{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T13:20:51Z","timestamp":1781788851600,"version":"3.54.5"},"reference-count":46,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2017,8,14]],"date-time":"2017-08-14T00:00:00Z","timestamp":1502668800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>We aimed at investigating whether, in Germany, the number of individual case safety reports (ICSR) of confirmed narcolepsy following Pandemrix\u00ae vaccination notified to the Paul\u2010Ehrlich\u2010Institut (PEI, German Federal Institute for Vaccines and Biomedicines) was higher than expected when compared with the prepandemic background incidence rates.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ICSR of narcolepsy after vaccination with Pandemrix\u00ae notified to the PEI until September 2016 were reviewed and validated according to the criteria of narcolepsy defined by the Brighton Collaboration (BC). Cases fulfilling the criteria of BC levels of diagnostic certainty 1 to 4a with symptoms onset after vaccination with Pandemrix\u00ae were eligible. Adjustment for underreporting was performed with cases of narcolepsy recruited within the scope of the German Narcolepsy Study using capture\u2010recapture methods. An observed versus expected (OvE) analysis was conducted based on adjusted case numbers using risk windows for symptoms onset within 4 and 6\u00a0months following vaccination.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>By the end of September 2016, a total of 85 ICSR of narcolepsy after vaccination with Pandemrix\u00ae had been notified to the PEI 52 of which were eligible. The OvE estimates for the 4 and 6\u00a0months risk windows were 3.8 (95% CI: 2.6\u20135.4) and 2.8 (95% CI: 2.0\u20133.9), respectively. The number of excess cases was higher in children and adolescents (15\u2010fold and 11.7\u2010fold increased OvE estimate) than in adults (2.1\u2010fold and 1.5\u2010fold increased estimate).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Compared with the prepandemic background incidence rate, the number of incident narcolepsy cases was 3.8\u2010fold and 2.8\u2010fold as high.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4292","type":"journal-article","created":{"date-parts":[[2017,8,15]],"date-time":"2017-08-15T01:26:41Z","timestamp":1502760401000},"page":"1321-1327","source":"Crossref","is-referenced-by-count":3,"title":["Spontaneous reporting of suspected narcolepsy after vaccination against pandemic influenza A (H1N1) in Germany"],"prefix":"10.1002","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4279-629X","authenticated-orcid":false,"given":"Doris","family":"Oberle","sequence":"first","affiliation":[{"name":"Department Safety of 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