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

Publication date: Jul 15, 2025

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-BarrcE9 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],

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Concepts Keywords
June Adolescent
Myelitis Adult
Vaccines Aged
Aged, 80 and over
Anaphylaxis
Child
COVID-19
COVID-19 Vaccines
COVID-19 Vaccines
Female
Humans
Male
Middle Aged
mRNA Vaccines
mRNA Vaccines
SARS-CoV-2
United States
Vaccination
Vaccines, Synthetic
Vaccines, Synthetic
Young Adult

Semantics

Type Source Name
disease MESH COVID-19
disease MESH syndrome
disease MESH seizure
disease MESH hemorrhagic stroke
disease MESH transient ischemic attack
disease MESH narcolepsy
disease MESH cataplexy
disease MESH anaphylaxis
disease MESH pericarditis
disease MESH Bell’s palsy
disease MESH transverse myelitis
disease MESH appendicitis
disease MESH pulmonary embolism
disease MESH encephalitis

Original Article

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