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This is VAERS ID 529131

Case Details

VAERS ID: 529131 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Submitted: 2014-04-23
   Days after onset:357
Entered: 2014-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Blood test normal, Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Headache, Myalgia, Nuclear magnetic resonance imaging brain normal, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Blood test, unremarkable biologic exploration; Computerised tomogram, normal thoraco-abdominal scan; Nuclear magnetic resonance imaging brain, normal
CDC Split Type: WAES1404FRA011567

Write-up: Information has been received from Sanofi Pasteur MSD (E2014-03479) on 18-APR-2014. Case received from the Health Authorities on 16-Apr-2014 under the reference number MP20140253. A 15 year-old-female patient with no relevant medical history had received a first dose of GARDASIL (batch number not reported) via intramuscular route in March or April 2013. In May 2013, she developed headache, skin eruption, asthenia, arthralgia and myalgia which evolved. The patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in July 2013. The causal link between the symptoms and vaccination was suggested since all the symptoms worsened following the second injection. The work-ups realised in December 2013 and February 2014 showed a normal brain MRI, normal thoraco-abdominal scan and a blood test with unremarkable biologic exploration. At the time of the report, the outcome was unknown. The Health Authorities assessed the causal relationship between the reported reactions and the vaccination as doubtful (C1 S2 I1) according to the method of assessment. It is noteworthy that the Health Authorities coded life-threatening and disability as seriousness criteria.

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