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This is VAERS ID 278786

Case Details

VAERS ID: 278786 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-02-09
Onset:2007-03-01
   Days after vaccination:20
Submitted: 2007-05-16
   Days after onset:75
Entered: 2007-05-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0013U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antepartum haemorrhage, Blood human chorionic gonadotropin abnormal, Foetal heart rate abnormal, Ultrasound scan, Urinary tract infection, Uterine dilation and curettage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Normal delivery
Allergies:
Diagnostic Lab Data: ultrasound 04/26/07 - Yolk sac, no fetal heart rate, ultrasound 05/04/07 - Yolk sac, no fetal heart rate, total serum human 04/26?/07 - Abnormal rise
CDC Split Type: WAES0704USA03160

Write-up: Initial and follow up information has been received, via the manufacturer pregnancy registry, from a registered nurse, and a 25 year old female with a history of one previous full term delivery with no complications (date unspecified), who on 09-FEB-2007, was vaccinated with a first dose of Gardasil (Lot #654741/0013U). There was no concomitant medication. On 16-APR-2007, the patient reported that she was "four or five weeks pregnant." The date of the LMP and estimated date of delivery were not provided. Follow up information received from a registered nurse, indicated that the patient was taking prenatal vitamins (PRENATAL ELITE), and had experienced bleeding during her pregnancy. On 26-APR-2007, an ultrasound confirmed the presence of a yolk sac, but a fetal heart sound or fetal motion was not detected. On 29-APR-2007, the patient was diagnosed with a urinary tract infection and was treated with MACROBID 100mg, twice daily, from 29-APR-2007 through 03-MAY-2007. During this time, an human chorionic gonadotroin test (HCG) test result confirmed an "abnormal rise" in the value (date not specified). On 04-MAY-2007, a repeat ultrasound confirmed the previous finding of yolk sac, but no detection of a fetal heart sound or fetal motion. a dilatation and curettage (D&C) was performed, and the products of conception was examined (results not specified). At the time of this report, it was unknown if the patient had recovered. Upon internal review, no fetal heart rate (resulting in a D&C) was determined to be an other important medical event. Additional information has been requested.


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