chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Oedema peripheral, Tremor, X-ray limb normal
Clinical narrative: Information has been received from a certificated medical assistant concerning a 15 year old female patient with no drug reactions or allergies reported and no pertinent medical history, who on 13-SEP-2010 (also reported as 18-SEP-2010) was vaccinated IM with the first dose of GARDASIL (Lot # 0765Z). Concomitant therapy included vaccination with a dose of FLUZONE. On an unspecified date, the patient reported shaking in her leg and knee edema after receiving her first vaccination with GARDASIL. It was unknown whether it was her right or left leg. On an unspecified date at the medical center the patient had a knee x-ray which was negative for fracture. The patient's mother was convinced that the events were because of GARDASIL. At the time of the report the patient had not recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pallor, Syncope, Underdose
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route no reported). The healthcare worker stated that when she was vaccinating the patient, she turned white and fainted. She stated they immediately withdrew the needle and caught the client before she fell off the table. Only one fourth of the vaccine was administered. Patient was laid down on the table and monitored for 45 minutes to 1 hour afterwards. Patient did not want to get more doses of GARDASIL. At the time of the report, the patient had recovered. The patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Injected limb mobility decreased, Sensory loss, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with no medical history or drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 666118/1539Y) on 13-AUG-2010, and the second dose (lot number 666118/1539Y) on 20-OCT-2010. Concomitant therapy included meningococcal vaccine (unspecified) with the first dose and influenza virus vaccine (unspecified) with the second dose. It was reported that the patient experienced loss of movements and sensations of the vaccine injected arm on both occasions after receiving first and second dose of GARDASIL. The patient developed the symptoms several hours after receiving the vaccines and recovered the next day. The patient sought unspecified medical attention. No laboratory diagnostic tests performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: Information has been received from a physician concerning a female patient who in November 2009, was vaccinated with the first dose of GARDASIL (lot number not provided). In February 2010, the patient was vaccinated with the second dose of GARDASIL (lot number not provided). The physician reported that in February 2010 the patient experienced nausea, diarrhea and generalized body aching after receiving the second dose of GARDASIL. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on approximately 29-SEP-2009 (one year ago) was vaccinated with a dose of GARDASIL (Lot # not provided). It was reported that the patient recently tested positive for high risk HIV. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unspecified. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a licensed practical nurse via concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Concomitant therapy included generic form of ORTHO TRI-CYCLEN. Shortly after receiving the vaccination, the patient was losing all of her body hair. Unspecified medical attention had been sought. The action taken and the status of the patient were unknown. This is one of several reports received from the same source. Follow-up information was received from the nurse. She reported that it was an acquaintance of one of her patients whose daughter had the experience. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old male patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot# not reported). It was reported that the patient had a syncopal episode in the exam room and was examined. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a consumer's mother concerning her 6 year old male patient with no pertinent medical history or drug reactions/allergies, who on 28-SEP-2010 was vaccinated with a dose of GARDASIL (Lot # not provided), instead of "flu shot". There was no concomitant medication. No adverse effect seen. The patient sought unspecified medical attention. Follow up information was received from physician indicated that the patient was given a dose of GARDASIL (Lot # not provided), instead of "flu shot" in error. No adverse effect was reported by parents. Follow up information has been received from a Registered Nurse concerning the student male patient with no illness at time of vaccination who on 28-SEP-2010 at 18:00 was vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL (Lot# 666163/0664Z). The nurse reported that the patient presented to office with family of four to receive influenza vaccine. 2 patient's sisters would be going to receive GARDASIL. GARDASIL was given to patient intramuscularly by mistake. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Vulvovaginal pain
Clinical narrative: Information has been received from a physician concerning a female patient that had not started her menstrual cycle who on an unspecified date was vaccinated with a dose of GARDASIL (Lot #, expire date and route not reported). Physician stated that on an unspecified date, the patient experienced abdominal and vaginal pain. It is unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Fall, Muscle twitching
Clinical narrative: Information has been received from a pharmacist concerning a 15 year old female patient with no known medical history and no known drug reactions/allergies who on 14-SEP-2010 was vaccinated with the first dose of GARDASIL (route and lot# not reported). There was no concomitant therapy. On 14-SEP-2010 the patient experienced right leg twitching since 2 hours after receiving the first dose of GARDASIL. The patient also experienced a fall during dance class. The patient was evaluated at a local urgent care facility and unspecified blood work was ordered. The blood work results were pending. At the time of the report, the patient had not recovered. The patient sought medical attention by contacting pharmacist. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse (the director of the facility) concerning a 4 year old female who 15-SEP-2010 was vaccinated with a single 0.5 ml dose of GARDASIL (lot # not reported). The nurse reported that on 15-SEP-2010 the patient was supposed to receive a pediatric vaccine (name and manufacturer unspecified), but instead received a dose of GARDASIL (lot # not reported). No adverse events involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient with no pertinent medical history who on 08-APR-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, IM (lot number 667866/1437Z, Exp. 25-FEB-2013). Concomitant therapy included doxycycline and OCELLA. On 08-APR-2011, the patient experienced injection site redness and swelling. Both arms from elbows to hands were covered with a pimply itchy rash. The patient did not seek medical attention. The patient did not receive any treatment for the event. Therapy with GARDASIL was discontinued and no reintroduced. At the time of the report the patient still had symptoms. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Foetal disorder, Maternal exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient who on 16-SEP-2010 was vaccinated with her first dose of GARDASIL (lot #660387/1967U) and subsequently was determined to be pregnant by a pregnancy test. Concomitant therapy included PROVENTIL. No adverse effects were being experienced by patient. Last menstrual period (LMP): 15-JUL-2010. Her estimated date of delivery (EDD) was 21-APR-2011. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow up information was received from the physician and reported that the patient with a history of asthma and obesity, 5 previous pregnancies, 3 full term deliveries, 2 spontaneous abortions (miscarriages), birth defects in previous pregnancies unknown and infant complications in previous pregnancies unknown. The patient took PROVENTIL every 4 hours as need for short of breathiness, and on 16-SEP-2010 the patient was treated with cyclobenzaprine hydrochloride (manufacturer unknown) 10 mg TID as needed for back pain. It is unknown if any tests are done for this patient. Follow up information was received from a registered nurse and reported that the patient with diagnosis of abnormal Phenolsulfonphthalein (PSP), chlamydia, Trichomoniasis, Gonorrhoea and no birth defect in previous pregnancies. On 17-SEP-2010 ultrasound showed single live fetus. On 10-FEB-2011 ultrasound showed normal fetal survey. On 02-MAR-2011 ultrasound showed no bleeding, normal pregnancy. On 13-APR-2011 the patient had ultrasound due to weight loss which showed  normal amniotic fluid (AFI). During pregnancy on unknown date, the patient experienced pressure which was treated with ZOLOFT, and experiencing nausea which was treated with PHENERGAN. On unknown date during pregnancy, it was found the size was less than dates (WAES # 1009USA03595B1). The patient also took prenatal vitamin during pregnancy. On 23-APR-2011 the patient had a liveborn male baby on 38 weeks from LMP who is 3505g, length 20.5 inch, Apgar score 9/10, head circumference 14inch. The baby is normal, and no congenital anomalies and no other complications. Ultrasound also showed weight loss, depression and size <dates. The baby's adverse event was captured in WAES 1009USA03595B1. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of pressure, Ultrasound antenatal screen, Ultrasound antenatal screen normal, Weight decreased
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient who on 16-SEP-2010 was vaccinated with her first dose of GARDASIL (lot #660387/1967U) and subsequently was determined to be pregnant by a pregnancy test. Concomitant therapy included PROVENTIL. No adverse effects were being experienced by patient. Last menstrual period (LMP): 15-JUL-2010. Her estimated date of delivery (EDD) was 21-APR-2011. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow up information was received from the physician and reported that the patient with a history of asthma and obesity, 5 previous pregnancies, 3 full term deliveries, 2 spontaneous abortions (miscarriages), birth defects in previous pregnancies unknown and infant complications in previous pregnancies unknown. The patient took PROVENTIL every 4 hours as need for short of breathiness, and on 16-SEP-2010 the patient was treated with cyclobenzaprine hydrochloride (manufacturer unknown) 10 mg TID as needed for back pain. It is unknown if any tests are done for this patient. Follow up information was received from a registered nurse and reported that the patient with diagnosis of abnormal Phenolsulfonphthalein (PSP), chlamydia, Trichomoniasis, Gonorrhoea and no birth defect in previous pregnancies. On 17-SEP-2010 ultrasound showed single live fetus. On 10-FEB-2011 ultrasound showed normal fetal survey. On 02-MAR-2011 ultrasound showed no bleeding, normal pregnancy. On 13-APR-2011 the patient had ultrasound due to weight loss which showed  normal amniotic fluid (AFI). During pregnancy on unknown date, the patient experienced pressure which was treated with ZOLOFT, and experiencing nausea which was treated with PHENERGAN. On unknown date during pregnancy, it was found the size was less than dates (WAES # 1009USA03595B1). The patient also took prenatal vitamin during pregnancy. On 23-APR-2011 the patient had a liveborn male baby on 38 weeks from LMP who is 3505g, length 20.5 inch, Apgar score 9/10, head circumference 14inch. The baby is normal, and no congenital anomalies and no other complications. Ultrasound also showed weight loss, depression and size <dates. The baby's adverse event was captured in WAES 1009USA03595B1. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Maternal exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a pediatrician concerning a male baby born to a 23 year old female who on 16-SEP-2010 was vaccinated with her first dose of GARDASIL (lot #660387/1967U) and subsequently was determined to be pregnant by a pregnancy test. Concomitant therapy included PROVENTIL and prenatal vitamin. On unknown date during pregnancy, it was found the size was less than dates. On 23-APR-2011 the patient was born on 38 weeks from mother's LMP who is 3505g, length 20.5 inch, Apgar score 9/10, head circumference 14m. The baby is normal, and no congenital anomalies and no other complications. The mother's adverse event was captured in WAES 1009USA03595. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Lymphadenopathy
Clinical narrative: Information has been received from a physician's assistant concerning a female patient, who on an unspecified date was vaccinated with a second 0.5 ml dose of GARDASIL (Lot # not reported). The physician's assistant reported that the patient received her second dose and had localized swelling and swelling of the interior lymph node in her neck. It was reported that the patient had not received treatment for the adverse events. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in approximately August 2010 "about one month ago", was vaccinated with the second dose of GARDASIL (Lot# not reported). The patient experienced immediate pain and the soreness had continued. The registered nurse reported that the vaccination was given very high on her arm and might have been into the joint. It was unknown if the patient sought medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cytology abnormal, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot # not reported). The physician reported that the patient received the complete series of GARDASIL and tested positive for HPV DNA 16 and 18 following cytology testing. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a 25 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot# not reported). The patient stated that she was unable to complete the 3 series because she had a negative reaction to the second injection. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma
Clinical narrative: Information has been received from a pharmacist student concerning a 64 year old female patient with a history of bruise after most injections who on 06-JAN-2010, was vaccinated in the deltoid with the first dose of GARDASIL (Lot# not provided). On 17-MAR-2010, the patient was vaccinated in the gluteus with the second dose of GARDASIL (Lot# not provided) and on 20-SEP-2010, the patient was vaccinated in the deltoid with the third dose of GARDASIL (Lot# not provided). The patient experienced bruising at the injection site after her second dose in the gluteus. At the time of the report, the patient recovered. The patient spoke to the pharmacist. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no drug reactions/allergies, who on 31-AUG-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported). There was no concomitant medication. On 31-AUG-2010, "within a day of vaccination", the patient developed "flu like symptoms" and tenderness at the site of vaccination. The "flu like symptoms" were described as body aches, and a low grade fever that started within a day of the vaccination and resolved on approximately 14-SEP-2010, "in 2 weeks". The tenderness was on left arm at the site of vaccination and was described as tender to touch, without a rash. The tenderness started within a day of the vaccination and resolved on approximately 14-SEP-2010 "in 2 weeks". The physician reported that the patient had not received a flu shot when GARDASIL was administered. There were no lab diagnosis/studies performed. The patient was in the office on 18-JAN-2011 to received second dose of GARDASIL. At the time of the report, the patient had recovered. The patient sought medical attention by office visit. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Laboratory test normal, Mean cell haemoglobin, Mean cell volume decreased
Clinical narrative: Information has been received from a Registered Nurse concerning a current 20 year old female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot # unknown). The nurse reported that a patient  said that 3 or 4 weeks after receiving the first dose of GARDASIL she started having joint pain on her wrists and ankles. The first dose of GARDASIL was administered by a different facility and this patient was new to the clinic. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. Follow up information has been received from a registered nurse via medical records, concerning a 20 year old female student patient with no illness at the time of vaccination or no known drug allergies who in approximately August 2010, received the first dose of GARDASIL. The patient stated that on 20-AUG-2010, she developed pain in her wrist, finger and ankles which started after the first dose of GARDASIL. On an unspecified date the patient was prescribed with NAPROSYN and minocycline hydrochloride. On 24-SEP-2010, the patient's labs were within normal limits except for mean corpuscular volume 79.1, mean corpuscular hemoglobin 26.0. The patient's serum rheumatoid factor test was <20 and serum antinuclear antibodies test was negative. On 01-OCT-2010, the patient had a follow up with her physician, it was reported that all symptoms had resolved, her exam of wrist and arm were remarkable. The patient had good response to NAPROSYN with no side effects. The patient was diagnosed with arthralgia (hand and finger) and joint pain. There was no no need of further work up unless her symptoms recurred. The patient was prescribed with NAPROSYN PRN. There were no new concerns. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor
Clinical narrative: Information has been received from a Registered Nurse concerning a current 20 year old female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot # unknown). The nurse reported that a patient  said that 3 or 4 weeks after receiving the first dose of GARDASIL she started having joint pain on her wrists and ankles. The first dose of GARDASIL was administered by a different facility and this patient was new to the clinic. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. Follow up information has been received from a registered nurse via medical records, concerning a 20 year old female student patient with no illness at the time of vaccination or no known drug allergies who in approximately August 2010, received the first dose of GARDASIL. The patient stated that on 20-AUG-2010, she developed pain in her wrist, finger and ankles which started after the first dose of GARDASIL. On an unspecified date the patient was prescribed with NAPROSYN and minocycline hydrochloride. On 24-SEP-2010, the patient's labs were within normal limits except for mean corpuscular volume 79.1, mean corpuscular hemoglobin 26.0. The patient's serum rheumatoid factor test was <20 and serum antinuclear antibodies test was negative. On 01-OCT-2010, the patient had a follow up with her physician, it was reported that all symptoms had resolved, her exam of wrist and arm were remarkable. The patient had good response to NAPROSYN with no side effects. The patient was diagnosed with arthralgia (hand and finger) and joint pain. There was no no need of further work up unless her symptoms recurred. The patient was prescribed with NAPROSYN PRN. There were no new concerns. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Tremor, Vision blurred, Wrong drug administered
Clinical narrative: Information has been received from an office manager and a female patient, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old pregnant female patient with drug allergies to DAYQUIL and COMPAZINE and no pertinent medical history who on 14-OCT-2010 was vaccinated with the first dose of GARDASIL (lot number reported as 0644Z), 0.5 ml (also reported as 0.5mg) by intramuscular injection. Her last menstrual period (LMP) was approximately on 19-AUG-2010, and estimated delivery date (EDD) was on 05-JUN-2011. It was stated that the patient was supposed to be received a "ROGAM" shot and received GARDASIL instead, accidentally. The following Saturday, which was on 16-OCT-2010 (also reported as on 14-OCT-2010), the patient's eyes were kind of blurry and her left arm was shaky. There was no concomitant medication. The patient did not seek medical attention and lab diagnostics studies were not performed. At the time of the report, the outcome was unknown. Follow up information has been received from the office manager who reported that it was a case of the wrong thing was pulled off the shelf and it was not product confusion. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female patient who, on an unspecified date, was vaccinated with the third dose of GARDASIL (dose, route and lot # unspecified). The Nurse reported that the patient experienced abdominal pain after receiving her third dose of GARDASIL (date unspecified). It was not specified if patient sought for medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female patient with post-traumatic stress disorder and allergy to VALIUM who on 30-SEP-2010, was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot # 666118/159Y). Concomitant therapy included IMPLANON, prazosin, sertraline HCl, carbamazepine, SEROQUEL, TEGRETOL and lorazepam. It was reported that within one hour after administration of the vaccine the patient returned to the clinic with severe abdominal cramping, diarrhea and vomiting. The vomiting was addressed with sublingual ZOFRAN, but it persisted. Lab diagnostics studies were not performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Oropharyngeal blistering, Pyrexia, Tongue blistering
Clinical narrative: Information has been received from a a registered nurse concerning an 18 year old female patient, who on 01-JUL-2010 was vaccinated with a first dose of GARDASIL (Lot # unknown), and on 01-SEP-2010 was vaccinated with a second dose of GARDASIL (lot # unknown). The nurse reported that on 02-SEP-2010 the patient developed fever 103.5 degrees Fahrenheit, blisters on the tongue and inside the mouth with difficulty swallowing. Therapy with GARDASIL would be discontinued. On 06-SEP-2010 the patient recovered. The patient sought unspecified medical attention. Follow-up information was received from the registered nurse, who reported that the female student with no known allergies was vaccinated with the second dose of GARDASIL (Lot # 666595/070Z), IM, in the left deltoid, on 01-SEP-210 at 16:10. There were no illness at the time of vaccination. The nurse also stated that the vaccin was given in their facility but the patient did not return to report for any care or any side effects. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a Bachelor of Science in Nursing concerning a female patient who, on an unspecified date, was vaccinated with the first dose of GARDASIL (dose, route and lot # unspecified). Concomitant vaccine included a dose of MENCTRA. The nurse reported that the patient after receiving the dose of GARDASIL and MENACTRA, immediately experienced a syncopal episode (date unspecified). At the time of the report patient's outcome was not reported. It was not specified if patient sought for medical attention. Follow up information has been received from a health professional concerning a 15 year old female student patient with drug allergy or reactions to MOTRIN and no illness at time of vaccination, who on 27-JAN-2011 at 15:40, was vaccinated intramuscularly on the right deltoid with the first dose of GARDASIL (lot#0765Z). The health care professional reported that on 27-JAN-2011, "5 minutes after vaccine was administered" at 15:45, the patient experienced an episode of syncope. Episode lasted approximately 2 minutes and the patient fully recovered on 27-JAN-2011. No injuries were reported as a result. No lab diagnostic tests were performed to the patient. The patient did not seek medical attention. No further information is available.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old male patient who on an unspecified date was vaccinated with the second dose of GARDASIL (lot #, expire date and route not reported). Nurse reported that on an unspecified date after receiving the second dose of GARDASIL, the patient experienced fainting while in the office, a second fainting spell the following day, and a third fainting spell later at an unspecified time. The dates of both the first and second dose of GARDASIL were not available. At the time of report, patient's outcome was unknown. Follow-up information was received from the nurse, concerning the patient, with no illness at the time of vaccination, and no pre-existing allergies, birth defects or medical conditions, who on 27-JAN-2011 was vaccinated intramuscularly in the left arm with the second dose of GARDASIL (lot number 666931/0337Z) at pm. It was reported that the patient had a vasal vagal event in the office after administration of vaccine and that the following day fainted in a store and then fainted a third tome at optometrist office. The patient recovered on 28-JAN-2011. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a physician concerning a female patient who on 02-FEB-2011 was vaccinated with a dose of GARDASIL (lot number not provided). Secondary suspect therapy also included anti-seizure medication (manufacturer unspecified). Physician reported that after receiving vaccination, (also reported as "yesterday afternoon"), the patient experienced dizziness and headache. The patient believed that the GARDASIL was interacting with her anti-seizure medication. The physician advised patient to go to the Emergency Room, but at the time of the report it was unknown if the patient went or not. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with no medical history or drug reactions/allergies who on 20-JAN-2011 and 08-FEB-2011 was vaccinated IM with the first and second doses of GARDASIL (for both doses: lot # 666987/1016Z, Exp: 22-NOV-2012), respectively. Concomitant therapy included CLINDAGEL and oral birth control. "Approximately 10 minutes after each administration, the patient experienced vomiting and moderate-to-severe shaking for a couple of moments. Within 10 minutes after vomiting, the patient was fine. The patient had completely recovered from both episodes. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Follow up information has been received from the medical assistant indicating that the patient with no preexisting medical conditions and had vomiting at the time of vaccination who on 20-JAN-2011 and 08-FEB-2011 was vaccinated IM into left deltoid with the first and second dose of GARDASIL  (for both doses: lot # 666987/1016Z, Exp: 22-NOV-2012), respectively. The patient stated 5 minutes after the first injection, she had vomiting. The patient thought it was related to something she ate. However, after the second injection, she had moderate shaking and vomiting. No further work up needed. The patient stated that she recovered to normal state in 5 minutes. No alb diagnostics were performed. The patient did not require ER/doctor visit. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: DTAP, FLU3, HPV4, MNQ, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient with no medical history and no drug reactions or allergies who on 16-NOV-2010, was vaccinated with a first 0.5 ml IM dose of GARDASIL (lot # 1017Z). On 16-NOV-2010, the patient also received a dose of VARIVAX, MENACTRA, DTaP and FLUZONE. On 26-NOV-2010 ("10 days after receiving the first dose of GARDASIL"), the patient experienced rash. On 24-JAN-2011, the patient received the second 0.5 ml IM dose of GARDASIL (lot # 1560Z). On 03-FEB-2011 ("10 days after receiving the second dose of GARDASIL"), the patient also experienced rash. The patient had office visit. No lab diagnostics studies were performed and no treatment was given to the patient. On unspecified date, the patient recovered from rash. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anal haemorrhage, Rectal haemorrhage
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with the first and second (0.5 ml) doses of GARDASIL (lot # not reported). The reporter stated that while on GARDASIL the patient experienced some anal or rectal bleeding after the first and second doses. At the time of reporting, the outcome of the patient was unknown. Therapy with GARDASIL was discontinued. The patient visited a proctologist. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 28-JAN-2011 was vaccinated with a dose of GARDASIL (therapy route and lot # not provided). On 29-JAN-2011 the patient experienced swollen lymph nodes underneath her arm. Vaccination with GARDASIL was reported to be continued. Adverse event improved after a week of onset. Patient sought unspecified medical attention. At the time of reporting, the patient' status was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 20-DEC-2010 was vaccinated with the first dose of GARDASIL (lot #, expire date and route not reported), in the gluteal region. On 21-FEB-2011, the patient was vaccinated with the second dose of dose of GARDASIL (Lot #, expire date and route not reported), in the deltoid. Registered nurse stated that the patient claimed that the dose of GARDASIL injection administered on 20-DEC-2010, was less painful that the one administered on 21-FEB-2011 in her arm. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning a female patient who, on an unspecified date, was vaccinated with a 0.5 ml dose of GARDASIL (route and lot# unspecified). Subsequently, it was reported that the patient experienced achiness in her muscles after getting a dose of GARDASIL (date unspecified). It was also reported that the pain was like a fibromyalgia type pain. The patient reported this one week post vaccination. No treatment was given to the patient. Subsequently, on an unspecified date, the patient recovered. It was unspecified if patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cytology abnormal, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a third dose of GARDASIL (lot # not reported). The physician reported that the patient received from the complete series of GARDASIL and tested positive for HPV DNA 16 and 18 following cytology testing. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. 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 physician concerning a female patient who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot # not reported). The physician reported that the patient received the complete series of GARDASIL and tested positive for HPV DNA 16 and 18 following cytology testing. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient, who received the full series of GARDASIL (Lot # not reported) on 21-JUL-2008, 29-SEP-2008 and 27-JAN-2009. The nurse reported that on 07-FEB-2011 the patient tested positive for high risk HPV on a screening test performed. A PAP smear was performed and the results were not abnormal and the patient had no symptoms. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Human chorionic gonadotropin negative
Clinical narrative: Information has been received from a Licensed Practitioner Nurse concerning a 21 year old female patient who on 21-JAN-2011 was vaccinated with a dose of GARDASIL (lot number not provided). The nurse reported that the patient last menses was on 21-DEC-2010 and at the time of the report had not yet had her menses. It was unspecified if the patient sought medical attention or if any treatment was given. On an unspecified date a pregnancy test was performed and was negative. At the time of the report the patient's outcome was unknown. Follow up information was received from the Licensed Practitioner Nurse concerning the 21 year old female patient with allergy to grass, wood and shavings and no illness at the time of vaccination. The nurse indicated that on 21-JAN-2011 at 9:29 am the patient was IM vaccinated with the first dose of GARDASIL (lot#667165/1167Z). It was reported that the patient stated she had not had a period since GARDASIL injection. It was also reported that on an unspecified date a urine pregnancy test was performed and resulted negative. Additional information ahs been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Colonoscopy normal, Rectal haemorrhage
Clinical narrative: Information has been received from a nurse practitioner concerning her approximately 28 year old daughter with no pertinent medical history and no drug reactions or allergies who on an unspecified date was vaccinated IM with the first 0.5 ml dose of GARDASIL. No concomitant medication. Within 4 to 6 hours after receiving vaccine the patient developed moderate to severe rectal bleeding which lasted 4 to 7 days and went away. However, 3 weeks later the rectal bleeding occurred again but then went away after a few days. Sometime in February 2011 the nurse practitioner's daughter received the second dose of GARDASIL and within 4 to 6 hours she developed rectal bleeding again which lasted 4 to 7 days. On 21-FEB-2011 she had a colonoscopy and at that time there was no active rectal bleeding. The colonoscopy did not reveal anything. Results were normal. The patient did office visit to a gastroenterologist and the gastroenterologist thought the rectal bleeding was from the GARDASIL. The daughter described the bleeding as "blood pouring into the toilet". No treatment was given. Lab test for anemia was performed (result not reported). The daughter had decided not to receive further doses of GARDASIL. Vaccine of GARDASIL was discontinued. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 21 year old female who in 2008 was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that the patient recently developed abnormal Papanicolaou smear (PAP) with high grade lesions. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Follow up information have been received from the physician who stated that she never had a patient with this adverse event. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: Information has been received from a physician assistant concerning a 22 year old female patient with sexually transmitted disease in 2007, kidney stone in 2008 and VICODIN and PERCOCET allergies who on 14-FEB-2011 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 666948/0886Z). There were no concomitant therapies or vaccines. On 14-FEB-2011 the patient experienced dizziness, vomiting and sweating 30 minutes after vaccination. The patient was sent to emergency room and was treated with BENADRYL (not known if oral or parenteral), ZOFRAN intravenously fluids and MEDROL pack orally were administered/prescribed. Patient was not admitted to hospital. The physician assistant was not sure which emergency room the patient was taken. Patient fully recovered and would not receive the rest of the GARDASIL series. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician's staff concerning a female who on an unknown date was vaccinated with a dose of 0.5 mg GARDASIL (lot # not reported). the reporter stated that patient passed out after being given GARDASIL. At the time of reporting, the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker (also reported as office manager) concerning a female patient who around August 2010, was vaccinated IM with a dose of 0.5 ml GARDASIL (lot # not reported). On an unspecified date the patient received the second dose of GARDASIL (lot # not reported). Around August 2010, the patient experienced injection site pain when she took hot showers and there was noticeable redness associated with that pain. The patient did not seek medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from the healthcare worker concerning the 15 year old female student patient who on 24-AUG-2010 at 3:30PM was vaccinated IM with her first dose of GARDASIL (lot # 666163/0664Z) in the right deltoid. On 25-OCT-2010 at 10:31AM the patient was vaccinated IM with her second dose of GARDASIL (lot # 666948/0886Z) in the left deltoid. In approximately October 2010 ("after the second dose"), the patient's mother called to tell the office that the patient experienced a lot of redness at the injection site (about 3" in diameter) which was warmed and sore over entire upper arm (not just at injection site). Soreness relieved after a week but returned after any exercise doing even 2 months later. The patient also had some itching in the injection site that came and went. The injection site got very red after any hot shower but went away after wards. Subsequently, the patient recovered from the events. None of the reactions was considered as serious by the patient's doctor or her mother but the patient was advised not to get the third dose of GARDASIL. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Syncope
Clinical narrative: Information has been received from a mother concerning an 18 year old daughter who in December 2010, was vaccinated with the first dose of GARDASIL. The patient fainted after receiving the dose. The patient also had been experienced headaches after receiving the dose. The patient received unspecified medical attention. The outcome was unknown. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 or 19 year old female patient who on unknown dates was vaccinated with three doses of GARDASIL (dose, route and lot # were not reported). The physician reported that on an unspecified date a patient found to be positive for HPV after receiving all 3 doses of GARDASIL. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. Laboratory diagnostics studies included Papanicolaou smear. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning one of two sisters (another sister's adverse event captured in WAES1105USA04011) who was vaccinated with GARDASIL. The nurse reported two sisters who wanted to be vaccinated simultaneously. She recollected that she and another nurses at both of the sisters on the same table, administered each sister a shot of GARDASIL at the same time, and she reported that both sisters lost consciousness at the same time. She reported that she and the other nurse held both of the sisters up to keep them from falling off the table, since they could not lay them down on the same table. She stated that this occurrence was over a year ago which was in approximately 2010, and that both sisters were "fine with no residual effects." Neither of the girls was injured in any way, but she state that she would never do that again. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 07-MAY-2011 was vaccinated IM with 0.5 ml first dose of GARDASIL (lot number:666987/1016Z). The patient received a dose of VARIVAX (Merck) at the same time on 07-MAY-2011. The physician reported that the patient "fainted about 5 minutes after receiving the shot". It could not be determined which vaccine caused the fainting. The patient did not seek medical attention. No treatment was given for the event. At the time of the report, the patient had recovered from fainted on 26-MAY-2011. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Vulvovaginal pain
Clinical narrative: Information has been received from a physician concerning a female patient that had not started her menstrual cycle who on an unspecified date was vaccinated with a dose of GARDASIL (Lot #, expired date and route not reported). Physician stated that on an unspecified date, the patient experienced abdominal and vaginal pain. It is unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This is one of several reports from the same source. No further information is available.