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Revista Cubana de Higiene y Epidemiología

On-line version ISSN 1561-3003


DIAZ PINERA, Addys María  and  CUEVAS VALDESPINO, Iván Edelberto. Adverse events associated with the vaccination of children under 2 at the children's hospital in the municipality of Centro Habana (2002-2007). Rev Cubana Hig Epidemiol [online]. 2014, vol.52, n.1, pp.81-97. ISSN 1561-3003.

Introduction: information about adverse reactions is collected from reports submitted by health professionals. Even when their relationship to drugs administered (including vaccines) is only a suspicion, such information might hint at potential new risks, thus allowing to take regulatory action. Objective: determine the exploratory results of the active search for serious adverse events associated with the vaccination of children under 2 hospitalized in the children's hospital of the municipality of Centro Habana from 2002 to 2007. Methods: a study was conducted of 13 912 hospital discharges of children under 2 from 2002 to 2007. The study followed an observational retrospective case-series design. Data were obtained from hospital records, medical records, and vaccination records and cards from central immunization centers and doctor's consultation offices. Result: vaccine-related adverse events were found in 83 cases, representing 0.6 % [CI 95 % (0.48-0.74)], of which 43 were detected by a combination of passive and active screening. The most common events were fever, cellulitis, abscesses, convulsions and irritability, associated with DPT vaccines and their combinations, with a satisfactory development in 93 % of the cases. Conclusions: exploration of the active screening of vaccine-related adverse events revealed the possibility of obtaining accurate diagnoses providing pediatric services in hospitals with relevant pharmacovigilance data about vaccination.

Keywords : vaccines; pharmacovigilance; case series.

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