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...

Tick-borne encephalitis is a vector-borne zoonotic disease with more than 12,000 annual clinical reported cases globally (WHO, 2021). Tick-borne encephalitis is caused by the flavivirus and transferred by Ixodes ricinus from roe deer to human and affects the central Nervous system. Climate change also increases tick-borne encephalitis incidences in Sweden and fluctuated considerably from year to year. A quantitative study design with secondary data was conducted to analyze the spatial and temporal pattern of Tick-borne encephalitis in Sweden from 1986-2020. The distribution of Tick-borne encephalitis within age and sex, along with other factors were also analyzed. The results showed that Tick-borne encephalitis with passing each year spread across the country. Male and age group, 50-59, have more incidence of Tick-borne encephalitis. Incidents were associated with climate conditions such as temperature and precipitation, which provided a favorable environment for Ixodes ricinus for its lifecycle activities, host searching, and disease transmission. Roe deer population, other vertebrates abundance, vaccination, population interest, economy, and land change are the critical factors that facilitate the disease incidence or control. People who visit forests for hunting, trekking, leisure, and professional activities without proper immunity and preventive measures are at risk to infect with Tick-borne encephalitis. The theory One health approach showed suitable performance for the control of this vulnerable climate zoonotic disease.

The thesis is devoted to the issue of vaccination problematics and awareness of tick-borne encephalitis in a selected population group in South Bohemia. For the needs of research, the selected group was composed of students of secondary schools and grammar schools in the South Bohemian Region in the age group from 13 to 19 years old. The objectives of this work was to analyze the incidence of tick-borne encephalitis in the Czech Republic and the South Bohemian Region between 2000 and 2015, to compare the vaccination in the Czech Republic with the other European countries, to find the vaccination of a selected age group in the South Bohemian Region and to analyze the level of awareness of the risks of tick-borne encephalitis by the polling method and the attitude of the age group to vaccination against this disease. To achieve the objectives was used a secondary analysis of the data from the EpiDat system, where the incidence of the disease was detected in the period in the South Bohemian Region and the Czech Republic. The questionnaire survey was used to obtain awareness on observed disease and attitude of the study group towards vaccination against tick-borne encephalitis. The conclusions of the questionnaire survey were obtained on the basis of statistical processing in the MS Excel spreadsheet. For my significant findings from my research, I consider 80% of the vaccination in the monitored group. Information on tick-borne encephalitis in most cases did not get the respondents from a doctor, but from family members, from the internet or from television. However, information on vaccination is given to respondents to a greater extent. Contributions by insurance companies do not motivate more than half of respondents to inoculation. Research has also shown, that respondents have insufficient information about the amount of the contribution and whether their insurance company provide the contribution at all. In view of these circumstances, I consider the increased promotion of this vaccination by insurance companies to be very desirable.