Table 2. Adverse events (AEs) and serious adverse events (SAEs) in seronegative and seropositive adults.

	BKSE1.0		Saline (1.0 mL)
	Sero−	Sero+	Sero−	Sero+
	[n = 18] (%)	[n = 18] (%)	[n = 10] (%)	[n = 10] (%)
Local AEs
Induration	16 (88.9)	17 (94.4)	0	0
Pain	6 (33.3)	8 (44.4)	1 (10)	0
Tenderness	13 (72.2)	10 (55.5)	0	0
Swelling	3 (16.7)	0	0	0
Erythema	0	1 (5.6)	0	0
Redness	1 (5.6)	0	0	0
Hyperpigmentation	0	2 (11.1)	0	0
Systemic AEs
Fever (≥37.5°C)	3 (16.7)	2 (11.1)	2 (20)	1 (10)
Fatigue	1 (5.6)	1 (5.6)	0	0
Blood pressure decrease	0	1 (5.6)	0	0
Blood pressure increase	1 (5.6)	4 (22.2)	5 (50)	1 (10)
Dizziness	1 (5.6)	0	0	0
Headache	1 (5.6)	1 (5.6)	0	0
Serious AEs
Acute gastritis†	1 (5.6)	0	0	0

For local AEs, number and percentages refer to the number of subjects with at least one upper arm experiencing a specified symptom; however, subjects can experience the same symptom in both arms.

^†One subject experienced acute gastritis and was hospitalized. On follow-up, the subject later admitted that he took 2 tablets of metronidazole on the day of vaccination and had a remote history of abdominal pain associated with vomiting and diarrhea. The subject recovered without sequelae.