Classification:
(1) regional disease
(2) extra-regional, localized disease
(3) disseminated disease
(4) other BCG-related syndromes that may be immune-based (no organisms isolated on culture)
Regional disease includes any of the following limited to the inoculation area:
(1) persistent ulcer
(2) abscess
(3) fistula
(4) lymphadenopathy
Extra-regional localized disease - both of the following:
(1) infection at a single anatomic site AND
(2) outside of the inoculation site
Disseminated disease - all 3 of the following are present:
(1) isolation and identification of BCG
(2) infection in 2 or more sites beyond the vaccination site OR positive bone marrow culture OR positive blood culture
(3) systemic symptoms consistent with mycobacterial disease
Other syndromes probably due to an immune response may include:
(1) keloid formation
(2) uveitis
(3) arthritis
