[Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)]. / Notificación de reacciones adversas a la vacuna frente al virus del papiloma humano en la Comunidad Valenciana (2007-2011).

INTRODUCTION: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. MATERIAL AND METHODS: Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. RESULTS: The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. CONCLUSIONS: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile.

Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana / Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre

Introducción: El sistema de Farmacovigilancia de Medicamentos de Uso Humano constituye un importante mecanismo para el seguimiento postautorización de la seguridad de las vacunas. La vacuna triple vírica es una vacuna combinada de virus vivos atenuados de sarampión, rubéola y parotiditis. A pesar de que los episodios adversos asociados son considerados generalmente leves, la vacuna ha sido ampliamente cuestionada. Nuestro objetivo fue describir las notificaciones de sospecha de reacciones adversas relacionadas con esta vacuna, realizadas al Centro de Farmacovigilancia de la Comunidad Valenciana. Material y métodos: Estudio descriptivo a partir de los casos notificados entre el 15 de mayo de 2005 y el 15 de mayo de 2010.Tras agrupar las sospechas de reacciones adversas por criterios diagnósticos, fue realizado un análisis descriptivo de las variables. Resultados: Tras la administración de 545.830 dosis fueron notificadas 96 sospechas de reacciones adversas (1,76 notificaciones/100.000 dosis), que incluyeron un total de 181 reacciones. Las reacciones descritas con más frecuencia fueron fiebre (42,7%) e inflamación en la zona de inyección (36,5%). Fueron clasificadas como graves el 8,3% de las notificaciones. En todos los casos la recuperación fue completa. Conclusiones: Las sospechas de reacciones adversas notificadas coinciden con las reacciones descritas en las fichas técnicas de las vacunas. La frecuencia de notificaciones es notablemente inferior a la descrita en la literatura, no obstante, a pesar de las probables limitaciones y con los datos obtenidos podemos afirmar que la vacuna triple vírica ofrece un buen perfil de seguridad, acorde con los datos publicados hasta ahora (AU)

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 (AU)

[Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre]. / Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana.

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.