Adverse Events Following Vaccination with Soberana®02 in Children in a Medical Office

Abstract

Introduction: Conducting pharmacovigilance studies to identify adverse events related to vaccine administration contributes to a true understanding of their benefits.

Objective: To characterize adverse events related to vaccination with Soberana®02 in children and adolescents in a medical office, under the conditions of routine medical practice.

Methods: A descriptive, retrospective, cross-sectional study was conducted with a sample of 78 children and adolescents between 3 and 18 years of age, out of the 234 immunized with Soberana®02 at Clinic 11, Policlínico América 1, Contramaestre municipality, Santiago de Cuba, from September 2021 to March 2022. Primary and secondary response variables to adverse events were analyzed, and the strength of the causal relationship was evaluated for individual suspected adverse reactions.

Results: Females in the 3-10 age group were predominant in the study. Local adverse events predominated, with higher frequency of occurrence in the 3-10 age group and in females. Reports were lower during the second dose, and in the causality analysis, probable adverse events prevailed, followed by definite adverse events. Only 13 cases (11.21%) were considered possible, with an association between their occurrence and age.

Conclusions: The adverse events reported with the administration of Soberana®02 under routine medical practice conditions confirm its safety, presenting a frequency similar to other studies conducted in Cuba, with a considerable reduction in the second dose.