chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac disorder
Clinical narrative: Information has been received from a consumer concerning her 14 year old female daughter who on 16-OCT-2008 was vaccinated with the first dose of GARDASIL vaccine. On 16-OCT-2008, the patient had heart problems. It is unknown if the patient sought medical attention. At the time of reporting the patient had not recovered. Therapy with human papillomavirus vaccine was discontinued. This is one of two reports from the same source. The patient's sibling experienced severe breathing problems after vaccination with GARDASIL vaccine (MSD WAES 0901USA03777). No further information is available. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on unspecified dates was vaccinated with the first dose and the second dose of GARDASIL vaccine. Concomitant therapy included hepatitis A Vaccine (inactive) (manufacturer unknown) when the patient received the first dose of GARDASIL vaccine. Subsequently, the patient developed 2 nodes on her neck and her "glands" were swollen within 24 hours after receiving the first dose of GARDASIL vaccine. Subsequently, the patient recovered. The physician also noted that the patient experienced the same symptoms after receiving the second dose of GARDASIL vaccine. The patient was seen by the physician. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased
Clinical narrative: Information has been received from a physician.  The physician reported that "she heard from a friend that the female patient, who was not the physician's patient, on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently the patient was unable to move the arm the injection was given.  The physician also reported that the patient had to go to physical therapy".  At the time of reporting, the patient's outcome is unknown.  Attempts to verify the existence of an identifiable patient (and/or reporter, as appropriate) have been unsuccessful.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Pyrexia
Clinical narrative: Information has been received from a clerk in a physician's office concerning her 19 year old daughter who in approximately June 2008 "Summer 2008", was vaccinated with first dose of GARDASIL (Lot # not reported).  Approximately 24 hours after she became lethargic and developed a fever.  The symptoms resolved after 3-4 days.  The patient has since had the second and third dose of GARDASIL (Lot # not reported) without any problems or adverse reactions.  Patient sought unspecified medical attention.  Additional information has been request.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain, Tremor
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient who on unspecified dates was vaccinated with the first and the second of GARDASIL. On 22-JAN-2009 the patient was vaccinated with 0.5 ml of the third dose of GARDASIL (Lot not reported). There was no concomitant medication. On 23-JAN-2009 the patient experienced achiness and shaky. As of 23-JAN-2009 the patient outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow up information was received from the licensed practical nurse who requested the report be disregarded since it was called in by mistake by the company representative. Additional information was received from the registered nurse who stated that she thought the patient received the vaccine at the original reporting doctor's office. The nurse stated she did not remember the patient's name or date of birth but she would be working in the other office on 11-Mar-2009 and would provide additional information if available. Further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dyspnoea, Injection site reaction, Mass, Myalgia
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified date was vaccinated with her second dose of GARDASIL (Lot not reported).  After vaccination the patient developed injection site reaction, fever, nausea, shortness of breath, muscle aches, weakness and lump in her back.  On unspecified date the patient recovered.   Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified date was vaccinated with her second dose of GARDASIL (Lot not reported).  After vaccination the patient developed injection site reaction, fever, nausea, shortness of breath, muscle aches, weakness and lump in her back.  On unspecified date the patient recovered.   Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes simplex, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a office manager concerning a 19 year old female patient with no known drug allergies/drug reactions who on 16-JAN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly.  On 12-MAR-2008 the patient received the second dose of GARDASIL (Lot # 659182/1757U).  There was no concomitant therapy.  It was reported that the patient experienced outbreak of herpes simplex type 1 on 02-JUN-2008.  It was reported that the patient was prescribed VALTREX, KEFLEX, and BACTROBAN ointment and subsequently recovered.  On 15-JUL-2008, the patient was vaccinated with the third dose of GARDASIL.  It was reported that the patient had a pa smear on 14-JAN-2009 which revealed high-risk HPV.  The patient sought medical attention with an office visit.  This is one of several cases from the same source.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning her 18 year old daughter who on 27-OCT-2006 was vaccinated with the first dose of GARDASIL vaccine (Lot#653937/0637F). Concomitant vaccination included influenza virus vaccine (unspecified). It was reported that patient experienced arm tingling 1 1/2-2 years after receiving her first dose of GARDASIL vaccine. It was reported that the patient did not receive the second or third doses. The patient had recovered on an unspecified date. The patient sought medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/11/2009. Follow up information was received on 02-FEB-2009 from a registered nurse concerning a female patient with no pertinent medical history and no known drug allergies/drug reactions who was vaccinated with the first dose of GARDASIL vaccine (Lot # 053937/0637F) on 26-OCT-2006 (previously reported as 27-Oct-2006) intramuscularly in her right arm. Concomitant vaccination included a fifth FLUZONE vaccine (previously unspecififed) (Lot # U2257AA) intramuscularly into the left arm. It was reported that on spring/summer 2007 the patient experienced arm tingling and numbness which came and went on and off over 1-2 months. The patient had been painting and excused it was related to strain and pinched nerve. It was reported that the patient was revaccinated a few months later. It was reported that the patient recovered at the end of summer 2007. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with a history of passing out every time she received an injection, who on 23-JAN-2009 was vaccination with the first dose of GARDASIL vaccine. Concomitant suspect therapy included VARIVAX vaccine (Oka/Merck) (duration and dose not reported). Other concomitant therapy included FLUMIST and HAVRIX. It was reported that the patient passed out after receiving GARDASIL vaccine. The patient passed out after receiving GARDASIL vaccine. The patient had recovered on 23-JAN-2009. The patient sought medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse at physician's office concerning a female patient who on 31-DEC-2008, was vaccinated with the third dose of GARDASIL, intramuscularly.  The nurse reported that on approximately 14-JAN-2009, the patient experienced redness and swelling around injection site about two and half weeks post vaccination.  The nurse reported that the patient did not have any reaction after the first or second dose of GARDASIL.  No lot number was provided.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician who on 01-DEC-2008 was vaccinated with a dose of GARDASIL vaccine. The patient had an abnormal pap. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning his 12 year old daughter with no known medical history and drug allergies, who on 22-JAN-2009 was vaccinated with a third dose of HPV vaccine at 15:00.  Concomitant therapy included PREVACID.  On 22-JAN-2009 the patient had a hard time falling sleep and woke up with a 102 degree fever and her legs were achy.  The physician had given his daughter ADVIL liquid gels 400 mg for her symptoms.  No laboratory studies were performed.  The patient sought medical attention with her father.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Metrorrhagia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with no drug reactions or allergies who on 23-JUL-2008 was vaccinated with a first dose of GARDASIL 0.5 ml, IM.  The patient received the second dose of GARDASIL 0.5 ml, IM on 02-JAN-2009.  The nurse reported that the patient experienced "spotting" after each dose.  The patient had not previously had a period prior to receiving GARDASIL, so the spotting was unexpected.  At time of reporting, the patient had recovered on an unspecified date.  There were no lab diagnostic studies performed.  The patient sought medical attention at the office.  Additional information has been requested. This is in follow-up to report (s) previously submittedon 2/13/2009.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia, Skin warm, Stomach discomfort
Clinical narrative: Information has been received from a consumer concerning his 15 year old daughter with acne, no known allergies and no pertinent medical history, who received her first dose of GARDASIL vaccine in 2008 (lot not reported) On 20-JAN-2009 the patient was vaccinated with 0.5 ml of the second dose of GARDASIL vaccine (yeast) (Lot not reported) intramuscularly.  There was no concomitant medication.  On the night of 21-JAN-2009 the patient developed upset stomach, headache and a fever (the reporter stated that the patient felt hot to touch).  The father stated it could be viral since his daughter was a teenager and was in high school.  As of 22-JAN-2009 the patient has not recovered.  Follow up information has been received from a physician concerning a 15 year old female patient with acne and asthma who in 2008 was vaccinated with the first dose of GARDISIL. On 20-JAN-2009 the patient received the second dose of GARDISIL (lot: 658558/1061U) intramuscularly on the left deltoid. On the same day she received a dose of ADACEL intramuscularly on the left deltoid. The reporter stated that the adverse events mentioned were not reported in their office. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope, Tuberculin test
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient who on 16-JAN-2009 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (Lot# 661531/1311X). Concomitant therapy included ADACEL and tuberculin purified protein derivative (unspecified). On the same day, the patient experienced syncope after receiving her first dose of GARDASIL vaccine. The patient was seen by a nurse. There were no laboratory or diagnostic tests performed. The ptient recovered shortly. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her 14 year old female daughter with no pertinent medical history, no drug reactions/allergies, who in April 2008 was vaccinated with the first dose of GARDASIL vaccine and on an unspecified date was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. In July 2008, the patient noticed that her hair began to thin out and within 2 months she lost all her hair. The reporter took her daughter to the dermatologist. The consumer specified they took test but did not provided what type of test. The consumer stated that "the patient had had wigs and shampoos, name of shampoo unspecified, to help hair grow back, but non of that was working." The dermatologist as well as the family doctor indicated this was due to GARDASIL vaccine. Therapy with human papilloma virus vaccine was discontinued. At the time of reporting, the patient had not recovered. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female patient who on 15-AUG-2008 was vaccinated with the first 0.5 mL dose of GARDASIL. Concomitant therapy included MENACTRA and hepatitis A virus vaccine (manufacturer unknown).  On the same day, the patient experienced dizziness.  Subsequently, the patient recovered.  The patient sought unspecified medical attention.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who was vaccinated IM with the first dose of GARDASIL vaccine (lot number not provided).  Subsequently the patient experienced fainting in the waiting room of the physician's office.  At the time of this report, the patient recovered.  The patient sought unspecified medical attention.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/13/2009. Follow up information was received from a physician concerning a 16 year old female who was vaccinated IM with the first dose of GARDASIL vaccine. Subsequently the patient experienced syncope. The patient recovered within five minutes. No lab diagnostic studies were performed. No other adverse events were noted. The patient did not seek medical attention. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Drug administered at inappropriate site
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a nurse practitioner concerning a 20 year old female with no known drug reaction/allergies and a history of exercise induced asthma who on 02-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine, 0.5ml, intramuscularly. On 05-AUG-2008 was vaccinated with the second dose of GARDASIL vaccine, 0.5ml, intramuscularly and on 12-JAN-2009 was vaccinated with the third dose of GARDASIL vaccine 0.5ml, intramuscularly. The nurse practitioner reported that on 12-JAN-2009, the patient experienced bruising after receiving her third dose of GARDASIL. The nurse also reported that the patient received the third dose as an intramuscular injection that was administered below the deltoid region of the arm. The lot numbers for the vaccines were not available. The patient recovered on an unspecified date. The patient sought medical attention calling to nurse's practice. In follow-up the nurse practitioner reported that she was a 20 year old female patient weighing 131 pounds and 65 7/6 in height, with no known drug reaction/allergies and no medical conditions (previously reported as with history of exercise induced asthma), who on 02-JUL-2008 was vaccinated with the first dose of GARDASIL (Lot # 660555/0279X) intramuscularly: on 05-AUG-2008 was vaccinated with the second dose of GARDASIL (660557/0072X), intramuscularly and on 12-JAN-2009 was vaccinated with the third dose of GARDASIL (Lot #663531/1311X), intramuscularly in the arm. There were no illnesses at the time of vaccination. The nurse practitioner reported that the patient's mother stated that vaccine was administered too low, just below deltoid muscle and there was a bruising associated with the injection. The mother was concerned that improper placement may impair absorption and diminish vaccine efficacy. The patient recovered on 14-JAN-2009. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Dyskinesia, Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who on 20-JAN-2009 was vaccinated with third dose of GARDASIL (Lot # not reported) Intramuscularly.  The patient received less than half her third dose because the patient jerked her arm away during administration of the vaccine.  No adverse effect was reported.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 18 year old female patient who was vaccinated with first dose of GARDASIL (Lot # not reported).  After the patient received the vaccine she developed hives and rashes on her face.  The patient sought medical attention with the physician.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who was vaccinated with two doses GARDASIL. Subsequently the patient may be experiencing irregular menstrual cycles. At the time of this report, the outcome was unknown. The patient sought medical attention via telephone. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who was vaccinated with a first dose of GARDASIL vaccine, and developed hives on her chest and neck. The patient sought nurse practitioner for medical attention. At the time of reporting, the patient's outcome was unspecified. Additional information has been requested
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Inappropriate schedule of drug administration, Psoriasis
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a physician concerning a 17 year old female patient who on 27-JUN-2008 was vaccinated with first dose of GARDASIL (Lot # 660555/0279X) and on 13-OCT-2008 she received second dose of GARDASIL (Lot # 660555/0279X).  At an unspecified interval after her second dose she developed "allergies".  The patient went to an immunologist and allergist for these "allergies".  Both specialists diagnosed her with "psoriasis due GARDASIL".  Patient was currently beginning treatment for this condition but no specifics known.  At the time on the report on 21-JAN-2009 patient was not recovered.  Patient sought medical attention at the office.  Additional information has been received from a physician who reported on 12-JUN-2008 the patient was vaccinated with of GARDASIL (Lot # 660555/0279X) 0.5ml at 12:00 PM. The patient's outcome was unknown. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager (also reported as an emergency medical technician concerning a 23 year old female patient with graves' disease, no drug reactions / allergies, who on 11-Oct-2007 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL. Concomitant therapy included ethinyl estradiol Seasonale and LEXAPRO. On 31-Dec-2008 the patient was vaccinated intramuscularly with the third 0.5ml dose of GARDASIL (lot#660391/0063X). On 19-Jan-2009 the patient developed a painful, swollen lump at the injection site. The patient was examined in the office on 21-Jan-2009 and was prescribed warm compresses and ibuprofen. There were no laboratory or diagnostic test performed. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who "sometime this month" was vaccinated with the first dose of GARDASIL vaccine. Subsequently the patient fainted. At time of the report the patient was recovered. The patient sought medical attention: the patient was in the clinic when AE occurred. Additional information has been requested.This is in follow-up to report (s) submitted on 2/13/2009. Follow-up informatin was received from the medical assistant. It was reported the 24 year old (previously reported as "14 year old") patient with drug hypersensitivity to condeine (reported as "codine") was vaccinated intramusculary into the left deltoid with the first dose of GARDASIL (lot # 661703/0651X) at 14:00 (reported as "2:00 pm") on 15-Jan-2009 1 - 2 minutes after receiving GARDASIL the patient had twitching and fainting episode. The patient regained consciousness after 1 to 2 minutes. She did not remember passing out. She claimed she had not eaten since the night before. She was given some cookies and water and observed. On that same date, the patient recovered. No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning several females who on unknown date were vaccinated with GARDASIL vaccine. On unspecified date the patients experienced mild nausea and vomiting. At the time of reporting, the outcome was not reported. Attempts were made to obtain additional identifying information to distinguish the individual patients mentioned in this report. The reporter did not know how many girls or their names. This is one of the several reports from the same source. No further information was available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from physician concerning a 14 year old female who was vaccinated the first dose of with GARDASIL on an unspecified date. Subsequently the patient experienced abnormal wart growth on the inside of her thigh. She was not given any further doses or medication to treat the wart. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Headache, Influenza like illness, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 03-DEC-2008 was vaccinated with the first dose of GARDASIL (lot # 0947X), IM, 0.5 ml. There was no concomitant medication. On the same day the patient experienced flu like symptoms including nausea, dizziness, headache, body ache and diarrhea. The patient did not perform any lab diagnostics study. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.  Follow-up information has been received from a nurse practitioner concerning a 22 year old female student who on 03-DEC-2008 at approximately 2:00 PM was vaccinated with the first dose of GARDASIL (lot # 0947X), IM, 0.5ml in the left deltoid.  After 5 hours post vaccine (on 03-DEC-2008 7:00 PM) the patient experienced fever, diarrhea, headache, dizziness, severe body aches which lasted about 24 hours.  Symptoms were improved after she began IBUPROFEN.  It did cause her to miss a final exam at college.  The patient was recovered on 04-DEC-2008.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 03-DEC-2008 was vaccinated with the first dose of GARDASIL (lot # 0947X), IM, 0.5 ml. There was no concomitant medication. On the same day the patient experienced flu like symptoms including nausea, dizziness, headache, body ache and diarrhea. The patient did not perform any lab diagnostics study. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.  Follow-up information has been received from a nurse practitioner concerning a 22 year old female student who on 03-DEC-2008 at approximately 2:00 PM was vaccinated with the first dose of GARDASIL (lot # 0947X), IM, 0.5ml in the left deltoid.  After 5 hours post vaccine (on 03-DEC-2008 7:00 PM) the patient experienced fever, diarrhea, headache, dizziness, severe body aches which lasted about 24 hours.  Symptoms were improved after she began IBUPROFEN.  It did cause her to miss a final exam at college.  The patient was recovered on 04-DEC-2008.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 12-MAY-2008 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (lot # 660387/1967U) 0.5 mL and on 19-DEC-2008 was vaccinated with a second dose of GARDASIL (lot # 660585/0297X). On 20-DEC-2008 the patient experienced swelling of her entire left arm and hand. On unspecified date, the patient recovered. This AE was mentioned to the physician by the patient's mother during an office visit with sibling of the patient. Additional information has been requested. Follow up information was received from the registered nurse. It was reported the patient with no illness at time of vaccination, no adverse event follow prior vaccination and no pre-existing allergies on 19-OCT-2008 was vaccinated intramuscularly with a second dose of GARDASIL in the left deltoid. On 19-DEC-2009 (previously reported as 20-DEC-2008) the patient experienced swelling of her entire left arm and hand. On 23-DEC-2008 the patient recovered. No further information available.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a pharmacist concerning her 9 year old daughter who in August 2008, was vaccinated with a first dose of GARDASIL and in October 2008, was vaccinated with a second dose of GARDASIL. There was no concomitant medication. In approximately October 2008 (some time after Dose 2), the patient experienced hair shedding and hair loss. The patient did not seek medical attention. At the time of reporting, the patient's hair shedding and hair loss persisted. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site haematoma
Clinical narrative: Information has been received from a nurse concerning a 25 year old female with no drug allergy who on 09-JAN-2009 was vaccinated with the first dose of GARDASIL (661531/1311X), 0.5 ml. Concomitant therapy included DEPO-PROVERA. The nurse indicated that the GARDASIL may have been administered as a subcutaneous injection. Subsequently the patient experienced bruising at the site of GARDASIL administered. The patient did not perform lab diagnostics study. At time of the report the patient was recovered. The patient called the practice. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Breast cyst
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with the first dose of GARDASIL. "Few months ago" the patient found a hard round cyst in left breast after receiving GARDASIL. The patient performed breast exam. At the time of the report the patient was not recovered. The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Heart rate decreased, Nausea, Syncope, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a physician concerning a female who on was vaccinated in the deltoid with the first and second dose of GARDASIL on unspecified date and experienced nausea. On 19-JAN-2009 she was vaccinated in the deltoid with a third dose of GARDASIL. On 19-JAN-2009, the patient experienced severe vomiting, nausea and low heart rate and became weak. The patient had electrocardiogram (EKG) performed and the result was not reported. The patient sought unspecified medical attention. On the same day shortly afterwards, the patient recovered. Follow-up information was received from the physician's nurse via phone call. The patient also experienced nausea after the first and second dose of GARDASIL. Follow-up information was received. A nurse reported the patient was 16 years old. Follow-up information was received from the physician. It was reported on 19-JAN-2009 the patient was vaccinated intramuscularly in the left deltoid with a third dose of GARDASIL (lot # 661701/0691X). The patient experienced vasovagal syncope lasted 20 minutes. Subsequently the patient vomited, got nauseated and bradycardic when trying to sit up 15 minutes. Later the patient was given Gatorade resolution at 30 minutes. This is one of the several reports from the same source. No further information was available.  3/3/09 Received vaccine records & medical records from PCP. FINAL DX: vasovagal attack Records reveal patient was in good health on 9/11/06 for HPV #1.  RTC 8/27/07 for HPV #2 w/dysmenorrhea & tender lymph node on neck.  Started BCP.  RTC 5/1/08 w/depression.  Tx w/meds & referred for counseling.  RTC 9/29/08 w/strep throat.  RTC 1/19/09 for HPV #3 then fainted, vomited, nauseated, bradycardia.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a healthcare worker concerning a 14 year old female with penicillin allergy and drug hypersensitivity of DARVOCET-N who on 16-JAN-2009 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 661766/0652X) 0.5 mL. There was no concomitant medication. Within a few hours of receiving GARDASIL the patient experienced a rash on her neck and chest. The patient called the practice. On unspecified date, the patient recovered. Follow up information was received from a medical assistant. It was reported the patient was vaccinated with GARDASIL at 10:00 am on 16-JAN-2009 in the left deltoid. The patient went home after receiving GARDASIL and took a bath. At 12:00 pm on 16-JAN-2009 she developed a rash on her neck and chest. She took over the counter Benadryl per package instruction. No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Cough, Dizziness
Clinical narrative: Information has been received from a physician concerning a female with eczema who about 1 year ago, was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscularly (lot number not reported). It was reported that the patient developed a persistent dry cough immediately after receiving the GARDASIL. The cough is worse at night but does not wake the patient. She experienced dizziness and weakness immediately after administration of the vaccine but the symptoms were resolved in 2 days without treatment. The patient did not return to the office to complete the vaccine series. They physician has scheduled the patient for an office evaluation. The physician did not think that the vaccine caused the persistent dry cough, and the patient will be worked up for allergies. Patient not recovered from persistent drug. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscular weakness, Paraesthesia
Clinical narrative: Information has been received from a registered pharmacist concerning three female patients who on unknown dates were vaccinated with GARDASIL, lot # not reported. The pharmacist stated that she heard of three patients who experienced immediately "electric feeling" pain at injection site when GARDASIL vaccine was administered. The pain extended down to the finger tips from the injection site of upper arm. The pain resolved without treatment within a few hours but the "arm felt weak for a couple of days". All three patients recovered fully. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Anaemia, Borrelia burgdorferi serology negative, Haematology test, Laboratory test normal
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with asthma who in the summer of 2008, was vaccinated with the first dose of GARDASIL (lot # was not reported). Concomitant therapy included ADVAIR. The patient's mother stated her daughter had 2 doses of the vaccine and reported that around the first week of September 2008 the patient's hair started to fall out. The consumer stated that her daughter's hair started to fall out in clumps and within months all of her fell out. The patient was seen by a rheumatologist, her primary care physician, and a dermatologist; numerous amounts of blood work were done for all auto immune disorders, vitamin deficiency, Lyme disease and many others. The only thing that the blood work has shown is that she was slightly anemic. They still can not find anything that would cause her hair to fall out. The consumer stated that she did not let her daughter get the third dose and stated that she did research that the vaccine can cause alopecia and she can not figure anything else but the vaccine that could cause this. This is one of several reports received from the same source. Additional information has been requested.  4/3/09 Office note received for DOS 2/26/09 with DX:  Alopecia areata, approaching universalis.   Pt presented with c/o progressive, extensive hair loss involving scalp, eyebrows, eyelashes and body hair since 9/2008. PE confirms c/o. Tx: steroids.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia areata, Alopecia effluvium, Alopecia universalis, Blood thyroid stimulating hormone, Full blood count normal
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with asthma who in the summer of 2008, was vaccinated with the first dose of GARDASIL (lot # was not reported). Concomitant therapy included ADVAIR. The patient's mother stated her daughter had 2 doses of the vaccine and reported that around the first week of September 2008 the patient's hair started to fall out. The consumer stated that her daughter's hair started to fall out in clumps and within months all of her fell out. The patient was seen by a rheumatologist, her primary care physician, and a dermatologist; numerous amounts of blood work were done for all auto immune disorders, vitamin deficiency, Lyme disease and many others. The only thing that the blood work has shown is that she was slightly anemic. They still can not find anything that would cause her hair to fall out. The consumer stated that she did not let her daughter get the third dose and stated that she did research that the vaccine can cause alopecia and she can not figure anything else but the vaccine that could cause this. This is one of several reports received from the same source. Additional information has been requested.  4/3/09 Office note received for DOS 2/26/09 with DX:  Alopecia areata, approaching universalis.   Pt presented with c/o progressive, extensive hair loss involving scalp, eyebrows, eyelashes and body hair since 9/2008. PE confirms c/o. Tx: steroids.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Menstruation irregular, Metabolic function test normal, Red blood cell sedimentation rate normal, Stress, Thyroxine
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with asthma who in the summer of 2008, was vaccinated with the first dose of GARDASIL (lot # was not reported). Concomitant therapy included ADVAIR. The patient's mother stated her daughter had 2 doses of the vaccine and reported that around the first week of September 2008 the patient's hair started to fall out. The consumer stated that her daughter's hair started to fall out in clumps and within months all of her fell out. The patient was seen by a rheumatologist, her primary care physician, and a dermatologist; numerous amounts of blood work were done for all auto immune disorders, vitamin deficiency, Lyme disease and many others. The only thing that the blood work has shown is that she was slightly anemic. They still can not find anything that would cause her hair to fall out. The consumer stated that she did not let her daughter get the third dose and stated that she did research that the vaccine can cause alopecia and she can not figure anything else but the vaccine that could cause this. This is one of several reports received from the same source. Additional information has been requested.  4/3/09 Office note received for DOS 2/26/09 with DX:  Alopecia areata, approaching universalis.   Pt presented with c/o progressive, extensive hair loss involving scalp, eyebrows, eyelashes and body hair since 9/2008. PE confirms c/o. Tx: steroids.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with asthma who in the summer of 2008, was vaccinated with the first dose of GARDASIL (lot # was not reported). Concomitant therapy included ADVAIR. The patient's mother stated her daughter had 2 doses of the vaccine and reported that around the first week of September 2008 the patient's hair started to fall out. The consumer stated that her daughter's hair started to fall out in clumps and within months all of her fell out. The patient was seen by a rheumatologist, her primary care physician, and a dermatologist; numerous amounts of blood work were done for all auto immune disorders, vitamin deficiency, Lyme disease and many others. The only thing that the blood work has shown is that she was slightly anemic. They still can not find anything that would cause her hair to fall out. The consumer stated that she did not let her daughter get the third dose and stated that she did research that the vaccine can cause alopecia and she can not figure anything else but the vaccine that could cause this. This is one of several reports received from the same source. Additional information has been requested.  4/3/09 Office note received for DOS 2/26/09 with DX:  Alopecia areata, approaching universalis.   Pt presented with c/o progressive, extensive hair loss involving scalp, eyebrows, eyelashes and body hair since 9/2008. PE confirms c/o. Tx: steroids.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Allergy to vaccine, Swelling face, Urticaria
Clinical narrative: Information has been received from a consumer concerning her approximately 20 year old daughter with no pertinent medical history, who in November or December 2008 was vaccinated with the second dose of GARDASIL (no lot # provided) and broke out in hives on her face with swelling on her face. There was no concomitant medication. Patient sought medical attention by going to the allergist and was allergy tested which determined she is allergic to GARDASIL which will not be reintroduced. At the time of this report, the patient had not yet recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Drug exposure during pregnancy, Vomiting in pregnancy
Clinical narrative: Information has been received from a consumer for the pregnancy registry of GARDASIL vaccine concerning his fiancee who has has two doses of GARDASIL vaccine beginning in June 2008. It was reported that the patient had the symptoms of pregnancy such as morning sickness and bloating. At the time of the report the patient had no pregnancy test done. The patient did not seek medical attention. No further information is available.
Age: 1.3
Sex: M
Vaccine: HPV4, MMR
Symptoms: Rash, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant and a registered nurse concerning a 15 month old patient who vaccinated with a dose of GARDASIL due to nursing error. No adverse effect reported. Follow up information was received on 27-Jan-2009: The healthcare worker reported that the patient was supposed to received  Enders-Edmonston + Jeryl-Lynn + Wistar RA 27/3 but the nurse grabbed GARDASIL instead. It was reported that the patient experienced a rash on his trunk and neck. It was reported that the patient was given Benadryl and the symptoms improved. It was reported that the patient has not received Enders-Edmonston + Jeryl-Lynn + Wistar RA 27/3 MSD. Follow-up information received from a registered nurse on 30-Jan-2009 who reported that the rash that the patient developed faded the next day and was gone by 2 days. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 14-JAN-2009 was vaccinated subcutaneously with the third dose of GARDASIL vaccine instead of intramuscularly. The reporter stated that the patient reported a "burning feeling" down her arm when the GARDASIL vaccine was given, and she did not have this "burning feeling" after the first two doses but only with this last dose. The patient currently had some soreness in the lower triceps of her arm. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Oligomenorrhoea, Urticaria
Clinical narrative: Information has been received from a patient's mother concerning her 12 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 03-JAN-2009 was vaccinated with the third dose of GARDASIL. There was no concomitant medication. It was reported that the patient's menstrual cycle was going on 10 days and had hives. At the time of the report the patient had not laboratory diagnostics studies performed. At the time of the report the patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female patient who on 15-JAN-2009 was vaccinated intramuscularly with the second dose of GARDASIL vaccine into the upper deltoid. Concomitant therapy included INFLUENZA VIRUS vaccine (unspecified) in the opposite arm. Within a few moments of receiving the second dose of GARDASIL vaccine, the patient fainted. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Inflammation, Injection site mass, Injection site pain, Mass
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a nurse practitioner concerning a 20 year old female patient with AZITHROMYCIN allergy and a history of seizures and a strong family history of cancer, who on 22-DEC-2008 was vaccinated with a dose of GARDASIL vaccine. Concomitant therapy included YASMIN. On an unknown date the patient developed a painful lump. It was reported that there is still a "knot" in the arm, tenderness and swelling.  An ultrasound was performed showing a subcutaneous small bruise and post inflammatory change. The patient was seen for an office visit. Follow-up information has been received from a nurse practitioner concerning the student. It was reported that the patient stated that she received GARDASIL vaccine in another office. On 15-JAN-2009, she was seen at this office, reporting a knot after receiving the shot that went away, then reappeared. It was described a small, tender subcutaneous lump on left upper arm. It is unknown if the patient recovered.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity, Tenderness, Ultrasound scan abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a nurse practitioner concerning a 20 year old female patient with AZITHROMYCIN allergy and a history of seizures and a strong family history of cancer, who on 22-DEC-2008 was vaccinated with a dose of GARDASIL vaccine. Concomitant therapy included YASMIN. On an unknown date the patient developed a painful lump. It was reported that there is still a "knot" in the arm, tenderness and swelling.  An ultrasound was performed showing a subcutaneous small bruise and post inflammatory change. The patient was seen for an office visit. Follow-up information has been received from a nurse practitioner concerning the student. It was reported that the patient stated that she received GARDASIL vaccine in another office. On 15-JAN-2009, she was seen at this office, reporting a knot after receiving the shot that went away, then reappeared. It was described a small, tender subcutaneous lump on left upper arm. It is unknown if the patient recovered.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female patient who completed GARDASIL vaccine (lot # not provided) series. The patient was sexually active and she was positive for the HPV Test. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a doctor of pharmacy who spoke with a nurse in her facility and stated that on an unspecified date another patient was vaccinated with the GARDASIL series. It was reported that the patient has experienced loss of menses after starting the GARDASIL series. This is one of several cases from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug exposure during pregnancy, Nausea
Clinical narrative: Information has bee received from a 19 year old female patient for GARDASIL, concerning herself with no pertinent medical history and no known drug allergies who on 01-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # not provided). There was no concomitant medication. In December 2008 the patient became pregnant. LMP was 20-NOV-2008, and EDD was 27-AUG-2009. In December 2008, the patient experienced pregnancy symptoms like dizziness and nausea. Home urine pregnancy test was performed (no result provided). At the time of this report, the adverse events were ongoing. The patient sought medical attention via contacting physician. Additional information has been requested.  No further information is available.