Evidence map›Paper›PMID 40664645›Full record

ArticleNature communications2025

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, Yongqun He, N3C Consortium

Abstract read
In one paragraph

Article in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Observational
  2. Review
  3. Review
  4. Article
  5. Next-Generation Allergen-Specific Immunotherapy for Food Allergy.Clinical reviews in allergy & immunology · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yuanyi PanDepartment of Radiology, People's Hospital of Guizhou Province, Guiyang, Guizhou Province, China.ORCID http://orcid.org/0000-0002-0595-4335
Yun HanDepartment of Internal Medicine, Division of Nephrology, University of Michigan, Medical School, Ann Arbor, MI, USA.
Chuan ZhouDepartment of Radiology, University of Michigan, Medical School, Ann Arbor, MI, USA.
Lili ZhaoDepartment of Preventive Medicine (Biostatistics Division), Northwestern University, Evanston, IL, USA.ORCID http://orcid.org/0000-0002-6366-8206
Jie ZhengUnit for Laboratory Animal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.ORCID http://orcid.org/0000-0002-2999-0103
Xianwei YeGuizhou University Medical College, Guiyang, Guizhou Province, China. yxw1205@163.com.
Yongqun HeUnit for Laboratory Animal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA. yongqunh@med.umich.edu.ORCID http://orcid.org/0000-0001-9189-9661
N3C Consortium

Funding

CD2H - The National COVID Cohort Collaborative (N3C) IDeA CTR CollaborationU24TR002306 · NCATS · UNIVERSITY OF COLORADO DENVER · PI CHUTE, CHRISTOPHER G, EICHMANN, DAVID A. · 2017 to 2021
$28.9M
VIOLIN 2.0: Vaccine Information and Ontology LInked kNowledgebaseU24AI171008 · NIAID · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Yongqun He, Junguk Hur · 2022 to 2026
$4.2M
Incorporation of multilevel ontologies of adverse events and vaccines for vaccine safety surveillanceR01AI158543 · NIAID · WILLIAM BEAUMONT HOSPITAL RESEARCH INST · PI ZHAO, LILI · 2021 to 2025
$1.8M
Chinese Academy of Medical Sciences (CAMS) 2019PT320003Division of Intramural Research, National Institute of Allergy and Infectious Diseases (Division of Intramural Research of the NIAID) R01AI158543Foundation for the National Institutes of Health (Foundation for the National Institutes of Health, Inc.) U24AI171008National Natural Science Foundation of China (National Science Foundation of China) No. 82460015NCATS NIH HHS U24 TR002306NIAID NIH HHS R01 AI158543NIAID NIH HHS U24 AI171008U.S. Department of Health & Human Services | Centers for Disease Control and Prevention (CDC) NU58DP006956U.S. Department of Health & Human Services | NIH | National Institute of Allergy and Infectious Diseases (NIAID) R01AI158543
6 · The paper itself

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], <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.

Indexed as

COVID-19COVID-19 VaccinesSARS-CoV-2AdolescentAdultAgedAged, 80 and overAnaphylaxisChildFemaleHumansMaleMiddle AgedmRNA VaccinesUnited StatesVaccinationCOVID-19 VaccinesmRNA VaccinesVaccines, Synthetic

Identifiers

PMID40664645
PMCPMC12264068

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.