Table 2– Summary of mild and severe adverse events
Nature of adverse eventDescriptionRate/doses
MildInjection site papule (onset 2–4 weeks)
Mild ulceration (1–2 months)Almost all vaccinees
Scar (2–5 months)
SevereLocal
Local abscess
Keloid
Lymphadenitis
Suppuration (onset 2–6 months)1 per 1000–10 000
Systemic (onset 1–12 months)
Cutaneous skin lesionsCase reports only
Osteitis1 per 3333–108
Disseminated BCG1 per 230 000–640 000
Immune reconstitution syndrome1 per 640 000
  • BCG: bacille Calmette–Guérin. Modified from [12].