Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre
Perez-Vilar, S, Gutierrez-Gimeno, M, Rodriguez-Galan, M, Diez-Domingo, J, Puig-Barbera, J, Gomar-Fayos, J, Alguacil-Ramos, A
Introduction: A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre. Material and methods: Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed. Results: After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases. Conclusions: The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies. (C) 2012 Asociacion Espanola de Pediatria. Published by Elsevier Espana, S.L. All rights reserved.
Repository: r-FISABIO: Repositorio Institucional de Producción Científica