Local and regional adverse reactions to BCG-SSI vaccination: a 12-month cohort follow-up study.

Abstract In a 12-month cohort follow-up study of 2435 children vaccinated in 2007 by Statens Serum Institute BCG strain (BCG SSI ® ), 17.8% had an adverse event (AE): erythema 12.4%, induration 12.2%, abscesses 2.5%, ulceration 0.9%, lymphadenitis 0.1%. The factors associated with a lower risk of AE were: age at vaccination 1 year (OR = 0.35 [0.2–0.6] for age ® vaccination were frequent but rarely severe.