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Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (2016006715) on 30-JUN-2016. Case received from a lawyer via HA on 27-JUN-2016, case number: 16-5278. A female adolescent patient experienced POTS, Overactive bladder, Difficulty focusing eyes, cannot get sharp focus, very Light sensitivity to eye, Often Headache, Constant Nausea, Problems with gastrointestinal system, Food intolerance, Constant Fatigue, Muscle weakness, Restless legs, Temperature regulation disorder, Decreased appetite, Underweight (have lost 17 kg), Loss of weight 17 kg, Dry eyes, Muscle spasms, Cold hands and feet, Dizziness, Tingling feet/hands, Muscle pain, Malaise, feels bad in summer temperatures and Had to drop out of 2 g. of high school. Full sick leave from August-2015 on an unknown date. PIC has sent the patient''s initial report. PIC has not yet decided in the matter. Side effects: The patient is diagnosed with POTS at Hospital. Overactive bladder. Cannot focus sharply. Is very sensitive to light. Often has headaches. Constant nausea. Problems with the gastrointestinal system. Hypersensitivity to food. Constant fatigue. Muscle weakness. Restless legs. Problems with the regulation of body temperature. Reduced appetite. Very underweight (have lost 17 kg) and cannot gain back. Dry eye. Muscle spasms. Cold feet and hands. The patient feels bad in summer temperatures. Dizziness. Tingling in the fingers. Muscle pain. Treatment of side effects: The patient takes medicine for high pulse and salt tablets. Goes to the physiotherapist, and has previously tried acupuncture without effect. She has also been to dietician and eat recommended diet. History around side effects: The patient has been ill since spring 2009, and has had to drop out of high school in 2nd grade because of side effects. She has since started up in high school again, and with the help of school counselors and management, made it through with a very high absenteeism. When she finished high school summer 2015 she started in a part-time job because she had not the energy to start an education. After 2 weeks, she had to stop her part-time work because she could not handle it. Since then, in August-2015, she had a full-time sick leave and have gone home because she cannot handle a regular job. Right now she goes and waits to be considered a resource through the municipality, for ultimately being approved for flexible working arrangements. Criteria for diagnosis of 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 criteria for patients between 12-19 years: Requires a heart rate increase of greater than 40 bpm to make the diagnosis, on the grounds that young people have a stronger physiological heart rate response to standing up. The use of any additional criteria to avoid false positives (Agency comment: Uncertain whether this criteria is used, it is not know when the survey was conducted, and thus how old the patient was on the survey). The patient''s outcome was reported as Not Recovered/Not Resolved.
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