Baker MA, et al. - The Food and Drug Administration conducted a study investigating the risk of Kawasaki disease following 13-valent pneumococcal conjugate vaccine (PCV13) vaccination in the claims-based Sentinel/Postlicensure Rapid Immunization Safety Monitoring (PRISM) surveillance system in order to ascertain the existence and magnitude of any increased risk of Kawasaki disease in the 28 days following PCV13 vaccination. Mostly commercially insured children from birth to <24 months of age in 2010 to 2015 across the US, comprised the study population. Outcomes yielded no evidence supporting an association between PCV13 vaccination and Kawasaki disease onset in the 4 weeks after vaccination and nor there was an elevated risk extending or concentrated somewhat beyond 4 weeks following vaccination. Across alternative designs, age-adjustment methods, control intervals, and categories of Kawasaki disease case included, these null results were consistently evident.