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Judicial Watch • Vaers Deaths 091511

Vaers Deaths 091511

Vaers Deaths 091511

Page 1: Vaers Deaths 091511

Category:General

Number of Pages:26

Date Created:October 19, 2011

Date Uploaded to the Library:February 20, 2014

Tags:MedDRA, Onset, Seriousness, Unknown, vaers, gardasil, Manufacturer, vaccine, MERCK, death, patient, received, Freedom, State, EPA, IRS, ICE, CIA


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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: Cardiac arrest, Death, Endotracheal intubation, Fall, Haematemesis, Joint stiffness, Loss consciousness, Peripheral coldness, Presyncope, Pulse
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page 299  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11 All comb. w/AND  

Age Gender 04-Jan-2011 Vaccine Date 02-Feb-2011 Onset Date Vaers Id: Type Manufacturer 17.0 417137-1 (D) VAX Detail: Related reports: 417137-2 HPV4 MNQ MERCK CO. INC. SANOFI PASTEUR Days  Lot Prev Doses 18-Feb-2011 Received Date 0096Z U3432AA  21-Feb-2011 Status Date State Site Right arm Left arm  TN1101 Mfr Report Route Intramuscular Intramuscular  26-May-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  

MedDRA 
absent, Resuscitation, Viral infection, Vomiting
Symptom Text: 	Patient deceased within days vaccine administration. The following information was obtained through follow-up and/or provided the government. 5/11/11 records received. Service date 2/2/11 Diagnosis: Cardiac Arrest. Patient and family members had recent viral illness and vomiting. Had taken nonsteroidals. Near syncope clinic, vomited blood and fell down. EMS found unconscious and pulseless. Arrived cardiac arrest/asystole. Hands cool, ankle stiffness. CPR/ALS continued, intubation. Chest compressions, femoral central venous catheter placed for ongoing resuscitation. Patient expired. 5/25/11 Received Autopsy Report which states COD as: group streptococcal toxic shock syndrome. Report also indicates had day sore throat, nausea, vomiting diarrhea. Findings autopsy included: DIC; (+) throat, lung, csf blood cultures; pulmonary hemorrhage; pleural effusions; dehydration; obesity; superficial abrasion left thigh. Original focus infection unclear but strep throat could not ruled out since postmortem c/s (+) illness began w/sore throat. 
Other Meds: 	NORINYL 
Lab Data: The following information was obtained through follow-up and/or provided the government. 5/11/11 Labs and Diagnostics: Glucose 150 mg/dL (H). CBC RDW 14.3% (H) Platelets K/uL (L) Segs (L) Lymph 67% (H) Mono 21% (H) Myelo (H) Segs# 0.6 K/uL (L) Lymph# 5.4 KuL (H) Mono# 
1.7 K/uL (H) NRBC /100WBC (H), Burr Cells mild, Schistocytes Mild, Many Bacteria Noted Compatible with Septicemia. >90.0 sec (H), INR >9.80 
(H) PTT >200 sec (H). ECG Abnormal. Chest X-ray Abnormal. 5/25/11 Autopsy report labs: throat c/s (+), lung c/s (+), csf c/s (+), blood c/s (+) all with heavy growth group streptococcus History: Hay fever; Animal fur 

Prex Illness:none Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:06  VAERS Line ist Report Page 415  
Vax Type: HPV4  Status Date: 01-JAN 30-APR-11  All comb. w/AND  

Age Gender 04-Oct-2010 Vaccine Date 07-Oct-2010 Onset Date Days Vaers Id: Type Manufacturer Lot Prev Doses 15.0 419174-1 (D) VAX Detail: 21-Mar-2011 Received Date HPV4 MERCK CO. INC. NULL  22-Mar-2011 Status Date Site nknown State  WAES1103USA00922 Mfr Report Route Intramuscular  22-Mar-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, HOSPITALIZED, LIFE THREATENING, SERIOUS  

MedDRA Cardiac disorder, Condition aggravated, Cough, Death, Haemoptysis, Malaise, Renal disorderSymptom Text: Information has been received from physician concerning year old female patient with longstanding health problems (according mother) since childhood who 04-OCT-2010 was vaccinated with second dose GARDASIL (Lot# not reported). September 2010, the patient experienced cough and was sick. 07-OCT-2010, the patient experienced cough and haemoptysis. 30-OCT-2010, the patient was diagnosed with kidney "problem" and heart "problem". The patient was admitted hospital. The patient's mother cannot recall treatment hospital number and had not kept files. 03-NOV-2010, the patient died. The cause death was not reported. Cough, sickness, haemoptysis, kidney "problem" and heart "problem" were considered immediately life-threatening the reporter. 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 List Report Page 421  
Vax Type: HPV4  Status Date: 01-JAN-1 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-Mar-2011 Received Date NULL  23-Mar-2011 Status Date Site nknown State  WAES1103USA02079 Mfr Report Route Unknown  23-Mar-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, LIFE THREATENING, SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: 	Information has been received from website concerning thousands other young girls who unspecified dates were vaccinated with dose GARDASIL (lot not reported). The girls have experienced "life-destroying side effects" death following their HPV vaccines. Life-destroying side effects were considered immediately life-threatening. This one two reports from the same source. further information available. 
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 List Report Page 578  
Vax Type: HPV4  Status Date: 01-JAN-1 30-APR-11  All comb. w/AND  

Age Gender 01-Nov-2010 Vaccine Date 01-Nov-2010 Onset Date Vaers Id: Type Manufacturer 17.0 421582-1 (D) VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 22-Apr-2011 Received Date NULL  25-Apr-2011 Status Date Site nknown State  WAES1104USA02226 Mfr Report Route Unknown  25-Apr-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, LIFE THREATENING, PERMANE DISABILITY,  SERIOUS  
MedDRA  Death, Sudden cardiac death 

Symptom Text: 	Information has been received from nurse practitioner concerning patient's nephew, year old male consumer who she "thought" was vaccinated with dose GARDASIL (lot number not provided) November 2010. The nurse practitioner stated that two weeks after the patient received the dose GARDASIL, approximately November 2010 (also reported "two weeks ago" approximately 01-APR-2011), the patient died sudden cardiac death the lacrosse field. Unspecified medical treatment was given. was unspecified any lab diagnostic test were performed. The cause death was sudden cardiac death. Sudden cardiac death was considered immediately life-threatening and disabling the reporting nurse practitioner. 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 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 ist Report Page  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11 All comb. w/AND  

Age Gender 04-Jan-2011 Vaccine Date Unknown Onset Date DVaers Id: Type Manufacturer 17.0 417137-2 (D) VAX Detail: Related reports: 417137-1 HPV4 MNQ MERCK CO. INC. SANOFI PASTEUR  ays Lot Prev Doses 02-May-2011 Received Date 0096Z U3432AA  03-May-2011 Status Date State Site Right arm Left arm  WAES1104USA01865 Mfr Report Route Intramuscular Intramuscular  08-Jun-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  
MedDRA  Death 

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 allergy animal fur and history hay fever 04-JAN-2011 was vaccinated with second dose GARDASIL (lot 666595/0096Z) into right arm and was vaccinated with first dose MENACTRA (lot U3432AA) into left arm. Concomitant therapy included NORINYL. was reported that patient deceased within days vaccine administration, (date not reported). The original reporting source was not provided. The VAERS 417137. standard lot check investigation has been finalized. All in-process quality checks for the lot number question (666595/0096Z) 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: 	NORINYL 

Lab Data: 	Unknown 
History: 
Prex Illness: 	Hay fever; allergy animal 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page 236  
Vax Type: HPV4  Status Date: 01-MAY-1 15-SEP-11  All comb. w/AND  

Age Gender Unknown Vaccine Date Unknown Onset Date Type Manufacturer 12.0 VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 01-Jun-2011 Received Date NULL  03-Jun-2011 Status Date Site nknown State  WAES1105USA03486 Mfr Report Route Unknown  03-Jun-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  
MedDRA  Death 

Symptom Text: 	Case reported consumer and retrieved from website healthcare professional (specialist) who transmitted agency 18-May-2011. This case was not medically confirmed. The consumer published open letter about vaccination the website, citizen's association. This open letter was addressed Agency. 12-year-old female patient was vaccinated with dose GARDASIL lot and batch number not reported) recent date in. was reported that the patient deceased days after the vaccination. Medical history: was reported that the patient was excellent condition before the vaccination. Following the reporter, the had told the parents that the vaccine was very safe but that, unfortunately, the patient had reacted it. Until now, other source confirmed the case. The healthcare professional (specialist) wrote the consumer for more information. Other business partner included E2011-03076. further information available. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36 ERS Line ist Report Page 239  
Vax Type: HPV4  Statu Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 15-Feb-2011 Vaccine Date 03-Apr-2011 Onset Date Vaers Id: Type Manufacturer Unknown 424381-1 (D) VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 01-Jun-2011 Received Date 1016Z  03-Jun-2011 Status Date Site nknown State  WAES1105USA03118 Mfr Report Route Unknown  03-Jun-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, HOSPITALIZED, LIFE THREATENING, SER IOUS  
MedDRA  Abdominal distension, Abdominal pain, Death 

Symptom Text: 	Information has been received from physician part the GARDASIL Access Program concerning female who entered HPV vaccine pilot project. 15-FEB-2011 was vaccinated with 3rd dose GARDASIL (lot 666987/1016Z). The patient was admitted hospital with abdominal pain and distension 03-APR-2011. The patient died hospital 07-APR-2011. The cause death was abdominal pain and abdominal distension. The reporting physician felt that abdominal pain (grade and abdominal distension (grade were not related GARDASIL. Abdominal pain (grade and abdominal distension (grade were considered immediately life-threatening. lot check has been initiated. 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 ist Report Page 349  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11 All comb. w/AND  

Age Gender 26-Apr-2011 Vaccine Date 28-Apr-2011 Onset Date Vaers Id: Type Manufacturer 18.0 425513-1 (D) VAX Detail: Related reports: 425513-2 VARCEL HPV4 MERCK CO. INC. MERCK CO. INC. Days  Lot Prev Doses 16-Jun-2011 Received Date 1492Z 0886Z  17-Jun-2011 Status Date State Site Right arm Left arm  Mfr Report Route Intramuscular Intramuscular  05-Jul-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  

MedDRA Asphyxia, Completed suicide, Death, Suicidal ideationSymptom Text: None known -suicidal ideation denied visit 4/26 known chronic depression she elected stop her medications when she turned 18. Committed suicide 04/28/11. Hung herself. The following information was obtained through follow-up and/or provided the government. 6/27/11 Autopsy report received. COD attributed Asphyxia due hanging ligature with Ligature mark neck. Hemorrhage Cricothyroid muscle and base thyroid cornu. Fractures RL sides hyoid bone. Report reveals that made statement intent hurt/kill themselves. was found police hanging from deck. Other Meds: ORTHO CYCLEN Lab Data: None History: Prex Illness: (1) Depression/chronic; (2) ADHD; (3) acne severe Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 08:36  VAERS Line List Report Page 364  
Vax Type: HPV4  Status Date: 01-MAY-1 15-SEP-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-Jun-2011 Received Date NULL  20-Jun-2011 Status Date Site nknown State  WAES1106USA01652 Mfr Report Route Unknown  20-Jun-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  
MedDRA  Death, Thrombosis 

Symptom Text: consumer reported that he/she read internet concerning female who unspecified date was vaccinated with dose GARDASIL (lot dose and route not reported). unspecified date, the patient died "clot blood" eight hours after vaccination. This one several reports from the same source. further information available. 
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 372  
Vax Type: HPV4  Status Date: 01-MAY 15-SEP-11  All comb. w/AND  

Age Gender 01-Jun-2007 Vaccine Date 01-Jun-2007 Onset Date Days Type Manufacturer 17.0 VAX Detail: HPV4 MERCK CO. INC.  Lot Prev Doses 20-Jun-2011 Received Date NULL  21-Jun-2011 Status Date Site nknown State  WAES1106USA01650 Mfr Report Route Unknown  21-Jun-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  
MedDRA  Death, Loss consciousness, Resuscitation 

Symptom Text: consumer reported that he/she obtained the information from internet concerning years old woman who June 2007 was vaccinated the first dose GARDASIL. the afternoon the same day, June 2007, the patient was found unconscious (without signs life) her mother. The doctor from the emergency crew attempted resuscitation, but without success. The cause death was unspecified. This one several reports received from the same source. further information available. 
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 Report Page 639  
Vax Type: HPV4  Status Date: 01-MAY-1 15-SEP-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 08-Aug-2011 Received Date NULL  09-Aug-2011 Status Date Site nknown State  WAES1108USA00348 Mfr Report Route Unknown  09-Aug-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  
MedDRA  Death 

Symptom Text: Information has been received from consumer concerning her daughter who was vaccinated with GARDASIL. The consumer reported that had nothing live for because GARDASIL killed his daughter. was unknown the patient sought medical attention. further information available. 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 647  
Vax Type: HPV4  Status Date: 01-MAY-11 15-SEP-11 All comb. w/AND  

Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
Unknown  Unknown  Unknown  09-Aug-2011  10-Aug-2011  WAES1107USA04018B  16-Aug-2011  
VAX Detail:  Type HPV4  Manufacturer MERCK CO. INC.  Lot NULL  Prev Doses  Site Unknown RouteUnknown  Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Death, Drug exposure via breast milk 

Symptom Text: 	Information has been received from Doctor science who authored article published journal. The author reported that breast-feeding mother unspecified date was vaccinated with GARDASIL and that shortly following the vaccination her baby died. The author stated that both mother and child were completely healthy prior the vaccination. The mother's experience has been captured WAES 1107USA04018. further information available. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10 All comb. w/AND  

Age Gender 26-Jun-2007 Vaccine Date 12-Feb-2010 Onset Date 962 Days Vaers Id: Type Manufacturer 13.0 381305-2 (D) VAX Detail: Related reports: 381305-1; 381305-3 HPV4 MERCK CO. INC.  Lot Prev Doses 01-Sep-2010 Received Date NULL  02-Sep-2010 Status Date State Site Unknown  Mfr Report Route Intramuscular  02-Sep-2010 Last Edit Date Other Vaccine  
MNQ  SANOFI PASTEUR  U2324AA  Left arm  Intramuscular  
Seriousness:  DIED, LIFE THREATENING, SERIOUS  

MedDRA Autopsy, Death, Headache, Meningococcal infection, Nausea, Petechiae, VomitingSymptom Text: Headache, nausea/vomiting began evening 2/12/2010. Patient found dead morning 2/13/2010. Autopsy performed 2/14/2010 meningococcal disease determined COD. Gram negative diplococci observed brain stem area, petechial rash observed pathologist. Other Meds: Possibly Lithium Lab Data: Neisseria meningitidis serogroup confirmed PCR brain stem tissue collected 2/14/2010. History: Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line Report Page 1813  
Vax Type: HPV4  Status Date: 01-SEP-1 31-DEC-10  All comb. w/AND  

Age Gender Unknown Vaccine Date Unknown Onset Date Vaers Id: Type Manufacturer Unknown 412282-1 (D) VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 09-Dec-2010 Received Date NULL  10-Dec-2010 Status Date Site nknown State  WAES1011USA03821 Mfr Report Route Unknown  10-Dec-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, LIFE THREATENING, PERMANE DISABILITY,  SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: 	Information has been received from nurse practitioner, who mentioned magazine's article concerning young female patients who, unspecified date, were vaccinated with dose GARDASIL (lot expire date and route not reported), 0.5 ml. unspecified date the patients died from "neurological causes" after being given GARDASIL. "Neurological disorders" were considered immediately life-threatening and disabling the nurse practitioner. Additional information has been requested. This one two reports from the same source. Attempts are being made verify the existence identifiable patients. This one two reports from the same source. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line Report Page 1834  
Vax Type: HPV4  Status Date: 01-SEP-1 31-DEC-10  All comb. w/AND  

Age Gender 01-Sep-2007 Vaccine Date 01-Sep-2007 Onset Date Type Manufacturer 17.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 15-Dec-2010 Received Date NULL  16-Dec-2010 Status Date Site nknown State  WAES1012USA01993 Mfr Report Route Unknown  16-Dec-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, VISIT, SERIOUS  

MedDRA 	Adverse event, Arthralgia, Death, Fatigue, Headache, Myalgia, Stress
Symptom Text: 	Information has been received from consumer who was received the information from the internet. The information the internet was received consumer concerning her year old daughter who July 2007 was vaccinated with the first dose GARDASIL (Lot not reported). There was adverse events. September 2007, the patient was vaccinated with the second dose GARDASIL (Lot not reported). Following vaccination, the patient experienced joints and muscle pain, fatigue, strong headaches etc. The physician related the symptoms mental stress and prescribed TYLENOL for the treatment headaches. The reporter indicated that one thought that the symptoms were related therapy with GARDASIL. 20-FEB-2008, the patient was vaccinated with the third dose GARDASIL (Lot not reported). 22-FEB-2010 the reporter found the patient dead the bathroom floor. autopsy did not find the cause death. The reporter felt that the patient had died because GARDASIL. further information available. 
Other Meds: 	Unknown 

Lab Data: 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line ist Report Page 1868  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10  All comb. w/AND  

Age Gender Unknown Vaccine Date Unknown Onset Date Vaers Id: Type Manufacturer Unknown 413697-1 (D) VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 29-Dec-2010 Received Date NULL  30-Dec-2010 Status Date Site nknown State  WAES1012USA02761 Mfr Report Route Unknown  30-Dec-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, LIFE THREATENING, PERMANE DISABILITY,  SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: 	Information has been received from physician concerning female who unspecified date was vaccinated with the second dose GARDASIL (lot number not provided). The physician was visiting his dentist and was talking the dental hygienist about GARDASIL. The dental hygienist said she had friend whose daughter died after getting the second dose GARDASIL. was unknown the patient sought medical attention. The reporter considered death disabling and life-threatening. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date birth, dates vaccination, lot number, date event, hospital name (if applicable), and healthcare provider name and contact information. 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 07:37  VAERS Line Report Page 119  
Vax Type: HPV4  Status Date: 01-SEP-1 31-DEC-10  All comb. w/AND  

Age Gender Unknown Vaccine Date Unknown Onset Date Vaers Id: Type Manufacturer Unknown 397437-1 (D) VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 03-Sep-2010 Received Date NULL  07-Sep-2010 Status Date Site nknown State  WAES1008USA04132 Mfr Report Route Intramuscular  07-Sep-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, LIFE THREATENING, PERMANE DISABILITY,  SERIOUS  
MedDRA  Death 

Symptom Text: 	Information has been received from physician that heard from parent one his patients who also heard from elsewhere concerning female who was vaccinated with 0.5ml dose GARDASIL, IM. "Some time passed, then she died". The cause death was not reported. The patient received unspecified medical attention. Died was considered disabling and immediately life-threatening. further information available. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page 323  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
0.2  01-Sep-2010  01-Sep-2010  17-Sep-2010  20-Sep-2010  WAES1009USA00625B  20-Sep-2010  
VAX Detail:  Type HPV4  Manufacturer MERCK CO. INC.  Lot NULL  Prev Doses  Site Unknown RouteIntramuscular  Other Vaccine  
Seriousness:  DIED, SERIOUS  

MedDRA Death, Drug exposure via breast milk, General physical health deteriorationSymptom Text: Information has been received from physician for the pregnancy registry for GARDASIL, concerning female who 01-SEP-2010 was vaccinated with the first dose GARDASIL (lot number not reported) intramuscularly while breastfed her baby was day old (WAES 1009USA00625), was reported that the mother's and baby's health were good (well controlled). 02-SEP-2010, the morning, the baby's condition was still good but the afternoon the condition suddenly drop. The family immediately took the baby hospital and did not help since the baby died shortly after that. The cause death was not reported, was also reported "not recovered from death". further information available. Other Meds: None Lab Data: None History: None Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page 1504  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id:  403759-1 (D)  Related reports:  403759-2  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
10.0  09-Sep-2010  17-Sep-2010  18-Oct-2010  19-Oct-2010  15-Aug-2011  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1778Y  Right arm  Unknown  
MNQ  SANOFI PASTEUR  UA3058AA  Left arm  Unknown  
TDAP  SANOFI PASTEUR  C3476AA  Left arm  Unknown  
HEPA  MERCK CO. INC.  0568Z  Right arm  Unknown  

Seriousness: DIED, VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS MedDRA Asthenia, Autopsy, Death, Malaise, MyocarditisSymptom Text: Mother called 9-17-10 afternoon that her son sick and feeling very weak. recommended the mother take him nearest the patient was about miles away and mother took him where was transferred another hospital. The following information was obtained through follow-up and/or provided the government. 8/12/11 Autopsy report received. COD Myocarditis. Manner Death: Natural. Other Meds: None Lab Data: Unknown History: None Prex Illness: None Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page 1556  
Vax Type: HPV4  Status Date: 01-SEP-1 31-DEC-10  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 26-Oct-2010 Received Date NULL  27-Oct-2010 Status Date Site nknown State  WAES1010PHL00038 Mfr Report Route Intramuscular  27-Oct-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  
MedDRA  Death 

Symptom Text: 	Information has been received from physician concerning friend her patient who was vaccinated with GARDASIL. Subsequently the patient's friend died. The cause death was not reported. The patient decided discontinue vaccination due the incident. further information available. Attempts confirm identifiable patient had been unsuccessful. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line ist Report Page 1576  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10  All comb. w/AND  

Age Gender 30-Aug-2010 Vaccine Date 27-Sep-2010 Onset Date Type Manufacturer 15.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 28-Oct-2010 Received Date 1333Y  29-Oct-2010 Status Date Site nknown State  WAES1010USA02704 Mfr Report Route Unknown  17-Feb-2011 Last Edit Date Other Vaccine  
Seriousness:  DIED, LIFE THREATENING, SERIOUS  

MedDRA 	Bronchial hyperreactivity, Cardiomegaly, Congenital cardiovascular anomaly, Death, Left ventricular hypertrophy, Pulmonary oedema
Symptom Text: 	Information has been received from physician concerning year old male with asthma and "cardiac history" (unspecified) who 30-AUG-2010 was vaccinated with GARDASIL (Lot number 665607/1333Y). Concomitant therapy included LIPITOR. 27-SEP-2010 the patient died while playing hockey. The physician reported "awaiting autopsy results". the time report further information was available. The reporter considered death life-threatening. lot check has been initiated. Additional information has been requested. The following information was obtained through follow-up and/or provided the government. 11/16/10 Received Autopsy report which states COD as: congenital subaortic membrane w/reactive airway disease contributing factor. Manner death: natural. Gross autopsy findings included: mod marked pulmonary edema; cardiomegaly; hypertrophy; subaortic membrane. 

Other Meds: 	LIPITOR 
Lab Data: 	Unknown 
History: 
Prex Illness: 	Cardiac disorder; Asthma 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line Report Page 1583  
Vax Type: HPV4  Status Date: 01-SEP-1 31-DEC-10  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 29-Oct-2010 Received Date NULL  01-Nov-2010 Status Date Site nknown State  WAES1010USA02400 Mfr Report Route Unknown  01-Nov-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, LIFE THREATENING, SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: 	Information has been received from physician who reported magazine article regarding Cervical Cancer and the article physician stated that "GARDASIL has caused young healthy girls die right after receiving the vaccine due neurological problems. CERVARIX covering three other HPV strains and has been proven." further information filed. There was specific patient information, physician information, date death for the patients the article. Neurological problems considered immediately life-threatening. Attempts are being made obtain additional identifying information distinguish the individual patients mentioned this report. Additional information will provided available. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line ist Report Page 1588  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10  All comb. w/AND  

Age Gender 06-Aug-2010 Vaccine Date 19-Aug-2010 Onset Date Type Manufacturer 19.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 02-Nov-2010 Received Date 0640Z  02-Nov-2010 Status Date Left arm  Site State  Mfr Report Route Intramuscular  18-Nov-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  

MedDRA 	Condition aggravated, Contusion, Grand mal convulsion, Pulmonary congestion, Pulmonary oedema, Sudden death
Symptom Text: 	Patient had her first Gardasil shot 02/15/2010. 02/19/2010, she had Grand Mal seizure. She had her 2nd shot 08/06/2010. She died 08/19/2010. Medical Examiner listed cause death Sudden unexpected death associated with Seizure Disorder. The following information was obtained through follow-up and/or provided the government. 11/16/10 Received Autopsy report which states COD as: sudden unexpected death associated with generalized seizure disorder. Manner death: natural. Autopsy findings: history below; pulmonary congestion edema; minor scalp contusion. 

Other Meds: 
Lab Data: 
History: 	Autism The following information was obtained through follow-up and/or provided the government. 11/16/10 Received Autopsy report which states 
PMH: autism; atraumatic generalized seizure disorder w/abnormal EEG. 11/16/10 Received PCP medical records for service date 2/15/10. w/acute 
right otitis media when received HPV #1. w/oral antibiotics. 
Prex Illness: 
Prex Vax Illns: seizure~HPV (Gardasil)~1~19.42~Patient 

FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line ist Report Page 1808  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10  All comb. w/AND  

Age Gender 01-Aug-2007 Vaccine Date Unknown Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC.  Days  Lot Prev Doses 08-Dec-2010 Received Date NULL  09-Dec-2010 Status Date Site nknown State  WAES1012USA00781 Mfr Report Route Unknown  09-Dec-2010 Last Edit Date Other Vaccine  
Seriousness:  DIED, SERIOUS  

Adverse event, Convulsion, Death, Fatigue, Hypoaesthesia, Initial insomnia, Mood altered, Ovarian cyst, Paraesthesia, Respiratory arrest, Syncope,

MedDRA 
Urinary tract infection
Symptom Text: 	Information has been received from physician via consumer who provided the physician with link forum. The information was received from the patient's mother, from the link, concerning her healthy year old daughter who August 2007, January 2008, and June 2008, was vaccinated with first, second and third dose GARDASIL (lot not provided). was reported that the patient experienced several symptoms including numbness and tingling her fingers and toes, fatigue, really hard time falling asleep, urinary tract infections, ovarian cyst, moody, trouble getting out bed and seizures. The patient had had upwards 150 seizures following her third shot June 2008. During her seizures she stopped breathing for periods seconds. The patient was diagnosed with Neurocardiogenic syndrome and seizures. was reported that the patient died due ovarian cyst. The reporter felt that the patient's symptoms were related vaccination with GARDASIL. Upon internal review, the seizures were considered other important medical events "seizures" other important medical event. further information available. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Unknown 

Prex Illness: 
Prex Vax Illns:



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