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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2016006420) on 22-JUN-2016. Case received from a physician via HA on 17-JUN-2016 under the references DK-DKMA-WBS-0003778 / DK-DKMA-ADR 23525691. A 12-year-old female adolescent patient received GARDASIL (batch number lot unk, Dose 1) via intramuscular route on 11-FEB-2009, GARDASIL (batch number lot unk, Dose 2) via intramuscular route on 06-MAY-2009, GARDASIL (batch number lot unk, Dose 3) via intramuscular route on 30-SEP-2009. The patient experienced fatigue extreme, headache, orthostatic intolerance, nausea, feeling bloated, menses pain aggravated, cognitive dysfunction, involuntary muscle movement, limb weakness in both arms, obstipation, blurred vision, could not bike to school in periods and a lot of absence from continuation school and in high school on an unknown date. The process of the adverse events: After the third vaccination within the year of 2009 the patient experiences a noticeable fatigue and cognitive dysfunction. Subsequently the other reported symptoms occurs. The patient informs that she has a lot of absence from continuation school and in high school. Could not bike to school in periods. Earlier the patient has been a moderately active girl and has been dancing amongst other things. According to tilt table test the patient does not fulfill diagnostic criteria for POTS. Other vaccines: No. Other medication: No. The patient''s outcome was reported as not recovered/not resolved.
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