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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur (MFR # 2016004000) on 15-APR-2016. Case received from a other health professional on 13-APR-2016 under the report ref number NT20160447. A 16-year-old female adolescent patient received GARDASIL (batch number unknown) via intramuscular route on 01-Oct-2008, GARDASIL (batch number unknown) via intramuscular route on 08-Dec-2008, GARDASIL (batch number unknown) via intramuscular route on 06-Apr-2009. The patient experienced Narcolepsy on an unknown date and idiopathic hypersomnia on an unknown date. Upon medical review the company considered relevant to code idiopathic hypersomnia that was mentioned in the narrative by the Health Authorities but not coded. She complained of fatigue since 2008-2009 and drowsiness from 2010. She presented with malaise and generalized fatigue concomitantly. There was an important school impact with drowsiness during courses/lessons. The patient also stopped her nurse studies because she couldn''t keep pace. The impact was daily with concentrating difficulty. No concept of infection prior to the installation of drowsiness. Biological assessments have not found abnormalities and no neurological or clinical disorders have been highlighted. Night''s sleep times were very long. Following iterative multiple sleep latency tests, excessive daytime sleepiness was found. The patient was treated by MODIODAL 100 mg : 2/day (at morning) that significantly improved daytime alertness, however, the patient kept concentrating difficulty. The patient had a medical history of wisdom teeth removal. The patient''s outcome was reported as Not Recovered/Not Resolved.
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