Summary of registered adverse events over the entire study period.
pneumonitis, hip dysplasia, depression, TBEV
PNEUMONITIS
Briefly, cohorts A1, A2 and C, all of which received TBEV vaccinations, had a greater number of total registered AEs compared to the other cohorts, ascribed to multiple (n = 3) TBEV vaccinations. Cohorts B1, B2, and D, all of which received JEV vaccinations, had greater number of total registered AEs compared to the E cohort, concordantly ascribed to multiple (n = 2) JEV vaccinations. At total of four AEs were deemed severe, all of which were determined SAEs. These SAEs included one case with hip dysplasia in a newborn child of a study participant, one case with pneumonitis, one case with depression, and one case with a fall, all four of which were determined to be unrelated to vaccination. These SAEs were all, in accordance with regulatory rules, reported to the Swedish Medical Product Agency.