title: Vasculitis as an adverse event following immunization - Systematic literature review.
abstract: Several types of vasculitis have been observed and reported in temporal association with the administration of various vaccines. A systematic review of current evidence is lacking.
  
  
  
  This systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI).
  
  
  
  We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population.
  
  
  
  The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis.
  
  
  
  Existing literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization.
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy. Electronic address: contact@brightoncollaboration.org.
authors.forename: Caterina
authors.initials: C
authors.lastname: Bonetto
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Trotta
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Felicetti
authors.affiliation: The University of Alabama at Birmingham, USA.
authors.forename: Graciela S
authors.initials: GS
authors.lastname: Alarcón
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Santuccio
authors.affiliation: Bio Farma Vaccine Institute, Bandung, West Java, Indonesia.
authors.forename: Novilia Sjafri
authors.initials: NS
authors.lastname: Bachtiar
authors.affiliation: Brighton Collaboration Foundation, Basel, Switzerland.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Brauchli Pernus
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Chandler
authors.affiliation: Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Girolomoni
authors.affiliation: King's College Hospital, London, United Kingdom.
authors.forename: Robert D M
authors.initials: RD
authors.lastname: Hadden
authors.affiliation: Department of Vaccines Control, National Agency for Medicines and Medical Devices, Tirana, Albania.
authors.forename: Merita
authors.initials: M
authors.lastname: Kucuku
authors.affiliation: Department of Pediatric Rheumatology, Hacettepe University, Ankara, Turkey.
authors.forename: Seza
authors.initials: S
authors.lastname: Ozen
authors.affiliation: Children's Mercy Hospital, Kansas City, MO, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Pahud
authors.affiliation: Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
authors.forename: Karina
authors.initials: K
authors.lastname: Top
authors.affiliation: Independent Consultant Vaccinologist, Wakefield, RI, USA.
authors.forename: Frederick
authors.initials: F
authors.lastname: Varricchio
authors.affiliation: MedImmune/AstraZeneca, Gaithersburg, MD, USA.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Wise
authors.affiliation: Immunology Unit, Policlinico G.B. Rossi, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Zanoni
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, USA.
authors.forename: Saša
authors.initials: S
authors.lastname: Živković
authors.affiliation: Brighton Collaboration Foundation, Basel, Switzerland; University of Basel Children's Hospital, Basel, Switzerland.
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
mesh_terms: D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D014657:Vasculitis / Q000139:chemically induced* / Q000473:pathology*
keywords: Adverse event following immunization (AEFI); Case definition; Immunization; Systematic review; Vaccine; Vasculitis