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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-2016007195) on 12-JUL-2016. 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). Case received from a lawyer via HA on 08-Jul-2016 under the reference numbers DK-DKMA-ADR 23553726 and 16-5855. A 15-year-old female adolescent patient received GARDASIL, (batch number Lot not rep, Dose 2) via intramuscular route on an unknown date, GARDASIL, (batch number Lot not rep., Dose 3) via intramuscular route on 11-May-2009, GARDASIL, (batch number Lot not rep) via intramuscular on 03-Oct-2008. The patient experienced POTS on 15-May-2016, recurrent lung infections on an unknown date, on full sick leave since summer 2014 on an unknown date, more ill on an unknown date, cold on an unknown date, nausea really often on 13-May-2009 2 days post administration, chronic migraine on an unknown date, tension headache on 13-May-2009 2 days post administration, Horton''s headache on an unknown date, constant dizziness on 13-May-2009 2 days post administration, concentration problems on an unknown date, poor memory on an unknown date, light sensitivity on an unknown date, tunnel vision on an unknown date, flashes in eyes on an unknown date, problems with temperature regulation on an unknown date, sweats much on an unknown date, freezes often on an unknown date, chronic fatigue on an unknown date, poor circulation on an unknown date, feet get purple on an unknown date, chest pain every day on an unknown date, abdominal pain on an unknown date, alternates between diarrhoea and constipation on an unknown date diarrhoea on an unknown date, constipation on an unknown date, diffuse neural pain on an unknown date, muscle tremor on an unknown date, vascular pain around the head on an unknown date, constant neck pain on an unknown date, bladder problems on an unknown date, hypersensitive genital region on an unknown date and bowel problems on an unknown date. The patient had a medical history of Concussion in 2012. The patient''s outcome was reported as not recovered/not resolved. Translated narrative: This is the patients initial report, PIC has not yet processed the case. After the vaccinations, the patient started to become ill more often. She had recurring lung infections, always got the cold, had nausea very often, dizziness very often and started to have headache very often. After a concussion in 2012, her symptoms worsened really much. She went to her GP, and after a long procedure with visits to neurologists and several hospitals, she has gotten the diagnosis POTS in May 2016 at an HPV clinic. She first noted the injury in 13-May-2009. She replies to the question if she has problems by describing chronic migraine and tension headache. She has migraine almost every day (4 times per week) and tension headache the other days. She also has Horton''s headache periodically. She has severe nausea every day and is constantly dizzy. Due to the other symptoms, she suffers from concentration problems and poor memory. She suffers from chronic fatigue and has a number of vision problems (light sensitivity, flashes and tunnel vision). She has problems with temperature regulation, either sweats much or freezes a lot. She has poor circulation which often causes her legs to become purple. She has chest pain every day. She has some abdominal pain and bowel problems and alternates between diarrhea and constipation. She periodically has some diffuse nerve pains in several places, muscle tremor and vascular pain around the head. She constantly has neck pain, bladder problems and a hypersensitive genital area. The patient describes that she is under evaluation at a hospital, where she has been prescribed some medicine to try, special diet and she is to start in physical therapy. The patient has been on sick leave since 2014. She describes that she has not been able to continue with her education due to illness. She has tried to lead a normal life over the years, which has become increasingly difficult and that she now can barely keep her everyday life together.
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