Study Reveals Insights and Concerns in COVID-19 mRNA Vaccine Safety—Serious Clusters in Vulnerable Groups

A new study published in Frontiers in Medicine examines real-world safety data for Moderna's Spikevax and Pfizer/BioNTech's Comirnaty COVID-19 vaccines, utilizing nearly 1 million individual case safety reports (ICSR) from the European pharmacovigilance database, EudraVigilance. The research, conducted by a team from the University of Porto, highlights the overall safety of these vaccines while identifying significant patterns in adverse events that warrant further scrutiny.

The analysis reviewed reports from January 2020 to December 2023, documenting over 3.5 million adverse event occurrences. Most reports originated from women (69%) and non-healthcare professionals (65%), with a notable variety of 10,804 distinct adverse event terms reported. Commonly observed adverse events included headache, fatigue, pyrexia (fever), myalgia, arthralgia, nausea, and chills, often clustering with vaccine failure reports.