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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-2016000081) on 12-JAN-2016. Case received from a physician via health authority on 07-JAN-2016 under reference number DK-DKMA-WBS-0002318. A 12-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 02-OCT-2014. Other suspect products included M-M-RVAXPRO, rHA, batch number unknown administered via intramuscular route on 02-OCT-2014. The patient experienced Dizziness on 17-DEC-2014, Muscle pain on 17-DEC-2014, Joint pain on 17-DEC-2014, Headache on an unknown date, Extreme fatigue on 17-DEC-2014, Abdominal pain on an unknown date, Near syncope on an unknown date, Palpitations on an unknown date, Nausea on an unknown date, Voiding dysfunction on an unknown date, Dry skin on an unknown date, Dyspnoea on an unknown date, Hyperventilation on an unknown date, Sleep disorder on an unknown date, Cognitive dysfunction on an unknown date, Blurred vision on an unknown date, Involuntary muscle movement on an unknown date. Limb weakness on an unknown date, Dry eyes on an unknown date, Light sensitivity to eye on an unknown date, Sound sensitivity on an unknown date, postural orthostatic tachycardia syndrome on an unknown date, has had a lot of absence (max 4 hours in school per day) on an unknown date and reduced function on an unknown date. 2.5 months after vaccination the patient experience dizziness, severe tiredness, bad muscles and joint pain. Afterwards addition of the other reported reactions. During tilt table test at syncope center hospital, the patient fulfills the diagnostic criteria for POTS, with unstable blood pressure regulation and near syncope of vaso depressive character. The patient has reduced function and has a lot of absence from school (max 4h per day). Other vaccines or medicines: no. 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 when 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 stronger physiological heart rate response when standing up. The additional criterion is used to avoid false positives. The patient was admitted to hospital on an unspecified date. The patient had a medical history of abdominal pain in January 2014. The patient''s outcome was reported as Not Recovered/Not resolved.
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