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Analysis of Spontaneous Adverse Events Reports after Tick-borne Encephalitis Vaccine
Brázdová, Tereza ; Zimčíková, Eva (advisor) ; Rejmanová, Anna (referee)
Analysis of Spontaneous Adverse Events Reports after Tick-Borne Encephalitis Vaccine Author: Tereza Brázdová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Consultant: PharmDr. Kateřina Malá, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction and aim: Tick-borne meningoencephalitis is one of the most frequent causes of viral meningitis in Europe. In recent years, the number of cases of this infection in the Czech Republic has begun to rise. Vaccination is the only reliable protection against infection, but it also comes with some risks. Analysis of spontaneous adverse reaction reports is a key source of information for signal detection, which is used to identify drug risks. The aim of this thesis was to analyse the spontaneous reporting of suspected adverse drug reactions (ADRs), using the data from the Central Database of ADRs provided by the State Institute for Drug Control. Methodology: Descriptive statistics were performed from reporting data in the period from June 2004 to October 2017. For example, the total number of reports, the number of ADRs and the patient characteristics were analysed. We compared the adverse reactions with the Vigibase database and evaluated the expectability of reported reactions. Results: During the...
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