chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Skin discolouration
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient who was vaccinated with the first and second doses of GARDASIL on 16-MAR-2009 and 26-MAY-2009 respectively. The nurse reported that when the patient was due for the third dose, the patient mentioned that "soon after she received the second dose of GARDASIL", on 26-MAY-2009, she developed rashes on her legs. The nurse also reported that the patient also developed discoloration on the top of her feet, around her ankles and the area behind her knees for both of her legs. The nurse decided not to give the third of GARDASIL dose to the patient until she saw her dermatologist. On 14-OCT-2009, the patient was seen by her dermatologist and a biopsy was performed (results not provided). The dermatologist prescribed LIDEX cream. At the time of the report, the patient's status was unknown. Follow-up information has been received from the licensed practical nurse regarding the 20 year old female patient with asthma and a history of chickenpox who was intramuscularly vaccinated with the first (Lot#660616/0570X) in the left deltoid and second (Lot#658271/0558X) in the right deltoid doses of GARDASIL on 16-MAR-2009 and 26-MAY-2009 respectively. The licensed practical nurse reported that the patient had a rash that developed on back and lower extremities after received the GARDASIL. Then the rash had been gradually worsening. Initially the rash itched but it had lessened. The patient was referred to dermatology. A biopsy was performed - results not available. The patient was diagnosed with postinflammatory hyperpigmentation. A complete blood cell count (CBC) and complete metabolic panel (CMP) were performed on 01-OCT-2009. All results were within normal limits. There was no illness at the time of vaccination. The patient's outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gestational diabetes
Clinical narrative: Information has been received from a 22 year old female with a history of pregnancy, for the pregnancy registry for GARDASIL, who in June 2008, was vaccinated with a 0.5 ml first dose of GARDASIL. Shortly thereafter, the patient found out she was pregnant with her second child. The remaining doses of the vaccine regime were deferred until resolution of the pregnancy. Subsequently, the patient developed gestational diabetes during the pregnancy,, however the baby was fine when it was born. The patient subsequently experienced vaccine exposure during pregnancy and inappropriate schedule of vaccine administration while on therapy with GARDASIL (MSD, WAES #0911USA02821). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal blistering, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who on 20-APR-2009 was vaccinated with the first dose of GARDASIL (Lot#661841/0653X). On 16-AUG-2009 the patient was vaccinated with the second dose of GARDASIL and on 26-OCT-2009 was vaccinated with the third dose of GARDASIL (Lot#662724/0313Y). The nurse reported that after the patient received the first two doses, on 20-APR-2009 and 16-AUG-2009 respectively, the patient developed blisters in her mouth. The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of the report, the patient had not reported any blisters or adverse effects after the third vaccination. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a pregnant female patient who on an unspecified date in 2009 ("in the last couple weeks") was accidentally vaccinated with a 0.5 ml dose of GARDASIL instead of flu vaccines. It was reported that the nurse had reached into her diebold dispenser to retrieve the flu vaccine syringes, but took out GARDASIL filled syringe instead. No adverse effect was reported. Unspecified medical attention was sought. It was unspecified which trimester the patient was in. This is one of several reports from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Nodule, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female patient who on 30-SEP-2009 was vaccinated with a third dose of GARDASIL (Lot No. not provided). Concomitant therapy included unspecified "birth control". On approximately 27-OCT-2009, four weeks after receiving the third dose of GARDASIL, the patient experienced pain and a knot in her arm, near the injection site. The patient called the physician for medical attention. At the time of the report, the patient had not recovered. Follow up information has been received from the physician who indicated that the patient had not followed up with him so he did not believe "it had anything to do with her GARDASIL" vaccination. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Pregnancy test positive, Sinusitis
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot #, route and site of administration not reported) respectively on time. On 04-JAN-2010 the patient came in at the office to receive her third dose of GARDASIL. The patient stated that she hadn't gotten her period yet and performed a pregnancy test before receiving the GARDASIL. The result came back positive and the patient was not vaccinated with the third dose of GARDASIL. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Follow up information was received from a completed pregnancy questionnaire via the registered nurse (R.N.) concerning the 27 year old female with itching of herpes simplex virus (HSV). It was reported that the patient had a history of two pregnancies and one live birth and one elective termination. There was no birth defects occurred in previous pregnancies. The patient "stopped pill from 2009". On 19-Dec-2008 the patient was vaccinated with the first dose of GARDASIL and on 19-FEB-2009 the patient was vaccinated with the second dose of GARDASIL while in "QC'S". Concomitant therapy included prenatal vitamins (PNV). It was reported that the patient's LMP was 08-OCT-2009, estimated conception date was 22-OCT-2009 and EDD is 15-JUL-2010. On 02-DEC-2009 the patient experienced nausea and started treatment with PHENERGAN, 25 mg Q8h. On 14-DEC-2009, the patient started treatment with generic ZOFRAN 8mg Q6h for nausea. On 22-JAN-2010 the patient developed sinusitis and started treatment with Z-PAK. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who on an unknown date was vaccinated with a third dose of GARDASIL (Lot numbers not reported). The patient was "sexually naive" until 9 months after completing her series of GARDASIL. It was reported that the patient was now presenting low-grade dysplasia and was testing positive for high risk HPV (unspecified diagnostic test). The patient sought medical attention with a physician's assistant. A colonoscopy diagnostic test was planned for the patient. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Injection site reaction, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 26-OCT-2009 was vaccinated on the left arm with a "first dose" of GARDASIL (lot# 663451/0216Y) and a dose of VAQTA (MSD) (lot# not reported). On the same day the patient also received a dose of MENACTRA (Sanofi Pasteur), a dose of VARIVAX (MSD) and a dose of influenza virus vaccine (unspecified) (manufacturer unknown) on the right arm. Other concomitant therapy included NASONEX. The nurse reported that on 26-OCT-2009 the patient developed an injection site reaction immediately after receiving all 5 different vaccines but the injection site reaction was just on the left arm of the patient where she received GARDASIL and VAQTA. The nurse noted that the patient did not have injection site reaction on her right arm. The nurse reported that the patient was given "XYZAL" (manufacturer unknown) to treat the injection site reaction. The patient was in the clinic when the adverse event occurred. At the time of the report, the patient's outcome was unknown. Follow-up information was received from the licensed practical nurse concerning the 14 year old female patient, with hypothyroidism who on 26-OCT-2009, at 17:00 hours was vaccinated with the first dose of GARDASIL (lot # 663451/0216Y) intramuscularly into her left arm; the first dose of VAQTA (MSD) (lot #664766/0604Y) intramuscularly into her left arm; the second dose of VARIVAX (Merck) (lot # 664718/0801Y) intramuscularly into her right arm; the first dose of MENACTRA (Sanofi Pasteur) (lot # U2926AA) intramuscularly into her left arm; and the first dose of FLUZONE (Sanofi Pasteur) (lot # U3187AA) intramuscularly into her right arm. The nurse reported that on the same date, at 17:05 hours, the patient experienced a large welt at the injection site with some swelling and that it was warm to touch. On 07-NOV-2009, the patient recovered from the injection site reaction. There were no relevant diagnostic test or laboratory data performed. There was no illness at the time of vaccination. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number unspecified). The physician stated that the patient called the office and mentioned that she experienced muscle and joint tenderness sand soreness mostly in her hands and arms after having received the first dose of GARDASIL. The consumer stated that the symptoms did go away eventually; however, the consumer decided not to receive any more doses of GARDASIL. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. Follow up information has been received from a registered nurse concerning the 24 year old female housekeeper with no pre-existing allergies or other relevant medical history who on 18-AUG-2009, at 15:15, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 659182/1757U) into her left arm. On 18-AUG-2009 the patient developed muscle and joint tenderness in hands and arms. The patient stated that she could not move her fingers for a couple of days and her legs were really stiff. There was no illness at time of vaccination. There were no laboratory diagnostics studies performed. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient who on approximately 27-DEC-2009 was vaccinated with the second dose of GARDASIL (lot #, route and site of administration not reported). Concomitant vaccination included ADACEL. On approximately 27-DEC-2009 ("sometime last week") the patient passed out after vaccination. The patient stayed in the clinic for 4 hours before the office allowed her to go home. At the time of this report, the patient had recovered. Follow up information has been received concerning a 16 year old female student who on 31-DEC-2009, at 9:45, was vaccinated with the first dose of GARDASIL (lot# 662304/1013Y) into her right arm. On 31-DEC-2009, at 9:44, the patient was vaccinated with the first dose of ADACEL (lot #C33838A) into her left arm. On 31-DEC-2009, at 9:45, the patient became faint and dizzy following administration of vaccines. The patient was given juice, lying down with feet elevated. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Fatigue, Heart rate irregular, Jaw fracture
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female patient who on 25-AUG-2009 was vaccinated intramuscularly with a dose of 0.5 ml of GARDASIL (Lot #659184/0843Y). There was no concomitant medication. According to the nurse on 27-AUG-2009 the patient fainted and fractured her jaw. Since then, the patient had had irregular heartbeats and was seeing an unspecified specialist. Additionally, the nurse mentioned that the office was notified by the patient's mother until 28-SEP-2009. The patient's mother continued to call the office and reported that her daughter continued to be very sore and tired. According to the reporter, the patient was previously very athletic and healthy and at the time of the report she got tired easily. The patient was sent  for evaluation by an unspecified family physician. The patient had an abnormal EKG with Holter monitor. At the time of the report the patient had not recovered. Follow up information has been received from the licensed practical nurse who indicated that the patient was a female student with no known allergies/reactions and no pertinent medical history who on 25-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot #659184/0843Y) in her left upper arm at 11:30. There was no illnesses reported at time of vaccination. According to the nurse, at the time of the report the patient had not recovered. The nurse also mentioned that the patient saw a family doctor and was referred to the another facility. Follow up information has been received from the licensed practical nurse who stated that she had not heard any more and that the patient went to another facility. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female patient who on 25-AUG-2009 was vaccinated intramuscularly with a dose of 0.5 ml of GARDASIL (Lot #659184/0843Y). There was no concomitant medication. According to the nurse on 27-AUG-2009 the patient fainted and fractured her jaw. Since then, the patient had had irregular heartbeats and was seeing an unspecified specialist. Additionally, the nurse mentioned that the office was notified by the patient's mother until 28-SEP-2009. The patient's mother continued to call the office and reported that her daughter continued to be very sore and tired. According to the reporter, the patient was previously very athletic and healthy and at the time of the report she got tired easily. The patient was sent  for evaluation by an unspecified family physician. The patient had an abnormal EKG with Holter monitor. At the time of the report the patient had not recovered. Follow up information has been received from the licensed practical nurse who indicated that the patient was a female student with no known allergies/reactions and no pertinent medical history who on 25-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot #659184/0843Y) in her left upper arm at 11:30. There was no illnesses reported at time of vaccination. According to the nurse, at the time of the report the patient had not recovered. The nurse also mentioned that the patient saw a family doctor and was referred to the another facility. Follow up information has been received from the licensed practical nurse who stated that she had not heard any more and that the patient went to another facility. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a pregnant female patient who on an unspecified date in 2009 ("in the last couple weeks") was accidentally vaccinated with a 0.5ml dose of GARDASIL instead of flu vaccines. It was reported that the nurse had reached into her diebold dispenser to retrieve the flu vaccines syringes, but took out GARDASIL filled syringe instead. No adverse effect was reported. Unspecified medical attention was sought. It was unspecified which trimester the patient was in. This is one of several reports from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Bone neoplasm
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). The physician heard from one of his patients that 2 other girls developed bone tumors after receiving HPV. At the time of this report the patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Information has been received from a pharmacist concerning a 19 year old female patient who on 12-NOV-2009 was vaccinated with the first dose of GARDASIL. The patient experienced headache, stomachache and felt tired, weak, light headed and nauseous after received GARDASIL. The patient sought unspecified medical attention. It was unspecified if lab tests were performed. At the time of the report, the patient had not recovered. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a pharmacist concerning a 19 year old female patient who on 12-NOV-2009 was vaccinated with the first dose of GARDASIL. The patient experienced headache, stomachache and felt tired, weak, light headed and nauseous after received GARDASIL. The patient sought unspecified medical attention. It was unspecified if lab tests were performed. At the time of the report, the patient had not recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site urticaria, Oedema peripheral, Rash macular, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old female patient with no pertinent medical history and no known drug allergies who on 29-SEP-2009 was vaccinated with a first 0.5 ml IM dose of GARDASIL. There was no concomitant medication. On 30-SEP-2009, the next day after vaccination, the patient developed hives at the injection site of the left arm. The symptoms resolved without treatment. On 11-NOV-2009 the patient received a second 0.5 ml IM dose of GARDASIL. Subsequently on 16-NOV-2009 the patient developed widespread hives. The patient called the physician's office and was recommended to take ZYRTEC or BENADRYL. At the time of this report, the patient was recovering. It was reported that the patient will not be receiving the third dose of GARDASIL. Follow up information was received from the nurse who indicated that the patient on 29-SEP-2009 was vaccinated with a first IM dose of GARDASIL (Lot No. 663453/0249Y) into her left deltoid at 2:45pm, a first IM dose of ADACEL (Lot No. 4F500BA) into her left deltoid at 2:45pm, a first IM dose of MENACTRA (Lot No. U3043AA) into her right deltoid at 2:45pm, a second SQ dose of VARIVAX (Merck) (Lot No. 664903/0864Y) into her left arm at 2:45pm. On approximately 03-OCT-2009 the patient developed blotchy rash and her arm became swollen after her first 'shot' of GARDASIL. On 11-NOV-2009 was vaccinated with a second IM dose of GARDASIL into her left deltoid. The reporter noted there were no other vaccines administered on that day. On 16-NOV-2009 the patient developed hives all over her body. At the time of the report, the patient had recovered (date unspecified). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter who on unknown dates was vaccinated with the first and second dose of GARDASIL (lot no, and route not reported). It was reported that the patient experienced rash after first and second dose of GARDASIL. The patient sought medical attention at the doctor's office. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a consumer concerning her daughter who on unspecified dates was vaccinated with the first and the second 0.5ml dose of GARDASIL (lot #, route and site of administration not reported) respectively. On an unspecified date after the second vaccination, the patient developed a hot, baseball sized lump on her shoulder near the injection site which took several days to go away. Unspecified medical attention was sought via called the physician. At the time of this report, the patient had recovered. No further information is available.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old male who was vaccinated with a dose of GARDASIL (dose, route, dose and lot number unspecified) by accident instead of a dose of MENACTRA (dose, route, dose and lot number unspecified). The wrong bottle was grabbed. This was a medical error. The patient was not experiencing any known symptoms. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who in the spring of 2009 was vaccinated with a second 0.5 ml IM dose of GARDASIL (Lot No. not reported). Subsequently the patient started to develop migraines every three weeks. The physician stated that the patient's migraines "go away but then they recur every 3 weeks". The patient sought medical attention by an office visit. No laboratory or diagnostic studies were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient in her mid teens who in September 2009, was vaccinated with the first 0.5 mL dose of GARDASIL. The patient waited 15 minutes and when she got up to leave she fainted fell and hit her head 'quite hard' on the table. The patient sought unspecified medical attention. No laboratory diagnosed studies were performed. At the same day, the patient had recovered. It was unknown if the patient ever got any more doses of GARDASIL. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with a history of occasional headaches and no known drug allergies who on 03-SEP-2009 was vaccinated intramuscularly with a 0.5ml GARDASIL (lot number not reported). There was no concomitant medication. On 03-SEP-2009, after administration of GARDASIL the patient experienced an increased in the frequency and intensity of headaches. The patient sought medical attention via office visit. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from the physician concerning the patient who on 03-SEP-2009 was vaccinated intramuscularly into the left deltoid with the first dose of GARDASIL (lot # not reported). There was no illness at the time of vaccination. On an unspecified date the patient developed persistent headache. There were no laboratory diagnostic studies performed. At the time of the report it was unknown if the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient "between 9 years and 26 years old" who on 16-NOV-2009 was vaccinated with a 0.5 ml dose of 0.5 GARDASIL. On 17-NOV-2009 the patient experienced muscle pain. The nurse practitioner believed that the pain "could be viral". Unspecified medical attention had been sought. The outcome of the event was unknown at the time of the report. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning the patient who was vaccinated with the first dose of GARDASIL. She asked "what is the incidence of rash after GARDASIL? should patient receive second and the third doses?" A follow-up voice mail received from the physician stated that the reporter did not have any questions about the GARDASIL and/or rash. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The nurse stated that the patient fainted after administration of GARDASIL. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Pyrexia
Clinical narrative: Information has been received from a consumer for GARDASIL, concerning a 17 year old daughter with no pertinent medical history and no drug reactions/allergies who on 29-DEC-2009 was vaccinated with the third 0.5 mL dose of GARDASIL (LOT# and route not reported). There was no concomitant medication. The patient experienced fever between 1010 and 103 degrees for several days. The patient had recovered from the fever. Her daughter was also about 10 days late for her menstrual cycle and was "possibly pregnant". No home pregnancy test had been done yet. No lab diagnostics study was performed. The patient was received the first 0.5 mL and second 0.5 mL dose of GARDASIL on unspecified dates. Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning her female daughter who on an unspecified date was vaccinated with GARDASIL (route and lot # unknown). Concomitant therapy included VARIVAX, MENACTRA and hepatitis B virus vaccine (unspecified). The patient complained that her both arms were swollen and red. At the time of this report the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced swollen arms. The patient would not be finishing the series. The patient had made phone calls for medical attention. The outcome of the patient's swollen arms was not reported. Additional information has been requested. This is one of several reports received from the same source.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician and a nurse concerning an approximately 19 year old female patient who on approximately 28-DEC-2009 (in the last week) was vaccinated "in the mid to post lateral part of the thigh" with a 0.5 ml third dose of GARDASIL (Lot number not reported), IM. The physician reported that the patient "passed out" after being given her third dose of GARDASIL. The patient recovered on the same day she got vaccinated. The patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site rash
Clinical narrative: Information has been received from a Registered Nurse concerning a 11 year old female with seasonal allergy who on 08-JUN-2009 was vaccinated with a first dose of GARDASIL (lot # 659054/0315Y) 0.5ml, intramuscularly in left upper arm. On 10-AUG-2009 she received second dose of GARDASIL (lot # 662404/0312Y) 0.5ml, intramuscularly in her right upper arm. Concomitant therapy included Tdap and MENACTRA administered on 08-JUN-2009, CLARITIN and FLONASE. A couple days after receiving first and second dose of GARDASIL the patient developed a rash on both arms from shoulders down to her elbows. The  patient sought unspecified medical attention. At the time of the report on 29-OCT-2009 the patient was recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient with "allergic to several unspecified medications" who on 06-OCT-2009 was vaccinated with the second dose of GARDASIL (dose unspecified, lot number was not available). Subsequently the patient developed quarter size hives and lips swelled after received the second dose of vaccine. The patient had sought a nurse practitioner for medical attention. At the time of reporting, the outcome of the events were unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection
Clinical narrative: Information has been received from a registered nurse concerning her 20 year old granddaughter with asthma, cyst in breast and no known drug allergies who in 03-JUN-2009, was vaccinated with the first dose of GARDASIL (Lot number unspecified). On 03-SEP-2009 the patient received another dose of GARDASIL. Concomitant therapy included oral contraceptives. Subsequently the patient experienced repeated yeast infections (at least 4 times) since receiving one dose of GARDASIL. The patient was examined by her physician on 17-NOV-2009 for her most recent yeast infection. The reporter was not aware of any other issues. The patient's reported yeast infections persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood test, Injection site pain, Nausea
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no medical history or allergies who on 17-NOV-2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. On 19-NOV-2009 the patient had stomach ache and nausea. The patient also mentioned her left arm was still sore where the injection was given. Blood work was performed but the result was unknown. The patient did not seek medical attention. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (dosing information and lot number not provided). The physician stated that the patient fainted after the vaccination. Unspecified medical attention was sought. It was unknown if there were lab studies performed. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Hypoaesthesia, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient with penicillin allergy and a history of kidney stones who on 10-AUG-2009 was vaccinated with a dose of GARDASIL, 0.5 mL, intramuscular route (lot # 661953/1130X). Concomitant therapy included birth control. The patient did not have any reactions with the first dose of GARDASIL. On 07-OCT-2009 the patient received the second dose of GARDASIL, IM left deltoid (lot # 663453/0249Y). The patient was kept at the clinic for 20 minutes after the vaccination and was okay and left the clinic. The patient returned 15 minutes later with diaphoretic, felt funny walking down the street and both hands felt numb. The patient was also given GATORADE. A blood pressure was monitored for 15 minutes. On 07-OCT-2009 the patient was recovered. Follow up information has been received from a registered nurse. The patient left the clinic after waiting 20 minutes. When the patient got to the street she felt very faint and she returned to the facility. The patient was monitored for another 15 minutes. The patient was given GATORADE and was discharged. 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 physician concerning a female who was vaccinated with 3 doses of GARDASIL IM, and was tested positive for HPV. Prior to the vaccination, the patient was negative against HPV. The physician reported that the vaccines failed to protect the patient against HPV. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Malaise, Nausea, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female patient with no known drug reactions/allergies or pertinent medical history who on 19-FEB-2009 was vaccinated intramuscularly with her first 0.5 mL dose of with GARDASIL (Lot#661531/1311X). Concomitant therapy included Flu shot (manufacturer unknown). The nurse practitioner reported that same night of vaccination, on 19-FEB-2009, the patient developed headache, nausea, general achiness that keep her out of school for 5 days. Also the patient's grandmother informed to the nurse practitioner that the patient "got really ill and have a fever after getting the vaccine and it all lasted about a week". No lab tests were performed. The patient sought medical attention by an follow-up visit. On an unspecified date, the patient had recovered from the headache, nausea and general achiness. At the time of the report, the patient had not received any additional doses of GARDASIL. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female patient with no known drug reactions/allergies or pertinent medical history who on 19-FEB-2009 was vaccinated intramuscularly with her first 0.5 mL dose of with GARDASIL (Lot#661531/1311X). Concomitant therapy included Flu shot (manufacturer unknown). The nurse practitioner reported that same night of vaccination, on 19-FEB-2009, the patient developed headache, nausea, general achiness that keep her out of school for 5 days. Also the patient's grandmother informed to the nurse practitioner that the patient "got really ill and have a fever after getting the vaccine and it all lasted about a week". No lab tests were performed. The patient sought medical attention by an follow-up visit. On an unspecified date, the patient had recovered from the headache, nausea and general achiness. At the time of the report, the patient had not received any additional doses of GARDASIL. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Aggression, Anxiety, Crying, Depression, Obsessive-compulsive disorder
Clinical narrative: Information has been received from a physician concerning a mother reported her daughter who was vaccinated with a first 0.5ml dose of GARDASIL, and "within a week of getting vaccinated, the patient became depressed and showed a sign of obsessive compulsive disorder." The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow up information was received from the physician concerning the 14 year old female student with 2 siblings, flat feet and back pain who on 17-AUG-2007 was vaccinated in the left deltoid with her first dose of GARDASIL (lot #: 658490/0802U). Concomitant therapy included a dose of HAVRIX and MENACTRA. The patient had learning difficulty and palpitations later diagnosed with supraventricular tachycardia at the time of vaccination. Subsequently the patient experienced anxiety, increased crying, depression and unusual aggressive behavior. The patient suspended from school and was evaluated by psychiatrist. The outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a consumer concerning his wife with no medical history or drugs allergies, who on 24-AUG-2009 was vaccinated with a first dose of GARDASIL. On 24-OCT-2009 the patient received a second dose of GARDASIL. There was no concomitant medication. The patient was 6 days late for her menses. At the time of this report no pregnancy testing or laboratories were done. The patient did not seek medical attention. The patient had not recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of GARDASIL. The patient fainted after receiving the GARDASIL dose. The sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Drug exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL from a 21 year old female consumer with no known drug allergies and a history of postpartum pre-eclampsia who on 12-OCT-2009 was accidentally vaccinated with a dose of GARDASIL, 0.5 ml, (Lot # not provided). Concomitant therapy included influenza virus vaccine (unspecified). The patient reported that she went to her OB/GYN on 12-OCT-2009 to receive the influenza virus vaccine (unspecified), but the nurse accidentally gave her a dose of GARDASIL instead. The patient then also received the influenza virus vaccine (unspecified). Unspecified medical attention was sought. There were no lab studies performed. No adverse event involved. The patient's last menstrual period was 07-MAR-2009 and the estimated delivery date is on 12-DEC-2009. Follow up information has been received from the physician who indicated that the patient gave birth to a normal infant with no congenital anomalies. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a "13-15" year old female patient who on an unknown date was vaccinated with a dose of GARDASIL (Lot No. not reported). The patient fainted after receiving GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician concerning a female patient who on unknown dates was vaccinated with three doses of GARDASIL. On an unspecified date, the patient came down with arthritis. It was reported that the patient required medical attention. The patient's final outcome was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Breast mass
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on an unknown date was vaccinated with a dose of GARDASIL (Lot No. not provided). On 09-OCT-2009 the patient developed a breast lump after completing the GARDASIL series. The patient called the physician office. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female patient with no previous medical history who on 06-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot number 661841/0653X). There was no concomitant medication. About one month after vaccination, approximately on 06-SEP-2009, the patient had hair loss. The patient's hair loss persisted. The patient sought medical attention, was seen in the office. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat negative, Erythema, Lymphadenopathy, Mononucleosis heterophile test negative, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with a history of "pre existing baltrim" who on 17-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot #659054/0314Y). The physician reported that on 19-SEP-2009, the patient experienced a rash on her ankles that progressed up to her legs and arms, her neck become red and she developed swollen glands and low grade fever. It was reported that the patient saw a different physician for what the patient experienced, and the patient had performed a throat culture, strep test and mono test which all results came back negative. The physician reported that on 21-SEP-2009 the patient had recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with a history of "pre existing baltrim" who on 17-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot #659054/0314Y). The physician reported that on 19-SEP-2009, the patient experienced a rash on her ankles that progressed up to her legs and arms, her neck become red and she developed swollen glands and low grade fever. It was reported that the patient saw a different physician for what the patient experienced, and the patient had performed a throat culture, strep test and mono test which all results came back negative. The physician reported that on 21-SEP-2009 the patient had recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood human chorionic gonadotropin negative, Blood test normal
Clinical narrative: Information has been received from a 24 year old female pharmacist with no known drug reactions/allergies or pertinent medical history who in May 2009, was intramuscularly vaccinated with her third dose of GARDASIL 0.5 mL. Concomitant therapy included birth control pills (unspecified). In July 2009, two months after she completed the GARDASIL series, she experienced amenorrhea. The pharmacist stated "at times it is spotty for a day and then there's nothing. Other times I have gone a month or two with nothing". The pharmacist stated that she was not pregnant, confirmed with a home pregnancy test. Medical attention was sought by an office visit. Blood tests were performed and the results were normal. At the time of the report, the pharmacist had not recovered. The pharmacist noted that all three doses of GARDASIL were given as per the dosing schedule. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with her first dose of GARDASIL (lot number not reported). After the vaccination, on an unspecified date the patient fainted and experienced chest pain. Unspecified medical attention was sought. On an unspecified date the patient fully recovered but it was not known if treatment was required. The patient elected  not to complete the GARDASIL series. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Malaise, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female patient with no allergies or pertinent medical history who was vaccinated with a first and second dose of GARDASIL on 27-APR-2009 and 29-JUN-2009 respectively. (Lot # 661953/1130X). The patient experienced fatigue, dizziness, and nausea for 3 days after vaccination with her second dose of GARDASIL. Three days after vaccination, on approximately 03-JUL-2009, the patient recovered. No lab diagnostics were performed. The patient has sought medical attention at office visit. Additional information has been received from the medical assistant concerning this 6 year old female student. It was confirmed that on 29-JUN-2009, the patient received a second dose of GARDASIL (Lot # 661953/1130X). The same day the patient experienced dizziness and feeling sick for 3 days after vaccine was given. The patient recovered from adverse events on 03-JUL-2009. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 14 year old female patient with migraine and no drug reactions/allergies and a history of acne who on 19-MAR-2008 was vaccinated with a first 0.5ml dose of GARDASIL (lot # 659655/1486U) via intramuscular route. It was reported that the patient possibly received the second dose on 29-MAY-2008. The patient's mother said that the office billed for this dose but it was not in the patient's chart. On 18-DEC-2008, the patient received the third dose of GARDASIL (lot # 661044/0548X), a dose of VARIVAX (MSD), HAVRIX, FLUZONE and TDAP. The fourth dose of GARDASIL (lot # 662518/0087Y) was given on 30-JUL-2009. Other concomitant therapy included BENZACLIN and RELPAX. The patient's mother also told the nurse that "daughter is having problems" but the nurse did not know if the problem was an adverse experience. The patient had sought medical attention by phone. No laboratory diagnostic study was performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Oedema peripheral, Petechiae, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 25 year old female patient with no drug reactions/allergies who on 11-SEP-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. On 02-NOV-2009, the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 665547/1318Y) at 15:00. Later that evening, the patient developed an injection site reaction. She developed a 1 inch band of red petechiae that extended from injection site to elbow. The arm was swollen and the patient had a slight fever. She was treating with ice. The patient sought medical attention at the physician's office. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.