Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Pregnancy test urine positive, Trisomy 21, Ultrasound scan abnormal, Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from the Merck Pregnancy Registry via a nurse practitioner concerning a 16 year old female with a history of a positive PPD in 2005 who on 08-MAY-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (654702/0011U).  On 10-JUL-2007 the patient was vaccinated with a second dose of Gardasil (654510/0962F).  Concomitant therapy included CLEOCIN T.  Subsequently the patient became pregnant.  The patient's last menstrual period was on 20-MAY-2007 and the estimated date of delivery will be 24-FEB-2008.  On approximately 26-JUN-2007 the patient developed vaginal spotting for five days.  On 16-AUG-2007 a urine pregnancy test was positive.  On an unspecified date the patient was seen for an office visit.  At the time of the report the patient's outcome was of pregnancy was unknown.  Additional information has been requested. 07/08/08 Initial and follow-up information has been received from the Merck Pregnancy Registry via a nurse practitioner concerning a 16 year old female with a history of a positive PPD in 2005 who on 08-MAY-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot #654702/0011U). Concomitant vaccinations on the same day included VARIVAX (Lot #656572/0115U). Other concomitant vaccinations on the same day included HAVRIX (Lot #AHAVB141AA). On 10-JUL-2007 the patient was vaccinated with a second dose of GARDASIL (Lot #654510/0962F). Concomitant therapy included CLEOCIN T. Subsequently the patient became pregnant. The patient's last menstrual period was on 20-MAY-2007 and the estimated date of delivery will be 24-FEB-2008. On approximately 26-JUN-2007 the patient developed one episode of vaginal spotting for five days. The patient was seen and treated for a urinary tract infection also. On 16-AUG-2007 a urine pregnancy test was positive. The patient was seen in the emergency department, she had a pelvic exam for vaginal bleeding. On an unspecified date the patient was seen for an office visit. On 07-SEP-2007 a urine c/s was performed and was found to be within normal limits. The patient recovered from the urinary tract infection. At the time of the report the patient's pregnancy outcome was unknown. Follow-up information was received from the registered nurse. Concomitant therapy included ferrous sulfate for anemia. On 14-SEP-2007 a maternal serum alpha fetoprotein test was performed and results was abnormal down's syndrome risk 1:23. On 01-OCT-2007 an ultrasound was performed for the abnormal MSAFP and was within normal limits. The patient had a healthy baby boy weighing 7 pounds 13 ounces, length was 20. The patient had severe pre-eclampsia during labor/delivery. Additional information is not expected.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from the Merck Pregnancy Registry via a nurse practitioner concerning a 16 year old female with a history of a positive PPD in 2005 who on 08-MAY-2007 as vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot #654702/0011U). Concomitant vaccinations on the same day included VARIVAX (Lot #656572/0115U). Other concomitant vaccinations on the same day included HAVRIX (Lot #AHAVB141AA). On 10-JUL-2007 the patient was vaccinated with a second dose of GARDASIL (Lot #654510/0962F). Concomitant therapy included CLEOCIN T. Subsequently the patient became pregnant. The patient's last menstrual period was on 20-MAY-2007 and the estimated date of delivery will be 24-Feb-2008. On approximately 26-JUN-2007 the patient developed one episode of vaginal spotting for five days. The patient was seen and treated for a urinary tract infection also. On 16-AUG-2007 a urine pregnancy test was positive. The patient was seen in the emergency department, she had a pelvic exam for vaginal bleeding. On an unspecified date the patient was seen for an office visit. On 07-SEP-2007 a urine c/s was performed and was found to be within normal limits. The patient recovered from the urinary tract infection. At the time of the report the patient's pregnancy outcome was unknown. Additional information has been requested.