COVID-19 vaccine safety: Background incidence rates of anaphylaxis, myocarditis, pericarditis, Guillain-Barré Syndrome, and mortality in South Korea using a nationwide population-based cohort study

To properly assess an association between vaccines and specific adverse events requires a comparison between the observed and background rates; however, studies in South Korea are currently limited. Therefore, in this study, we estimated the background incidence of anaphylaxis, myocarditis, pericard...

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Bibliographic Details
Published in:PloS one 2024-02, Vol.19 (2), p.e0297902-e0297902
Main Authors: Jeong, Hye Su, Chun, Byung Chul
Format: Article
Language:English
Subjects:
Anaphylaxis
Biology and Life Sciences
Diagnosis
Evaluation
Guillain-Barre syndrome
Medicine and Health Sciences
Mortality
Myocarditis
People and Places
Risk factors
South Korea
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Summary:To properly assess an association between vaccines and specific adverse events requires a comparison between the observed and background rates; however, studies in South Korea are currently limited. Therefore, in this study, we estimated the background incidence of anaphylaxis, myocarditis, pericarditis, Guillain-Barré syndrome (GBS), and mortality in South Korea. A retrospective cohort study was conducted using the National Sample Cohort (NSC) data. Using NSC, the background incidence rate was estimated by dividing the number of episodes during 2009-2019 by the total population by year and then multiplying by 100,000. Using Statistics Korea data, the background mortality rate was estimated by dividing the number of deaths, during 2009-2019 by the standard population for that year and then multiplying by 100,000. Using background mortality rates, we predicted mortality rates for 2021 using autoregressive integrated moving average models. Further, the expected mortality rates were compared with observed mortality rates. The age-adjusted incidence rate (AIR) of anaphylaxis increased from 4.28 to 22.90 cases per 100,000 population (p = 0.003); myocarditis showed no significant increase, changing from 0.56 to 1.26 cases per 100,000 population (p = 0.276); pericarditis increased from 0.94 to 1.88 cases per 100,000 population (p = 0.005); and GBS increased from 0.78 to 1.21 cases per 100,000 population (p = 0.013). The age-adjusted mortality rate decreased from 645.24 to 475.70 deaths per 100,000 population (p
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0297902