Table 4.

UnSolicited adverse events reported after administration of BBV154 or Covaxin.

Adverse events	BBV154 (N = 2989) [m] n (%)	Covaxin® (N = 161) [m] n (%)
Overall	[45] 36(1.2%)	[5] 5(3.1%)
Cough	[13] 13 (0.8%)	[2] 2 (1.2%)
Rhinorrhoea	[3] 3 (0.1%)	[2] 2 (1.2%)
Nasal pruritus	[4] 3 (0.1%)	[0] 0 (0.0%)
Nasal congestion	[2] 2 (0.1%)	[0] 0 (0.0%)
Nasal discomfort	[1] 1 (0.0%)	[0] 0 (0.0%)
Sneezing	[1] 1 (0.0%)	[0] 0 (0.0%)
Lower respiratory tract infection	[1] 1 (0.0%)	[0] 0 (0.0%)
Upper respiratory tract infection	[1] 1 (0.0%)	[0] 0 (0.0%)
Pyrexia	[3] 3 (0.1%)	[0] 0 (0.0%)
Fatigue	[2] 2 (0.1%)	[0] 0 (0.0%)
Malaise	[0] 0 (0.0%)	[2] 2 (1.2%)
Chills	[1] 1 (0.0%)	[0] 0 (0.0%)
Headache	[5] 5 (0.2%)	[0] 0 (0.0%)
Dizziness	[1] 1 (0.0%)	[0] 0 (0.0%)
Diarrhoea	[1] 1 (0.0%)	[1] 1 (0.6%)
Stomatitis	[1] 1 (0.0%)	[0] 0 (0.0%)
Irritability	[2] 2 (0.1%)	[0] 0 (0.0%)
Radius fracture	[1] 1 (0.0%)	[0] 0 (0.0%)
Rhinitis	[1] 1 (0.0%)	[0] 0 (0.0%)
Rhinorrhoea	[1] 1 (0.0%)	[0] 0 (0.0%)
Vestibular neuronitis	[1] 1 (0.0%)	[0] 0 (0.0%)
Myalgia	[1] 1 (0.0%)	[0] 0 (0.0%)

m = No. of adverse events, n = No. of participants.

% is calculated by dividing the No. of participants reporting AE by total No. of participants in respective treatment group.