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This is VAERS ID 287759

Case Details

VAERS ID: 287759 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-03-19
Onset:2007-06-24
   Days after vaccination:97
Submitted: 2007-08-09
   Days after onset:46
Entered: 2007-08-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Muscle spasms, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC; PREVACID
Current Illness: Pregnancy NOS (LMP = 6/24/2007)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound 07/29/07 - no fetus/pregnancy; beta-human chorionic 07/23/07 - positive
CDC Split Type: WAES0708USA00038

Write-up: Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 29-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F) injection 0.5mL IM left deltoid. On 19-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # 656372/0243U) injection 0.5mL IM left deltoid. Concomitant medication included ZYRTEC and PREVACID. The date of the patient''s last menstrual period was 24-JUN-2007. On 23-JUL-2007, the patient reported that she tested positive for pregnancy. On 29-JUL-2007, the patient sought medical attention for a miscarriage (the estimated date of delivery was 30-MAR-2008). On 29-JUL-2007, the patient arrived at the emergency room with complaints of bleeding and cramping. An ultrasound performed showed no fetus/pregnancy. Additional information was received from the registered nurse via telephone. It was originally reported that the miscarriage was life-threatening. The nurse clarified that it was not life-threatening to the mother but was unknown to the fetus as it was very early on in the pregnancy. The relationship of the miscarriage to Gardasil was unknown. Upon internal review, spontaneous abortion was considered to be an Other Important Medical Event. No additional information is expected.


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