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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (reference No. IE-1577272925-2015001488) as a part of a business agreement on 28-DEC-2015. This case was received from the RA health authority on 23-DEC-2015 with reference number IE-HPRA-2015-025495. Initial report was received by the RA on 11/Dec/2015 from a member of the public which concerns a 13 year old Female patient who was diagnosed with Systemic lupus erythematosus following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None. The patient was vaccinated with 3 doses of GARDASIL at a dose of 0.5 ml via IV route between 13/Sep/2010 and 05/Apr/2011. Only one batch/lot number was provided - NM31130 (expiration date was not reported). 7 months post last dose, in Sep/2011, the patient was diagnosed with lupus (SLE). Corrective treatment: Prednisolone, azathioprine and PLAQUENIL. At the time of reporting the patient''s symptoms were ongoing. The patient outcome is not recovered/not resolved.
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