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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, five infants were described [two girls and three boys; not all ages stated], who developed disseminated Bacillus Calmette Guerin (BCG) infections following an inadvertent administration of BCG vaccines to immunodeficient infants [Danish-SSI 1331; dosages, routes and times to reactions onsets not stated; not all outcomes stated].
Patient 1: The 4-month-old girl, who had received BCG vaccine at her birth, presented with erythematous skin nodules and persistent fever. Upon review of her medical history, it was revealed that one of her siblings and died at 20 days of age due to meningitis, and an another sibling died in infancy due to a presumed familial haemophagocytic lymphohistiocytosis. Based on the history, it was determined that the BCG vaccine was...