chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Computerised tomogram, Headache, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a mother concerning her 12 year old daughter who sometime in October 2007, was vaccinated with the first dose, in DEC 2007 with her second dose of Gardasil (lot numbers not provided). In October 2007, the patient experienced terrible consistent headaches. The headaches went away for a while but came back after she had the second dose in December 2007. The patient states the headaches have remained constant and she said on a scale of 1-10 they remain a 7 and they last all day and all night. Patient has missed 2 weeks of school because of it. The patient's mother states that her daughter has been to the physician 13 times regarding her daughter's headaches. Patient has been to several neurologists and they could not find anything wrong. Patient has been give Tylenol with codeine, Aleve, hydrocodone, Motrin, Advil and Immatrex (manufacturers unknown) and this past week she was given Depakote intravenously. Patient's mother states that none of the medications have helped but have only made her feel worse. The patient's terrible consistent headaches persisted. No further information is available. 07/08/08 Follow up was received on 31-MAR-2008. There was not further AE information and the practice does not want to receive any further letters.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 31-JUL-2007 was vaccinated with GARDASIL (lot number: 656371/0181U).  On 31-JUL-2007 the patient experienced syncope.  Subsequently, the patient recovered from syncope.  No further information is available.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hypomenorrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number: 657617/0384U), on 20-SEP-2007 with the second dose (lot number: 658282/0929U) and 20-JAN-2008 with the third dose of Gardasil (lot number not provided). Concomitant therapy included VAQTA. It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day." It was also reported that this "also occurred after she had received her second dose of Gardasil, with her period only lasting a day." The patient's mother was reluctant and didn't schedule her for her third dose. The patient recovered. On an unspecified date the patient received her third dose. No further information is available. This is in follow up to report(s) previously submitted on 3/14/2008.  Informatino has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number:  657617/0384U), on 20-SEP-2007 with the second dose:  lot number:  658282/0829U) and 20-JAN-2008 with the third dose of GARDASIL (lot number:  058563/1063U).  Concomitant therapy included VAQTA.  It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day."  It was also reported that this "also occurred after she had received her second dose of GARDASIL, with her period only lasting a day."  The patient's mother was reluctant and didn't schedule her for her third dose.  The patient recovered.  On an unspecified date the patient received her third dose.  Follow-up information was received on 19-Mar-2008 the mom reports that child began first period after dose of 1 of GARDASIL for 1-2 days.  Then the second cycle for 1-2 days after 2nd dose of GARDASIL.  Mom held off for one month for dose 3 and child had third cycle at time that the third dose was to be received.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 25-JAN-2008 was vaccinated with GARDASIL (lot number: 656371/0181U).  On 31-JAN-2008 the patient experienced rash all over body, including back, chest, and legs.  The patient was treated by physician with Benadryl.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Influenza like illness, Pain in extremity
Clinical narrative: Information has been received from a representative concerning a 17 year old female who on 22-JAN-2008 was vaccinated with GARDASIL (lot# not reported).  On 23-JAN-2008 the patient experienced severe pains up her back and down her legs that lasted for two days.  She also had flu-like symptoms but no fever, congestion, or nausea.  Subsequently, the patient recovered from severe pains and flu-like symptoms.  No further information was provided.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 27 year old female who on 12-JUN-2007 was vaccinated intramuscularly with her first dose of Gardasil. On 13-AUG-2007 the patient was vaccinated intramuscularly with her second dose of Gardasil. On 12-DEC-2007 the patient was vaccinated intramuscularly with her third dose of Gardasil (lot # 659439/1267U). Concomitant therapy included albuterol (VENTILAN (albuterol)) as needed and cough, cold, and flu therapies (unspecified). On approximately 12-JAN-2008 the patient experienced a tender "knot" at the injection site. The patient's tender "knot" at the injection site persisted. The patient saw her primary physician and he will be ordering unspecified tests. No other details. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with a history of acne who on 30-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot # not reported). Concomitant therapy included DENTOMYCIN and vitamins (unspecified). On 31-OCT-2007 the patient experienced a syncopal episode. Patient passed out and regained consciousness almost immediately. Subsequently, the patient recovered from syncopal episode on the same day. On 02-JAN-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported) with no adverse reaction noted. The patient sought medical attention in the office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemoglobin decreased, Placental disorder, Ultrasound abdomen
Clinical narrative: Information has been received from a 19 year old black female, with no drug allergies, a medical history of an abnormal pap smear, a colposcopy in 2007, one pregnancy, and an elective termination of a subsequent pregnancy in 2002 (LMP was 16 weeks), and a family history of heart disease, hypertension and diabetes.  The patient was vaccinated with her second dose of 0.5 ml of GARDASIL intramuscularly on an unspecified date.  Concomitant therapy during the pregnancy included ferrous sulfate (FeSO4) and prenatal vitamins.  The patient became pregnant sometime after receiving her second dose of GARDASIL.  The patient did not seek medical attention.  No adverse event was reported.  Follow up information has been received from a certified nurse midwife.  The patient sought medical attention and on the 20th of an unspecified month and 18-DEC-2007 ultrasounds were performed which revealed complete previa.  Additional information was not readable.  The comment was that previa was cleared.  Other diagnostic laboratory tests included haemoglobin at 9.5.  The patient was started on ferrous sulfate (FeSO4).  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 19 year old female who on 01-FEB-2008 was IM vaccinated with her first dose of GARDASIL (Lot # 659439/1267U). On 01-FEB-2008 the patient experienced syncope. The patient sought unspecified medical treatment. Subsequently, the patient recovered from syncope. Additional information has been requested. 02/12/2010 Follow up information obtained on 03-Apr-2008 indicated the nurse does not have any additional information. The nurse does not plan to follow up letter to her.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a female who was vaccinated with her second dose of GARDASIL 0.5 ml (therapy route not reported).  Subsequently the patient experienced syncope.  No other information was reported.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a certified medical assistant concerning a female, approximately 12 years old, who was vaccinated with Gardasil. Subsequently, the patient experienced a delayed period of one month. The patient's menstrual cycle returned to normal on it's own and the patient was reported to be recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient between 13-16 years old, who was vaccinated with GARDASIL.  The certified medical assistant reported the patient wanted to receive her GARDASIL vaccine while standing up had passed out almost immediately after the vaccine was administered.  Subsequently, the patient recovered and was fine before leaving the office.  No further information is available.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Inappropriate schedule of drug administration, Laboratory test normal, Muscular weakness
Clinical narrative: Information has been received from a nurse concerning a 33 year old female who on 28-NOV-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot#658560/1062U). On 30-JAN-2008 the patient was vaccinated intramuscularly with her second dose of Gardasil (lot# 659653/1448U). On 01-FEB-2007 the patient had complete muscle weakness and was seen in by the doctor. No treatment was ordered. The patient was also on an antibiotic for a sinus infection. The nurse spoke with the patient on 04-FEB-2007 and she cannot write, hold a glass or pick up her 18 month old child. She will be seen on 05-FEB-2008 by her primary care physician. The patient had unnamed blood tests that were negative. Additional information has been requested. 6/3/08-office notes received for DOS 11/28/07-C/O upper respiratory like infections ever since she stopped nursing at end of July, just kind of ongoing problems, fatigue. Husband had Guillain Barre syndrome.  01/31/08-body aches all over, muscle weakness, C/O sinus infection.  Gardasil administered on 1/30/08- 6/20/08-records received-12/7/07-C/O stomach issues,  symptoms of IBS, bloating, diarrhea, cramping, gas. 12/26/07-URI symptoms, temperature 101, sinus pain. 2/21/08-C/O myalgia, sinusitis, muscle weakness. C/O injection site soreness. Feeling weak, impression:adverse reaction vs. post viral syndrome.
Sex: F
Vaccine: HPV4
Symptoms: Renal failure
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced renal failure. The physician was in a hospital facility when a nurse approached him and stated that a family member of hers had received Gardasil and went into renal failure. No further information was provided and the physician can not be contacted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Heart rate decreased, Nausea
Clinical narrative: Information has been received from a 14 year old female who was vaccinated with all three doses of Gardasil on unspecified dates. Subsequently the patient experienced nausea, dizziness and heart rate dropped into the 20s after receiving the first vaccination. No further information was available. The patient's outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Activities of daily living impaired, Arthropathy, Asthenia, Fatigue, Injected limb mobility decreased
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in September 2007, was vaccinated with the first dose of GARDASIL (lot# reported as 02444). Concomitant therapy included MENACTRA and ADACEL. During follow-up on 22-JAN-2008, the patient has been complaining of reduced energy, not being able to participate in sports, tired type of reaction and reduced ability to use joints and arms. The intensity has increased since onset a few days after the administration of the first dose of GARDASIL. The patient has continued with the series and had doses two and three. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a health professional concerning a 24 year old white female who on 17-JUL-2007 was vaccinated with her first dose of GARDASIL (lot# 658490/0802U).  On 29-JAN-2008 the patient was vaccinated with another dose of GARDASIL (lot# 659439/1267U).  The patient reported on 29-JAN-2008 that since she began GARDASIL on 17-JUL-2007 she has had three full periods in a two month time frame.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diagnostic procedure, Fatigue, Headache, Nausea
Clinical narrative: Information has been received from a consumer concerning her daughter who had a sulfonamide allergy who on 27-DEC-2007 was vaccinated with her 1st dose, 0.5 ml of GARDASIL (lot # not provided).  Concomitant therapy included amoxicillin, lansoprazole (PREVACID) and calcium (unspecified).  Since the beginning of January 2008, the patient has been experiencing mild and severe headaches, abdominal pain, tiredness and she feels like she has to vomit everyday.  The patient's mild and severe headaches, abdominal pain, tiredness and she feels like she has to vomit everyday persisted.  The patient sought unspecified medical attention and had unspecified blood work performed.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 23 year old female with a history of asthma and cow's milk allergy who on 15-JAN-2008 was vaccinated with her 1st dose. IM with Gardasil (lot # not provided). On 15-JAN-2008 the patient developed a "fine red rash all over her face that itched within an hour post injection." Subsequently, the rash lasted for an hour and cleared on its own. The patient sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a health professional concerning a 26 year old female with a history of drug hypersensitivity who on 17-DEC-2007 was vaccinated IM with the first dose of Gardasil (0530u). Concomitant therapy included hormonal contraceptives (unspecified). On 17-DEC-2007 the patient experienced severe headache. Per the reporter, the headache continued for 21 days. TYLENOL was effective but if the patient did not take it the headache would reoccur. The patient sought unspecified medical attention. No other symptoms were noted. Subsequently, the patient recovered from the severe headache on 07-JAN-2008. No additional information is available at the this time. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Oral herpes, Paraesthesia, Pruritus
Clinical narrative: Initial information has been received from a physician and follow up information received from a health professional concerning a 17 year old female student patient with no known drug allergies, and no previous medical history, who on 31-JAN-2008 at 4:30 PM, was vaccinated IM in the left arm with the first dose of Gardasil (lot# 659439/1267U). Concomitant therapy included YASMIN. Subsequently the patient experienced headache, dizziness, pruritus, fever, fingers tingling on left hand and fever blisters on her lips and inside her mouth. Emergency room medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Initial information has been received from a physician and follow up information received from a health professional concerning a 17 year old female student patient with no known drug allergies, and no previous medical history, who on 31-JAN-2008 at 4:30 PM, was vaccinated IM in the left arm with the first dose of Gardasil (lot# 659439/1267U). Concomitant therapy included YASMIN. Subsequently the patient experienced headache, dizziness, pruritus, fever, fingers tingling on left hand and fever blisters on her lips and inside her mouth. Emergency room medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 21-JAN-2008 was vaccinated with her third dose of GARDASIL.  About two hours after receiving the vaccine, on 21-JAN-2008, the patient developed itching, an then not too much later, the patient experienced welts.  The patient took Benadryl and developed hives.  The patient was given epi pens and steroids and was sent to her OB/GYN's office who had given her Zyrtec, but the patient's problems persisted.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who was vaccinated with a dose of GARDASIL.  Subsequently the patient fainted.  It was also reported that the patient did not feel right after the vaccination.  It was reported that before the vaccination the patient had hardly eaten anything and had played basketball for an hour.  No medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a physician's assistant concerning a 14 year old white female patient who on 29-Aug-2007, was vaccinated IM with the dose of GARDASIL (lot# 658490/0802U). On 29-Oct-2007 the patient was vaccinated IM with the second dose (lot# 659435/1266U). Subsequently the patient fainted. It was also reported that the patient did not feel right after the vaccination. It was reported that before the vaccination the patient had hardly eaten anything and had played basketball for an hour. No medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Follow up information indicated that the patient  had her first menstral period after her first vaccination with GARDASIL and second menstral period after second vaccination with GARDASIL. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 17 year old female with a history of asthma and drug hypersensitivity to Keflex who on 13-NOV-2007, originally reported as 20-Nov-2007, was intramuscularly vaccinated with Gardasil (lot # 657737/0522U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 14-Nov-2007, originally reported as 21-NOV-2007, the patient experienced dizziness, nausea, vomiting and tenderness at injection site.  Subsequently, the patient recovered from dizziness, nausea, vomiting and tenderness at injection site on 14-Nov-2007, originally reported as 22-Nov-2007.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus test positive, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who tested positive for infectious mononucleosis who was intramuscularly vaccinated with the first dose of Gardasil.  Subsequently the patient experienced hives.  The patient sought unspecified medical treatment.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a physician concerning an unknown number of patients who were vaccinated with GARDASIL and complained of pain and burning when the vaccine is being injected.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who on 19-NOV-2007 was vaccinated with her first dose of GARDASIL.  On 28-JAN-2008 the patient received her second dose of 0.5 ml of GARDASIL (Lot #659653/1448U).  Concomitant therapy included ethinyl estradiol (+) levonorgestrel (ALESSE).  On 02-FEB-2008 the patient developed hives.  The patient's outcome was not reported.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 05-DEC-2007 was vaccinated with her first dose of Gardasil (lot 0530U).  She did not experience any difficulties at that time.  She received her second dose on 05-FEB-2008. There was no concomitant medication.  On 06-FEB-2008 the patient woke up with a sore throat, aching body and a generalized body soreness, like she was lifting weights.  She did not have a fever.  Additional information has been requested. 07/08/08 Follow up information from the nurse indicated that "we are not sure if (she) had a reaction to GARDASIL". She stated that the following morning (06-FEB-2008), the patient's mother called and reported that her daughter "was doing fine". The nurse added that it "sounds like a flu bug". Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Rash pruritic, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 10 year old female who in November 2007, was vaccinated with GARDASIL (lot 658219/0755U).  There was no adverse reaction.  She received her second dose on 20-JAN-2008.  On 24-JAN-2008 she developed an itchy rash with lesions on her trunk which then spread to her extremities.  She was treated with diphenhydramine (BENADRYL).  On 28-JAN-2008 the patient recovered from itchy rash and lesions.  The physician reported she was unsure if it was related to GARDASIL vaccine or if it may be chicken pox despite being vaccinated as a young child.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hot flush, Syncope, Visual disturbance
Clinical narrative: Information has been received from a health professional who states that some clients had experienced adverse events post vaccination with Gardasil.  The events included fainting, dizziness, visual changes and hot flashes.  The number of patients involved was unknown and the reporter thinks that the clients have recovered.  The reporter states that she made this call for the doctor and has no other information on the clients.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Papilloma viral infection, Skin papilloma
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who on 10-JUL-2007 was vaccinated intramuscularly with her first dose of Gardasil (Lot # 653735/0688F).  On an unspecified date, the patient developed a wart on her upper lip.  On an unspecified date, the patient was vaccinated with her second dose of Gardasil.  Subsequently, a biopsy was performed on the wart which determined it was an HPV wart.  The patient had the wart removed.  No further information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who was vaccinated intramuscularly with the second dose of Gardasil (date unspecified).  Per the reporter the patient's period started early and she experienced very bad cramps.  Subsequently, the patient recovered from her period starting early and very bad cramps.  No further information is available.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a company representative concerning a female who on 04-FEB-2008 was vaccinated with the first dose of Gardasil.  On 04-FEB-2008 the patient experienced injection site swelling and injection site redness.  The patient's injection site swelling and injection site redness persisted.  The patient sought unspecified medical attention.  This is a hearsay report in the absence of an identifiable patient.  Attempts are being made to verify the existence of a patient.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Electrocardiogram normal, Muscle strain
Clinical narrative: Information has been received from a physician concerning a 19 year old female with attention deficit/hyperactivity disorder who on 21-JAN-2008 was vaccinated with her third dose of GARDASIL.  The patient experienced transient abdominal discomfort with a prior dose of GARDASIL.  On 26-JAN-2008 the patient was seen for complaints of a sore throat and felt to have neck muscle strain accounting for her pain.  On 29-JAN-2008 the patient was seen again for chest pain and light headedness.  An electrocardiogram (EKG) was normal.  Pain seemed to be musculoskeletal in nature (costochondritis).  Anti-inflammatory agents were prescribed, which the patient did not take, but instead went to the emergency room for narcotic analgesics.  The physician does not feel that these complaints are related to GARDASIL, but rather to heavy lifting (patient works in a nursing home).  The patients outcome is unknown.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 19 year old female with attention deficit/hyperactivity disorder who on 21-JAN-2008 was vaccinated with her third dose of GARDASIL.  The patient experienced transient abdominal discomfort with a prior dose of GARDASIL.  On 26-JAN-2008 the patient was seen for complaints of a sore throat and felt to have neck muscle strain accounting for her pain.  On 29-JAN-2008 the patient was seen again for chest pain and light headedness.  An electrocardiogram (EKG) was normal.  Pain seemed to be musculoskeletal in nature (costochondritis).  Anti-inflammatory agents were prescribed, which the patient did not take, but instead went to the emergency room for narcotic analgesics.  The physician does not feel that these complaints are related to GARDASIL, but rather to heavy lifting (patient works in a nursing home).  The patients outcome is unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Eosinophilic fasciitis
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who, on an unspecified date was vaccinated with Gardasil (Lot # not provided).  Subsequently the patient developed eosinophilic fascitis.  The reporting physician was not the treating physician.  The reporter received the information through a phone call from a pediatrician.  No specified information regarding the patient was given.  No further information was provided.  Additional information has been requested. Follow-up received 4/16/2008. No further information was provided due to confidentiality concerns, as the parents of the patient were pursuing litigation against the pediatrician. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: Information has been received from a female consumer who in July 2007, was vaccinated intramuscularly with the first dose of Gardasil.  Per the patient, she has been diagnosed with an ovarian cyst since receiving the Gardasil.  The patient had no physician information and requested prescribing information.  The patient sought unspecified medical attention.  No further information is available.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Wrong drug administered
Clinical narrative: Information has been received from the husband of a 33 year old female who on 08-FEB-2008 was inadvertently vaccinated with GARDASIL instead of the influenza virus vaccine (unspecified).  The reporter stated that the patient was in her second trimester of pregnancy.  The patient sought unspecified medical attention.  No additional information was provided.
Sex: F
Vaccine: HPV4
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female, with no history of allergies, who was vaccinated with Gardasil.  Subsequently the patient experienced coughing, sore throat and fever.  No additional information was provided.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a licensed practical nurse concerning a 21 year old female with no pertinent medical history or drug reactions/allergies who on 02-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the left arm.  The patient did not experience any problems after the first dose.  There was no concomitant medication.  On 04-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the right arm.  On 18-JAN-2008 the patient experienced an outbreak of venereal warts.  Medical attention was sought.  The patient used (imiquimod) ALDARA cream which cleared up the venereal warts.  On 07-FEB-2008 the patient recovered from venereal warts.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008. Initial and follow-up information has been received from a licensed practical nurse concerning a 21 year old white female with no pertinent medical history or drug reactions/allergies who on 02-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the left deltoid. The patient did not experience any problems after the first dose. There was no concomitant medication. On 04-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (lot# 659435/1265U) 0.5 mL IM in the right deltoid. On 18-JAN-2008 the patient experienced an outbreak of perinal warts. The patient complained of "bumps" in the vaginal area. The diagnosis was perianal warts by the physician. The patient used ALDARA cream which cleared up the perianal warts. On 07-FEB-2008 the patient recovered from perianal warts. Additional information iss not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 09-AUG-2007 was vaccinated by "injection" (originally reported as orally) with 0.5 mL of the first dose of GARDASIL (lot #658554/0928U).  On 09-AUG-2007 the patient experienced vomiting, "within five minutes of receiving her first dose".  It was also reported that the patient received her second dose of GARDASIL (lot #659653/1448U) on 04-FEB-2008 and experienced vomiting "within five minutes of receiving the dose".  The patient sought unspecified medical attention.  Additional information has been requested. 07/08/08 Information has been received from a nurse concerning a 14 year old female with an allergy to "SEPTRA"/"rash" who on 09-AUG-2007 was vaccinated intramuscularly in the right arm with a 0.5 mL first dose of GARDASIL (lot # 658554/0928U). Concomitant therapy included ADACEL (lot # reported as "C2720AA") and MENACTRA (lot # reported as "U2386BA"), both administered intramuscularly in the left arm on 09-AUG-2007. On 09-AUG-2007, after the patient was vaccinated, she "immediately" experienced "nausea and vomiting". On 04-FEB-2008 the patient was vaccinated intramuscularly in the left arm with a 0.5 mL second dose of GARDASIL (lot # 659653/1449U) and the patient "immediately (originally reported as "within 5 minutes") had nausea and vomiting again". The nausea and vomiting subsided within 15 minutes. The patient sought unspecified medical attention. No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Excessive eye blinking, Muscle twitching, Neurological examination abnormal, Nuclear magnetic resonance imaging, Tourette's disorder
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter who on 19-DEC-2007 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included pimozide (ORAP) and guanfacine HC1 (TENEX).  The consumer reported that her daughter had minor ticks in her face for about 2 years but they were controlled with the ORAP.  About a week after receiving GARDASIL, the patient started having ticks where her arms, legs and head would twitch about every 4 seconds and her eyes would blink about every 4 seconds as well.  The patient had gone to a neurologist, and had an MRI done of her brain.  The patient was diagnosed with Tourette's syndrome and was placed on TENET. Additional information has been requested.  4/1/08 Reviewed PCP medical records which reveal patient having nervous tics since approx 2003.  DX: motor tic.  Referred to neuro. 7/11/08 Case closed as incomplete.  Will reopen should neuro medical records become available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning her 18 year old daughter who was vaccinated on unspecified dates intramuscularly with 0.5 mL of Gardasil (lot numbers not reported).  It was reported that the patient experienced severe pain at the injection site during administration of all three doses of Gardasil.  The physician reported that "the pain resolved without requiring treatment and the patient completely recovered."  No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a patient's mother concerning her 12 year old daughter with a history of injection site reactions who on 29-JAN-2008 was vaccinated intramuscularly with her first dose of Gardasil.  There was no concomitant medication.  On 29-JAN-2008 the patient experienced warmth and swelling at the injection site.  The patient's warmth and swelling at the injection site persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female with attention deficit/hyperactivity disorder who on 06-FEB-2008 was vaccinated 0.5mL with her first dose of GARDASIL (lot #659655/1486U).  On 06-FEB-2008 the patient fainted 2 minutes after receiving her vaccination.  Reporter noted they were not sure if it was a seizure because they did not witness the fainting.  The patient recovered on the same day and went home.  Additional information has been requested. 07/08/08 Follow up information received 24-MAR-2008 stated after the patient received the vaccination (approximately 3:30PM) she stiffened and passed out (approximately 3:40PM). It was reported the patient was taken to an exam room and examined by physician. The patient blood pressure measurement was 94/68 lying down and 88/62 sitting up. The patient's blood glucose was 88. Subsequently, the patient recovered on the same day. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female with a history of attention deficit disorder who was vaccinated with all three doses of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently the patient experienced alot of pain at the injection site for all three doses.  The patient sought unspecified medical attention in the physician's office.  Subsequently, the patient recovered from the injection site pain.  No further information is available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female with a history of hidradenitis suppurative who on 30-MAY-2007 was vaccinated IM with the first dose of Gardasil.  Concomitant therapy included ACCUTANE and YASMIN.  On 30-MAY-2007 the patient experienced pain at the injection site.  On 31-DEC-2007 the patient was vaccinated IM with the second dose of Gardasil.  Subsequently, the patient experienced pain at the injection site and inappropriate schedule of vaccine administered.  The second vaccine was given at a clinic.  The patient sought unspecified medical attention in the physician's office and subsequently recovered from the injection site pain and inappropriate schedule of vaccine administered.  No further information is available.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with GARDASIL.  Subsequently the patient fainted about 1 week after receiving the vaccination.  Per the reporter this patient also fainted two more times in the week following her initial episode of fainting.  The patient sought unspecified medical attention in the physician's office and was referred to a cardiologist.  No other information is available at this time.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning her daughter with psoriasis who on 30-MAY-2007 was vaccinated IM with the first dose of GARDASIL.  Concomitant therapy included topical creams and lotions (unspecified).  The patient received the second dose late on 31-Dec-2007.  It was reported that the patient experienced pain at the injection site after the 1st and 2nd dose.  Medical attention was sought in the office.  The patient was recovered day after the vaccination.  No product quality complaint was involved.  This is one of the multiple reports from the same source (WAES# 0802USA01954 and 0802USA01957).  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies, who on 28-SEP-2007 was vaccinated with her 0.5 ml second dose of Gardasil (lot number: 1427F/655619) and fainted.  Concomitant therapy included ADACEL.  On unspecified date the patient recovered from fainting.  Unspecified medical attention was sought.  No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pain
Clinical narrative: Information has been received from a female concerning another female who was vaccinated with Gardasil.  The patient received two "shots" and on unknown date she experienced dizziness and pain.  The outcome of the event and action taking regarding therapy with Gardasil was not reported.  No further information was available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Reaction to previous exposure to any vaccine, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated intramuscularly with her first dose of Gardasil.  Subsequently the patient fainted after receiving the dose.  The physician mentioned that the patient faints after every shot and blood draws.  It was not mentioned whether or not the patient had received anymore doses of Gardasil.  Subsequently, the patient recovered from fainting.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Joint injury
Clinical narrative: Information has been received from a nurse concerning her 16 year old granddaughter with a dust allergy and a history of sinus infection who "sometime in 2007" received an unknown number of vaccinations of Gardasil (lot numbers not provided) when she was 15 years old.  It was reported that in the beginning in the fall of 2007 the patient experienced crying a lot and gone to a psychologist for treatment.  The patient also hurt her knee at sometime and is unable to play soccer.  The patient's crying a lot and hurt knee persisted.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female "around 20-21 years old" who was vaccinated with three doses of Gardasil (lot numbers not provided).  Subsequently the patient experienced pain at injection site and bruising at injection site.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a female who in approximately December 2007, was vaccinated with her first dose of Gardasil.  Within 20 minutes of receiving the dose, the patient experienced abdominal cramping and vomited.  Subsequently, the patient recovered from abdominal cramping and vomiting on the same day.  She sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her second dose of GARDASIL.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently the patient fainted after receiving both vaccines.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Heart rate increased, Hypotension
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with a history of methicillin-resistant staphylococcal aureus infection who on 02-FEB-2008 at 9:30 am was vaccinated IM with the first (0.5 ml) dose of GARDASIL (Lot # 657617/0384U).  Concomitant therapy included the second dose of HAVRIX.  On 02-FEB-2008 at 9:30 pm the patient experienced fainting episode.  The next several days the patient had several fainting spells, one per day.  The patient also experienced dizziness, rapid heartbeat and low blood pressure.  The patient sought medical attention in the office on 04, 05, and 07-Feb-2008.  The patient was sent to the ER on 05-FEB-2008.  The patient is being referred to an unspecified pediatric cardiologist.  The patient is getting better.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with a history of methicillin-resistant staphylococcal aureus infection who on 02-FEB-2008 at 9:30 am was vaccinated IM with the first (0.5 ml) dose of GARDASIL (Lot # 657617/0384U).  Concomitant therapy included the second dose of HAVRIX.  On 02-FEB-2008 at 9:30 pm the patient experienced fainting episode.  The next several days the patient had several fainting spells, one per day.  The patient also experienced dizziness, rapid heartbeat and low blood pressure.  The patient sought medical attention in the office on 04, 05, and 07-Feb-2008.  The patient was sent to the ER on 05-FEB-2008.  The patient is being referred to an unspecified pediatric cardiologist.  The patient is getting better.  No product quality complaint was involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a 23 year old female consumer with anxiety who on approximately 17-JUL-2007 was vaccinated with the first dose of GARDASIL.  On 24-JAN-2008 she had received her third dose of GARDASIL and that same day she also has a PAP test done.  Then on 05-FEB-2008 she found out that her PAP test came back abnormal for one of the high risk forms of HPV.  Unknown medical attention was sought.  Patient outcome is unknown.  No product quality complaint was involved.  Additional information has been requested. 07/08/08 The office does not know of the above patient. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Petechiae
Clinical narrative: Initial and follow-up information has been received from a physician concerning his 13 year old daughter who on approximately 05-FEB-2008, "two weeks ago on a Tuesday", was vaccinated intramuscularly "in the arm with her second dose" (originally reported as "first dose") of GARDASIL (lot # not reported).  Concomitant therapy included MENACTRA, "administered in the other arm at the same visit".  "On Thursday, 07-FEB-2008", originally reported as "08-FEB-2008", the patient presented to the office with petechiae around the hip and buttocks.  At the time of follow-up, 20-FEB-2008, it was reported that "the spotting was going away already".  No other symptoms such as pain were reported.  The patient was not sick at all.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Skin papilloma, Surgery
Clinical narrative: Information has been received from a physician's assistant concerning a 16 year old female who in November 2006, was vaccinated intramuscularly with GARDASIL (lot # not reported).  Concomitant therapy included tetanus toxoid and meningococcal vaccine (unspecified) given "on the same day" in November 2006.  In approximately January 2007, "two to three months later", the patient developed a wart on her forehead.  The patient sought medical attention for treatment of the wart.  The wart was surgically removed on an unspecified date.  The patient was not hospitalized for the procedure.  It was reported that the removed wart tested positive for HPV.  Therapy with human papillomavirus vaccine was discontinued.  Subsequently, on an unspecified date, the patient recovered from the wart on her forehead.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on 14-AUG-2007 was vaccinated with a first dose of GARDASIL (Lot# reported as 22U).  Within the same day the patient developed a hive on top of her hand where she received the shot.  It was unknown whether medical attention was sought.  The patient had not received subsequent doses due to the allergic reaction she had.  The patient's outcome was not reported.  Additional information has been requested.