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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from the Health Authorities on 08-JUN-2011 under the reference number: PP20110180. Case medically confirmed. A 15 year old female patient had received a dose of yellow fever virus vaccine on 07-DEC-2006, the first dose of GARDASIL (lot and batch number not reported) on 03-SEP-2009 and the second dose of GARDASIL (lot and batch number not reported) on 09-FEB-2010. On 15-DEC-2009, the patient received a dose of PANDEMRIX (batch number A81CA257A), and on 12-JUL-2010, she received the third dose of GARDASIL (lot and batch number not reported). In January 2009 as the patient was going to another country for 3 months, she was found to have difficulty in getting asleep from the first night on, in a context of seromucous otitis. Then she woke up at night every two hours. These insomnias persisted for almost two years. In June 2010, the patient developed somnolence at the end of the school academic year. In September 2010, when the patient went back to school, she started to fight in classroom not to get asleep and to have extended naps on Wednesdays afternoons - i.e. during two hours - from which she woke up confused. In December 2010, the hypersomnolence clearly increased, associated with frank concentration disorders in classroom, with her mind going blank, getting asleep once during an exam, and getting asleep once or twice a day in classroom, in the beginning and end of day. The patient experienced excessive somnolence during the whole academic year 2009-2010, with her mind going blank and difficulty to get up in the morning. At the time of reporting, the following symptoms were present: significant diurnal somnolence with an Epworth scale at 16/24 without medication and 15/24 with 300 mg of MODIODAL, need of 2 to 3 naps a day with medication, one with medication. The patient had short and restful naps - rares hypnagogic hallucinations: auditory (first name, alarm clock), sensation of a presence (somebody coming into her room), sensation of a body sleeping next to her or of a tee-shirt on her body - sleep paralysis: only one episode at three times during the night, in a context of fatigue - cataplexies: the patient experienced weakness sometimes when laughing, as well as one atypical knee giving away. There was no fall - dyssomnia: initially the patient presented with sleep disorder and did not get asleep before 2 am, associated with phases of two hours of sleep interrupted by long awakening, and sensation of excessive sleepiness in the morning. Since the patient had been taking MODIODAL, she had more continuous sleeps with easier awakenings. Dysexecutive disorders: attention disorders. It bothered her in the acquisition of a new and more complex strategy, the patient worked in an automatic way. On a biological level, genotyping was DRB1 07, DQB1 03 on one of the genes and DRB1 13, DQB1 06 on the other. A brain magnetic resonance imaging (MRI) was performed and was normal. Biological work-up performed on 26-JAN-2011 [Due to memory limitations, the remainder of this text could not be compared.] AN-2011 was normal. To be noted that the patient was allergic to cat hair. There was no familial history of narcolepsy. She had experienced several traumas in 2010 (knee, coccyx, finger). At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccinations with PANDEMRIX as doubtful (C1 S2 11) according to the method of assessment. Additional information received on 14-JUN-2011: A sleep night study was performed in another ward and resulted in normal hypnogram (no further information was available). The patient''s night sleep was correct but during the 4 sleep latency tests she felt asleep in 3 minutes on average and paradoxical sleep cycles were observed 3 times. This was characteristic of narcolepsy. Cataplexy started in February 2011. At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccinations with PANDEMRIX as doubtful (C1 S2 11) according to the method of assessment. Narcolepsy and cataplexy were considered to be disabling. Other business partner number included: E2011-03559. No further information is available.
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