Clinical Characteristics and Outcomes of Severe Adverse Reactions to Bacille Calmette-Guérin (BCG) Vaccination in China: A Single-Center Retrospective Study

Objectives This study investigated the clinical features, treatment approaches, and outcomes of severe Bacille Calmette-Guérin (BCG) vaccine complications in Chinese children. Introduction BCG is the only available vaccine for tuberculosis (TB) prevention but can cause serious complications such as local abscesses, lymphadenitis, and disseminated BCG. Research on their management in China is limited. Methods This observational study reviewed 95 children with severe BCG-related complications treated at a tuberculosis-specialized hospital in Guangdong, China (2016-2020). Of these, 33 (34.7%) had injection site reactions, 55 (57.9%) developed lymphadenitis with 31 suppurative cases, and 7 (7.4%) had disseminated BCG. All deep abscesses and suppurative lymphadenitis were successfully treated with surgery and anti-tubercular therapy. Two disseminated BCG cases had primary immunodeficiency, and 1 of them died. Conclusion Most local reactions respond to conservative treatment. Surgery combined with anti-tubercular therapy is effective for suppurative lymphadenitis. Early immunological evaluation is essential for disseminated disease.