Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jan 27:15:20420986241226566.
doi: 10.1177/20420986241226566. eCollection 2024.

Determinants of COVID-19 vaccine-induced myocarditis

Jessica Rose  1 , Nicolas Hulscher  2 , Peter A McCullough  3
Affiliations

Determinants of COVID-19 vaccine-induced myocarditis

Jessica Rose et al. Ther Adv Drug Saf. .

Expression of concern in

  • Expression of Concern.
    [No authors listed] [No authors listed] Ther Adv Drug Saf. 2024 Mar 7;15:20420986241239903. doi: 10.1177/20420986241239903. eCollection 2024. Ther Adv Drug Saf. 2024. PMID: 38464905 Free PMC article. No abstract available.

Abstract

Background: Following the roll-out of the Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, and Janssen Ad26.COV2.S coronavirus disease 2019 (COVID-19) injections in the United States, millions of individuals have reported adverse events (AEs) using the vaccine adverse events reports system (VAERS). The objective of this analysis is to describe the myocarditis data in VAERS and the COVID-19 vaccines as potential determinants of myocarditis.

Methods: We used VAERS data to examine the frequency of reporting myocarditis since the beginning of the mass vaccination campaign and compared this with historical values in VAERS and COVID-19 vaccine administration data from the Our World in Data database. We examined myocarditis reports in VAERS in the context of sex, age, and dose. Statistical analysis was done using the Student's t-test to determine statistically significant differences between ages among myocarditis adverse events (AEs) and the chi-square test to determine relationships between categorical variables with statistical significance.

Results: We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years. This represented a 2500% increase in the absolute number of reports in the first year of the campaign when comparing historical values prior to 2021. Demographic data revealed that myocarditis occurred most in youths (50%) and males (69%). A total of 76% of cases resulted in emergency care and hospitalization. Of the total myocarditis reports, 92 individuals died (3%). Myocarditis was more likely after dose 2 (p < 0.00001) and individuals less than 30 years of age were more likely than individuals older than 30 to acquire myocarditis (p < 0.00001).

Conclusion: COVID-19 vaccination is strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death. Further investigation into the underlying mechanisms of COVID-19 vaccine-induced myocarditis is imperative to create effective mitigation strategies and ensure the safety of COVID-19 vaccination programs across populations.

Keywords: COVID-19 vaccine; SARS-CoV-2; VAERS; adverse events; death; mortality; myocarditis; serious adverse events.

Plain language summary

Using VAERS to understand myocarditis associated with COVID-19 vaccination Why was the study done? Heart inflammation, known as myocarditis, has been previously associated with COVID-19 vaccination. After the Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines were given in the United States, millions of people reported side effects, including myocarditis, using a system called the Vaccine Adverse Event Reporting System (VAERS). Therefore, the researchers sought to further investigate possible links between COVID-19 vaccination and myocarditis using VAERS. What did the researchers do? The researchers used VAERS to check the frequency of myocarditis reports after COVID-19 vaccination and compared this with past reports from other vaccines over the years. They also studied details such as the age and gender of those affected, and which dose of the vaccine they had received. What did the researchers find? In 2021, there was a dramatic increase in the number of myocarditis reports linked to the COVID-19 vaccine, far higher than the reports from all other vaccines combined over the previous 30 years. This side effect was mostly reported in young individuals, especially males. Most of those who reported myocarditis needed emergency medical care or had to be hospitalized. Out of those affected, 92 individuals died. Myocarditis was more likely following a second dose of vaccine. Furthermore, individuals under the age of 30 were more prone to acquire myocarditis from COVID-19 vaccination compared to those aged 30 and above. What do the findings mean? The researchers found a strong link between COVID-19 vaccination and myocarditis, especially in kids and young adults. This can lead to hospital stays and, in some cases, death. We need to study more about how the COVID-19 vaccine might cause heart inflammation to find ways to prevent it and make sure the vaccine is safe for continued use in all age groups.

PubMed Disclaimer

Conflict of interest statement

The authors declare that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
(a) Number of reports filed to VAERS since 1990–2020 for all vaccines combined (gray) shown with the number of reports filed to VAERS from 2021 to 11 August 2023 for only the COVID-19 injections (purple). (b) Number of reports for myocarditis filed to VAERS since 1990–2020 for all vaccines combined (black) is shown with the number of myocarditis reports filed to VAERS from 2021 to 11 August 2023 for only the COVID-19 injections (red). (c) Number of reports for myocarditis filed to VAERS (red) plotted against the number of COVID-19 injections administered (blue) from 1 May 2020 to 3 July 2023. COVID-19, coronavirus disease 2019; VAERS, vaccine adverse events report system.
Figure 2.
Figure 2.
Comparison of the number of vaccines on the market in the United States per year (green) (according to VAERS reports) versus the number of VAERS AE reports (blue) from 1990 to 2020. AE, adverse event; COVID-19, coronavirus disease 2019; VAERS, vaccine adverse events reports system.
Figure 3.
Figure 3.
(a) All myocarditis reports in VAERS Domestic Data as of 11 August 2023 according to CDC age grouping. (b) All myocarditis reports filed to VAERS normalized to shot number as per CDC age grouping. CDC, Centers for Disease Control and Prevention; VAERS, vaccine adverse events reports system.
Figure 4.
Figure 4.
All myocarditis reports in VAERS Domestic Data as of 11 August 2023 are plotted according to age and dose [dose 1 (pink), dose 2 (green), and dose 3 (blue)]. VAERS, vaccine adverse events report system.
Figure 5.
Figure 5.
(a) VAERS reports of cardiac AEs by age group as of 11 August 2023. (b) VAERS reports of cardiac AEs by age group as of 11 August 2023, normalized to dose data. AE, adverse event; VAERS, vaccine adverse events report system.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Cooper LT., Jr. Myocarditis. N Engl J Med 2009; 9: 1526–1538. - PMC - PubMed
    1. Camm AJ, Lüscher TF, Serruys PW. (eds). The ESC textbook of cardiovascular medicine. 3rd ed. The European Society of Cardiology Series. Oxford: Oxford University Press, 2018.
    1. Libby P, Swirski FK, Nahrendorf M. The myocardium: more than myocytes. J Am Coll Cardiol 2019; 74: 3136–3138. - PubMed
    1. Banerjee I, Fuseler JW, Price RL, et al.. Determination of cell types and numbers during cardiac development in the neonatal and adult rat and mouse. Am J Physiol Heart Circ Physiol 2007; 293: 1883–1891. - PubMed
    1. Weinhaus AJ, Roberts KP. Anatomy of the human heart. In: Iaizzo P. (ed.) Handbook of cardiac anatomy, physiology and devices. Totowa, NJ: Humana Press, 2009, pp. 51–79.

LinkOut - more resources