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Life Threatening? No
Write-up: Initial and follow up information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 24 year old female with no known drug allergies, no pertinent medical history, who on 30-MAY-2007 was vaccinated with the first dose of GARDASIL (lot # 657736/0389U) 0.5ml intramuscular left deltoid. It was reported the patient was vaccinated while she was pregnant (last menstrual period 09-MAY-2007). Concomitant therapy included pre natal vitamins (unspecified). On 13-MAR-2008 the patient required a C-section due to ''non reassuring fetal heart tone" and "arrested dilation at 5-6 cm". The infant was a male; birth weight was 7# 4 oz, Apgars 8-9, no problems. "On 16-JUL-2008, the patient was dating 6 Nl d." No other adverse events were reported. Upon internal review, non reassuring fetal heart tone and arrested dilation at 5-6cm that required a C-section were considered to be other important medical events. This is one of several reports by the same source. Additional information has been requested.
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