chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting projectile, Wheezing
Clinical narrative: Information has been received from a certified medical assistant (CMA) and a physician concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ ( lot#65788/1193U). Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB. It was reported that on 22-JAN-2008 the patient experienced vomiting, it continued and was seen in the office on 25-Jan-2008 with some projectile vomiting and belly pain. Patient was seen in the office on 29-JAN-2008 with less appetite, increased sleeping and still spitting up. On 31-JAN-2008 patient was still vomiting, very fussy and afebrile. Intussusception was ruled out and vomiting and fussiness resolved. On 18-FEB-2008, the patient was seen in the office for congestion and was diagnosed with bronchiolitis, wet cough and wheezing. Patient was seen again on 19-FEB-2008, 21-FEB-2008 and 22-FEB-2008 in the office for the bronchiolitis. On 23-FEB-2008, the patient was reported to be doing better. On 25-FEB-2008 the patient was seen in the emergency room with bronchiolitis (was not admitted to the hospital). Allergy tests were negative and the patient was diagnosed with intermittent wheezing. The patient was placed on therapy with FLOVENT and albuterol prn. On 19-Mar-2008 patient was seen in the office and was reported as doing "great" and physician opted not to give the ROTATEQ. The outcome is reported as recovered. This is one of several reports from the same source. No additional information is expected.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 week old female infant with no known allergies or pertinent medical history who on an unspecified date was vaccinated orally with 2ml of ROTATEQ (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is one several reported from the same source. This is in follow-up to report (s) previously submitted on 7/15/2008. Follow-up information has been received from a nurse practioner concering this 17 week old previously reported as 14 week old female infant with no known allergies of pertinent medical history who on 23-Jun-2008 was vaccinated orally in the AM with a second dose of ROTATEQ (lot # 660596/0211X) (previously reported as lot # 660679/0407X). There was no illness at the time of vacciantion of any adverse events following prior vaccination with the patient or the patient's sibling. Subsequently, in the late PM on 23-Jun-2008 the patient started having 4 - 5 watery green stools daily for 5 - 6 days. There were no lab studies performed. At the time of the report, the patient recovered in 4- 5 days on approximately 27-Jun-2008. Additional information is not expected. This is one of several reports from the same source.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: this is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a nurse practitioner concerning a 8 week old female infant with no known allergies or pertinent medical history who an unspecified date was vaccinated orally with 2ml of ROTATEQ (Oka/Merck) (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is one of several reports the same source. Follow-up information has been recovered from a nurse practitioner concerning this 8 week old female infant with no known allergies or pertinent medical history who on 21-JUN-2008 was vaccinated orally in the PM with a first dose of ROTATEQ vaccine (Lot # 660596/0122X) (previously reported as lot # 660679/0407X). There was no illness at the time of vaccination. Subsequently since 23-JUN-2008 in the PM, the patient has 4-6 watery stools per day. On 26-JUN-2008 the family called the office. There were no lab studies performed. At the time of the report, the patient recovered after 4-5 days on approximately 27-JUN-2008. It was reported that the diarrhea resolved without treatment. Additional information is not expected. The patiet's twin brother also has an adverse event after vaccination with ROTATEQ vaccine (WAES 086USA0924). This is on of several reports from the same source.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 8 week old male infant with no known allergies or pertinent medical history who on an unspecified date was vaccinated orally with 2ml of ROTATEQ (Oka/Merck) (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008. Follow-up information has been received from a registered nurse concerning this 8 week old male infant with no known allergies or pertinent medical history who on 23-JUN-2008 was vaccinated orally in the PM with a first dose of ROTATEQ (lot # 660598/0211X) (previously reported as lot # 660679/0407X). There was no illness at the time of vaccination. Subsequently, since 23-JUN-2008 in the PM, the patient had 4-6 watery stools per day. On 26-JUN-2009 the family called the office. There were no lab studies performed. At the time of the report, the patient recovered after 4-5 days on approximately 29-JUN-2008. Additional information is not expected. The patient's twin sister also had an adverse event after vaccination with ROTATEQ (WAES#060USA09016). This is one of several reports from the same source.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 week old male infant with no known allergies or pertinent medical history who on an unspecified date was vaccinated orally with 2ml of ROTATEQ (Oka/Merck) (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 8 week old female infant with no known allergies or pertinent medical history who on an unspecified date was vaccinated orally with 2ml of ROTATEQ (Oka/Merck) (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 month old male infant with no known allergies or pertinent medical history who on an unspecified date was vaccinated orally with 2ml of ROTATEQ (Oka/Merck) (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 7/15/2008. Follow-up information has been received from a nurse practioner concerning this 6 month old male infant with no known allergis and grade 11 vesicureteral reflux who on 23-2008 was vaccinated orally in the AM with a third dose of ROTATEQ (lot # 660596/0211X) (previously reported as lot # 660679/0407X). There was no illness at the time of vaccination or any adverse events following prior vacciantion. Subsquently. On the same day of vaccination the patient started having 4 - 6 watery stools daily. There were no lab activities performed. At the time of the report, the patient recovered in 4 - 5 days on approximately 27-Jun-2009. It was reported that the diarrhea resolved without treatment. Additional information is not expected. This is one of several reports from the same source.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 2 month old female who on an unspecified date was vaccinated with a dose of ROTATEQ. The patient also received unspecified routine 2 month vaccinations. The next day, the patient had a fever of 104.5 Fahrenheit and was hospitalized. At the time of report, no outcome was reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a 2 month old female who on an unspecified date was vaccinated with ROTATEQ (lot# 660599/0208X) and other unspecified routine 2 month vaccinations. The next evening the patient had a seizure. The patient's outcome was not reported. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Depression, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry from a physician concerning an 18 year old female with asthma, an obstetrical history of a prior pregnancy electively terminated in the first trimester, and a medical history of Chlamydia (2004), vulvar intraepithelial neoplasia (VIN III) (treated October 2006) and Cervical intraepithelial neoplasia (CINI), who on 12-OCT-2006 was vaccinated in the left arm with the first dose of GARDASIL (Lot # 653735/0688F) and on 07-DEC-2006 was vaccinated in the left arm with the second dose of GARDASIL (Lot # 654540/1161F). Concomitant therapy included ADDERALL, CELEXA, CATAPRESS, montelukast sodium (MSD), ZOLOFT, and CALAN. Subsequently, the patient informed her physician that she was pregnant. The date of the LMP was 30-DEC-2006 (previously reported as approximately 26-DEC-2006), with an estimated date of delivery of 02-OCT-2007. The patient sought unspecified  medical attention. In approximately December 2006 the patient experienced depression. On 03-OCT-2007 the patient delivered a healthy, normal male infant, birthweight 3523 grams and 53.3 cm in length. Apgar score of 3/8/9, taken at 1/5/ and 10 minutes. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Initial and follow up information has been received from a medical assistant and the patient's mother, concerning her daughter with no known drug allergies or past medical history, who in approximately, October 2006, was vaccinated, intramuscularly with the first dose of GARDASIL. In approximately, February 2007, the patient was vaccinated, intramuscularly with the second dose GARDASIL and on 06-MAR-2007, the patient was vaccinated, intramuscularly with third dose GARDASIL. The specific dates for the first and second dose were not available. Concomitant therapy included an unspecified allergy medication. The patient's mother reported that after the first dose, the patient experienced tenderness in her arm at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Drug screen positive, Pregnancy test positive, Premature labour, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL via an obstetrician and a 20 year old white female on methadone maintainence for opiate abuse with a history of an adverse drug reaction to REGLAN, herion abuse, panic attacks, frequent urinary tract infections, pyelonephritis (2002, normal urology on follow up) and one previous pregnancy with first trimester spontaneous abortion. On 23-JAN-2007, she was vaccinated with a first dose of (Lot#655165/1425F). On 27-MAR-2007, she was vaccinated with a second dose of GARDASIL (Lot#655503/0012U). Concomitant therapy include methadone HCl 80 mg daily. Last menstrual period was 30-MAR-2007 (previously reported as LMP 05-APR-2007) and estimated dates of delivery was 04-JAN-2008. On approximately 31-MAY-2007, the patient was informed that she was pregnant. Subsequently, the patient experienced hyperemesis and was treated with ZOFRAN 8 mg prn and TIGAN 300 mg prn. On 07-AUG-2007 the patient had an ultrasound at 18-20 weeks with a result within normal limits. On approximately 01-DEC-2007, the patient's pregnancy was complicated by preterm labor at 35 weeks. On 05-DEC-2007 urine drug screen results were positive for methadone and opiates. On 13-DEC-2007, at 36 6/7 weeks from LMP the patient had a "technically, a pre-term delivery" with a 6 lb. 11 oz. male infant. Apgar score was 9/9. The outcome of the hyperemesis, pre-term labor and pre-term delivery were unknown. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL via an obstetrician and a 20 year old white female on methadone maintainence for opiate abuse with a history of an adverse drug reaction to REGLAN, herion abuse, panic attacks, frequent urinary tract infections, pyelonephritis (2002, normal urology on follow up) and one previous pregnancy with first trimester spontaneous abortion. On 23-JAN-2007, she was vaccinated with a first dose of (Lot#655165/1425F). On 27-MAR-2007, she was vaccinated with a second dose of GARDASIL (Lot#655503/0012U). Concomitant therapy include methadone HCl 80 mg daily. Last menstrual period was 30-MAR-2007 (previously reported as LMP 05-APR-2007) and estimated dates of delivery was 04-JAN-2008. On approximately 31-MAY-2007, the patient was informed that she was pregnant. Subsequently, the patient experienced hyperemesis and was treated with ZOFRAN 8 mg prn and TIGAN 300 mg prn. On 07-AUG-2007 the patient had an ultrasound at 18-20 weeks with a result within normal limits. On approximately 01-DEC-2007, the patient's pregnancy was complicated by preterm labor at 35 weeks. On 05-DEC-2007 urine drug screen results were positive for methadone and opiates. On 13-DEC-2007, at 36 6/7 weeks from LMP the patient had a "technically, a pre-term delivery" with a 6 lb. 11 oz. male infant. Apgar score was 9/9. The outcome of the hyperemesis, pre-term labor and pre-term delivery were unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Pyelocaliectasis, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient, with asthma and drug hypersensitivities to ibuprofen and BACTRIM, who in January 2007, was vaccinated with the first dose of GARDASIL. Concomitant therapy included DEPO-PRVERA and pre-natal vitamins (started on 24-MAY-2007). On approximately 07-JAN-2007, the patient had her LMP. On 12-APR-2007, the patient was vaccinated with the second dose GARDASIL (Lot# 657621/0387U), with the patient reported as "20 weeks gestation" (estimated date of delivery on 14-OCT-2007). There were no problems reported. On 18-MAY-2007, the patient's pregnancy was confirmed by a pregnancy test. On  24-MAY-2007, 04-JUN-2007 and 07-JUL-2007 the patient had an ultrasound for fetal dates and growth. It also revealed left pyelectasis. On 07-SEP-2007, an ultrasound confirmed that the left pyelectasis had resolved. There were no previous pregnancies, deliveries or spontaneous abortions. On 08-OCT-2007, the patient gave birth to a healthy and normal baby boy. He weighed between 6 to 7.5 lbs. and his apgar score was reported as 8/9. The patient was 38 weeks and 2 days from her last menstrual period. There were no congenital anomalies reported. It was reported that all was fine. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received for the Merck Pregnancy Registry for the GARDASIL via a medical assistant concerning a 15 year old female with no pertinent medical history who on 15-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL (Lot # 656051/0244U). Concomitant therapy included PROTONIX, PROZAC, magnesium supplement (unspecified), SEROQUEL and ZONEGRAN. A blood HCG test was performed on 15-MAY-2007 and was negative. The blood HCG test was repeated on 31-MAY-2007 and was positive. An ultrasound was performed on approximately 15-JUN-2007 which showed that the patient is approximately 4.5 to 6.5 weeks pregnant. The patient's last menstrual period was approximately 17-May-2007 and the estimated due date was 21-Feb-2008. The reporter stated that "the patient will not be having a therapeutic abortion." Follow up information has been received from a health professional at the pediatrician's office and from a registered nurse at the obstetrician's office, concerning the outcome of the pregnancy. There were no complications or illnesses during the patient's pregnancy. The health professional and the nurse reported that on 27-JAN-2008, the patient gave birth to a healthy and normal male infant, apgar: 8/1; weight: (3668gms), 8lbs 1oz; length 21; and head circumference: 14. The health professional noted that the infant had no congenital anomalies. The baby however experienced respiratory distress and fever during delivery. No further information was provided. Additional information was provided. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MMR, TTOX
Symptoms: Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received through the Merck Pregnancy Registry from a licensed practical nurse concerning a 16 year old white female with no previous pregnancies, with asthma who on 02-FEB-2007 (previously reported as 09-APR-2007) was vaccinated with a first dose of GARDASIL (lot # 655205/1426F). Concomitant vaccination on 09-APR-2007 included MMR II. Concomitant therapy included albuterol and "quar". The patient was in her first trimester at the time of the vaccination. Unspecified medical attention was sought. No adverse event was reported. It was reported that the patient delivered a healthy and normal baby girl on 13-DEC-2007 at 38 weeks gestation. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Drug exposure during pregnancy, Hypertension
Clinical narrative: Initial and follow-up information has been received through the pregnancy registry, from a nurse and a consumer concerning her 16 year old daughter with a cold and allergies to AUGMENTIN and erythromiycin and no medical history, who on 13-JUN-2007 was vaccinated with a 0.5mL third dose of GARDASIL. Concomitant therapy included Prenatal vitamins (unspecified), FLOVENT and ROBITUSSIN. Subsequently, after receiving the vaccination, the patient found out that she was 14 weeks pregnant. The patient sought unspecified medical attention. Blood work taken (results unknown). No product quality complaint was involved. On 29-JAN-2008 the patient delivered her baby "a bit early due to high blood pressure" (in the patient). The baby weighed 8 pounds 5 ounces and was healthy and normal. The patient was seen on 13-MAR-2008 and her blood pressure was normal at 116/74. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Premature separation of placenta
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 23 year old female with papilloma viral infection (diagnosed in 2006), peanut oil allergy, egg allergy and allergy to nuts and a history of Papanicolaou smear abnormal, loop electrosurgical excision procedure for the treatment of dysplasia (2007) who on 08-DEC-2006 was vaccinated with her first dose GARDASIL (653978/0955F), 0.5 ml, IM, left deltoid. Concomitant therapy included YASMIN, which was discontinued on approximately 12-FEB-2007. On 13-FEB-2007, the patient received her second dose GARDASIL (lot #654702/0011U), 0.5ml, IM, left deltoid. On that same date, the patient was placed on therapy with YAZ. On 22-JUN-2007, the patient received her third dose of GARDASIL (lot #657868/0523U), 0.5ml, IM, left deltoid. Therapy with YAZ was discontinued (date and reason not reported). On 24-AUG-2007, the LPN reported that the patient was pregnant Last menstrual period reported as 28-JUN-2007, estimated delivery date is 03-APR-2008. Follow up information has been received from a nurse who reported that on an unspecified date the patient had a vaginal preterm delivery at 35 weeks gestation due to a partial placental abruption with pre-term labor. She delivered a healthy, normal male, weighing 6 pounds 4 ounces with good cord blood ph values at delivery. No additional information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from the Merck Pregnancy registry from a nurse concerning a 22 year old female who on 12-JUN-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL. When the patient received her first vaccination she was not pregnant. On 14-AUG-2007 the patient received the second dose of of GARDASIL (Lot # 658222/0927U). There was no concomitant medication. Subsequently, the patient was pregnant at the time of the vaccination. On 29-AUG-2007 the patient came into the physician office and had a positive pregnancy test. The patient last menstrual period was 21-JUL-2007 and the estimated date of delivery was 26-APR-2008. On 11-APR-2008, the patient gave birth to a healthy female. It was reported that during labor/delivery, the mother developed increased blood pressure. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received via the Merck pregnancy registry, from a physician, concerning a 19 year old female patient with no known allergies and no pertinent history, who on 04-MAY-2007 was vaccinated with the first dose of GARDASIL (lot # not reported). On 18-JUL-2007, the patient had her LMP and was unknowingly pregnant, when on 20-AUG-2007, she was vaccinated with the second dose of GARDASIL (Lot #655617/1447F). The estimated date of delivery was 23-APR-2007. The patient sought unspecified medical attention. Follow up information has been received from a nurse who reported that the patient had a "slightly early" delivery on 07-MAR-2008, approximately 33 weeks from last menstrual period. No problems were reported with mother or baby. No further information was reported regarding the pregnancy outcome. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Drug exposure during pregnancy, Pregnancy test negative, Thrombocytopenia, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received through the Merck Pregnancy registry via a healthcare professional and a physician concerning a 22 year old white female with mild cervical dysplasia and a history of 2 previous pregnancies with full term delivered (January 2002 and August 2004) who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL (lot #653736/0014U). On 25-JUL-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #657872/0515U). Concomitant medications included UNISOM and PREMESIS. On approximately 25-MAY-2007, the patient developed vaginitis and on 25-MAY-2007 was placed on therapy with TINDAMAX. It was reported on 10-SEP-2007, the patient was 6 weeks pregnant. On 20-SEP-2007, ultrasound revealed intra-uterine pregnancy at 7.2 weeks. The patient last menstrual period (LMP) was of 30-JUL-2007 and estimated of delivery was 05-MAY-2008. The patient underwent unspecified blood work (results not reported). Unspecified medial attention was sought. On an unspecified date, the patient developed thrombocytopenia. On 22-APR-2008, 38.1 weeks from LMP, the patient delivered a healthy male infant. Weight was 7 pounds 8 ounces, head circumference was 13 5/8 inches and length was 20.5 inches. Apgar score was 8/9. On 20-MAY, the patient was vaccinated with a third dose of GARDASIL (lot # 660387/1967U). Other medications used this pregnancy included PRIMACARE ONE. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal infection
Clinical narrative: Initial and follow-up information has been received through the Merck Pregnancy registry via a healthcare professional and a physician concerning a 22 year old white female with mild cervical dysplasia and a history of 2 previous pregnancies with full term delivered (January 2002 and August 2004) who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL (lot #653736/0014U). On 25-JUL-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #657872/0515U). Concomitant medications included UNISOM and PREMESIS. On approximately 25-MAY-2007, the patient developed vaginitis and on 25-MAY-2007 was placed on therapy with TINDAMAX. It was reported on 10-SEP-2007, the patient was 6 weeks pregnant. On 20-SEP-2007, ultrasound revealed intra-uterine pregnancy at 7.2 weeks. The patient last menstrual period (LMP) was of 30-JUL-2007 and estimated of delivery was 05-MAY-2008. The patient underwent unspecified blood work (results not reported). Unspecified medial attention was sought. On an unspecified date, the patient developed thrombocytopenia. On 22-APR-2008, 38.1 weeks from LMP, the patient delivered a healthy male infant. Weight was 7 pounds 8 ounces, head circumference was 13 5/8 inches and length was 20.5 inches. Apgar score was 8/9. On 20-MAY, the patient was vaccinated with a third dose of GARDASIL (lot # 660387/1967U). Other medications used this pregnancy included PRIMACARE ONE. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from a retired certified medical assistant, who is also the mother of the patient and a member of the certified nurse midwife's office, for the Pregnancy Registry for GARDASIL, concerning a 16 year old female with allergies to sulfa antibiotics and prior history of smoking. On 27-FEB-2007, the patient was vaccinated with her first dose of GARDASIL (Lot #, 654702/00110). On 02-MAY-2007, the patient was vaccinated with her second dose of GARDASIL (Lot # 657617/0384U). On 28-AUG-2007, the patient was vaccinated with her third dose of GARDASIL (Lot # 658556/1060U). Concomitant therapy included TANDEM OB. On 25-SEP-2007 it was reported that the patient was 8 weeks and 6 days pregnant. On 25-SEP-2007, 10-DEC-2007, 10-APR-2008 and on 18-APR-2008 the patient had an ultrasound due to large for gestational age and right testicle hydrocele. On 26-NOV-2007 the patient had an elective serum alpha-fetoprotein test. The patient sought unspecified medical attention in the office. It was reported that on an unspecified date the patient had unspecified blood  work and a urine pregnancy test. "As far as the delivery went everything was fine" (no further information was provided). The patient delivered a normal male infant on 04-MAY-2008, weighing 8 pounds and 15 ounces. It was reported that the baby experienced fetal distress during labor and delivery. There were no congenital anomalies, complications or abnormalities. It was reported that the mother experienced a 50 plus pound weight gain. On 04-JUN-2008, the patient went to the office for her postpartum visit (not otherwise specified). On 11-JUL-2008, the infants pediatrician was contacted regarding whether or not the baby had any right testicular hydrocele (earlier identified on a sonogram). He said that after doing several exams on the infant there was no hydrocele noted. It was also reported that he had no access to the prenatal ultrasound reports and was not aware of these findings. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin normal, Drug exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This is in follow-up report(s) previously submitted on 7/15/2008. Initial and follow up information has bee received from a physician, a medical assistant and from a female patient through the Merck pregnancy registry, concerning the 26 year old patient with no known allergies, one previously pregnancy with one full term delivery, and no pertinent medical history, who on 21-May 2007 was vaccinated with her first dose of GARDASIL (lot #0210U), and on 22-JUL-207 was vaccinated with her second dose of GARDASIL (lot #0469U). There was no concomitant medication. The patient reported that in September 2007 she was currently 2 months pregnant. Follow up information received from the physician indicated the date of the patient's LMP was 26-JUL-2007, and the estimated date of delivery was 01-MAY-2008. The patient took prenatal vitamins (unspecified) during the pregnancy. On 28-DEC-2007, the patient had a routine ultrasound which was within normal limits. No further details were provided. Follow up information has been received from a medical assistant who reported that on 08-APR-2008 the patient had a normal vaginal delivery of a healthy and normal female infant born at 36 5/7 weeks estimated gestational age, pre-term with birth weight of 5 lbs 7 ozs. There were no complications for the mother or baby. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Polyhydramnios, Ultrasound scan abnormal
Clinical narrative: Initial and follow up information has been received from a nurse and a certified nurse midwife for the Pregnancy Registry for GARDASIL concerning a 15 year old female who on 03-AUG-007 was vaccinated with the first dose of GARDASIL (Lot #, site and route not reported). Concomitant therapy included vaccination with the meningococcal vaccine (unspecified). Subsequently, it was determined that the patient was pregnant (LMP 15-Apr-2007). The patient sought unspecified medical attention. On 25-NOV-2007, '(also reported as 32 weeks gestation), the patient was sent for a amniotic fluid index (AFI) and the prenatal sonogram found that the patient had polyhydramnios. No numeric AFI was reported. On 20-JAN-2008, the patient delivered vaginally at term with "massive polyhydramnios". She delivered a healthy, and normal baby weighing 7 lbs, 6 oz. Both the mother and baby are doing well. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Gestational diabetes, Glucose tolerance impaired, Polyhydramnios
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning an 18 year old female with a family history of diabetes mellitus and familial risk factor (gestational diabetes mellitus, and pre-eclampsia in patient's mother), who on 14-SEP-2007 was vaccinated with her first dose of 0.5 mL GARDASIL (lot #658554/0928U). The patient is now 8 weeks pregnant with last menstrual period 04-Sep-2007 and an estimated due date of 11-JUN-2008. There is no information about the vaccine because it was given at another office. The patient sought medical attention with an exam in the office. Follow up information has been received from the obstetrician/gynaecologist who reported that on 08-JAN-2008, the patient underwent an ultrasound indicated for gestational diabetes mellitus (GDM) and polyhydraminos which showed polyhydraminos. She also had a serum alpha-fetaprotein test, indicated for (GDM) and polyhydraminos, which was negative. On 31-MAR-2008, 09-MAY-2008, 15-MAY-2008 and 30-MAY-2008 the patient underwent ultrasounds indicated for (GDM) and polyhydraminos, all showed polyhydraminos, but otherwise normal. A 35 glucose tolerance test done during the pregnancy was abnormal -1. Gestational diabetes was diagnosed (date not reported). The treatment for the gestational diabetes mellitus included insulin NPH BID and insulin regular daily. The physician reported that the patient underwent several neonatal stress tests (dates not specified) which were normal and reactive. The patient also experienced pre-eclampsia during her pregnancy (date not specified). The physician reported that on 06-JUN-2008, at 38 5/7 weeks from last menstrual period, the patient delivered a normal male infant with apgar: 9/9, weight: 7lbs 11ozs, length: 21 inches, and head circumference: 37 cm. The infant had mild jaundice. Additional is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pre-eclampsia, Ultrasound antenatal screen normal, Ultrasound scan abnormal
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning an 18 year old female with a family history of diabetes mellitus and familial risk factor (gestational diabetes mellitus, and pre-eclampsia in patient's mother), who on 14-SEP-2007 was vaccinated with her first dose of 0.5 mL GARDASIL (lot #658554/0928U). The patient is now 8 weeks pregnant with last menstrual period 04-Sep-2007 and an estimated due date of 11-JUN-2008. There is no information about the vaccine because it was given at another office. The patient sought medical attention with an exam in the office. Follow up information has been received from the obstetrician/gynaecologist who reported that on 08-JAN-2008, the patient underwent an ultrasound indicated for gestational diabetes mellitus (GDM) and polyhydraminos which showed polyhydraminos. She also had a serum alpha-fetaprotein test, indicated for (GDM) and polyhydraminos, which was negative. On 31-MAR-2008, 09-MAY-2008, 15-MAY-2008 and 30-MAY-2008 the patient underwent ultrasounds indicated for (GDM) and polyhydraminos, all showed polyhydraminos, but otherwise normal. A 35 glucose tolerance test done during the pregnancy was abnormal -1. Gestational diabetes was diagnosed (date not reported). The treatment for the gestational diabetes mellitus included insulin NPH BID and insulin regular daily. The physician reported that the patient underwent several neonatal stress tests (dates not specified) which were normal and reactive. The patient also experienced pre-eclampsia during her pregnancy (date not specified). The physician reported that on 06-JUN-2008, at 38 5/7 weeks from last menstrual period, the patient delivered a normal male infant with apgar: 9/9, weight: 7lbs 11ozs, length: 21 inches, and head circumference: 37 cm. The infant had mild jaundice. Additional is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydial infection, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received as part of a pregnancy registry from a registered nurse concerning a 16 year old white female who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (lot# 658490/0802U), intramuscularly. On 18-OCT-2007 the patient received her second dose of GARDASIL (lot #658556/1060U), intramuscularly. The patient was given two doses of GARDASIL while she was pregnant. It was reported that on 27-NOV-2007 patient was treated 500 mg (two tablets) of ZITHROMAX for chlamydia. She was also started on prenatal vitamins on October 2007 1 tablet daily for pregnancy. No adverse events were reported. On 21-NOV-2007 the patient had a routine ultrasound that showed single IUC, 13 weeks and 5 days. The patient's last menstrual period was estimated to be 15-AUG-2007, " mid August" and her estimated date of delivery is 23-May-2008. In follow up telephone call the nurse reported that the patient delivered a healthy and normal infant on 12-MAY-2008 weighing 8 lb 1 oz "8-1" with apgars of 9/10. The baby's length was 20 inches long. No problem was reported. Additional information is not available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Antibody test, Chlamydial infection, Drug exposure during pregnancy
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL from a Registered Nurse concerning an 18 year old female who in August 2007 was vaccinated with a first dose of GARDASIL. On 08-NOV-2007 the patient was vaccinated with a second dose of GARDASIL and was pregnant. There was no concomitant medication and diagnostic laboratory tests included Complete Blood Count (CBC), Human immunodeficiency (HIV), rubella, Hepatitis B, and antibody type and screen. No results were given. The GARDASIL was given by another physician at another office.  The patient experienced chlamydia and upper respiratory infection during her pregnancy (dates unknown). Since 27-NOV-2007 the patient has been prescribed pre-natal vitamins. On 17-DEC-2007 the patient experienced heartburn and was treated with PREVACID and had a maternal serum alpha fetoprotein survery (MSAFP) and the result of the test was negative. On 21-DEC-2007 the patient experienced gastroesophageal reflux disease and was treated with PREVACID. On 18-JAN-2008 the patient had an ultrasound for anatomical survey and the result of the test was unremarkable and within limits. On 17-MAR-2008 the patient experienced anemia and was treated with REPLIVA 21/7). On 25-MAY-2008 the patient delivered a normal, healthy female baby weighing 7 pounds and 14 ounces and length was 20.5 inches. At the time of the report the outcome of the heartburn, gastroesophageal reflux disease, anemia, chlamydia and upper respiratory disease were unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspepsia, Full blood count, Gastrooesophageal reflux disease, HIV test, Hepatitis B antibody
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL from a Registered Nurse concerning an 18 year old female who in August 2007 was vaccinated with a first dose of GARDASIL. On 08-NOV-2007 the patient was vaccinated with a second dose of GARDASIL and was pregnant. There was no concomitant medication and diagnostic laboratory tests included Complete Blood Count (CBC), Human immunodeficiency (HIV), rubella, Hepatitis B, and antibody type and screen. No results were given. The GARDASIL was given by another physician at another office.  The patient experienced chlamydia and upper respiratory infection during her pregnancy (dates unknown). Since 27-NOV-2007 the patient has been prescribed pre-natal vitamins. On 17-DEC-2007 the patient experienced heartburn and was treated with PREVACID and had a maternal serum alpha fetoprotein survery (MSAFP) and the result of the test was negative. On 21-DEC-2007 the patient experienced gastroesophageal reflux disease and was treated with PREVACID. On 18-JAN-2008 the patient had an ultrasound for anatomical survey and the result of the test was unremarkable and within limits. On 17-MAR-2008 the patient experienced anemia and was treated with REPLIVA 21/7). On 25-MAY-2008 the patient delivered a normal, healthy female baby weighing 7 pounds and 14 ounces and length was 20.5 inches. At the time of the report the outcome of the heartburn, gastroesophageal reflux disease, anemia, chlamydia and upper respiratory disease were unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rubella antibody test, Ultrasound scan normal, Upper respiratory tract infection
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL from a Registered Nurse concerning an 18 year old female who in August 2007 was vaccinated with a first dose of GARDASIL. On 08-NOV-2007 the patient was vaccinated with a second dose of GARDASIL and was pregnant. There was no concomitant medication and diagnostic laboratory tests included Complete Blood Count (CBC), Human immunodeficiency (HIV), rubella, Hepatitis B, and antibody type and screen. No results were given. The GARDASIL was given by another physician at another office.  The patient experienced chlamydia and upper respiratory infection during her pregnancy (dates unknown). Since 27-NOV-2007 the patient has been prescribed pre-natal vitamins. On 17-DEC-2007 the patient experienced heartburn and was treated with PREVACID and had a maternal serum alpha fetoprotein survery (MSAFP) and the result of the test was negative. On 21-DEC-2007 the patient experienced gastroesophageal reflux disease and was treated with PREVACID. On 18-JAN-2008 the patient had an ultrasound for anatomical survey and the result of the test was unremarkable and within limits. On 17-MAR-2008 the patient experienced anemia and was treated with REPLIVA 21/7). On 25-MAY-2008 the patient delivered a normal, healthy female baby weighing 7 pounds and 14 ounces and length was 20.5 inches. At the time of the report the outcome of the heartburn, gastroesophageal reflux disease, anemia, chlamydia and upper respiratory disease were unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Amniocentesis normal, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Haemorrhage, Ultrasound scan normal
Clinical narrative: Information has been received for the Pregnancy Registry of GARDASIL from a Registered Nurse (R.N.) concerning an 18 year old female patient who on 10-MAY-2007 was vaccinated with a dose of GARDASIL (lot # 654389/0961F). In follow up information from the doctor's office it was reported that on 02-OCT-2007 patient had ultrasound (19 weekd pregnancy) for bleeding and result was within normal limit. On 22-OCT-2007 she had a amniocenticsis (at 21weeks pregnancy) and the result was within normal limit. On 23-JAN-2008 she was treated for gastric esophageal reflux disease (GERD) with PRILOSEC twice a day and with KEFLEX twice a day for urinary tract infection. On an unspecified day patient was started with prenatal vitamins. The office learnt about the pregnancy when patient went to the office on 26-JUL-2007. In a follow up telephone call and from the follow up information from the doctor's office it was reported that patient's last menstrual period (LMP) was on 27-MAY-2007 and she delivered a normal male baby on 21-FEB-2008. The apgar score for the baby was 9/9. The baby weighed 7 lb 8 oz. The nurse stated that the baby was "fine". No other information was provided. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received for the Pregnancy Registry of GARDASIL from a Registered Nurse (R.N.) concerning an 18 year old female patient who on 10-MAY-2007 was vaccinated with a dose of GARDASIL (lot # 654389/0961F). In follow up information from the doctor's office it was reported that on 02-OCT-2007 patient had ultrasound (19 weekd pregnancy) for bleeding and result was within normal limit. On 22-OCT-2007 she had a amniocenticsis (at 21weeks pregnancy) and the result was within normal limit. On 23-JAN-2008 she was treated for gastric esophageal reflux disease (GERD) with PRILOSEC twice a day and with KEFLEX twice a day for urinary tract infection. On an unspecified day patient was started with prenatal vitamins. The office learnt about the pregnancy when patient went to the office on 26-JUL-2007. In a follow up telephone call and from the follow up information from the doctor's office it was reported that patient's last menstrual period (LMP) was on 27-MAY-2007 and she delivered a normal male baby on 21-FEB-2008. The apgar score for the baby was 9/9. The baby weighed 7 lb 8 oz. The nurse stated that the baby was "fine". No other information was provided. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female who on 19-DEc-2007 was vaccinated with a first dose of GARDASIL and on 18-JAN-2008 was vaccinated with a second dose of GARDASIL. On 03-MAR-2008 at 15:24, the patient was inadvertently vaccinated intramuscularly with her third dose of GARDASIL in place of hepatitis B virus vaccine rHBsAg (yeast) (MSD). There were no adverse symptoms. This is not a case of product confusion. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac disorder, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow up information has been received from a medical assistant and a physician concerning an approximately 25 year old female who on 30-OCT-2006 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot#653937/0637F). On 02-JAN-2007, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot#654389/0961F). In approximately 2007, the patient had a "problem with her heart" between the second and third doses. On 11-APR-2008, she was vaccinated IM with the third 0.5 ml dose of GARDASIL. The patient sought medical attention by an physician other than the reporter. At the time of the report, the patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anxiety, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received for the Merck Pregnancy Registry for GARDASIL from a certified nurse midwife concerning a 22 year old female with depression, no pertinent medical history and no drug reactions/allergies who on 21-FEB-2007 was vaccinated with a first dose of GARDASIL (lot# 655618/0186U) 0.5 mL IM. On 22-AUG-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 658282/0929U) 0.5 mL IM. The patient became pregnant after two doses of GARDASIL. The patient's date of last menstrual period was 30-SEP-2007. Medical attention was sought. On 05-DEC-2007 an ultrasound was performed for dating and was viable 7.5 "fup" and on 31-JAN-2008 a maternal serum alpha-fetoprotein test (MSAFP) was performed and was within normal limits. No further information was available. The estimated date of delivery is 06-JUL-2008. Follow-up information was received the patient also had a history of papanicolaou smear abnormal. On an unspecified date the patient had anxiety and on 28-FEB-2008 CYMBALTA was prescribed. On an unspecified date the patient had gastrooesophageal reflux disease (GERD) and on 25-MAR-2008 the patient was given PREVACID. Additional information has been requested.