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Administered by: Other Purchased by: Unknown
Life Threatening? No
Write-up: This information was received from Sanofi Pasteur (SE-001) on 08-DEC-2016. This report was received from SPMSD (SE-001) and is from the Agency (reference number: SE-MPA-2016-006965). 2016-006965 (0.0) A report was received from a nurse concerning a 11 year old healthy girl. The day after another report was received from a physician regarding the same event. The same day as the girl received GARDASIL; she experienced tiredness and painful condition in arms and legs. Thereafter also nausea and "pain in the head". The pain and the tiredness diminished after one week but the girl then had sometimes pain in the back and neck. One week after the vaccination, she was able to stand up. The outcome has been reported as not yet recovered. On 30-NOV-2016, a report was received from a consumer which described nausea, tiredness, joint pain, muscular weakness and lasting muscular pain. She had difficulty moving. Worst was the pain in the muscles and joints. In addition, pain in the shoulder, back and neck. It was mentioned that all the adverse reactions started on the same day as the vaccine was given. Reported that this has led to permanent disability. SPC 4.8 pain in extremity, asthenia/LL/TL. No follow-up: For health authority reports the initial reporter is anonymized towards the pharma company and it is not possible to request FU information.
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