Konishi Ayako, Fukushima Wakaba, Matsuura Tomoka, Ohfuji Satoko, Kase Tetsuo, Kondo Kyoko, Matsumoto Kazuhiro, Suita Asae, Mukai Emiko, Kasamatsu Ayane, Kido Yasutoshi, Nakagama Yu, Nitahara Yuko, Kaneko Yukihiro, Kaneko Akira, Nakagami-Yamaguchi Etsuko, Kakeya Hiroshi, Hirota Yoshio
Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan.
Department of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Hum Vaccin Immunother. 2025 Dec;21(1):2518646. doi: 10.1080/21645515.2025.2518646. Epub 2025 Jun 24.
A clear consensus on the factors contributing to adverse reactions following the mRNA COVID-19 vaccine has yet to be reached. Therefore, the present study investigated adverse reactions following the first three doses of the BNT162b2 mRNA COVID-19 vaccine and examined associated factors, including previous experience of adverse reactions. Two prospective cohort studies were integrated for this study, and 218 participants (79% female; median age 46.5 years) who had completed all three doses of BNT162b2 were included in the final analyses. Data were collected through self-administered electronic questionnaires. Local and systemic adverse reactions following vaccinations were classified with severity grading. Modified Poisson regression models were used to examine the association of adverse reactions. Local reactions were reported by 91-96% of participants, with moderate or severe local reactions in 27-43%. Systemic reactions were reported by 56-88% of participants, with moderate or severe systemic reactions in 19-56%. Participants with a history of moderate or severe local reactions were more likely to subsequently have moderate or severe local reactions (relative risk: 2.32 [95% confidence interval: 1.52-3.55] for the second dose, 1.89 [1.33-2.69] for the third dose), but not systemic reactions. Participants with a history of moderate or severe systemic reactions were more likely to subsequently have moderate or severe systemic reactions (1.31 [0.99-1.72] for the second dose, 2.18 [1.56-3.06] for the third dose), but not local reactions. These results may contribute to a more detailed understanding of mRNA COVID-19 vaccines and provide information for future vaccine development.
对于导致新冠mRNA疫苗接种后出现不良反应的因素，目前尚未达成明确共识。因此，本研究调查了BNT162b2新冠mRNA疫苗前三剂接种后的不良反应，并研究了相关因素，包括既往不良反应史。本研究整合了两项前瞻性队列研究，最终分析纳入了218名完成全部三剂BNT162b2疫苗接种的参与者（79%为女性；中位年龄46.5岁）。通过自行填写的电子问卷收集数据。根据严重程度对接种后的局部和全身不良反应进行分类。使用修正泊松回归模型研究不良反应的相关性。91%-96%的参与者报告了局部反应，其中27%-43%为中度或重度局部反应。56%-88%的参与者报告了全身反应，其中19%-56%为中度或重度全身反应。有中度或重度局部反应史的参与者随后更有可能出现中度或重度局部反应（第二剂的相对风险：2.32[95%置信区间：1.52-3.55]，第三剂为1.89[1.33-2.69]），但全身反应并非如此。有中度或重度全身反应史的参与者随后更有可能出现中度或重度全身反应（第二剂为1.31[0.99-1.72]，第三剂为2.18[1.56-3.06]），但局部反应并非如此。这些结果可能有助于更详细地了解新冠mRNA疫苗，并为未来疫苗研发提供信息。
