title: Kawasaki disease and immunisation: A systematic review.
abstract: Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation.
  
  
  
  We conducted a systematic literature review using various reference sources to review the available evidence published in the literature.
  
  
  
  We identified twenty seven publications reporting a temporal association between immunisation and Kawasaki disease. We present a systematic review of data drawn from randomised controlled trials, observational studies, case series and reports, and reviews. Overall there was a lack of standardised case definitions, making data interpretation and comparability challenging.
  
  
  
  Although a temporal relationship between immunisation and Kawasaki disease is suggested, evidence for an increased risk or a causal association is lacking. Implementation of a standardised Kawasaki disease case definition would increase confidence in the findings and add value to future studies of pre- or post-licensure vaccine safety studies.
authors.affiliation: Monash Children's Hospital, Clayton, Melbourne, Australia; Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Linny Kimly
authors.initials: LK
authors.lastname: Phuong
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Bonetto
authors.affiliation: Monash Children's Hospital, Clayton, Melbourne, Australia; Murdoch Childrens Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, Monash University, Clayton, Victoria, Australia.
authors.forename: Jim
authors.initials: J
authors.lastname: Buttery
authors.affiliation: The Brighton Collaboration Foundation, Basel, Switzerland.
authors.forename: Yolanda Brauchli
authors.initials: YB
authors.lastname: Pernus
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Chandler
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Felicetti
authors.affiliation: Independent Consultant, Bethesda, MD, USA.
authors.forename: Karen L
authors.initials: KL
authors.lastname: Goldenthal
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: Pharmacovigilance Regional Centre of Lombardy, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Monaco
authors.affiliation: Children's Mercy Hospital, Kansas City, MO, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Pahud
authors.affiliation: Ann & Robert H. Lurie Children's Hospital of Chicago, USA.
authors.forename: Stanford T
authors.initials: ST
authors.lastname: Shulman
authors.affiliation: Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
authors.forename: Karina A
authors.initials: KA
authors.lastname: Top
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Trotta
authors.affiliation: Hospital Nacional de Niños "Dr. Carlos Sáenz Herrera, San José, Costa Rica.
authors.forename: Rolando
authors.initials: R
authors.lastname: Ulloa-Gutierrez
authors.affiliation: Independent Consultant Vaccinologist, Wakefield, RI, USA.
authors.forename: Frederick
authors.initials: F
authors.lastname: Varricchio
authors.affiliation: Boston Children's Hospital, Boston, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: de Ferranti
authors.affiliation: Boston Children's Hospital, Boston, USA.
authors.forename: Jane W
authors.initials: JW
authors.lastname: Newburger
authors.affiliation: CHU Sainte-Justine, Montreal, Canada.
authors.forename: Nagib
authors.initials: N
authors.lastname: Dahdah
authors.affiliation: Post Graduate Institute of Medical Education and Research (PGIMER)- Chandigarh, India.
authors.forename: Surjit
authors.initials: S
authors.lastname: Singh
authors.affiliation: The Brighton Collaboration Foundation, Basel, Switzerland; University of Basel Children's Hospital, Basel, Switzerland. Electronic address: contact@brightoncollaboration.org.
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
authors.affiliation: Monash Children's Hospital, Clayton, Melbourne, Australia; Murdoch Childrens Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, Monash University, Clayton, Victoria, Australia; Department of Paediatrics, Melbourne University, Parkville, Victoria, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Burgner
mesh_terms: D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D009080:Mucocutaneous Lymph Node Syndrome / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology* / Q000628:therapy; D012306:Risk; D014611:Vaccination / Q000009:adverse effects; D014612:Vaccines / Q000009:adverse effects / Q000276:immunology
chemical_list: D014612:Vaccines
keywords: Adverse event; Case definition; Guidelines; Immunisation; Kawasaki disease; Systematic review