PLoS Med
July 2022
Background: Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy.
Methods And Findings: We conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases.
The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law.
View Article and Find Full Text PDFAim: To describe and evaluate spontaneous reports of suspected adverse reactions (ARs) associated with herbal laxatives received by the Italian Medicines Agency and the Italian National Institute of Health between April 2002 and January 2011.
Methods: Spontaneous reports of suspected ARs were individually analyzed by a multidisciplinary group of experts, and a causality assessment was performed.
Results: Twenty-six reactions were reported during the study period.