We publish the Guide to evaluating adverse reactions observable after vaccination published by the Italian Medicines Agency.
"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