Guide to Evaluating Adverse Reactions Observable After Vaccination (2017)
We publish the Guide to evaluating adverse reactions observable after vaccination published by the Italian Medicines Agency.
We quote:
"The goal of the "Guide to evaluating adverse reactions observable after vaccination", developed by the working group on Vaccinovigilance, is to provide a tool for the evaluation of adverse reactions.
Il document aims to:
- present the case definitions for a list of adverse events, updating and integrating the definitions reported in the DM 12/12/2003, in the light of the available evidence;
- provide time windows by type of reaction and vaccine;
- when possible, indicate the background of incidence for the specific reaction / event.
Events that were sometimes reported after vaccination have also been included in the list, but for which the available evidence does not support the hypothesis of a causal relationship with the vaccine, precisely to provide elements of clarity. "
2017 update: AIFA-Guide-to-evaluation-adverse-reaction-2017.pdf