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Life Threatening? No
Write-up: Information has bee received from Sanofi Pasteur MSD (SPM) (manufacturer control # 2016000048) on 08-JAN-2016. Case received from a physician via health authority on 05-Jan-2016 under reference number DK-DKMA-WBS-0002164. A 14-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route in 2011, GARDASIL (batch number unknown, Dose 2) via intramuscular route in 2011, GARDASIL (batch number unknown, Dose 3) via intramuscular route in 2011. The patient experienced Joint pain in 2011, Headache in 2011, Syncope on an unknown date, Near syncope on an unknown date, Dizziness on an unknown date, Palpitations on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Dyspnosea on effort on an unknown date, Fatigue extreme on an unknown date, Cognitive dysfunction on an unknown date, Limb weakness on an unknown date, Vascular abnormalities on an unknown date, Light sensitivity to eye on an unknown date, Blurred vision on an unknown date and POTS on an unknown date. Vaccination dates not known (probably in 2011), therefore not possible for a time relationship between the vaccine and that symptoms. First symptoms were joint pain and headache a couple of months after 3 dose, thereafter the other reported symptoms. During tilt table test is the patient fulfilling the diagnostic criteria for POTS. The patient has previously danced on high level, but has stopped due to joint pain. The patient describes reduced function, and has a lot of sick leave from her education (30-35 % absence). Diagnostic criteria for 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 the hospital uses further criterion in patients between 12-19 years: requires a heart rate increase of greater than 40 bpm to make the diagnosis, the reasons for this is that young people have a stronger physiological heart rate response when standing up. The additional criterion is used to avoid false positives. Other vaccines or medicines: Not known. The patient''s outcome was reported as Not Recovered/Not Resolved.
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