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Life Threatening? No
Write-up: Initial and follow-up information has been received through the Merck pregnancy registry from a registered nurse concerning an 18 year old female with 1 previous pregnancy that resulted in miscarriage, who on 27-OCT-2006 was vaccinated with the first dose of Gardasil (lot # 653937/0637F) when she was 17 1/7 weeks pregnant, last menstrual period 29-JUN-2006. Concomitant medication included hormonal contraceptives (unspecified). On 03-DEC-2006 the patient found out she was pregnant via a home beta-human chorionic gonadotropin test (unspecified) and concomitant medication was stopped. A full term baby was born on 25-MAR-2007. Subsequently, the infant was born with a left club foot and two vessel umbilical cord. On 04-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 0210U). There were no other birth defects in the family. The nurse felt that the left club foot and two vessel umbilical cord were other important medical events. This is one of two patients received from the same source. This is an amended report. The terms Medication error and No adverse effect and information regarding the events have been deleted from this report and entered into WAES 0701USA02073.
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