Following the start of the COVID-19 vaccination campaign, the adverse events of myocarditis
and pericarditis were linked mainly to mRNA COVID-19 vaccines by the regulatory …

The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders …

Introduction During the COVID-19 pandemic, EMA set-up a large-scale cohort event
monitoring (CEM) system to estimate incidence rates of patient-reported adverse drug …

Introduction From 2009 to 2015, the IMI PROTECT conducted rigorous studies addressing
questions about optimal implementation and significance of disproportionality analyses …

Abstract Objectives Despite concerted efforts, Mycobacterium tuberculosis (M. tb), the
pathogen that causes tuberculosis (TB), continues to be a burden on global health …

Concerns remain regarding the rare cardiovascular adverse events, myocarditis and
pericarditis (myo/pericarditis), particularly in younger individuals following mRNA COVID-19 …

High prevalence of spin was found in pharmacovigilance studies using disproportionality
analyses to detect safety signals: a meta-epidemiological study. We read with interest the …

Introduction During the signal detection process, statistical methods are used to identify drug–
event combinations (DECs) which are disproportionately reported when compared with …

This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU).
Its legislative aim of better patient and public health protection through new responsibilities …

Abstract Background and Objective During the COVID-19 vaccination campaign, over
34,000 reports of heavy menstrual bleeding following the administration of COVID-19 …