Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Maternal exposure during pregnancy, Neonatal disorder, Pre-eclampsia, Prolonged labour
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient with high cholesterol and no drug reactions/allergies who on 09-DEC-2010 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 666595/0887Z). Concomitant therapy included simvastatin (manufacturer unknown). On 22-JAN-2011 the patient had a pregnancy test done and the result was positive. The medical assistant also stated that they did a quantitative confirmatory pregnancy test on 24-JAN-2011 and it was positive. No negative reported. Follow up information has been received from a physician assistant concerning the 21 year old female patient with familial hyperlipidaemia and 1 elective termination (weeks from LMP unknown) who on 09-DEC-2010 was vaccinated with the first dose of GARDASIL (lot # 666595/0887Z). Concomitant therapy included simvastatin (manufacturer unknown) for hyperlipidaemia, now off using due to pregnancy. The patient's date of last menstrual period was 21-DEC-2010. Follow up information has been received from a licensed practical nurse reported 11-FEB-2011 was the patient's last office visit. The patient was six weeks pregnant at that visit (no LMP was documented), and "incidental pregnancy" was noted. Follow up information has been received from a registered nurse concerning the patient with increased cholesterol and a history of abnormal Papanicolaou test and Human Papillomavirus Infection (HPV) and one elective termination who was pregnant and doing well. Concomitant therapy simvastatin had been stopped. On 14-FEB-2011, ultrasound was performed for viability testing, revealed 7 weeks pregnant. The estimated conception date was also reported as 07-SEP-2011. Follow up information has been received from a physician concerning the 21 year old female patient who on 09-DEC-2010 was vaccinated with the first dose of GARDASIL. Other medications used during this pregnancy included simvastatin and prenatal vitamins. On 20-APR-2011, MSAFP test (QUAD screen) was performed and the result was negative. The patient had routine prenatal care and ultrasound and results not provided. The patient developed severe preeclampsia during pregnancy. On unknown date, the patient developed vomiting and treated with ZOFRAN on 18-FEB-2011. On unknown date, the patient developed Urinary tract infection (UTI) and treatment with MACROBID on 02-JUN-2011. No infections or illnesses during pregnancy. On 16-SEP-2011, 38 weeks and 2 days from LMP, the patient delivered a female liveborn infant. The infant's length was 57 cm. Her apgar score was 9/9. The infant was normal. There were no congenital anomalies. At the time of reporting, the patient's outcome for severe preeclampsia, vomiting and UTI was unknown. Follow up information has been received from a Pediatric medical record regarding the female patient with hyperlipidaemia (severe: total cholesterol (T.Chol.) >400), non-smoking and other prenatal labs were normal. The patient was Oneg./GBS+ (Blood type O negative/Group B streptococcus positive). During the pregnancy, the patient experienced maternal toxemia (onset unknown) and GBS+ (onset unknown). On 16-SEP-2011, the patient delivered a female baby weighing 6 pounds, 7 ounces (2921 gm) and birth length 51 cm via C-section due to preeclampsia and failure to progress. At the time of reporting, the mother's outcome was not reported. The baby experienced hepatitis B which was considered to be congenital anomaly. The baby's experience has been captured in WAES# 1101USA03381B1. Additional information has been requested. All available medical records will be provided upon request.