title: [Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception].
abstract: BACKGROUND
  The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception.
  
  
  METHODS
  Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry.
  
  
  RESULTS
  The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%.
  
  
  CONCLUSIONS
  Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines.
authors.affiliation: Área de Investigación en Vacunas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana, FISABIO-Salud Pública, Valencia. España. Electronic address: perez_silvil@gva.es.
authors.forename: S
authors.initials: S
authors.lastname: Pérez-Vilar
authors.affiliation: Área de Investigación en Vacunas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana, FISABIO-Salud Pública, Valencia. España.
authors.forename: J
authors.initials: J
authors.lastname: Díez-Domingo
authors.affiliation: Servicio de Ordenación y Control del Medicamento, Dirección General de Farmacia y Productos Sanitarios, Valencia, España.
authors.forename: J
authors.initials: J
authors.lastname: Gomar-Fayos
authors.affiliation: Servicio de Salud Infantil y de la Mujer, Dirección General de Salud Pública, Valencia, España.
authors.forename: E
authors.initials: E
authors.lastname: Pastor-Villalba
authors.affiliation: Área de Investigación en Vacunas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana, FISABIO-Salud Pública, Valencia. España.
authors.forename: M
authors.initials: M
authors.lastname: Sastre-Cantón
authors.affiliation: Área de Investigación en Vacunas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana, FISABIO-Salud Pública, Valencia. España.
authors.forename: J
authors.initials: J
authors.lastname: Puig-Barberà
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D007223:Infant; D007443:Intussusception / Q000821:virology*; D008297:Male; D060735:Pharmacovigilance; D012189:Retrospective Studies; D022243:Rotavirus Vaccines / Q000009:adverse effects*
chemical_list: D022243:Rotavirus Vaccines
keywords: Farmacovigilancia; Intussusception; Invaginación intestinal; Pharmacovigilance; Rotavirus vaccines; Vacunas frente a rotavirus