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This is VAERS ID 283520

Case Details

VAERS ID: 283520 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-03-06
Onset:2007-03-06
   Days after vaccination:0
Submitted: 2007-06-29
   Days after onset:114
Entered: 2007-07-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Deep vein thrombosis, Drug exposure during pregnancy, Dyspnoea, Laboratory test, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 1/28/2007)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory - results not provided 7/11/07-records received Labs: Sticky platelet syndrome epinephrine response mildly increased ADP response normal amplitutde. PTT 25.3, PT 12.6. INR 1.1. D-Dimer 8706 high. Antithrombin III low 76. Doppler venous unilateral: acute deep venous thrombosis of left common femoral, superficial femoral and popliteal veins.X-rays no fracture.
CDC Split Type: WAES0706USA04112

Write-up: Information has been received from the Merck Pregnancy Registry from a physician concerning a 17 year old female with no pertinent medical history who on 06-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 656049/0187U). The patient was prescribed ethinyl estradiol (+) norgestimate (ORTHO TRI-CYCLEN) on the day she received the vaccination, but the reporter did not have any information regarding whether the patient was taking them or not. It was later learned that the patient was pregnancy when she received the vaccination. On 07-APR-2007, the patient experienced shortness of breath. On 14-APR-2007, she was hospitalized due to shortness of breath. It was later determined that the patient was experiencing a blood clot in her left leg, deep vein thrombosis (DVT). On 16-APR-2007, the hospital determined that the patient was 11 weeks and 1 day pregnant. The estimated date of delivery was 04-NOV-2007. Subsequently, the patient had an abortion performed for personal reasons not related to the vaccine. On 14-JUN-2007, the patient had not recovered from the blood clot and the reporter indicated that an unspecified blood thinner was recommended as treatment. At the time of the report, the blood clot persisted. The physician considered shortness of breath, abortion and blood clot in left leg to be other important medical events. The physician considered shortness of breath and blood clot in left leg to be immediately life threatening events. Additional information has been requested. 7/11/07-ER records received for DOS 4/14/07-DX: Recently diagnosed deep venous thrombosis. Possible pulmonary embolism. DX of blood clot 2 weeks prior. 4/14/07-attempted to terminate pregnancy, 12 weeks pregnant. Procedure not performed. C/O dyspnes on exertion. RX with Lovenox. No chest pain. Left let swelling and tenderness especially in popliteal fossa this has been ongoing for 2-3 weeks. 8/24/07-records received for DOS 04/07-04/10/07- DC DX: Deep venous thrombosis, left lower extremity. Intrauterine pregnancy. Status post trauma. Hypercoagulable state. Found to have a DVT of the lower extremity. Seen on 4/07/07-HX of few days before admission falling off the tub in the bathroom and hurting her legs. PE: tenderness and swelling in left lower extremity at level of calf and distal area of left thigh. Peripheral pulses present.


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