Eventos adversos temporalmente asociados a VAMENGOC- BC®. Municipio La Lisa, 1998-1999.

Adverse events temporally associated to VA-MENGOC-BC®. La Lisa municipality, 1998-1999

Iván Edelberto Cuevas1, Georgina Cruz2, Luis Enrique Rosete2, Victoria Casanueva1, Ileana Castañeda2, Julia Pérez2 .

1. Instituto Finlay, Centro de Investigación-Producción de Vacunas y Sueros. Ciudad de La Habana, Cuba. ]]> E-mail:cuevas@finlay.edu.cu
2. Escuela Nacional de Salud Pública. Línea e I, Vedado. Ciudad de La Habana, Cuba.

RESUMEN

Con el objetivo de describir la frecuencia de eventos temporalmente asociados a la vacuna cubana VAMENGOC- BC®, se realizó un estudio observacional de tipo descriptivo, cuyo universo estuvo constituido por los lactantes en las edades comprendidas de tres (3549) y cinco meses (3832) de edad de las áreas de salud del Municipio La Lisa en Ciudad de La Habana. Hubo un 3,21% de niños con eventos adversos, con una mayor frecuencia después de la primera dosis; sin diferencias apreciables por sexo. La clasificación fue de un 52% de tipo sistémico, locales un 19% y no solicitados un 29%. La mayor parte de los niños afectados fue en las primeras 72 horas posteriores a la vacunación, y desaparecieron antes de 72 horas desde su comienzo. Las manifestaciones más frecuentes fueron fiebre (predominó entre todos los eventos adversos con 1,53 casos por 100 vacunados); la induración (0,31 por 100 vacunados), eritema (0,30 por 100 vacunados) y el dolor (0,136 por 100 vacunados) en el sitio de administración de la vacuna; irritabilidad (0,244 por 100 vacunados) y pérdida de apetito (0,311 por 100 vacunados). Los eventos no solicitados más frecuentes fueron la Enfermedad Respiratoria Aguda (0,637 por 100 vacunados), la Enfermedad Diarreica Aguda (0,311 por 100 vacunados) y la Otitis Media (0,176 por 100 vacunados). Los eventos adversos serios fueron infrecuentes. No hubo fallecidos y todos los casos se recuperaron en menos de diez días, sin secuelas, discapacidades ni minusvalías.

Palabras claves: Neisseria meningitidis, vacunas, eventos adversos, vigilancia.

ABSTRACT

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.

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