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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR # 2016004789) on 29-APR-2016. Case received from a physician via health authority on 27-Apr-2016 under reference number DK-DKMA-WBS-0003229. A 11-year-old female child patient received GARDASIL (batch no unk) via intramuscular route on 02-Feb-2009, GARDASIL (batch number unknown) via intramuscular route on 10-Aug-2009. The patient experienced Syncope in 2009, Headache on an unknown date, Joint pain on an unknown date, Dizziness on an unknown date, Nausea on an unknown date, Palpitation in 2009, Abdominal pain on an unknown date, Obstipation on an unknown date, Diarrhea on an unknown date, Voiding difficulty on an unknown date, Skin disorder on an unknown date, Hyperventilation on an unknown date, Sleep disorder on an unknown date, Fatigue/tired in 2009, Cognitive disorder on an unknown date, Involuntary muscle movement on an unknown date, Weakness in extremity on an unknown date, Cystitis on an unknown date, Food allergy on an unknown date, Cold extremities on an unknown date, Dry eyes on an unknown date, malaise in 2009, reduced social life on an unknown date, very active in the period before the vaccination on an unknown date and near syncopes in 2009. Patient informs about symptom debut after 2nd dose. She started to faint, to have near syncope, malaise, be tired and have palpitations. The other symptoms came after. The patient was very active in the period before the vaccination. As a consequence of her symptoms has she had a lot of absence in grade 7, 8 and 9. She is now in high school, but has a lot of absence. She also tells that her social life is reduced. Tilt table test shows that she does not fulfill the diagnostic criteria for POTS. Other medicines or vaccines: Unknown. The patient''s outcome was reported as Not Recovered/Not Resolved for all events except presyncope, Exercise capacity decreased, Disturbance in social behaviour, food allergy, cystitis, cognitive disorder, syncope and malaise that were reported as unknown.
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