Evaluation of adverse event clusters following immunization with mRNA COVID-19 vaccines: a real-world analysis using EudraVigilance data

Study identification

• EU PAS number:
  EUPAS43083
• Study ID:
  48901
• Official title and acronym:
  Evaluation of adverse event clusters following immunization with mRNA COVID-19 vaccines: a real-world analysis using EudraVigilance data
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  This study is designed as a retrospective observational analysis using individual case safety reports (ICSRs) submitted to EudraVigilance, the European pharmacovigilance database maintained by the European Medicines Agency. It aims to characterize and explore patterns of adverse events following immunization (AEFI) associated with mRNA COVID-19 vaccines, namely Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax), within the European Economic Area.; The main objective is to identify clusters of AEFI based on their frequency of co-occurrence, using descriptive statistics, co-occurrence network analysis, and correspondence analysis. Reports from 1 January 2020 to 31 December 2023 will be retrieved, and no exclusion filters will be applied, ensuring a comprehensive dataset. Analyses will also stratify patterns according to seriousness and age groups.; This study is expected to enhance understanding of safety signals related to mRNA COVID-19 vaccines, inform pharmacovigilance practice, and support the continued assessment of vaccine safety profiles under real-world conditions. The methodology will comply with STROBE guidelines and the ENCePP Guide on Methodological Standards in Pharmacoepidemiology.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Porto Pharmacovigilance Centre, Faculty of Medicine, University of Porto (UFPorto)

Portugal

University of Porto

Faculty of Medicine

Study timelines

Date when funding contract was signed

Actual:15/09/2021

Study start date

Planned:01/10/2021

Actual:01/10/2020

Data analysis start date

Planned:01/01/2024

Date of final study report

Planned:19/02/2025

Sources of funding

EU institutional research programme

More details on funding

Portuguese national funds and Community funds from the European Social Fund (ESF) through FCT – Fundação para a Ciência e a Tecnologia (Portugal)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable