Epidemiol Health.  2023;45(1):e2023006. 10.4178/epih.e2023006.

Self-reported adverse events after 2 doses of COVID-19 vaccine in Korea

Affiliations
  • 1Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea
  • 2Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea
  • 3Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea

Abstract


OBJECTIVES
In Korea, a national coronavirus disease 2019 (COVID-19) vaccination program was implemented, including 4 vaccines against COVID-19. A text messaging-based survey, in addition to a passive adverse event reporting system, was launched to quickly report unusual symptoms post-vaccination. This study compared the frequency of adverse events after COVID-19 vaccination based on the vaccine type and the type of 2-dose regimen (homologous or heterologous).
METHODS
Self-reported adverse events were collected through a text-message survey for 7 days after each vaccination. This study included 50,950 vaccine recipients who responded to the survey at least once. Informed consent to receive surveys via text was obtained from the vaccine recipients on the date of first vaccination.
RESULTS
The recipients of mRNA vaccines reported local and systemic reactions 1.6 times to 2.8 times more frequently after dose 2 than after dose 1 (p<0.001), whereas ChAdOx1-S recipients reported significantly fewer local and systemic reactions after dose 2 than after dose 1 (p<0.001). Local and systemic reactions were approximately 2 times and 4 times more frequent for heterologous vaccination than for BNT162b2/BNT162b2 and ChAdOx1-S/ChAdOx1-S regimens, respectively. Young individuals, female, and those receiving heterologous vaccine regimens including ChAdOx1-S/BNT162b2 vaccines reported more adverse events than older participants, male, and those with homologous vaccine regimens.
CONCLUSIONS
Although a heterologous regimen, youth, and female sex were associated with a higher risk of adverse reactions after COVID-19 vaccination, no critical issues were noted. Active consideration of heterologous schedules based on the evidence of efficacy and safety appears desirable.

Keyword

Safety; COVID-19 vaccine; Heterologous; Homologous; Prime-boost
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