Case definitions
BCG-osis, allergic reaction, regional lymphadenopathy, abscess, osteitis/osteomyelitis, ulcer
SCAR, ALLERGIC REACTION, ADVERSE EVENT, BCG INFECTION, ABSCESS, REGIONAL LYMPHADENOPATHY, VASOVAGAL EPISODE, ULCER
BCG-revaccination was defined as BCG vaccination in a participant who had any prior BCG vaccination history. Adverse events of special interest included: injection site abscess, large ulcer (>1.5 cm diameter), keloid scar, unusual local reaction, regional lymphadenopathy, BCG osteitis/osteomyelitis, disseminated BCG infection (BCG-osis), allergic reaction due to vaccination or vasovagal episode following vaccination. Further details on case definitions are provided in Supplementary Material 1.