BACKGROUND. Vaccines have been reported as uncommon triggers for KD .
After a case of KD onset in the same day after second dose of Rotavirus vaccine ( Rotateq) and first of meningococcal B vaccine ( Bexsero) , we reviewed KD cases reported after administration of these two vaccines in Emilia- Romagna, Italy, and in Europe ( Eudravigilance) .
METHODS. We reviewed forms of notification of adverse reactions of Italian Agency of Drug in Emilia Romagna ( 2017-2023) and of Eudravigilance ( 2001-2023) filled out with KD diagnosis after Rotavirus and Meningococcal B vaccines.
RESULTS. In Emilia Romagna, 6 cases of KD after vaccines against Rotavirus ( Rotateq) and Meningococcus B ( Bexsero) have been reported . Two cases after combination of immunization against Rotateq and Bexsero ; 1 case after combination of Rotateq, hexavalent and Pneumococcal vaccines; 3 cases after Bexsero.
The average of Reporting rate for dose of vaccine administrated is 0,00001 for Rotateq and 0,000011 for Bexsero.
ROR ( Reportig odds ratio) :1,36 ( IC: 0,72-2,59) for Rotateq and 1,59 ( IC: 0,63- 4,03) for Bexsero.
Of these 6 cases, 5 cases were male and 1 female. The median age at the onset of KD was 8,83 months; 3 cases in summer, 2 cases in spring and 1 case in winter.
4 cases presented KD in the same day of the immunization, 1 case after 4 days and 1 case after 6 days with a median day of KD onset of 1,6 days after immunization.
About the 3 cases of KD after immunization with Rotateq , the median age at KD onset was 2,6 months and the median day of KD appearence after immunization was 2 days.
About the 5 cases of KD after Bexsero , the median age at KD onset was 12 months and the median day of KD onset was 1 day.
In Europe 364 cases of KD after administration of Rotateq and Rotarix have been reported from 2001 and the average of reporting rate for dose of vaccine administrated is 0,00002 .
For Bexsero , in Europe, 84 cases of KD after immunization