The Italian Drug Agency (AIFA) has published on the institutional portal the Vaccini 2017 Report, which describes all the suspected adverse reactions included in the 2017 in the National Network of Pharmacovigilance (RNF), including those that arose in previous years.
"With the publication of the 2017 Report, AIFA continues with the transparency operation already underway, providing rigorous data and analysis which once again shows that vaccines are among the most controlled and safe medicines. From the evaluation of the reports - says the General Manager, Mario Melazzini - there are no safety issues that could modify the risk benefit ratio of the vaccines used. Healthcare professionals and citizens are more likely to report possible adverse reactions through the National Network of Pharmacovigilance spread throughout the country, thanks to a growing awareness on these issues. However, the reports taken into consideration concern, in most cases, known reactions, not serious, and in any case included among the possible undesirable effects of the leaflets of each product ".
About 80% of the reports arising in the 2017 were classified as "not serious" in line with previous years.
The reports for vaccines (6.696) represent 16% of the total reports for drugs and vaccines entered in 2017 and come mainly from non-medical health personnel (57%). This is followed by reports from doctors (21,4%) and citizens / patients (13,2%).
The most frequently described adverse reactions were fever, local reactions, generalized skin reactions and hyperpyrexia. Less common reactions were agitation / irritability, allergic conditions, vomiting, pain, crying and headache, usually reported in the product package leaflet. Allergic conditions and generalized skin reactions were less frequent for mandatory vaccines.
Reports of suspected adverse reactions considered serious were rare and in most cases were transitory, with complete resolution of the reported event and not related to vaccination.
It should be emphasized that the definition of "severe reaction" also includes hospitalization, every major clinical event and cases of non-efficacy.