title: [Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)].
abstract: BACKGROUND
  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.
  
  
  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.
authors.affiliation: Área de Investigación en Vacunas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana FISABIO - Salud Pública, Valencia, España. Electronic address: rodriguez_margal@gva.es.
authors.forename: M A
authors.initials: MA
authors.lastname: Rodríguez-Galán
authors.affiliation: Área de Investigación en Vacunas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana FISABIO - Salud Pública, Valencia, España.
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 Comunitat Valenciana FISABIO - Salud Pública, Valencia, España.
authors.forename: J
authors.initials: J
authors.lastname: Díez-Domingo
authors.affiliation: Cátedra de Vacunología Balmis UA-FISABIO, Universidad de Alicante, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana FISABIO - Salud Pública, Valencia, España.
authors.forename: J
authors.initials: J
authors.lastname: Tuells
authors.affiliation: Centro Autonómico de Farmacovigilancia de la Comunidad Valenciana, Dirección General de Farmacia y Productos Sanitarios, Conselleria de Sanitat, Valencia, España.
authors.forename: J
authors.initials: J
authors.lastname: Gomar-Fayos
authors.affiliation: Departamento de Farmacología, Universidad de Valencia, Valencia, España.
authors.forename: F
authors.initials: F
authors.lastname: Morales-Olivas
authors.affiliation: Unidad de Coordinación y Promoción de la Salud, Dirección General de Salud Pública, Conselleria de Sanitat, Valencia, España.
authors.forename: E
authors.initials: E
authors.lastname: Pastor-Villalba
mesh_terms: D000293:Adolescent; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000009:adverse effects*; D006801:Humans; D060735:Pharmacovigilance; D012189:Retrospective Studies; D012640:Seizures / Q000453:epidemiology / Q000209:etiology; D013030:Spain; D013575:Syncope / Q000453:epidemiology / Q000209:etiology; D013997:Time Factors
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
keywords: Adverse reactions; Farmacovigilancia; Human papillomavirus; Pharmacovigilance; Reacción adversa; Reporting rate; Tasa de notificación; Vaccine; Vacuna; Virus del papiloma humano