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Life Threatening? No
Write-up: Information has been received via the manufacturer pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F). On 18-DEC-2006, the patient had a positive pregnancy test; the date of the LMP was 11-NOV-2006, with an estimated date of delivery of 18-AUG-2007. The CMA confirmed that on 22-DEC-2006, the patient had a spontaneous miscarriage, through hospitalization was not reported and testing of the miscarried fetus was unavailable. It was not specified if the patient sought medical attention, nor if the patient had recovered from the spontaneous abortion. On 27-DEC-2006, the patient was vaccinated IM, with the second dose of Gardasil (Lot #654540/0800F). Upon internal review, spontaneous miscarriage was determined to be an other important medical event. This patient also experienced a pregnancy following vaccination with the second dose of Gardasil (WAES #0705USA01062). Additional information has been requested.
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