Clinical Characteristics and Outcomes of Adverse Reactions to Chinese Bacille Calmette- Guérin (BCG) Vaccine: A Single-Center Retrospective Study

Abstract

Background: Bacille Calmette-Guérin (BCG) is widely used and considered to be the safest vaccine for preventing tuberculosis (TB). However, there are potential complications associated with BCG vaccination, such as adverse reactions at the injection site, regional lymphadenitis and disseminated BCG. Currently, there is limited research on the management of adverse reactions specifically related to the Chinese BCG vaccine. This article presents a detailed description of the clinical features, management strategies, and outcomes of BCG complications at a large TB-specialized hospital in Guangdong Province, China. Methods: This observational study included all children who presented with complications of BCG vaccination between January 2016 and December 2020. Medical and electronic laboratory records were examined to ascertain clinical characteristics, treatment approaches, and outcomes. Results: A total of 76 children presented with adverse reactions following BCG vaccination. Among them, 14 (18.4%) had injection site adverse reactions classified as follow: ulceration, lichenoid lesions, superficial abscesses covered by a scab or deep abscesses. Only 5 cases (35.7%) with deep abscesses were treated with oral isoniazid and surgical interventions. 55 cases (72.4%) of all had regional lymphadenitis, with 32 patients (58.2%) being less than 6 months old. Suppurative lymphadenitis was seen in 31 of 55 cases (56.4%) who all recovered fully by oral antituberculosis drugs and surgery. 7 cases (9.2%) had disseminated BCG, among whom primary immunodeficiency (PID) was identified in two (28.6%). All disseminated cases received treatment involving at least three kinds of antituberculosis drugs and 6 cases (85.7%) were improved. Conclusions: Injection site adverse reactions to the BCG vaccine can present with various cutaneous manifestations, and the majority of patients do not require antituberculosis drugs and surgery. Regional lymphadenitis is the most predominant complications, and more than half of these cases are suppurative. Surgical interventions combined with anti-tuberculosis medications for suppurative lymphadenitis tends to be effective and safe. Early diagnosis and prompt treatment for disseminated BCG disease are likely to contribute to a good prognosis.