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Life Threatening? No
Write-up: Information has been received from a health professional, for the Pregnancy registry for GARDASIL, concerning a male baby patient whose 24 year old mother with tobacco use and a history of 1 pregnancy and 1 live birth was vaccinated intramuscularly with the first, second and third 0.5 ml doses of GARDASIL on 03-DEC-2007, 04-FEB-2008 and 04-JUN-2008, respectively (lot # of the 2nd dose: 655327/1287U; lot # of 3rd dose: 655604/0052X). There was no concomitant medication. The mother was two weeks pregnant while receiving the third dose of GARDASIL. The pregnancy test was positive. On 23-SEP-2008, ultrasound was performed with normal result. On 15-OCT-2008, maternal serum alpha-fetoprotein (MSAFP) was performed with negative result. On 13-FEB-2009 (Weeks from LMP: 39), the baby was born with congenital anomaly cleft palate, weight: 8 pounds 3 oz and Apgar score 8/9. As of 01-JUL-2009, the outcome of cleft palate was unknown. Follow-up information was received from a nurse who reported that the baby was born with congenital anomaly cleft palate and cleft lip, height: 22 inch. The baby visited a cleft craniofacial center on 18-FEB-2009 and visited an audiology center on 09-JUN-2009. At the time of reporting, the outcome of cleft palate and cleft lip were unknown. Follow-up information was received from a nurse via medical records indicating that the baby''s Apgar was 8 at 1 minute, 9 at 5 minutes. Birth weight was 8 pounds and 5 ounces. He failed the newborn hearing screen of the left. The baby was born with cleft lip unilateral complete and cleft palate unilateral complete. On 25-FEB-2009, the infant was 12 days old. This was a well visit. It was noted that the cleft lip and palate would be repaired when the child was 4-6 months of age. On 04-SEP-2009 the patient had cleft lip repaired and had myringotomy with tubes. On 17-NOV-2009 the patient presented for a scheduled 9 months well child visit. He had ear tubes. Physical exam showed tympanic membranes normal landmarks, no fluid or erythema bilaterally. At the time of this report, the patient''s outcome regarding cleft palate was unknown. The reporting health professional considered cleft palate and cleft lip to be other important medical events and disabling. The mother''s experience has been captured in WAES #0807USA03163. The baby also experienced adverse events after being vaccinated with hepatitis B vaccine (manufacturer unknown) (WAES#0912USA01491). Additional information is not expected. All available medical records will be provided upon request.
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