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Judicial Watch • 2011 vaers-090110-123110

2011 vaers-090110-123110

2011 vaers-090110-123110

Page 1: 2011 vaers-090110-123110

Category:Obtained Document

Number of Pages:1874

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 07:37  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 311652-2  Related reports:  311652-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  01-May-2008  02-May-2008  08-Sep-2010  01-Oct-2010  WAES0909USA03621  01-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1448U  Right arm  Intramuscular  
TDAP  GLAXOSMITHKLINE  AC52B019AA  Left arm  Intramuscular  
BIOLOGICALS  
VARCEL  MERCK CO. INC.  1768U  Left arm  Subcutaneously  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: 	Information has been received from registered nurse concerning female who May 2008, was vaccinated with her first and only dose GARDASIL. Subsequently the patient had local injection site reaction. The red and swollen area was approximately 20cm 10cm. was unknown the patient sought medical attention. the time the report, the patient had recovered. Follow information has been received from registered nurse concerning year old female with obesity, anxiety, depression and attention deficit/hyperactivity disorder, who 01-MAY-2008 was vaccinated with the first dose GARDASIL (lot 659653/1448U) the right arm. Concomitant therapy included the first dose BOOSTRIX (GSK) (lot AC52B019AA) the left arm 01-MAY-2009 and the second dose VARIVAX (MSD, lot 659699/1768U) the left arm 01-MAY-2009. 02-MAY-2008 the patient experienced redness and swelling injection site, approximately 20cm 10cm and painful. The patient was treated with KEFLEX with diagnosis allergic reaction versus cellulitis. The patient did not seek medical attention. the time the report, the patient recovered unknown date. further information available. 
Other Meds: 
Lab Data: 	Unknown 
History: 
Prex Illness: 	Obesity; Anxiety; Depression; Attention deficit/hyperactivity disorder 

Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  
Vaers Id: 316071-2 (S)  Related reports:  316071-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
11.0  18-Mar-2008  19-Mar-2008  28-Dec-2010  30-Dec-2010  30-Dec-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0389U  Left arm  Intramuscular  
Seriousness: VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS  
MedDRA  Convulsion 
Symptom Text: After receiving second HPV, later had seizure.  
Other Meds:  
Lab Data:  
History:  None  
Prex Illness:  None  
Prex Vax Illns:  

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

Vaers Id: 337590-2  Related reports:  337590-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
22.0  01-May-2009  01-May-2009  08-Sep-2010  27-Sep-2010  WAES1005USA01037  28-Sep-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Anxiety, Hypersensitivity, Skin test, Swelling, Urticaria, Vision blurred
Symptom Text: 	Information has been received from medical assistant concerning approximately year old female patient with pertinent medical history and drug reactions allergies who May 2009 ("1 year ago"), was vaccinated with the first dose GARDASIL. The date administration was unknown. There was concomitant medication. Subsequently the patient experienced blurred vision and swelling. She was evaluated local emergency room and was diagnosed with anaphylactic reaction. The patient was treated with BENADRYL and recovered unspecified date. The patient was now referred the reporting practice for allergy evaluation due the history anaphylactic reaction her first dose GARDASIL. Because the event happened year prior, and the patient lived and was treated another state, therapy event details were available. The physician's record did not contain the names any the patient's other physicians. The health care professional contacted during telephone follow could not supply the following information: date vaccination, lot number, date event, hospital name, and primary healthcare provider name and contact information. Follow information was received from the allergy and asthma physician who reported that the year old female patient received her first dose GARDASIL about one year ago. May 2009 ("several hours later"), the patient developed urticaria but respiratory circulatory compromise. Therefore, while she appeared have had hypersensitivity reaction, was not anaphylaxis. Over the past year, the patient had several similar episodes urticaria and anxiety, cause unknown. The patient was recently seen the physician who performed skin testing followed administration dose GARDASIL without incident. There was evidence IgE mediated reaction. vial vaccine was being requested replace the one used make dilutions for allergy testing. The patient wished complete the vaccine series, and the physician felt that her urticaria was unlikely related GARDASIL vaccine. Additional information not expected. This amended report. The adverse event "anaphylactic reaction" has been changed "hypersensitivity reaction". 
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  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id:  339034-4 (S)  Related reports:  339034-1; 339034-2; 339034-3  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
11.0  19-Sep-2008  01-Oct-2008  22-Nov-2010  23-Nov-2010  23-Nov-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  

Seriousness: VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Acute disseminated encephalomyelitis, Areflexia, Balance disorder, Eye pain, Guillain-Barre syndrome, Headache, Hypoaesthesia, Hyporeflexia, Livedo

MedDRA 
reticularis, Movement disorder, Muscle atrophy, Muscle spasms, Muscle twitching, Muscular weakness, Pain, Pain extremity, Paraesthesia, Poor peripheral circulation, Syncope, Tachycardia
Symptom Text: 	pain/cramping legs and feet, tingling legs and arms/hands, numbness areas feet/toes, weakness feet then bilateral leg weakness, shooting pains legs/feet, loss balance, muscle wasting/atrophy legs, unable move feet/toes, weakness ascending from toes lower legs then upper legs, tachycardia, fainting, questionable seizure activity, loss reflexes legs and diminished reflexes arms, abnormal EMG and NCV studies, pain eyes, headaches, impaired circulation both legs with mottling noted, body twitching 
Other Meds: none 
Lab Data: This actually addendum previous entry order update VAERS report which has listed diagnosis juvenile ALS which incorrect. 

Diagnosis combination ADEM and GBS. All pertinent labs/workup/testing has been done. History: allergic sulfa, asthma Prex Illness: none Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line Report Page  
Vax Type: HPV4  Status Date: 01-SEP-1 31-DEC-10  All comb. w/AND  

Age Gender Unknown Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer Unknown 339652-3 VAX Detail: Related reports: 339652-1; 339652-2 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date NULL  30-Sep-2010 Status Date Site nknown State  WAES0909USA00331 Mfr Report Route Unknown  13-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: 	Information has been received from consumer regarding case litigation concerning her niece who unspecified date was vaccinated with dose GARDASIL (dose, route and lot number not reported). The patient had "devastating consequences" after she was given the vaccine. The reporter stated "if sister had known all the side effects she would not have given her daughter the vaccine. are causing our most important commodity (our children) suffer needlessly". 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 Report Page  
Vax Type: HPV4  Status Date: 01-SEP-1 31-DEC-10  All comb. w/AND  

Age Gender Unknown Vaccine Date 08-Dec-2008 Onset Date Vaers Id: Type Manufacturer 13.0 339660-2 (S) VAX Detail: Related reports: 339660-1 HPV4 MERCK CO. INC.  Days  Lot Prev Doses 22-Sep-2010 Received Date NULL  23-Sep-2010 Status Date Site nknown State  Mfr Report Route Unknown  23-Sep-2010 Last Edit Date Other Vaccine  
Seriousness:  HOSPITALIZED, SERIOUS  

MedDRA 	Abdominal pain upper, Activities daily living impaired, Arthralgia, Dizziness, Fatigue, Fibromyalgia, Hot flush, Nausea
Symptom Text: daughter was given GARDASIL and within days she began having stomach pain and horrible hot flashes. After these initial symptoms, horrible joint pain, extreme fatigue, dizzy spells, extreme nausea and stomach pain all began. has been months, and have spent countless hours visiting numerous specialists, hospital visits, visits trying find diagnosis. have questioned GARDASIL all the doctors, and until yesterday have been told there connection between daughter's illness and the shot she received. The Chronic Pain Doctor saw yesterday agrees that daughter's illness was caused the shot. daughter will have live with these symptoms, multiple daily medications, and therapies for the rest her life all because shot that hadn't been fully investigated before had been pushed young girls. 
Other Meds: Lab Data: X-rays every section her body; lab work; colonoscopy; every teste had come back normal. Finally diagnosed June 2010 with Fibromyalgia History: daughter had outgrown childhood epilepsy. She was year old girl from middle class family the time she received the shot. Other than the 
seizure disorder, daughter was healthy, active girl. Now she can't participate sports, can't gym class, misses extreme amount school, goes doctor's appointments all the time. 

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

Vaers Id: 340172-2  Related reports:  340172-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
26.0  01-Feb-2009  01-Feb-2009  08-Sep-2010  27-Sep-2010  WAES1005USA01522  28-Sep-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Bronchospasm, Chest pain, Cough, Dizziness, Fatigue, Haemoptysis, Influenza like illness, Nausea, Pleural effusion, Pneumonia, Pyrexia, Vomiting
Symptom Text: 	Information has been received from year old female with pertinent medical history and drug allergies, who February 2009, was vaccinated with the first dose GARDASIL. There was concomitant medication. She remained the office for minutes after her injection. Upon driving home she became dizzy and tired. She went home and laid down. She then developed nausea and vomiting, "very high fever and became really dizzy.
 She was seen the hospital and received phenergan and medication lower her fever. She was then discharged home. She continued with flu-like symptoms and week later developed "really bad chest pains." She was seen doctor. chest x-ray diagnosed her with pneumonia. She was given injection ROCEPHIN the office and sent home with "z-pack" for days. She needed second round antibiotics that lasted for additional days. The patient recovered within 2.5 weeks. Follow information received from licensed practical nurse stated that the patient was seen the office 29-FEB-2009 stating she had been coughing blood for days and was treated noted above. March 2009 second chest x-ray for follow-up showed right lower lobe improved but pleural infusion noted since last study. 01-APR-2009 another chest x-ray was normal. She was complaining coughing, sent pulmonologist, for post infection bronchospasm and was started steroid. She was last seen the office 01-APR2009. further information available. 
Other Meds: None 
Lab Data: Chest X-ray, diagnosed her with pneumonia; Chest X-ray, 03/??/09, right lower lobe improved but pleural infusion noted since last study; Chest X-ray, 

04/01/09, normal History: None Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 346298-2  Related reports:  346298-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
20.0  12-May-2009  12-May-2009  08-Sep-2010  30-Sep-2010  WAES0910USA00400  20-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0100Y  Left arm  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Dizziness, Hyperhidrosis, Hypoaesthesia, Loss consciousness, Oropharyngeal pain, Swelling, Syncope, Tinnitus
Symptom Text: 	Information has been received from registered nurse concerning year old female student with history anxiety and with known allergies the time injection who 12-MAY-2009 was vaccinated the left deltoid with the first dose GARDASIL (Lot# 662300/0100Y) approximately noon. Concomitant therapy included YAZ. 12-MAY-2009 15-20 seconds after injection the patient experienced dizziness, diaphoretic, and loss consciousness (LOC) for 15-20 seconds while upright chair. The patient regained consciousness seconds. The patient reported throat soreness, feeling swelling, syncope, ringing ears and numbness left "FA". The patient was given XYZAL 5mg orally. After minutes the patient felt "normal" and symptoms resolved. The patient had visible palpable swelling neck pharynx. There was SOB, stridor room air and respiratory rate and heart rate remained WNL. There was rash. Additional information not expected. 
Other Meds: 	YAZ 

Lab Data: 	Unknown 
History: 	Anxiety 
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 15-Dec-2006 Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer 18.0 346337-3 (S) VAX Detail: Related reports: 346337-1; 346337-2 HPV4 MERCK CO. INC.  Lot Prev Doses 10-Dec-2010 Received Date 0637F  13-Dec-2010 Status Date Site nknown State  WAES1012USA01336 Mfr Report Route Unknown  13-Dec-2010 Last Edit Date Other Vaccine  
Seriousness:  PERMANENT DISABILITY, SERIOUS  

Abdominal discomfort, Activities daily living impaired, Amnesia, Anger, Arthralgia, Body temperature fluctuation, Constipation, Diarrhoea, Disturbance attention, Dysarthria, Dysmenorrhoea, Fatigue, Gastrointestinal disorder, Hyperaesthesia, Initial insomnia, Insomnia, Joint range motion decreased,

MedDRA 
Mass, Menstruation irregular, Mood altered, Muscular weakness, Myalgia, Night sweats, Pain, Palpitations, Panic attack, Pharyngitis streptococcal, Postural orthostatic tachycardia syndrome, Rhinorrhoea, Sleep disorder, Upper respiratory tract infection, Urinary tract infection, Vomiting
Symptom Text: 	Information has been received from consumer via internet concerning her year old daughter with history infectious mononucleosis who 15DEC-2006 was vaccinated with the first dose GARDASIL (Lot 653937/0637F), her second dose 15-FEB-2007 (Lot 655618/0186U) and her final vaccination 02-JUL-2007 (Lot 657737/0522U). was reported that the patient was healthy, athletic girl until she had mononucleosis the age May 2006. December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) April 2009. Her symptoms during this period time have included: Immediately Urinary tract infections Upper respiratory tract infection, strep throat times, progressing joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, bumps growing under the skin her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke and was pain all day long joint, neck, shins, knees and her body was sensitive touch. She could not take shower and lift her arm over her head, walking upstairs caused her heart race and she could not get sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days row. she was not vomiting having diarrhea with stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read book, which she always used enjoy. She was constantly exhausted and this was just not she used be. until 05-MAY-2006, the patient was healthy, active year old teenager getting A's and B's school and playing volleyball national tournaments. She had give volleyball because her chronic illness and February 2009 had medically withdraw from college due medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered disabling. Additional information has been requested. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 	Infectious mononucleosis 
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 11-May-2007 Vaccine Date 11-May-2007 Onset Date Vaers Id: Type Manufacturer 27.0 346485-2 (O) VAX Detail: Related reports: 346485-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 09-Dec-2010 Received Date NULL  10-Dec-2010 Status Date Right arm  Site State  WAES1012USA01326 Mfr Report Route Unknown  06-Jan-2011 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  

Abdominal pain upper, Activities daily living impaired, Anger, Anxiety, Arthralgia, Back pain, Burning sensation, Constipation, Decreased appetite, Decreased interest, Depressed mood, Dizziness, Dyspepsia, Dysstasia, Fatigue, Feeling abnormal, Flank pain, Gastric ulcer, Headache, Immediate

MedDRA 
post-injection reaction, Injection site nodule, Injection site pain, Intestinal ulcer, Memory impairment, Menstrual disorder, Myalgia, Myositis, Neck pain, Pain, Pain extremity, Pancreatitis, Paraesthesia, Personality change, Photophobia, Stress, Surgery, Systemic lupus erythematosus, Tremor, Vaccine positive rechallenge
Symptom Text: 	Information has been received from year old female via internet. The patient stated that before shot she was young, vibrant, and full energy woman. 11-MAY-2007 the patient was vaccinated with the first dose GARDASIL. soon went into the arm the patient felt burning sensation going through her arm and her body. The patient left the doctor's office after this and went back work. Her right arm was sore. Her right side was extremely sore for over week. She had this kind knot her arm the injection site. 08-JUN-2007 the patient felt pain her stomach, achy all over. Saturday morning she felt horrible and hurt bad just stand upright. Her belly hurt much and she hadn't eaten anything since that Friday morning. She just did not have appetite. Her head, eyes, arms, legs, abdomen, felt like she was falling apart. The patient could not even take off her dress. The patient's brother took she the ER. The patient experienced dizzy, feeling like crap. The patient called her family practice physician, they told her come that day. She arrived the surgery and they really did not know what was wrong with her. They drew blood and put her out work for the week. The patient saw specialist (Rheumatologist). They did the exact same thing before, run tests and draw blood. Once they got the results back they tell her that she had Lupus. The Rheumatologist said the condition was controllable. 19-JUL-2007 the patient went back her gynaecologist get the next shot. She had the same symptoms after the fact, but now she was having these trembles. She had never had this before her life. certain periods time her arm her legs just started shake. She still had the joint and muscle pain, headaches, sensitivity sunlight. She was not active all and didn't want anything and she was complaining about everything. The patient stated she was angry and was forgetting the simplest things. 18-OCT-2007 the patient went and got the last shot. The patient received the 3rd dose GARDASIL one arm and PROVERA shot the other. she had both arms pain. Now it's December 2008, and she was still going through the same thing, only she started getting worse. She went physician again for advice she was just pain everyday. Medicine wasn't working and she was taking hot bath everyday. Everything she did made her feel tired and she had attitude "that this was off the hook". Her back hurt, her neck hurt, she also had trembles, tingling, headaches, and dizzy spells. But she went the doctor and they ran tests and took x-rays. When the physician got her blood work back the physician said everything was normal other than WBC was low. The chest x-ray showed something she ended having get scan and this did not identify any problem. She went back the doctor and she had muscle enzyme test, which was highly elevated showing she had inflammation her muscles. Her WBC went back normal but her iron levels had decreased. she was iron pills. When the patient started the vaccine her menstrual cycle changed and she had not had her period over year. Since September 2008, her cycle had been going crazy. The patient stated "It's like this depression that cannot get out of. The worry, the stress, it's just too much sometimes." 19-FEB-2009 the patient was still going the doctor regular basis for everything. The patient was diagnosed with pancreatitis. She had ulcers her stomach and intestines. She went through memory lapses when she forgot things. Her food did not digest she went long periods without having bowel movement. The patient had had ultrasounds, MRI's. Upon internal review, lupus and pancreatitis were considered other important medical events. Additional information not expected. 

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

Lab Data:  cervical smear, 05/11?/07, abnormal; diagnostic laboratory, muscle enzyme highly elevated; WBC count, low; serum iron assay, decreased  
History:  Unknown  
Prex Illness:  
Prex Vax Illns:  

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

Vaers Id: 348547-2 (S)  Related reports:  348547-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
-0.7  20-Jun-2008  20-Jun-2008  07-Sep-2010  08-Sep-2010  WAES0907USA05185B  08-Sep-2010  
VAX Detail:  Type HPV4  Manufacturer MERCK CO. INC.  Lot 1740U  Prev Doses  Site Unknown RouteUnknown  Other Vaccine  
HEPA  GLAXOSMITHKLINE  AHAVB264CA  Unknown  Unknown  
BIOLOGICALS  

Seriousness: VISIT, PERMANENT DISABILITY, SERIOUS 
MedDRA 	Breech presentation, Caesarean section, Congenital anomaly, Drug exposure during pregnancy, Ear tube insertion, Limb reduction defect
Symptom Text: 	This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. female patient unspecified date was vaccinated with third dose GARDASIL (lot site and route administration not reported). the time that the patient was vaccinated, she did not know that she was weeks pregnant. unspecified date ultrasound before birth revealed legs. Laboratory tests performed found genetic defect. The mother was instructed register this web site. unspecified date she had male baby (weight pounds ounces) who was born without legs. Onset date reported age 0.3 (28-JUN-2008). During the pregnancy, the mother did not receive any other medication vaccines. The listing indicated that the event was considered disabling and congenital anomaly. The original reporting source was not provided. The VAERS 348547. Follow information has been received from medical assistant concerning baby male patient, whose mother 29-JUN-2007 was vaccinated with the first dose GARDASIL (Lot 657736/0389U) (route not reported), 03-MAR-2008 was vaccinated with the second dose GARDASIL (Lot 659441/1446U) (route not reported) and 20-JUN-2008, when she was weeks pregnant was vaccinated with the third dose GARDASIL (Lot 659962/1740U) (route not reported). Concomitant therapy given 20-JUN-2008 included dose HAVRIX (Lot AHAVB264CA) (route not reported). Medical assistant reported that 23-FEB-2009 the patient was born C-section due breech birth. The baby was born with lower extremities. unspecified date, the baby had tubes placed his ears. The baby was seen orthopedic specialist for prosthesis lower extremities. The patient sought medical attention seeing orthopedic specialist. Upon internal review, breech birth was considered other important medical event. The baby born with not lower extremities was disabling and congenital anomaly. The mother's experience has been captured WAES 0907USA05158. Additional information has been requested. The information describe above has been previously submitted WAES 0907USA05185. 
Other Meds: 

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 13-Jul-2009 Vaccine Date 13-Jul-2009 Onset Date Days Vaers Id: Type Manufacturer 17.0 351325-3 VAX Detail: Related reports: 351325-1; 351325-2 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date 0652X  17-Sep-2010 Status Date Left arm  Site State  WAES0907USA02865 Mfr Report Route Intramuscular  27-Sep-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Abdominal pain upper, Headache, Malaise, Pyrexia 

Symptom Text: 	Information has been received from registered nurse concerning female who was vaccinated with the second dose GARDASIL (lot number not available). Subsequently, "the patient developed fever 104 degrees after receiving her second dose GARDASIL". Unspecified medical attention had been sought. the time the report, the patient had recovered. Follow-up information has been received from registered nurse concerning year old female with illness time vaccination who 3:15 13-JUL-2009 was vaccinated with the second dose GARDASIL (lot#661766/0652X) into the left arm. About minutes after receiving the vaccine, 5:00 the patient experienced headache. She took ibuprofen but did not receive any relief until the second dose ibuprofen was given hours after the first dose. Symptoms progressed with fever 102 degrees stomach ache and general malaise. Fever continued over 4-5 days reaching maximum 104 degrees Alternate doses ibuprofen and acetaminophen were given control fever. The patient called the doctor but was not seen the doctor. There were relevant diagnostic tests performed. 4-5 days post vaccination, the patient recovered. Additional information not expected. 
Other Meds: 	Unknown 
Lab Data: 	body temp, 07/13/09, 102 degre, Fever; body temp, Maximum 104 degrees 
History: 	None 
Prex Illness: 

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

Vaers Id: 351596-2  Related reports:  351596-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  06-May-2009  06-May-2009  08-Sep-2010  16-Sep-2010  WAES0907USA02575  17-Sep-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
VARCEL  MERCK CO. INC.  0050Y  Unknown  Subcutaneously  
HEPA  MERCK CO. INC.  0932X  Unknown  Intramuscular  
HPV4  MERCK CO. INC.  1129X  Unknown  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Dizziness, Muscular weakness, Weight bearing difficulty 

Symptom Text: 	Information has been received from physician concerning year old female patient with asthma and rhinitis allergic who 06-MAY-2009 was vaccinated with first standard dose GARDASIL (lot#661952/1129X) via intramuscular route. Concomitant therapy included VAQTA (MSD) (lot#659832/0932X) and VARIVAX (MSD) (lot#663322/0050Y). 06-MAY-2009, after receiving the first dose GARDASIL, the patient felt dizzy and leg weakness. The symptoms resolved the next day but reoccurred days after vaccinations. The symptoms again resolved the next day. was also reported that the patient received the first dose GARDASIL from her pediatrician. Within hours receiving GARDASIL, the patient experienced generalized muscle weakness her body. The patient had sought unspecified medical attention. laboratory diagnostics study was performed. Follow-up information received from the physician indicated that 06-MAY-2009, the patient received the first dose GARDASIL (lot#661952/1129X) via intramuscular route, VAQTA (MSD) (lot#659832/0932X) via intramuscular route and VARIVAX (MSD) (lot# 663322/0050Y) via subcutaneous route. There was illness time vaccination. 15-JUL-2009, the primary medical doctor e-mailed the physician concerning the patient who had "extreme dizziness and leg weakness few hours after the first dose GARDASIL which recurred the next day and again days later. The leg weakness was significant enough that the patient could not bear weight the leg. was reported that the patient did not require emergency room/doctor visit. the time report, the patient recovered. Additional information not expected. 
Other Meds: 	Unknown 

Lab Data: 	None 
History: 
Prex Illness: 	Asthma; Rhinitis allergic 

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

Vaers Id: 351706-2  Related reports:  351706-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
26.0  08-Jul-2009  12-Jul-2009  08-Sep-2010  16-Sep-2010  WAES0907USA02209  27-Sep-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0100Y  Left arm  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Injection site induration, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Symptom Text: 	Information has been received from Registered Nurse (R.N) concerning year old female patient with pertinent medical history and known drug allergies/drug reactions who 04-MAY-2009 was vaccinated with the first 0.5 dose GARDASIL (Lot 661846/1312X) intramuscularly. 08-JUL-2009 the patient received the second 0.5 dose GARDASIL (Lot 662300/0100Y) intramuscularly. Concomitant therapy included NUVARING. was reported that 13-JUL-2009, five days after receiving her second dose GARDASIL, the patient developed 3-4 nodule her left arm the injection site. was reported that the nodule was warm the touch. There were laboratory diagnostic tests performed. The patient sought medical attention with office visit. was reported that the patient had not recovered the time the report. Follow-up information has been received from physician concerning this patient with known drug allergies medical history. The physician reported that the patient 12-JUL2009 experienced left arm swelling, tenderness and induration. The patient performed serial physical exam with known results. the time this report, unspecified date the patient recovered from left arm swelling, tenderness and induration. 
Other Meds: 	NUVARING 

Lab Data: 	None 
History: 	None 
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 16-Jul-2009 Vaccine Date 16-Jul-2009 Onset Date Days Vaers Id: Type Manufacturer 22.0 352159-2 VAX Detail: Related reports: 352159-1 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date 0063X  17-Sep-2010 Status Date Site nknown State  WAES0907USA02624 Mfr Report Route Unknown  05-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Head injury, Lip injury, Loss consciousness 

Symptom Text: 	Information has been received from nurse concerning year old female who 16-JUL-2009 was vaccinated with the first dose GARDASIL (lot# 660616/0570X) (dose, route not specified). 16-JUL-2009 the patient passed out after receiving the first dose GARDASIL. The patient recovered 16-JUL-2009. The patient sought unspecified medical attention. Follow-up information has been received from physician via medical records. was reported that the patient was female with known drug allergies who 16-JUL-2009, received the first dose (on right side, exact site not specified) GARDASIL (lot 660391/0063X, also reported lot# 660616/0570X) 10:00 am. There was illness time vaccination. was reported that the patient had appointment with the physician for physical exam. The patient received the vaccination and appeared fine and left the exam room and walked out the front desk check out. She was speaking the check out desk and without any warning fell the floor 10:15. She was immediately assisted. The patient was unconscious briefly, bit her lip and hit her head the floor pretty hard. was reported that the patient had deep laceration her lip. She was left lying the floor with ice her lip and given smelling salts. She was moved exam room and monitored for about hours and recovered. 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 22-Jul-2009 Vaccine Date 22-Jul-2009 Onset Date Days Vaers Id: Type Manufacturer 11.0 352391-2 VAX Detail: Related reports: 352391-1 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date NULL  27-Sep-2010 Status Date Site nknown State  WAES0908USA00356 Mfr Report Route Intramuscular  13-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Chest pain, Cold sweat, Dizziness, Nausea, Pallor 

Symptom Text: 	Information has been received from physician concerning year old female with asthma and with drug reactions/allergies who 22-JUL-2009 23-JUL-2009 was vaccinated with the first 0.5ml dose GARDASIL. Concomitant therapies included FLOVENT and PROAIR. Within minutes the injection the patient developed chest pain, nausea, dizziness, feeling clammy and pale coloring. The patient was the office the time the reaction. The patient was discharged home and then sent the physician for follow and determine the patient should continue with the GARDASIL series. The physician will not recommend continuing the GARDASIL series until additional information obtained (not specified). the time report the patient's status was recovered. Additional information has been requested. 
Other Meds: 	PROAIR (albuterol sulfate); FLOVENT 

Lab Data: 	None 
History: 
Prex Illness: 	Asthma 

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

Vaers Id: 352895-2  Related reports:  352895-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  29-Jul-2009  29-Jul-2009  08-Sep-2010  27-Sep-2010  WAES0908USA00092  13-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1497X  Right  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA Injection site erythema, Injection site pruritus, Injection site warmthSymptom Text: Information has been received from registered nurse concerning year old female with pertinent medical history and known allergies who 29-JUL-2009 was vaccinated the right arm with the first 0.5ml dose GARDASIL (lot# 662229/1497X). There was concomitant medication. The nurse reported that the patient had developed injection site reaction the back the arm involving area inches wide and inches length 30-JUL-2009. was more oval-shaped area. She was itching, warmth and redness that area. The nurse thought the GARDASIL might have been given the back the arm subcutaneously but she was not positive The patient sought medical attention through office visit. lab diagnostics study was performed. the time reporting, the patient had not recovered. 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 07:37  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 352897-2  Related reports:  352897-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  31-Jul-2009  31-Jul-2009  08-Sep-2010  27-Sep-2010  WAES0908USA00337  18-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1497X  Unknown  Unknown  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA reaction previous exposure drug, Swollen tongue, UrticariaSymptom Text: Information has been received from nurse practitioner concerning year old female with asthma and penicillin allergy and some unspecified allergies, who 31-JUL-2009 was vaccinated with her 2nd dose GARDASIL (lot#662229/1497X). The date the 1st dose was unknown. the same day the patient experienced swollen tongue and hives the right side her face after the 2nd dose the vaccination 31-JUL-2009. There were labs and diagnostic tests performed. The patient sought unspecified medical attention. the time the report. The patient's status was recovered. The nurse practitioner stated that the patient did not experience and adverse events after the first dose GARDASIL. Additional information has been requested. Other Meds: Unknown Lab Data: None History: Prex Illness: Asthma; Hypersensitivity; Penicillin allergy Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 353106-2  Related reports:  353106-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
16.0  24-Jul-2009  26-Jul-2009  08-Sep-2010  30-Sep-2010  WAES0908USA00769  15-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  1130X  Right  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Symptom Text: 	Information has been received from registered nurse concerning her daughter, year old female patient who 24-JUL-2009, 2:30 p.m. was vaccinated with second dose GARDASIL (lot#661953/1130X) intramuscularly the right deltoid. 27-JUL-2009, 1:00 p.m., the patient's right arm was red, swollen and real sore, she also could not pick her right arm very high. The nurse reported that the patient's right arm was hot touch and from elbow hands were turning purplish blue. The patient was sent emergency room. time report, the patient's outcome was unknown. Follow-up information has been received from the registered nurse concerning her daughter with penicillin allergy whose arm was red, swollen and very painful 26-JUL-2009. 27-JUL-2009, the registered nurse called back report that the patient was instructed elevate arm and take BENADRYL, TYLENOL MOTRIN for pain. the time the report, the patient recovered. Additional information not expected. 
Other Meds: 	Unknown 

Lab Data: 	Unknown 
History: 
Prex Illness: 	Penicillin allergy 

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 04-Aug-2009 Vaccine Date 04-Aug-2009 Onset Date Vaers Id: Type Manufacturer 14.0 353561-2 VAX Detail: Related reports: 353561-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 08-Sep-2010 Received Date 1312X  30-Sep-2010 Status Date Site nknown State  WAES0910USA00564 Mfr Report Route Unknown  20-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Syncope 

Symptom Text: 	Information has been received from physician concerning year old female patient with known drug reactions/allergies pertinent medical history who 04-AUG-2009 was vaccinated with the first dose GARDASIL (LOT#661846/1312X). There was concomitant medication. The physician reported that the patient fainted after administration GARDASIL. lab tests were performed. was noted that the patient recovered while she was still the office. 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 07:37  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10 All comb. w/AND  

Age Gender 10-Aug-2009 Vaccine Date 10-Aug-2009 Onset Date Vaers Id: Type Manufacturer 16.0 353615-2 VAX Detail: Related reports: 353615-1 VARCEL MERCK CO. INC. Days  Lot Prev Doses 08-Sep-2010 Received Date NULL  30-Sep-2010 Status Date State Site Unknown  WAES0908USA02486 Mfr Report Route Unknown  20-Oct-2010 Last Edit Date Other Vaccine  
HPV4  MERCK CO. INC.  0100Y  Unknown  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Arthralgia, Contusion, Dizziness, Erythema, Haemorrhage, Head injury, Syncope
Symptom Text: 	Information has been received from medical assistant concerning year old female with pertinent history and drug reactions/allergies who 07-OCT-2008 was vaccinated with the first 0.5ml dose GARDASIL (Lot# 659184/0843X) and 10-AUG-2009 was vaccinated with the second 0.5ml dose GARDASIL (Lot# 662300/0100Y). The patient also received the second dose VARIVAX (Merck) (first dose given 02-DEC-1996) 10-AUG-2009. Concomitant therapy included amoxicillin (manufacturer unknown). 10-AUG-2009 the patient fainted after receiving the GARDASIL. The patient hit her head when she fainted and the left ear was bleeding around the earring. There was bleeding the left side the face and head. The patient also had left knee pain. The patient was alert and oriented during the time she was resting pillow. There was red new bruise the left cheek. The patient left after minutes. The patient went unspecified emergency room 11-AUG-2009 because she was feeling faint and was diagnosed with vasovagal syncope. Lab diagnostics studies performed: vitals checked the office 10-AUG-2009, EKG and blood work were normal the emergency room 11-AUG-2009. the time report the patient's status was unknown. Additional information has been requested. 
Other Meds: 	Amoxicillin 
Lab Data: 	Electrocardiogram, 08/11/09, normal; Hematology, 08/11/09, normal; Vital sign, 08/10/09 
History: 	None 
Prex Illness: 

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

Vaers Id: 354934-2  Related reports:  354934-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
11.0  17-Aug-2009  17-Aug-2009  08-Sep-2010  01-Oct-2010  WAES0908USA03172  28-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
TDAP  GLAXOSMITHKLINE  AC52B029AA  Left arm  Intramuscular  
BIOLOGICALS  
HPV4  MERCK CO. INC.  0100Y  Right arm  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Syncope 

Symptom Text: 	Information has been received from physician concerning year old female who was vaccinated intramuscularly with her second 0.5 dose GARDASIL and fainted 17-AUG-2009. Concomitant therapy included BOOSTRIX. was not known she had similar experience after the first dose. The patient sought medical attention the physician's office. The patient recovered the same day. Follow information was received from registered nurse (R.N.) concerning the year old female student with medical history concurrent condition who 17-AUG-2009 11:00 was vaccinated intramuscularly the right deltoid with her first (also reported the second dose) dose GARDASIL (lot 662300/0100Y). Concomitant therapy included the first dose BOOSTRIX vaccinated intramuscularly the left deltoid (lot#AC52B029AA) 17-AUG-2009 11:00. There was illness the time vaccination. 17-AUG-2009 11:00 the patient experienced vasovagal syncope within minutes GARDASIL and BOOSTRIX administration. the time report the patient had recovered. relevant diagnostic tests laboratory data was collected. further information available. 

Other Meds: 
Lab Data: 	None 
History: 	None 
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 Unknown Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer Unknown 355717-3 VAX Detail: Related reports: 355717-1; 355717-2 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date NULL  27-Sep-2010 Status Date Site nknown State  WAES1003USA00489 Mfr Report Route Unknown  13-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Headache, Laboratory test 

Symptom Text: 	Information has been received from physician concerning his daughter with unspecified medical history, drug reactions allergies, who unspecified date was vaccinated with the second dose GARDASIL (route and lot unknown). Concomitant medication was unspecified. The physician reported that after receiving the second dose GARDASIL the patient experienced headaches. Lab diagnostic studies performed were unspecified. was unspecified the patient sought medical attention. the time the report the patient's outcome was unknown. Follow information has been received. was reported that the patient had not returned the office. They did not receive any records the patient and had not seen heard anything regarding the patient. 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 List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 355885-2  Related reports:  355885-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  18-Jun-2007  Unknown  08-Sep-2010  27-Sep-2010  WAES0908USA04486  14-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0388U  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Drug exposure before pregnancy, Headache, Loss consciousness, Palpitations
Symptom Text: 	Information has been received from physician and office worker, for the Pregnancy Registry for GARDASIL, concerning year old female who 18-JUN-2007 was vaccinated with the first dose GARDASIL (Lot 657622/0388U). 20-AUG-2007 the patient was vaccinated with the second dose GARDASIL (LOT 658282/0929U, expiration date 25-MAR-2010) and 17-DEC-2007 she received the third dose GARDASIL (LOT 654540/1209U, expiration dated 21-DEC-2009). There was concomitant medication. Between the first and third dose GARDASIL the patient developed headaches, blackouts and heart palpitations. The patient experienced these symptoms daily for two years and had blackouts 2-3 times daily. The results tilt test were unspecified. The patient was prescribed TIPURIC (manufacturer unspecified) for epilepsy, but the physician believed this was misdiagnosis and the patient was taken off the medication. February 2009 the patient found out she was pregnant and the symptoms went away. After the baby was delivered 28-JUL-2009 the headaches, blackouts and heart palpitations returned. The patient saw neurologist who told the patient that her symptoms were from GARDASIL. the time the report, the patient had not recovered. Additional information has been requested. 
Other Meds: 	None 

Lab Data: 	tilt test 
History: 
Prex Illness: 	Pregnancy NOS (LMP Unknown) 

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 25-Apr-2008 Vaccine Date 01-Sep-2008 Onset Date 129 Days Vaers Id: Type Manufacturer Lot Prev Doses 18.0 356031-3 VAX Detail: Related reports: 356031-1; 356031-2 08-Sep-2010 Received Date HPV4 MERCK CO. INC. NULL  27-Sep-2010 Status Date Site nknown State  WAES0908USA04766 Mfr Report Route Unknown  18-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Arthralgia, Blood test, Pain extremity, Rheumatoid arthritis 

Symptom Text: 	Information has been received from consumer who the patient's father and medical assistant concerning year old female with penicillin allergy and history unspecified back problems who 03-OCT-2007 was vaccinated with the first dose GARDASIL (lot#658558/1061U). 14DEC-2007 and 25-APR-2008 the patient was vaccinated with the second dose (lot# 659055/1522U) and the third dose GARDASIL. There was concomitant medication. fall 2008, the patient started experiencing pain her feet, ankles and knees. June 2009, the patient complained about joint pain and "she cannot get out her bed the morning". The patient was seen the physician last week and was diagnosed rheumatoid arthritis. The blood test was performed with unspecified result. The patient referred rheumatologist for the treatment rheumatoid arthritis. The medical assistant could not comment whether not the condition was disabling life threatening. the time the report, the patient had not recovered. further information available. 

Other Meds: 	None 
Lab Data: 	Unknown 
History: 	Back disorder 
Prex Illness: 	Penicillin allergy 

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 16-Jul-2009 Vaccine Date 22-Jul-2009 Onset Date Vaers Id: Type Manufacturer 17.0 356236-2 VAX Detail: Related reports: 356236-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 08-Sep-2010 Received Date 1968U  27-Sep-2010 Status Date Right arm  Site State  WAES0907USA04093 Mfr Report Route Intramuscular  18-Oct-2010 Last Edit Date Other Vaccine DTAP MNQ  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Headache, Pyrexia 

Symptom Text: 	Information has been received from physician's assistant concerning year old female with pertinent medical history reported and known drug allergies who 16-JUL-2009 was vaccinated intramuscularly with the first 0.5mL dose GARDASIL (lot number 660389/1968U), into the right arm. was noted that the patient received dose DTAP (manufacturer unknown) and the first dose MENACTRA, lot number U2621AA, intramuscularly into the left arm, 09-JUL-2009. Six days after receiving the dose GARDASIL, the patient developed headache. She also had temperature 100 degrees lab tests were performed. the time reporting, the patient had not recovered from headache and temperature 100 degrees The patient sought medical attention making office visit. Follow-up information was received from the physician's assistant who reported that the patient 09-JUL-2009 was also vaccinated with the first dose DAPTACEL (previously reported manufacturer unknown), lot number C3098AA, intramuscularly into the right arm the morning. was reported that 22-JUL-2009 (also reported 23-JUL-2009) the patient had severe headache with fever 100 degrees 24-JUL-2009 the patient recovered. further information available. 
Other Meds: 

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  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 356520-2  Related reports:  356520-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
11.0  12-Aug-2009  25-Aug-2009  08-Sep-2010  30-Sep-2010  WAES0908USA04517  18-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0100Y  Left arm  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Injected limb mobility decreased, Joint range motion decreased, Myalgia, Tenderness
Symptom Text: 	Information has been received from registered nurse (R.N.)concerning year old female who 12-AUG-2009 was vaccinated with the first dose GARDASIL (lot 662300/0100Y) her left arm. 25-AUG-2009, "yesterday", the patient had decreased left shoulder mobility and was unable move her left arm. The nurse stated the patient had myalgia the arm. the time this report, the patient's symptoms persisted. The patient contacted the physician's office and sought unspecified medical attention. Follow-up information has been received from the registered nurse concerning the year old female student with rhinitis allergic, known drug allergies, and illness time vaccination who 12-AUG-2009 9:30 was vaccinated with the first dose GARDASIL her left deltoid. There was concomitant medication. 25-AUG-2009 a.m. the patient experienced decreased movement left arm, point tenderness left shoulder, reduced shoulder flexion and external rotation, masses; full shoulder rotation, deformity, swelling tenderness left arm. The patient had normal neurologic sensation. was diagnosed with myalgia 729.1. The patient was instructed rest, slowly resume activity, range motion exercises, massage the affected area. The patient was treated with ibuprofen and heat prn. There were laboratory studies performed. There were adverse events following prior vaccination. The patient's mother called 01-SEP-2009 and reported the patient had symptoms and was doing well. The responsible physician consulted with Infectious Disease and will observe the patient for signs and symptoms brachial plexitis. Additional information not expected. 
Other Meds: 	None 

Lab Data: 	None 
History: 
Prex Illness: 	Rhinitis allergic 

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

Vaers Id: 356523-2  Related reports:  356523-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  31-Aug-2009  31-Aug-2009  08-Sep-2010  30-Sep-2010  WAES0909USA00728  20-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
FLU  SANOFI PASTEUR  V3190AA  Right arm  Unknown  
HPV4  MERCK CO. INC.  0672Y  Left arm  Unknown  
HEPA  GLAXOSMITHKLINE  AHAVB357CA  Right arm  Unknown  
BIOLOGICALS  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Head injury, Laceration, Syncope 

Symptom Text: 	Information has been received from physician concerning year old female patient who 31-AUG-2009 was vaccinated with dose GARDASIL (lot number 663454/0672Y). Concomitant therapy includes other vaccines" (dose and indication unknown). The physician reported that 31-AUG2009 the patient fainted the hallway minutes after receiving the GARDASIL. The physician reported that the patient had 1/4 inch laceration her head and was taken the ER. the time the report the patient's outcome was recovered. Follow information has been received from registered nurse concerning year old female student who 31-AUG-2009 was vaccinated into left arm with first dose GARDASIL (lot number 663454/0672Y). Concomitant vaccination the same day included second dose FLUZONE (Sanofi, lot# V3190AA) and second dose HAVRIX (GSK, lot# AHAVB357CA) the patient's right arm. Subsequently, the patient fainted hallway exiting room and hit her head with laceration. Neurological examination was normal. The patient was sent for suture. the time the report, the patient had recovered. Additional information not expected. 
Other Meds: 
Lab Data: 	Neurological examination, 08/31?/09, normal 
History: 	Unknown 
Prex Illness: 

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

Vaers Id:  356962-2 (S)  Related reports:  356962-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
17.0  08-Sep-2009  Unknown  08-Sep-2010  27-Sep-2010  WAES1001USA00150  27-Sep-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0249Y  Unknown  Unknown  
MNQ  SANOFI PASTEUR  U3021AA  Unknown  Unknown  

Seriousness: VISIT, PERMANENT DISABILITY, SERIOUS 
MedDRA 	Fibromyalgia, Laboratory test normal, Musculoskeletal pain, Myalgia
Symptom Text: 	Information has been received from physician concerning year old female who 08-SEP-2009 was vaccinated with first dose GARDASIL (lot# 663453/0249Y). Concomitant vaccination the same day included dose MENACTRA. After receiving the first dose GARDASIL the patient experienced soreness her shoulder, the specific shoulder was unspecified, and muscles. The physician reported that the patient was sent see neurologist and any test done came back negative. the patient was then sent see rheumatologist and was diagnosed with fibro myalgia. the time the report, the patient had not recovered. Follow information from the physician indicated that 08-SEP-2009 the patient received the first dose GARDASIL and concomitantly received dose MENACTRA (lot# U3021AA). After the patient received the first dose GARDASIL she experienced soreness her shoulder and muscles. The patient had normal electromyography (EMG) test and other tests (not specified) that were performed, which were normal. The patient was diagnosed with Fibromyalgia. The physician considered the patient's condition disabling and not life-threatening. The patient was not hospitalized. Additional information has been requested. 
Other Meds: 
Lab Data: 	Electromyography, ?/?/09, normal 
History: 	Unknown 
Prex Illness: 

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

Vaers Id: 357372-2  Related reports:  357372-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  15-Sep-2009  15-Sep-2009  08-Sep-2010  30-Sep-2010  WAES0909USA01969  20-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0312Y  Left arm  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Dizziness, Headache, Hypoaesthesia, Nausea, Neurological examination normal, reaction previous exposure drug, Paraesthesia, Vomiting
Symptom Text: 	Information has been received from registered nurse concerning year old female with pertinent medical history and drug allergies, who 11-MAR-2009 was vaccinated with her first dose GARDASIL (0.5ml, IM, lot 662404/0312Y) the left arm. There was concomitant medications. Two hours after the second vaccination, the patient developed dizziness, vomiting, numbness/tingling the left arm and both legs. 16-SEP-2009 the patient experienced numbness her feet. There were labs and diagnostic tests performed. reports adverse effects after the first vaccination. The patient made phone call for medical attention. the time the report, the patient was not recovered. Follow information has been received from registered nurse concerning year old female with known drug allergies, who 11-MAR-2009 9:30 was vaccinated with the second dose GARDASIL (lot 662404/0312Y) the left arm deltoid. The patient's mom called after the patient received injection and stated that her daughter was experienced dizziness, vomiting, headache and tingling the left arm and both feet 15-SEP-2009. The patient went neurologist 17-SEP-2009 for further evaluation, and her examination was negative. The Lyme's test was negative. The neurologist did consider Guillain-Barre syndrome because symptoms. The outcome was not reported. Follow information has been received 10-MAR-2010 via phone call from the medical assistant stated that after the patient had received the second dose GARDASIL, she complained headache, nausea and left upper extremity tingling. The medical assistant reported that the patient's "numbness improved". The patient was referred Neurologist for Neurology evaluation. was reported that the patient's father reportedly had past history Guillain-Barre syndrome, (GBS) "several years before". The neurologist documented that the patient's symptoms and neurology exam findings were not suggestive GBS Transverse Myelitis. Additional information has been requested. 
Other Meds: 	None 
Lab Data: 	Lyme disease assay, 09/17/09, negative 
History: 	None 
Prex Illness: 

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

Age Gender 09-Jul-2008 Vaccine Date 24-Aug-2008 Onset Date Vaers Id: Type Manufacturer 23.0 357517-2 (S) VAX Detail: Related reports: 357517-1 HPV4 MERCK CO. INC. Days  01-Dec-2010 Status Date Lot Prev Doses Site 30-Nov-2010 Received Date NULL Unknown State  Mfr Report Route Intramuscular  21-Dec-2010 Last Edit Date Other Vaccine  
Seriousness:  HOSPITALIZED, PERMANENT DISABILITY, SERIOUS  
MedDRA  Amnesia, Convulsion, Dizziness, Headache, Nausea, Speech disorder, Staring, Tongue biting 

Symptom Text: was given the first two the GARDASIL shots the summer 2008. Shortly after receiving the shots, began have staring seizures. They were horrific. felt though was going vomit and pass out. was unable speak while the seizures were going on. Unaware what had caused these "staring episodes" got the flu shot November 2008. Within week had seizure sleep. awoke the next morning with tongue chewed pieces, memory loss, and headache like I've never had life. brushed off, not seeking any medical attention for this occurrence. happened again the summer 2009. awoke with tongue chewed, memory loss and terrible headache. went the local emergency room where they admitted for seizure. was put KEPPRA 500mg 1/day. have thankfully not had any seizures since then, but deeply angered the lack responsibility the FDA taking regarding GARDASIL. This not miracle vaccine. has very harmful effects, and has caused quite few deaths. highly suggest you your job and look into this product more thoroughly before you o.k. it's use for everyone use. life not permanently changed and affected because trusted the government and the drug company. How much regret that decision. Shame you! Now, you are approving for little boys well. hope you can live with yourselves after children start seizing all over doctors offices. feel sorry for the parents who not their proper research before allowing their children received this vaccine. only hope that you can come your senses and see that the risks involved outweigh the "benefits" there even are any. 
Other Meds: 

Lab Data: 
History: previous medical history. was perfectly healthy. 
Prex Illness: 

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

Vaers Id: 358040-2  Related reports:  358040-1; 358040-3  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  14-Sep-2009  14-Sep-2009  08-Sep-2010  27-Sep-2010  WAES0910USA01722  12-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
FLU  UNKNOWN MANUFACTURER  NULL  Left arm  Unknown  
HPV4  MERCK CO. INC.  0087Y  Right arm  Unknown  
MNQ  SANOFI PASTEUR  NULL  Left arm  Unknown  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Corrective lens user, Fall, Laceration, Syncope 

Symptom Text: 	Information has been received from physician and nurse concerning young female patient wear eyeglasses who one month ago was vaccinated with dose GARDASIL (Lot not provided). Physician reported that the patient fainted his practice after receiving GARDASIL and MENACTRA and third vaccine. The patient fainted and fell off the exam table. Physician stated that the patient "cut herself" because she was wearing glasses and had have some stitches. The nurse stated the patient seemed fine, got sucker and the nurse walked out the room the patient sitting the exam table tumbled down. the time this report, the patient's outcome was unspecified. Follow-up information has been received via medical records from physician and registered nurse concerning year old female patient with asthma and minimal slight nasal allergy who 13-JUL-2009 was vaccinated with the first dose GARDASIL, her first dose hepatitis virus vaccine (unspecified) and her ADACEL. this time she was scheduled for her second dose GARDASIL, and MENACTRA. The registered nurse reported that 14-SEP-2009 12:20 the patient was vaccinated into the right arm with the second 0.5 dose GARDASIL (Lot 662518/0087Y), into the left arm with the first 0.5 dose MENACTRA (Lot 42919AA) and into the left arm with the fourth 0.5 dose influenza virus vaccine (unspecified). Concomitant therapy included albuterol, montelukast sodium (MSD), CLARITIN and NASONEX. The physician reported that her impression the initial evaluation was that the child had mild allergies. arrive the physical examination (Head Ears Eyes Nose Throat (HEENT) exam) showed membranes were normal though slightly thickened from previous infections. There was minimal slight nasal allergy. postnasal drainage. evidence sinus infections and pharyngitis. The patient was given the vaccines and within seconds received the vaccines, however, the patient had sudden syncopal episode. the previous time her vaccinations, the child had wanted the doctor present and helping her with the vaccines. She felt more comfortable this time being the presence the nurse and her mother. There were problems giving the vaccines, but noted above, she had complete syncopal episode. The mother said she turned her head the side take care the business part the visit when she saw the patient falling forward onto the floor. The child fell forward, striking her forehead and glasses. Immediately the physician's staff arrived care for her and noted that she had bleeding around the right eye. Her glasses were broken. However, the right temporal part the glasses was embedded pinched into the skin once the laceration. After several minutes working with hemostat and forceps, the physician's staff was able remove the temple part the glasses from the skin. Further evaluation revealed that there were two lacerations, one length and one length. The top one was right the level the right eyebrow and seems fairly superficial. The one lower than this was little deeper with some subcutaneous tissue being noted. The bleeding was stopped with pressure. The physician's staff then washed the lacerations completely. The physician repeated HEENT exam. There was evidence eye damage and evidence ear problems and pupils were equal and reactive light accommodation. The lacerations were noted above. There did not appear any further injuries outside the two lacerations noted above. The patient's blood pressure was checked after stabilized her and found 98/62. should noted that July her blood pressure was 100/64. the time reporting the patient had recovered. Additional information not expected. 
Other Meds: 	albuterol; CLARITIN; NASONEX; SINGULAIR puff 
Lab Data: 	physical examination, 09/14/09, HEENT exam: see narrative; blood pressure, 09/14/09, 98/62; blood pressure, 07/??/09, 100/64 

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

Prex Illness: Eyeglasses wearer; Asthma; Rhinitis allergic Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 358040-3  Related reports:  358040-1; 358040-2  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  14-Sep-2009  14-Sep-2009  08-Sep-2010  23-Sep-2010  WAES0911USA01134  11-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Right arm  Unknown  
FLU  SANOFI PASTEUR  U317615A  Left arm  Unknown  
MNQ  SANOFI PASTEUR  U2919AA  Left arm  Unknown  
Seriousness: VISIT, NOT SERIOUS  

MedDRA Face injury, Fall, Skin laceration, SyncopeSymptom Text: This report was identified from line listing obtained request the Company from the FDA under the Freedom Information Act. 14-SEP-2009 year old female patient with asthma was vaccinated with the second dose GARDASIL (lot not provided) the right arm, the first dose MENACTRA (Lot #U2919AA) the left arm, and FLUZONE (Lot U317615A) the left arm. Concomitant therapy included VENTOLIN and montelukast sodium (MSD). Approximately one minute after administration, adolescent, while sitting down, had syncopal episode, landed face first the floor, breaking glasses and causing lacerations the right eye between eyebrow and eyelid. Patient sought medical attention going the and had eye exam and stitches. The original reporting source was not provided. The VAERS 358040. further information available. Other Meds: VENTOLIN (ALBUTEROL); SINGULAIR Lab Data: ophthalmological exam, 09/14/09 History: Asthma Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: SEP 2011 07:37  VAERS Line List Report Page  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 359747-2  Related reports:  359747-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
14.0  02-Oct-2009  02-Oct-2009  08-Sep-2010  01-Oct-2010  WAES0910USA01050  01-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0672Y  Unknown  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA Abdominal pain upper, Dizziness, Heart rate increased, Hypoaesthesia, Nervousness, Paraesthesia, Psychomotor hyperactivitySymptom Text: Information has been received from Licensed practical nurse concerning year old female patient with drug reactions/allergies pertinent medical history, who 02-OCT-2009 was vaccinated with her first 0.5 dose GARDASIL, intramuscularly (lot 663454/0672Y). Concomitant therapy included BUSPAR. The nurse reported that the patient had been complaining "hyperactivity, increased heart rate, dizziness, stomach aches, jumpy inside, numb and tingling hands" after receiving her first dose GARDASIL. the time the report the patient had not recovered. The patient called the office. laboratory diagnostics studies were performed. Additional information has been requested. Other Meds: BUSPAR Lab Data: None History: None 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 25-Sep-2009 Vaccine Date 25-Sep-2009 Onset Date Days Vaers Id: Type Manufacturer 16.0 360409-2 VAX Detail: Related reports: 360409-1 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date NULL  01-Oct-2010 Status Date Site nknown State  WAES0909USA04650 Mfr Report Route Unknown  01-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Headache, Migraine, Nausea, Photophobia 

Symptom Text: 	Information has been received from licensed practical nurse (L.P.N.) concerning year old female with allergy NAPROSYN who 25-SEP2009 was vaccinated with second dose GARDASIL. Concomitant therapy included oral contraceptives. 25-SEP-2009, after minutes after vaccination, the patient experienced migraine and photophobia. Unspecified medical attention was sought and laboratory diagnostic tests were performed. Subsequently, the patient recovered from migraine and photophobia. Follow information has been received from physician concerning the year old female student who 25-SEP-2009, 11:00, developed instant headache within minutes getting vaccine. She also developed photophobia and nausea which consistent with migraine. The patient had illness time vaccination. unspecified date, the patient recovered. Additional information not expected. 
Other Meds: 	hormonal contraceptives 

Lab Data: 	None 
History: 
Prex Illness: 	Drug hypersensitivity 

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

Vaers Id: 360773-2  Related reports:  360773-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
12.0  07-Oct-2009  07-Oct-2009  08-Sep-2010  04-Oct-2010  WAES0910USA01182  28-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
FLU  SANOFI PASTEUR  NULL  Left arm  Intramuscular  
HPV4  MERCK CO. INC.  0229X  Right arm  Intramuscular  
MNQ  SANOFI PASTEUR  NULL  Left arm  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Rash generalised, Similar reaction previous exposure drug
Symptom Text: 	Information has been received from nurse concerning year old female with asthma and attention deficit/hyperactivity disorder and drug reaction/allergies who 10-AUG-2009 was vaccinated with the first dose GARDASIL. 07-OCT-2009 the patient received the second dose GARDASIL (IM, 0.5ml). Concomitant therapy included albuterol, PROVENTIL, FLOVENT (MSD), FLUZONE. Information has been received from nurse concerning year old female with asthma and attention deficit/hyperactivity disorder and drug reaction/allergies who 10-AUG-2009 was vaccinated with the first dose GARDASIL. 07-OCT-2009 the patient received the second dose GARDASIL (IM, 0.5ml). Concomitant therapy included albuterol, PROVENTIL, FLOVENT, montelukast sodium (MSD) and VYVANSE. 07-OCT-2009 within minutes the injection the patient developed generalized rash throughout her body. The patient was given BENADRYL (dose not reported) the office and was discharged from the office home with her mother. The office called the patient's mother the following day and the rash had resolved. The mother stated the nurse that the patient had similar experience following her first dose GARDASIL. the time the report, the patient had recovered 08-OCT-2009. Follow-up information has been received from registered nurse indicating that the year old female with illness the time vaccination had received the second dose GARDASIL (LOT 660612/0299X) 07-OCT-2009 4:30PM into the right deltoid. Concomitant therapy included the first dose MENACTRA and the first dose FLUZONE both administered the left deltoid. 07-OCT-2009, the patient developed generalized rash minutes following the vaccination 4:45PM. The patient denied itching, difficulty breathing complaint. Fifty BENADRYL was given and after minutes observation, the patient's rash recovered. She was discharged with mother. There were labs and diagnostic tests performed. The mother stated 08-OCT-2009 13:30 that the rash had cleared, problems. The patient was doing well. She recovered 08-OCT-2009. further information available. 
Other Meds: 	albuterol; PROVENTIL; FLOVENT; VYVANSE; SINGULAIR 

Lab Data: 	None 
History: 
Prex Illness: 	Asthma; Attention deficit/hyperactivity disorder 

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 05-Oct-2009 Vaccine Date 13-Oct-2009 Onset Date Vaers Id: Type Manufacturer 24.0 361548-2 VAX Detail: Related reports: 361548-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 08-Sep-2010 Received Date 0670Y  01-Oct-2010 Status Date Left arm  Site State  WAES0910USA01913 Mfr Report Route Intramuscular  11-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Limb discomfort 

Symptom Text: 	Information has been received from registered nurse concerning year old female patient with doxycycline allergy and pertinent medical history who 05-OCT-2009 was vaccinated intramuscularly with the first 0.5ml dose GARDASIL (lot# 0670Y) into the left deltoid. Concomitant therapy included NUVARING. 13-OCT-2009 the inside the patient's left arm felt like was pulsating. The patient said that she could use her arm but felt like was "asleep". She called the office seek some medical attention. There were laboratory diagnostics studies performed. the time this report, the patient had not recovered. Follow information has been received concerning the year old female patient who 13-OCT-2009 experienced pulsating feeling the inside her arm after the first vaccination with GARDASIL. There was illness time vaccination. 15-OCT2009 the patient recovered. Additional information not expected. 
Other Meds: 	NUVARING 

Lab Data: 	None 
History: 
Prex Illness: 	Allergic reaction antibiotics 

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 14-Jul-2009 Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer 14.0 361718-2 VAX Detail: Related reports: 361718-1 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date NULL  01-Oct-2010 Status Date Site nknown State  WAES0909USA04247 Mfr Report Route Unknown  01-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Lip swelling, Rash, Vaccine positive rechallenge 

Symptom Text: 	Information has been received from physician assistant concerning year old female patient with known drug reactions/allergies pertinent medical history who 14-JUL-2009 was vaccinated with her first dose GARDASIL (lot number unknown). 22-SEP-2009 the patient was vaccinated with the second dose GARDASIL (LOT# 663573/0969Y) and the same visit with influenza virus vaccine (unspecified) (manufacturer unknown). was reported the physician assistant that after the first vaccination with GARDASIL, approximately July 2009, the patient experienced swelling her lips and rash her face, forehead and arms that progressed over couple weeks and lasted about month (until approximately August 2009). After the second dose, given 22-SEP-2009, the patient unspecified date September 2009, experience swelling her lips. lab tests were performed. The patient sought unspecified medical attention. The patient was prescribed BENADRYL. The physician assistant decided discontinue the series. 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 07:37  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10 All comb. w/AND  

Age Gender 19-Oct-2009 Vaccine Date 19-Oct-2009 Onset Date Days Vaers Id: Type Manufacturer Lot Prev Doses 15.0 363389-2 VAX Detail: Related reports: 363389-1 08-Sep-2010 Received Date FLU UNKNOWN MANUFACTURER U3201AA  23-Sep-2010 Status Date State Site Unknown  WAES0910USA02672 Mfr Report Route Unknown  12-Oct-2010 Last Edit Date Other Vaccine  
HPV4  MERCK CO. INC. 0381X  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Fall, Loss consciousness, Muscle twitching, Skin laceration 

Symptom Text: 	Information has been received from physician and registered nurse concerning year old female patient with pertinent medical history and known drug allergies who 19-OCT-2009 was vaccinated with first dose GARDASIL (Lot No. 661046/0381X). Concomitant vaccination the same day included "flu shot" (Lot No. U3201AA). was reported that the GARDASIL was given first, followed the "flu shot". Subsequently, after the patient received the injections the patient fell and lacerated her chin. She also became unconscious this time and experienced some twitching her arms and legs which lasted only few seconds. The patient was taken the emergency room where X-Rays the jaw and nose were taken, which revealed negative results. electroencephalography (EEG) computed axial tomography (CT) diagnostic studies were performed. The patient was not admitted for hospitalization. the time the report, the patient had recovered. further information available. 
Other Meds: 
Lab Data: 	Nasal sinus x-ray, negative result; mandibular x-ray, negative result 
History: 	None 
Prex Illness: 

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

Vaers Id: 364319-2  Related reports:  364319-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
16.0  23-Sep-2009  23-Sep-2009  08-Sep-2010  30-Sep-2010  WAES0910USA01011  22-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
FLU  NOVARTIS VACCINES AND  97838P1  Left arm  Intramuscular  
DIAGNOSTICS  
HPV4  MERCK CO. INC.  0216Y  Right arm  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Abdominal discomfort, Asthenia, Dizziness, Malaise 

Symptom Text: 	Information has been received from physician concerning year old female patient who unspecified date was vaccinated with the second dose GARDASIL. The physician reported that after received the second dose GARDASIL the patient started feel weak, dizzy and did not feel well. The patient stayed the office for another minutes and within that time frame the patient started complain upset stomach. The physician reported that the patient went home after minutes and had recovered. The patient did not received any other vaccines that day. Follow-up information was received from the physician who reported that female patient 23-SEP-2009 11:30 was vaccinated with the second dose GARDASIL (lot 663451/0216Y), intramuscularly her right arm. the same day, the patient received the first dose influenza virus vaccine (unspecified) (lot 97838P1), intramuscularly her left arm. Ten minutes after the vaccines administered the patient experienced weakness, dizziness and abdominal discomfort. the time the report, the patient had recovered. Additional information has been requested. 
Other Meds: 

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  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 367710-2  Related reports:  367710-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
14.0  06-Nov-2009  06-Nov-2009  08-Sep-2010  01-Oct-2010  WAES0911USA02609  12-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0702X  Left arm  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA Erythema, Hypoaesthesia, Musculoskeletal pain, Oedema peripheral, Pain extremity, ParaesthesiaSymptom Text: Information has been received from health professional concerning year old female student who 06-NOV-2009 07:59 was vaccinated intramuscularly with the third dose GARDASIL (lot# 0702X) her left deltoid. 15:00 06-NOV-2009 (also reported 3-4 hours after receiving the injection), the patient complained numbness her left arm. The pain radiated the shoulder. There was local reaction the area red and swollen also complained and numbness and tingling. the time the rep ort, the patient had recovered unspecified date. 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 15-Apr-2009 Vaccine Date 15-Apr-2009 Onset Date Vaers Id: Type Manufacturer 28.0 368008-2 (S) VAX Detail: Related reports: 368008-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 08-Sep-2010 Received Date 1129X  27-Sep-2010 Status Date Site nknown State  WAES0911USA01883 Mfr Report Route Intramuscular  27-Sep-2010 Last Edit Date Other Vaccine  
Seriousness: VISIT, PERMANENT DISABILITY, RIOUS  
MedDRA  Arthralgia, Myalgia 

Symptom Text: 	Information has been received from physician concerning female patient "in her 20's" who approximately May 2009, "about months ago", was vaccinated with first 0.5 dose GARDASIL (Lot No. not reported). 2009 after receiving her first dose the patient developed ankle and knee pain. The patient sought the attention acupuncturist. the time this report, the patient had not recovered. 13-NOV-2009, follow information was received from the physician's office receptionist who indicated that the patient was seen the physician's office 22-APR-2009 and offered complaints. notation joint pain muscle aches was listed the patient's chart. 17-JUL-2009 the patient was seen again the physician's office and her evaluation was listed "normal" and there was documentation complaints joint muscle pain. 14-OCT-2009 the patient was administered her third dose GARDASIL. There was nothing listed the patient's chart that time about joint muscle pain, the progress note stated that the patient "offered complaints". 09-NOV-2009 the patient called the office and reported that she had searched the internet for "side effects" GARDASIL and then reported the muscle and joint pain. The receptionist also noted that nowhere the patient's chart was any documentation that she had been disabled any way and there was notation treatment any kind for the joint muscle pain. Follow information was received from the physician 16-NOV-2009. The physician indicated that the patient with headaches, anxiety, depression, irritable bowel syndrome and allergy sulfa 15-APR-2009 was vaccinated with first 0.5 dose GARDASIL (Lot No. 661952/1129X), second dose (Lot No. 662300/0100Y) 15-JUN-2009 and third dose (663452/0671Y) 14-OCT-2009. Concomitant therapy included NUVARING and WELLBUTRIN. There was concomitant vaccination. The patient reported the physician 09-NOV-2009, that "ever since first shot" 15-APR-2009 she experienced joint and muscle aches. The patient saw her primary care physician 11-NOV-2009 (no further information provided). This one two reports received from the same source. Muscle aches and joint pain were considered disabling the reporting physician. Additional information has been requested. 
Other Meds: 	WELLBUTRIN; NUVARING 

Lab Data: 	None 
History: 
Prex Illness: 	headache; anxiety; depression; irritable bowl syndrome; sulfonamide allergy 

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 23-Nov-2009 Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer 26.0 370123-2 VAX Detail: Related reports: 370123-1 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date NULL  01-Oct-2010 Status Date Left arm  Site State  WAES1002USA00298 Mfr Report Route Intramuscular  15-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Hypoaesthesia, Pain extremity, Paraesthesia 

Symptom Text: 	Information has been received from registered nurse concerning year old female patient with pertinent medical history and known allergies who 23-NOV-2009 was vaccinated the left upper deltoid with the first 0.5 dose GARDASIL (lot number not reported). There was concomitant medication. Subsequently unspecified date the patient experienced numbness, tingling and pain from her toes her left foot her left leg after administration vaccine. The patient stated that her whole left side went numb. Medical attention was sought via telephone. There was lab studies performed. the time the report, the patient was recovering. 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 07:37  VAERS Line ist Report Page  
Vax Type: HPV4  Status Date: 01-SEP 31-DEC-10  All comb. w/AND  

Age Gender 01-Dec-2009 Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer Lot Prev Doses 16.0 372747-3 VAX Detail: Related reports: 372747-1; 372747-2 08-Sep-2010 Received Date HPV4 MERCK CO. INC. NULL  22-Sep-2010 Status Date Site nknown State  WAES0912USA03761 Mfr Report Route Unknown  06-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Blister, Erythema, Pruritus, Pyrexia, Vaccine positive rechallenge 

Symptom Text: 	Information has been received from consumer concerning her year old daughter with known drug allergies who 03-AUG-2009 was vaccinated with the first dose GARDASIL. The patient experienced fever after the first vaccination. 01-DEC-2009, the patient was vaccinated with the second dose GARDASIL. lot number was given. After the second vaccination the patient experienced fever and itching, red, swollen blisters all over her body. Unspecified medical attention was sought. laboratory diagnostic studies were performed. the time the report, the patient recovered unspecified date. Additional information has been requested. 
Other Meds: 	Unknown 

Lab Data: 	None 
History: 	Unknown 
Prex Illness: 

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

Vaers Id: 375371-2  Related reports:  375371-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
18.0  08-Dec-2009  08-Dec-2009  08-Sep-2010  01-Oct-2010  WAES1003USA04811  12-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0672Y  Right  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Grip strength decreased, Injection site pain, Muscular weakness, reaction previous exposure drug, Oedema peripheral, Pain extremity
Symptom Text: 	Information has been received from Registered Nurse concerning female patient who unspecified date was vaccinated intramuscularly with the second 0.5 dose GARDASIL. Within days vaccination the patient developed pain radiating down her right hand, swelling her fingers and weakness her right hand. unspecified date, the patient recovered but would not receive further doses. The patient sought unspecified medical attention. Follow information has been received from the Registered Nurse who reported that the year old female student with preexisting allergies, birth defects medical conditions and illness the time vaccination, was vaccinated intramuscularly the right deltoid with the second dose GARDASIL (lot 663454/0672Y) 08-DEC-2009 10:30. Concomitant therapy included ADDERALL XR. The patient had not experienced any adverse reaction following prior vaccination. was reported that the same day approximately 7-8 hour after administration (also reported beginning 17:00), the patient developed pain radiating down right arm from injection site, with the fingers the right hand becoming swollen. 22-DEC-2009 swelling persisted, with decreased strength hand. The hand returned normal 23-DEC-2009 but the patient still had pain upper arm site injection. laboratory diagnostic studies were performed. further information available. 
Other Meds: 	ADDERALL 

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  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 378204-2  Related reports:  378204-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
22.0  23-Oct-2009  23-Oct-2009  08-Sep-2010  01-Oct-2010  WAES1001USA02088  01-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0819Y  Left arm  Unknown  
Seriousness: VISIT, NOT SERIOUS  

Erythema, Hypoaesthesia, Hypokinesia, Nerve injury, Neuropathy peripheral, reaction previous exposure drug, Oedema peripheral, Pain

MedDRA 
extremity
Symptom Text: 	Information has been received from consumer concerning her year old daughter with known drug reactions/allergies and pertinent medical history who 23-OCT-2009 was vaccinated with her second dose GARDASIL (Lot 663558/0819Y) her left arm. Concomitant therapy included WELLBUTRIN. was reported that the night 23-OCT-2009, the patient went the emergency room because she was experiencing swelling, numbness, redness, she had walk with her hand the air because her arm and hand were pounding when her side, and she could not close her hand. The consumer reported that 23-OCT-2009 the emergency room sent her home and told her that was still bothering her come back the next night. Then 24-OCT-2009 the patient went back the emergency room and stated that she was experiencing neuropathy and that they were "watching her for the onset Guillain-Barre". The consumer also reported that the patient was put round steroids (name and manufacturer unspecified) and took two weeks for her recover. There were diagnostic tests performed. was reported that therapy with GARDASIL was stopped and not reintroduced. Follow information has been received from the medical assistant and the physician's office administrator. The medical assistant, who was able access the patient's chart and stated that the patient's first dose GARDASIL was given 24-AUG-2009 (Lot 663453/0249Y). There was notation the patient's chart that she had any issues following this injection. The second dose GARDASIL (Lot 663558/0819Y) was given 23-OCT-2009. The medical assistant was unable provide more information. The office administrator indicated after the second dose GARDASIL the patient experienced swelling, pain, numbness and redness her left arm the evening after her injection. The patient was evaluated the and was treated with oral steroids and released. The office administrator stated that there was notation the chart that the patient had been admitted the hospital. note the patient's chart indicated that she was told the staff that her reaction were more likely due nerve injury rather than allergic reaction the GARDASIL injection. The patient refused GARDASIL third dose. The patient was seen the physician's office 04-DEC-2009. There was mention Guillain-barre neurology consult the patient's chart. was also reported that the patient had not reported anything about Guillain-Barre them and therefore had idea how when was discussed with the patient she had any follow-up result it. There was nothing the patient's chart that indicated that her experiences were disabling anyway. The administrator further reported that the note the patient's chart from 04-DEC-2009 suggested follow visit with their office months time. Additional information not expected. 
Other Meds: 	WELLBUTRIN 

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  
Vax Type: HPV4  Status Date: 01-SEP-10 31-DEC-10 All comb. w/AND  

Vaers Id: 379523-2  Related reports:  379523-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
27.0  17-Nov-2009  17-Nov-2009  08-Sep-2010  01-Oct-2010  WAES1002USA00055  18-Oct-2010  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0819Y  Unknown  Unknown  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Dizziness, Nausea, reaction previous exposure drug, Urticaria, Vomiting
Symptom Text: 	Information has been received from nurse practitioner concerning year old female patient with asthma and allergy peanut and grass who 17NOV-2009 was vaccinated with the third dose GARDASIL (lot number not reported). 18-NOV-2009 the patient developed vomiting and hives. There was reaction the first doses. was unknown medical attention was sought. There were lab studies performed. Subsequently, the patient recovered from vomiting and hives. Follow-up information has been received from the nurse practitioner concerning the year old female with allergy peanut and grass and illness the time vaccination who 17-NOV-2009, 13:30 was vaccinated with the third dose GARDASIL (lot number 663558/0819Y). The day after vaccination, 18-NOV-2009, the patient called the nurse practitioner and reported that she woke nauseated, then vomited and lightheaded. Later day she developed hives her arms and thighs. the time she called the nurse practitioner (15:15), most the symptoms were resolving. The patient was advised take BENADRYL. There were lab studies performed. the time the report, the patient had recovered (date unspecified). Additional information not expected. 
Other Meds: 	Unknown 

Lab Data: 	None 
History: 
Prex Illness: 	Asthma; Peanut allergy; Pollen allergy 

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-Jan-2010 Vaccine Date 27-Jan-2010 Onset Date Vaers Id: Type Manufacturer 12.0 380346-2 VAX Detail: Related reports: 380346-1 HPV4 MERCK CO. INC. Days  Lot Prev Doses 08-Sep-2010 Received Date 1013Y  01-Oct-2010 Status Date Site nknown tate  WAES1002USA01009 Mfr Report Route Unknown  11-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Chills, Nausea, Pyrexia 

Symptom Text: 	Information has been received from physician concerning year old female who 26-JAN-2010 was vaccinated with the third dose GARDASIL (lot 662304/1013Y). The patient received the same lot 662304/1013Y for her second dose. 27-JAN-2010 1:00 AM, the patient had fever 101.4, chills and nausea. The physician reported that the patient called the office and came into the office 27-JAN-2010. 27-JAN-2010 the patient recovered. Additional information has been requested. 
Other Meds: Unknown Lab Data: body temp, 101.4 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 01-Jul-2009 Vaccine Date Unknown Onset Date Days Vaers Id: Type Manufacturer 12.0 380599-2 VAX Detail: Related reports: 380599-1 HPV4 MERCK CO. INC.  Lot Prev Doses 08-Sep-2010 Received Date NULL  01-Oct-2010 Status Date Site nknown State  WAES1001USA02610 Mfr Report Route Intramuscular  12-Oct-2010 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Dyspnoea, Fatigue, Headache, Nausea, Tremor 

Symptom Text: 	Information has been received from consumer concerning her year old daughter with known drug reactions/allergies and pertinent medical history who July 2009, was vaccinated intramuscularly with her first 0.5 dose GARDASIL and September 2009 and December 2009 was vaccinated with her second and third dose GARDASIL respectively. There was concomitant medication. was reported that the patient developed headaches, fatigue, nausea and "feeling winded" after receiving the first dose GARDASIL. Then, the patient developed left sided tremors after receiving her second dose GARDASIL. The patient was evaluated unspecified physician and had toxicology testing, complete blood count and metabolic panel. The testing was normal. The patient was prescribed unspecified sedative medication and the tremors had improved. The patient sought medical attention office visit. further information available. 
Other Meds: 	None