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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur (manufacturer control # GB-1577272925-E2014-05052) on 10-JUN-2014. Serious case received from the MHRA under reference GB MHRA ADR 22553964 on 4-Jun-2014. This case is not medically confirmed as the reporter was a consumer. A 13-year-old male patient (50/80 kg), with no medical history and concomitant medication reported, received an injection of GARDASIL (batch number J007240), series site and route not reported, on unreported date. On 24-May-2014, the patient experienced vomiting, pains in joints, fever, chills, dizzy and headache. On unreported date, the patient experienced sleep symptoms. The pain was so bad that the wheelchair was used for the afternoon. After 16 hours of sleep the symptoms disappeared. The patient recovered from all the events except "sleep symptoms" on 25-May-2014. Duration was reported as 1 day. At the time of the reporting the outcome was reported as recovered for all events. The MHRA considered the case serious for disability and other medically significant reasons.
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