Lack of association of Kawasaki disease after immunization in a cohort of infants followed for multiple autoimmune diagnoses in a large, phase-4 observational database safety study of 7-valent pneumococcal conjugate vaccine: lack of association between Kawasaki disease and seven-valent pneumococcal conjugate vaccine.

A large-scale, postmarketing observational database safety study was conducted following 7-valent pneumococcal conjugate vaccine (PCV7) licensure. A secondary outcome was the occurrence of predefined diagnoses among PCV7 vaccinees versus historic controls. Forty-two PCV7 recipients and 17 controls were hospitalized for Kawasaki disease (P = 0.012). After adjusting for potential confounding variables, this difference was not significant (P = 0.083). No association between Kawasaki disease and PCV7 was found.