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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR # 2015001191 on 21-DEC-2015. Case received from a physician on 17-Dec-2015 under the report ref number DK-DKMA-ADR 23278239. A female adolescent patient of unknown age received GARDASIL, (batch number unknown) via intramuscular route in 2009. The patient experienced Syncope in 2009, Fatigue on an unknown date and Orthostatic intolerance on an unknown date. Additional investigations included Tilt Table Test orthostatic intolerance n/a on an unknown date. Other HA comment: A tilt table test shows orthostatic intolerance, but the patient does not fulfill the criteria POTS. Other vaccines or medicines: unknown. The patient has experienced syncope almost daily since vaccinations, comes in standing position and not lying/sitting, probably since vaccination in 2009. The reporter does not have vaccination dates (probably 2009), hence an assessment of a temporal connection between start of symptoms and vaccination is not possible.
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