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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control No. Sanofi Pasteur MSD) on 22-DEC-2015. Case received from a physician via HA on 18-Dec-2015 under the reference number DK-DKMA-ADR 23278857 and DK-DKMA-WBS-0002055. A 13-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 22-Jan-2009, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 23-Mar-2009, GARDASIL (batch number unknown, Dose 3) via intramuscular route on 25-Sep-2009. The patient experienced Abdominal pain on 22-JAN-2009, Fatigue in JAN-2009, Nausea on JAN-2009, Dizziness in JAN-2009, vascular abnormalities on an unknown date, Sensory disturbance on an unknown date, Muscle pain on an unknown date, Syncope on an unknown date, Palpitations on an unknown date, Voiding difficulty on an unknown date, Sleep disorder on an unknown date, Cognitive disorder on an unknown date, Involuntary muscle movement on an unknown date, Limb weakness on an unknown date, Dyspnoea on an unknown date, Irregular menstruation on an unknown date, Dry eyes on an unknown date, Dry mouth on an unknown date, Postural orthostatic tachycardia syndrome on an unknown date, Vascular abnormalities on an unknown date and patient is out of school and work market on an unknown date. The patient informs that her symptoms debuted after the 1st vaccine. The first symptoms that developed were abdominal pain, fatigue, nausea and dizziness. Subsequently the other reported symptoms developed. A consequence is that the patient is out of the school and work market. Diagnostic criteria for POTS: 1) 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). 2) Symptoms worsen with standing and improved with recumbence. 3) Symptoms last greater than or equal to 6 months. 4) Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition, Hospital, uses an additional criteria for patient''s between 12-19 years old: require a pulse increase greater than 40 bpm to set the diagnosis, based on that younger people have a greater physiological pulse response upon standing up. This is used to avoid false positives. Unknown whether there were other medications or vaccines. At Tilt table test at the Syncope center, Hospital, it is seen she fulfills the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. The patient''s outcome was reported as Not Recovered/Not Resolved.
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