Ko Hwa Yeon, Yoon Dongwon, Kim Ju Hwan, Jeong Han Eol, Hong Seung Bong, Shin Won-Chul, Shin Ju-Young
School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.
Epidemiol Health. 2025;47:e2025024. doi: 10.4178/epih.e2025024. Epub 2025 May 2.
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.
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.
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).
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.
尽管有新出现的关于2019冠状病毒病（COVID-19）疫苗接种后新发癫痫（NOS）的报道，但关于接种疫苗后发生NOS风险的安全性证据仍然有限。我们旨在调查NOS与COVID-19疫苗接种之间的潜在关联。
我们利用一个将COVID-19疫苗接种登记册与国家健康信息数据库相链接的全国性数据库（2021年2月至2022年10月）进行了一项自我对照病例系列研究。我们确定了接种COVID-19疫苗（BNT162b2、ChAdOx1 nCoV-19、mRNA-1273、NVX-CoV2373或Ad26.COV2.S）且被诊断为NOS并伴有抗癫痫药物处方的成年人（≥18岁）。观察期定义为接种疫苗后的240天。我们评估了接种疫苗后28天风险期内发生NOS的风险，并与对照期（排除风险期后的剩余观察期）进行比较。使用条件泊松回归模型估计发病率比（IRR）及其95%置信区间（CI）。
在42,155,198名COVID-19疫苗接种者中，我们在风险期和对照期分别确定了1,849例和4,217例NOS患者。接种疫苗后28天内发生NOS的风险没有增加（IRR，0.99；95%CI，0.94至1.05）。尽管按疫苗类型进行的亚组分析结果与主要发现基本一致（BNT162b2的IRR，0.95；95%CI，0.88至1.03；ChAdOx1 nCoV-19的IRR，0.95；95%CI，0.77至1.16；Ad26.COV2.S的IRR，1.58；95%CI，0.52至4.83），但观察到mRNA-1273的风险略有升高（IRR，1.21；95%CI，1.04至1.42）。
没有证据表明COVID-19疫苗接种后发生NOS的风险增加。这些发现可作为临床决策中的安全性证据，并增强公众对COVID-19疫苗的信心。
