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This is VAERS ID 287889

(NOTE: This result is from the 6/14/2018 version of the VAERS database)

Case Details

VAERS ID: 287889 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Unknown  
   Days after vaccination:31
Submitted: 2007-08-10
   Days after onset:123
Entered: 2007-08-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Uterine dilation and curettage
SMQs:, Tumour markers (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC Split Type: WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.

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