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This is VAERS ID 284483

Case Details

VAERS ID: 284483 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:161
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / - UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth, Skin lesion, Skin ulcer, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Latex allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA04564

Write-up: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female experienced injection site erythema, injection site warmth, skin ulcer and tenderness following vaccination with Gardasil. The patient experienced on the left deltoid site a 5 cm x 3 1/2 cm circular erythematous tender area that was warm to the touch, and a lesion that was very tender. No further information is available. The original reporting source was not provided. Additional information has been requested.


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