Sex: F
Vaccine: HPV4
Symptoms: Drug exposure before pregnancy, Neonatal disorder, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician concerning a baby patient who was exposed through his mother who on 22-SEP-2008 was vaccinated with the first dose of GARDASIL IM and was pregnant. There was no concomitant medication. On 13-OCT-2008, the patient reported she had done a home pregnancy test and also went to the primary care physician who did a urine beta-human chorionic gonadotropin test that was positive. The patient reported that at the time of the report was 6 weeks pregnant. The patient's LMP was approximately on 04-SEP-2008 (previously reported as 28-AUG-2008). The estimated delivery date is 15-JUN-2009 (previously reported as 16-JUN-2009). The patient reported she was seeing a midwife for the pregnancy. Follow up information has been received from a nurse practitioner concerning the patient. The nurse stated that the patient does not qualify for the pregnancy registry since GARDASIL was given prior to conception date. Follow up information has been received from a registered nurse and a nurse practitioner concerning the patient's pregnancy. It was confirmed that the patient's last menstrual period was on 04-SEP-2009. On an unknown date, at 10.5 weeks of gestation, a first trimester ultrasound was performed which confirmed that the estimated delivery date was 15-JUN-2009. On 16-JUN-2009, the patient was seen in the office when she was 40 weeks and 1 day pregnant. Some time after the last office visit, in June 2009, the patient delivered a healthy normal baby with no congenital abnormalities. Additional information has been received from a physician via medical records concerning the male patient who was born on 21-JUN-2009, weight 9 lbs and 1 oz and diagnosed with feeding problems, pyogenic granuloma and prenatal jaundice. On 24-JUN-2009, the baby's weight was 8 lbs and 3.5oz. The mother went to hospital for newborn follow up. The patient was discharged on 23-JUN-2009. It was not any complications, currently breast feeding q a lot each time, mother's milk had not come in and special concerns were jaundice and urine color. On 25-JUN-2009, the mother had pink crystals in diaper, breast feeding milk not in yet and was with fine urination. The baby's general appearance was alert and NAD; head was normal shape and AF normal; eyes normal and BRR; ENT was normal and palate intact; neck was full ROM and no masses; chest with lungs clear to auscultation and clavicles intact, CV was RRR, no murmur and normal femoral pulses; abdomen was soft, nontender, no masses and no HSM; genitalia was normal and urate crystals diaper; extremities hips full ROM, without hip click and feet straight; back was normal; neuro was intact, normal tone and moro present and skin was with moderate jaundice extending to ambilicus. The physician's assessment was well child. The physician's plan was given newborn information sheet, discussed sleep position, feeding, growth, crying, smoke detector, smoke exposure, limit visitors and exposure to crowds, frequent hand washing to limit spread of infections and monitor for increasing jaundice put in sunlight; weight check 2 days and follow up in 1 month HS. On 26-JUN-2009, the baby was with no known allergies and was ordered laboratory (chemical cautery granulant tissue) (result not provided). The baby's weight was 8 lb and 15 oz and it was not pain reported. Breast feeding approximately 10 minutes each side q 1 hour. The physician's subjective was Bw 9-1 breast feeding-wt 2 days prior 8-4; breast milk in good urination, stooling (yellow seedy, check umbilicus cord fell off 1 day prior some clear discharge, check jaundice breast feeding- mom type a blood). The baby's general appearance, head, eyes, ears, nose and OP were normal, neck was supple, in chest lungs were clear to auscultation, good air exchange, normal AP diameter abd umbilical granuloma, and skin was mild jaundice to lower abd. The physician's assessment was umbilical granuloma. Follow up will be at one week. The baby was vaccinated with PENTACEL (Sanofi) on 19-AUG-2009, 21-OCT-2009 and 30-DEC-2009; hepatitis B virus vaccine rHBsAg (yeast) (unspecified) on 21-JUN-2009, 19-AUG-2009 and 30-DEC-2009; pneumococcal vaccine (unspecified) 19-AUG-2009, 21-OCT-2009 and 30-DEC-2009 and ROTATEQ (unspecified) on 19-AUG-2009, 21-OCT-2009 and 30-DEC-2009. On 06-JUL-2009, congenital adrenal hyperplasia (CAH), hemoglobinopathy, biotinidase, galactosemia, congenital hypothyroidism(CH), cystic fibrosis (CF), amino acid profile, organic acid profile and fatty acid profile were performed and results in all were with normal findings. The mother's experience has been captured in WAES 0810USA03193. No further information is available.