Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions
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 p...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2518646 |
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| author | Ayako Konishi Wakaba Fukushima Tomoka Matsuura Satoko Ohfuji Tetsuo Kase Kyoko Kondo Kazuhiro Matsumoto Asae Suita Emiko Mukai Ayane Kasamatsu Yasutoshi Kido Yu Nakagama Yuko Nitahara Yukihiro Kaneko Akira Kaneko Etsuko Nakagami-Yamaguchi Hiroshi Kakeya Yoshio Hirota |
| author_facet | Ayako Konishi Wakaba Fukushima Tomoka Matsuura Satoko Ohfuji Tetsuo Kase Kyoko Kondo Kazuhiro Matsumoto Asae Suita Emiko Mukai Ayane Kasamatsu Yasutoshi Kido Yu Nakagama Yuko Nitahara Yukihiro Kaneko Akira Kaneko Etsuko Nakagami-Yamaguchi Hiroshi Kakeya Yoshio Hirota |
| author_sort | Ayako Konishi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-2dde8e2511eb41c49e17ead228d595a7 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-2dde8e2511eb41c49e17ead228d595a72025-08-20T03:24:07ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2518646Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactionsAyako Konishi0Wakaba Fukushima1Tomoka Matsuura2Satoko Ohfuji3Tetsuo Kase4Kyoko Kondo5Kazuhiro Matsumoto6Asae Suita7Emiko Mukai8Ayane Kasamatsu9Yasutoshi Kido10Yu Nakagama11Yuko Nitahara12Yukihiro Kaneko13Akira Kaneko14Etsuko Nakagami-Yamaguchi15Hiroshi Kakeya16Yoshio Hirota17Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, JapanDepartment of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanOMU Core Facilities Life Sciences Section, Osaka Metropolitan University, Osaka, JapanDepartment of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Public Health, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Public Health, Osaka City University Graduate School of Medicine, Osaka, JapanResearch Center for Infectious Disease Sciences, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanResearch Center for Infectious Disease Sciences, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Virology and Parasitology, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanResearch Center for Infectious Disease Sciences, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanResearch Center for Infectious Disease Sciences, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Medical Quality and Safety Science, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanResearch Center for Infectious Disease Sciences, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanClinical Epidemiology Research Center, SOUSEIKAI Medical Group (Medical Co., LTA), Fukuoka, JapanA 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.https://www.tandfonline.com/doi/10.1080/21645515.2025.2518646SARS-CoV-2mRNACOVID-19 vaccineBNT162b2adverse reactionsadverse effectsvaccine safety |
| spellingShingle | Ayako Konishi Wakaba Fukushima Tomoka Matsuura Satoko Ohfuji Tetsuo Kase Kyoko Kondo Kazuhiro Matsumoto Asae Suita Emiko Mukai Ayane Kasamatsu Yasutoshi Kido Yu Nakagama Yuko Nitahara Yukihiro Kaneko Akira Kaneko Etsuko Nakagami-Yamaguchi Hiroshi Kakeya Yoshio Hirota Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions Human Vaccines & Immunotherapeutics SARS-CoV-2 mRNACOVID-19 vaccine BNT162b2 adverse reactions adverse effects vaccine safety |
| title | Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions |
| title_full | Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions |
| title_fullStr | Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions |
| title_full_unstemmed | Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions |
| title_short | Adverse reactions following first three doses of the BNT162b2 mRNA COVID-19 vaccine: A prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions |
| title_sort | adverse reactions following first three doses of the bnt162b2 mrna covid 19 vaccine a prospective cohort study on relationships with individual characteristics and previous experience of adverse reactions |
| topic | SARS-CoV-2 mRNACOVID-19 vaccine BNT162b2 adverse reactions adverse effects vaccine safety |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2518646 |
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