Kawasaki disease and immunisation: A systematic review

Background: Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation. Methods: We conducted a systematic literature review using various reference sources to review the available evidence published in the literature. Results: 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. Conclusions: 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.