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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number IE-1577272925-2016002338) on 16-MAR-2016. This case was received from Regulatory Authority Agency (Ref no. IE-HPRA-2016-026118) 11-MAR-2016. Initial case report received from a consumer/other non-health professional concerns a 13-year-old female adolescent patient received GARDASIL, (batch number K021266) via intramuscular route in Arm left site on 28-SEP-2015. Concomitant medications: None. Medical history/concurrent conditions: None reported. The patient experienced chronic tiredness, dizzy, virus after virus, weakness, pains in joints, constant headaches, sensitive to lights, constant sore throat, earaches on 10-OCT-2015, chronic fatigue syndrome and ME on an unknown date. The reporter indicated that the patient''s doctors think she has CFS/ME. The reporter assessed the causal relationship: between chronic tiredness, dizzy, virus after virus, weakness, pains in joints, constant headaches, sensitive to lights, constant sore throat, earaches, Chronic fatigue syndrome, ME and GARDASIL as unknown. Corrective treatment included: None reported. The patient''s outcome was reported as not recovered/not resolved. This case is linked to ref no. 2016-026120 provided by Regulatory Authority Agency. (Patients'' sister).
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