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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2016008234) on 17-AUG-2016. Case received from a physician via health authority on 15-Aug-2016 under reference number DK-DKMA-WBS-0004245 and DK-DKMA-ADR 23606121. A 12-year-old female adolescent patient received GARDASIL (batch number Not available, Dose 1) via intramuscular route on 06-Apr-2011, GARDASIL (batch number Not available, Dose 2) via intramuscular route on 08-Jun-2011, GARDASIL (batch number Not available, Dose 3) via intramuscular route on 16-Nov-2011. The patient experienced Dizziness, Near syncope, Fatigue, Abdominal pain, Voiding difficulty, Sweating increased, Cognitive disorder, Cold hands and feet and Up to the vaccination the patient was active 4-5 times a week on an unknown date. The patient stated that her first symptoms came after the 3rd vaccination, exact point in time was unknown. Her symptoms came creeping - starting with dizziness, near syncope and tiredness. Up to the vaccinations the patient was active 4-5 times a week. The tilt tablet test shows that the patient does not fulfill the criteria for Postural Orthostatic Tachycardia Syndrome. Other vaccinations or medications unknown. The patient''s outcome was reported as Not Recovered/Not Resolved.
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