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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-2015001037) on 18-DEC-2015. Case received from a physician via HA on 15-DEC-2015 under the reference number DK-DKMA-ADR 23274784 and DK-DKMA-WBS-0002029. A 15-year-old female adolescent patient received GARDASIL, (lot/batch number unknown, Dose 1) via intramuscular route in MAR-2009, GARDASIL, (lot/batch number unknown, Dose 2) via intramuscular route in MAY-2009, GARDASIL, (lot/batch number unknown, Dose 3) via intramuscular route in JUN-2009. The patient experienced Fatigue extreme in MAR-2009, Recurrent syncope in 2009, Near syncope on an unknown date, Headache on an unknown date, Dizziness on an unknown date, Palpitations on an unknown date, Abdominal crampy pains on an unknown date, Voiding dysfunction on an unknown date, Sleep disorder on an unknown date, Cognitive disorder on an unknown date, Light sensitivity to eye on an unknown date, Blurred vision on an unknown date, Nausea on an unknown date and POTS on an unknown date. The patient describes that the first symptoms were increased tiredness and syncope, which started after the first vaccination in MAR/APR 2009. Subsequently, the other reported reactions developed. During tilt table test at the reporter''s department the patient fulfills the diagnostic criteria for POTS. The patient describes decreased functional level and has had many short days at her work place. Unknown whether there are concomitant vaccines or medications. Criteria for diagnosis of POTS: Heart rate increases greater than or equal to 30 bpm from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg). Symptoms worsen with standing and improved with recumbence. Symptoms last greater than or equal to 6 months. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition hospital uses an additional criterion for patient''s between 12-19 years: Require a pulse increase greater than 40 bpm to confirm the diagnosis, based on that young people have a greater physiological pulse response upon standing up. They are this additional criterion to avoid false positive. The patient''s outcome was reported as Not Recovered/Not Resolved.
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