Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Cephalo-pelvic disproportion, Drug exposure during pregnancy, Ultrasound antenatal screen normal, Umbilical cord around neck
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with no pertinent medical history and no known allergies who on. On 22-JUN-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 0294Y). There was no concomitant medication. On an unspecified date, the patient was determined to be pregnant by a urine pregnancy test. The last menstrual period (LMP) was 07-JUN-2009 and the estimated delivery date (EDD) was 15-MAR-2010. Medical attention was sought in the office (date unspecified). On 06-AUG-2009, the patient had an ultrasound to confirm dating results were reported as within normal limits (WNL). Follow-up information has been received from the medical assistant concerning the female patient with a history of one elective termination (date unspecified) who on 20-APR-2009 was vaccinated with the first dose of GARDASIL (lot number 1702X). On 02-SEP-2009 an "ultrascreen" was performed in order to rule out early detection of DOWN syndrome, Trisomy 18/13. The result of the test was within normal limits. Additional information has been requested. Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with no pertinent medical history and no known allergies who on. On 22-JUN-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 0294Y). There was no concomitant medication. On an unspecified date, the patient was determined to be pregnant by a urine pregnancy test. The last menstrual period (LMP) was 07-JUN-2009 and the estimated delivery date (EDD) was 15-MAR-2010. Medical attention was sought in the office (date unspecified). On 06-AUG-2009, the patient had an ultrasound to confirm dating results were reported as within normal limits (WNL). Follow-up information has been received from the medical assistant concerning the female patient with a history of one elective termination (date unspecified) who on 20-APR-2009 was vaccinated with the first dose of GARDASIL (lot number 1702X). On 02-SEP-2009 an "ultrascreen" was performed in order to rule out early detection of DOWN syndrome, Trisomy 18/13. The result of the test was within normal limits. Additional information has been requested. Information has been received from a medical assistant, GARDASIL a Pregnancy Registry product, concerning a 24 year old female patient with no pertinent medical history and no known allergies who on. On 22-Jun-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 0294Y). There was no concomitant medications. On an unspecified date, the patient was determined to be pregnant by a urine pregnancy test. The last menstrual period was 07-Jun-2009 and the estimated delivery date was 15-Mar-2010. Medical attention was sought in the office (date unspecified). On 06-Aug-2009, the patient had an ultrasound to confirm dating results were reported as within normal limits. Follow-up information has been received from the medical assistant concerning the female patient with a history of one elective termination (date unspecified) who on 20-Apr-2009 was vaccinated with the first dose of GARDASIL (lot number 1702X). On 02-Sep-2009 an "ultrascreen" was performed in order to rule out early detection of Down syndrome, Trisomy 18/13. The result of the test was within normal limits. Follow-up information received from the medical assistant concerning the patient who on 19-Mar-2010 gave birth via C-section due to cephalo-pelvic disproportion to a normal female baby. The baby weighed 7 pounds 8 ounces, 18 inches long. The Apgar score was 8 at one minute and 9 at five minutes. Medication during the pregnancy included prenatal vitamin daily. There was no complication during pregnancy, however, the baby's cord was wrapped around her neck twice (0908USA00845B1). Neither mom nor baby has been back to the office for follow up care. Their current status was not reported. Upon internal review, C-section was determined to be an other important medical event. The baby's experience has been captured in WAES # 0908USA00845B1. Additional information is not expected.