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    Article

    Annual report on adverse events related with vaccines use in Calabria (Italy): 2012

    Orietta Staltari1, Felisa Cilurzo1, Benedetto Caroleo1, Alexia Greco1, Francesco Corasaniti1, Maria Antonietta Genovesi2, Luca Gallelli1 Corresponding author

    1. 1Centro Regionale di Informazione sul farmaco, AO Mater Domini, Catanzaro, and Department of Health Science, School of Medicine, University of Catanzaro, Italy.
    2. 2Azienda Sanitaria Provinciale di Catanzaro, Italy.

    CORRESPONDENCE

    Luca Gallelli

    Centro Regionale di Informazione sul farmaco, AO Mater Domini, Catanzaro, and Department of Health Science, School of Medicine, University of Catanzaro, Italy.

    gallelli@unicz.it

    Volume 4, Issue 4S · pp. S61–S62 · PUBLISHED 2013 · DOI: 10.4103/0976-500X.120951

    View on J Pharmacol. Pharmacother. original site ↗

    ABSTRACT

    Vaccines are administered to large population of healthy individuals, particularly to millions of infants every year, through national immunization programs. Although vaccines represent a good defense against some infectious diseases, their administration may be related with the development of adverse vaccine events (AVEs); therefore their use is continually monitored to detect these side effects. In the presents work, we reported the suspected AVEs recorded in 2012 in Calabria, Italy. We performed a retrospective study on report forms of patients that developed AVEs in Calabria from January 1, 2012 to December 31, 2012. Naranjo score was used to evaluate the association between AVEs and vaccines and only suspected AVEs definable as certain, probable, or possible were included in this analysis. During the study period, we evaluated 461 records of adverse drug reactions (ADRs) and 18 (3.9%) were probably induced by vaccination. AVEs were common in females (almost 77.7%) and in children aged 0-3 years. The largest number of non-serious AVEs involved “skin and subcutaneous tissue disorders” and “general disorders and administration site conditions.” In conclusion, we documented that in Calabria the total number of AVEs is very low and it may be useful to increase the pharmacovigilance culture in order to evaluate the safety of these products in large populations.

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      Staltari, O., Cilurzo, F., Caroleo, B., Greco, A., Corasaniti, F., Genovesi, M. A., & Gallelli, L. (2013). Annual report on adverse events related with vaccines use in Calabria (Italy): 2012. Journal of Pharmacology and Pharmacotherapeutics, 4(4S), S61–S62. https://doi.org/10.4103/0976-500X.120951