Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Postpartum haemorrhage, Ultrasound scan normal, Upper respiratory tract infection
Clinical narrative: Information has been received from a Merck pregnancy registry for GARDASIL from a 25 year old female with a history of previous pregnancy/full term delivery and no drug allergies who on 24-JAN-2007 was vaccinated with her first dose of GARDASIL (lot# 654741/1208F).  On 23-MAY-2007 the patient was vaccinated with her second dose of GARDASIL (lot# 654741/1208F).  There was no concomitant medication.  The patient is 19 weeks pregnant. Unspecified medical attention was sought.  Follow up information received from a physician, indicated that the patient was on prenatal vitamins for all through the pregnancy, ferrous sulfate 28 to 40 weeks, 325 mg daily for anemia, BACTRIM as prescribed for urinary tract infection and Z-PACK for upper respiratory infection.  On 18-Feb-2008, the patient delivered a normal female baby weeks from LMP 38.  The baby weighed 7 pounds and 9.8 ounces with an Apgar score 7/8.  The patient experienced postpartum haemorrhage during labour and delivery.  The patient's outcome was not reported.  Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. Pediatric medical records were received and reviewed. On 25-FEB-2008 the well child check-up was performed for the 1 week old baby. The baby was fed with breast milk and Similac supplement every 3 hours. The baby developed gastrointestinal gas and was recommended to stop breast milk feeding for 2 days. The exam results showed that the height of the baby was 20.5 inch; the weight was 7 pounds and 8.5 ounces; the head circumference was 13.5 inch; fontanelle, eyes, ears, nose, mouth/throat, clavicle, chest, femoral pulses, heart, abdomen, extremities/hips, genitalia and neural system were all normal; skin was mild-mode yellow. The physician assessed that the baby had jaundice and suggested to treat with phototherapy. The result of infant hearing screen was normal. State newborn screens were pending. On 18-APR-2008 the baby was vaccinated with the first dose of ROTATEQ (MSD) (lot # 660201/0142X) given orally, the first dose of PEDIARIX (lot # AC21B142AA) given into the right thigh, the first dose of ACTHIB (lot # UF251AB) given into the left thigh and the first dose of PREVNAR (lot # C547610) given into the left thigh. On 30-JUN-2008 the baby was vaccinated with the second dose of ROTATEQ (MSD) (lot # 660679/0407X) given orally, the second dose of PEDIARIX (lot # AC21B149AA) given into the right thigh, the second dose of ACTHIB (lot # UF262AA) given into the left thigh and the second dose of PREVNAR (lot # C65044) given into the left thigh. On 25-AUG-2008 the baby was vaccinated with the third dose of ROTATEQ (MSD) (lot # 660377/0274X) given orally, the third dose of PEDIARIX (lot # AC21B150AA) given into the right thigh, the third dose of ACTHIB (lot # UF400AA) given into the left thigh and the third dose of PREVNAR (lot # C68306) given into the left thigh. On 25-AUG-2008 the well child check-up was performed for the 6 month old baby. The baby was fed with  Gentleease, fruit and veggie. The exam results showed that the height of the baby was 27 inch; the weight was 18 pounds; the head circumference was 17 inch; fontanelle, eyes, ears, nose, mouth/throat, clavicle, chest, femoral pulses, heart, abdomen, extremities/hips, genitalia and neural system and skin were all normal. The result of personal disorder questionnaire was normal. Additional information is not expected.