title: Serious adverse events associated with bacille Calmette-Guérin vaccine in Canada.
abstract: BACKGROUND
  Targeted Bacille Calmette-Guérin (BCG) vaccination is offered to neonates in some First Nations and Inuit (FNI) communities in Canada. Serious adverse events associated with BCG vaccine prompted a review to assess causality.
  
  
  METHODS
  The Immunization Monitoring Program Active (IMPACT), a pediatric hospital-based active surveillance network, reported admissions for BCG-related adverse events between 1993 and April 2002. The Canadian Advisory Committee on Causality Assessment (ACCA) reviewed the reports to assess causality. Data between 1987 and September 2002 from the Vaccine-Associated Adverse Event Surveillance (VAAES) Program, a passive national reporting system, were also reviewed.
  
  
  RESULTS
  IMPACT identified 21 pediatric cases; 19 were Canadian-born, and 18 were FNI. Six disseminated BCG cases were identified; 5 were FNI infants who subsequently died. All had immunodeficiencies and concurrent infections. Other adverse events included 2 cases of osteomyelitis, BCG abscesses and lymphadenitis. ACCA reviewed the 21 cases and determined that 14 were very likely associated with the vaccine, including the 6 disseminated BCGs; 5 were probably associated and 1 was possibly associated with the vaccine; 1 was unclassifiable. The VAAES program identified 157 adverse events. No additional serious systemic adverse events (disseminated BCG or osteomyelitis) were identified.
  
  
  CONCLUSIONS
  Serious BCG vaccine-associated complications continue to occur in Canada. The numbers of FNI children with disseminated disease was greater than expected from reported rates in the literature.
authors.affiliation: Immunization and Respiratory Infections Division, Community Acquired Infections Division, Public Health Agency of Canada, Health Canada, Ottawa, Ontario.
authors.forename: Shelley L
authors.initials: SL
authors.lastname: Deeks
authors.forename: Michael
authors.initials: M
authors.lastname: Clark
authors.forename: David W
authors.initials: DW
authors.lastname: Scheifele
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Law
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Dawar
authors.forename: Nooshin
authors.initials: N
authors.lastname: Ahmadipour
authors.forename: Wikke
authors.initials: W
authors.lastname: Walop
authors.forename: C Edward
authors.initials: CE
authors.lastname: Ellis
authors.forename: Arlene
authors.initials: A
authors.lastname: King
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D002170:Canada / Q000453:epidemiology / Q000208:ethnology; D005260:Female; D006801:Humans; D017589:Immunization Programs; D007198:Indians, North American; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009163:Mycobacterium bovis / Q000276:immunology; D010019:Osteomyelitis / Q000453:epidemiology / Q000208:ethnology / Q000209:etiology; D014376:Tuberculosis / Q000453:epidemiology / Q000208:ethnology / Q000209:etiology / Q000517:prevention & control*
chemical_list: D001500:BCG Vaccine