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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a registered nurse concerning a 17 year old female patient with a drug allergy to erythromycin and no medical history, who on 21-FEB-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (Lot# 655324/0089U). There was no concomitant medication. On 25-APR-2007 the patient received her second dose of the vaccine while pregnant (LMP 28-MAR-2007). On 16-MAY-2007, the patient experienced an uncomplicated spontaneous miscarriage. Unspecified medical attention was sought. It was reported that the patient has not required any treatment and has not experienced any further problems. Laboratory diagnostic studies included a quantitative HCG. At the time of this report, the patient was recovering. No product complaint was involved. Upon internal review, uncomplicated spontaneous miscarriage was considered to be an other important medical event. Additional information has been requested.
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