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Evaluating the safety of XBB.1.5-containing COVID-19 mRNA vaccines using a self-controlled case series study

Author

Listed:
  • Yuanyi Pan

    (People’s Hospital of Guizhou Province
    University of Michigan Medical School
    Guizhou University Medical College)

  • Yun Han

    (Medical School)

  • Chuan Zhou

    (Medical School)

  • Lili Zhao

    (Northwestern University)

  • Jie Zheng

    (University of Michigan Medical School)

  • Xianwei Ye

    (Guizhou University Medical College
    People’s Hospital of Guizhou Province)

  • Yongqun He

    (University of Michigan Medical School
    University of Michigan Medical School
    University of Michigan Medical School)

Abstract

The safety of XBB.1.5-containing COVID-19 mRNA vaccines warrants investigation. We assessed the relative risk of 15 adverse events following the XBB.1.5 vaccination using a self-controlled case series study design with data from the National COVID Cohort Collaborative (N3C) from September 11, 2023, to June 1, 2024 in the USA. Based on a baseline population of 244,494 patients, adverse events included Guillain-Barré syndrome, seizure, non-hemorrhagic stroke and transient ischemic attack, hemorrhagic stroke, narcolepsy or cataplexy, anaphylaxis, acute myocardial infarction, myo/pericarditis, coagulopathy, multisystem inflammatory syndrome, Bell’s palsy, transverse myelitis, appendicitis, pulmonary embolism, and encephalitis. We found an association between vaccination and anaphylaxis (IRR [95% CI]: day 0–17.35 [9.32–30.03], day 1–9.35 [5.12–15.95], day 2–6.20 [3.40–10.57],

Suggested Citation

  • Yuanyi Pan & Yun Han & Chuan Zhou & Lili Zhao & Jie Zheng & Xianwei Ye & Yongqun He, 2025. "Evaluating the safety of XBB.1.5-containing COVID-19 mRNA vaccines using a self-controlled case series study," Nature Communications, Nature, vol. 16(1), pages 1-10, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-61613-4
    DOI: 10.1038/s41467-025-61613-4
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    1. Samantha Ip & Teri-Louise North & Fatemeh Torabi & Yangfan Li & Hoda Abbasizanjani & Ashley Akbari & Elsie Horne & Rachel Denholm & Spencer Keene & Spiros Denaxas & Amitava Banerjee & Kamlesh Khunti &, 2024. "Cohort study of cardiovascular safety of different COVID-19 vaccination doses among 46 million adults in England," Nature Communications, Nature, vol. 15(1), pages 1-12, December.
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