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<p>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], &lt;20 patients in each risk period). No other outcomes showed significantly increased risk following vaccination. Our results contribute to the safety profile evaluation for XBB.1.5-containing COVID-19 mRNA vaccines utilizing N3C big data.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年7月15日

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  • Yuanyi Pan,
  • Yun Han,
  • Chuan Zhou,
  • Lili Zhao,
  • Jie Zheng,
  • Xianwei Ye,
  • Yongqun He,
  • Christopher G. Chute

摘要

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], <20 patients in each risk period). No other outcomes showed significantly increased risk following vaccination. Our results contribute to the safety profile evaluation for XBB.1.5-containing COVID-19 mRNA vaccines utilizing N3C big data.