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This is VAERS ID 289488

Case Details

VAERS ID: 289488 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-04-10
Onset:2007-04-18
   Days after vaccination:8
Submitted: 2007-08-14
   Days after onset:118
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Antiphospholipid antibodies negative, Antithrombin III, Blood homocysteine normal, Blood test normal, Cardiolipin antibody negative, Coagulation factor V level normal, Coagulation factor decreased, Deep vein thrombosis, Immunology test normal, Protein C, Protein total normal, Prothrombin level normal, Skin discolouration, Subclavian vein thrombosis, Ultrasound Doppler, Venogram
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Hypotonic-hyporesponsive episode (broad)

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? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC Split Type: WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


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