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Life Threatening? No
Write-up: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and drug reactions/allergies who on 15-JUN-2007 was vaccinated with Gardasil (lot# 657617/0384U) "single dose" in the left arm IM. There was no concomitant medication. The patient is currently pregnant. The date of the last menstrual period was in "early June 2007". Medical attention was sought. On an unspecified date the patient had a urine beta-human chorionic gonadotropin test performed and the results were positive. No symptoms have been reported. No further information was available. The estimated date of delivery is 07-MAR-2008. Follow-up information was received from the physician via telephone. The physician reported that the patient was going to be terminating her pregnancy. No further information was provided. Follow up information was received from a registered nurse via telephone. The patient was a white female who was seen in the office on 15-JUN-2007 at which time she was menstruating. The patient reported that she was not sexually active. The patient was vaccinated with Gardasil. On 10-AUG-2007 the patient returned to the office at which time she reported that she had become sexually active. A urine beta-human chorionic gonadotropin test sample was taken which was positive for pregnancy. The patient did not receive the vaccination. On 24-AUG-2007 a telephone call was placed to the patient and the physician''s office was told that the pregnancy had been terminated electively. The patient was reported to be doing well. The nurse reported that the series of vaccinations will be continued when the patient returns to the office. Upon internal review elective abortion is considered to be an other important medical event. Additional information has been requested.
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