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Life Threatening? No
Write-up: This is in follow-up to report(s) previously submitted on 3/14/2007; 4/6/2007. Information has been received from a registered nurse, for the Pregnancy registry for Gardasil, concerning a 19 year old female with no previous pregnancies, no known drug allergies, and a history of anxiety who on 03-NOV-2006 was vaccinated with first dose of Gardasil (lot # 653938/0954F) 0.5 ml in the left deltoid. Concomitant therapy included promethazine hydrochloride. On 05-JAN-2007, the patient was vaccinated with second dose of GARDASIL (lot # 655165/1425) 0.5 ml. There was no concomitant medication. The patient sought medical attention. Her last menstrual period was on 05-DEC-2006. On 29-JAN-2007, the patient''s primary physician performed a quantitative beta blood test at the physician''s office which was positive for pregnancy. Estimate date of delivery is 11-SEP-2007. On 08-FEB-2007, the patient experienced abdominal discomfort and was sent to the hospital for an ultrasound which was positive for pregnancy. The patient was not hospitalized. At the time of reporting, the patient no longer had abdominal discomfort. Additional information was received from the registered nurse. On 08-FEB-2007, an ultrasound was performed for pain that revealed intrauterine pregnancy of 6 weeks and 5 days and subchorionic hemorrhage. On 16-MAY-2007, an ultrasound was performed that revealed normal anatomy scan. The estimated date of delivery was calculated as 30-SEP-2007. Additional information was received from the registered nurse. The patient''s LMP was on 25-DEC-2006. On 09-OCT-2007, 40 weeks from LMP, the patient delivered a female baby weighing 7 pounds 10 ounces. Apgar scale 8/9. The infant was reported as normal and healthy, no congenital anomalies and no complications. Additional information is not expected. 07/08/08 Follow-up information was obtained from a health professional in the physician''s office via voice mail. It was reported that they did see the baby one time in the hospital, but it was not their patient. They do not have any medical records for this patient. Additional information is not expected.
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