chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician's assistant concerning a male patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided). The medical assistant reported that the patient passed out shortly after receiving the GARDASIL injection. The patient was given a chance to rest and he recovered. It was unspecified if the patient sought medical attention. Follow-up information was received from a medical assistant who reported that the 13 year old male student patient on 16-JUL-2010 at 8 a.m. was vaccinated into the right deltoid with a dose of GARDASIL (Lot # 662518/0087Y). No illness at time of vaccination. Child passed out after shot given on 16-JUL-2010. He quickly recovered with no problems on the same day. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning female patient in her 20's who on an unspecified date when she was 16 or 17 years old was vaccinated with the third dose in series of GARDASIL (lot number not provided). The physician stated that the patient's mother who was in the office reported that on an unspecified time the patient went to see the obstetrician-gynecologist (OB-GYN) and a Papanicolaou (PAP) smear was done which showed that the patient had abnormal cells. The physician reported that the obstetrician-gynecologist office did a scrape to remove some of the cells, but stated that the abnormal cells that the patient had were not any of the human papillomavirus types in GARDASIL. The physician reported that they were waiting to see if the patient had any more abnormal cells. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 15 year old female daughter with penicillin allergy and sinus problems who on an unspecified date was vaccinated with the third 0.5 ml dose of GARDASIL (Lot# not reported). Concomitant therapy included OMNARIS. The consumer stated that on approximately 23-NOV-2010 the patient experienced pain at the injection site, a knot on her muscle the size of a half dollar and it was tender to touch. There were no laboratories diagnostics studies performed. At the time of the report the patient had not recovered of these symptoms. Follow up information was received from the physician who stated that the patient with no illness at the time of vaccination and allergy to penicillin on 23-NOV-2010 at 13:30 pm was vaccinated with the third dose of GARDASIL (Lot# 0765Z) intramuscularly into her left deltoid. The physician reported that the patient never contacted her office regarding to the adverse event. The patient did not seek medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female patient with no other pertinent medical history who on 02-APR-2010 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 659054/0311Y). There was no concomitant medication. The patient came to the office today, 23-JUL-2010, to receive the second dose of GARDASIL. The patient mentioned that on 02-APR-2010, 2 hours after receiving the first dose of GARDASIL, she developed nausea and vomiting. No medical attention was sought. There were no laboratory diagnostics studies performed. The nausea and vomiting resolved spontaneously that day without requiring treatment. Follow up information has been received from the nurse practitioner who stated that she did not remember who this patient was. She had nausea and vomiting post first dose of GARDASIL. The patient had no problems with the second dose of GARDASIL. So she doubted that the nausea and vomiting were related to the first dose of GARDASIL. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter a 16 year old female with exercise induced asthma and no drug reactions/allergies who on unspecified dates were vaccinated with all three doses of GARDASIL. Concomitant medication reported as PROHALER. The patient experienced pain at the injection site when she received all three of her GARDASIL injections. There was no lab diagnostics studies performed. The pain was only during the injections and occurred in the physician's office and did not persist. This is one of the cases reported from same source. Follow-up information has been received from a health professional concerning the 16 year old female who on 21-MAY-2010 was vaccinated at left arm with the second dose of GARDASIL (LOT# 666121/1778Y). The health professional stated that the patient on 21-MAY-2010 experienced painful injection. No further information is available at this time of reporting. Follow-up information has been received from the patient's mother who reported that the patient complained of pain at the injection site after injection was given. There was no lab diagnostics studies performed, no illness at time of vaccination. No further information is available.
Age: 48.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Information has been received from a female physician in her late 40s who in approximately 2009 (about a year ago) was vaccinated with a second 0.5 ml GARDASIL (lot# not reported). In approximately 2009 (about a year ago) the patient experienced a "frozen shoulder" and could not lift her arm and had limited arm movement. The physician had to go to physical therapy for 6 to 8 weeks and subsequently recovered. Unspecified medical attention was sought. She did not complete the series. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Skin papilloma, Therapeutic procedure
Clinical narrative: Information has been received from a 23 year old female consumer who in approximately 2006 was vaccinated with a third dose of GARDASIL (Lot# not reported). The consumer stated that in approximately 2006, about six months after the third dose of GARDASIL was administered; the consumer experienced red itchy warts and had been experiencing these warts for "at least 4 years". The consumer also stated that the warts were frozen off by herself not by doctor. At the time of the report the patient's red itchy warts persisted. The patient sought unspecified medical attention. (also reported as "NO medical attention has been sought). 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 an unknown date, was vaccinated with a dose of GARDASIL (lot #, dose and route not reported). The physician reported that her patient developed arm pain and knots on her arm, after receiving the GARDASIL (date unspecified). The physician reported that the patient's arm was in a sling. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient with no pertinent medical history who on 21-JUL-2010 was vaccinated with a second dose of GARDASIL (Lot# unknown). The nurse reported that on 21-JUL-2010 after receiving the vaccine, the patient fainted. She stated that even after the patient woke up, the patient experienced the dizziness and nausea for an hour. There were no laboratory tests or diagnostic studies performed. The patient recovered from fainted, dizziness and nausea on 21-JUL-2010. The patient sought unspecified medical attention. Follow-up information has been received from a nurse practitioner concerning 17 year old student female with no pertinent medical history, drug reactions or allergies reported who on 19-JUL-2010 (previously reported as 21-JUL-2010) was vaccinated into the left arm at 15:30 pm. The reporter stated that the patient went to grocery store within 20 minutes of getting the second dose of GARDASIL and passed out. EMT's were called. The patient complained of dizziness and nausea for one hour. Blood pressure was 120/60. On the same date, the patient fully recovered and went home from ambulance. Patient was not transported to hospital. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Folliculitis, Papule, Rash generalised
Clinical narrative: Initial and follow-up information has been received from a dermatologist and a medical assistant concerning a 14 year old female with no medical history and no known allergies who on 16-JUN-2010 (also reported as approximately one month ago by the dermatologist) was vaccinated with the first dose of GARDASIL (lot # 662452/0671Y). There was no concomitant medication. The medical assistant reported that the patient did not have any rash on the day she received the vaccination. On 14-JUL-2010 the patient was seen by the physician in their office. The patient at that time had a rash all over her body and was referred to the dermatologist. The dermatologist reported that she did not administer the vaccine for the patient and it was given at another health care facility. On 17-JUN-2010, I day post vaccination with GARDASIL, the patient developed papules on her buttocks, shoulder, and girdle area. Dermatologist stated the patient was seen at her office and she performed a skin biopsy of the left buttock and the result was necrotizing folliculitis. The patient was placed on VALTREX therapy of 1 gram twice a day "last Friday". The patient was going to coming into the office on 28-JUL-2010 at 10:00 AM to have suture removed from her left buttock. The dermatologist stated she had never seen a case of herpetic necrotizing folliculitis from the GARDASIL vaccination before and this child had mounds of papules. At the time of the report, the patient had not recovered. The second dose of GARDASIL was scheduled 19-AUG-2010. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site nodule, Subcutaneous nodule
Clinical narrative: Information has been received from a physician for concerning a 22 year old female patient with asthma, no allergies and no medical history, who on 07-OCT-2010 was vaccinated with a first dose of GARDASIL (Lot# 666945/0886Z, Exp date. 21-NOV-2012) and on 02-DEC-2010 was vaccinated with a second dose of GARDASIL (Lot# 666945/0886Z, Exp date. 21-NOV-2012). Concomitant therapy included Asthma inhaler and DESOGEN. The physician reported  that on 02-DEC-2010 the patient experienced redness and a surface nodule at the injection site after administration of the second dose of GARDASIL. The patient was treated with warm packs applied to the area. As of 10-DEC-2010 the redness resolved and the surface nodule was gone, but at the time of the report she had a 4 by 7 mm subsurface nodule. There were no laboratories performed. At the time of the report the patient's outcome from the subsurface nodule was unknown. The patient sought unspecified medical attention. Follow-up information was received which stated that the female patient with no illness at the time of vaccination was vaccinated with a second dose of GARDASIL on 02-DEC-2010, Right deltoid, unknown time. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 05-APR-2007 was vaccinated into the left deltoid with the first dose of GARDASIL (Lot # and route not reported), on 05-JUN-2007, received the second dose into the right deltoid and on 05-OCT-2007 was vaccinated with the third dose into the left deltoid. It was reported that on 17-JUN-2008 the patient was found to have high and low risk HPV by PAP test and Atypical squamous cells of undetermined significance (ASCUS) despite given 3 doses of GARDASIL. The patient's outcome was unknown. On April 2007 a PAP test was performed (result no showed). On 17-Jun-2008 Papanicolaou test was performed which showed atypical squamous cells of undetermined significance with positive high risk HPV (HRHPV) and low risk HPV (LRHPV). On 15-Jul-2008 Papanicolaou test was performed which showed atypical squamous cells of undetermined significance with positive high risk HPV (HRHPV) and low risk HPV (LRHPV). On 10-Nov-2009 Papanicolaou test was performed which showed atypical squamous cells of undetermined significance with positive high risk HPV (HRHPV). 09-Nov-2010 Papanicolaou test was performed which showed atypical squamous cells of undetermined significance with positive high risk HPV (HRHPV). This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: Information has been received from an office manager, concerning a 14 year old female patient, who on 16-JUN-2010, was vaccinated intramuscularly with the first dose of GARDASIL (dose and route not provided) (Lot number 666110/1539Y). Concomitant therapy included PPD. On 16-JUN-2010, the patient got dizzy and fainted. The blood pressure was taken and the results were not provided. The office manager reported that the patient was recovering from fainting but still had headaches at the time of reporting. Therapy series with GARDASIL continued. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pallor, Presyncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with a history of alopecia who on 11-MAY-2010 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 662529/1317Y). There was no concomitant medication. On 11-MAY-2010, the patient experienced "near syncope" after administration of GARDASIL. The patient sought medical attention in office. The patient was given soda and was monitored. There was no diagnostics studies performed. On 11-MAY-2010, the patient was fully recovered while in the office. Follow-up information has been received from the physician concerning the female patient who on 11-MAY-2010, at 7:00 PM was vaccinated IM with the first dose of GARDASIL (lot # 662529/1317Y). Concomitant therapy included MENACTRA (lot # 43433AA). There was no illness at time of vaccination. On 11-MAY-2010, at 7:15 PM, the patient experienced "near syncope" episode after vaccine administration. Her face turned pale, BP 132/86, P 60. Approximately 15 minutes later, the patient recovered after drinking soda. The patient did not seek medical attention (previously reported as sought medical attention in office). Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 17 year old male patient with no pertinent medical history and no drug reactions or allergies, who "a couple of weeks ago" was vaccinated with a first dose of GARDASIL (Lot # not reported). There was no concomitant medication. The nurse reported that "a couple of weeks ago" the patient experienced dizziness and became diaphoretic. There was no lab diagnosis/performed. The patient was treated with cool compresses and observation in office for 15 minutes. The patient had fully recovered later the same day. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a Licensed Visiting Nurse concerning a 21 year old female patient with hypothyroidism and no drug reactions or allergies, who on 14-APR-2010 was vaccinated intramuscularly with a dose of GARDASIL (LOT# 0040Z, Expiration Date: 03-NOV-2011). Concomitant therapy included SYNTHROID. On 14-APR-2010, the patient experienced rash down to the elbow. Subsequently, on 17-APR-2010, the patient recovered from rash down to the elbow. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a registered nurse concerning an approximately 16 year old female with no known drug allergies who on 30-DEC-2009 (lot# 662229/1497X, Exp 15-APR-2011), 06-MAR-2010 (lot# 658271/0558X, Exp 21-MAR-2010), and 06-JUL-2010 (lot# 665607/1332Y, Exp 25-JUN-2012) was vaccinated IM into left deltoid with a first, second, and third dose of GARDASIL. there was no concomitant medication. The nurse stated on well check visit 30-DEC-2009, the patient's periods were documented as irregular every 20 to 60 days. The patient had not had a period, menstrual cycle, since December 2009. The nurse stated the patient told her she was not sexually active and she was not pregnant. No diagnostic laboratory tests were performed. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a registered nurse concerning a 17 year old patient with a history of missed menses and no sexual activity. It was reported that since the first dose given on 30-DEC-2009 at 15:00, the patient had not had period. This said Hx no diagnosis. At the time of this report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who in July 2008, was vaccinated with a 0.5ml first dose of GARDASIL (Lot # not reported), IM. The physician stated that the patient has started receiving GARDASIL two years ago in approximately 2008 but never completed it because she started getting severe headaches, possibly migraines and vomiting. The patient was scheduled for gastrointestinal (G.I), and neurology exams (No results reported). It was reported that the patient received unspecified treatment. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a "late teens" female who completed the GARDASIL series, 0.5ml, IM in 2007. Recently (a couple of weeks ago) the patient had a routine screening and had tested positive for HPV. Therapy was reported as continued. The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Molluscum contagiosum
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient, who on approximately 16-AUG-2010, 4 months ago", was vaccinated with a first dose of GARDASIL (route and Lot # not reported). Approximately on 15-SEP-2010 the patient received the second dose of GARDASIL (route and Lot # not reported). The physician reported that on approximately 15-OCT-2010, "two months ago", the patient was diagnosed with "molluscum contagiosum", "one month after" receiving her second dose of GARDASIL which occurred on the face and neck area. The patient was currently being treated by a dermatologist. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Local reaction, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was possibly vaccinated with once 0.5ml dose of GARDASIL (lot # not reported). On an unspecified date the patient developed a local reaction. Her upper arm was red and swollen with fever of 101 degrees F. The reaction lasted for one week. The physician was not sure if it was GARDASIL or another company's vaccine. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine leiomyoma
Clinical narrative: This report was received from Abbott concerning a 16 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Shortly after the vaccination the patient developed uterine fibroids. It was unknown of the patient had sought medical attention. The status of the patient was unknown. This was originally reported by a consumer. No further information is available.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an approximately 12 year old patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (therapy route and lot # not provided). It was reported that the patient passed out after being given GARDASIL, the patient sought unspecified medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a 20 year old female patient reported herself who completed the vaccination schedule for GARADSIL. After that, in June 2009 she experienced abnormal PAP Smears. No lot number provided. The patient sought unknown medical attention. At the time of report the patient's status was not recovered. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head injury, Headache, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a nurse concerning her 12 year old daughter who on "summer of 2007" approximately June 2007, was vaccinated with a first dose IM of GARDASIL (Lot#, not reported), the patient did not have side effects. On an unspecified date the nurse's daughter received the second dose of GARDASIL (Lot# not reported), she fainted and 4 months later, after her third dose of GARDASIL (Lot#: not reported), the nurse's daughter fainted, blacked out and hit her head. 24 hours after this happened, she got her period and was nauseous, vomiting, had headaches and got dizzy. The nurse's daughter did not seek medical attention. At time time of the report, the nurse's daughter was recovering. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from a nurse concerning her 12 year old daughter who on "summer of 2007" approximately June 2007, was vaccinated with a first dose IM of GARDASIL (Lot#, not reported), the patient did not have side effects. On an unspecified date the nurse's daughter received the second dose of GARDASIL (Lot# not reported), she fainted and 4 months later, after her third dose of GARDASIL (Lot#: not reported), the nurse's daughter fainted, blacked out and hit her head. 24 hours after this happened, she got her period and was nauseous, vomiting, had headaches and got dizzy. The nurse's daughter did not seek medical attention. At time time of the report, the nurse's daughter was recovering. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient with "fear of needles" who on 18-MAR-2008, was vaccinated with the first dose of GARDASIL, on 19-MAY-2008, with the second dose of the vaccine, on 20-DEC-2008, with the third dose of the vaccine and on 29-JUN-2009, with a fourth dose of the vaccine. The nurse reported that the patient fainted right after receiving the first, second and third doses of GARDASIL and was fine after the 4th one. The event improved. The patient recovered the same day of vaccinations. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a certified medical assistant and an unspecified reporter, concerning a 22 year old patient who on 06-JAN-2010 was vaccinated with the first dose and on 03-MAR-2010 with the second dose of GARDASIL (lot # 663558/0819Y). On 14-JUN-2010 the patient went to get the third dose and complained of "having a bump" where the second injection was given. The red bump at injection site has not resolved after 2 months (also reported as "three to four months later the patient still has a red bump"). Follow up information was received from the certified medical assistant who reported that the on 06-JAN-2010 and 03-MAR-2010, the 23 year old female patient (also reported as 22 year old) with no known allergy was vaccinated with the first and second doses of GARDASIL respectively (lot # 663558/0819Y) IM into her left deltoid. There was no known illness at time of vaccination. On 06-JAN-2010, the patient also received a dose of H1N1 IM into her right deltoid (lot # 10132859) and the first dose of FLUZONE IM into her right deltoid (lot #U32711A). The patient called and was concerned about getting the third dose of GARDASIL shot. The patient said that after the second dose was given on 03-MAR-2010, the patient experienced a red bump and was a little tender. At the time of reporting, the outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient who on unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL. The nurse reported that the patient received her first dose of GARDASIL and the patient was menstruating upon being vaccinated but for about a month after being vaccinated the patient was still menstruating. According to the nurse, GARDASIL was the only change. At the time of the report the patient was not recovered. The patient sought medical attention by a visit to the doctor's office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Injection site pain, Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on unspecified date was vaccinated with a third dose of GARDASIL (Lot# unknown) 0.5mL, IM. Series completed. The physician reported that an unspecified date "the patient had a welt from swelling on her arm and experienced soreness at the injection site after receiving the GARDASIL injection. The adverse experienced lasted for three weeks and went away without any additional treatment. The patient experienced welt from swelling on her arm and soreness at the injection site only on the third injection of the GARDASIL series". At the time of the report patient had recovered from swelling on her arm and soreness at the injection site (date unknown). The patient did not sought medical attention. Follow up information has been received from a health professional who reported that the patient was vaccinated in the left upper arm with the third dose of GARDASIL (lot number was reported as 664242/0908Y, valid for ROTATEQ not for GARDASIL) on 08-OCT-2009 at 9:40. In the morning of 09-OCT-2009 a lump developed on the injection site. The site was hard and very hard to touch. The health professional reported that it went away after 2-3 weeks (approximately on 30-OCT-2009). No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who was vaccinated intramuscularly with three doses of GARDASIL (lot#s not reported) with schedule as 2 months, 4 months and 6 months. On an unknown date, the patient came back for Papanicolaou test and it presented with C1N1. Unspecified medical attention was sought. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who in "approximately February 2008", was vaccinated IM with the first dose of GARDASIL (lot # not reported), 0.5 mL. There was no concomitant medication. Subsequently the patient experienced "a true anaphylactic reaction" and was hospitalized (length and place of hospitalization unspecified). Subsequently, the patient recovered from "a true anaphylactic reaction". The patient only received the first dose of GARDASIL. Unspecified medical attention was sought. Follow up information from a nurse practitioner stated that the patient had no past medical history. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Depression
Clinical narrative: Information has been received from a physician who was not the administering physician concerning a 14 year old female patient who on 04-APR-2008 was vaccinated with the first dose of GARDASIL (Lot# 659982/1740U, expiration unspecified) and a dose of Tdap (manufacturer unknown). On 11-JUN-2008 the patient was vaccinated with the second dose of GARDASIL (Lot# 650553/0070X, expiration date unspecified) and a dose of MENACTRA (manufacturer unspecified). The physician reported that the patient was seen in the office in December 2008 and was taking ZOLOFT (manufacturer unspecified) at the time. Now the patient came into the office to day on 21-JUN-2010 and the mother of the patient stated that the patient would not received the third dose of GARDASIL since she was diagnosed with depression and polyarthralgia. The physician reported that the patient was now taking WELLBUTRIN (manufacturer unspecified), CYMBALTA (manufacturer unspecified) and NEURONTIN (manufacturer unspecified). The physician reported that the patient was not on ZOLOFT any longer and he did not believe GARDASIL caused the patient to have depression. At the time of report the patient's status was unknown. Additional information has been received from the physician indicated that the patient received GARDASIL vaccinations in his office. In December 2008 the patient complained of joint pain. The physician stated that the patient was referred to a psychiatrist for depression. The patient was being treated for her depression with WELLBUTRIN and CYMBALTA therapies and was on therapy with NEURONTIN for polyarthralgia. The physician stated that the psychiatrist has prescribed the medication. The physician stated the patient's depression and polyarthralgia was controlled while on the prescribed medications. The physician stated that another physician in his practice was the patient's physician. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a register nurse concerning a 19 years old female patient, who was vaccinated with the complete doses of GARDASIL. The nurse reported that on an unspecified date a PAP smear test was performed, the patient tested positive for HPV. One of the strains she tested positive was strain 16 (along with many other strains of HPV). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who 3 weeks ago on approximately 31-MAY-2010, was vaccinated with a first dose of GARDASIL. The pharmacist reported that the patient developed itching the follow day on approximately 01-JUN-2010 and later the patient developed a rash. At the time of the report the rash still persisted and the patient was recovering from itching. The patient sought medical attention by an office visit. Follow-up information was received from the registered pharmacist who stated that the physician was taking care of reporting the adverse event and that he was not familiar with the case and did not even know the patient's name. No further information is available.
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 "three doses" of GARDASIL (Lot# unknown), 0.5mL, IM. The physician reported that the patient was using GARDASIL and on an unspecified date experienced syncope. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female patient with no pertinent medical history, who on "07 June or 08 June 2010", was vaccinated with a first dose of GARDASIL (Lot# unknown). The nurse reported that "after receiving the first dose of GARDASIL on 07 June or 08 June 2010, the patient passed out. Was also stated that the patient felt lightheaded so they laid her down and then on 07 June or 08 June 2010 the patient recovered". The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Cervical dysplasia, Culture, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with "all three doses" of GARDASIL (Lot# unknown) at a different physician office. The physician reported that the patient received the GARDASIL series before becoming sexually active. The patient had an abnormal pap smear and on an unspecified date was referred to the reporting physician who "did a culture test" (results not provided). The physician also stated that the patient had four-quadrant dysplasia and the biopsy results were still pending. The patient did not seek medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated on her right arm with a first 0.5 mL dose of GARDASIL (LOT# not reported). Right after injection, the patient experienced numbness on her right side of the body that lasted one day. Unspecified medical attention was sought. The patient did not want to receive any more doses of GARDASIL. No further information was provided. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain, Syncope
Clinical narrative: Information has been received from a physician concerning an 19 year old patient who on 14-JUL-2010 was vaccinated with a third dose of GARDASIL (route not reported and lot number: 661758/0968Y, expiration date: 14-FEB-2011). On 14-JUL-2010 after vaccination the patient experienced a syncopal episode. Also, the patient had severe abdominal pain after the syncopal episode. The patient went  to the Emergency Room, but the pain resolved within 1 hour after the GARDASIL was given. The patient was not admitted to the hospital. The physician reported that the patient received the second and third dose late (second dose date unspecified). On 14-JUL-2010, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer reporting that her daughter, who was vaccinated with GARDASIL (lot #, route and dose not reported) "few years ago", had experienced hair loss. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a registered nurse concerning an approximately 13 year old female who on 30-DEC-2009 (lot# 662229/1497Z, Exp 15-APR-2011), 06-MAR-2010 (lot# 658271/0558X, Exp 21-MAR-2010), and 05-JUL-2010 (lot# 661530/0575X, Exp February 2011) was vaccinated IM into left deltoid with a first, second, and third doses of GARDASIL. The patient's menstrual cycle was delayed for 4 to 5 weeks after her second dose of GARDASIL. The patient told nurse that her menstrual cycle did resume. The patient's outcome was not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning an 17 year old female who in December 2009 completed her 3 doses of 0.5ml GARDASIL. In February 2010, the patient had symptoms of inguinal lymph nodes. The patient went to the doctor's office. At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old male patient with asthma who on 08-JUL-2010 was vaccinated IM with a 0.5 ml single dose of GARDASIL in his left arm. On 09-JUL-2010 after vaccination the patient developed a blister on his left arm, approximately two inches away from the injection site. This patient was also vaccinated with a dose of MENACTRA and a dose of Tdap (manufacturer unknown) in his right arm on 09-JUL-2010. Patient sought medical attention on 09-JUL-2010 after the physician's office had closed via phone call. At the time of report the patient had not returned to the physician's office for follow up and the status was unknown. The medical assistant also reported that other patients that had similar reaction, said she had heard about them but did not see them. She thought there was 2 more patients. She did not know what vaccines had been given (if they were Merck drugs) or any other details, other than they had blisters near the injection sites also. Additional information has been requested. This is one of several reports from the same source.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no drug reactions/allergies, who in December 2007, was vaccinated with the third dose of GARDASIL (Lot # not reported). Concomitant therapy included NUVARING. The physician reported that the patient was testing positive for high grade HPV. PAP tests were performed in July 2008 and in October 2009 results were normal, PAP test was performed on 19-NOV-2010 result was abnormal. The patient did not seek medical attention. At the time of the report, the patient had not recovered. The physician said this was the 15th patient she had seen who had received 2 doses of GARDASIL at least 3 years ago but was now testing positive for HPV. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female patient, who in approximately June 2009, "one and a half years ago" (also reported as last summer), was vaccinated with a dose of GARDASIL (Lot # not reported). The pharmacist stated that his niece was experiencing abdominal cramping. He stated that she was going to be seen by the physician the next day. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 12-DEC-2007, 13-FEB-2008 was vaccinated IM with the first and second dose of GARDASIL (lot # not reported), respectively. On 30-JUN-2008 the patient was vaccinated with the third dose of GARDASIL (lot # 660553/0070X, expiration date October 2010). Concomitant therapy included loratadine and TRI-LEVLEN. In MAY 2009 the patient had Papanicolaou (PAP) smear done. The PAP was normal but the human papillomavirus (HPV) reflux did not meet the criteria and was not performed. On 29-DEC-2010 another PAP smear was done which was abnormal and the patient's HPV DNA was positive for high risk HPV. The patient sought unspecified medical attention. The patient did not recover at the time of reporting. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Local reaction
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 23 year old female with abnormal cervical cell result and no drug allergies who on 06-OCT-2010 was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL, on 08-DEC-2010 was intramuscularly vaccinated with the second 0.5 ml dose of GARDASIL (lot # 666595/0992Z, exp date 14-OCT-2012). Concomitant therapy included birth control pills. The reporter stated that patient experienced local reaction around injection site after receiving second dose of GARDASIL on 08-DEC-2010. Patient called next day to complain of the tenderness around the injection side and little bump. Patient was prescribed TYLENOL and told to apply ice pack. Patient came in on 21-DEC-2010 for an office visit and bump around the injection was still present. Tenderness to touch was also noted. No lab diagnostics studies were performed. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 19-MAR-2010 was vaccinated intramuscularly into the right arm with a first 0.5 ml dose of GARDASIL (lot # not reported). There was no concomitant medication, it was reported that the patient received her first dose of GARDASIL on her right arm and was fine until on 15-JUL-2010 she reported that now her left leg was tingly and had some soreness in her left arm. The patient sought unspecified medical attention. No lab test performed. As of 15-JUL-2010 the patient had not recovered, the patient decided not to receive other doses. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bronchitis, Dyspnoea
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 (Lot # not reported). The physician stated that the patient developed bronchitis, shortness of breath and possible bronchospasm. The patient said that might have been sick before receiving the vaccination. The patient went to an emergency room and was discharged with antibiotics. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a physician concerning a 15 year old female student who the morning of 09-NOV-2010 received a dose of GARDASIL (lot number: 666163/0664Z) intramuscularly in her left arm. It was unknown if the patient sought medical attention. Follow up information has been received from a health professional reported the patient had not yet received the second dose of GARDASIL. She had a reaction to the first dose of GARDASIL. At the time of the report, the outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a physician who reported that the patient received the second dose of GARDASIL on unreported time with no adverse problems reported. This is one of several reports from the same source. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route no reported). The physician reported that the patient received the first dose and had a lump at the injection site. At the time of the report, the outcome of the patient was not reported. The patient did not seek medical attention. Follow up information has been received from a health care professional concerning the 17 year old female patient with allergy to morphine, who on 22-DEC-2010 at 14:00 was vaccinated with the second dose of GARDASIL (Lot # 666595/0992Z) in the left deltoid. On 27-DEC-2010 the patient developed a lump at the site of injection which required emergency room/doctor visit. The patient recovered on 04-JAN-2011. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Full blood count, Headache, Lipase
Clinical narrative: Information has been received from a physician concerning a 17 year old female with lyme disease who on 12-JUL-2010 was vaccinated with the first dose of GARDASIL (therapy dose, site and route unknown). Concomitant therapy included hormonal contraceptives (unspecified) and ZANTAC. On 12-JUL-2010 after receiving the first dose the patient experienced headaches, fainting, dizziness and abdominal pain. The patient sought medical attention, complete blood count, "CMT", lipase and urine analysis were done (results unknown). At the time of this report, the patient's headache and fainting and dizziness and abdominal pain persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Urine analysis
Clinical narrative: Information has been received from a physician concerning a 17 year old female with lyme disease who on 12-JUL-2010 was vaccinated with the first dose of GARDASIL (therapy dose, site and route unknown). Concomitant therapy included hormonal contraceptives (unspecified) and ZANTAC. On 12-JUL-2010 after receiving the first dose the patient experienced headaches, fainting, dizziness and abdominal pain. The patient sought medical attention, complete blood count, "CMT", lipase and urine analysis were done (results unknown). At the time of this report, the patient's headache and fainting and dizziness and abdominal pain persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a physician assistant concerning her 17 year old niece who on an unspecified date, was vaccinated IM with GARDASIL (lot# not reported) at another physician's office. Subsequently the patient experienced heart palpitations. Subsequently, the patient recovered from heart palpitations. The patient sought unspecified medical attention. Additional information has been requested.