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Life Threatening? No
Write-up: Lupus erythematosus syndrome; This spontaneous report as received from a regulatory authority refers to female patient with age reported as 17 (units not provided). There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), with dose reported as 4 (units not reported) (route of administration, lot# and expiration date were not reported), for prophylaxis. On an unknown date, the patient experienced systemic lupus erythematosus and died. It was unknown if an autopsy was performed. The cause of death was not reported. The relatedness between the event and the suspect therapy was not reported. The Agency considered the event of systemic lupus erythematosus to be serious.
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