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This is VAERS ID 279328

Case Details

VAERS ID: 279328 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-02-13
Onset:2007-02-13
   Days after vaccination:0
Submitted: 2007-05-22
   Days after onset:97
Entered: 2007-05-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Foetal movements decreased, Inappropriate schedule of drug administration, Intra-uterine death, Medication error, Ultrasound scan abnormal, Ultrasound scan normal, Umbilical cord abnormality
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Intra-uterine death
Allergies:
Diagnostic Lab Data: ultrasound 11/13/06 - fetal leiometry for size and dates, ultrasound 01/13/07 - adequate fetal growth since last ultrasound, fetal anatomy appears to be normal, ultrasound 04/13/07 - decreased fetal movements, threatened preterm labor, biophysical profile 8/8, AFI 20.5 cm, S/D 2.71, ultrasound 04/23/07 - adequate fetal growth since ultrasound AFI 12.1 cm, serum alpha-fetoprotein 12/04/06 negat
CDC Split Type: WAES0702USA02398

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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