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Life Threatening? No
Write-up: Case received from the Health Authorities on 26-APR-2013 under the reference number PP20130163. Case medically confirmed. A 16-year-old female patient had received the first dose of human papillomavirus vaccine in Jan-2010 and the second dose (batch number unknown) via intramuscular route in Mar-2010. The batch numbers could not be found. She did not received influenza vaccine. In Mar-2010, 15 days after vaccination, the patient experienced isolated hypersomnia. Her needs for sleep increased with a non-restorative sleep. She also developed significant and invalidating daytime sleepiness. There was no hypnagogic hallucinations, no cataplexy and no sleep paralysis. On 20-Oct-2011, night polysomnography showed stable sleep (normal architecture) of extended length with sleep modes (micro-arousals suggestive of idiopathic hypersomnia). There was no obstructive event and no periodic legs movements. Multiple sleep latency test showed an excessive day sleepiness with an average falling asleep latency of 5 minutes on the four first tests and 3.7 minutes on the three first tests. Paradoxical sleep was present only during one recording. Psychostimulant treatments with MODIODAL then RITALINE both failed. At the time of reporting, the patient had not recovered. She was receiving treatment with pitolisant which enabled a good improvement of vigilance, and melatoline 2 mg for excessive sleepiness, which was inefficient. Upon medical review the company judged relevant to code the adverse event daytime sleepiness which was mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C2 S1 I1) according to the foreign method of assessment.
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