Synapse
⌘+K
Synapse
PulseExploreJournal ClubResearchersJournals
Instagram
HomeJournal ClubExplore
September 17, 2026ESC Heart FailureOpen Access

Prognostic Factors Associated with Fatal Outcomes in COVID-19 Vaccine-Related Myocarditis

View Full Paper
Ask AI
Bookmark
Share

Why the study?

What factors are associated with fatal outcomes in patients with COVID-19 vaccine-related myocarditis?

Population

1,041 reports of COVID-19 vaccine-related myocarditis from the Japanese Adverse Drug Event Report database…

Design

Cohort

Key result

Among reports of COVID-19 vaccine-related myocarditis, age ≥70 years was independently associated with reported fatal outcomes (OR 8.67; 95% CI 4.41-17.3; P<0.001).

Authors

TUTomomi UedaEAEisuke AmiyaMHMasaru Hatano

Discussion

Loading...

Member takes

Overview

May warrant closer monitoring in elderly patients with vaccine myocarditis; hypothesis-generating and requires prospective confirmation.

Key Points

  • To characterize the clinical features and prognostic factors associated with reported fatal outcomes among patients with COVID-19 vaccine-related myocarditis.
  • Retrospectively analyzed reports from the Japanese Adverse Drug Event Report database spanning 2021 to 2024 (N=31,022 reports listing COVID-19 vaccines as suspected drugs).
  • Stratified vaccine-related myocarditis cases into survival and death groups according to recorded clinical outcomes.
  • Identified prognostic factors associated with death using multivariable logistic regression analyses.
  • Myocarditis was recorded in 1,041 reports (reporting odds ratio 31.3, 95% CI 29.0–33.8), predominantly in men (77.8%) and individuals aged ≤39 years (68.6%), with a median onset of 2 days (IQR 1–4).
  • Among 863 cases with available outcomes, death occurred in 97 cases (11.2%, 95% CI 9.3%–13.5%), occurring more frequently in women, individuals aged ≥70 years, cases with onset ≥8 days, and those with comorbidities.
  • Multivariable logistic regression identified age ≥70 years as independently associated with fatal outcomes (OR 8.67, 95% CI 4.41–17.3; P < 0.001).

Study Design

Type

Observational (n=1,041)

Structured PICO

What factors are associated with fatal outcomes in patients with COVID-19 vaccine-related myocarditis?

P
Population
1,041 reports of COVID-19 vaccine-related myocarditis from a Japanese pharmacovigilance database between 2021 and 2024, predominantly young males, analyzed to identify factors associated with fatal outcomes.
E
Exposure
COVID-19 vaccination
O
Outcome
Reported fatal outcomeshard clinical

Main Result

Odds Ratio: 8.67 (95% CI 4.41–17.3)

p-value: p=< 0.001

In a Japanese pharmacovigilance database, older age (≥70 years) was strongly associated with fatal outcomes in COVID-19 vaccine-related myocarditis.

Limitations

  • Exploratory findings require validation in clinically adjudicated studies

Cite This Study

Ueda et al. (2026) conducted an observational in COVID-19 vaccine-related myocarditis (n=1,041). Age ≥70 years vs. Age <70 years was evaluated on Reported fatal outcomes (OR 8.67, 95% CI 4.41-17.3, p=< 0.001). Among reports of COVID-19 vaccine-related myocarditis, age ≥70 years was independently associated with reported fatal outcomes (OR 8.67; 95% CI 4.41-17.3; P<0.001).

synapsesocial.com/papers/6aabb6e95f706d05830e5a6ahttps://doi.org/10.1093/eschf/xvag239
View Full Paper
Ask AI
Bookmark
Share