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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2015001034) on 18-DEC-2015. Case received from a physician via HA on 15-Dec-2015 under the reference number DK-DKMA-WBS-0002028 and DK-DKMA-ADR 23274783. A 16-year-old female patient adolescent patient received GARDASIL (batch number unknown) via intramuscular route on an unknown date. The patient experience Tiredness in FEB-2014, Headache on an unknown date, Chest pain (non-cardiac) on an unknown date, numbness in arms on an unknown date, Dizziness on an unknown date, Palpitation on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Acne on an unknown, Sleep disorder on an unknown date, Voiding difficulty on an unknown date, Cognitive disturbance on an unknown date, Muscle hyper excitability on an unknown date, Muscle weak lower limb on an unknown date, Hyperventilation on an unknown date, Dyspnea on an unknown date, Menstrual disorder on an unknown date, ortostatic tolerance on an unknown date and significant fall in activity level on an unknown date. The reporter does not have the patient''s vaccination dates, therefore it is not possibly certain to relate to a temporal relationship between the vaccine and symptom debut. The patient describes that the first symptom was increased tiredness and started in Feb-2014. Subsequently, the other reported adverse reaction develop. Significant fall in activity level and sick leave from work/education. At tilt table test at the reporter''s department orthostatic intolerance is seen - but the patient does not fulfill the diagnostic criteria for POTS. Unknown whether there are other vaccines or medications. The patient''s outcome was reported as Not Recovered/Not Resolved.
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