Nature of adverse event | Description | Rate/doses |
Mild | Injection site papule (onset 2–4 weeks) | |
Mild ulceration (1–2 months) | Almost all vaccinees | |
Scar (2–5 months) | ||
Severe | Local | |
Local abscess | ||
Keloid | ||
Lymphadenitis | ||
Suppuration (onset 2–6 months) | 1 per 1000–10 000 | |
Systemic (onset 1–12 months) | ||
Cutaneous skin lesions | Case reports only | |
Osteitis | 1 per 3333–108 | |
Disseminated BCG | 1 per 230 000–640 000 | |
Immune reconstitution syndrome | 1 per 640 000 |
BCG: bacille Calmette–Guérin. Modified from [12].