Rev Esp Quimioter 2019; 32(5):432-439

Vaccine-related adverse reactions in immunocompromised patients and in special situations of a hospital Vaccine Unit 

MARÍA FERNÁNDEZ-PRADA, ANDREA VIEJO-GONZÁLEZ, ALBA MARTÍNEZ-TORRÓN, CARMEN MARTÍNEZ-ORTEGA, JESÚS RUIZ-SALAZAR, ISMAEL HUERTA-GONZÁLEZ

Objectives. The aim of the study was to describe the type of vaccines administered in the Vaccine Unit at a reference hospital. Calculate the overall and specific reporting rate of adverse reactions.
Methods. Retrospective observational study for the period between November 2014 and November 2017, on patients who developed an adverse drug reaction (ADR) after the administration of a vaccine and who were notified to the Spanish Pharmacovigilance System. The variables analyzed were age, sex, risk group, vaccine class, co-administration and type of ADR. A univariate and bivariate analysis was performed. The global and vaccine specific rate of ADR notification was calculated.
Results. A total of 18,123 vaccines were administered, of which 20.7% corresponded to hepatitis B virus vaccine. Fifty-three RAM suspects were reported. In 64.2% of cases only one vaccine was administered. Inactivated vaccines accounted for 88.7% of notifications. The highest number of notifications was generated by the 23 serotypes pneumococcal polysaccharide vaccine. The overall reporting rate was 0.42%. The hexavalent vaccine had the highest reporting rate (2.81%). 49.1% of the ADR were systemic.
Conclusions. The overall reporting rate was low but higher than that of other authors. Proper reporting of possible adverse post-vaccine reactions is essential to contribute to vaccine safety and to increase public confidence in vaccines.

Rev Esp Quimioter 2019; 32(5):432-439 [Texto completo PDF]