Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance.

ABSTRACT:

Objective

To analyses real-world safety data of mRNA COVID-19 vaccines within the European Economic Area (EEA), using Individual Case Safety Reports (ICSR), and to evaluate the variability in safety profiles between different vaccine versions.

Methods

We utilized EudraVigilance data from 1 January 2020, to 31 December 2023, focusing on Moderna (Spikevax) and Pfizer/BioNTech (Comirnaty) vaccines against COVID-19. We performed descriptive statistics, co-occurrence analysis, and correspondence analysis to identify patterns and clusters of adverse events following immunization (AEFI).

Results

We retrieved 993,199 ICSR (Moderna: 394,484; Pfizer: 605,794), with most reports related to women patients (69%) and non-healthcare professionals (65%). A total of 10,804 distinct AE

SUBMITTER: Ferreira-da-Silva R 

PROVIDER: S-EPMC11879978 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature