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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR Control number DK-1577272925-2016006526) on 24-JUN-2016. Case received from a physician via HA with reference no. DK-DKMA-ADR 23529267 / WBS-0003802 on 21-Jun-2016. A 12-year-old female adolescent patient received GARDASIL (batch/lot number Unknown, Dose 1) via intramuscular route on 02-May-2012, GARDASIL (batch/lot number Unknown, Dose 2) via intramuscular route on 13-Jun-2012, GARDASIL (batch/lot number Unknown, Dose 3) via intramuscular route on 09-Oct-2012. The patient experienced Abdominal pain, Flu like symptoms, Headache, Joint pain, Muscle pain, Orthostatic intolerance, Palpitations, Nausea, Voiding dysfunction, Bruising with no known cause. Dyspnoea, Fatigue extreme, Cognitive dysfunction, Involuntary muscle movement, Limb weakness, Chest tightness, Temperature regulation disorder, Dry mouth, Pains in the whole body and Cognitive dysfunction on an unknown date and Arm got swollen and The arm became swollen and red after all three doses were given on 02-MAY-2012. Case description: The patient reports that the symptoms started with abdominal pain and pain over the whole body. She also tells that after all the vaccines were given, her arm became swollen, red and unusable for a couple of days. The other symptoms have developed since then. Until the vaccinations, the patient played handball 4 times/week plus matches in the weekends. Due to the symptoms, the patient now struggles with not being absent from school. She told that even small things consume much energy, and that she therefore needs to prioritize her energy. A tilt-table test shows that she does not fulfill the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. Other vaccines: Unknown. Other medication: Unknown. The patient recovered from Arm got swollen in OCT-2012, The arm became swollen and red after all three doses were given in OCT-2012. He/ She had not recovered from Abdominal pain, Headache, Pains in the whole body, Temperature regulation disorder, Dry mouth, Chest tightness.
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