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Life Threatening? No
Write-up: Information has been received from a physician through a manufacturer pregnancy registry concerning a 32 year old female with a history of 5 pregnancies and 4 live births (one fetal loss at 16-20 weeks) who on 13-FEB-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F). Concomitant medication was not reported. On 13-NOV-2006, an ultrasound was performed results reported were fetal leiometry which corresponds the size and dates. On 04-DEC-2006, serum alpha-fetoprotein test was performed results were negative. On 13-FEB-2007, after the patient was vaccinated with Gardasil, the physician found out that the patient was pregnant. The physician reported that the pregnancy was normal to date. Follow-up information has been received from a physician. On 13-JAN-2007, an ultrasound performed showed adequate fetal growth since last sonography and fetal anatomy appears to be normal. On 13-APR-2007, an ultrasound performed showed biophysical profile 8/8, AFI 20.5 cm, S/D ratio 2.71, cervical length 4.44cm. On 23-APR-2007, an ultrasound performed showed adequate fetal growth since last ultrasound AFI 12.1 cm. On 24-APR-2007, the patient was diagnosed with intrauterine fetal demise and a female infant was delivered on 26-APR-2007 at 06:40, 3.235 kg. The placenta and cord were sent to pathology with no pathological diagnosis. Autopsy was refused. Clinically fetal death was due to cord accident, long umbilical cord, around body once and legs twice. Upon internal review, intrauterine fetal demise and umbilical cord complication were considered to be other important medical events. Additional ifnormation is not expected.
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