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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016000050) on 08-JAN-2016. Case received from physician via health Authority on 05-Jan-2016 under reference number DK-DKMA-WBS-0002162. Case received from a physician via health Authority on 05-Jan-2016 under reference number DK-DKMA-WBS-002162. A 13-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 08-Oct -2013, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 17-Dec-2013, GARDASIL (batch number J0101618, Dose 3) via intramuscular route on 16-Feb-2015. The patient experienced Can not ride as she did earlier on an unknown date, faints 1-2 times per week on an unknown date, Involuntary muscle movement on an unknown date, Shortness of breath on an unknown date, Nausea on an unknown date, headache in 2013, problem keeping a social network on an unknown date, Postural orthostatic tachycardia syndrome on an unknown date, dizziness in 2015, numb areas in fingers and arms on an unknown date, Exhausted / fatigue on an unknown date, shaking/tics in right hand on an unknown date, near fainting 1-2 times per day on an unknown date, concentration problems on an unknown date, Cognitive disorder on an unknown date, can not go to school on an unknown date and shoulder pain on 07-OCT-2015. The patient''s outcome was reported as Not Recovered/Not Resolved. The HA has received the report from the hospital and another physician. The patient has reported to the center that she was vaccinated 5 times, unknown dates. She describes that the symptom started in 2013, when she developed headache that lasted approximately for a month. In 2015 the headache returned and is now constant, but varies in intensity. Dizziness started also in 2015. She describes that she faint in average 1 time per week. Tilt table test shows that she fulfills the diagnostic criteria for POTS. The patient describes that this has consequences for her, she has problem keeping her social network, and can not go to school and she can not ride as she used to. Until vaccination she was riding 5-6 times per week, 1-1,5 h per time. 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 other physician reports the following: headache, dizziness constant, fainting 1-2 times per week, near fainting 1-2 times per day, tiredness, shaking/tics in right hand, numb area in fingers and arm. She can not read or write, as the headache and dizziness get worse. Concentration problems. She has not been in school for 6 months. Medical record 07-Oct-2015: Medical history She has fainted today again at home. She had 5 minutes before got up from the sofa, walked around in the house, and goes to lie down, next thing she remember is the she woke up on the floor and has shoulder pain. No warning that she should faint. Thus no sensation of warmth, redness, sweating tendency, increased dizziness, or vision disturbance before she faint. She has constant headache, does not wake up of it, but has headache when she wakes up. The headache has over the last months increases. It got worse when she should read or write. Turn of the subtitles from the TV, but can follow when she watch TV, and does not get worse headache. There are attempted physiotherapy of this (optapening of shoulder, manipulation of the neck, stretching exercises) no effect. Has been seen by optician, that does not find a need of glasses. Is constant dizzy, dizziness of nautical character. Better when she lie down with her eyes closed, but doesn''t disappear totally. No double vision. The symptoms are so profound that she has only been school a few days since the summer break. Has previously liked school, has good friends. Parents are very concerned, see their daughter that has been very active and now only sit at home. Are worried that she has something in her head and which a scan of the head. DKMA comment: The HA has been in contact with the treating physician to clarify the vaccination dates. From the medical records they can inform that she was vaccinated 08-Oct-2013, 17-Dec-2013 and 16-Feb-2015.
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