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

Yuanyi Pan, Yun Han, Chuan Zhou, Lili Zhao, Jie Zheng, Xianwei Ye () and Yongqun He ()
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Yuanyi Pan: People’s Hospital of Guizhou Province
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
Yongqun He: University of Michigan Medical School

Nature Communications, 2025, vol. 16, issue 1, 1-10

Abstract: 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],

Date: 2025
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DOI: 10.1038/s41467-025-61613-4

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