National study of adverse reactions after vaccination with bacille Calmette-Guérin
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Date
2002
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Turnbull, F.
McIntyre, P.
Achat, H.
Wang, H.
Stapledon, R.
Gold, M.
Burgess, M.
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Clinical Infectious Diseases, 2002; 34(4):447-453
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F. M. Turnbull, P. B. McIntyre, H. M. Achat, H. Wang, R. Stapledon, M. Gold, and M. A. Burgess
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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 6 months) vaccinated by trained (vs. untrained) providers (relative risk [RR], 0.24; 95% confidence interval [CI], 0.090.68). Injection-site abscesses (RR, 2.96; 95% CI, 1.117.90) and severe local reactions (RR, 4.93; 95% CI, 1.1121.90) 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, 1.5932.45). Adverse reactions were not significantly associated with any currently available vaccine batch, previous receipt of BCG vaccine, or concomitant administration of other vaccines.
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© 2002 by the Infectious Diseases Society of America