COVID-19 vaccine safety profile in Republic of Korea, February 26, 2021 through April 30, 2022

As of June, 2022, five coronavirus disease 2019 (COVID-19) vaccine brands were used for the national immunization program. The Korea Diseases Control and Prevention Agency has enhanced vaccine safety monitoring through a passive, web-based reporting system and active, text message-based mornitoring. This study described the enhanced safety monitoring system of COVID-19 vaccines, and analyzed the frequencies and types of AEs among five brands of COVID-19 vaccines. AEs reports through the web-based Adverse Events Reporting System in COVID-19 Vaccination Management System and the text message-based among recipients were analyzed. AEs were classified as non-serious AEs and serious AEs (e.g., death and anaphylaxis). AEs were classified as non-serious AEs and serious AEs (e.g., death and anaphylaxis). AE reporting rates were calculated based on the number of COVID-19 vaccine dose administered. A total of 125,107,883 doses were administered in Korea from February 26, 2021 to June 4, 2022. Among them, a total of 471,068 AEs reported, of which 96.1% were non-serious AEs and 3.9% were serious AEs. Among the 72,609 participants in the text message-based AE monitoring, a higher AE rate was reported in the 3rd dose compare to primary doses in both local and systemic reactions. A total of 874 cases of anaphylaxis (7.0 per 1,000,000 doses), four cases of TTS, 511 cases of myocarditis (4.1 per 1,000,000 doses) and 210 cases of pericarditis (1.7 per 1,000,000 doses) were confirmed. A total of seven fatal cases were associated with COVID-19 vaccination (1 TTS case and 5 myocarditis cases). Young adult and female sex were related with a higher reported rate of AEs with COVID-19 vaccines, most of the reported AEs of COVID-19 vaccines was non-serious AEs of mild intensity.