COVID-19 Vaccine Safety Research Center, Seoul, Korea.
Department of Preventive Medicine, College of Medicine, Graduate Program in System Health Science & Engineering, Ewha Womans University, Seoul, Korea.
J Korean Med Sci. 2024 Nov 4;39(42):e274. doi: 10.3346/jkms.2024.39.e274.
Despite their effectiveness, coronavirus disease 2019 (COVID-19) vaccines have been associated with adverse effects, underscoring the importance of continuous surveillance to ensure vaccine safety and effective management of public health. Herein, the characteristics and risk factors of vaccine-related adverse events (AEs) were identified to gain an in-depth understanding of vaccine safety by investigating the impact of the vaccination dose on changes in post-vaccination AEs.
Herein, a linked database of COVID-19 vaccination records from the Korea Disease Control and Prevention Agency, AE reports from the COVID-19 Vaccination Management System, and healthcare claims from the National Health Insurance Service, targeting ≥ 5-year-old individuals, was utilized (study duration = February 26, 2021, to January 31, 2023). The frequency and severity of reported post-vaccination AEs were evaluated. Furthermore, we specifically explored AEs in relation to the cumulative dosage of vaccines administered while evaluating associated risk factors.
During the observation period, 42,804,523 individuals completed the COVID-19 vaccination series, with 365,900 reporting AEs, with headache, muscle pain, and fever being the most frequently reported. Notably, the AE reports were approximately twice as high for women than for men, which was further exacerbated following both doses. Analysis by age group revealed that AE reports were lower among children, adolescents, and older adults than in the middle-aged cohort (age = 50-64 years), with higher reports observed for 18-49-year-old individuals. Additionally, a higher risk of reporting was identified among individuals with lower socioeconomic status compared with those of middle socioeconomic status. Excluding dementia, the risk of reporting AEs was high in individuals with underlying diseases compared with those without, for instance, the risk of reporting AEs following two-dose vaccinations was approximately twice as high in individuals with chronic obstructive pulmonary disease and asthma.
These findings indicate that women, younger people, those with a lower socioeconomic status, and those with underlying health conditions reported a higher incidence of AEs following COVID-19 vaccinations. This emphasizes the need for continued monitoring to ensure safe vaccination and address vaccine-related anxiety and fear, especially within the aforementioned groups.
尽管新冠病毒病 2019（COVID-19）疫苗具有有效性，但它们与不良反应相关，这突显了持续监测以确保疫苗安全性和有效管理公共卫生的重要性。在此，通过研究接种剂量对疫苗接种后不良反应变化的影响，确定疫苗相关不良事件（AE）的特征和危险因素，以深入了解疫苗安全性。
本研究利用了韩国疾病控制和预防机构的 COVID-19 疫苗接种记录的链接数据库、COVID-19 疫苗接种管理系统的 AE 报告以及国家健康保险服务的医疗保健索赔，针对≥5 岁的个体（研究期间=2021 年 2 月 26 日至 2023 年 1 月 31 日）。评估了报告的疫苗接种后不良反应的频率和严重程度。此外，我们还专门探讨了与疫苗接种累积剂量相关的不良反应，并评估了相关危险因素。
在观察期间，42804523 人完成了 COVID-19 疫苗接种系列，其中 365900 人报告了 AE，头痛、肌肉疼痛和发热是最常报告的。值得注意的是，女性的 AE 报告几乎是男性的两倍，而且在接种两剂后进一步增加。按年龄组分析显示，儿童、青少年和老年人的 AE 报告低于中年组（年龄=50-64 岁），18-49 岁人群的报告更高。此外，与中社会经济地位的人相比，社会经济地位较低的人报告 AE 的风险更高。排除痴呆症后，与没有基础疾病的人相比，有基础疾病的人报告 AE 的风险更高，例如，患有慢性阻塞性肺疾病和哮喘的人接种两剂疫苗后报告 AE 的风险约为两倍。
这些发现表明，女性、年轻人、社会经济地位较低的人以及有基础疾病的人接种 COVID-19 疫苗后报告 AE 的发生率更高。这强调了需要持续监测以确保安全接种疫苗，并解决疫苗相关的焦虑和恐惧，特别是在上述人群中。
