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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (local reference # AUS/12/2712; agency # 308298) concerning a 13-year-old female patient. On 12-OCT-2012, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On 12-OCT-2012, the patient experienced shaking, headache and chest pain. The patient received Paracetamol as treatment for the adverse event. The outcome of shaking, headache and chest pain was reported as recovered/resolved. Relationship between shaking, headache and chest pain and therapy with GARDASIL was reported as possible by the agency. Shaking, headache and chest pain were considered disabling by the agency. The original reporting source was not provided. Additional information is not expected.
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