chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Rash
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included sertraline HCl (ZOLOFT) and hormonal contraceptives (unspecified). Subsequently, a week after the vaccination, the patient developed a rash. It was reported that the patient went to the emergency room due to shortness of breath. The patient was not admitted. Subsequently, the patients symptoms "cleared up." Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Injection site anaesthesia, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 22-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0696F). There was no concomitant medication. On 22-AUG-2007 the patient experienced redness, swelling, numbness at the injection site, some fever and chills. Subsequently, on 23-AUG-2007 the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 20-AUG-2007 was vaccinated intramuscularly with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot number 658490/0802U) There was no concomitant medication. On 22-OCT-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot number 658563/1063U) intramuscularly. On 23-OCT-2007 the patient experienced a fever of 103.1F, headache, chills, nausea and fatigue. The patient sought unspecified medical attention. At the time of the report, 23-Oct-2007, the patient still had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant medication was not reported. Subsequently within a week, the patient complained of weakness in the body. The reporting physician felt that complained of weakness in the body was not related to therapy with HPV rL1 6 11 16 18 VLP vaccine (yeast). The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a grandmother concerning her granddaughter who on approximately 22-AUG-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). On approximately 22-AUG-2007 the patient experienced injection site pain. No additional problems were reported. This is one of several reports reported from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Injection site urticaria, Rash generalised, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a pharmacist concerning a 14 year old female with a history of asthma and multiple allergies (dust mites, grass, weeds, and others) who on 14-OCT-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included influenza virus vaccine (unspecified) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) in the other deltoid. On 17-OCT-2007 the patient experienced a minor rash. On 18-OCT-2007 the rash increased to go all over the patient's body and she was given Benadryl. The hives were reappearing on and off by day 5. On 19-Oct-2007 the patient was ok, however later that evening the patient got hives and took BENADRYL again. The patient was taken to the pediatirician on 20-Oct-2007 and was told to take BENADRYL "around the clock". On 22-OCT-2007 the patient got hives again, and one big hive, "the size of a pencil eraser" appeared at the injection site. After an additional dose of BENADRYL, the hives resolved. MENACTRA and flu vaccines were administered in the other deltoid at the same visit. The patient has not been tested for any yeast allergies. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first and only dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The following day, the patient developed pimples on her face. The vaccine was given at another physician's office. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from physician concerning a 16 year old female with a sore arm to a horse riding internal injury who reported on 24-Oct-2007 that "2-3 weeks ago" she was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, "2-3 weeks ago", the patient developed little blisters around the injection site. The patient outcome was not reported. The patient did not think she would get the second or third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient did not seek medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 05-JUL-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On 05-JUL-2007 the patient experienced numbness in her arm and the patient felt faint. On 08-OCT-2007 the patient was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and the patient fainted. The patient sought unspecified medical treatment. Subsequently the patient recovered from numbness in her arm, feeling faint, and fainting on an unspecified date. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a patient services representative at a health clinic concerning a 19 year old female who In the "middle of August" 2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included "birth control" (therapy unspecified) and cetirizine hydrochloride (ZYRTEC). On 13-OCT-2007, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot #655324/0088U). On 15-OCT-2007, the patient developed hives on her head from which she was recovering. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Initial and follow up information has been received form a receptionist in a physician's office, via a company representative, concerning a 23 year old female student (presumed relative), patient with a history of no reaction on previous exposure to the first and second dose of GARDASIL, who was vaccinated IM on 16-OCT-2007 in the morning, with the third dose, 0.5 ml, of GARDASIL. On 17-OCT-2007 in the morning, the student developed a baseball sized lump with soreness at the injection site. The student did not seek medical attention. At the time of this report, the outcome of the event was unknown On 27-OCT-2007, the patient had recovered from the events. Additional information has been requested.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse midwife concerning a 22 year old female with no pertinent medical history who on 22-OCT-2007 was vaccinated intramuscularly into the left deltoid with a third dose of GARDASIL. There was no concomitant medication. On 22-OCT-2007 the patient experienced a sore left arm. The patient took MOTRIN and it relieved the sore arm. The patient also experienced discomfort in the left arm.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pre-existing medical conditions or drug allergies who on 06-JUL-2007 at 1pm was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (lot# 654741/1208F) and experienced syncope post vaccination. The patient was monitored in the office and fully recovered on 06-JUL-2007, no sequelae. On 25-SEP-2007, the patient was vaccinated  (site and route not reported) with the second dose of GARDASIL (lot# not reported) and experienced no adverse event post vaccination. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. No additional information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic inflammatory disease
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who was vaccinated with a dose of GARDASIL. The physician reported that patient developed pelvic inflammatory disease after being vaccinated with a dose of GARDASIL. It was unknown if the patient sought unspecified medical attention. The outcome was unknown. The physician reported that this is one of the two patient who experienced same adverse event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a licensed practical nurse concerning 1 female (age not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with GARDASIL (lot # unknown). There was no concomitant medication. The nurse reported that on an unspecified date post-vaccination the patient felt light headed after vaccination with GARDASIL. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. Follow-up information was received. It was unknown to the reporter. The patient never reported to the office that she had an advers effect. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Feeling cold, Loss of consciousness, Malaise, Pallor
Clinical narrative: Information has been received from a medical technologist concerning her 16 year old daughter and follow up information has been received from license practical nurse. The patient with no relevant medical history and no history of drug reactions/allergies who on 14-JUN-2007 was vaccinated (route not reported) in the left deltoid with a first dose of GARDASIL (lot # 657736/0389U). Concomitant therapy included ZYRTEC and ERYTHROMYCIN BASE. On 14-JUN-2007, about 5 minutes after receiving the first dose, the patient experienced severe hives. The hives were everywhere (on top of the head mentioned) and she had terrible itching. The patient took BENADRYL and was okay. On 15-JUN-2007, the patient recovered. On 20-AUG-2007, the patient received the second dose of GARDASIL (lot # 658282/0929U). Post vaccination, the patient complained of not feeling well, she was pale,cool, clammy so patient mother laid her on the floor. The patient was not in pain. The patient passed out in the exam room and recovered shortly thereafter. The doctor instructed for the patient's vitals to be taken. Vitals taken at 3:40 pm were BP, 98/60 right arm seated, Pulse 60 (right arm), vitals taken at 3:48pm were BP:90/60 right arm seated, Pulse:72 (right arm) the pulse was regular and respiratory rate: 16. The patient insisted that she was feeling better so the patient's mother stated she was taking her home. The patient mother stated that the patient was worried about getting her 2nd GARDISIL vaccination today and thinks tha's why she reacted this way. Doctor was notified patient was feeling better and going home. The patient broke out in hives after going home. The patient was treated with BENADRYL.NO additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a medical technologist concerning her 16 year old daughter and follow up information has been received from license practical nurse. The patient with no relevant medical history and no history of drug reactions/allergies who on 14-JUN-2007 was vaccinated (route not reported) in the left deltoid with a first dose of GARDASIL (lot # 657736/0389U). Concomitant therapy included ZYRTEC and ERYTHROMYCIN BASE. On 14-JUN-2007, about 5 minutes after receiving the first dose, the patient experienced severe hives. The hives were everywhere (on top of the head mentioned) and she had terrible itching. The patient took BENADRYL and was okay. On 15-JUN-2007, the patient recovered. On 20-AUG-2007, the patient received the second dose of GARDASIL (lot # 658282/0929U). Post vaccination, the patient complained of not feeling well, she was pale,cool, clammy so patient mother laid her on the floor. The patient was not in pain. The patient passed out in the exam room and recovered shortly thereafter. The doctor instructed for the patient's vitals to be taken. Vitals taken at 3:40 pm were BP, 98/60 right arm seated, Pulse 60 (right arm), vitals taken at 3:48pm were BP:90/60 right arm seated, Pulse:72 (right arm) the pulse was regular and respiratory rate: 16. The patient insisted that she was feeling better so the patient's mother stated she was taking her home. The patient mother stated that the patient was worried about getting her 2nd GARDISIL vaccination today and thinks tha's why she reacted this way. Doctor was notified patient was feeling better and going home. The patient broke out in hives after going home. The patient was treated with BENADRYL.NO additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Syncope
Clinical narrative: Information has been received from a physician concerning a female with no prior history of fainting who in approximately April 2007, "about six months ago, " was vaccinated IM with the first dose of Gardasil. It was reported that after receiving her first dose of Gardasil the patient fainted and has fainted several times since the injection. On one occasion the patient developed a concussion. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with the third 0.5 ml dose of Gardasil. It was reported that the patient had experienced injection site pain for 1-2 days. At the time of the report, it was unknown if the patient recovered. The physician also reported a patient that received the third dose of Gardasil and complained of general body aches, nausea and vomiting and reportedly the patient was pregnant, (WAES #0710USA02438).
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Sinusitis, Ultrasound scan normal, Umbilical cord abnormality
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a certified medical assistant concerning a 27 year old female with a history of an abnormal pap with Atypical squamous cells of undetermined significance (ASCUS) (04-Aug-2007) and a 36.6 full term normal delivery, who on 16-October-2007 was vaccinated IM with a first 0.5 mL dose of Gardasil (Lot# 654540/0800F). The patient received a second vaccination of Gardasil, a 0.5 mL dose administered IM (Lot# 653938/0954F). Concomitant therapy included prenatal vitamins. On 03-Jan-2007, the patient reported that a home pregnancy test was positive. The patient's last menstrual period was on 01-DEC-2006 and the estimated date of delivery was 16-AUG-2007. On 18-JAN-2007 and 12-FEB-2007 ultrasounds were preformed, results normal. On 20-MAR-2007, the patient developed a vaginal infection and was treated with amoxicillin. On 10-MAY, the patient developed a sinus infection as was treated with azithromycin (Z-Pack). On 16-AUG-2007 the patient delivered a 7 pound 1 ounce, 20 1/4 inch normal male infant. The APGAR scores at one and five minutes were 9 and the head circumference was "12" cm. It was reported that there was a 2 vessel cord. The infant experienced neonatal jaundice. Laboratory diagnostics were performed on the infant (the results can be found in the laboratory results section). On 23-AUG-2007 the infant recovered from the neonatal jaundice. The infant was kept under light for two days. On 29-DEC-2007 the infant experienced cough and pharyngitis. On approximately 21-JAN-2008 the infant experienced constipation and ws treated with apple juice and water. On 11-FEB-2008 the infant was positive for respiratory syncytial virus bronchiolitis. The outcome of the infant's symptoms were unknown. At the time of the report the patient had recovered from the pregnancy, but the outcome of the vaginal and sinus infections were unknown. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal infection
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a certified medical assistant concerning a 27 year old female with a history of an abnormal pap with Atypical squamous cells of undetermined significance (ASCUS) (04-Aug-2007) and a 36.6 full term normal delivery, who on 16-October-2007 was vaccinated IM with a first 0.5 mL dose of Gardasil (Lot# 654540/0800F). The patient received a second vaccination of Gardasil, a 0.5 mL dose administered IM (Lot# 653938/0954F). Concomitant therapy included prenatal vitamins. On 03-Jan-2007, the patient reported that a home pregnancy test was positive. The patient's last menstrual period was on 01-DEC-2006 and the estimated date of delivery was 16-AUG-2007. On 18-JAN-2007 and 12-FEB-2007 ultrasounds were preformed, results normal. On 20-MAR-2007, the patient developed a vaginal infection and was treated with amoxicillin. On 10-MAY, the patient developed a sinus infection as was treated with azithromycin (Z-Pack). On 16-AUG-2007 the patient delivered a 7 pound 1 ounce, 20 1/4 inch normal male infant. The APGAR scores at one and five minutes were 9 and the head circumference was "12" cm. It was reported that there was a 2 vessel cord. The infant experienced neonatal jaundice. Laboratory diagnostics were performed on the infant (the results can be found in the laboratory results section). On 23-AUG-2007 the infant recovered from the neonatal jaundice. The infant was kept under light for two days. On 29-DEC-2007 the infant experienced cough and pharyngitis. On approximately 21-JAN-2008 the infant experienced constipation and ws treated with apple juice and water. On 11-FEB-2008 the infant was positive for respiratory syncytial virus bronchiolitis. The outcome of the infant's symptoms were unknown. At the time of the report the patient had recovered from the pregnancy, but the outcome of the vaginal and sinus infections were unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Influenza like illness, Injection site pain, Somnolence
Clinical narrative: Information has been received from a nurse practitioner/certified nurse midwife concerning a female with no known drug reactions/allergies or pertinent medical history who in June 2007, was vaccinated with her second dose of GARDASIL vaccine (yeast), 0.5 ml, IM. Subsequently the patient experienced injection site pain, flu-like symptoms, drowsiness and headache after she received her second dosage of GARDASIL vaccine (yeast) sometime in June 2007. No laboratory diagnostic studies were performed. It was reported that the patient has since fully recovered from the events. It was not specified if the patient sought medical attention. Patient Quality Complaints (PQC) was not involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Streptococcal identification test positive, Trichomoniasis
Clinical narrative: Initial and follow-up information has been received from a physician and a health professional through the Merck pregnancy registry concerning a 25 year old female with no known allergies or adverse drug reactions reported. On 16-NOV-2006, the patient was vaccinated with the first dose of GARDASIL vaccine (yeast). There were no concomitant medications reported. On 09-JAN-2007, the patient was vaccinated with the second 0.5 ml dose of GARDASIL vaccine (yeast). It was reported that the patient had the two shots while pregnant. The patient sought unspecified medical attention. It was reported that the patient planned to have the third shot. Subsequently, the patient experienced Group B streptococcus and trichomoniasis. On 24-JUL-2007 the patient delivered at 39 weeks a normal 6 pound 14 ounce female infant. It was unknown if there were complications during the labor or delivery. The apgar score was 8 and 9. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Culture urine, Drug exposure during pregnancy, Drug screen positive, Pregnancy test, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse, through the Merck pregnancy registry, concerning a 17 year old female smoker with an allergy to codeine and had a history of positive papilloma viral infection (HPV). On 02-JAN-2007, the patient was vaccinated with Gardasil, at another facility, while she was 4 weeks pregnant. Concomitant therapy included prenatal vitamins. The patient sought unspecified medical attention. On an unspecified date, the patient underwent a pregnancy test, "OB panel", urine culture and urine drug screen (results not reported). At the time of this report, the outcome of the event was unknown. Follow up information received stated that on 15-JAN-2007 the patient had a positive urine screen for marijuana. It was also noted that on 04-APR-2007 she had a normal quad screen and on 19-APR-2007 an ultrasound which showed normal fetal anatomy. Additional information has been requested. 12/12/2010 Information recieved from the physician's office indicated that the patient never returned for follow up care, and was lost to follow up. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test, Laceration, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a nurse practioner for the Merck pregnancy registry of GARDASIL vaccine (yeast) concerning a 17 year old white female with depression and allergies to amoxicillin and clavoloe acid and a history of marijuana abuse, and a smoker until she found out that she was pregnant, who on 29-NOV-2006 was vaccinated with a 0.5ml dose of GARDASIL vaccine (yeast), (lot# 653735/0388F). Concomitant therapy included minerals (unspecified) (+) vitamins (unspecified) (Precare). It was reported that the patient was pregnant (LMP = 01-DEC-2006) when vaccinated for the first time with GARDASIL vaccine (yeast). The patient had prenatal labs (results not reported). On 13-FEB-2007 the patient had an ultrasound that revealed a 10 week fetus. As of 27-FEB-2007 the pregnancy was normal to date. On 17-APR-2007 the patient had an ultrasound for anatomy scan that was normal. The patient did not have any previous pregnancies. The estimated date of delivery was 08-SEP-2007. On 28-AUG-2007 the patient gave birth to a liveborn male infant. The infant weighed 7 pounds and 5 ounces, the length was 19 3/4 inches, and the apgar score was 9/9. The infant was normal. there were no congenital anomalies and no other complications or abnormalities. The patient had no complications during pregnancy and gave birth 38 weeks from her last menstrual period. During labor and delivery there was a repair of a primary laceration. The patient did not experience any infections or illnesses during pregnancy. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Complication of pregnancy, Drug exposure during pregnancy, Pregnancy, Shoulder dystocia, Shoulder dystocia
Clinical narrative: Initial and follow up information has been received from a physician, concerning a 17 year old female patient with depression and morbid obesity, and a smoker, who on 26-JAN-2007 was vaccinated with the first does, 0.5 mL, IM of Gardasil (Lot# 655619/1427F). Concomitant therapy included Zoloft and Lunesta. On 26-JAN-2007, the physician reported that the patient "became pregnant," and stated "her due date is 19-OCT-2007." An ultrasound provided "confirmation of pregnancy," and the physician reported the "prenatal labs" (unspecified) were "normal." Follow up information indicated that on 14-OCT-2007, a normal female infant, weight 9'2, "21 inches, was delivered on the mother's gestational date of 39 1/7 weeks. Complications during pregnancy and delivery included the mother's morbid obesity, and shoulder dystocia of the infant (details not provided). The infant's Apgar score was 9/9. At the time of this report, the outcome of shoulder dystocia was unknown. Additional information is not expected. Follow up information in the form of medical records from the pediatrician, indicated that on 16-OCT-2007, the infant visited the physician for a weight check. Newborn feeding problems were mentioned and a concern of weight loss, though the medical assistant indicated "normal weight for newborn." On 19-OCT-2007, the infant returned for a weight check, with "good weight gain," and was feeding better. On 19-OCT-2007, the infant parents took the infant to the emergency department with concerns related to jaundice. The infant was sent home with a bili blanket, to use for 24 hours. On 22-OCT-2007, the infant visited the physician and "jaundice on upper trunk only" was noted. The jaundice was resolving, with no dehydration and normal skin turgor noted. On 19-OCT-2007, bilirubin level was 15.9 (unit not specified), and on 20-OCT-2007, bilirubin level was 11.4. On 11-DEC-2007, the infant returned for a 2 week baby check, and the mother reported concerns of possible thrush, onset 2 days prior. The physician prescribed nystatin suspension for thrush, with "Healthy child with normal growth and development" noted. The first dose of ROTATEQ, PEDIARIX, PREVNAR, and ACTHIB were administered. The infant subsequently experienced viral enteritis, acute upper respiratory infections, and unspecified constipation while on therapy with ROTATEQ. Additional information is not expected. All medical records will be provided upon request.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Initial and follow up information has been received from a physician, concerning a 17 year old female patient with depression and morbid obesity, and a smoker, who on 26-JAN-2007 was vaccinated with the first does, 0.5 mL, IM of Gardasil (Lot# 655619/1427F). Concomitant therapy included Zoloft and Lunesta. On 26-JAN-2007, the physician reported that the patient "became pregnant," and stated "her due date is 19-OCT-2007." An ultrasound provided "confirmation of pregnancy," and the physician reported the "prenatal labs" (unspecified) were "normal." Follow up information indicated that on 14-OCT-2007, a normal female infant, weight 9'2, "21 inches, was delivered on the mother's gestational date of 39 1/7 weeks. Complications during pregnancy and delivery included the mother's morbid obesity, and shoulder dystocia of the infant (details not provided). The infant's Apgar score was 9/9. At the time of this report, the outcome of shoulder dystocia was unknown. Additional information is not expected. Follow up information in the form of medical records from the pediatrician, indicated that on 16-OCT-2007, the infant visited the physician for a weight check. Newborn feeding problems were mentioned and a concern of weight loss, though the medical assistant indicated "normal weight for newborn." On 19-OCT-2007, the infant returned for a weight check, with "good weight gain," and was feeding better. On 19-OCT-2007, the infant parents took the infant to the emergency department with concerns related to jaundice. The infant was sent home with a bili blanket, to use for 24 hours. On 22-OCT-2007, the infant visited the physician and "jaundice on upper trunk only" was noted. The jaundice was resolving, with no dehydration and normal skin turgor noted. On 19-OCT-2007, bilirubin level was 15.9 (unit not specified), and on 20-OCT-2007, bilirubin level was 11.4. On 11-DEC-2007, the infant returned for a 2 week baby check, and the mother reported concerns of possible thrush, onset 2 days prior. The physician prescribed nystatin suspension for thrush, with "Healthy child with normal growth and development" noted. The first dose of ROTATEQ, PEDIARIX, PREVNAR, and ACTHIB were administered. The infant subsequently experienced viral enteritis, acute upper respiratory infections, and unspecified constipation while on therapy with ROTATEQ. Additional information is not expected. All medical records will be provided upon request.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Urine human chorionic gonadotropin negative
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 24 year old female with no known drug allergies, who was vaccinated with a second dose of Gardasil. On 01-AUG-2007, the patient's menstrual cycle was heavier and longer than normal. A urine pregnancy test was performed before the vaccination, and the patient was not pregnant. Unspecified medical attention was sought. The "patient refused follow-up appointment and/or testing." At the time of the report the patient's menstrual cycle returned to normal at the next cycle. Subsequently, the patient recovered. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Medical device complication, Musculoskeletal stiffness, Nausea, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 25 year old female (weight 106#, height 60") who on 01-OCT-2007 at 17:00 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #0530U), IM in the left deltoid. Concomitant medication was not reported. No illness was noted at the time of vaccination. The physician said that the GARDASIL vaccine (yeast) plunger would not push down on the syringe and the needle would not retract. On 01-OCT-2007, two minutes after the injection the patient became unresponsive and her body became stiff. The patient was administered one ammonia inhalant and she became alert and oriented. The patient complained of nausea. Her blood pressure at that time was 120/70. on 01-OCT-2007, the patient recovered from the events. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Dyspepsia, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from the Merck pregnancy registry for Gardasil vaccine from a nurse practitioner concerning an 18 year old female, with no drug reactions/allergies and asthma, who on 16-APR-2007 was vaccinated with a 0.5 mL dose of Gardasil intramuscularly at another facility. Concomitant therapy included albuterol inhaler and possibly other unspecified medications. On 16-APR-2007 a urine pregnancy test was negative. The nurse practitioner reported that subsequently the patient was determined to be pregnant. A urine pregnancy test on 25-MAY-2007 was positive. Last menstrual period was 09-MAR-2007 and the estimated date of delivery was 15-DEC-2007. The nurse practitioner noted that the conception may have occurred on 14-APR-2007. On approximately 20-JUL-2007, the patient developed anemia. On 20-JUL-2007, the patient was placed on therapy ferrous sulfate for the treatment of anemia. On approximately 07-SEP-2007, the patient developed heartburn. On 07-SEP-2007, the patient was placed on Tums for the treatment of heartburn. Additional information has been requested. On 07-JAN-2008, 40 weeks and 1 day from LMP, the patient gave birth to a normal female baby. The baby's weight was 1065 gm, length was 49.5 cm. APGAR score 9/9. Pediatric medical records were received and reviewed and the following experience was identified: the nurse practioner reported that the baby had mongolian spots on her back. Mongolina spots are considered to be an congenital anomaly. Addiitonal information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a Family Nurse Practitioner concerning a female who was vaccinated with GARDASILl vaccine (yeast). The patient received two doses of GARDASIL vaccine (yeast) and developed urticaria after the second dose. The patient was not going to receive the third dose. No other information was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with a second dose of GARDASIL vaccine (yeast). Subsequently the patient developed "mono". At the time of the report, the patient's outcome was unknown. The nurse reported that the nurse practitioner did not feel that the "mono" was related to GARDASIL vaccine (yeast). Additional information has been requested. This is in follow-up report(s) received on 11/14/2007  1/7/2008.  Information has been received from a licensed practical nurse concerning a female who was vaccinated with a second dose of GARDASIL.  Subsequently the patient developed "mono".  At the time of the report, the patient's outcome was unknown.  The nurse reported that the nurse practitioner did not feel that the "mono" was related to GARDASIL.  The practice has no further information regarding this AE.  Additional information was received from a nurse stating that the office had no record of the patient's experience.  No additional information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician and a nurse practitioner concerning her 21 year old daughter with no pre-existing allergies, birth defects or medical conditions, who on 16-MAR-2007 in the morning was vaccinated with the first dose of Gardasil vaccine (lot# 657006/0188U), injection (form) in the left deltoid. On an unspecified date in July 2007 in the morning, the patient was vaccinated with the second dose of Gardasil, injection (form) in the right deltoid. On 17-SEP-2007, in the morning, the patient was vaccinated with the third dose of Gardasil vaccine (lot #658556/1060U), injection (form) in the left deltoid. Concomitant medication was not reported. No illness was reported at the time of vaccinations. On approximately 24-SEP-2007 "one week after the last Gardasil vaccine injection, the patient experienced pubic hair loss. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Head injury, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who in approximately August 2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast). Concomitant therapy included 3 other vaccines (therapy unspecified). The physician reported that the patient received the first dose of GARDASIL vaccine (yeast) and experienced syncope within a few minutes. She hit "here" head and lost consciousness for a few minutes. At a later date she had a computed axial tomography (CT scan) of her head which was negative. The patient sought medical attention in the doctor's office. No additional information at this time. She recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Rash
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with Gardasil vaccine. One day after she was given Gardasil vaccine, the patient's arm was swollen and she had a rash. The patient contacted her physician. Subsequently, the patient recovered from the arm swelling and rash. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was vaccinated with Gardasil vaccine. The patient had an abnormal PAP after she was given the Gardasil vaccine. No other information was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness, Dyskinesia, Headache, Immediate post-injection reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no medical history and no drug allergies, who on 20-AUG-2007 was vaccinated intramuscularly with a 1 vial first dose of Gardasil vaccine (Lot#655205/1426F). There was no concomitant medication. On 20-aug-2007 the patient experienced dizziness and neck spasm immediately after the vaccination. The patient recovered quickly. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 13 year old female student with no medical history and no drug allergies, who on 20-AUG-2007 at 16:45 was vaccinated intramuscularly in the left deltoid with a 1 vial first dose of GARDASIL (Lot# 655205/1426F). There was no concomitant medication. On 20-AUG-2007 at 16:45 the patient experienced dizziness, lightheadedness, then syncope with neck spasm, twitching/jerking, and loss of consciousness that lasted a few seconds. The patient regained consciousness and improved quickly/appropriately over a time period of 3 to 5 minutes. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. The patient recovered 15 days later on an unspecified date. It was noted that the patient has a fraternal twin with controlled asthma. No product quality complaint was involved. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle spasms, Muscle twitching, Nausea, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no medical history and no drug allergies, who on 20-AUG-2007 was vaccinated intramuscularly with a 1 vial first dose of Gardasil vaccine (Lot#655205/1426F). There was no concomitant medication. On 20-aug-2007 the patient experienced dizziness and neck spasm immediately after the vaccination. The patient recovered quickly. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 13 year old female student with no medical history and no drug allergies, who on 20-AUG-2007 at 16:45 was vaccinated intramuscularly in the left deltoid with a 1 vial first dose of GARDASIL (Lot# 655205/1426F). There was no concomitant medication. On 20-AUG-2007 at 16:45 the patient experienced dizziness, lightheadedness, then syncope with neck spasm, twitching/jerking, and loss of consciousness that lasted a few seconds. The patient regained consciousness and improved quickly/appropriately over a time period of 3 to 5 minutes. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. The patient recovered 15 days later on an unspecified date. It was noted that the patient has a fraternal twin with controlled asthma. No product quality complaint was involved. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no medical history and no drug allergies, who on 20-AUG-2007 was vaccinated intramuscularly with a 1 vial first dose of Gardasil vaccine (Lot#655205/1426F). There was no concomitant medication. On 20-aug-2007 the patient experienced dizziness and neck spasm immediately after the vaccination. The patient recovered quickly. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 13 year old female student with no medical history and no drug allergies, who on 20-AUG-2007 at 16:45 was vaccinated intramuscularly in the left deltoid with a 1 vial first dose of GARDASIL (Lot# 655205/1426F). There was no concomitant medication. On 20-AUG-2007 at 16:45 the patient experienced dizziness, lightheadedness, then syncope with neck spasm, twitching/jerking, and loss of consciousness that lasted a few seconds. The patient regained consciousness and improved quickly/appropriately over a time period of 3 to 5 minutes. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. The patient recovered 15 days later on an unspecified date. It was noted that the patient has a fraternal twin with controlled asthma. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot# unknown). On the same day as the vaccination the patient developed dizziness, shortly after her vaccination with GARDASIL vaccine (yeast). Medical attention was sought at the office. The symptoms resolved later on the same day. No other symptoms were noted. No other information was available. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hepatic enzyme increased
Clinical narrative: Information has been received from the mother of a 21 year old female consumer with pertinent medical history and drug reactions/allergies reported as none, who on September 2007, was vaccinated with a dose of Gardasil vaccine, injection (form), 0.5 mL. Concomitant therapy included vitamins (unspecified). Subsequently on an unspecified date, the patient experienced elevated liver enzymes (AST & ALT) and fatigue. On an unspecified date, a blood test was performed with results not reported. Unspecified medical attention was sought. The patient's elevated liver enzymes (AST & ALT) and fatigue persisted. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who in the last week of September 2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast), lot #658556/1060U. She received diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) at the same visit. The nurse reported that the patient fainted when she turned to put her chart in the container. The patient had been out for about 3 seconds and was unaware that she had passed out. The patient fainted around 4 p.m. and noted that she had eaten an afternoon snack before coming to the office. She recovered and "was fine before leaving the office". Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Hyperhidrosis, Pain, Syncope, Tremor
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 year old female with no known allergies and no pertinent medical history, who on 01-OCT-2007, was vaccinated with Gardasil vaccine. Concomitant therapy included unspecified birth control. On 01-OCT-2007, the patient received her first dose of Gardasil vaccine and fainted. The patient felt sweaty and then her eyes rolled back and she passed out. The patient was in the office at the time of the event. No labs or diagnostic studies were performed. On 01-OCT-2007, the patient recovered from fainting but when she left the office she felt a little shaky and achy. No other information was reported. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a Certified Registered Nurse Practitioner (CRNP) concerning an 18 year old female who on 18-SEP-2007 was vaccinated with GARDASIL vaccine (yeast) IM in her left deltoid (lot number 1061U). The patient received her injection on 18-SEP-2007 at 10:59 am. The patient called at 5:39 pm and stated the injection site itched, bumps appeared going down her arm that itched, she had swelling and pain at the injection site and she ran a slight fever. The patient took diphenhydramine hydrochloride (Benadryl) 50 mg po and the symptoms resolved (2007, exact date not reported). Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Flushing, Nausea, No reaction on previous exposure to drug, Vomiting
Clinical narrative: Information has been received from a Registered Nurse concerning a 23 year old female patient with allergic reaction to antibiotics (Biaxin), who on 13-SEP-2007 was vaccinated IM with a second dose of Gardasil vaccine, lot #657872/0515U. The nurse reported that on 14-SEP-2007 the patient called the office complaining of nausea, vomiting, flushed face and diarrhea. It was reported that the patient did not have any reaction when she received her first injection. No further information was available. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a health professional, an immunization coordinator, concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil vaccine. After receiving the first dose of the vaccine, the patient experienced an abnormal menstrual period (i.e. lasted 2 weeks). The patient sought medical attention. At the time of reporting, the patient recovered. No further information is available.