Adverse reactions in young children receiving the coronavirus disease 2019 vaccine

Background: We sought to investigate the occurrence of adverse reactions in Japanese children aged 6 months to 4 years who received the BNT162b2 coronavirus disease 2019 (COVID-19) vaccine, to examine parental considerations, and to evaluate potential risk factors associated with post-vaccination fever.Methods: This cross-sectional survey study targeted 1617 children aged 6 months to 4 years who received their primary doses of BNT162b2 from November 10, 2022, to April 30, 2023, in Okayama Prefecture. We surveyed the occurrence of local and systemic reactions within 1 week after vaccination, and described the incidence proportions of adverse reactions for 515 participants overall and by age group. The study also examined the impact of previous COVID-19 infection and co-administration of the seasonal influenza vaccine on post-vaccination fever. A survey also assessed parents' reasons for vaccinating their children and the sources of information they used.Results: Adverse reactions were infrequent (5.2%, with fever >= 37.5 degrees C; no cases exceeded 39 degrees C) and did not increase with vaccine doses administered. The risk of post-vaccination fever was not statistically associated with a history of COVID-19-the adjusted risk ratio (aRR) was 0.99, and the 95% confidence interval (CI) was 0.41-2.39-but was associated with co-administration of the seasonal influenza vaccine (aRR 3.24, 95% CI 1.14-9.18). Parental decisions regarding vaccination were influenced by official government guidelines and primary care physicians' opinion.Conclusion: This study provides valuable insight into the safety profile of the BNT162b2 vaccine in Japanese children aged 6 months to 4 years. Further research involving larger cohorts and appropriate control groups is needed.