Sex: F
Vaccine: HPV4
Symptoms: Complication of pregnancy, Drug exposure during pregnancy, Premature labour, Premature rupture of membranes
Clinical narrative: Information has been received from a medical assistant concerning one of twin babies. The baby's 18 year old mother was vaccinated with the first and second 0.5 ml doses of GARDASIL by different provider and was vaccinated IM with the third 0.5ml dose of GARDASIL (lot#: 659962/1740U) on 01-DEC-2008. The mother's last menstrual period was 19-NOV-2008 and estimated delivery date was 05-SEP-2009. The medical assistant reported that the baby was born about 1 month early, in approximately August 2009, but as far as she knew, the baby was born normal and healthy. Follow-up information was received from a pediatrician via medical records. The father of baby (FOB) was a twin. It was reported that the pregnancy complicated by premature rupture of membranes (PROM) and preterm labor, breech presentation and a history of mild pregnancy induced hypertension. The mother received one dose of betamethasone at 23:00 of 12-JUL-2009 and was transferred to another hospital on MgSO4. The mother delivered twin babies (one male and one female) via cesarean section for transverse presentation at 13-JUL-2009. The baby boy was born at 02:07 of 13-JUL-2010, 32 2/7 weeks of gestation, weighing 1690 grams. His head circumference was 27.5 cm and birth length was 45 cm. The apgar score is 9 at 1 minutes and 9 at 5 minutes. The baby boy was vigorous at birth, had decreased air entry and was masked continuous positive airway pressure (CPAP) with Neopuff used. It was reported that the boy developed respiratory distress at birth. On 13-JUL-2009, blood gas capillary revealed PCO2 capillary of 54, PO2 capillary of 53, bicarbonate of 25, O2 Sat of 90, capillary total Hgb of 19.8, capillary oxygen Hgb of 88 and capillary CO Hgb of 1. Chest x-ray revealed hazy and no free air. The baby was transferred to NICU for follow up care. Examination on admission revealed mild to moderate retractions presented in the substernal and intercostal areas, consistent with the prematurity of the baby. Active medications included ampicillin, gentamicin, erythromycin, eye ointment and vitamin K started on 13-JUL-2009. The boy was placed on nasal CPAP for respiratory distress. The settings for nasal CPAP was FiO2 0.21 and CPAP 6. Blood gas capillary on 14-JUL-2009 revealed PCO2 capillary of 47. PO2 capillary of 41, bicarbonate of 24, O2 Sat of 85, capillary total Hgb of 18.8, capillary oxygen Hgb of 83.9 and capillary CO Hgb of 1. The respiratory distress had been stable in room air since 15-JUL-2009. Blood gas capillary on the same day revealed PCO2 capillary of 45, PO2 capillary of 39, bicarbonate of 23, O2 Sat of 84, capillary total Hgb of 18, capillary oxygen Hgb of 82.6 and capillary CO Hgb of 1. The baby boy recovered from respiratory distress newborn on 16-JUL-2009. Blood culture was collected and revealed no growth. Methicillin-resistant Staphylococcus aureus (MRSA) by PCR on 13-JUL-2009, 19-JUL-2009 and 26-JUL-2009 was negative. Newborn sepsis was ruled out. It was reported that the boy was at risk for retinopathy of prematurity and intraventricular hemorrhage. On 20-JUL-2009 cranial ultrasound was performed to evaluate for intracranial hemorrhage. The result was normal. Retinal examination on 28-JUL-2009 showed immature retina which needed to follow up with the doctor. The baby received circumcision during hospitalization. On 30-JUL-2009 the boy received a dose of hepatitis B vaccine. On 31-JUL-2009 the baby boy was discharged from the hospital on multivitamins with iron which started on 27-JUL-2009. Upon discharge risk for intraventricular hemorrhage and respiratory distress newborn resolved, while prematurity and risk for retinopathy of prematurity persisted. Discharge physical exam showed no abnormalities and the circumcision was healing well. On discharge the boy's weight was 1980 grams, circumference of head was 27.5 cm and length was 46 cm. The boy was feeding very well on 22 cal, voided x 9 and stooled x2. The mother's experience has been captured in WAES # 0904USA01164. The other baby's experience has been captured in WAES # 0904USA01164B1. Additional information has been requested.