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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-2015001039) on 18-DEC-2015. Case received from a physician via health authority on 15-DEC-2015 under reference number DK-DKMA-WBS-0002030. The case was assessed as serious due to disability. A 12-year-old female adolescent patient received GARDASIL, (lot/batch number unknown, Dose 1) via intramuscular route on 05-MAR-2010, GARDASIL, (lot/batch number unknown, Dose 2) via intramuscular route on 11-MAY-2010, GARDASIL, (lot/batch number unknown, Dose 3) via intramuscular route on 03-AUG-2010. The patient experienced Palpitation on 03-AUG-2010, Shortness of breath on 03-AUG-2010, Dizziness on 03-AUG-2010, Headache on an unknown date, Joint pain on an unknown date, Near syncope on an unknown date, Nausea on an unknown date, Frequency urinary on an unknown date, incontinence of urine on an unknown date, Dry skin on an unknown date, Bruise on an unknown date, Hair loss on an unknown date, Dry hair on an unknown date, Hyperventilation on an unknown date, Sleep disorder on an unknown date, Fatigue in 2011, Cognitive disorder on an unknown date, Involuntary muscle movement on an unknown date, Temperature intolerance on an unknown date and Postural orthostatic tachycardia syndrome on an unknown date. The first symptoms were developed after the third dose, when she was on her way home from the physician. Severe palpitation, dyspnea and dizziness. Half year later tiredness and palpitation, and after the rest of the symptoms. Criteria of POTS diagnosis: 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 over cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition, further criterion for patient''s between 12-19 years: Requires a heart rate increase greater than 40 bpm to make the diagnosis, young people have a stronger physiological heart rate response to standing up. The use of any additional criterion to avoid false positives. The patient''s outcome was reported as Not Recovered/Not Resolved.
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