chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female, with unknown medical history, who was vaccinated with a dose of GARDASIL (Lot # unknown). Subsequently, on an unknown date, the patient experienced itchiness at the injection site. The nurse did not administer the vaccine herself. It is unknown if the patient sought medical attention. Outcome unknown. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, No adverse event, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female with unknown medical history, who was vaccinated with the three dose regimen of GARDASIL (Lot # unknown). Subsequently, on an unknown date, the patient had an abnormal pap smear test, result in which she was positive for low-grade dysplasia and HPV. The patient sought unspecified medical attention. Outcome unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow up information has been received from a certified medical assistant.  The medical assistant reports that "no AE, since they recently found out patient was sexually active and did not want her mom to know so she denied it previously (at time of vaccination).  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil (Lot# 658556/1060U).  Subsequently, the patient experienced pain in arm and trouble lifting the arm.  At the time of the report, the outcome of the patient was unknown.  This is one of two reports from the same source.  Additional information has been requested. Initial and follow-up information has been received from a physician and a certified medical assistant concernign a 71 year old female with an allergy to PERCOCET, who on 28-NOV-2007 and 19-FEB-2008 was vaccinated with a first and second dose of HPV vaccine (lot# 658556/106oU), respectively. The physician reported that on 19-FEB-2008 the patient experienced mild pain of the entire left arm, and severe pain at the injection site. The patient used MOTRIN intermittently and was offered physical therapy, which the patient decline. The certified medical assistant reported that on "13-APR-2008" the patient experienced pain in the arm, slight weakness, and left shoulder pain. The patient recovered from severe arm pain at the injection site, and mild pain of the entire left arm in April 2008 and the outcome for pain in arm, slight weakness, and left shoulderpain were not reported. The medical assistant considered the left shoulder pain, arm pain, and slight weakness to be disabling. This is an amended report.The physician was made to be the primary reporter. This is one of two reports from the same source. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner and a certified medical assistant concerning a 25 year old female student (weight 193#, height 63") with penicillin allergy who on approximately 14-MAR-2008 was vaccinated with her first dose of Gardasil intramuscularly (lot number and site of administration not reported). Concomitant medication was not reported. About an hour after being vaccinated the patient developed a full body rash.  The patient sought unspecified medical attention on an unspecified date.  The patient has recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  On 14-MAR-2008 at 11 am, within 45 minutes (also reported as about an hour) after being vaccinated, the patient developed a full body rash. The patient returned to the clinic for evaluation and the rash was already starting to disappear. On an unspecified date, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse in a doctor's office concerning a female (age not specified) patient who on approximately 17-MAR-2008 was vaccinated with Gardasil (dose number unknown) (lot number, route and site of administration not specified) and then fainted.  The patient's outcome is unknown.  No additional information was available.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no history of drug reactions or allergies who on 04-OCT-2007 was vaccinated with her first dose of Gardasil intramuscularly (Lot #658282/1263U).  Concomitant suspect therapy included ACCUTANE.  On 04-OCT-2007, after the vaccination, the patient fainted twice in
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Hypoaesthesia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician, concerning his 27 year old daughter with no pertinent medical history and no known allergies, who "six to eight weeks ago" was vaccinated with a dose of GARDASIL (lot # not reported). There was no concomitant medication. On approximately 12-MAR-2008 ("about one week ago"), this daughter developed bilateral numbness of the feet and lower legs, that "seems to be worse in the evening." Unspecified blood tests were preformed, with normal results (date not provided). The physician stated that his daughter was being followed by a neurologist. No further information was available. At the time of this report, the physician's daughter had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient (age not specified) who in March 2008 ("within the past week"), was vaccinated with the first dose of Gardasil (lot # not reported).  On the same day of vaccination, the patient developed an injection site reaction described by the patient's mother as swollen and red from the shoulder to the elbow, with a blister at the injection site.  The mother called the physician's office, and the physician told her to discontinue the series.  Subsequently, the patient recovered from the events (duration not specified).  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Early sexual debut, Hyperemesis gravidarum, Injection site haemorrhage
Clinical narrative: Information has been received from a certified medical assistant, via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. The patient's pregnancy was confirmed by an ultrasound (date not reported). She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, irregular spotting and bleeding was ongoing; the outcome of vomiting was not specified. The patient was seen at the physician's office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2009. Initial and follow up information has been received from a certified medical assistant and a registered nurse, certified. Via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. There were no previous pregnancies. In February 2008, the pregnancy was confirmed by a pregnancy test, and on 11-MAR-2008, the patient had and ultrasound that was "normal for dates, placenta, amniotic fluid good." She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, the outcome of irregular spotting and bleeding and the outcome of vomiting was not specified. The patient was seen at the physician's office, and was currently living in a treatment shelter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy with young maternal age, Ultrasound uterus
Clinical narrative: Information has been received from a certified medical assistant, via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. The patient's pregnancy was confirmed by an ultrasound (date not reported). She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, irregular spotting and bleeding was ongoing; the outcome of vomiting was not specified. The patient was seen at the physician's office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2009. Initial and follow up information has been received from a certified medical assistant and a registered nurse, certified. Via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. There were no previous pregnancies. In February 2008, the pregnancy was confirmed by a pregnancy test, and on 11-MAR-2008, the patient had and ultrasound that was "normal for dates, placenta, amniotic fluid good." She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, the outcome of irregular spotting and bleeding and the outcome of vomiting was not specified. The patient was seen at the physician's office, and was currently living in a treatment shelter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient (age not specified), who in October 2007, was vaccinated in her deltoid region, with the first dose 0.5 ml, of GARDASIL (lot # not specified). The following day, she developed a rash on her buttocks. She sought the medical advise of her physician. The patient refused to continue the series, because of the rash. At the time of this report, the outcome of the event was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 16 or 17 year old female who in March 2008, was vaccinated IM with a 1st dose of Gardasil (lot# not reported).  In March 2008, the patient fainted after receiving her vaccination.  Subsequently, the patient recovered from fainted and was fine before leaving the office.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated 0.5mL, IM with GARDASIL (dose and lot# not reported). Subsequently the patient experienced pain in the arm (left or right not specified) after her vaccination (unspecified if immediately or several days later). Subsequently, the patient "improved" and was able to use her arm by the time she left the office (unspecified if day of vaccination or several days later). The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 25 year old female who on 15-JAN-2008 was vaccinated IM, 0.5mL with a 1st dose of Gardasil (lot# 6582219/0755U).  On 17-MAR-2008 the patient was vaccinated IM, 0.5mL with a 2nd dose of Gardasil (lot# 654272/0073X).  Concomitant therapy included hormonal contraceptives (unspecified) and TWINRIX "given in the other arm".  On 17-MAR-2008 the patient experienced soreness, redness and a bump under skin size of a dime at injection site.  The patient's soreness at injection site and redness at injection site and bump under skin size of a dime at injection site persisted.  On an unspecified date, the patient sought unspecified medical attention at her physician's office.  The patient was treated with ice.  At the time of this report the patient had not recovered from the reaction.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the third dose of GARDASIL (lot not reported). Later that night the patient experienced temperature of 103 degrees, nausea and vomiting. The patient's status was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Follow-up information received indicated that the 18 year old female student who had no previous medical history had received the third dose of GARDASIL (lot #659657)/1487U) IM in the deltoid on 25-Mar-2008 at 3:30 p.m. The patient's symptoms started at 11:45p.m. on the same day. She had a fever of 100.3 and vomiting. She felt ok prior to the injection and had no problems with previous injections. The patient reported the symptoms to the physicians office the day after vaccination, on 26-Mar-2008. Unspecified medical attention was sought at the doctors office. She was diagnosed with a virus. Subsequently, the patient recovered on 27-Mar-2008. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received  from a company representative concerning a female who on 30-MAR-2007 was vaccinated with her first dose of GARDASIL (lot# unspecified) and experienced dizziness and chest pain. On 30-May-2007, the patient was vaccinated with her second dose of GARDASIL (lot# unspecified) and again experienced dizziness and chest pain. It was reported that the patient refused her third dose. At the time of this report the outcome was unknown. No further information was provided. Additional information has been requested.  4/29/2008 MR received from PCP for multiple OVs 3/30/07-3/18/08.  First seen in F/u for ER visit 3/28/07 for viral infection.  Elevated HR note in ER. DX: URI,  ? Heart murmur.  HPV#2 given 5/30/07. Seen 1 week later for URI and Tachycardia.  ? Hypothyroidism. Seen again 6/13/07 with Tachycardia and palpitations.  Refered to cardiology. Dx: Asthma 8/13/07. Seen again 2/15/08 for chest pain. DX: ? Esophagitis, ? Anxiety and 2/21/08 for dizziness and shaking. ? Anxiety. 5/22/08 Cardiac consult of 8/28/2007 recd with DX: Non-specific tachycardia, no evidence of arrhthmia or cardiac disease. Pt presented with c/o intermittent, brief heartrate increases which have occurred every week or 2 for the past few months. PE (+) for S3 at the apex in the supine position, otherwise WNL.
Sex: F
Vaccine: HPV4
Symptoms: Drug screen positive
Clinical narrative: Information has been received from a nurse concerning a female who on unspecified date was vaccinated with her first dose of GARDASIL (lot#unspecified). Concomitant therapy included DEPAKOTE, ZOLOFT and PRILOSEC. On unspecified date the benzodiazepine drug test was performed. It was reported that the patient's benzodiazepine drug test came back positive even though she did not take any benzodiapine drugs. the only new drug that she received prior to the test was the first dose of GARDASIL. She has not yet received the second dose. Unspecified medical attention was sought in physician's office. No further information is available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who in mid February 2008 was vaccinated with GARDASIL (lot # not reported) and MENACTRA (lot # not reported).  It was reported that "the patient fainted shortly after the vaccine was administered."  The patient fully recovered while still in the office.  No product quality complaint was involved.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 22 year old female who on 14-MAR-2008 was vaccinated by injection with a first dose of Gardasil (lot # not reported) and fainted 15 minutes later.  No product quality complaint was involved.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a certified nurse midwife concerning a 23 year old female with no known drug allergies, who on 10-AUG-2007 was vaccinated with a first dose of Gardasil (Lot # unknown) at another office.  On 13-NOV-2007 and 20-FEB-2008 the patient was vaccinated in the left deltoid with a second and third dose of Gardasil (Lot # 659437/1266U & 659655/1486U), respectively.  Concomitant therapy included SEASONIQUE, CYMBALTA and VALTREX, as needed.  On 13-NOV-2007 and the 20-FEB-2008 the patient experienced swelling between fingers of injected arm that lasted 2 days each time.  The swelling between the pointer and middle finger had small bumps on skin.  It was noted that the adverse events were less intense after each injection.  The outcome was reported as recovered.  There were no illnesses at the time of the vaccination.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Feeling abnormal, Heart rate increased
Clinical narrative: Information has been received from a medical assistant, via a company representative, concerning an 11 or 12 year old female patient who in approximately late January or early February 2008, was vaccinated with the first dose of GARDASIL (lot # not reported).  She broke out in a cold sweat, was in a daze and had an elevated heart rate.  The patient stated that she had not eaten yet that day.  The outcome of the event was not specified.  This is one of several reports received from the same source.  Additional information is not expected.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Dizziness, Heart rate decreased
Clinical narrative: Information has been received from a medical assistant, via a company representative, concerning a female patient (age not specified), who in late December 2007 or early January 2008 was vaccinated with the first dose of GARDASIL (lot # not reported).  Concomitant therapy included an unspecified vaccine.  Following the vaccination, she became dizzy and her heart rate dropped.  The patient stated that she had not eaten yet that day.  The outcome of the events was not specified.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Pyrexia, Swelling face
Clinical narrative: Information has been received from a nurse concerning a 24 year old female with allergies to amoxicillin, penicillin, clarithromycin (BIAXIN) and IMITREX, who on 14-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 655154/1210U; site not reported).  There was no concomitant medication.  On 15-FEB-2008 (also reported as 13 hours post vaccination) the patient experienced fever of 102F, swelling of face and swelling of neck.  The symptoms lasted for 2 days, and the patient recovered from the fever of 102F, swelling of face and swelling of neck.  The patient sought unspecified medical attention in the ER.  No further information is available.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on approximately 19-MAR-2008 was vaccinated IM with the first dose of Gardasil (lot# not reported).  On approximately 19-MAR-2008 the patient experienced nausea.  The patient sought unspecified medical attention in the physician's office.  Subsequently, the patient recovered from nausea.  Per the reporter, the patient was followed up with the next day by phone and that she did not describe any additional adverse events.  No additional information is available.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 12-MAR-2008 was vaccinated with her first dose of GARDASIL (lot # and site unknown).  On 18-MAR-2008 the patient "fainted before she left the office".  The patient sought unspecified medical attention.  No further information was provided.  Additional information has been requested. This is a follw-up to the report (s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician concerning a 17 year old femal, with a history of a syncopal episode (approximately 2006) and with mild anemia, who on 12-MAR-2008 was vaccinated intramuscularly in the right arm with her first dose of GARDASIL (lot # 659180-1758U). Concomitant theroy included vaccination in the left arm with a first dose of VARIVAX (Oka/Merck) (Lot # reported as1656U). On 12-MAR-2008 the patient "fainted before she left the office". The reporter indicated the patient's mother was contacted on the night of 12-MAR-2008, and the patient had recovered. The patient had mild anemia and on 14-MAR-2008, the patient had a CBC, ferritin and TRH testing which were normal. No additional informaton is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Breast cyst
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who, on an unspecified date, was vaccinated intramuscularly with her first dose of GARDASIL.  The patient discovered a cyst in one of her breasts sometime after receiving the vaccination.  The patient sought unspecified medical attention in the office.  No other information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pain in extremity, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL (Lot #, dose, and site not reported). Subsequently the "patient experienced extreme pain in the arm, nausea, dizziness and vomiting. The pain was so bad that she went to the ER". No additional information was provided. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Erythema, Familial risk factor, Pain in extremity, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 21-FEB-2008 was vaccinated intramuscularly in her left arm with a first dose of GARDASIL (Lot # unknown) and vaccinated subcutaneously in her left arm with a second dose of VARIVAX (Lot # unknown). Less than 24 hours later, on approximately 21-FEB-2008, the patient's bicep became very painful and very red. She also experienced syncope and dizziness. It was also reported that the patient's brother (WAES No. 0803USA03075) experienced similar symptoms with a 2nd dose of Varicella virus vaccine live. Outcome unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Ear discomfort, Flushing, Nausea, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no medical history and no known drug reactions/allergies reported, who on 03-JAN-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot # unknown).  No concomitant medication were reported.  The patient left the office and at home on 03-JAN-2008 became flushed, shaky, burning ears, threw-up and was light-headed.  The patient rested, got something to drink and felt better later the same day.  The office discovered the adverse reaction when the patient called for the second vaccination.  Subsequently, on 03-JAN-2005, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a registered nurse and the mother of a 14 year old female student, with no medical history, no known drug reactions/allergies reported, and no illnesses prior to vaccination, who in the PM on 03-JAN-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot # unknown). On 11-APR-2008 the patient was vaccinated intramuscularly with a second dose of GARDASIL (Lot # unknown). No concomitant medication were reported. The patient left the office and at home in the PM on 03-JAN-2008 became flushed, shaky, burning ears, nauseated, threw-up (1X) and was lightheaded. The patient rested, got something to drink and felt better later the same day. The office discovered the adverse reaction when the patient called for the second vaccination. Subsequently, on 03-JAN-2008, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no medical history and no known drug reactions/allergies reported, who on 03-JAN-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot # unknown).  No concomitant medication were reported.  The patient left the office and at home on 03-JAN-2008 became flushed, shaky, burning ears, threw-up and was light-headed.  The patient rested, got something to drink and felt better later the same day.  The office discovered the adverse reaction when the patient called for the second vaccination.  Subsequently, on 03-JAN-2005, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a registered nurse and the mother of a 14 year old female student, with no medical history, no known drug reactions/allergies reported, and no illnesses prior to vaccination, who in the PM on 03-JAN-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot # unknown). On 11-APR-2008 the patient was vaccinated intramuscularly with a second dose of GARDASIL (Lot # unknown). No concomitant medication were reported. The patient left the office and at home in the PM on 03-JAN-2008 became flushed, shaky, burning ears, nauseated, threw-up (1X) and was lightheaded. The patient rested, got something to drink and felt better later the same day. The office discovered the adverse reaction when the patient called for the second vaccination. Subsequently, on 03-JAN-2008, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Drug hypersensitivity, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a "23 year old female" with unknown medical history, who was vaccinated intramuscularly with a first dose of Gardasil (Lot # unknown).  Subsequently on an unknown date, the patient experienced nausea and vomiting for two days and was diagnosed with fever (of 101 degrees) after receiving the first dose.  Outcome reported as recovering.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested. 02/17/2010 On 10-OCT-2007, the patient experienced nausea and vomiting and a fever of 101 x 2 days. The signs and symptoms went away without any problems. Unspecified medical attention sought. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Swollen tongue
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a second dose of Gardasil (lot # not provided).  The patient developed a swollen tongue and edema of the extremities after receiving the second dose.  Subsequently, the patient recovered from a swollen tongue and edema of the extremities.  The patient contacted the pharmacy for medical attention.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a "high-risk" female (age unknown) with an early history of a HPV positive pap smear, followed by a "cleared" HPV pap smear (dates of testing not provided) who was then vaccinated with an unknown number of doses of GARDASIL (Lot # unknown).  It was reported that the patient may have received 2 doses.  Post vaccination, on an unspecified date, the patient had a positive HPV result on pap smear.  The patient sought unspecified medical attention in the doctor's office.  The patient's outcome was reported as not recovered.  No product quality complaint was involved.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a company representative concerning a female who on an unspecified date was vaccinated with 2nd dose of Gardasil (lot# not provided).  Subsequently the patient experienced felt faint.  The patient outcome was not reported.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 11-MAR-2008 was vaccinated with Gardasil (lot# not provided).  On 11-MAR-2008 as the patient left the practice she fainted and hit her head on a curb.  The resulting injury to her head required treatment at an emergency room.  The patient had 15 sutures.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a health professional concerning approximately 15 patients who on an unspecified date were vaccinated IM with GARDASIL (dose and lot#s not reported). It was reported that post vaccination on an unspecified date the patients developed itching and redness at the injection site. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Menstruation irregular, Metrorrhagia, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician, through the Pregnancy Registry for GARDASIL, concerning a 25 year old female who on 30-JAN-2008 was vaccinated with her first dose of GARDASIL (Lot # and route not reported). At the time of vaccination, the patient reported that she did not have her period for 3 months. A few days after her vaccination, the patient experienced spotting and went to the emergency room. A pregnancy test was administered and was positive (LMP approximately 05-Nov-2007). The patient was not admitted to the hospital. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a female who in August 2007, was vaccinated intramuscularly with a first dose GARDASIL (lot # not reported). There was no concomitant medication. It was reported that "two weeks after receiving her first dose of GARDASIL (lot # not reported), the patient presented with headaches and two weeks after that had an MRI done. Subsequently, the patient recovered from headaches a "couple weeks after the first dose." The patient still received her second dose of GARDASIL (lot # not reported) in October 2007 and had no adverse experience afterwards." No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with her first dose of GARDASIL (Lot # and route not reported). On an unspecified date, the patient developed diarrhea. The diarrhea resolved in one week without requiring treatment, and the patient fully recovered. The patient sought unspecified medical attention by contacting the physician by phone. No further information is available. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female who on unspecified dates was vaccinated with her first two doses of Gardasil (Lot # and route not reported). The patient experienced burning at the injection site during her second vaccination with Gardasil. The injection site became fevered, red and swollen with 2x3" knot after the second vaccination. The patient was treated with and ice pack and MOTRIN. The patient recovered in 4 days. On 05-MAR-2008 the patient was vaccinated intramuscularly in the left deltoid with her third vaccination of Gardasil (Lot # not reported). The patient experienced burning at the injection site during her third vaccination. The injection site became fevered, red and swollen with a 2x3" knot after the third vaccination. The patient was treated with ice pack and MOTRIN. The patient recovered in 4 days. The patient sought unspecified medical attention by calling the office. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female who on unspecified dates was vaccinated with her first two doses of Gardasil (Lot # and route not reported). The patient experienced burning at the injection site during her second vaccination with Gardasil. The injection site became fevered, red and swollen with 2x3" knot after the second vaccination. The patient was treated with and ice pack and MOTRIN. The patient recovered in 4 days. On 05-MAR-2008 the patient was vaccinated intramuscularly in the left deltoid with her third vaccination of Gardasil (Lot # not reported). The patient experienced burning at the injection site during her third vaccination. The injection site became fevered, red and swollen with a 2x3" knot after the third vaccination. The patient was treated with ice pack and MOTRIN. The patient recovered in 4 days. The patient sought unspecified medical attention by calling the office. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Attention deficit/hyperactivity disorder, Dry skin, Eye rolling, Flushing, Headache
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on 26-MAR-2008 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot # not reported).  On 26-MAR-2008 the patient fainted 1 minute after receiving the vaccination.  The patient sought unspecified medical attention by speaking to a nurse.  Subsequently, the patient recovered (duration not specified).  Additional information has been requested. 02/17/2010 Information has been received from a physician and a healthcare professional, concerning a 14 year old female patient, a student with attention deficit disorder, who on 26-MAR-2008 at 4:00 pm, was vaccinated IM in the right deltoid, with the first dose 0.5ml, of GARDASIL (lot # 655327/1287U), The patient stepped off of the table, sat in a chair and "within approx. 10 seconds," stated "my head hurts." Her face became flushed, her eyes rolled back, and "she experienced a syncopal episode which lasted approx 10 se." She was assisted to the table. Vital sign lincluded blood pressure of 102/60 mmHg, heart rate 70. In 5 minutes, her BP was 118/70 mmHg and heart rate with 76. She stated she felt fine, her skine was pale and dry, and after 30 minutes, she left the office. The patient was considered to haver recovered the same day. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope, Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on 26-MAR-2008 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot # not reported).  On 26-MAR-2008 the patient fainted 1 minute after receiving the vaccination.  The patient sought unspecified medical attention by speaking to a nurse.  Subsequently, the patient recovered (duration not specified).  Additional information has been requested. 02/17/2010 Information has been received from a physician and a healthcare professional, concerning a 14 year old female patient, a student with attention deficit disorder, who on 26-MAR-2008 at 4:00 pm, was vaccinated IM in the right deltoid, with the first dose 0.5ml, of GARDASIL (lot # 655327/1287U), The patient stepped off of the table, sat in a chair and "within approx. 10 seconds," stated "my head hurts." Her face became flushed, her eyes rolled back, and "she experienced a syncopal episode which lasted approx 10 se." She was assisted to the table. Vital sign lincluded blood pressure of 102/60 mmHg, heart rate 70. In 5 minutes, her BP was 118/70 mmHg and heart rate with 76. She stated she felt fine, her skine was pale and dry, and after 30 minutes, she left the office. The patient was considered to haver recovered the same day. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with her first dose of Gardasil (lot number unspecified). Subsequently the patient experienced severe joint pain. The physician does not have any information about the patient as he only saw her for the joint pain. The patient sought unspecified medical treatment. The physician does not want to be contacted. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fall, Head injury, Nervousness, Syncope
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 12-MAR-2008 was IM vaccinated with her first dose of Gardasil (lot number unspecified) in her deltoid of an unknown arm.  Report states a 175 pound female client was vaccinated and felt weak post vaccination.  Nurse observed client acted nervous during vaccination.  When client arrived at her home, she fainted, broke out into hives and fainted again.  When client fainted the second time she fell and hit her jaw.  Client went to the Emergency room for unspecified medical attention.  Additional information has been requested. Follow up information received from the physician indicated the patient also had shortness of breath. The emergency room ruled out reaction to the shot. Patient has history of hives when she gets excited. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 12-MAR-2008 was IM vaccinated with her first dose of Gardasil (lot number unspecified) in her deltoid of an unknown arm.  Report states a 175 pound female client was vaccinated and felt weak post vaccination.  Nurse observed client acted nervous during vaccination.  When client arrived at her home, she fainted, broke out into hives and fainted again.  When client fainted the second time she fell and hit her jaw.  Client went to the Emergency room for unspecified medical attention.  Additional information has been requested. Follow up information received from the physician indicated the patient also had shortness of breath. The emergency room ruled out reaction to the shot. Patient has history of hives when she gets excited. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 20 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, the patient became light headed.  It was reported that they thought the patient may faint or pass out so they laid her down.  The patient was "ok" and left the office by herself.  At the time of the report, the patient had recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Pharyngeal oedema
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with her second dose of Gardasil (lot number unspecified).  Subsequently the patient experienced swelling of lips and swelling of throat.  Subsequently, the patient recovered from swelling of lips and swelling of throat.  No treatment and no therapy were necessary.  The patient sought unspecified medical treatment in the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a teen age female who on 13-MAR-2008 was IM vaccinated with GARDASIL (dose # unknown, Lot number unspecified). On 13-MAR-2008 the patient fainted just after the vaccine was given. The patient sought unspecified medical treatment while still in the office. No other symptoms were noted. The patient fully recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician's wife concerning a 16 year old female who on 25-FEB-2008 was vaccinated with the third dose of Gardasil (lot number: 659182/1757U). On approximately 27-FEB-2008 the patient experienced a hive-like eruption at the injection site within 48 hours post vaccination. It was reported by the physician's wife that the patient called the office on 27-FEB-2008 to report her symptoms and the patient was then treated with Benadryl 25mg and cold compress until the symptoms resolved. Subsequently, the patient recovered from hive-like eruption. No further information is available. This is in follow-up to report (s) previously submitted on 4/14/2008.  Follow-up information was received which indicated that the patient had received the 3rd dose of the GARDASIL and experienced a local reaction redness and swelling which lasted for 4 days.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with an unspecified dose of Gardasil (lot number unspecified).  Subsequently, the next day, the patient experienced vaginal bleeding.  No further information provided.  The physician requested not to be contacted.  No further information available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Urinary incontinence, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female with a history of anxiety with such procedures as blood drawing and vaccinations and no known drug allergies who on 05-DEC-2007 was vaccinated IM with her first dose of GARDASIL (lot# 659437/1266U).  There was no concomitant medication.  Subsequently the patient had fainted several times.  She also vomited, urinated and had terrible sweating.  An ambulance was called into the office, but she wasn't taken to a hospital because she recovered at the site.  The patient had sought medical attention with her physician.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/14/2008. The patient had experienced a syncopal episode that was on-going, multiple episodes lasting for greater than 30 minutes. Her blood pressure and heart rate were normal. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neutropenia, White blood cell count decreased
Clinical narrative: Information has been received from a company representative who reported that a physician informed him about a 16 year old female with no known drug allergies and no past medical history who on 29-JUN-2007 was vaccinated with her first dose of GARDASIL (lot# unspecified, site and route not reported). The patient received the second dose of GARDASIL (lot# unspecified, site and route not reported) and the third of GARDASIL (lot # unspecified, site and route not reported) was given on 15-MAR-2008. There was no concomitant medication. Subsequently the patient experienced a very low white blood cell count. The white blood cell count is so low that she may be neutropenic. The patient has no known underlying causes for neutropenia. The patient sought medical attention at the doctors' office. A blood test was performed on 24-MAR-2008. The patient's outcome was reported as not recovered. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with an unspecified dose of GARDASIL (lot# not reported) and was found to be positive for HPV.  Also another report was mentioned about a different patient who was vaccinated with an unspecified dose of GARDASIL (lot# not reported) and fainted in the elevator.  The patient's outcomes were note reported.  A phone call was placed on 08-APR-2008 to obtain patient identifiers.  Additional information has been requested.