chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiomyopathy, Condition aggravated, Drug exposure during pregnancy, Electrocardiogram abnormal, Pregnancy test positive
Clinical narrative: Information has been received from a Licensed nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female with a history of gastric bypass surgery who on 10-JUL-2009 had a pregnancy test showing negative after 3 minutes and then was vaccinated with the first dose of GARDASIL (0.5 ml, lot number 662404/0312Y). After 5 minutes the negative pregnancy test result turned into positive. The nurse reported they will complete the GARDASIL after completion of pregnancy. The patient had sought unspecified medical attention by nurse. Follow-up information was received from a licensed nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female with a history of gastric bypass and no previous pregnancies who on 10-JUL-2009 was vaccinated with the first dose of GARDASIL (lot number 662404/0312Y). The patient was confirmed pregnancy at the vaccination time. Ultrasound was performed on 22-JUL-2009, the result showed she was 5 weeks + 4 days pregnancy but the LMP was not sure. Another ultrasound was performed 05-AUG-2009, the result showed she was 7 weeks 1 day pregnancy and the EDC would be on 23-MAR-2010. Follow-up information was received from a licensed nurse practitioner. The nurse stated "Everything was fine." The patient had no complications with her pregnancy and the baby was born full-term, vaginally, and was healthy. She also reported that the mother did have "one complication unrelated to the vaccine." The mother had a history of cardiomyopathy and a history of gastric bypass surgery. The nurse stated the patient had an exacerbation of the cardiomyopathy during her pregnancy, but everything has resolved. The patient had a follow-up EKG postpartum and it was normal. She had no further information to add as the chart was not with her. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen
Clinical narrative: Information has been received from a Licensed nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female with a history of gastric bypass surgery who on 10-JUL-2009 had a pregnancy test showing negative after 3 minutes and then was vaccinated with the first dose of GARDASIL (0.5 ml, lot number 662404/0312Y). After 5 minutes the negative pregnancy test result turned into positive. The nurse reported they will complete the GARDASIL after completion of pregnancy. The patient had sought unspecified medical attention by nurse. Follow-up information was received from a licensed nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female with a history of gastric bypass and no previous pregnancies who on 10-JUL-2009 was vaccinated with the first dose of GARDASIL (lot number 662404/0312Y). The patient was confirmed pregnancy at the vaccination time. Ultrasound was performed on 22-JUL-2009, the result showed she was 5 weeks + 4 days pregnancy but the LMP was not sure. Another ultrasound was performed 05-AUG-2009, the result showed she was 7 weeks 1 day pregnancy and the EDC would be on 23-MAR-2010. Follow-up information was received from a licensed nurse practitioner. The nurse stated "Everything was fine." The patient had no complications with her pregnancy and the baby was born full-term, vaginally, and was healthy. She also reported that the mother did have "one complication unrelated to the vaccine." The mother had a history of cardiomyopathy and a history of gastric bypass surgery. The nurse stated the patient had an exacerbation of the cardiomyopathy during her pregnancy, but everything has resolved. The patient had a follow-up EKG postpartum and it was normal. She had no further information to add as the chart was not with her. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a nurse concerning an 18 days old baby. Patient's mother was vaccinated on 05-MAY-2009 and on 10-JUL-2009 IM with a first and second dose of GARDASIL respectively (lot number of the first dose unspecified and lot number of the second dose: 661953/1130X). It was reported the patient received the third dose of GARDASIL on 04-NOV-2009. the Medical Assistant reported that the patient received her third dose of GARDASIL while she was pregnant (LMP: 01-OCT-2009 and EDD: 08-JUL-2010). The mother's patient reported that on 23-JUL-2010, the patient was seen at the E.R. for a possible choking episode or possible increased temperature; she was not quite sure which. The same day the patient had a follow-up visit at the pediatrician's office and the mom reported her that the patient was doing well. Follow-up information was received via telephone call from a nurse who indicated that 2 weeks post-partum, the patient was seen in the hospital for a "choking spell". The patient was being followed by a physician. The mother experience was captured on WAES 0912USA00016. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Beta haemolytic streptococcal infection, Drug exposure during pregnancy, Dyspepsia, Foetal growth restriction, Neonatal disorder
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with no known drug reactions/allergies and a history of headache and heartburn who on 15-OCT-2009 was intramuscularly vaccinated with the first dose of GARDASIL (Lot#663552/1350Y) 0.5mL. Secondary suspect vaccine included measles-mumps-rubella vaccine and Tdap (manufacturer unknown). Other concomitant therapy included ZANTAC and TYLENOL. On 17-NOV-2009 the patient was intramuscularly vaccinated with the second dose of GARDASIL (Lot#663552/1350Y) 0.5ml. It was reported that the patient LMP was in "late September 2009" and estimated date of delivery (EDD) is approximately on 07-JUL-2010. On an unspecified date a serum pregnancy test was performed and the result was positive. The patient sought medical attention by an office visit. Follow-up information has been received from a registered nurse who reported that the patient was with no medical history/concurrent condition. During pregnancy, intrauterine growth restriction (IUGR) was found. On approximately 12-JAN-2010, the patient developed heartburn that was treated with PRILOSEC and ringworm that was treated with LOTRISONE. Ultrasounds for growth anatomy and amniotic fluid Index (AFI) were done on 19-MAY-2010 1139 grams, on 16-JUN-2010 1673 grams, 22-JUN-2010 (no result reported). The patient experienced group b strep infection, and was treated with penicillin C (dose not specified) in labor on 07-JUL-2010. On 29-JUL-2010, at 39 4/7 weeks from LMP, the patient delivered a normal male baby, weighing 6 lb 5.9 oz, APGAR ( Appearance, Pulse, Grimace, Activity, Respiration.) score 8/9. The baby experienced umbilical mass (also reported infant normal). The baby's umbilical mass was considered a congenital anomaly. The baby's experiences had been reported in WAES# 0912USA01991A. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Tinea infection, Ultrasound antenatal screen
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with no known drug reactions/allergies and a history of headache and heartburn who on 15-OCT-2009 was intramuscularly vaccinated with the first dose of GARDASIL (Lot#663552/1350Y) 0.5mL. Secondary suspect vaccine included measles-mumps-rubella vaccine and Tdap (manufacturer unknown). Other concomitant therapy included ZANTAC and TYLENOL. On 17-NOV-2009 the patient was intramuscularly vaccinated with the second dose of GARDASIL (Lot#663552/1350Y) 0.5ml. It was reported that the patient LMP was in "late September 2009" and estimated date of delivery (EDD) is approximately on 07-JUL-2010. On an unspecified date a serum pregnancy test was performed and the result was positive. The patient sought medical attention by an office visit. Follow-up information has been received from a registered nurse who reported that the patient was with no medical history/concurrent condition. During pregnancy, intrauterine growth restriction (IUGR) was found. On approximately 12-JAN-2010, the patient developed heartburn that was treated with PRILOSEC and ringworm that was treated with LOTRISONE. Ultrasounds for growth anatomy and amniotic fluid Index (AFI) were done on 19-MAY-2010 1139 grams, on 16-JUN-2010 1673 grams, 22-JUN-2010 (no result reported). The patient experienced group b strep infection, and was treated with penicillin C (dose not specified) in labor on 07-JUL-2010. On 29-JUL-2010, at 39 4/7 weeks from LMP, the patient delivered a normal male baby, weighing 6 lb 5.9 oz, APGAR ( Appearance, Pulse, Grimace, Activity, Respiration.) score 8/9. The baby experienced umbilical mass (also reported infant normal). The baby's umbilical mass was considered a congenital anomaly. The baby's experiences had been reported in WAES# 0912USA01991A. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Complication of delivery, Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a consumer for the Merck Pregnancy Registry, for GARDASIL, a Pregnancy Registry product, concerning a 7 months old male patient who on 20-AUG-2009 received a dose of GARDASIL (Lot # not provided) via transplacental administration (WAES 0909USA00366). Patient's mother reported that her pregnancy was awesome; she had no problems and it went very smoothly. She went into labor at 38 weeks, but had a difficult time with the birth because the baby had a tight nuchal cord three times around his neck. Her son weighted 7lbs, 2 oz and was born on 30-APR-2010. She reported that the only problem he had was "pretty bad asthma" and he was treated. The patient saw his pulmonologist and they "upped" his daily FLOVENT and added an allergy medication (not specified). Patient's mother added that the baby did not have any congenital anomalies-nothing like that. She confirmed that the pediatrician's name was on the consent form. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer concerning her 15 years old daughter with no drug reactions or allergies and no pertinent medical history who received first, second and third doses of GARDASIL (Lot number unknown), on August-2009, October 2009 and May-2010 respectively. There was no concomitant medication. The consumer reported that her daughter noticed she was beginning to lose hair after the second shot of GARDASIL and had progressively gotten worse ever since. There were no laboratory tests performed. The patient did not seek medical attention. At the time of this report, the patient had not recovered from "lose hair". No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure before pregnancy, Foetal growth restriction, Normal newborn, Pregnancy test negative
Clinical narrative: Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning an approximately 23 year old patient who on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently the patient was pregnant. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Follow up information was received from the health professional which reported that on 16-SEP-2009, the 23 year old female patient was vaccinated with a dose of GARDASIL (lot # 663453/0249Y). On the same day, she had a negative pregnancy test. Subsequently the patient was pregnant, with last menstrual period (LMP) 22-SEP-2009, estimated delivery date (EDD) 30-JUN-2010. The patient visited the physician. Follow-up information was received from the health professional concerning a patient with anaemia and depression who on 16-SEP-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins and NIFEREX-150. On 01-DEC-2009, the patient's ultrasound test revealed viable intrauterine pregnancy (IUP). On 21-DEC-2009, the patient's Maternal Serum Alpha-Fetoprotein Screening (MSAFP) test showed normal. On 06-JAN-2010, another ultrasound test revealed normal. It was reported that the patient had no previous pregnancies. Follow up information has been received from a registered nurse who reported that the patient had depression which was treated with ZOLOFT sporadically prior to pregnancy but the patient did not take it during the pregnancy. She also smoked during 2007 to 2010. Other concomitant medications used during pregnancy also included: KEFLEX, MACROBID, PREFERA OB and FERRI. On 09-NOV-2009 the patient developed urinary tract infection. In November 2009, the patient experienced anemia. On 20-APR-2010 (also reported on 28-APR-2010) the patient developed intrauterine growth restriction (IUGR). On 29-MAY-2010, the patient delivered a normal male baby with no congenital anomalies. There were no other complications or abnormalities. The baby's experience has been captured in WAES # 1001USA00985B1. This is an amended report, the AE term of foetal growth restriction was moved to 1001USA00985B1, and the concomitant therapies and narrative were updated. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning an approximately 23 year old patient who on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently the patient was pregnant. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Follow up information was received from the health professional which reported that on 16-SEP-2009, the 23 year old female patient was vaccinated with a dose of GARDASIL (lot # 663453/0249Y). On the same day, she had a negative pregnancy test. Subsequently the patient was pregnant, with last menstrual period (LMP) 22-SEP-2009, estimated delivery date (EDD) 30-JUN-2010. The patient visited the physician. Follow-up information was received from the health professional concerning a patient with anaemia and depression who on 16-SEP-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins and NIFEREX-150. On 01-DEC-2009, the patient's ultrasound test revealed viable intrauterine pregnancy (IUP). On 21-DEC-2009, the patient's Maternal Serum Alpha-Fetoprotein Screening (MSAFP) test showed normal. On 06-JAN-2010, another ultrasound test revealed normal. It was reported that the patient had no previous pregnancies. Follow up information has been received from a registered nurse who reported that the patient had depression which was treated with ZOLOFT sporadically prior to pregnancy but the patient did not take it during the pregnancy. She also smoked during 2007 to 2010. Other concomitant medications used during pregnancy also included: KEFLEX, MACROBID, PREFERA OB and FERRI. On 09-NOV-2009 the patient developed urinary tract infection. In November 2009, the patient experienced anemia. On 20-APR-2010 (also reported on 28-APR-2010) the patient developed intrauterine growth restriction (IUGR). On 29-MAY-2010, the patient delivered a normal male baby with no congenital anomalies. There were no other complications or abnormalities. The baby's experience has been captured in WAES # 1001USA00985B1. This is an amended report, the AE term of foetal growth restriction was moved to 1001USA00985B1, and the concomitant therapies and narrative were updated. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Foetal growth restriction, Maternal exposure before pregnancy, Normal newborn, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning an approximately 23 year old patient who on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently the patient was pregnant. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Follow up information was received from the health professional which reported that on 16-SEP-2009, the 23 year old female patient was vaccinated with a dose of GARDASIL (lot # 663453/0249Y). On the same day, she had a negative pregnancy test. Subsequently the patient was pregnant, with last menstrual period (LMP) 22-SEP-2009, estimated delivery date (EDD) 30-JUN-2010. The patient visited the physician. Follow-up information was received from the health professional concerning a patient with anaemia and depression who on 16-SEP-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins and NIFEREX-150. On 01-DEC-2009, the patient's ultrasound test revealed viable intrauterine pregnancy (IUP). On 21-DEC-2009, the patient's Maternal Serum Alpha-Fetoprotein Screening (MSAFP) test showed normal. On 06-JAN-2010, another ultrasound test revealed normal. It was reported that the patient had no previous pregnancies. Follow up information has been received from a registered nurse who reported that the patient had depression which was treated with ZOLOFT sporadically prior to pregnancy but the patient did not take it during the pregnancy. She also smoked during 2007 to 2010. Other concomitant medications used during pregnancy also included: KEFLEX, MACROBID, PREFERA OB and FERRI. On 09-NOV-2009 the patient developed urinary tract infection. In November 2009, the patient experienced anemia. On 20-APR-2010 (also reported on 28-APR-2010) the patient developed intrauterine growth restriction (IUGR). On 29-MAY-2010, the patient delivered a normal male baby with no congenital anomalies. There were no other complications or abnormalities. The baby's experience has been captured in WAES # 1001USA00985B1. This is an amended report, the AE term of foetal growth restriction was moved to 1001USA00985B1, and the concomitant therapies and narrative were updated. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure before pregnancy, Foetal growth restriction, Normal newborn, Pregnancy test negative
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a male infant whose mother on 16-SEP-2009 was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y). Subsequently the mother was pregnant. Concomitant therapy included prenatal vitamins (unspecified), NIFEREX-150, KEFLEX, MACROBID, FERRI, FLINTSTONES MULTIVITAMIN and PREFERA OB. On 01-DEC-2009, the mother's ultrasound test revealed viable intrauterine pregnancy (IUP). On 21-DEC-2009, the mother's Maternal Serum Alpha-Fetoprotein Screening (MSAFP) test showed normal. On 06-JAN-2010, another ultrasound test revealed normal. On 20-APR-2010 (also reported as 28-APR-2010) the ultrasound test revealed that the patient experienced intrauterine growth restriction (IUGR). On 28-MAY-2010, the patient was delivered with no congenital anomalies. There were no other complications or abnormalities. This information was previously reported in WAES # 1001USA00985 in which the mother's experience has been captured. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a male infant whose mother on 16-SEP-2009 was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y). Subsequently the mother was pregnant. Concomitant therapy included prenatal vitamins (unspecified), NIFEREX-150, KEFLEX, MACROBID, FERRI, FLINTSTONES MULTIVITAMIN and PREFERA OB. On 01-DEC-2009, the mother's ultrasound test revealed viable intrauterine pregnancy (IUP). On 21-DEC-2009, the mother's Maternal Serum Alpha-Fetoprotein Screening (MSAFP) test showed normal. On 06-JAN-2010, another ultrasound test revealed normal. On 20-APR-2010 (also reported as 28-APR-2010) the ultrasound test revealed that the patient experienced intrauterine growth restriction (IUGR). On 28-MAY-2010, the patient was delivered with no congenital anomalies. There were no other complications or abnormalities. This information was previously reported in WAES # 1001USA00985 in which the mother's experience has been captured. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Foetal growth restriction, Maternal exposure before pregnancy, Normal newborn, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a male infant whose mother on 16-SEP-2009 was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y). Subsequently the mother was pregnant. Concomitant therapy included prenatal vitamins (unspecified), NIFEREX-150, KEFLEX, MACROBID, FERRI, FLINTSTONES MULTIVITAMIN and PREFERA OB. On 01-DEC-2009, the mother's ultrasound test revealed viable intrauterine pregnancy (IUP). On 21-DEC-2009, the mother's Maternal Serum Alpha-Fetoprotein Screening (MSAFP) test showed normal. On 06-JAN-2010, another ultrasound test revealed normal. On 20-APR-2010 (also reported as 28-APR-2010) the ultrasound test revealed that the patient experienced intrauterine growth restriction (IUGR). On 28-MAY-2010, the patient was delivered with no congenital anomalies. There were no other complications or abnormalities. This information was previously reported in WAES # 1001USA00985 in which the mother's experience has been captured. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Chlamydial infection, Drug exposure before pregnancy, Menstruation irregular
Clinical narrative: Information has been received from a physician for the Pregnant Registry for GARDASIL, concerning a 15 year old female patient who on 03-APR_2009 was vaccinated with one dose of GARDASIL and was currently pregnant. The physician reported that the patient had a positive home pregnancy test on 30-AUG-2009, her last "normal day 7" period was June 2009. The physician stated that the patient had an irregular period in July 2009 and that the dates of conception and due date have not been determined. The patient sought medical attention by calling the physician's office. The physician declined to provide a fax as it is a central fax for several offices, she preferred to be contacted by mail or phone as mail was also confusing in this practice. Follow up information was received from the physician concerning the 15 year old female with no previous pregnancies and no medical history or concurrent conditions who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). The patient's last menstrual period was approximately on 29-AUG-2009. Follow up information was received from a physician via pregnancy questionnaire concerning a 15 year old female patient with anemia, Chlamydia (in October 2009), no previous pregnancies and no medical history who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). Concomitant medications included prenatal vitamins, ZITHROMAX, and iron (unspecified). Laboratory diagnostic tests were performed: on 16-OCT-2009, 30-OCT-2009, 07-DEC-2009, 04-JAN-2010, and on 12-FEB-2010 an ultrasound was performed and the results were normal; on 12-NOV-2009, a serum alpha-fetoprotein test was carried out and was within normal limits. It was reported that on 09-APR-2010, at 36.6 weeks of gestation, the patient delivered a healthy female baby (weight: 6 pounds and 10 ounces; Apgar score: 8/9). There were no congenital anomalies but the mother experienced severe preeclampsia and postpartum hemorrhage (500 cc). At the time of the report the outcome of the patient was not reported. The baby's experience has been captured in WAES # 0909USA01172B1. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Normal newborn, Postpartum haemorrhage, Pre-eclampsia, Pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician for the Pregnant Registry for GARDASIL, concerning a 15 year old female patient who on 03-APR_2009 was vaccinated with one dose of GARDASIL and was currently pregnant. The physician reported that the patient had a positive home pregnancy test on 30-AUG-2009, her last "normal day 7" period was June 2009. The physician stated that the patient had an irregular period in July 2009 and that the dates of conception and due date have not been determined. The patient sought medical attention by calling the physician's office. The physician declined to provide a fax as it is a central fax for several offices, she preferred to be contacted by mail or phone as mail was also confusing in this practice. Follow up information was received from the physician concerning the 15 year old female with no previous pregnancies and no medical history or concurrent conditions who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). The patient's last menstrual period was approximately on 29-AUG-2009. Follow up information was received from a physician via pregnancy questionnaire concerning a 15 year old female patient with anemia, Chlamydia (in October 2009), no previous pregnancies and no medical history who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). Concomitant medications included prenatal vitamins, ZITHROMAX, and iron (unspecified). Laboratory diagnostic tests were performed: on 16-OCT-2009, 30-OCT-2009, 07-DEC-2009, 04-JAN-2010, and on 12-FEB-2010 an ultrasound was performed and the results were normal; on 12-NOV-2009, a serum alpha-fetoprotein test was carried out and was within normal limits. It was reported that on 09-APR-2010, at 36.6 weeks of gestation, the patient delivered a healthy female baby (weight: 6 pounds and 10 ounces; Apgar score: 8/9). There were no congenital anomalies but the mother experienced severe preeclampsia and postpartum hemorrhage (500 cc). At the time of the report the outcome of the patient was not reported. The baby's experience has been captured in WAES # 0909USA01172B1. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician for the Pregnant Registry for GARDASIL, concerning a 15 year old female patient who on 03-APR_2009 was vaccinated with one dose of GARDASIL and was currently pregnant. The physician reported that the patient had a positive home pregnancy test on 30-AUG-2009, her last "normal day 7" period was June 2009. The physician stated that the patient had an irregular period in July 2009 and that the dates of conception and due date have not been determined. The patient sought medical attention by calling the physician's office. The physician declined to provide a fax as it is a central fax for several offices, she preferred to be contacted by mail or phone as mail was also confusing in this practice. Follow up information was received from the physician concerning the 15 year old female with no previous pregnancies and no medical history or concurrent conditions who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). The patient's last menstrual period was approximately on 29-AUG-2009. Follow up information was received from a physician via pregnancy questionnaire concerning a 15 year old female patient with anemia, Chlamydia (in October 2009), no previous pregnancies and no medical history who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). Concomitant medications included prenatal vitamins, ZITHROMAX, and iron (unspecified). Laboratory diagnostic tests were performed: on 16-OCT-2009, 30-OCT-2009, 07-DEC-2009, 04-JAN-2010, and on 12-FEB-2010 an ultrasound was performed and the results were normal; on 12-NOV-2009, a serum alpha-fetoprotein test was carried out and was within normal limits. It was reported that on 09-APR-2010, at 36.6 weeks of gestation, the patient delivered a healthy female baby (weight: 6 pounds and 10 ounces; Apgar score: 8/9). There were no congenital anomalies but the mother experienced severe preeclampsia and postpartum hemorrhage (500 cc). At the time of the report the outcome of the patient was not reported. The baby's experience has been captured in WAES # 0909USA01172B1. No further information is available.
Age: 43.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 43 year old patient who on 27-JUL-2010 was inadvertently vaccinated with ZOSTAVAX (Merck) instead of VARIVAX (Merck). The patient sought unspecified medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Foetal disorder
Clinical narrative: Information has been received from a physician via pregnancy questionnaire concerning a female baby whose mother was vaccinated with a dose of GARDASIL (Lot # 659184/0843X) on 03-APR-2009. Concomitant therapy included vitamins (unspecified), ZITHROMAX, iron (unspecified), vitamins (unspecified), iron (unspecified) and ZITHROMAX. It was reported that the baby was born at 36.6 weeks of gestation but there were no congenital anomalies. On 09-APR-2010, the Apgar score showed the following results: 8/9. At the time of the report the outcome of the patient was unknown. The mother's experiences have been captured in WAES # 0909USA01172. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Amniocentesis, Drug exposure during pregnancy, Perineal laceration, Ultrasound foetal
Clinical narrative: Information has been received from a 26 year old female consumer with no pertinent medical history and no drug allergies, for GARDASIL, a Pregnancy Registry product, concerning that on 13-JUL-2009 she was vaccinated with her third dose of GARDASIL (lot # not provided). There was no concomitant medication. She became pregnant after receiving her full dosing schedule of GARDASIL. The patient's last menstrual period was approximately 26-JUN-2009; estimated delivery date was 02-APR-2010. There were no labs and diagnostic tests performed. Follow up information received from a pregnancy questionnaire indicating that on an unknown date in April 2010 the patient had delivered a normal infant without congenital anomaly. Follow up information received from a pregnancy questionnaire indicating that on 13-JUL-2009 the female patient was vaccinated with her third dose of GARDASIL (lot # 662229/1497X). On 24-MAR-2010 the patient had delivered a female infant without congenital anomaly at 41 week and one day from LMP. The patient's current medication included prenatal vitamins. No infections or illnesses were specified during pregnancy. There were no medications used during pregnancy. The patient experienced fourth degree laceration. Lab test included ultrasound on 03-MAR-2010 which showed normal 36 weeks fetal age, amniocentesis and MSAFP (results unknown). The patient had 5 previous pregnancies and 5 elective terminations. The patient's estimated conception date was reported as 01-APR-2010. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a 26 year old female consumer with no pertinent medical history and no drug allergies, for GARDASIL, a Pregnancy Registry product, concerning that on 13-JUL-2009 she was vaccinated with her third dose of GARDASIL (lot # not provided). There was no concomitant medication. She became pregnant after receiving her full dosing schedule of GARDASIL. The patient's last menstrual period was approximately 26-JUN-2009; estimated delivery date was 02-APR-2010. There were no labs and diagnostic tests performed. Follow up information received from a pregnancy questionnaire indicating that on an unknown date in April 2010 the patient had delivered a normal infant without congenital anomaly. Follow up information received from a pregnancy questionnaire indicating that on 13-JUL-2009 the female patient was vaccinated with her third dose of GARDASIL (lot # 662229/1497X). On 24-MAR-2010 the patient had delivered a female infant without congenital anomaly at 41 week and one day from LMP. The patient's current medication included prenatal vitamins. No infections or illnesses were specified during pregnancy. There were no medications used during pregnancy. The patient experienced fourth degree laceration. Lab test included ultrasound on 03-MAR-2010 which showed normal 36 weeks fetal age, amniocentesis and MSAFP (results unknown). The patient had 5 previous pregnancies and 5 elective terminations. The patient's estimated conception date was reported as 01-APR-2010. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Menstruation irregular
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female with no medical history or allergies who on 10-JUL-2007 and 11-SEP-2007 was vaccinated IM with the first and second doses of GARDASIL (lot# not reported) respectively. On 09-APR-2009 the patient received the third dose of GARDASIL (IM, lot# 661703/0651X). There was no concomitant medication. On 04-MAY-2009 the patient called the office to inform that she was pregnant. No lab diagnostics studies were performed. No adverse event was reported. Unspecified medical attention was sought. Follow-up information was received from the Office Supervisor, who stated this patient has not been seen in their office again since April 2009, when she was in for a Well Clinic visit and her GARDASIL dose 3. The patient reported irregular menses at that time, and was referred to a Gyn office. The physician did not find out the patient was pregnant, but was informed of the pregnancy by the Emergency Room at the hospital. The reporter did not know for certain who the prenatal HCP contact person might be. This case is now considered lost to follow up. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Premature delivery
Clinical narrative: Information has been received from a nurse concerning a 24 year old female patient who on 11-JUN-2009 was vaccinated with the first dose of GARDASIL (lot # not specified). It was reported that the patient was already pregnant when received the first dose of GARDASIL. No adverse effects were reported. The patient sought unspecified medical attention. Follow up information has been received from the nurse who reported that on 20-JAN-2010, at approximately 36 weeks of gestation, the patient delivered twins by planned C-section. It was noted that it was a repeat C-section for this patient. The patient due date was on 20-FEB-2010. The nurse did not known the birth weights of the twins. The nurse also reported that there was nothing mentioned about any problems with either baby. The baby's experience has been captured in WAES 0906USA04966B1 and WAES 0906USA04966B2. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse concerning a twin patient who on 11-JUN-2009, was exposed through the mother who was vaccinated with the first dose of GARDASIL. On 20-JAN-2010, at approximately 36 weeks of gestation, the twin's mother delivered them by a planned C-section. It was noted that it was a repeat C-section for the mother. The nurse did not known the birth weights of the twin. The nurse also reported that there was nothing mentioned about any problems with either baby. The mother's experience has been captured in WAES 0906USA04966. The brother's experience has been captured in WAES 0906USA04966B2. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse concerning a twin patient who on 11-JUN-2009, was exposed through the mother who was vaccinated with the first dose of GARDASIL. On 20-JAN-2010, at approximately 36 weeks of gestation, the twin's mother delivered them by a planned C-section. It was noted that it was a repeat C-section for the mother. The nurse did not known the birth weights of the twin. The nurse also reported that there was nothing mentioned about any problems with either baby. The mother's experience has been captured in WAES 0906USA04966. The brother's experience has been captured in WAES 0906USA04966B1. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL (Lot # not reported) and experienced all over body tingling. At the time of the report the outcome of the patient was unknown. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Blood glucose normal, Drug exposure before pregnancy, Foetal disorder, Foetal growth restriction
Clinical narrative: Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old pregnant female with a history of 0 pregnancies and 0 live births and with no other medical history who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated intramuscularly with the first, second and third doses of GARDASIL (lot# for the third dose was 662304/1013Y) respectively. Concomitant therapy included OTC prenatal vitamins (PNV) (25-MAR-2010 to present) which was used for pregnancy. The patient's LMP was approximately 22-FEB-2010 and her estimated delivery date was reported as 15-NOV-2010 by the nurse. On 30-APR-2010 HPV test showed HPV positive. On 01-MAY-2010 (11 week 3 days) ultrasound was performed for testing size and date it showed there were abnormal cranial vault, no normal cerebral, hemispheres or choroid and portion of baby "calictium" absent. Then on 11-MAY-2010 (12 week 2 days), ultrasound was performed again and showed results within normal limits. ON an unspecified date the mother experienced anemia which was treated by ferrous sulfate (since late July 2010, 325 mg daily). In August 2010, at 28 weeks of gestation, the mother experienced preterm labor (PTL) which was treated by betamethasone (from 27-AUG-2010 to 28-AUG-2010, 12 mg X2). On 27-AUG-2010 the mother experienced bacterial vaginosis which was treated by cytarabine (+) fludarabine phosphate (+) granulocyte colony stimulating factor (unspecified) (from 27-AUG-2010, duration 1 week, 500 mg twice a day). It was reported that the baby also experience intrauterine growth retardation (IUGR). On 05-NOV-2010, at 38 1/2 weeks (also reported as 38 8/7 weeks) of gestation, the mother delivered a normal, healthy male baby weighing 5 pounds, 7. Apgar score was 8/9. Baby's length was 19 and head circumference was 81.5. There were no congenital abnormalities reported. There were no complications during labor. However, the reporter thought the baby was delivered at small gestation age (SGA). Other laboratory test included: fetal fibronectin test (FFN) which was performed on 27-AUG-2010 and showed positive result, Gestational Blood Sugar (GBS) which was performed on 12-OCT-2010 and showed negative. The mother's experience has been captured in WAES 1004USA00203. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Laboratory test abnormal, Premature labour, Ultrasound antenatal screen abnormal, Vaginitis bacterial
Clinical narrative: Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old pregnant female with a history of 0 pregnancies and 0 live births and with no other medical history who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated intramuscularly with the first, second and third doses of GARDASIL (lot# for the third dose was 662304/1013Y) respectively. Concomitant therapy included OTC prenatal vitamins (PNV) (25-MAR-2010 to present) which was used for pregnancy. The patient's LMP was approximately 22-FEB-2010 and her estimated delivery date was reported as 15-NOV-2010 by the nurse. On 30-APR-2010 HPV test showed HPV positive. On 01-MAY-2010 (11 week 3 days) ultrasound was performed for testing size and date it showed there were abnormal cranial vault, no normal cerebral, hemispheres or choroid and portion of baby "calictium" absent. Then on 11-MAY-2010 (12 week 2 days), ultrasound was performed again and showed results within normal limits. ON an unspecified date the mother experienced anemia which was treated by ferrous sulfate (since late July 2010, 325 mg daily). In August 2010, at 28 weeks of gestation, the mother experienced preterm labor (PTL) which was treated by betamethasone (from 27-AUG-2010 to 28-AUG-2010, 12 mg X2). On 27-AUG-2010 the mother experienced bacterial vaginosis which was treated by cytarabine (+) fludarabine phosphate (+) granulocyte colony stimulating factor (unspecified) (from 27-AUG-2010, duration 1 week, 500 mg twice a day). It was reported that the baby also experience intrauterine growth retardation (IUGR). On 05-NOV-2010, at 38 1/2 weeks (also reported as 38 8/7 weeks) of gestation, the mother delivered a normal, healthy male baby weighing 5 pounds, 7. Apgar score was 8/9. Baby's length was 19 and head circumference was 81.5. There were no congenital abnormalities reported. There were no complications during labor. However, the reporter thought the baby was delivered at small gestation age (SGA). Other laboratory test included: fetal fibronectin test (FFN) which was performed on 27-AUG-2010 and showed positive result, Gestational Blood Sugar (GBS) which was performed on 12-OCT-2010 and showed negative. The mother's experience has been captured in WAES 1004USA00203. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Cystitis, Drug exposure before pregnancy, Perineal laceration, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a 18 year old consumer, for GARDASIL, a Pregnancy Registry product, who on 25-MAR-2010 was vaccinated with the second dose of GARDASIL. The patient stated that she found out she was pregnant on 15-APR-2010 at her physician's office. The patient also stated that she got an ultrasound at a hospital and was notified that she was "no more than 4 weeks pregnant." The estimated delivery date is 23-DEC-2010. Follow up information had been received from a pregnancy questionnaire concerning that an 18 year old female with heart murmur as a child, had recent monitor and no current evidence of murmur, and no previous pregnancy who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 661758/1480Y) and on 25-MAR-2010 was vaccinated with the second dose of GARDASIL (lot # 661758/1480Y). The patient was Rh-negative during pregnancy and experienced bladder infection at 20 weeks gestation (approximately 20-SEP-2010) and was treated with MACROBID. Ultrasound on 29-APR-2010 showed positive cardiac activity. Ultrasound on 07-JUL-2010, 30-SEP-2010 and 07-DEC-2010 were normal fetal anatomy. On 17-DEC-2010 the patient delivered a normal, healthy male baby (weight 7 pounds 10 ounces, length 21 inch, Apgar score 7/9, head circumference 13, Rh negative status) at 39 weeks and 2 days gestation. The mother had 2 degree perineal laceration during labor/delivery. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan normal, Urinary tract infection
Clinical narrative: Information has been received from a 18 year old consumer, for GARDASIL, a Pregnancy Registry product, who on 25-MAR-2010 was vaccinated with the second dose of GARDASIL. The patient stated that she found out she was pregnant on 15-APR-2010 at her physician's office. The patient also stated that she got an ultrasound at a hospital and was notified that she was "no more than 4 weeks pregnant." The estimated delivery date is 23-DEC-2010. Follow up information had been received from a pregnancy questionnaire concerning that an 18 year old female with heart murmur as a child, had recent monitor and no current evidence of murmur, and no previous pregnancy who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 661758/1480Y) and on 25-MAR-2010 was vaccinated with the second dose of GARDASIL (lot # 661758/1480Y). The patient was Rh-negative during pregnancy and experienced bladder infection at 20 weeks gestation (approximately 20-SEP-2010) and was treated with MACROBID. Ultrasound on 29-APR-2010 showed positive cardiac activity. Ultrasound on 07-JUL-2010, 30-SEP-2010 and 07-DEC-2010 were normal fetal anatomy. On 17-DEC-2010 the patient delivered a normal, healthy male baby (weight 7 pounds 10 ounces, length 21 inch, Apgar score 7/9, head circumference 13, Rh negative status) at 39 weeks and 2 days gestation. The mother had 2 degree perineal laceration during labor/delivery. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cystitis, Drug exposure during pregnancy, Perineal laceration, Rhesus antibodies negative, Ultrasound antenatal screen
Clinical narrative: Information has been received from a 18 year old consumer, for GARDASIL, a Pregnancy Registry product, who on 25-MAR-2010 was vaccinated with the second dose of GARDASIL. The patient stated that she found out she was pregnant on 15-APR-2010 at her physician's office. The patient also stated that she got an ultrasound at a hospital and was notified that she was "no more than 4 weeks pregnant." The estimated delivery date is 23-DEC-2010. Follow up information had been received from a pregnancy questionnaire concerning that an 18 year old female with heart murmur as a child, had recent monitor and no current evidence of murmur, and no previous pregnancy who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 661758/1480Y) and on 25-MAR-2010 was vaccinated with the second dose of GARDASIL (lot # 661758/1480Y). The patient was Rh-negative during pregnancy and experienced bladder infection at 20 weeks gestation (approximately 20-SEP-2010) and was treated with MACROBID. Ultrasound on 29-APR-2010 showed positive cardiac activity. Ultrasound on 07-JUL-2010, 30-SEP-2010 and 07-DEC-2010 were normal fetal anatomy. On 17-DEC-2010 the patient delivered a normal, healthy male baby (weight 7 pounds 10 ounces, length 21 inch, Apgar score 7/9, head circumference 13, Rh negative status) at 39 weeks and 2 days gestation. The mother had 2 degree perineal laceration during labor/delivery. Additional information is not expected.