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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Initial and follow up information has been received, via the manufacturer pregnancy registry, from a registered nurse, and a 25 year old female with a history of one previous full term delivery with no complications (date unspecified), who on 09-FEB-2007, was vaccinated with a first dose of Gardasil (Lot #654741/0013U). There was no concomitant medication. On 16-APR-2007, the patient reported that she was "four or five weeks pregnant." The date of the LMP and estimated date of delivery were not provided. Follow up information received from a registered nurse, indicated that the patient was taking prenatal vitamins (PRENATAL ELITE), and had experienced bleeding during her pregnancy. On 26-APR-2007, an ultrasound confirmed the presence of a yolk sac, but a fetal heart sound or fetal motion was not detected. On 29-APR-2007, the patient was diagnosed with a urinary tract infection and was treated with MACROBID 100mg, twice daily, from 29-APR-2007 through 03-MAY-2007. During this time, an human chorionic gonadotroin test (HCG) test result confirmed an "abnormal rise" in the value (date not specified). On 04-MAY-2007, a repeat ultrasound confirmed the previous finding of yolk sac, but no detection of a fetal heart sound or fetal motion. a dilatation and curettage (D&C) was performed, and the products of conception was examined (results not specified). At the time of this report, it was unknown if the patient had recovered. Upon internal review, no fetal heart rate (resulting in a D&C) was determined to be an other important medical event. Additional information has been requested.
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