Vaccine safety for COVID-19 prevention

Abstract

BACKGROUND: In 2021, the Uppsala Monitoring Center of the World Health Organization included 52 vaccines for coronavirus disease-2019 (COVID-19) prevention in the international database, VigiBase, and almost immediately, this group of medicines (drugs) took the lead in the increased rate of reported adverse reactions (ARs).

AIM: This study aimed to review the case reports of ARs from COVID-19 vaccines in the VigiBase database.

MATERIALS AND METHODS: Statistical analysis of cases that describe ARs in the international pharmacovigilance VigiBase database was performed.

RESULTS: On May 12, 2021, the VigiBase database included 26,099,906 reports that describe AR cases on drugs, including 585,744 reports of AR on vaccines for COVID-19 prevention. Serious ARs after immunization with these vaccines were registered in 31.5% of reports, including 0.9% fatal and 1.3% life-threatening. Headache (37.1% of reports), pyrexia (31.1%), chills (23.2%), and fatigue (22.7%) were most frequently recorded.

CONCLUSIONS: More data are required to confirm the association between the COVID-19 vaccines and the increased risk of ARs following their use.

Keywords

vaccine / COVID-19 / adverse reactions / safety / VigiBase

References

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