JAN-2011, the patient was vaccinated intramuscularly with the second dose GARDASIL (Lot# unknown). There was concomitant medication. The consumer reported that 03-JAN-2011, the patient experienced "dizziness, almost fainted, pain the thighs and especially severe pain the knees." The patient also experienced "pain the calves". The consumer reported that the patient "was such pain she could not walk". The consumer had been talking with doctors and "was all night talking with them". The consumer said that the patient had been given BENADRYL and ADVIL for the adverse events. There were laboratory tests diagnostic studies performed. the time the report, the patient had not recovered. Information was received from health care provider who reported that 03JAN2011 year old female student, 107 pounds, inches, who received dose GARDASIL (lot 663559/1178Y) intramuscularly her left arm. The patient had received one previous dose October 2010. 03JAN2011 the patient experienced headaches, dizziness, nausea and shooting pains arms and legs. The patient required emergency room/doctor visit. Chemistry labs were performed 14JAN2011. These labs indicated abnormal results low red blood cells 4.28 x10^6/mcl, neutrophils absolute (high) 7.1 x10^3/mcl, alkaline phosphatase 143 units/liter (high) and serum C-reactive protein test normal