Table 5.

Adverse events of special interest.

	Total BCG (Stage 1 & 2) n = 3379	BCG (Stage 1) n = 1387	BCG (Stage 2) n = 1992	Placebo n = 1972
Injection site abscess	55 (1.6%)	41 (3.0%)	14 (0.7%)	0 (0.0%)
Large ulcer (>1.5 cm)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Keloid scar	2 (0.06%)	0 (0.0%)	2 (0.1%)	0 (0.0%)
Unusual local reaction*	4 (0.1%)	4 (0.3%)	0 (0.0%)	1 (0.05%)
Regional lymphadenopathy (axillary/neck)	101 (3.0%)	48 (3.5%)	53 (2.7%)	9 (0.5%)
Allergic reaction due to BCG**	1 (0.03%)	0 (0.0%)	1 (0.05%)	–
Vasovagal episode following vaccination†	3 (0.1%)	2 (0.1%)	1 (0.05%)	0 (0.0%)
BCG osteitis/osteomyelitis	0 (0.0%)	0 (0.0%)	0 (0.0%)	–
Disseminated BCG infection (BCG-osis)	0 (0.0%)	0 (0.0%)	0 (0.0%)	–

*BCG: 2 participants had a persistent firm swelling at the BCG site, without meeting abscess criteria; one surgically removed by local medical practitioner with local anaesthetic four months post vaccination, and the other (onset day 35 following vaccination, size 3 cm diameter) self-resolved after three months. One participant had a painful shoulder with restricted movement (onset day 51 following vaccination) self-resolving within one week. One participant had a diagnosis of disseminated granuloma annulare, commencing two months following vaccination, with a single buttock lesion.

*Placebo: 1 participant with intermittent tingling from left shoulder to elbow (onset day 30 following vaccination) self-resolving after 2–3 weeks.

**Participant with localized urticaria in left arm progressing to generalized pruritis, onset day 1, treated with antihistamines, resolved within one week.

^†All occurred following blood sampling and receiving vaccination in patients with history of needle-associated vasovagal episodes.