Nurminen, Marja-Leena https://orcid.org/0009-0008-4681-5180
Lindemo, Per https://orcid.org/0009-0006-9431-4319
Sundström, Anders https://orcid.org/0000-0003-2337-3371
Zethelius, Björn https://orcid.org/0000-0002-1738-0834
Larsson, Maria https://orcid.org/0009-0004-3496-8922
Attelind, Sofia https://orcid.org/0000-0002-7631-7376
Pihlström, Nicklas https://orcid.org/0000-0001-6812-0971
Ljung, Rickard https://orcid.org/0000-0002-0654-4530
Arthurson, Veronica https://orcid.org/0009-0007-6603-224X
Funding for this research was provided by:
Medical Products Agency
Article History
Accepted: 22 July 2025
First Online: 12 August 2025
Declarations
:
: Open access funding provided by Medical Products Agency. The study was conducted as a pharmacovigilance activity by the Swedish MPA, which is a Swedish Government agency. The study has received no external funding.
: Marja-Leena Nurminen, Per Lindemo, Anders Sundström, Björn Zethelius, Maria Larsson, Sofia Attelind, Nicklas Pihlström, Rickard Ljung, and Veronica Arthurson have no conflicts of interest that are directly relevant to the content of this article.
: This study was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Swedish Ethical Review Authority (2020-06859, 2021-02186).
: Not applicable.
: Not applicable.
: The data of this article are not publicly available because of the EMA’s policy of access to EudraVigilance data for medical products for human use in accordance with Regulation (EU) 2016/679, the General Data Protection Regulation and Regulation (EU) 2018/1725, and the European Union data protection legislation. For more information, see: .
: Not applicable.
: MLN drafted the manuscript and constructed the tables. NP constructed the graphs. MLN, PL, ML, and SA provided the ADR data. AS and NP accomplished the statistics on mortality and hospitalizations due to COVID-19, positive COVID-19 tests, and exposure to COVID-19 vaccines from nationwide healthcare register data. BZ administered the submission. RL and VA supervised the project. All authors reviewed, edited, and approved the final version of the manuscript.