Table 2

Side effects of BCG vaccination

Side effects of BCG vaccinationNotes
NoneA correctly given intradermal injection should produce a tense, blanched, raised bleb which generally results in a local reaction of a small pustule followed by a small scar. Local complications below occur in about 1:1000 given BCG vaccine
Injection site reaction/abscessLocal abscess can develop around 1 month post-vaccination. This is more common when vaccination is given at less than 6 months of age or when the vaccine is administered by an untrained vaccinator. These can usually be managed conservatively with no additional intervention. The efficacy of anti-tuberculous therapy for local abscess is unclear and limited by poor penetration of drugs into the abscess cavity
BCG lymphadenitisAdenitis in the regional lymph nodes is common and may be suppurative or non-suppurative. Non-suppurative nodes can be managed conservatively
There is a lack of consensus on suppurative node management.17 Options include conservative management, needle aspiration and surgical excision if there is sinus formation. Incision and drainage should be avoided
Disseminated BCG diseaseAlso called BCG-osis, occurs in the context of T cell immunodeficiencies, innate immunity, natural killer cells phagocytic or specific cytokine-mediated immune deficiencies (such as chronic granulomatous disease and Mendelian susceptibility to mycobacterial diseases). These should prompt investigation. It is defined by the presence of BCG in more than one anatomical site distant from the region of inoculation. Common sites include bones, skin, liver, spleen and lung. Mortality is high, in part reflecting the underlying immune deficiency. This condition should be managed by experts in paediatric immunology and infectious disease
Immune reconstitution inflammatory syndromeThis can occur following the initiation of antiretroviral therapy in HIV-infected BCG-vaccinated children or following successful haematopoietic stem cell transplant for SCID. This can manifest as local reaction, adenitis or systemic inflammatory response. This condition should be managed by experts in paediatric immunology and infectious disease
  • SCID, severe combined immunodeficiency.