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 medical assistant, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with no pertinent medical history and no drug reactions/allergies who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (0.5 ml, IM). On 25-MAR-2010, the patient received the second dose of GARDASIL (0.5 ml, IM). On specified date, the patient called the office stating she had been determined to be pregnant. The LMP was unknown at the time of the report. There were no lab diagnostics studies performed. The patient scheduled for her first obstetrical visit in June 2010, At the reporting time, the outcome was unknown. Follow up information was received from the medical assistant concerning the 18 year old female with heart murmur who was vaccinated with the first and second dose of GARDASIL (lot # 661758/1480Y) on 14-JAN-2010 and 25-MAR-2010 respectively. The patient was determined to be pregnant before her initial screening was performed. The medical assistant will re-send the information after the patient has been seen initially and more information on her pregnancy is obtained. Follow up information has been received from the medical assistant concerning the 18 year old female with heart murmur (outgrown) and with no previous pregnancies and no spontaneous abortions who was vaccinated with the first dose of GARDASIL (lot # 661758/1480Y) in the right deltoid on 14-JAN-2010. On 25-MAR-2010 the patient received the second dose of GARDASIL (lot # 661758/1480Y) in the left deltoid. The patient was pregnant after the 2nd injection. The estimated conception date was 29-MAR-2010. The patient' last menstrual period was 15-MAR-2010. Estimated delivery date was 22-DEC-2010. Follow-up information was received from the medical assistant who reported the patient on an unspecified date was experienced urinary tract infection (UTI). The estimated conception date was 30-MAR-2010. On 22-JUL-2010 the patient had routine maternal serum alpha fetoprotein (MSAFP) test and the result was negative. On 30-SEP-2010 the patient had ultrasound which revealed within normal limits (WNL). The patient was treated with MACROBID on 30-SEP-2010 for UTI. From April 2010 to present the patient was treated with prenatal vitamins (PNV) daily. Follow-up information was received from an office worker reporting the patient with negative Rhesus factor (RF), on approximately 27-SEP-2010, at 28 weeks of gestation experienced bladder infection. The patient was treated with MACROBID, 100 mg, twice a day from 30-SEP-2010 to 06-OCT-2010 for urinary tract infection (UTI). Ultrasound performed in 6 weeks, 8 weeks, 28 weeks of gestation, all normal fetal anatomy. On 17-DEC-2010, the patient experienced 2 degree perineal laceration during labor/delivery. On 17-DEC-2010, 39 weeks from LMP, the patient delivered a male normal baby with no congenital anomalies and no other complication or abnormalities. The baby's weight was 7 pound 10 ounce, length was 21 inches, APGAR score 7/9, head circumference was 13. No further information is available.