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Risk of new-onset seizures following immunization against COVID-19: a self-controlled case-series study
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Hwa Yeon Ko, Dongwon Yoon, Ju Hwan Kim, Han Eol Jeong, Seung Bong Hong, Won-Chul Shin, Ju-Young Shin, on behalf of the CoVaSC Investigators
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Epidemiol Health. 2025;47:e2025024. Published online May 2, 2025
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DOI: https://doi.org/10.4178/epih.e2025024
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 Abstract
Summary
 PDF Supplementary Material
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Abstract
OBJECTIVES
Despite emerging reports of new-onset seizures (NOS) following coronavirus disease 2019 (COVID-19) vaccination, safety evidence regarding the risk of NOS after vaccination remains limited. We aimed to investigate the potential association between NOS and COVID-19 vaccination.
METHODS We conducted a self-controlled case series study utilizing a nationwide database linking the COVID-19 vaccination registry and the National Health Information Database (from February 2021 to October 2022). We identified adults (≥18 years) who received COVID-19 vaccination (BNT162b2, ChAdOx1 nCoV-19, mRNA-1273, NVX-CoV2373, or Ad26.COV2.S) and had a diagnosis of NOS accompanied by prescriptions of anti-seizure drugs. The observation period was defined as 240 days following vaccination. We evaluated the risk of NOS during a risk window of 28 days after vaccination compared to the control window (the remaining observation period excluding the risk window). Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were estimated using a conditional Poisson regression model.
RESULTS Among 42,155,198 COVID-19 vaccine recipients, we identified 1,849 and 4,217 patients with NOS in the risk and control windows, respectively. There was no increased risk of NOS within the 28-day period following vaccination (IRR, 0.99; 95% CI, 0.94 to 1.05). Although results from subgroup analyses by vaccine type were largely consistent with the main findings (IRR, 0.95; 95% CI, 0.88 to 1.03 for BNT162b2; IRR, 0.95; 95% CI, 0.77 to 1.16 for ChAdOx1 nCoV-19; IRR, 1.58; 95% CI, 0.52 to 4.83 for Ad26.COV2.S), a marginally elevated risk was observed for mRNA-1273 (IRR, 1.21; 95% CI, 1.04 to 1.42).
CONCLUSIONS There was no evidence of an increased risk of NOS following COVID-19 vaccination. These findings can be used as safety evidence in clinical decision-making and to bolster public confidence in COVID-19 vaccines.
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Summary
Korean summary
· 질병관리청 코로나19백신 접종 등록자료와 국민건강보험공단의 청구 데이터베이스 연계 자료원을 활용하여 코로나19백신 접종과 경련/발작 발생 간의 관련성에 대한 안전성 평가를 수행함.
· 자기-대조환자군 연구설계를 적용하여 4,215만 명 이상의 코로나19백신 접종자를 대상으로 분석한 결과, 대부분의 백신 종류에서 접종 후 28일 이내에 경련/발작 발생 위험이 증가하지 않았으며, mRNA-1273 백신에서만 위험이 다소 증가한 것으로 나타남.
· 전반적으로, 본 연구는 코로나19백신 접종 후 경련/발작 발생 위험이 증가하지 않음을 보여주었으며, 이는 임상적 의사결정과 백신 안전성에 대한 신뢰를 높이는 근거로 활용될 수 있음.
Key Message
· A nationwide self-controlled case series study investigated whether COVID-19 vaccination increases the risk of new-onset seizures (NOS) in adults by analyzing over 42 million vaccine recipients.
· The results showed no increased risk of NOS within 28 days after vaccination for most vaccine types, with the exception of a marginally elevated risk for the mRNA-1273 vaccine.
· Overall, the study found no evidence of increased NOS risk following COVID-19 vaccination, supporting the safety of these vaccines for clinical decision-making.
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Barriers to COVID-19 vaccine surveillance: the issue of under-reporting adverse events
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Yunha Noh, Hwa Yeon Ko, Ju Hwan Kim, Dongwon Yoon, Young June Choe, Seung-Ah Choe, Jaehun Jung, Ju-Young Shin
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Epidemiol Health. 2023;45:e2023054. Published online June 7, 2023
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DOI: https://doi.org/10.4178/epih.e2023054
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Abstract
Summary
PDFSupplementary Material
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Abstract
OBJECTIVES
This study investigated the reporting rates of adverse events following immunization (AEFIs) to the spontaneous reporting system (SRS) and its predictors among individuals with AEFIs after coronavirus disease 2019 (COVID-19) vaccination.
METHODS A cross-sectional, web-based survey was conducted from December 2, 2021 to December 20, 2021, recruiting participants >14 days after completion of a primary COVID-19 vaccination series. Reporting rates were calculated by dividing the number of participants who reported AEFIs to the SRS by the total number of participants who experienced AEFIs. We estimated adjusted odds ratios (aORs) using multivariate logistic regression to determine factors associated with spontaneous AEFIs reporting.
RESULTS Among 2,993 participants, 90.9% and 88.7% experienced AEFIs after the first and second vaccine doses, respectively (reporting rates, 11.6 and 12.7%). Furthermore, 3.3% and 4.2% suffered moderate to severe AEFIs, respectively (reporting rates, 50.5 and 50.0%). Spontaneous reporting was more prevalent in female (aOR, 1.54; 95% confidence interval [CI], 1.31 to 1.81); those with moderate to severe AEFIs (aOR, 5.47; 95% CI, 4.45 to 6.73), comorbidities (aOR, 1.31; 95% CI, 1.09 to 1.57), a history of severe allergic reactions (aOR, 2.02; 95% CI, 1.47 to 2.77); and those who had received mRNA-1273 (aOR, 1.25; 95% CI, 1.05 to 1.49) or ChAdOx1 (aOR, 1.62; 95% CI, 1.15 to 2.30) vaccines versus BNT162b2. Reporting was less likely in older individuals (aOR, 0.98; 95% CI, 0.98 to 0.99 per 1-year age increment).
CONCLUSIONS Spontaneous reporting of AEFIs after COVID-19 vaccination was associated with younger age, female sex, moderate to severe AEFIs, comorbidities, history of allergic reactions, and vaccine type. AEFIs under-reporting should be considered when delivering information to the community and in public health decision-making.
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Summary
Korean summary
본 연구는 국내 19-49세 성인을 대상으로, 코로나19 예방 백신 접종 후 이상반응 경험에 대한 자발적 보고율을 조사하고, 자발적 보고와 관련된 요인을 파악하고자 하였다. 2021년 12월 2일부터 20일까지 온라인 설문조사를 통하여 자료를 수집하였으며, 연구대상자는 코로나19 예방 백신의 기초접종을 완료한 후 2주 경과한 19-49세 성인으로, 전국 대표성을 확보하기 위해 성별, 연령, 지역별로 층화하여 모집하였다. 이상반응 자발적 보고율은 1차 접종과 2차 접종 후 각각 약 11.6%, 12.7%로 나타났으며, 중등도에서 중증의 이상반응에 대한 자발적 보고율은 약 50.5%, 50.0%로 나타났다. 이상반응 자발적 보고율 관련 영향요인으로는 젊은 연령층, 여성, 이상반응의 중증도, 동반질환, 알러지 반응 이력, 기초접종 백신 종류가 포함되었다.
Key Message
Spontaneous reporting rates of adverse events following immunization (AEFIs) against coronavirus disease 2019 (COVID-19) were low, at around 12 % of any AEFIs and 50 % of moderate-to-severe AEFIs. Younger age, female sex, severe AEFIs, comorbidities, history of allergic reactions, and the type of COVID-19 vaccine were associated with the AEFIs reporting.
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Citations
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Vaccine: X.2025; 24: 100647. CrossRef - Serious adverse drug reactions associated with anti-SARS-CoV-2 vaccines and their reporting trends in the EudraVigilance database
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Indian Journal of Obstetrics and Gynecology Research.2024; 11(1): 70. CrossRef - Cardiac adverse drug reactions to COVID-19 vaccines. A cross-sectional study based on the Europe-wide data
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European Heart Journal - Cardiovascular Pharmacotherapy.2024; 10(7): 599. CrossRef
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