"1.2 Safety
... This study aims to characterize the common adverse events experienced within a diverse population following the administration of the mRNA-1273 vaccine from the Vaccine Adverse Event Reporting System (VAERS) data...
3. Results
869,556 individual case reports associated with COVID-19 vaccines were retrieved between 1 January 2021, and 27 October 2022, from the United States (US).. 186 MedDRA PTs [preferred terms by Medical Dictionary for Regulatory Activities] compromising a total of 702,495 AEs associated with the mRNA-1273 vaccine were identified from reports...
3.1. Commonly occurring AEs according to MedDRA system organ classes
‘Injury, poisoning, and procedural complications’ were associated with 51,802 AEs (7.38%). Common issues in this category included reports of ‘expired product being administered’, ‘product storage error’, and ‘products administered to the patient of inappropriate age’. Interestingly, product-related issues haven’t been frequently reported as AEs for the mRNA-1273 vaccine. However, the observed disproportionality signals suggest an increased reporting of these AEs, warranting further investigation...
5. Conclusions
In this study, the most frequently identified AEs following mRNA-1273 vaccination agree with the common side effects listed within the SmPC. However, the disproportionality analysis results for ‘Product issues’ were unexpected due to the absence of these concerns within the existing literature. This signifies a gap in understanding the occurrence of product-related errors and their source. Furthermore, since errors in the handling or quality of the product (mRNA-1273 vaccine) are not typically evaluated within RCTs and other observational studies, data regarding them is insufficient."
© 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
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