Rapporto sugli eventi avversi ai vaccini somministrati in età pediatrica (0-17 anni) segnalati in Emilia-Romagna nel 2001

Aims. The surveillance of adverse reactions from vaccines is a fundamental tool for evaluating the overall results obtained from vaccinating. In this context, the Emilia-Romagna Region created a report on the adverse reactions in children and adolescents (0-17 years) following vaccination. The specific objectives were to verify the safety of the vaccines used and the level of information exchange concerning adverse event reporting, but also to provide the doctors who reported adverse reactions initially with this data and to aid the dissemination of correct information to the community. Methods. All adverse event reports following vaccinations given to 0-17 year olds in 2001, found in either the Pharmaceutical Service's database or the Public Health Service's archive, were analised. Results. The overall rate of reported events (172) for the 498.485 doses administered was 3,5 per 10.000 doses. Only 72 were significant (1,4 per 10.000 doses), with 28 of these (0,6 per 10.000 doses) leading to hospital or emergency department admission. In all, there were 20 cases of immediate hypersensitivity reaction (0,4 per 10.000), and all healed uneventfully. The 10 cases of hypotony-hyporesponsiveness events, the 11 neurological events, the 2 arthropathies and other rare symptoms observed were all transitory and disappeared uneventfully except for 1 chronic arthropathy and 1 polyneuropathy, both of which were still present at the time of the study. However, in both cases, the data available did not allow for a definite correlation to be established. Conclusions. The results reveal an adequate tendency, on the part of doctors and the vaccination centres in the Emilia-Romagna Region, to report adverse events, including rare ones, as well as a considerable safety of the vaccines used. When comparing the adverse events reported with the frequent, serious complications related to the diseases preventable with vaccinations, the benefit obtained by immunising is clear. The completeness of the data analysed was possible because two different sources were used: the database alone does not provide data necessary for surveillance.