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Social Medicine

Dynamics and sources of adverse drug reaction reports related to COVID-19 vaccines in Bulgaria

Bogdan Kirilov, Lydmil Antonov, Evgeni Grigorov

Abstract

Objective: To track and analyze the dynamics of adverse drug reaction reports of authorized COVID-19 vaccines in the database of the national competent authority in Bulgaria – Bulgarian Drug Agency (BDA) and to identify the sources of ADR in our country during the considered time period.

Material and methods: For the analysis of ADR reports, the specialized database of the national competent authority in Bulgaria was used, containing information on all reported adverse drug reactions for the period 01.01.2018 - 31.03.2022.

Results and conclusions: The first report of an ADR with a suspected connection to a vaccine against COVID-19 (with the trade name Comirnaty) was received in the BDA on 27.12.2020, on the first day of the start of the vaccination process in Bulgaria and the EU.

The number of ADRs reported after SARS-CoV-2 immunization in the period of the study was about 2.3 times greater than the number of ADRs reported after taking any other drugs. Patients showed a higher activity in reporting ADRs for the studied period (90% of all reports were submitted by patients), which is significantly higher than previous periods. The increase in the number of ADR reports is not smooth, but 3 peaks are emerging: in the months of February, July and November of 2021.

Keywords

dynamics, reports, adverse drug reactions, COVID-19 vaccines, Bulgaria

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DOI: http://dx.doi.org/10.14748/sm.v0i0.8749

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