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Life Threatening? No
Write-up: Information has been received from a registered nurse for the pregnancy registry for Gardasil, concerning a 26 year old female with a drug reaction/allergy to Wellbutrin, factor v laiden mutation/clotting disorder, prothrombin mutation, bipolar disorder, seizure disorder and Mthfr and a history of pulmonary embolism and multiple deep vein thrombosis and herpes virus infection who on 13-SEP-2006 was vaccinated with her first Gardasil 0.5 ml IM (lot # 653735/0688F). Concomitant therapy included Coumadin, Topamax and clonazepam. The nurse stated that the patient was very non-complaint and never returned for the second or third dose of the vaccine. On 16-APR-2007, the patient was found to be pregnant which was confirmed by ultrasound and a pregnancy test. The patient''s last menstrual period, gestational age or due date were not reported. On 11-MAY-2007 the patient experienced spontaneous miscarriage which was confirmed by ultrasound. The patient sought unspecified medical attention. The patient was not hospitalized. Upon internal review, spontaneous miscarriage was determined to be an other important medical event. Additional information has been requested.
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