Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia

Abstract

mRNA-based COVID-19 vaccines such as BNT162b2 have recently been a target of anti-vaccination campaigns due to their novelty in the healthcare industry; nevertheless, these vaccines have exhibited excellent results in terms of efficacy and safety. As a consequence, they acquired the first approvals from drug regulators and were deployed at a large scale among priority groups, including healthcare workers. This phase IV study was designed as a nationwide cross-sectional survey to evaluate the post-vaccination side effects among healthcare workers in Slovakia. The study used a validated self-administered questionnaire that inquired about participants' demographic information, medical anamneses, COVID-19-related anamnesis, and local, systemic, oral, and skin-related side effects following receiving the BNT162b2 vaccine. A total of 522 participants were included in this study, of whom 77% were females, 55.7% were aged between 31 and 54 years, and 41.6% were from Banska Bystrica. Most of the participants (91.6%) reported at least one side effect. Injection site pain (85.2%) was the most common local side effect, while fatigue (54.2%), headache (34.3%), muscle pain (28.4%), and chills (26.4%) were the most common systemic side effects. The reported side effects were of a mild nature (99.6%) that did not require medical attention and a short duration, as most of them (90.4%) were resolved within three days. Females and young adults were more likely to report post-vaccination side effects; such a finding is also consistent with what was previously reported by other phase IV studies worldwide. The role of chronic illnesses and medical treatments in post-vaccination side effect incidence and intensity requires further robust investigation among large population groups.

Keywords: BNT162b2 vaccine; COVID-19; cross-sectional studies; drug-related side effects and adverse reactions; health personnel; mass vaccination; prevalence.

Figure 1

Geographic distribution of participating Slovak healthcare workers, February–March 2021 (n = 522).

Figure 2

Side effects experienced by Slovak healthcare workers who received BNT162b2 and stratified by gender, February–March 2021 (n = 522). * Significance level < 0.05.

Figure 3

Side effects experienced by Slovak healthcare workers who received BNT162b2 and stratified by age group, February–March 2021 (n = 522). * Significance level < 0.05.

Figure 4

Sample size of the Slovak healthcare workers: Epi Info^TM version 7.2.4. Population Size: According to the latest report of the National Health Information Centre (NHIC), there were 83,859 healthcare workers in Slovakia by 2019 [33]. Expected Frequency: The overall prevalence of side effects following COVID-19 vaccines ranged between 62% and 93% [19,67,68,69]. Acceptable Error Margin: 5% was assumed permissible because the expected frequency ranged between 10% and 90% [70]. Design Effect: 1–per the recommendation of the CDC for simple sampling [71]. Clusters: 1–per the recommendation of the CDC for simple sampling [71].