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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received via SPMSD (Sender''s case unique identifier SE-1577272925-2016001100) on 11-JUL-2016. Case received from a lawyer at Patient insurance company on 23May2016. (corrective version done 27May2016 since last drug date: 28-May-2013 was reported in error). A female patient of unknown age received GARDASIL, (batch number lot not rep) via unknown route in Unknown site on 28-May-2013. As reported last drug date was 28 May 2013, no more information is given on dose number nor other doses. Data privacy law prevents information to be shared by reporter. The patient experienced essential tremor (shaking in hands and feet) in 2013. Start of AE is "Summer 2013". The patient''s outcome was reported as Unknown. Follow-up information received from the consumer via the Health Authority on 23-May-2016 under reference number SE-MPA-2016-003098. The female patient had received another dose of GARDASIL, (batch number lot not rep) via unknown route in Unknown site on 15-Oct-2012. The Health Authority assessed the causal relationship between Essential tremor and GARDASIL as possible. Corrective version created 27May2016 since last drug date: 28-May-2013 was reported in error as IRD. Corrective version for initial report is "IRD 23May2016". The "follow up"/complementary information was included in initial report. Follow up received from lawyer at patient insurance company. Information regarding decision in case regarding GARDASIL. Decision: Not an injury caused by using the drug (No connection). Likely connection between the injury and the medicine: No. Reimbursement from medical insurance: No.
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