Analysis of the adverse events following the mRNA-1273 COVID-19 vaccine

ABSTRACT

Objective

This study aims to characterize the adverse events (AEs) following the administration of the mRNA-1273 COVID-19 vaccine from the Vaccine Adverse Event Reporting System (VAERS) data.

Methods

In this case/non-case analysis, reports between 1 January 2021, and 27 October 2022, were extracted from VAERS. AEs were defined as preferred terms (PTs) by Medical Dictionary for Regulatory Activities (MedDRA) terminology. Disproportionality analyses were conducted to calculate the reporting odds and proportional reporting ratios. The Bayesian approach was used to calculate information component (IC) values and Empirical Bayesian Geometric Mean scores for all the AEs detected.

Results

186 MedDRA PTs compromising 702,495 AEs associated with the mRNA-1273 vaccine were identified. Three statistically significant signals were identified for general and systemic AEs, administration site conditions, and product issues. Cardiac disorders were rarely reported, the most common being; 489 reports for ‘myocarditis’ (19.44%), 475 for ‘acute myocardial infarction’ (18.88%), 457 for ‘myocardial infarction’ (18.16%), 290 for ‘bradycardia’ (11.53%) and 281 for ‘pericarditis’ (11.17%).

Conclusions

The most frequently identified AEs following mRNA-1273 vaccination agree with those listed within the Summary of Product Characteristics. In addition, disproportionality analysis did not find any statistically significant signals for myocarditis or pericarditis.

KEYWORDS:

• Adverse events (AEs)
• COVID-19
• mRNA-1273
• moderna
• SARS-CoV-2

Article highlights

• Reports regarding adverse events (AEs) associated with the mRNA-1273 vaccine were obtained from the Vaccine Adverse Event Reporting System (VAERS) from January 1, 2021, and October 27, 2022.

• Age analyses for ‘myocarditis’ and ‘pericarditis’ found that the majority of reports were made from individuals aged 18-29 years (185 reports for ‘myocarditis’ and 67 for ‘pericarditis’) and 30-64 years (193 reports for ‘myocarditis’ and 281 for ‘pericarditis’). However, disproportionality analysis did not find any statistically significant signals

• Statistical analysis identified three significant signals for thirteen AEs and two for fifteen AEs. These adverse events included several general and systemic AEs, administration site conditions and product issues.

• The most frequently identified AEs following mRNA-1273 vaccination agree with the common side effects listed within the Summary of Product Characteristics (SmPC). However, the disproportionality analysis results for ‘Product issues’ were unexpected.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors have substantially contributed to the conception and design of the review article and interpreting the relevant literature and have been involved in writing the review article or revising it for intellectual content.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14760584.2023.2260477

Additional information

Funding

This paper was not funded.