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Judicial Watch • Gardasil VAERS Reports

Gardasil VAERS Reports

Gardasil VAERS Reports

Page 1: Gardasil VAERS Reports

Category:General

Number of Pages:1637

Date Created:March 1, 2013

Date Uploaded to the Library:February 20, 2014

Tags:Illness, Onset, Seriousness, Unknown, vaers, gardasil, Manufacturer, Route, vaccine, MERCK, History, patient, received, DHS, ATF, FBI, EPA, IRS, ICE, CIA


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FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb.  w/AND  

Age Vaers Id: 14.0 Gender 11-Jul-2006 Vaccine Date 11-Jul-2006 Onset Date 259545-1 (S) Related reports: 259545-2 Days  14-Jul-2006 Received Dat  14-Jul-2006 Status Date State  Mfr Report  13-Nov-2006 Last Edit Date  
VAX Detail:  Type Manufacturer HPV4 MERCK CO. INC.  Lot Prev Doses 0637F  Right arm  Site  Route Unknown  Other Vaccine  
Seriousness: VISIT, HOSPITALIZED, SERIOUS  

MedDRA 	Dehydration, Fall, Headache, Hyperventilation, Injection site pain, Muscle spasms, Speech disorder, Syncope, Vision blurred, Vomiting
Symptom Text: 	Immediately after injection complained severe pain site. Fell off table and fainted for approximately seconds. Hyperventilated and cried progressingChvostek's sign hands and feet. Rebreathing into bag progressing clearing symptoms. Complained headache, blurry vision; Vision test was normal.Vomiting parking lot and speech was momentarily inarticulate. Sent ER. neuro exam was normal except for word recall "coffee instead ofcoughing" "Sired instead tired." Continued complaint headache. Vomited All symptoms spontaneously cleared approximately hours after incident.Overnight hospitalization for observation. Neurological evaluation before discharge was normal. Diagnosis also included dehydration. fluids were taken from7/10/2006 until ER. Anion gap noted chemistries and concentration urine obtained after several hours hydration. Discharge diagnosis:Dehydration, Vasovagal syncope secondary shot pain injection site. 7/17/06 Medical records received from reporter/provider which included vaxrecord, office note 7/11 neuro consult 7/15 who also saw her the hospital 7/11-12. Neuro report indicates the scan head was WNL that syncope probably precipitated pain vax injection along w/dehydration (no fluid intake since evening 7/10 until IVF given ER). 7/15patient continued have throbbing when bending down also c/o strong heart beats ocassionally. PMH: dehydration requiring hospitalization age yo.
Also has mild anxiety. Family hx: patient's mother has Fuch's disease (genetic degenertive corneal disease which her mother also had) patient's father
has depression. There are siblings. was noted that she had episodes emesis following vax along sustaining mild concussion when fell from exam
table which was characterized brief episode aphasia, slurred speech possible right facial paresis noted only patient's mother./ss 10/27/06 Received
medic 
Other Meds: 	NONE 
Lab Data: 	LABS: WBC 11.7, neutros 84, lymphs 9.7. 
History: 	Allergic rhinitis, spring pollens/ragweed/dust/mold 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Age Vaers Id: 14.0 Gender 11-Jul-2006 Vaccine Date 11-Jul-2006 Onset Date 259545-2 Related reports: 259545-1 Days  16-Mar-2007 Received Date  21-Mar-2007 Status Date -tate  WAES0702USA03647 Mfr Report  22-Mar-2007 Last Edit Date  
VAX Detail:  Type Manufacturer HPV4 MERCK CO. INC.  Lot NULL  Prev  Doses Site nknown  Route Unknown  Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Amblyopia, Fall, Headache, Pain, Speech disorder, Syncope, Syncope, Vomiting
Symptom Text: 	Information has been received via company representative regarding article reported concerning year old female. 11-JUL-2006, the patientwas vaccinated with Gardasil (yeast). Immediately following the vaccination, the patient developed severe pain, fell off the examining table and experienced a10 second fainting spell. was reported that the patient ended the emergency room with headache and speech problems. was further that thepatient had developed syncopal episode combined with amblyopia (poor vision one eye), abnormal speech and vomiting. the time this report, theoutcome the events were unknown. further information available. 
Other Meds: 	UNK 
Lab Data: 	UNK 
History: 	UNK 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb. w/AND  

Vaers Id:  260144-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
13.0  25-Jul-2006  25-Jul-2006  26-Jul-2006  28-Jul-2006  10-Aug-2006  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  0637F  Left arm  Unknown  
HEPA  MERCK CO. INC.  0144F  Right arm  Unknown  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA Dyskinesia, Hypertonia, Hypoaesthesia, Hypotonia, Pain, Syncope
Symptom Text: Patient received Hep right arm. Then received HPV left arm. C/O pains, numbness. Started walking down hall fainted and had tonic/clonic movement for sec. Other Meds: NONE Lab Data: 90/30 90/62 110/70 110/60, 114 Pulse 99, Strep culture neg. History: NONE Prex Illness: Viral with low grade fever Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb.  w/AND  

Age Gender Vaers Id: Type 17.0 260907-1 VAX Detail: HPV4  18-Jul-2006 Vaccine Date 18-Jul-2006 Onset Date Manufacturer Related reports: 260907-2 MERCK CO. INC. Days  Lot Prev Doses 01-Aug-2006 Received Date 0702F  02-Aug-2006 Status Date Right arm  Site State  Mfr Report Route Unknown  02-Aug-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Rash, Swelling 

Symptom Text: Swelling immediately after vaccine was administered, also rash. Ice pack was applied for minutes and swelling decreases. Rash was still visible, but cream was applied. Other Meds: NONE Lab Data: History: NONE Prex Illness: human papilloma virus, genital warts Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Age Gender Vaers Id: Type 17.0 260907-2 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer Related reports: 260907-1 MERCK CO. INC.  Days  
 Lot Prev15-Aug-2006 Received Date NULL  23-Aug-2006 Status Date Doses Site nknown State  WAES0607USA04365 Mfr Report Route Unknown  19-Dec-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Pain, Swelling 

Symptom Text: 	Information has been received from physician concerning year old female who unspecified date was vaccinated with 0.5 HPV rLI 18VLP vaccine (yeast). Subsequently the patient experienced painful swelling the size golf ball". The patient recovered the "next day". Unspecifiedmedical attention was sought. Additional information has been requested. 
Other Meds: Unknown Lab Data: NONE History: Unknown Prex Illness: Unknown Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report Vax Name: HPV (GARDASIL) All comb. w/AND  Page  
Vaers Id: 261359-1  
Age Gender 13-Jul-2006 Vaccine Date Unknown Onset Date Days Type Manufacturer 11.0 VAX Detail: HPV4 UNKNOWN MANUFACTURER MERCK CO. INC.  11-Aug-2006 Status Date State Lot Prev Doses Site 10-Aug-2006 Received Date C2457AA 0702F Right arm Left arm  Mfr Report Route Unknown Unknown  11-Aug-2006 Last Edit Date Other Vaccine  
MEN  UNKNOWN MANUFACTURER  U1920AA  Left arm  Unknown  
MedDRA Symptom Text: Dizzy, nauseated, developed axillary lymphadenopathy side with Menactra inoculation. NONEOther Meds: Seriousness: Dizziness, Lymphadenopathy, Nausea CONDITIONS, NOT SERIOUS  
Lab Data:  
History: Prex Illness:  NONE NONE  
Prex Vax Illns:  

FDA Freedom Info rmation Distribution  
Report run on: MAY 007 03:14  VAERS Line List Report  Page Name: HPV (GARDASIL)  All comb. w/AND  

Vaers Id:  261575-1  
Age Gender Type 24.0 VAX Detail: TDAP  12-Jul-2006 Vaccine Date 12-Jul-2006 Onset Date Manufacturer UNKNOWN MANUFACT Days URER  Lot Prev15-Aug-2006 Received Date NULL  23-Aug-2006 Status Date State Doses Site Unknown  WAES0607USA041063 Mfr Report Route Unknown  25-Apr-2007 Last Edit Date Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Unknown  Unknown  
Seriousness: SIT, NOT SERIOUS  
MedDRA  Rash 

Symptom Text: 	Information has been received from physician concerning year old female with medical history and drug allergies who "last week" onapproximately 12-JUL-2006 was vaccinated with HPV vaccine rLI VLP vaccine (yeast) (0.5 ml). Concomitant therapy that day included diphtheriatoxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The vaccines were administered different arms. Subsequently, "12 hours aftervaccination" the patient developed rash throughout her whole body that lasted for two days. Unspecified medical attention was sought. The patientrecovered two days after injection. Additional information has been requested. 
Other Meds: 
Lab Data: 	NONE 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  261576-1  
Age Gender Type 16.0 VAX Detail: HPV4  19-Jul-2006 Vaccine Date 19-Jul-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev15-Aug-2006 Received Date NULL  23-Aug-2006 Status Date Doses Site nknown State  WAES0607USA04314 Mfr Report Route Unknown  19-Dec-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain, Pain, Swelling 

Symptom Text: 	Information has been received from physician concerning approximately year old female who 19-JUL-2006 was vaccinated with HPV rLI 18VLP vaccine (yeast). was reported that "immediately after the injection", 19-JUL-2006, the patient experienced pain and stinging the injection site thatlasted about minutes and radiated the arm. The patient also reported feeling faint following the injection and experienced swelling. was reported that theswelling went down but the pain persisted. Unspecified medical attention was sought. 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: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  261577-1  
Age Gender Type 16.0 VAX Detail: HPV4  27-Jul-2006 Vaccine Date 27-Jul-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 15-Aug-2006 Received Date 0702F  23-Aug-2006 Status Date Site nknown State  WAES0607USA05727 Mfr Report Route Intramuscular  23-Aug-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain, Syncope 

Symptom Text: 	Information has been received from registered nurse and physician concerning year old female medical history and drug allergies who 27JUL-2006 was vaccinated intramuscularly the right deltoid with the first dose HPV rLI VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There were concomitant medications. the time vaccination the patient experienced extreme pain the injection site and fainted. The nurse reported that"the onset the pain was immediate and lasted for and half minutes and then the patient passed out for seconds and then was all right". The physician reported that the patient had vasovagal syncopal episode, was not incontinent, and experienced post- ictal state. Unspecified medical attentionwas sought. Subsequently, the same day the patient recovered from the extreme pain the injection site and vasovagal syncopal episode. The patient didnot wish continue the series result the adverse experience. 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: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  261578-1  
Age Gender Type 21.0 VAX Detail: HPV4  27-Jul-2006 Vaccine Date 27-Jul-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 15-Aug-2006 Received Date 0702F  23-Aug-2006 Status Date Site nknown State  WAES0607USA05775 Mfr Report Route Intramuscular  23-Aug-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain 

Symptom Text: 	Information has been received from physician and registered nurse concerning year old female with medical history drug allergies who 27-JUL2006 was vaccinated intramuscularly the left deltoid with the first dose HPV rLI VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). Concomitant therapy included possible hormonal contraceptives (unspecified). 27-JUL-2006 the patient experienced extreme pain the injection site. The onset the pain was immediate and lasted for minutes and then resolved. Unspecified medical attention was sought. was reported that the patient does not wishto continue the series vaccinations. Additional information has been requested. 
Other Meds: 	hormonal contraceptives 
Lab Data: 
History: 	Unknown 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page Name: HPV (GARDASIL)  All comb. w/AND  

Vaers Id:  261579-1  
Age Gender Type 14.0 VAX Detail: HPV4  28-Jul-2006 Vaccine Date 28-Jul-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev15-Aug-2006 Received Date NULL  23-Aug-2006 Status Date State Doses Site Unknown  WAES0608USA00186 Mfr Report Route Unknown  25-Apr-2007 Last Edit Date Other Vaccine  
DTP  UNKNOWN MANUFACT URER  NULL  Unknown  Unknown  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain 

Symptom Text: 	Information has been received from physician concerning year old female who 28-JUL-2006 was vaccinated with HPV rLI VLP vaccine(yeast). Concomitant vaccination 28-JUL-2006 included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. The patient stated thatfollowing vaccination 28-JUL-2006, she experienced great deal pain the injection site". Unspecified medical attention was sought. the time this report, the outcome the event was unknown. Additional information has been requested. 
Other Meds: 
Lab Data: Unknown 
History: Unknown 
Prex Illness: 
Prex Vax Illns: 

Report run on: MAY 2007 03:14 FDA Freedom Information Distribution  VAERS Line List Report Vax Name: HPV (GARDASIL) All comb. w/AND  Page  
MedDRA Age Gender 14-Aug-2006 Vaccine Date 22-Aug-2006 Onset Date Days 25-Aug-2006 Status Date State Symptom Text: Patient developed fine, red rash over torso and legs with itching reported on8/22/2006. OrthoTricyclen-LoOther Meds: Lab Data: History: nonePrex Illness: none Vaers Id: Type Manufacturer Lot Prev Doses Site 25.0 262070-1 VAX Detail: Seriousness: Pruritus, Rash CONDITIONS, NOT SERIOUS Related reports: 262070-2 24-Aug-2006 Received Date Prex Vax Illns: HPV4 MERCK CO. INC. 0637F Right arm  Mfr Report Route Intramuscular  25-Aug-2006 Last Edit Date Other Vaccine  

FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb.  w/AND  

Age Gender Vaers Id: Type 25.0 262070-2 VAX Detail: HPV4  14-Aug-2006 Vaccine Date 19-Aug-2006 Onset Date Manufacturer Related reports: 262070-1 MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0637F  21-Sep-2006 Status Date Site nknown State  WAES0608USA05899 Mfr Report Route Intramuscular  05-Oct-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Pyrexia, Rash 

Symptom Text: 	Information has been received from nurse practitioner concerning year old female with pertinent medical history drug allergies, who 8/14/06 wasvaccinated the right deltoid with the first dose HPV rL1 VLP vaccine (yeast) 0.5ml (lot 653937/0637F). There was concomitantmedication. 8/19/06 the notified her physicians office stating that she had developed rash both legs and torso. The did not experienced fever .Unspecified medical attention was sought. Treatment advised was antihistamine. Subsequently, the recovered. Additional information has beenrequested. 
Other Meds: 	NONE 
Lab Data: 	NONE 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  262096-1  
Age Gender 14-Aug-2006 Vaccine Date 14-Aug-2006 Onset Date Type Manufacturer 17.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 25-Aug-2006 Received Date 0637C  28-Aug-2006 Status Date Right arm  Site State  Mfr Report Route Intramuscular  28-Aug-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  

MedDRA 	Asthenia, Chills, Cyanosis, Dizziness, Pallor, Pyrexia, Visual disturbance
Symptom Text: after vaccination, reported feel dizzy, weak, vision went black for few seconds, got pale with purple lips 1/2hr. Felt better after drinking OJ. Thengot temp 101F and chills day. 
Other Meds: 
Lab Data: 
History: NONE 
Prex Illness: NONE 
Prex Vax Illns: 

FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb. w/AND  

Vaers Id:  262242-1  
Age Gender Type 14.0 VAX Detail: HPV4  23-Aug-2006 Vaccine Date 23-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 29-Aug-2006 Received Date 0637F  31-Aug-2006 Status Date State Site Left arm  Mfr Report Route Intramuscular  31-Aug-2006 Last Edit Date Other Vaccine  
HEPA  MERCK CO. INC.  0706R  Left arm  Intramuscular  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Fall, Fracture, Syncope vasovagal 

Symptom Text: Vasovagal syncope shortly after receiving hep and Gardasil vaccine, fell, hit nose drawer, loss consciousness, sent transport broke nose. 
Other Meds: 
Lab Data: 
History: NONE 
Prex Illness: NONE 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  262243-1  
Age Gender Type 16.0 VAX Detail: HPV4  25-Jul-2006 Vaccine Date 25-Jul-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 29-Aug-2006 Received Date 0637F  31-Aug-2006 Status Date Right arm  Site State  Mfr Report Route Intramuscular  31-Aug-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injury, Syncope, Tremor 

Symptom Text: 	Vaccine given after physical. fainted, vasovagal, hit head carpeted cement floor. Loss consciousness min, had tonic posturing right hand onlysome shaking. 
Other Meds: 
Lab Data: MRI next History: NONE Prex Illness: NONE 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  262451-1  
Age Gender Type 18.0 VAX Detail: HPV4  17-Aug-2006 Vaccine Date 18-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev01-Sep-2006 Received Date 0702F  05-Sep-2006 Status Date Doses Site nknown State  WAES0608USA04945 Mfr Report Route Intramuscular  05-Oct-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, OMIC, SERIOUS  
MedDRA  Rash, Urticaria 

Symptom Text: 	Information has been received from physician and medical assistant concerning old female with pertinent medical history allergies, who on17Aug06 was vaccinated with HPV rL1 VLP vaccine (yeast) (0.5ml) (lot 653650/0702F). There was concomitant therapy. Subsequently, on18Aug06 the developed rash and hives. was reported that this was not injection site rash. The presented her physician's office 18Aug06 withhives all over her body. She was treated with oral diphenhydramine hydrochloride (Benadryl). was also reported that the went the twice 19Aug06and 20Aug06 and was treated with intravenous methylprednisolone sodium succinate (Solu Medrol) for the hives and welts all over her body and was released(it was also reported that the was given saline). The was scheduled have follow visit with her physician within week. the time this report,the had not recovered. The rash and generalized urticaria were felt other important medical events. Additional information has been requested. 
Other Meds: 	NONE 
Lab Data: 
History: 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb. w/AND  
Vaers Id: 262482-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
23.0  25-Jul-2006  26-Jul-2006  31-Aug-2006  01-Sep-2006  01-Sep-2006  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
HPV4  MERCK CO. INC.  NULL  Left arm  Intramuscular  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Fatigue, Feeling hot, Injection site hypersensitivity, Injection site mass, Injection site pain 
Symptom Text: Hard painful lump site injection, red, site hot the touch. states feeling "tired run down" since injection.  
Other Meds:  
Lab Data:  
History:  
Prex Illness:  
Prex Vax Illns:  

FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb. w/AND  

Age Gender 31-Jul-2006 Vaccine Date 13-Aug-2006 Onset Date Days Vaers Id: Type Manufacturer 17.0 262735-1 (S) VAX Detail: Related reports: 262735-2; 262735-3 MNQ AVENTIS PASTEUR  Lot Prev Doses 07-Sep-2006 Received Date 42107AA  08-Sep-2006 Status Date State Site Gluteous maxima  Mfr Report Route Intramuscular  22-Dec-2006 Last Edit Date Other Vaccine  
HPV4 MERCK CO. INC.  0697F  Gluteous maxima  Intramuscular  
Seriousness:  HOSPITALIZED, LIFE THREATENING, SERIOUS  

MedDRA 	Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Proteinuria, Red blood cell sedimentation rate increased
Symptom Text: 	Vaccine was given July 2006. She began having numbness and tingling her feet and hands around August 13th 14th, which persisted andslightly worsened until she was seen our office August 21st. Her neurological examination was normal, she had elevated sedimation rate (39), mildprotienuria, otherwize normal labs. MRI her lumbosacral spine showed (possibly old, chronic) subarachnoid cyst. She was referred neurologist andwas seen August 25th and was found have weakened severely and was admitted PICU for suspected Guillian-Barre syndrome which was confirmed bylumbar puncture. She was treated with IVIG with rapid improvement and has gone home. She slowly improving and has residual weakness. Medical records including neurology received/reviewed. Final diagnosis GBS. Was treated with IVIG indicated VAERS form. Per records has residualweakness. 12/19/06-progress notes received for and Summary DX: GBS. 
Other Meds: 
Lab Data: 	MRI brain, cervical, thoracic and lumbosacral spine, drug screen, pregnancy test, sed rate, Blood count, blood chemistries, Lumbar Puncture. 
History: 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb. w/AND  

Age Gender 31-Jul-2006 Vaccine Date 13-Aug-2006 Onset Date Days Vaers Id: Type Manufacturer 16.0 262735-2 (S) VAX Detail: Related reports: 262735-1; 262735-3 MNQ HPV4 AVENTIS PASTEUR MERCK CO. INC.  Lot Prev15-Dec-2006 Received Date 42107A 0697F  29-Dec-2006 Status Date Doses Site Unknown Unknown State  200602493 Mfr Report Route Intramuscular Intramuscular  29-Dec-2006 Last Edit Date Other Vaccine  
Seriousness:  HOSPITALIZED, SERIOUS  
MedDRA  Asthenia, Guillain-Barre syndrome, Hypoaesthesia 

Symptom Text: 	Initial report received 22/Sep/2006 from the Centers for Disease Control and Prevention (CDC). year old female patient had received intramuscular,first dose injection Menactra, lot number reported 42017AA; and intramuscular, first dose injection Human Papillomavirus Recombinant Vaccine, lotnumber 0697F; 31/Jul/2006. around 13/Aug/2006, the patient experienced numbness and tingling her feet and hands. The symptoms persisted andhad slightly worsened the time her examination physician 21/Aug/2006. that time, "neurological examination was normal." She had andelevated sedimentation rate (39), mild proteinuria, and "otherwise normal labs." Other laboratory tests performed, (specific results not provided), included ablood count, blood chemistries, pregnancy test and drug screen. MRI was performed the brain, cervical, thoracic and lumbosacral spine. MRI thelumbosacral spine showed (possibly old, chronic) subarachnoid cyst. The patient was referred and examined neurologist 25/Aug/2006. During thatexam, she was found have weakened severely. She was admitted pediatric intensive care unit for suspected Guillain Barre syndrome which wasconfirmed lumbar puncture. Lumbar puncture results were not provided. She was treated with IVIG with rapid improvement; and after five days ofhospitalization, was discharged home. Per the reported, she slowly improving and had residual weakness. Recovery status was documented unknown.As per the CDC this case was confirmed CISA (Clinical Immunization Safety Assessment network) being Guillain Barre syndrome following Menactravaccination. Follow-up information received 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the reported, the patient was hospitalizedon 25/Aug/2006. The date discharge was not reported. The patient's Guillain Barre Syndrome was confirmed lumbar puncture testing. 
Other Meds: 
Lab Data: 
History: 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb. w/AND  

Age Gender 31-Jul-2006 Vaccine Date 13-Aug-2006 Onset Date Days Vaers Id: Type Manufacturer 16.0 262735-3 (S) VAX Detail: Related reports: 262735-1; 262735-2 MNQ HPV4 AVENTIS PASTEUR MERCK CO. INC.  Lot Prev Doses 08-Mar-2007 Received Date 42107A 0697F  09-Mar-2007 Status Date State Site Gluteous maxima Gluteous maxima  200602493 Mfr Report Route Intramuscular Intramuscular  09-Mar-2007 Last Edit Date Other Vaccine  
Seriousness:  HOSPITALIZED, LIFE THREATENING, SERIOUS  

Areflexia, Asthenia, Asthenia, Cyst, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia, Laboratory test normal, Lumbar puncture, Muscular weakness,MedDRA Nerve conduction studies abnormal, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Occupational therapy, Paraesthesia,Physiotherapy, Pregnancy test, Proteinuria, Red blood cell sedimentation rate increased
Symptom Text: 	Initial report received 22/Sep/2006. 16-year-old female patient had received intramuscular, first dose injection Menactra, lot number reported as42107AA (not valid manufacturer lot number), and intramuscular, first dose injection Gardasil, lot number 0697F, 31/Jul/2006. around13/Aug/2006 14/Aug/2006, the patient experienced numbness and tingling her feet and hands. The symptoms persisted and had slightly worsened thetime her examination physician 21/Aug/2006. that time, neurological examination was normal. She had elevated sedimentation rate (39), mildproteinuria, and otherwise normal labs. Other laboratory tests performed, (specific results not provided), included blood count, blood chemistries, pregnancytest and drug screen. MRI was performed the brain, cervical, thoracic and lumbosacral spine. MRI the lumbosacral spine showed (possibly old, chronic)subarachoid cyst. The patient was referred and examined neurologist 25/Aug/2006. During that exam, she was found have weakened severely.She was admitted pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed lumbar puncture. Lumbar puncture resultswere not provided. She was treated with IVIG with rapid improvement, and after five days hospitalization, was discharged home. Per the reporter, she isslowly improving and has residual weakness. Recovery status was documented unknown. This case was confirmed being Guillain Barre syndromefollowing Menactra vaccination. Follow-up information received 27/Sep/2006. Per the reporter, the patient was hospitalized 25/Aug/2006. The date ofdischarge was not reported. The patient's Guillain Barre syndrome was confirmed lumbar puncture testing. Literature citation, update: Guillain Barresyndrome among recipients Menactra Meningococcal conjugate vaccine June 2005-September 2006. Follow-up information received October 2006from health care professional concerning publication. 
Other Meds: 
Lab Data: 	Blood chemistries normal, urinalysis Albuminuria, nerve conduction study GBS, MRI spine, brain, Cervical, thoracic possibly old, Chronic subarachnoidcyst, blood drug screen normal, erythrocyte elevated, serum beta human normal, CBC
History: 	The patient was well the day immunization. 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report  Page  
Vax Name: HPV (GARDASIL)  All comb. w/AND  

Vaers Id:  262742-1  
Age  Gender  Vaccine Date  Onset Date  Days  Received Date  Status Date  State  Mfr Report  Last Edit Date  
15.0  01-Aug-2006  01-Aug-2006  08-Sep-2006  11-Sep-2006  WAES0608USA06904  11-Sep-2006  
VAX Detail:  Type  Manufacturer  Lot  Prev Doses  Site  Route  Other Vaccine  
MNQ  AVENTIS PASTEUR  NULL  Unknown  Unknown  
HPV4  MERCK CO. INC.  NULL  Unknown  Intramuscular  
HEPA  MERCK CO. INC.  NULL  Unknown  Unknown  
Seriousness: VISIT, OMIC, SERIOUS  
MedDRA  Convulsion, Injection site pain 

Symptom Text: 	Information has been received from physician concerning year old female patient who August 2006, was vaccinated with dose HPV rL1 1116 VLP vaccine. Prior administration, the patient received the following concomitant therapy: hepatitis vaccine and meningococcal ACYW conjugatevaccine. The patient had mild seizure after receiving HPV rL1 VLP vaccine injection. She also complained great deal pain injection site.Medical attention was sought. was reported that the patient recovered day after the event. Her mother called the physician home day after theinjections state that the patient was fine. Upon internal review, mild seizure was considered other important medical event (OMIC). Additionalinformation has been requested. 
Other Meds: 
Lab Data: 
History: 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  262743-1  
Age Gender Type 17.0 VAX Detail: HPV4  22-Aug-2006 Vaccine Date 23-Aug-2006 Onset Date Days Manufacturer MERCK CO. INC.  Lot Prev08-Sep-2006 Received Date NULL  11-Sep-2006 Status Date Doses Site nknown  -State  WAES0608USA05911 Mfr Report Route Intramuscular  11-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, OMIC, SERIOUS  
MedDRA  Chest discomfort, Erythema, Oedema peripheral 

Symptom Text: 	Information has been received from nurse concerning her year old daughter with asthma who 8/22/06 was vaccinated with HPV rL1 VLPvaccine (0.5ml). 8/23/06 the patient developed swollen thumb and her palms became red and hot. The patient later developed tightness her chest.The patient was immediately taken physician (an allergist who was the mother's employer) who immediately gave the patient huge dose cetirizinehydrochloride and acetaminophen intervention. The patient was not hospitalized and did not got the emergency room. was unknown the affectedsite was the same arm that the vaccine was given in. The patient subsequently recovered from the red and hot palms, swollen thumb, and chest tightness onan unspecified date. The red and hot palms, swollen thumb and chest tightness were felt other important medical events. Additional information has beenrequested. 
Other Meds: 	UNK 
Lab Data: 
History: 	Asthma 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  262785-1  
Age Gender Type 19.0 VAX Detail: HPV4  10-Aug-2006 Vaccine Date 15-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 08-Sep-2006 Received Date 0702F  11-Sep-2006 Status Date Left arm  Site State  Mfr Report Route Intramuscular  11-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Movement disorder 

Symptom Text: 09/01/06 call with c/o decreased ROM arm days after injection administration current date. with Naproxen days and Tylenol #3. 
Other Meds: NONE 
Lab Data: 
History: NONE 
Prex Illness: NONE 
Prex Vax Illns: 
FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Age Gender 23-Aug-2006 Vaccine Date 27-Aug-2006 Onset Date Vaers Id: Type Manufacturer 17.0 262809-1 VAX Detail: Related reports: 262809-2 HPV4 MERCK CO. INC. Days  Lot Prev11-Sep-2006 Received Date 0689F  12-Sep-2006 Status Date Doses Site nknown State  WAES0608USA06930 Mfr Report Route Intramuscular  13-Mar-2007 Last Edit Date Other Vaccine  
Seriousness: VISIT, OMIC, SERIOUS  

MedDRA 	Hypokinesia, Lymphadenopathy, Lymphadenopathy, Skin nodule
Symptom Text: 	Information had been received from healthcare worker concerning year old female with sulfonamide allergy who 8/23/06 was vaccinated leftupper arm with dose HPV rL1 VLP vaccine yeast, lot 653736/089F. There was concomitant medication. was reported that days aftervaccination, 8/27/06, the developed lymph node swelling the clavicle area, described grape size. The complained interference upper armmovement and felt something was present the clavicle area. Unspecified blood work was done. 8/29/06 CAT scan was performed and lump wasdescribed having smaller and larger lymph nodes involved. 8/30/06 the was scheduled for surgery have the lymph nodes removed and biopsied.As the report date, the had not recovered. The reporter felt that the lymph node swelling and interference with upper arm movement were other importantmedical events (OMIC). Additional information has been requested. 10/13/06 Received medical records from hospital which reeal patient seen 8/29/06for enlarged lymph node left supraclavicular area which was tender palpation. Final Dx: lymphadenopathy. 8/31/06 surgical biopsy done left node several other lymph nodes were palpated sent lab. 
Other Meds: 	NONE 
Lab Data: 	Computed axial 8/29/06 lump having smaller and larger lymph nodes involved. LABS: all WNL. chest/abd/pelvis revealed 14mm circumscribed noein left supraclavicular node several less than nodes bilateral axillary areas
History: 	Sulfonamide allergy 
Prex Illness: 
Prex Vax Illns: 
Report run on: MAY 2007 03:14 FDA Freedom Information Distribution  VAERS Line List Report Vax Name: HPV (GARDASIL) All comb. w/AND  Page  
Age Gender 23-Aug-2006 Vaccine Date 27-Aug-2006 Onset Date Vaers Id: Type Manufacturer 17.0 262809-2 (S) VAX Detail: Related reports: 262809-1 HPV4 MERCK CO. INC. Days  18-Sep-2006 Status Date State Lot Prev Doses Site 13-Sep-2006 Received Date 0689F Left arm  Mfr Report Route Intramuscular  19-Sep-2006 Last Edit Date Other Vaccine  
MedDRA Symptom Text: Enlarged nodes the clavicle area. Other Meds: Lab Data: History: nonePrex Illness: none Seriousness: Lymphadenopathy VISIT, HOSPITALIZED, SERIOUS Prex Vax Illns:  

Report run on: MAY 2007 03:14 FDA Freedom Information Distribution  VAERS Line List Report Vax Name: HPV (GARDASIL) All comb. w/AND  Page  
MedDRA Age Gender 06-Sep-2006 Vaccine Date 06-Sep-2006 Onset Date Days 12-Sep-2006 Status Date State Mfr Report Patient said right deltoid area, became red, swollen, quarter size hard knot, achy, painful raise arm. Knot was hot touch.Symptom Text: NONEOther Meds: Lab Data: History: yearly examinationPrex Illness: NONE NONE Vaers Id: Type Manufacturer Lot Prev Doses Site Route 25.0 262847-1 VAX Detail: Seriousness: Erythema, Joint range motion decreased, Pain, Pain, Swelling CONDITIONS, NOT SERIOUS 11-Sep-2006 Received Date Prex Vax Illns: MNQ HPV4 AVENTIS PASTEUR MERCK CO. INC. U2117AA 0688F Right arm Left arm Intramuscular Intramuscular  12-Sep-2006 Last Edit Date Other Vaccine  

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Vax Name: HPV (GARDASI  All comb.  w/AND  

Age Gender Vaers Id: Type 11.0 262872-1 VAX Detail: HPV4  02-Sep-2006 Vaccine Date 02-Sep-2006 Onset Date Manufacturer Related reports: 262872-2 MERCK CO. INC. Days  Lot Prev Doses 12-Sep-2006 Received Date 08007  13-Sep-2006 Status Date Left arm  Site State  Mfr Report Route Intramuscular  13-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Syncope, Tonic clonic movements 

Symptom Text: 	Immediately after vaccine administration patient had syncopal episode with tonic posturing fell from table. Responded with gentle stimulation versus normal 5minutes post regaining full consciousness. 
Other Meds: 
Lab Data: vital signs stable History: NONE Prex Illness: NONE 
Prex Vax Illns: 
FDA Freedom Info rmation Distribution  
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Age Vaers Id: 11.0 Gender 262872-2  Unknown Vaccine Date Unknown Onset Date Related reports: 262872-1  Days  
 16-Mar-2007 Received Date  21-Mar-2007 Status Date -tate  WAES0702USA03649 Mfr Report  22-Mar-2007 Last Edit Date  
VAX Detail:  Type HPV4  Manufacturer Lot MERCK CO. INC. NULL  Prev  Doses Site nknown  Route Unknown  Other Vaccine  
Seriousness: ONDITIONS, NOT SERIOUS  
MedDRA  Fall 

Symptom Text: 	Information has been received via company representative regarding article concerning year old female. unspecified date, the patient wasvaccinated with Gardasil. Subsequently the patient fell from the examining table. the time this report, the outcome the event was unknown. furtherinformation available. 
Other Meds: UNK Lab Data: UNK History: UNK Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line List Report Vax Name: HPV (GARDASIL) All comb. w/AND  Page  
Vaers Id: 263024-1  
Age Gender 11-Sep-2006 Vaccine Date Unknown Onset Date Days Type Manufacturer 1.5 VAX Detail: PNC HPV4 LEDERLE LABORATORIES MERCK CO. INC.  14-Sep-2006 Status Date State Lot Prev Doses Site 13-Sep-2006 Received Date B08682H NULL Left leg Unknown  Mfr Report Route Intramuscular Unknown  14-Sep-2006 Last Edit Date Other Vaccine  
MedDRA Seriousness:  Medication error CONDITIONS, NOT SERIOUS DTAP AVENTIS PASTEUR  U1751AB  Right leg  Intramuscular  
Symptom Text: Wrong vaccine was given Gardasil was given instead Hep mistake. Other Meds:  
Lab Data:  NONE  
History: Prex Illness:  NONE NONE  
Prex Vax Illns:  

FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASI  All comb. w/AND  

Age Gender 07-Jul-2006 Vaccine Date 20-Jul-2006 Onset Date Days Vaers Id: Type Manufacturer 16.0 263032-1 (S) VAX Detail: Related reports: 263032-2; 263032-3 MNQ AVENTIS PASTEUR  Lot Prev Doses 14-Sep-2006 Received Date U2069AA  15-Sep-2006 Status Date Site Unknown State  Mfr Report Route Intramuscular  03-Oct-2006 Last Edit Date Other Vaccine  
HPV4 MERCK CO. INC.  0637F  Unknown  Intramuscular  
Seriousness:  HOSPITALIZED, SERIOUS  

MedDRA 	Asthenia, Dehydration, Gait disturbance, Guillain-Barre syndrome, Paraesthesia, Psychomotor hyperactivity
Symptom Text: 	Guillain Barre. She was well day immunization but later said she was weak and several months this was not objectively noticed then, but shortly after thevaccine. 9/28/06 Received medical records from neurologists which reveal patient seen PCP 7/31/06 with complaint loss strength over past mos.Labs were done PCP showed mild dehydration elevated neutrophils, eos were absent. Patient referred neuro initial eval 8/3 reveals patientnoted weakness beginning June which had progressively worsened. Symptoms included tingling sensation tip fingers significant weakness thepoint she could not her own hair. Birth history was WNL only PMH ADD has been Adderall for about year well BCP. Exam showed definite weakness all extremities, esp upper extremities, neck. Reflexes were absent legs. Gait was normal but had difficulty taking steps w/o support could not rise from sitting w/o help. Normal CPK made difficult EMG/NCS was done 8/4 which was strongly positive for GBS copy test includedwith records. Treated with IVIG days placed rehab facility 8/5/06 for eval therapy then received home PT. Seen neuro next 8/24 whichshowed improvement but still with weakness especially the hands. Now able rise from sitting floor w/o support. Still reflexes legs. Complete butslow recovery was expected that time/ss 9/28/06 Received medical records from hospital which reveal patient admitted 8/4/-8/6/06 for IVIG PT./ss 
Other Meds: Adderall Lab Data: 
History: 	Attention deficit disorder. 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASI  All comb. w/AND  

Age Vaers Id: 16.0 Gender 07-Jul-2006 Vaccine Date 20-Jul-2006 Onset Date Days 263032-2 (S) Related reports: 263032-1; 263032-3  15-Dec-2006 Received Date  29-Dec-2006 Status Date State  200602494 Mfr Report  29-Dec-2006 Last Edit Date  
VAX Detail:  Type MNQ HPV4  Manufacturer AVENTIS PASTEUR MERCK CO. INC.  Lot U2069A 0637F  Prev Doses  Site Unknown Unknown  Route Intramuscular Intramuscular  Other Vaccine  
Seriousness:  HOSPITALIZED, SERIOUS  
MedDRA  Asthenia, Guillain-Barre syndrome 

Symptom Text: 	Initial report received 22/Sep/2006 from the Centers for Disease Control and Prevention. "approximately" year old female patient, with history ofattention deficit disorder, had received intramuscular, first dose injection Menactra, lot number U2069AA; and intramuscular, first dose injection ofGardasil, lot number 06373F; 07/Jul/2006. She had illness the time vaccination. Concomitant medications included Adderall 50mg. Thirteen dayspost-vaccination, the patient experienced weakness "times several months." Although the report difficult read, appears the reporter had written, "this wasnot objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined neurologist andtreated with IVIG. The event was reported Guillain Barre syndrome. The patient recovered from the event. per the CDC this case has not yet beenconfirmed CISA (Clinical Immunization Safety Assessment network) being Guillain Barre syndrome following Menactra vaccination. The onset ofsymptoms may have been prior vaccination. Follow information, received 27/Sep/2006 from the Centers for Disease Control and Prevention. Per thereport, "there doubt regarding the date onset. The symptoms may have started June 2006 prior vaccination. The neurologist's history weaknessgoes back late June before immunization. The primary care physician's report the VAERS form was based physician assistant's screening historyprior vaccine administration that was not specific for neurologic symptoms." Per the CDC comments regarding GBS confirmation status, "Unless get otherinformation from the patient/family the contrary, the neurologist's consult should stand, and this would not post-vaccine Guillain Barre case." 
Other Meds: 	Adderall, oral contraceptives 
Lab Data: 
History: 	The patient had history attention deficit disorder for which she took Adderall 50mg. 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
Report run on: MAY 2007 03:14  VAERS Line ist Report  Page  
Vax Name: HPV (GARDASI  All comb. w/AND  

Age Vaers Id: 16.0 Gender 07-Jul-2006 Vaccine Date 20-Jul-2006 Onset Date Days 263032-3 (S) Related reports: 263032-1; 263032-2  21-Feb-2007 Received Date  22-Feb-2007 Status Date State  200602494 Mfr Report  22-Feb-2007 Last Edit Date  
VAX Detail:  Type Manufacturer MNQ HPV4 AVENTIS PASTEUR MERCK CO. INC.  Lot U2069AA 0637F  Prev Doses  Site Unknown Unknown  Route Intramuscular Intramuscular  Other Vaccine  
Seriousness:  HOSPITALIZED, SERIOUS  

MedDRA 	Asthenia, Asthenia, Dehydration, Gait disturbance, Guillain-Barre syndrome, Hyperkinesia, Paraesthesia
Symptom Text: 	Initial report received 22/Sep/2006. "approximately" year old female patient, with history attention deficit disorder, had received intramuscular,first dose injection Menactra, lot number U2069AA, and intramuscular, first dose injection Gardasil, Lot number 0637F, 07/Jul/2006. She noillness the time vaccination. Concomitant medications included Adderall mg. Thirteen days post vaccination, the patient experienced weakness "timesseveral months."Although the report difficult read, appears the reporter had written, "this was not objectively noticed then, but mostly after the vaccine."The event required hospitalization for one day. The patient was examined neurologist and treated with IVIG. The event was reported Guillain Barresyndrome. The patient recovered from the event. This case has not yet been confirmed CISA (Clinical immunization safety assessment network) beingGuillain Barre syndrome following Menactra vaccination. The onset symptoms may have been prior vaccination. Follow-up information received on27/Sep/2006. Per the reporter, "there doubt regarding the date onset. The symptoms may have started June 2006 prior vaccination. Theneurologist's history weakness goes back late June before immunization. The primary care physician's report the VAERS form was based aphysician assistant's screening history prior vaccine administration that was not specific for neurologic symptoms. Comments regarding GBS confirmationstatus, "unless get other information from the patient/family the contrary, the neurologist's consult should stand, and this would not post vaccineGuillain Barre case. Follow information received February 2007 from manufacturer, whose reference number WAES0702USA00828. Thismanufacturer received the original report. This manufacturer reported the lot number for Gardasil being 653937/0637F. The lot number the case wasamended from 0637F 653937/0637F per this 
Other Meds: 	Adderall, oral contraceptives 
Lab Data: 
History: 	The patient had history attention deficit disorder for which she took Adderall mg. 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Age Gender Vaers Id: Type 15.0 263185-1 VAX Detail: HPV4  29-Aug-2006 Vaccine Date 29-Aug-2006 Onset Date Manufacturer Related reports: 263185-2 MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0688F  20-Sep-2006 Status Date Left arm  Site State  Mfr Report Route Intramuscular  20-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Dysphagia 

Symptom Text: hours after Gardasil Administration developed inability swallow. Advised take Benadryl covering physician and ER. not given EPI butSolumedrol take for days. Other Meds: Singulair, Allegra, Flovent, Rhinocort Lab Data: History: Asthma, Penicillin allergy. Prex Illness: Prex Vax Illns: 
FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Age Gender Vaers Id: Type 15.0 263185-2 VAX Detail: HPV4  29-Aug-2006 Vaccine Date 29-Aug-2006 Onset Date Manufacturer Related reports: 263185-1 MERCK CO. INC. Days  Lot Prev 16-Mar-2007 Received Date NULL  21-Mar-2007 Status Date Doses Site nknown -tate  WAES0702USA03648 Mfr Report Route Unknown  22-Mar-2007 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Dysphagia 

Symptom Text: 	Information has been received via company representative regarding article concerning year old female with asthma. 29-AUG-2006, the patientwas vaccinated with Gardasil. Concomitant therapy included four unspecified therapies for the treatment asthma. 29-AUG-2006, two hours postvaccination, the patient developed difficulty swallowing prompting visit the emergency room. the time this report, the outcome the event wasunknown. further information available. 
Other Meds: Therapy unspecified Lab Data: UNK History: Prex Illness: Asthma Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263200-1  
Age Gender Type Unknown VAX Detail: HPV4  25-Jul-2006 Vaccine Date 25-Jul-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown  -State  WAES0608USA00410 Mfr Report Route Unknown  19-Dec-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Injection site pain 

Symptom Text: 	Information has been received from pharmacist concerning her daughter who approximately 25-JUL-2006 was vaccinated with HPV rLi VLPvaccine (yeast). approximately 25-JUL-2006 the patient experienced soreness the injection site that lasted approximately one week and the time ofthis report had not resolved. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263201-1  
Age Gender Type Unknown VAX Detail: HPV4  02-Aug-2006 Vaccine Date 02-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Site nknown State  WAES0608USA01129 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Syncope 

Symptom Text: 	Information has been received from registered nurse concerning female who 02-AUG-2006 was vaccinated with the first dose HPV rLi VLPvaccine (yeast). was reported that the patient fainted "shortly after receiving the vaccination". The nurse did not feel the experience was vaccine related andstated "the patient was very uneasy with the idea injection". The patient subsequently recovered "shortly after fainting". Unspecified medical attentionwas sought. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263202-1  
Age Gender 03-Aug-2006 Vaccine Date 04-Aug-2006 Onset Date Type Manufacturer 14.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0637F  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA01355 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Pruritus, Rash, Rash papular, Skin burning sensation, Skin ulcer
Symptom Text: 	Information has been received from registered nurse concerning year old female with seasonal allergies who was exposed roseola 25-JUL-2006and had fever 02-AUG-2006. 03-AUG-2006, the patient was vaccinated intramuscularly with 0.5 dose HPV rLi VLP vaccine (yeast)(lot#653937/0637F). Concomitant therapy included loratadine (CLARITIN) and vitamins (unspecified). 04-AUG-2006, the patient developed extensiverash. The patient discovered the rash the back her legs. was reported that the rash spread her back and shoulders and had started tospread her abdomen. The rash consisted non vesicular papular single lesions that were slightly larger than pinpoint and too numerous count. The lesions were described "burning and itchy". Unspecified medical attention was sought. the time the report, the patient's rash persisted. Additional information has been requested. 
Other Meds: 	CLARITIN, vitamins (unspecified) 
Lab Data: 	NONE 
History: 	MEDICAL HISTORY: fever, CONCURRENT CONDITIONS: seasonal allergy 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263203-1  
Age Gender Type 26.0 VAX Detail: HPV4  09-Aug-2006 Vaccine Date 09-Aug-2006 Onset Date Days Manufacturer Lot Prev19-Sep-2006 Received Date MERCK CO. INC. 0637F  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA02569 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Arthralgia, Influenza like illness, Nausea, Pain, Pyrexia 

Symptom Text: 	Information has been received form physician concerning year old female with pertinent medical history and history drug reactions allergies whoon 8/9/06 was vaccinated with HPV rL1 VLP vaccine yeast (lot 653937/0637F) inappropriate schedule vaccina administration. There was noconcomitant medication. 8/9/06 the experienced fever, nausea, body aches, joint pains and experienced flu like symptoms. Unspecified medicalattention was sought. the time this report, the was recovering from the fever, nausea, body aches, joint pains and flu like symptoms. 
Other Meds: NONE Lab Data: NONE History: NONE Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263204-1  
Age Gender 18-Jul-2006 Vaccine Date 18-Jul-2006 Onset Date Type Manufacturer 22.0 VAX Detail: HPV4 MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0640F  21-Sep-2006 Status Date Site nknown State  WAES0608USA02804 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  

MedDRA 	Dizziness, Dysarthria, Injection site pain, Musculoskeletal stiffness, Pallor, Shock, Skin papilloma, Syncope
Symptom Text: 	Initial and follow information has been received from year old female with breast implants and had history abnormal pap test and dysplasia andfrom nurse practitioner. 7/18/06 the was vaccinated with the first dose HPV rL1 VLP vaccine yeast (lot 653650/0640F). Concomitanttherapy included ethinyl estradiol norgestimate (Ortho Lo). 7/18/06, immediately following vaccination, the experienced slurred speech for approx 4minutes and reported that she felt her body went into shock. She noted that her fingers curled into fist and her fingers and hands stiffened up. Shereported that the later symptoms lasted for approx minutes. Also approx two weeks after receiving the vaccination, she began have some pain andstiffness her upper left arm and shoulder the same arm she had received the injection. Unspecified medical attention was sought. the time this report,the pain and stiffness the left arm and shoulder had not resolved. The also reported that although she had never had nay type genital warts the past,on approx 8/4/06 she noted she had small genital warts which were confirmed her health care professional. follow nurse practitioner reportedconflicting information that what the described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the ptappeared pale and almost fainted. The became woozy and could speak clearly. The was attended both the nurse practitioner and another nurse. Thept was diagnosed with having near syncopal episode. The was treated with cool compress and she recovered quickly and was noted fine afterwards.The pts blood pressure was fine noted 130/80 mmHg. was reported that the did not experience any drop hart rate, did not loose consciousness, didnot seize and did not experience wheezing. The nurse practitioner did not see what she would describe any adverse reaction the vaccines and describedth 
Other Meds: 	Ortho Tri cyclen 
Lab Data: 	Blood pressure 7/18/06 130/80 
History: 	Pap smear abnormal, Dysplasia, Breast Prosthesis user. 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263205-1  
Age Gender Type Unknown VAX Detail: HPV4  08-Aug-2006 Vaccine Date 11-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown  -State  WAES0608USA02806 Mfr Report Route Intramuscular  05-Oct-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Dizziness 

Symptom Text: 	Information has been received from nurse concerning two female pts (WAES0609USA01112) who approx 8/8/06 were vaccinated with HPV rL1 1618 VLP vaccine yeast (lot not provided). was reported that after receiving the vaccinations both pts fainted. Additional information regarding the pts was notprovided. Additional information has been requested. 
Other Meds: UNK 
Lab Data: 
History: UNK 
Prex Illness: 
Prex Vax Illns: 

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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263206-1  
Age Gender Type 18.0 VAX Detail: HPV4  14-Aug-2006 Vaccine Date 14-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Site nknown State  WAES0608USA03642 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Myalgia, Nausea, Pyrexia, Vomiting 

Symptom Text: 	Information has been received from physician concerning year old who 14-AUG-2006 was vaccinated (yeast). Concomitant therapy included anunspecified therapy ("ESTRASTEP"). 14-AUG-2006 the patient experienced profuse nausea, vomiting, low grade fever and myalgia. The patient soughtunspecified medical attention. the time this report, the outcome the events were unknown. Additional information has been requested. 
Other Meds: (therapy unspecified) 
Lab Data: body temperature 08/14/06 "low grade fever" 
History: Unknown 
Prex Illness: 
Prex Vax Illns: 

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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263207-1  
Age Gender Type 20.0 VAX Detail: HPV4  08-Aug-2006 Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Site nknown  -State  WAES0608USA03841 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Diarrhoea 

Symptom Text: 	Information has been received from nurse practitioner concerning year old female who 08-AUG-2006 was vaccinated with the first dose HPV rLi 611 VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). Following the vaccination, anunspecified date August 2006, the patient experienced diarrhea. Unspecified medical attention was sought. the time this report, the outcome thediarrhea was unknown. Additional information has been requested. 
Other Meds: ORTHO TRI CYCLEN Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263208-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA03934 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Urticaria 

Symptom Text: 	Information has been received from physician concerning who unspecified date was vaccinated with HPV rL1 VLP vaccine yeast.Subsequently the experienced hives. further details were provided, and the time this report, the outcome the event was unknown. Additionalinformation has been requested. 
Other Meds: UNK Lab Data: UNK History: UNK Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263209-1  
Age Gender Type 19.0 VAX Detail: HPV4  15-Aug-2006 Vaccine Date 15-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0702F  21-Sep-2006 Status Date Site nknown State  WAES0608USA03961 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Dizziness 

Symptom Text: 	Information has been received from nurse concerning year old female with pertinent medical history drug reactions allergies who 8/15/06 wasvaccinated with the first dose HPV rL1 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Menactra. unspecifieddate the was given tuberculin purified protein derivative. 8/15/06, minutes after vaccination with HPV rL1 VLP vaccine yeast, the becamefaint. The was given water and chocolate treatment. Subsequently, the recovered 8/15/06. Additional information has been requested. 
Other Meds: 
Lab Data: Tuberculin skin test 
History: NONE 
Prex Illness: 
Prex Vax Illns: 

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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263210-1  
Age Gender Type 20.0 VAX Detail: HPV4  15-Aug-2006 Vaccine Date 15-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0702F  26-Sep-2006 Status Date Site nknown State  WAES0608USA03962 Mfr Report Route Intramuscular  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Syncope 

Symptom Text: 	Information has been received from nurse concerning year old female with penicillin allergy, drug hypersensitivity cefaclor (CECLOR) and otherpertinent medical history reported. 15-AUG-2006, the patient was vaccinated intramuscularly with HPV rLi VLP vaccine (yeast)(Lot#653650/0702F). Concomitant therapy included paroxetine HCL (PAXIL), bupropion HCL (WELLBUTRIN) and famotidine. was reported that the patientbecame faint within minutes vaccination with HPV rLi VLP vaccine (yeast). The patient was given soda drink treatment. There were laboratory diagnostic studies performed. 15-AUG-2006, the patient recovered from the event. Additional information has been requested. 
Other Meds: 	WELLBUTRIN, PEPCID, PAXIL 
Lab Data: 	NONE 
History: 	CONCURRENT CONDITIONS: Penicillin allergy, drug hypersensitivity 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263211-1  
Age Gender Type 19.0 VAX Detail: HPV4  11-Aug-2006 Vaccine Date 12-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0702F  26-Sep-2006 Status Date Site nknown State  WAES0608USA03973 Mfr Report Route Intramuscular  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: ONDITIONS, NOT SERIOUS  
MedDRA  Pain 

Symptom Text: 	Initial and follow has been received from healthcare worker physician's office concerning her year old daughter who was student and anunspecified person the physician's office. 11-AUG-2006, 11:15 am, the patient was vaccinated intramuscularly the deltoid with the first dose HPVrLi VLP vaccine (yeast) (Lot#653650/0702F). Other concomitant therapy included unspecified therapy ('LO-L"). 12-AUG-2006 (previouslyreported 14-AUG-2006) the patient developed pain her right arm and ribcage the same side where the vaccine was administered. 16-AUG-2006, the patient had recovered from the events. further information available. 
Other Meds: 	(therapy unspecified) 
Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263212-1  
Age Gender Type 19.0 VAX Detail: HPV4  14-Aug-2006 Vaccine Date 14-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0689F  26-Sep-2006 Status Date Doses Site nknown State  WAES0608USA04253 Mfr Report Route Subcutaneously  20-Nov-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Pruritus, Rash 

Symptom Text: 	Information has been received from registered nurse concerning year old female with pertinent medical history drug reactions/allergies who 14AUG-2006 was vaccinated subcutaneously with "the standard dose" HPV rLi VLP vaccine (yeast) (lot#653736/0689F). There was concomitant medication. 15-AUG-2006 the patient developed rash her face and experienced itching her face. was reported that the rash wasonly the patient's face and not the injection site any other part her body. The patient was instructed take diphenhydramine hydrochloride(BENADRYL). 17-AUG-2006, the morning, the patient was instructed take diphenhydramine hydrochloride (BENADRYL). 17-AUG-2006, the morning, the patient called her physician's office and reported that "it was responding diphenhydramine hydrochloride (BENADRYL) but had not fullyrecovered". The patient was scheduled seen her physician 17-AUG-2006. Additional information has been requested. 
Other Meds: 	NONE 
Lab Data: 	NONE 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263213-1  
Age Gender Type 14.0 VAX Detail: HPV4  17-Aug-2006 Vaccine Date 17-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0702F  26-Sep-2006 Status Date Doses Site nknown State  WAES0608USA04330 Mfr Report Route Intramuscular  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Loss consciousness 

Symptom Text: 	Information has been received from physician concerning year old female with pertinent medial history drug reactions/allergies, who 17-AUG2006 was vaccinated intramuscularly with HPV rLI VLP vaccine (yeast) (lot#653650/0702F). There was concomitant medication. 17-AUG2006, minutes after receiving the vaccination, the patient "passed out" the car her way home. The patient was driven back the physician's office,where she "woke and was given soda and cold compresses". There was reactions the injection site and the patient had additional reactions.Additional information has been requested. 
Other Meds: 	NONE 
Lab Data: 	NONE 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263214-1  
Age Gender Type 18.0 VAX Detail: HPV4  16-Aug-2006 Vaccine Date 16-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date NULL  26-Sep-2006 Status Date Doses Site nknown State  WAES0608USA04456 Mfr Report Route Intramuscular  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain 

Symptom Text: 	Information has been received from registered nurse concerning year old female who 16-AUG-2006 was vaccinated intramuscularly the deltoidwith HPV rLi VLP vaccine (yeast) (0.5 ml). The patient subsequently experienced severe injection site pain. was reported that the patientremarked that the injection really hurt and that the pain flew down her arm. The patient rubbed her arm for few minutes after receiving the injection. The patient subsequently went home and the nurse had not heard back from the patient. The patient was followed her physician's office. The nurse also reported that she had not agitated the syringe prior injection. the time this report, the outcome the event was unknown. Additional information has been requested. 
Other Meds: 	Unknown 
Lab Data: 	Unknown 
History: 	Unknown 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263215-1  
Age Gender Type 18.0 VAX Detail: HPV4  10-Aug-2006 Vaccine Date 10-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0702F  26-Sep-2006 Status Date Doses Site nknown State  WAES0608USA04457 Mfr Report Route Intramuscular  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Vomiting 

Symptom Text: 	Information has been received from physician concerning year old female with pertinent medical history drug reactions/allergies, who 10-AUG2006 was vaccinated intramuscularly with HPV rLi VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). Concomitant therapy included ethinylestradiol/norgestimate (TRINESSA). 10-AUG-2006 the patient experienced multiple episodes vomiting. Unspecified medical attention was sought.Subsequently, the patient recovered from the vomiting within hours. Additional information has been requested. 
Other Meds: TRINESSA Lab Data: NONE History: NONE Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263216-1  
Age Gender Type 15.0 VAX Detail: HPV4  17-Aug-2006 Vaccine Date 17-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0702F  26-Sep-2006 Status Date Doses Site nknown State  WAES0608USA04465 Mfr Report Route Intramuscular  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Nausea 

Symptom Text: 	Information has been received from physician concerning year old female with pertinent medical history drug reactions/allergies, who 17-AUG2006 was vaccinated intramuscularly with HPV rLi VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There was concomitant medication. 17aug-2006 the patient experienced nausea. Unspecified medical attention was sought. the time this report, the patient's nausea persisted. Additional information has been requested. 
Other Meds: NONE Lab Data: NONE History: NONE Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263217-1  
Age Gender Type 18.0 VAX Detail: HPV4  18-Aug-2006 Vaccine Date 18-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0702F  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA04485 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain, Syncope 

Symptom Text: 	Information has been received from nurse concerning year old female with known allergies and other pertinent medical history reported. 18AUG-2006, the patient was vaccinated intramuscularly the deltoid with 0.5 "single dose prefilled syringe" HPV rLi VLP vaccine (yeast)(Lot#653650/0702F). There were concomitant medication reported. 18-AUG-2006, the patient developed severe injection site pain with HPV rLi 1618 VLP vaccine (yeast) injection. The patient remarked that "it hurt and felt that the injection went her head". The nurse reported that the patient felt faintimmediately after the vaccination. The nurse had the patient lay down. was reported that the patient "got after minute and said that she was ok.". Thenurse reported that the "patient left the office immediately after this and the nurse was following with the patient later today make sure that the patient wasok." The nurse reported that she had not agitated the syringe prior injection. The patient sought unspecified medical attention. There were laboratorydiagnostic studies performed. 18-AUG-2006, the patient recovered from the events. Additional information has been requested. 
Other Meds: 	NONE 
Lab Data: 	NONE 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263218-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Site nknown State  WAES0608USA04520 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site reaction 

Symptom Text: 	Information has been received from physician concerning female (age not reported) who unspecified date was vaccinated intramuscularly with thefirst dose 0.5 HPV rLi VLP vaccine (yeast). unspecified date, the patient developed "burning the injection site". was reportedthat the event improved after medical attention. was reported that the event improved after "stopping therapy". the time this report, the outcome theevent was unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263219-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Site nknown State  WAES0608USA05355 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Influenza like illness 

Symptom Text: 	Information has been received from physician concerning female (age not reported) who unspecified date, was vaccinated intramuscularly with thefirst dose 0.5 HPV rLi VLP vaccine (yeast). The day after receiving HPV rLi VLP vaccine (yeast), the patient developed "flu-likesymptoms" (date unknown). The patient sought unspecified medical attention. the time this report, the patient had recovered from the event (dateunknown). Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263220-1  
Age Gender Type 22.0 VAX Detail: HPV4  21-Aug-2006 Vaccine Date 21-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA05414 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Loss consciousness 

Symptom Text: 	Information has been received from year old female with allergy meperidine hydrochloride (DEMEROL) who 21-AUG-2006 was vaccinated withHPV rLi VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). 21-AUG-2006, following thevaccination, the patient fainted. Unspecified medical attention was sought. the time this report, the patient was recovering. Additional information has been requested. 
Other Meds: ORTHO TRI CYCLEN Lab Data: NONE History: CONCURRENT CONDITIONS: drug hypersensitivity Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263221-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Site nknown State  WAES0609USA00390 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site vesicles 

Symptom Text: 	Information has been received from registered nurse concerning female patient who 2006 was vaccinated with her first dose HPV rLi VLPvaccine (yeast). Subsequently, she was vaccinated with her second dose HPV rLi VLP vaccine (yeast). Subsequently, she developed blister atthe injection site. Medical attention was sought. The patient's outcome was unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263222-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Site nknown State  WAES0609USA00391 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site vesicles 

Symptom Text: 	Information has been received from registered nurse concerning female patient who 2006 was vaccinated with her first dose HPV rLi VLPvaccine (yeast). Subsequently, she was vaccinated with her second dose HPV rLi VLP vaccine (yeast). Subsequently, she developed blister atthe injection site. Medical attention was sought. The patient's outcome was unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263223-1  
Age Gender Type Unknown VAX Detail: HPV4  08-Aug-2006 Vaccine Date 11-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown  -State  WAES0609USA01112 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: Information has been received from nurse concerning two female patients who approximately 08-AUG-2006 were vaccinated with HPV rLi VLPvaccine (yeast). Other Meds: Unknown Lab Data: History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263224-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown  -State  WAES0608USA05808 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Injection site pain 

Symptom Text: 	Information has been received from licensed practical nurse concerning female college students 9exact number patients unspecified) who were vaccinatedintramuscularly with HPV rLi VLP vaccine (yeast). Subsequently the patients experienced injection site (deltoid) pain. the time this report, theoutcome the event was unknown. Further attempts are being made identify the exact number patients and identifiers the patients involved this report. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263225-1  
Age Gender Type 15.0 VAX Detail: HPV4  19-Jul-2006 Vaccine Date 19-Jul-2006 Onset Date Days Manufacturer MERCK CO. INC.  Lot Prev Doses 19-Sep-2006 Received Date 0637F  21-Sep-2006 Status Date Site nknown State  WAES0608USA06029 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Erythema, Erythema, Injection site pain, Pain 

Symptom Text: 	Information has been receiving from registered nurse concerning year old female with medical history who 19-JUL-2006 was vaccinated theright deltoid with the first dose HPV rLi VLP vaccine (yeast) (lot#653937/0637F). Subsequently, approximately 19-JUL-2006, the patientexperienced burning the injection site that lasted approximately seconds and her arm became red and painful enough cause the patient cry.The patient subsequently recovered from the pain the extremity, erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient's sister experienced pain the extremity, erythema, and injection site irritation following vaccination with HPV rLi6 VLP vaccine (yeast) (LOT#653937/0637F). 
Other Meds: 	Unknown 
Lab Data: 	Unknown 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
FDA Freedom Information Distribution  
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263226-1  
Age Gender Type 24.0 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA06089 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Arthralgia, Pyrexia 

Symptom Text: 	Information has been received from physician concerning year old female patient who approximately August 2006, was vaccinated with dose HPVrLi VLP vaccine (yeast). Subsequently, the patient experienced pain joints and developed low grade fever. Unspecified medical attention wassought. The patient's outcome was unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263227-1  
Age Gender Type 20.0 VAX Detail: HPV4  07-Aug-2006 Vaccine Date 07-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0702F  21-Sep-2006 Status Date Site nknown State  WAES0608USA06260 Mfr Report Route Intramuscular  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: SIT, NOT SERIOUS  
MedDRA  Pain 

Symptom Text: 	Information has been received from year old female patient who 07-AUG-2006 was vaccinated intramuscularly with her first dose HPV rLi 18VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The patient stated that "right after getting theshot" she experienced pain the upper arm and off throughout the day. She also stated that the pain"feels like she has knife her arm". Unspecifiedmedical attention was sought. The patient was treated with Ibuprofen. the report date, she was recovering. Additional information has been requested. 
Other Meds: YAZ Lab Data: NONE History: NONE Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263228-1  
Age Gender Type 27.0 VAX Detail: HPV4  25-Aug-2006 Vaccine Date 25-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0702F  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA06297 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Skin burning sensation 

Symptom Text: 	Information has been received from nurse practitioner concerning year old female who 25-AUG-2006 was vaccinated with dose HPV rLi 1618 VLP vaccine (yeast), lot#653650/0702F. During the administration the vaccine, part the fluid went into the patient's arm, the patient's arm, the patientpulled away and the remainder went the skin (no adverse reaction noted). The patient complained burning during administration. Medical attention was sought. The patient received repeat dose with burning noted. Patient's status was reported recovered. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263229-1  
Age Gender Type 17.0 VAX Detail: HPV4  19-Jul-2006 Vaccine Date 19-Jul-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0637F  21-Sep-2006 Status Date Site nknown State  WAES0608USA06310 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Erythema, Erythema, Pain 

Symptom Text: 	Information has been received from registered nurse concerning year old female with medical history who 19-JUL-2006 was vaccinated theright deltoid with the first dose HPV rLi VLP vaccine (yeast) (lot#653937/0637F). Subsequently approximately site that lasted approximately60 seconds and her arm became red and painful enough cause the patient cry. The patient subsequently recovered from the pain the extremity,erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient's sister experienced painin the extremity, erythema,and injection site irritation following vaccination with HPV rLi VLP vaccine (yeast) (lot#653937/0637F). 
Other Meds: 	Unknown 
Lab Data: 	Unknown 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263230-1  
Age Gender Type 19.0 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA06470 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Arthralgia, Pyrexia 

Symptom Text: 	Information has been received from physician concerning year old female patient who approximately August 2006, was vaccinated with dose HPVrLi VLP vaccine (yeast). Subsequently,the patient experienced pain joints and developed low grade fever. Unspecified medical attention wassought. The patient's outcome was unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263231-1  
Age Gender Type 18.0 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  21-Sep-2006 Status Date Doses Site nknown State  WAES0608USA06471 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Arthralgia, Pyrexia 

Symptom Text: 	Information has been received from physician concerning year old male patient who approximately August 2006, was vaccinated with dose HPV rLi VLP vaccine (yeast). Subsequently, the patient experienced pain joints and developed low grade fever. Unspecified medical attention wassought. The patient's outcome was unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263232-1  
Age Gender Type 26.0 VAX Detail: HPV4  21-Aug-2006 Vaccine Date 21-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date 0702F  21-Sep-2006 Status Date Site nknown State  WAES0608USA06478 Mfr Report Route Unknown  21-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: 	Information has been received from other health professional concerning year old female sales with pre-existing allergies, birth defects medicalconditions reported. 21-AUG-2006, the pm, the patient was vaccinated the left deltoid with the first dose HPV rLi VLP vaccine (yeast)(lot#653650/0702F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). There were illness noted the time vaccination. 21-AUG-2006, the pm, the patient experienced unspecified adverse event. The patient went the emergency room and was reportedthat she "went home that day". 21-AUG-2006, the patient underwent complete blood count (CBC), comprehensive metabolic panel, estimated glomerularfiltration rate (GFR), urine microscopic analysis, urinalysis and electrocardiogram (EKG). 21-AUG-2006, the patient's laboratory data revealed anabsolute neutrophil count noted 7.9 K/ul, urine ketones noted >-80, urine white blood cell count noted 30-40/hpf and urine bacteria noted 4+. 21-AUG-2006, the patient recovered from the events. Additional information has been requested. 
Other Meds: 	ORTHO TRI CYCLEN 
Lab Data: 	diagnostic laboratory 08/21/2006 "comprehensive metabolic panel tests", electrocardiogram 08/21/06, absolute neutrophil 08/21/06 7.9 K/ul 2.0-609, total urineketones 08/21/06 >-80 negative, urine bacteria screen 08/21/2006 4+, urine WBC
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263233-1  
Age Gender Type 26.0 VAX Detail: HPV4  07-Aug-2006 Vaccine Date 07-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date 0696F  22-Sep-2006 Status Date Doses Site nknown  -State  WAES0608USA06605 Mfr Report Route Intramuscular  22-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Unevaluable event 

Symptom Text: 	Information has been received from year old female licensed practical nurse with pertinent medical history and known allergies adverse drugreactions reported who 07-AUG-2006 was vaccinated intramuscularly with 0.5 dose HPV rLi VLP vaccine (yeast) (Lot#653650/0696F).There were concomitant medications reported. The licensed practical nurse reported that she received HPV rLi VLP vaccine (yeast) herdeltoid from pre-filled syringe. was reported that when the injection was completed, the nurse administering "let the plunger before taking out ofher arm" and the "spring shot the syringe out the arm like dart". was reported that "some fluid leaked out her arm". The licensed practical nursereported that "stung little when the vaccine was administered" and then resolved few moments. The area the spill was cleansed with alcohol. The patient sought unspecified medical attention. There were laboratory diagnostic studies performed. the time this report, the patient had recovered fromthe events. Additional information has been requested. 
Other Meds: 	NONE 
Lab Data: 	NONE 
History: 	NONE 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263234-1  
Age Gender Type 15.0 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  22-Sep-2006 Status Date Site nknown State  WAES0608USA06614 Mfr Report Route Intramuscular  22-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Syncope 

Symptom Text: 	Information has been received from physician concerning year old female who unspecified date was vaccinated intramuscularly with the first doseof 0.5 HPV rLi VLP vaccine (yeast). The patient "fainted after receiving HPV rLi VLP vaccine (yeast)". The patient "fainted afterreceiving HPV rLi VLP vaccine (yeast). was reported that the patient had not eaten anything. The patient sought unspecified medical attention.At the time this report, the patient was recovering from the event. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263235-1  
Age Gender Type 23.0 VAX Detail: HPV4  24-Aug-2006 Vaccine Date 29-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev19-Sep-2006 Received Date NULL  22-Sep-2006 Status Date Doses Site nknown State  WAES0608USA06869 Mfr Report Route Intramuscular  22-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: ONDITIONS, NOT SERIOUS  
MedDRA  Rash 

Symptom Text: 	Information has been received from physician concerning year old female who approximately 24-AUG-2006 was vaccinated with HPV rLi 18VLP vaccine (yeast). approximately 29-AUG-2006 (about days after vaccination) the patient developed rash (site rash unspecified0. Unspecifiedmedical attention was sought. the time this report, the outcome the event was unknown. Additional information has been requested. 
Other Meds: Unknown 
Lab Data: 
History: Unknown 
Prex Illness: 
Prex Vax Illns: 

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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263236-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  22-Sep-2006 Status Date Site nknown State  WAES0608USA06941 Mfr Report Route Intramuscular  22-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site vesicles 

Symptom Text: 	Information has been received from registered nurse concerning female patient who 2006 was vaccinated with her first dose HPV rLi VLPvaccine (yeast). Subsequently, she was vaccinated with her second dose HPV rLi VLP vaccine (yeast). Subsequently, she developed blister atthe injection site. Medical attention was sought. The patient's outcome was unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263237-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  22-Sep-2006 Status Date Doses Site nknown State  WAES0608USA07071 Mfr Report Route Unknown  22-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Injection site reaction 

Symptom Text: Information has been received from nurse practitioner concerning unspecified number patient's who were vaccinated with HPV rLi VLPvaccine (yeast) and complained burning during administration. The patient's outcomes were not reported. Additional information has been requested. Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263238-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  26-Sep-2006 Status Date Doses Site nknown State  WAES0609USA00001 Mfr Report Route Unknown  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Syncope 

Symptom Text: 	Information has been received from physician concerning three patients (age and gender not reported) who unspecified date, the morning, werevaccinated with HPV rLi VLP vaccine (yeast). Subsequently, the patients fainted after receiving HPV rLi VLP vaccine (yeast) (dateunknown). was reported that the patients had not eaten anything. the time this report, the outcome the events were unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263239-1  
Age Gender Type Unknown VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  26-Sep-2006 Status Date Doses Site nknown State  WAES0609USA00041 Mfr Report Route Unknown  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain 

Symptom Text: 	Information has been received from registered nurse concerning patients 9age and gender not reported) who unspecified date were vaccinated withHPV rLi VLP vaccine (yeast). Subsequently the patients developed injection site pain (date unknown). The patients sought unspecified medicalattention. the time this report, the outcome the events were unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263240-1  
Age Gender Type 26.0 VAX Detail: HPV4  30-Aug-2006 Vaccine Date 30-Aug-2006 Onset Date Manufacturer MERCK CO. INC. Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  26-Sep-2006 Status Date Site nknown State  WAES0609USA00066 Mfr Report Route Intramuscular  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Dizziness, Loss consciousness 

Symptom Text: Information has been received from physician concerning year old female who 30-AUG-2006 was vaccinated intramuscularly her right arm with
0.5 dose HPV rLi VLP vaccine (yeast). Concomitant therapy included ketorolac tromethamine (TORADOL). 30-aUG-2006, the patient felt"dizzy" after the injection. The patient was then given ketorolac tromethamine (TORADOL) injection and she "passed out" after receiving that injection (alsoreported "dizziness followed syncope"). was reported that the patient was seeing the physician her pain shot. The syncope occurred after her paininjection. The physician believed this was vaso vagal response. was reported that "it was not known the patient was that she was scheduled receive".The patient sought unspecified medical attention. was reported that "she did not her second shot yet". 30-AUG-2006, few minutes after", the patientrecovered from the events. Additional information has been requested. 
Other Meds: TORADOL Lab Data: Unknown 
History: Unknown 
Prex Illness: 
Prex Vax Illns: 
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Vax Name: HPV (GARDASI  All comb.  w/AND  

Vaers Id:  263241-1  
Age Gender Type 20.0 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev Doses 19-Sep-2006 Received Date NULL  26-Sep-2006 Status Date Site nknown State  WAES0609USA00077 Mfr Report Route Unknown  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: VISIT, NOT SERIOUS  
MedDRA  Injection site pain, Injection site swelling 

Symptom Text: 	Information has been received from physician concerning female patient her early 20's who was vaccinated with her first dose HPV rLi VLPvaccine (yeast). Subsequently, the patient experienced high amount pain and swelling the injection site. Medical attention was sought. Subsequently,the patient recovered. Additional information has been requested. 
Other Meds: Lab Data: NONE History: NONE Prex Illness: Unknown Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263242-1  
Age Gender Type 23.0 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  26-Sep-2006 Status Date Doses Site nknown State  WAES0609USA00264 Mfr Report Route Unknown  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Dizziness, Pallor 

Symptom Text: 	Information has been received from physician concerning year old female. was reported that was "not known the patient was pregnant, she wastaking any other medications had history drug reactions allergies." unspecified date, the patient was vaccinated with HPV rLi VLPvaccine (yeast). was reported that the patient felt "light headed and dizzy" after receiving HPV rLi VLP vaccine (yeast). The patient also "turnedvery pale", but did not faint. the time this report, the outcome the events were unknown. Additional information has been requested. 
Other Meds: Unknown Lab Data: Unknown History: Unknown Prex Illness: Prex Vax Illns: 
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Vax Name: HPV (GARDASIL)  All comb.  w/AND  

Vaers Id:  263243-1  
Age Gender Type 20.0 VAX Detail: HPV4  Unknown Vaccine Date Unknown Onset Date Manufacturer MERCK CO. INC.  Days  Lot Prev19-Sep-2006 Received Date NULL  26-Sep-2006 Status Date Doses Site nknown State  WAES0609USA00265 Mfr Report Route Unknown  26-Sep-2006 Last Edit Date Other Vaccine  
Seriousness: CONDITIONS, NOT SERIOUS  
MedDRA  Syncope 

Symptom Text: 	Information has been received from nurse physician's office concerning female patient "in her 20's" who unspecified date was vaccinated withHPV rLi VLP vaccine (yeast). was reported that the patient "fainted" after being given HPV rLi VLP vaccine (yeast) (date unknown). the time this report, the outcome