title: National study of adverse reactions after vaccination with bacille Calmette-Guérin.
abstract: Few large prospective studies of adverse reactions after bacille Calmette-Guérin (BCG) vaccination are available. In a prospective national study of such adverse reactions among 918 subjects (aged 1 day to 54 years) over a 14-month period, 45 vaccinees (5%) reported 53 adverse reactions (23 injection-site abscesses, 14 severe local reactions, 10 cases of lymphadenitis, and 6 other reactions). Only 1% of vaccinees required medical attention. Reactions, particularly lymphadenitis, were significantly less common in infants <6 months old (but not in subjects aged > or =6 months) vaccinated by trained (vs. untrained) providers (relative risk [RR], 0.24; 95% confidence interval [CI], 0.09-0.68). Injection-site abscesses (RR, 2.96; 95% CI, 1.11-7.90) and severe local reactions (RR, 4.93; 95% CI, 1.11-21.90) were significantly more common in older vaccinees. Local reactions were more frequently reported by adult females than by adult males (RR, 7.18; 95% CI, 1.59-32.45). Adverse reactions were not significantly associated with any currently available vaccine batch, previous receipt of BCG vaccine, or concomitant administration of other vaccines.
authors.affiliation: National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Royal Alexandra Hospital for Children and the University of Sydney, Sydney, Australia.
authors.forename: F M
authors.initials: FM
authors.lastname: Turnbull
authors.forename: P B
authors.initials: PB
authors.lastname: McIntyre
authors.forename: H M
authors.initials: HM
authors.lastname: Achat
authors.forename: H
authors.initials: H
authors.lastname: Wang
authors.forename: R
authors.initials: R
authors.lastname: Stapledon
authors.forename: M
authors.initials: M
authors.lastname: Gold
authors.forename: M A
authors.initials: MA
authors.lastname: Burgess
mesh_terms: D000293:Adolescent; D000328:Adult; D001500:BCG Vaccine / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D001500:BCG Vaccine