Patterns of spontaneous reports on narcolepsy following administration of pandemic influenza vaccine; a case series of individual case safety reports in Eudravigilance

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Patterns of spontaneous reports on narcolepsy following administration of pandemic influenza vaccine; a case series of individual case safety reports in Eudravigilance

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作者：Kartini Gadroen ; MD^a ; ^b ; ^{k.gadroen@erasmusmc.nl" class="auth_mail" title="E-mail the corresponding author} ; Sabine M.J.M. Straus ; MD^a ; ^b ; Alexandra Pacurariu ; MSc^a ; ^b ; Daniel Weibel ; PhD^b ; Xavier Kurz ; MD^c ; Miriam C.J.M. Sturkenboom ; PhD^b
关键词：ADR ; Adverse Drug Reaction ; AESI ; Adverse Events of Special Interest ; BC ; Brighton Collaboration ; ABC-tool ; Automated Brighton Collaboration Case definition tool ; EMA ; European Medicines Agency ; EU/EEA ; European Union/European Economic Area ; HCP ; Health Care Provider ; ICSR ; Individual Case Safety Report ; PY ; Person-years
刊名：Vaccine
出版年：2016
出版时间：22 September 2016
年：2016
卷：34
期：41
页码：4892-4897
全文大小：333 K

文摘

•: Increased reporting in Eudravigilance is evident only after awareness had been raised by Finland and Sweden.
•: Most reports of narcolepsy in Eudravigilance originate from Finland and Sweden.
•: Even after de-duplication by Eudravigilance, there are many suspect duplicate case reports.
•: Almost all reports concern Pandemrix®, and most reports regard children and adolescents.
•: The case reports do not collect enough information to assess diagnostic certainty according to the Brighton Collaboration case definition.