chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia foetal, Drug exposure during pregnancy, Umbilical cord around neck
Clinical narrative: Information has been received from a nurse practitioner concerning a newborn female who on 03-JUN-2009 at 12 weeks of gestation was exposed to a dose of GARDASIL in utero. The patient was also exposed to a dose of influenza virus vaccine (unspecified), H1N1, vitamins (unspecified), ferrousSO4 and ranitidine during her gestation. On 23-NOV-2009 the patient experienced nuchal cord and fetal bradycardia. The patient's outcome was unknown. This report is related to WAES # 0906USA03366 (mother's report). Follow up information was received from a healthcare professional. It was reported that this patient was not a patient of their practice. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure before pregnancy, Gestational diabetes, Ultrasound scan normal
Clinical narrative: Information has been received from Merck Pregnancy Registry for GARDASIL from a physician concerning a 21 year old female patient with a history of back surgery for scoliosis and one previous pregnancy with live birth (no complications or birth defects) who on 30-APR-2009 was vaccinated with a first dose of GARDASIL (lot # 661044/0548X). There was no concomitant medication. On 15-MAR-2009 the patient had last menstrual period. When she received first dose of vaccine she was pregnant. On 20-APR-2009 was estimated conception date. 08-JUN-2009 she began to take prenatal vitamins 1 tablet once a day for supplement. On 09-JUN-2009 ultrasound was performed for estimated delivery date. Estimated delivery date is on 11-JAN-2010. Follow up information received from a physician indicated that the patient was a female. Sonograms performed on 01-SEP-2009 and 07-SEP-2009 showed no anomalies. On 14-JAN-2010 at 40 weeks from her last menstrual period the patient gave birth to a normal male with no congenital anomalies. The baby's weight was 3718 g, length 19.5 inches, apgar score were 9/9. The baby's head circumference was 34.5 cm. A On an unspecified date the patient developed gestational diabetes. The patient's gestational diabetes was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 17 year old female student with no illness at time of vaccination who was vaccinated with the second dose of unspecified vaccine. On 19-DEC-2008 the patient experienced rash at injection site and flu like symptoms. The patient was last seen on 20-APR-2009 and the patient was still had a rash at injection site. Subsequently, the patient recovered from rash at injection site and flu like symptoms. Follow up information has been received from a physician concerning the patient who was vaccinated with the first and the second dose of GARDASIL (lot #s were 0947X) on 22-OCT-2008 at 14:29AM and on 19-DEC-2008 at 16:06 AM respectively, both doses were vaccinated IM in right deltoid. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan normal, Urine analysis, Vaginitis bacterial
Clinical narrative: Information has been received for the pregnancy registry of GARDASIL, from a 24 year old female patient who on 15-JUN-2009 was vaccinated with a first 0.5 mL dose of GARDASIL (LOT #660620/0571X). There was no concomitant medication. It was reported that as of 30-JUN-2009 the patient was 8 weeks pregnant. On an unknown date a urine test was performed; results were not reported. The patient's last menstrual period was 25-MAY-2009 and the estimated delivery date is 01-MAR-2010. The patient sought unspecified medical attention. No adverse events were involved. Follow up information received from a registered nurse indicated that the patient was a female with migraine, anxiety, depression, hypersensitivity, nausea and tooth pain, and a previous live birth. Concomitant therapy included CLARITIN, PROZAC, COMPAZINE, XANAX and TYLENOL WITH CODEINE. On an unspecified date during her pregnancy, the patient developed bacterial vaginosis. The patient was treated with CLEOCIN VAGINAL, cream and with METROGEL VAGINAL cream. The outcome of the patient's bacterial vaginosis was not reported. On 28-AUG-2009, 14-OCT-2009 and 13-JAN-2010 the patient had normal ultrasounds tests done. On 22-FEB-2010 at 39 weeks and 4 days from her last menstrual period, the patient gave birth to a normal female who weighed "07.3" ounces, the baby's length was 20 inches and her apgar score was 8/9. Follow up information received via medical records indicated that the patient had a term baby through a repeat c-section. On 01-MAR-2010, the baby had a newborn weight check and the assessment was a normal newborn. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 27 year old female patient who on 29-JUN-2009 was vaccinated with a dose of GARDASIL that was improperly stored. The vaccine was left out for 7 days in an air conditioned room (specific temperature unknown). The vaccine was picked up by the patient on 22-JUN-2009 from the pharmacy (the vaccine was stored in the fridge properly until the patient picked it up). The patient  was not experiencing any known symptoms. Follow up information was received from consumer. She stated the injection site where the GARDASIL (first dose) was given is now red and swollen. She had not yet been given the second or third dose. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Incorrect storage of drug, Paraesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female with allergies to sulfonamide, CEFTIN and SUPRAX and no pertinent medical history who on unspecified dates was vaccinated with the first, second and third dose of GARDASIL (routes and lot numbers unspecified). There was no concomitant medication. The nurse practitioner reported that the patient received the second dose of GARDASIL but was told it was invalid due to incorrect storage. The patient then received a third dose. After the patient received the third dose of GARDASIL the patient experienced numbness and tingling of her hands that lasted for one month. It was noted that the sensations were worse at night. Medical attention was sought, the patient was seen by her primary physician. There were no laboratory tests performed. At the time of the report, the patient recovered on an unspecified date.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with sulfonamide allergy who on approximately 17-JUN-2009 (reported as "about 2 weeks ago") was vaccinated with the first dose of GARDASIL intramuscularly. Few hours after vaccination, the patient broke out in hives. The physician told the patient to take BENDARYL and the patient recovered after few days. Therapy with human papillomavirus vaccine was discontinued. Follow up information has been received from a physician concerning a 15 year old female who on 01-JUN-2009 at 11:30 AM, was vaccinated the the first dose of GARDASIL (Lot: 661953/1130X) intramuscularly. On 03-JUN-2009, 48 hours post vaccination at 11:00 AM, the patient developed hives that were itchy and slightly raised. Subsequently on 05-JUN-2009, the  patient recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 22-year-old female patient with a medical history of menstrual migraine and dysmenorrhoea and with no drug reactions/allergies who on 23-APR-2009 was vaccinated IM with the first dose of GARDASIL (Lot # 661531/1311X). On 26-JUN-2009 the patient was vaccinated IM with the second dose of GARDASIL (Lot# 662404/0312Y). Concomitant therapy included omeprazole (MSD), butalbital and YASMIN. On 30-June-2009 the patient developed a red bump rash on her stomach, arms and chest. The patient had called the office on 30-JUN-2009. There were no labs or diagnostic studies performed. The patient's status was unknown at the time of report. The Health Care Professional contacted during telephone follow-up could not supply the following information: recovery status. Follow-up information has been received from a nurse indicated that the patient was a 22 year old admin assistant with no illness at time of vaccination. The second dose of GARDASIL was vaccinated in the left deltoid at 3:15PM on 26-JUN-2009. On 27-JUN-2009, the next day after GARDASIL, the patient noticed a rash located on trunk, back, upper arms and upper thighs which was bumpy and red rash. The patient was treated with BENADRYL 25 mg and the rash improved. There were no lab diagnostic tests performed. On 01-JUL-2009 the patient was recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a healthcare worker concerning a 15 year old female patient with no pertinent medical history and no drug reactions or allergies who on 10-JUN-2009 was vaccinated with first dose of GARDASIL (lot # 0294Y) 0.5ml, intramuscularly. Concomitant therapy included YAZ. The patient had been experienced hair loss since she received the first and only dose of GARDASIL. There were no laboratories diagnostics studies performed. The patient sought unspecified medical attention. At the time on the report on 01-JUL-2009 the patient had not recovered. Follow up information has been received from a nurse practitioner concerning a 15 year old female patient with no known drug allergies and illness at the time of vaccination reported as none who on 10-JUN-2009 was vaccinated with a first dose of GARDASIL (lot # 0294Y) intramuscularly into her deltoid. It was noted that since her first dose of vaccine was given on 10-JUN-2009 the patient experienced hair loss. The patient followed up with a pediatrician who was going to check her thyroid levels. In the middle of July, the patient's hair loss stopped and the patient did not have follow-up on her thyroid. There were no laboratory studies performed. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a 24 year old female on birth control who on 25-JUN-2009 was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not reported).  Concomitant therapy included NUVARING. On 28-JUN-2009, the patient experienced tiredness and fatigue. On 29-JUN-2009, the patient called the physician's office and reported that she was exhausted and was still experiencing tiredness. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 12 year old female with no pertinent medical history who was vaccinated with the first 0.5 ml dose of GARDASIL (IM, lot number 661044/0548X) on 30-JUN-2009 and fainted. Concomitant therapy included MCV4. Unspecified medical attention was sought. There was a "finger stick to check her sugar" (results were not reported). At the time of the report, the patient recovered. Follow-up information has been received from a member of the office. It was reported that the patient received GARDASIL and about 10 minutes later she fainted. However, it was reported that the patient walked to the office that day and it was hot outside. Follow-up information has been received from another member in the office who confirmed the above information as well the patient's birth date, vaccination date and lot number. She also added that the day the patient came into the office it was hot outside, their air conditioning was not working and the patient did walk to the office. Therefore, it could not be certain if the fainting was from the GARDASIL or from heat exhaustion. This is one of several reports from the same source. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Musculoskeletal pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female patient with a drug allergy to DEMEROL who on 27-JUN-2008 was vaccinated with the first dose of GARDASIL (lot# 660555/0279X) (dose and route not reported). The patient received her second dose of GARDASIL (lot# 661764/0650X) on 25-NOV-2008 and the third dose of GARDASIL (lot# 662300/0100Y) on 12-JUN-2009. The patient had shoulder pain that radiated to her back toward her shoulder blades after the third dose of GARDASIL was given on 12-JUN-2009. The patient had no adverse reactions after the first two doses. The patient was treated with "two CELESTONE injections and anti-inflammatory medications". The patient had sought unspecified medical attention. At the time of reporting, the patient had recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram QT prolonged, Electrocardiogram abnormal, Malaise, Skin papilloma, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5ml dose of GARDASIL and fainted. After the patient came to she fainted again. The patient seemed better when she was leaving the office however later that night she was still didn't feel well and she went to ER for medical attention. The tests showed that the patient had long QT. At the time if the report, the patient's outcome was unknown. Information has been received from a health professional concerning a 13 year old female with viral-wart on foot at the time of vaccination who on 07-JUL-2009 was vaccinated with the first 0.5ml dose of GARDASIL (lot#659437/1266U) in the left deltoid. On 07-JUL-2009 the patient experienced short episode syncope at 2:52pm. On 07-JUL-2009, the patient recovered. No further information is available.
Sex: F
Vaccine: HPV2
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a female who about a year ago, in approximately July 2008, was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). About a year ago, in approximately July 2008, the patient experienced flu like symptoms after each dose of GARDASIL. The patient sought medical attention by making an office visit. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Local swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 23 year old female with no pertinent medical history reported and no known drug allergies who on 30-APR-2009 was vaccinated with first dose of GARDASIL (route not reported, lot number 661954/1131X). There was no concomitant medication. One day after vaccination, on 01-MAY-2009, the patient experienced groin swelling and flu-like symptoms. The patient recovered on an unspecified date. The patient sought medical attention by calling the office. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Activities of daily living impaired, Chills, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL first dose of GARDASIL. The patient developed high fever and was in bed for two days after receive the GARDASIL dose. No laboratories studies performed. The patient sought unspecified medical attention. The patient recovered on an unspecified date. Follow up information received on 23-JUL-2009 from a physician indicated that the patient was a 15 year old female. Concomitant therapy included an unspecified number of doses of RECOMBIVAX HB (manufacturer unknown) on unspecified dates; no problems reported with this series. On an unspecified date the patient was "very sick" and experienced high fever and chills; it was also reported that the patient couldn't get out of bed. The physician was unsure if any office, ER visit or work up by this. The patient recovered on an unspecified date. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Ocular hyperaemia
Clinical narrative: Information has been received from a registered nurse who knows by third hand knowledge that a female who was vaccinated with a first dose of GARDASIL at another office, woke up in the middle of the night with itchy red eyes. The other office does not want the patient to receive the second dose of GARDASIL. The nurse did not want to answer any questions since she knows this by third hand knowledge. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Nausea
Clinical narrative: Information has been received from a health professional concerning a 19 year old female patient who on 20-APR-2009 was vaccinated with the first dose of GARDASIL and on 19-JUN-2009 received the second 0.5 mL dose of GARDASIL (lot # 661953/1130X). Concomitant therapy included patches of ORTHO EVRA. On 19-JUN-2009 after receiving the second dose of GARDASIL the patient experienced difficulty breathing, severe stomach pain, nauseas and chills and was brought to the ER room. The medical assistant stated that the patient was not admitted to the hospital but went home on the evening of 19-JUN-2009. It was reported that the patient will not receive the third dose of GARDASIL. The patient fully recovered on 20-JUN-2009. Follow-up information was received from a healthcare professional concerning the patient. It was reported that the patient did not receive concomitantly other vaccines at the time of the GARDASIL vaccination. However, the office has no information as to which hospital ER the patient went, neither the treatment that the patient received. The healthcare professional contacted during telephone follow-up could not supply the following information: Hospital name (ER). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of GARDASIL. It was reported that the patient fainted after getting GARDASIL. The patient sought unspecified medical attention. The patient's final outcome was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Abnormal dreams, Decreased interest, Dizziness, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient who on 29-MAY-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (lot # 662300/0100Y). It was reported that on an unspecified date the patient experienced headache, nausea, stomach ache, lost of interest for social activities, dizziness, lots of dreams and she always wants to sleep. The GARDASIL was discontinued. At the time of the report. her outcome was unknown. The patient sought medical attention with a nurse. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Somnolence
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient who on 29-MAY-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (lot # 662300/0100Y). It was reported that on an unspecified date the patient experienced headache, nausea, stomach ache, lost of interest for social activities, dizziness, lots of dreams and she always wants to sleep. The GARDASIL was discontinued. At the time of the report. her outcome was unknown. The patient sought medical attention with a nurse. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Myalgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with the second dose of GARDASIL (lot no. not reported). The nurse reported that the patient experienced lingering muscle pain and was unable to move her arm for two weeks after receiving her second dose of GARDASIL. On an unknown date, the patient recovered. Follow up information was received from a registered nurse which reported that the patient received her first two doses of GARDASIL (lot no.  not reported) at a different facility. It was reported that the patient experienced arm muscle soreness which lasted two weeks with each dose. The nurse reported that the initial facility refused to administer the third dose to the patient. The patient's mother insisted the daughter get the third shot, so the patient came to the reporter's facility requesting the third dose. At the time of reporting it was unknown if the patient received the third dose of GARDASIL. It was determined that the patient's adverse event was not serious. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female who in June 2008, was vaccinated with the first dose of GARDASIL 0.5 ml I.M. route, in June 2008 was vaccinated with the second dose of GARDASIL 0.5 ml I.M. route and in December 2008 was vaccinated with the third dose of GARDASIL 0.5 ml I.M. route. On 26-JUN-2009, the patient was tested Positive for HPV, the PAP smear the same date was normal. At the time of the report the patient was not recovered. The patient sought unspecified medical attention in the office. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a consumer concerning a friend's daughter who was vaccinated with a 0.5 mL fourth dose of GARDASIL. Follow up information was received on 09-OCT-2009 from the patient's mother. It was reported that she was willing to provide information and that she was "now noticing symptoms that she would like to report". At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no pertinent medical history or no known drug allergies, who on 23-MAR-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL intramuscularly. In approximately April or May 2009 did not have her menstrual cycle. She did have her menstrual cycle in June 2009 so not believed to be pregnant. She did report unprotected sex but that was in June 2009 not during the time of the amenorrhea. The patient sought medical attention in the office physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a consumer concerning a 15 year old daughter with no pertinent medical history reported and no known drug allergies who in June 2008, December 2008 and April 2009 was vaccinated with first, second and third doses of GARDASIL (dose, route and lot number not reported). There was no concomitant medication. The consumer reported that in May 2009, the patient experienced headaches and dizziness after receiving GARDASIL. At the time of reporting the patient had not recovered from the events. No lab studies were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a healthcare professional concerning a 19 year old female who on 24-JUN-2009 was vaccinated with a dose of GARDASIL. ON 28-JUN-2009 the patient experienced itchy with hives. The patient's itchy with hives persisted. The patient sought medical attention via telephone. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Amniocentesis normal, Drug exposure before pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 17-DEC-2008 was vaccinated with IM with the first 0.5ml dose of GARDASIL (Lot #661703/0651X). On 23-FEB-2009 the patient was given IM the second 0.5ml dose of GARDASIL (Lot #661841/0653X). On 23-JUN-2009 the patient was given IM the third 0.5ml dose of GARDASIL (Lot #658271/0558X). Concomitant medications included prenatal vitamins (unspecified) "just started" and tetracycline (unspecified) during pregnancy but now stopped. The patient was pregnant at the time of report. Her last menstruation period date was 07-DEC-2008 and her estimated delivery date was 15-SEP-2009. The lab diagnostics studies performance included ultrasound. There were no known symptoms reported. The patient had sought medical attention, office visit. At the time of report the patient's status was unknown.  Follow-up information has been received from a registered nurse concerning 18 year old female patient with no previous pregnancies, deliveries, abortions, elective terminations or fetal deaths and with no concurrent medical conditions or family medical history who was vaccinated with the first, second and third dose of GARDASIL respectively on 17-DEC-2008, 23-FEB-2009 and 23-JUN-2009. Concomitant therapies included prenatal vitamins (unspecified) (manufacturer unknown) and tetracycline (manufacturer unknown). The patient was pregnant. The last menstruation period date was 07-DEC-2008, the estimated delivery date was 15-SEP-2009 and the estimated conception date was 26-NOV-2008. The patient delivered a healthy normal male infant with no congenital anomalies weighting 7.13 pound on 01-OCT-2009. The weeks from LMP were 41 6/7 weeks. The apgar score was 3/6. The length of the infant was 53.5 cm and the head circumference of the infant was 35 cm. There was no complication, diagnostic test or infection or illness during pregnancy. There were complications during delivery: first, cord avulsion which required manual extraction of placenta; second, vacuum assistance; third, episiotomy; fourth, shoulder dystocia and fifth, stage III placenta. The following lab prenatal tests were performed: on 30-JUN-2009 the ultrasound was normal and the amniocentesis test was normal.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a physician concerning a female who in April 2008, was vaccinated with the third and final dose of GARDASIL. In this year 2009, the patient had been experiencing malaise. Unspecified medical attention had been sought and the the patient had not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Panic attack
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 16-JUN-2009 was vaccinated with her 1st dose of GARDASIL, 0.5ml. IM. Subsequently "after the 1st dose", the patient experienced anxiety and panic attacks. The patient hadn't sought medical attention. The patient hadn't recovered at the time of report. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Gestational diabetes
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no medical history or drugs allergies, who on 01-MAY-2009 was vaccinated with a first dose of GARDASIL. There was no concomitant medication. Subsequently the patient was determined to be pregnant. Her LMP was in April 2009. The pregnancy was confirmed with a home pregnancy test. The patient will be contacting her primary physician for referral to obstetrical practice. The patient did not seek medical attention. Follow up information has been received from a physician concerning a female with asthma and no previous pregnancies, who on 01-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot: 661953/1130X). The physician reported that the pregnancy was not diagnosed in her office; the mother of the patient called to the office on 02-JUL-2009 and reported that the patient was 2-3 months pregnant (LMP: 02-APR-2009, EDD: 07-JAN-2010). The physician also reported that the patient was being followed by an OB/GYN. Follow up information has been received from the physician who indicated that the patient had just been seen in the office (no further details provided). Follow up information received from the physician indicated that on 03-FEB-2010 at 41 2/7 weeks from her last menstrual period, the patient gave birth to a normal female with no congenital anomalies. The baby's weight was 6 pounds and 15 ounces, her length was 20 inches; apgar score was 9/9. The patient did no have complications during pregnancy or labor. It was also reported that on an unspecified date the patient experience increase gestational blood sugar. The outcome of the patient's increase gestational blood sugar was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Sinus disorder
Clinical narrative: Information has been received from a nurse concerning a female patient who in May 2009, was vaccinated with a first dose of GARDASIL (lot # not reported). In May 2009, after received the first dose of vaccine the patient experienced sinus problems and fever. The patient did not sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MMR, VARCEL
Symptoms: Haematology test, Lymphadenopathy
Clinical narrative: Information has been received from a consumer concerning her daughter, with latex allergy and no medical pertinent history, who on 19-JUN-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL intramuscularly in her left arm. On the same day the patient received one dose of MMR II (manufacturer unknown) and VARIVAX (manufacturer unknown) in her right arm. There was no concomitant medication. The reporter stated that she noticed "swelling" in the left side of her daughter's neck on 30-JUN2009. She took her daughter to see her doctor that day and the swelling was diagnosed as swollen lymph nodes. The reporter did not know when the swelling actually started. The swelling has "gone up and down" since it first started, and at the time of reporting on 09-JUL-2009 "I think it's the worst that it's ever been". Since GARDASIL was given in her left arm the reported thought that the symptoms may be due to GARDASIL. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Radiculitis brachial, Syncope, Vaccination site pain
Clinical narrative: Information has been received from an office manager concerning a female "couple" of patients who on an unspecified date were vaccinated with GARDASIL (lot # not reported). On an unspecified date the patients experienced syncope and the patients said that the vaccination "hurt". The patients sought unspecified medical attention. Follow up information has been received from a physician concerning a 13 year old female patient who on an unspecified date experienced prolonged pain brachial neuritis for 3 plus weeks. It was noted that the patient's nerve factor was okay motor function was okay. At the time of report, the patient had totally resolved on treatment with MOTRIN. There was no work-up performed. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a physician concerning her daughter, a 14 female was vaccinated with the first dose of GARDASIL 0.5 mL and later experienced heart palpitations. The patient recovered and did not have any adverse experiences after receiving the second dose. The patient sought unspecified medical attention in the office. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female who on 08-JUN-2009 was vaccinated with a first dose of GARDASIL. The patient fainted after receiving the GARDASIL dose. The patient recovered in the office without treatment. This is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Vulvovaginal discomfort
Clinical narrative: Information has been received from a 17 year old female for the Pregnancy Registry for GARDASIL, who in approximately February 2008, was vaccinated with the third dose of GARDASIL when she was 3-4 months pregnant. The patient delivered a healthy baby on 25-SEP-2008. After the third vaccination, the patient had vaginal irritation and sensitivity. She was exposed to HPV after her 2nd dose of GARDASIL. The patient sought unspecified medical attention in the office. Follow up information was received from a Medical Assistant (M.A.) who reported that the patient received the vaccines from her primary physician but baby was delivered by the physician in this office. It was reported that the baby was healthy. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Suture insertion, Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 30-JUN-2009 was vaccinated IM with the first 0.5 mL dose of GARDASIL. On 30-JUN-2009, after receiving GARDASIL, the patient got up to vomit, fainted and hit her head on the bathroom door. The patient was taken to the emergency room, received 8 stitches above her right eyebrow, and was released on the same day. The patient's final outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Syncope
Clinical narrative: Information has been received from an office manager concerning a 22 year old female with AUGMENTIN allergy and no pertinent medical history who on 25-JUN-2009 was inadvertently vaccinated with a fourth dose of GARDASIL (dose, route and lot number not reported). There was no concomitant medication. "About four weeks ago" (on approximately 06-JUN-2009) the patient experienced fainting spells. It was reported that on 06-JUN-2007, the patient fainted twice during a job interview. The office manager reported that she also fainted a couple of weeks ago. At the time of reporting the patient had not recovered from fainting spells. No lab studies were performed. The patient sought medical attention by making an office visit. Conflicting information was received in follow up from the physician. It was reported that the female patient was accidentally vaccinated intramuscularly into the left deltoid with a fourth dose of GARDASIL (lot number 662300/0100Y) and no adverse effects were noted. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient with drug reactions or allergies reported as none who on 15-DEC-2008 was vaccinated with a first dose of GARDASIL (lot # 661530/0575X). On 07-MAR-2009 she received second dose of GARDASIL (lot # 661952/1129X). On 07-JUL-2009 she received third dose of GARDASIL (lot #661952/1129X). Concomitant therapy included YAZ. On 07-JUL-2009 within 3 minutes of given third dose of vaccine, the patient "passed out". The patient claimed she did not eat anything and that was the cause. The patient was given food and cold compresses in the office and watched for 20-30 minutes after she woke up. The patient went home and the next day the mother was upset that the patient was sent home because the patient had another reaction when she came home. The mother took her daughter to the emergency room but the patient was not admitted to the hospital. The emergency room informed the child's mother that the child had a reaction to the GARDASIL. No reaction was reported after first and second doses of GARDASIL were given. On unspecified date the patient recovered. Follow-up information has been received from the registered nurse concerning the 20 year old female with no drug allergies who on 07-JUL-2009 at 16:15 was vaccinated into left deltoid with third dose of GARDASIL (lot # 661952/1129X) without problems or complaints. There was no illness at the time of vaccination. Three minutes after vaccination, patient fainted in the exam room, no injures occurred. Patient complained of dizziness and nausea. The patient was treated with cool compresses. The patient remained in office about 15 minutes due to adverse effects. She left the office ambulating with complaints of "problems. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 29-JUN-2009 was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). Concomitant therapy included "birth control". It was reported that "on 01-JUL-2009", the patient came to the walk in clinic with nausea, headache, fatigue and sweating. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pain
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A) concerning a 23 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 28-APR-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # 0074Y) intramuscularly. On 09-JUL-2009 the patient was in the office to receive the second dose of GARDASIL. There was no concomitant medication reported. It was reported that "an hour or two after vaccination" the patient developed flu like symptoms consisting of body aches. The patient stated that she had body aches but was still able to go to work. The patient did not experience fever. The patient did not seek medical attention. There were no laboratory diagnostic tests performed. It was reported that "2 days after vaccination" the patient had recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 20 years old female with no medical history and no drug allergies who on 11-JUN-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently, the patient experienced headache and nausea 4 hours after receiving the first dose of GARDASIL and symptoms lasted 5 hours. Unspecified medical attention was sought. At the time of the report, the patient recovered from headache and nausea. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 years old female who was vaccinated with the first dose of GARDASIL "2 and a half weeks ago", on approximately 21-JUN-2009. Concomitant therapy included MENACTRA and DTAP. The patient's skin became itchy all over her body "8 to 10 hours" after she received the 1st dose of GARDASIL and the patient's skin became blotchy from head to toe. The patient called the office and was prescribed BENADRYL and the symptoms improved within 48 hours. At the time of the report, the patient recovered. Follow-up information has been received from a physician concerning an 11 year old (previously reported 14 year old) female with no illness at time of vaccination who on 11-JUN-2009 was vaccinated with the first dose of GARDASIL (lot#661531/1311X) intramuscularly into the left deltoid at 1:20pm. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis vaccine (unspecified). In the evening of 11-JUN-2009, 4 hours after vaccine administration, the patient had full body hives with extreme pruritus. The patient was given a dose of BENADRYL and the symptoms improved within the first 24 hours. The urticaria completely resolved after 4 days. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning a 22 year old daughter with no pertinent medical history reported and no known drug allergies who on 28-JUL-2008 was vaccinated with first dose of GARDASIL (dose, route and lot number not reported). There was no concomitant medication. The consumer stated her daughter had all three doses administered within an eleven month period. She stated that between the first and the second dose three months went by and between the second and third dose maybe two to three months. The consumer also stated that her daughter was given a pap test abnormal on the same days she received her third dose of GARDASIL and it came back abnormal. It was not specified if the patient sought medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site atrophy
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history and no known drug allergies who on an unspecified date may have been vaccinated with a 0.5 ml dose of GARDASIL in her right buttock while at another physician's office. Lot number 0573X was reported, but the dose number was unknown. The total number of doses given was not reported. Concomitant therapy included YAZ. Subsequently the patient developed visible dimpling at the site. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with 2 doses of GARDASIL, date of doses unknown, lot # was not reported. The patient experienced breakthrough bleeding after getting GARDASIL. Unspecified medical attention had been sought. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female who on 06-JUL-2009 was vaccinated with a third dose of GARDASIL. The patient fainted after receiving the GARDASIL dose. The patient recovered in the office without treatment. This is one of two reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray dental
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with three 0.5ml doses of GARDASIL (lot#, dates and site of administration not reported). Concomitant medication therapy included hormonal contraceptives (unspecified). Subsequently, the patient developed breakthrough vaginal bleeding (date not specified). It was reported that the patient also had "lip swelling" after she had "some dental surgery", it was unknown how long prior to the lip swelling the surgery was performed. The physician stated that the swelling may have been from a food allergy. There was no adverse event (AE) after the first dose, and it was unknown if these AEs happened at the same time or not, and if they occurred after the second or third dose of GARDSIL. Stool cultures had performed with no results reported. Unspecified medical attention was sought. The patient's lip swelling was reported as recovered, the outcome of breakthrough bleeding was unknown. The physician contacted during telephone follow-up could not supply the following information: (patient's name, date of birth, GARDASIL administration dates, lot#, concomitant vaccinations, AE onset dates, stool culture results and patient recovery status). The physician requested a call back in a few days and she needed to be in her office so that she could reference the patient's chart at that time. No further information is available at this time. Follow up information has been received from the physician concerning the 26 year old female with allergy to penicillin, polymycin, neomycin, bacitracin, and late allergies, migraine, temporomandibular joint syndrome, anxiety, back pain, anaemia, attention deficit disorder, abscess and lactose intolerance who on 08-DEC-2008, at 10 a.m., was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# 0152X) into the left arm. On 09-FEB-2009, at 9 a.m., she was vaccinated intramuscularly with the second dose of GARDASIL (lot# 0152X) into the left arm. On approximately 14-MAR-2009 the patient  developed lip swelling. Her lip swelling was at times part of the lip (mostly upper) but generally not the whole lip. This had continued and no cause had been found (including dental, parasitic, food allergies). On 07-JUL-2009 the patient came to the office and complained of post-coital bleeding for approximately 1 month. She was on birth control pills. Pregnancy test showed negative. Pap test in December 2008 was normal. Chlamydia & gonorrhea DNA test, dental X-ray test, stool culture test and beta-HCG test were all negative. Cervical polyp was seen on exam. There was no illness at the time of vaccination. At the time of reporting the patient was not recovered. On 09-JUN-2009, at 2 p.m., she was vaccinated with third 0.5ml dose of GARDASIL (lot# 661046/0546X) into the left arm. Follow-up information was received on 26-AUG-2009 from the physician's office. On 14-AUG-2009, the physician had an appointment with the patient and the patient had recovered from breakthrough vaginal bleeding and lip swelling. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Arthralgia, Back pain
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was vaccinated with the first 0.5ml dose of GARDASIL on "around 11-MAY-2009". Concomitant therapy included MENACTRA and hepatitis A vaccine (inactive) (MSD) (duration and dose not reported). On 10-JUL-2009 it was reported that the patient experienced back and knee pain after receiving first dose of GARDASIL "within the last couple weeks". The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Hypoaesthesia, Malaise, Migraine, Nausea
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient with an allergic reaction to Z-PACK and a history of migraines who on 10-FEB-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 659437/1266U). On 07-JUL-2009 the patient received the second IM, 0.5 ml dose of GARDASIL (lot number 662404/0312Y) and within one hour of the injection she developed a migraine that lasted for 24 hours. Concomitant therapy included TYLENOL. The patient called the office that day and told the nurse that she "was too sick to come back in". The patient was seen for a follow up appointment 2 days later, on 12-JUL-2009, and "she was fine". There were no lab diagnostics studies performed. Follow up information has been received from a Registered nurse who reported that the female patient who on 7-JUL-2009 was vaccinated IM with a second dose of GARDASIL (lot # 662404/0312Y) at 11:30 a.m into the left arm. The Registered nurse reported that on 07-JUL-2009, the patient experienced migraines, nausea, sore and numb arm at 12:30 p.m. At the time of the report, the patient recovered on 09-JUL-2009 (also reported by Registered nurse as 08-Jul-2009). Additional information is not expected requested.