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

J 2021

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

RIAD, Abanoub, Barbora HOCKOVÁ, Lucia KANTOROVÁ, Rastislav SLÁVIK, Lucia SPURNÁ et. al.

Basic information

Original name

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

Authors

RIAD, Abanoub (818 Egypt, guarantor, belonging to the institution), Barbora HOCKOVÁ (203 Czech Republic), Lucia KANTOROVÁ (703 Slovakia, belonging to the institution), Rastislav SLÁVIK (703 Slovakia), Lucia SPURNÁ (703 Slovakia), Adam STEBEL (703 Slovakia), Michal HAVRIĽAK (703 Slovakia) and Miloslav KLUGAR (203 Czech Republic, belonging to the institution)

Edition

Pharmaceuticals, Basel, MDPI, 2021, 1424-8247

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.215

RIV identification code

RIV/00216224:14110/21:00122210

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.3390/ph14090873

UT WoS

000701939600001

Keywords in English

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

Abstract

V originále

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.

Links

LTC20031, research and development project

Name: Towards an International Network for Evidence-based Research in Clinical Health Research in the Czech Republic

Investor: Ministry of Education, Youth and Sports of the CR, INTER-COST

MUNI/A/1608/2020, interní kód MU

Name: Prohlubování znalostí v oblasti zdravotních rizik a benefitů výživy, prostředí a životního stylu III

Investor: Masaryk University

MUNI/IGA/1068/2020, interní kód MU

Name: Methodological and practical aspects of the development of guidelines and rapid guidelines in public health (Acronym: RAPguidelines-public-health)

Investor: Masaryk University

MUNI/IGA/1543/2020, interní kód MU

Name: Evidence-based Practice of Healthcare Professionals and Students in the Czech Republic (Acronym: Evidence-Based Practice in Czechia)

Investor: Masaryk University

Citovat

RIAD, Abanoub, Barbora HOCKOVÁ, Lucia KANTOROVÁ, Rastislav SLÁVIK, Lucia SPURNÁ, Adam STEBEL, Michal HAVRIĽAK and Miloslav KLUGAR. Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia. Pharmaceuticals. Basel: MDPI, 2021, vol. 14, No 9, p. 1-24. ISSN 1424-8247. Available from: https://dx.doi.org/10.3390/ph14090873.

@article{1789157,
   author = {Riad, Abanoub and Hocková, Barbora and Kantorová, Lucia and Slávik, Rastislav and Spurná, Lucia and Stebel, Adam and Havriľak, Michal and Klugar, Miloslav},
   article_location = {Basel},
   article_number = {9},
   doi = {http://dx.doi.org/10.3390/ph14090873},
   keywords = {BNT162b2 vaccine; cross-sectional studies; COVID-19; drug-related side effects and adverse reactions; health personnel; mass vaccination; prevalence},
   language = {eng},
   issn = {1424-8247},
   journal = {Pharmaceuticals},
   title = {Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia},
   url = {https://www.mdpi.com/1424-8247/14/9/873},
   volume = {14},
   year = {2021}
}

TY  - JOUR
ID  - 1789157
AU  - Riad, Abanoub - Hocková, Barbora - Kantorová, Lucia - Slávik, Rastislav - Spurná, Lucia - Stebel, Adam - Havriľak, Michal - Klugar, Miloslav
PY  - 2021
TI  - Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia
JF  - Pharmaceuticals
VL  - 14
IS  - 9
SP  - 1-24
EP  - 1-24
PB  - MDPI
SN  - 14248247
KW  - BNT162b2 vaccine
KW  - cross-sectional studies
KW  - COVID-19
KW  - drug-related side effects and adverse reactions
KW  - health personnel
KW  - mass vaccination
KW  - prevalence
UR  - https://www.mdpi.com/1424-8247/14/9/873
N2  - 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.
ER  -

RIAD, Abanoub, Barbora HOCKOVÁ, Lucia KANTOROVÁ, Rastislav SLÁVIK, Lucia SPURNÁ, Adam STEBEL, Michal HAVRIĽAK and Miloslav KLUGAR. Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia. \textit{Pharmaceuticals}. Basel: MDPI, 2021, vol.~14, No~9, p.~1-24. ISSN~1424-8247. Available from: https://dx.doi.org/10.3390/ph14090873.

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