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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) on 17-OCT-2016. This report was received from the RA on 12-OCT-2016 under reference number GB-MHRA-ADR 23673719. Case received from a consumer/other non health professional concerning a 12-year-old female adolescent patient who received GARDASIL (batch number unknown) via parenteral route on 30-SEP-2016. The patient had a medical history of fatigue (as per mother, when asked if fatigue might be a problem in having the vaccination, the General Practitioner (GP) advised that it wouldn''t be). Concomitant medications included OPATANOL on an unknown date. The vaccine was given at school and assistance from the school nurse was needed. The patient was in shock and experienced sore neck and shoulder on administered side, muscle twitching through whole body, chills, nausea, unable to speak, dizziness on standing up, visual disturbance, no energy/weakness, fatigue and presyncope (almost passed out) on 30-SEP-2016 1 day post administration. The symptoms began about 20 minutes after the vaccine was administered and became worse over the following hour. They had gradually faded but were still not gone 3 days later. Still incapacitated but was also recovering from fatigue, which, may have exacerbated once again. The outcome of sore neck and shoulder on administered side was recovering/resolving, muscle twitching through whole body, chills, nausea and unable to speak was recovered/resolved, dizziness on standing up, no energy/weakness and fatigue was not recovered/not resolved, visual disturbance was recovered/resolving with sequelae, presyncope and in shock was unknown. The patient''s overall outcome was reported as not recovered/not resolved.
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