PMID- 38293564 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240311 IS - 2042-0986 (Print) IS - 2042-0994 (Electronic) IS - 2042-0986 (Linking) VI - 15 DP - 2024 TI - Determinants of COVID-19 vaccine-induced myocarditis. PG - 20420986241226566 LID - 10.1177/20420986241226566 [doi] LID - 20420986241226566 AB - 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. CI - (c) The Author(s), 2024. FAU - Rose, Jessica AU - Rose J AD - Independent Researcher, Ontario, Canada. FAU - Hulscher, Nicolas AU - Hulscher N AUID- ORCID: 0009-0008-0677-7386 AD - University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, MI 48109, USA. FAU - McCullough, Peter A AU - McCullough PA AD - McCullough Foundation, Dallas, TX, USA. LA - eng PT - Journal Article DEP - 20240127 PL - England TA - Ther Adv Drug Saf JT - Therapeutic advances in drug safety JID - 101549074 ECI - Ther Adv Drug Saf. 2024 Mar 7;15:20420986241239903. PMID: 38464905 PMC - PMC10823859 OAB - 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. OABL- eng OTO - NOTNLM OT - COVID-19 vaccine OT - SARS-CoV-2 OT - VAERS OT - adverse events OT - death OT - mortality OT - myocarditis OT - serious adverse events COIS- The authors declare that there is no conflict of interest. EDAT- 2024/01/31 06:43 MHDA- 2024/01/31 06:44 PMCR- 2024/01/27 CRDT- 2024/01/31 04:29 PHST- 2023/10/30 00:00 [received] PHST- 2024/01/01 00:00 [accepted] PHST- 2024/01/31 06:44 [medline] PHST- 2024/01/31 06:43 [pubmed] PHST- 2024/01/31 04:29 [entrez] PHST- 2024/01/27 00:00 [pmc-release] AID - 10.1177_20420986241226566 [pii] AID - 10.1177/20420986241226566 [doi] PST - epublish SO - Ther Adv Drug Saf. 2024 Jan 27;15:20420986241226566. doi: 10.1177/20420986241226566. eCollection 2024.