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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a Sanofi Pasteur (MSD) (manufacturer control# 2016006758) as part of a business agreement on 01-JUL-2016. Case received from a other health professional under the CA report ref number PP2016304 on 28-Jun-2016. A 15-year-old female adolescent patient received GARDASIL, batch number unknown, Dose 1 via intramuscular route on 28-Apr-2011, GARDASIL, batch number unknown, Dose 2 via intramuscular route on 18-Jun-2011, GARDASIL, batch number NP39110, Dose 3, expiry date in April 2012 via intramuscular route on 02-Nov-2011. Other suspect products included PANDEMRIX, batch/lot number A81CA103A, Dose 1 administered via intramuscular route on 17-Dec-2009. The patient experienced narcolepsy, Catalexy and headache on an unknown date. The female patient had received one dose of PANDEMRIX (antigen batch number AFLSA093AA, adjuvant batch number: AA03A215BA). It was not known whether she had received a second dose. Both GARDASIL and PANDEMRIX were well tolerated. No excessive daytime sleepiness but headache were mentioned following each injections. The patient had a medical history of Low iron level. Additional investigations included: Infectious Mononucleosis positive n/a in Nov-2013. Thyroid Function Test normal n/a in Nov-2013. Nuclear Magnetic Resonance Imaging Brain normal n/a on 15-Apr-2014. Thyroid Function Test normal n/a in Jan-2016. Hla Marker Study positive for dqb1 and drb1 n/a on an unknown date. In 2012, as she was 15 years old, she presented with first signs of excessive daytime sleepiness, without having sleep insufficiency, no concomitant infection nor associated to mood disorder. Since 2013, she also presented with tonus decreased triggered by emotions. Diagnosis of type 1 narcolepsy was established in November 2013. No family history. Episodes of cataplexy first with low frequency but triggered by laughing became more and more frequent and pervasive: one every two other day in Feb 2015 and event night in Jan 2016 (partial or complete cataplexy). First cured with methylphenidate alone (up to 60 mg/day) then associated to ANAFRANIL (20 mg/day). This was stopped in Jan 2016 and EFFEXOR was prescribed (75 mg) as well as Modiopal. Modiopal was stopped because was not effective and WAKIX was prescribed in Jun 2016. ADEPAL (contractive pill) was used since several years. The patient''s outcome was reported as Not Recovered/Not Resolved.
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