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Life Threatening? No
Write-up: Encephalomyelitis; Information has been received from the Regulatory Authority (2019PVCL2614) on 20-SEP-2019, concerning to female patient of 13 age (units not provided); The patient''s pertinent concurrent conditions, concomitant therapies, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), the dose was 1200 milligram as prophylaxis (the concentration, frequency, route and anatomical location of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced encephalomyelitis. The outcome of encephalomyelitis was reported as fatal. It was unknown if an autopsy was performed. The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) and encephalomyelitis was not reported by the Health Authority.
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