Abstract

CUEVAS, Iván Edelberto et al. Adverse events temporally associated to VA-MENGOC-BC®. La Lisa municipality, 1998-1999. Vaccimonitor [online]. 2000, vol.9, n.4, pp.1-9. ISSN 1025-028X.

In order to describe the temporally associated adverse events after the use of VA-MENGOC-BC® a descriptive and observational study was done. The universe was 3549 children of three months of age and 3832 children of five months of age from primary health care centers of La Lisa municipality. There were 3.21% of children with adverse events in general, but the frequency was higher after the first dose without noticeable differences between sex. The 52% of those adverse events were systemic, 19% on the site of administration of the vaccine and 29% were no related to the vaccine. Most of children were affected in the first 72 hours after the vaccination, and the clinical manifestations disappeared before 72 hours since its beginning. The more frequent manifestations were fever: (the main adverse event with 1.53 cases per 100 vaccinated children); hardness (0.31 cases per 100 vaccinated children), redness (0.30 cases per 100 vaccinated children) and pain (0.136 cases per 100 vaccinated children) on the site of vaccination, irritation (0.244 cases per 100 vaccinated children) and appetite lost (0.311 cases per 100 vaccinated children). The main unrelated adverse events were acute respiratory disease (0.637 cases per 100 vaccinated children), acute diarrhea disease (0.311 cases per 100 vaccinated children) and acute middle ear infection (0.176 cases per 100 vaccinated children). Serious adverse events were scarce. There were not deaths, and all the hospitalized cases were discharged within ten days in complete recuperation without sequel, incapability or handicap.

Keywords : Neisseria meningitidis; vaccines; adverse events; surveillance.

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