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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received through the manufacturer pregnancy registry and from a medical assistant concerning a 37 year old female who on 09-OCT-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (lot # 653736/0868F). It was reported that on 22-OCT-2006 "the patient discovered she was 7 weeks pregnant) method of confirmation of pregnancy was reported to be a pap smear. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information was received from a medical assistant who reported that on 15-DEC-2006 the patient experienced vaginal spotting. That same day the patient was seen by her obstetrician who performed an abdominal ultrasound. The ultrasound confirmed that there was no fetal heartbeat. On an unspecified date a total serum human chorionic gonadotropin test was performed, results not provided. On 18-DEC-2006, the patient underwent an uncomplicated uterine dilation and curettage as an outpatient. On 02-JAN-2007 the patient was seen by her obstetrician for a post-operative exam which revealed that the patient had a full recovery without complications. The patient was advised to return to full regular activity. Upon internal review, the spontaneous abortion was considered to be an other medical event (OMIC). Additional information has been requested.
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