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Life Threatening? No
Write-up: Information has been received through the pregnancy registry from a nurse practitioner concerning a 15 year old female with no known drug allergies, and with depression who on 8/31/06 at 3:00pm was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot 653937/0637F). Illnesses at the time of vaccination included flu symptoms and a breast lump. Concomitant therapy included Zoloft. Other vaccinations given on 9/6/06 included Tdap. On 9/6/06 the pt was seen at her physician with a complaint of continued viral illness. It was reported that the pt was aware that she was pregnant but did not disclose this information to her health care provider until after vaccination. A urine pregnancy test was performed and found to be positive. The pt was advised no to receive the second dose of HPV. At the time of this report, the outcome of the viral illness and vaccine exposure during pregnancy was not known. Follow-up information has been received from the patient''s OB-GYN. A nurse reported that the patient was last seen at 28 weeks gestation on 12-JAN-2007. At that time, she was transfered to the department of maternal-fetal medicine at a local hospital. A nurse at the maternal-fetal medicine department reported that the patient delivered via vaginal delivery a "healthy baby boy but had gastroschisis". The baby was born on 07-APR-2007 and APGAR scores were 8 and 9 at one and five minutes, respectively. The nurse was unable to provide the infant''s birhtweight and indicated that infants born with this congenital anomaly are generally hospitalized for 12 weks. The nurse could not confirm when and if thin infant had been discharged from the hospital. Additional information has been requested.
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