Table 2

Frequency of adverse events included in the study

Type	n	%	Events	n	%
Fever	446 223	12.68	Fever symptoms	268 921	7.64
			High fever (>39.5°C)	5334	0.15
			Mild fever (≤38.5°C)	139 397	3.96
			Moderate fever (38.6°C–39.5°C)	32 571	0.93
Gastrointestinal	432 509	12.29	Diarrhoea	218 436	6.21
			Loss of appetite	9520	0.27
			Nausea	23 177	0.66
			Vomiting	181 376	5.16
General symptoms	245 240	6.97	Drowsiness	771	0.02
			Fatigue	41 285	1.17
			Headache	153 319	4.6
			Malaise	45 383	1.29
			O/E—irritable	4482	0.13
Local symptoms	259	0.01	Local erythema	259	0.01
Musculoskeletal	136 835	3.89	Myalgia	134 940	3.84
Musculoskeletal	136 835	3.89	Postimmunisation arthropathy	1895	0.05
Neurological	32 363	0.92	Bell’s palsy	1807	0.05
			Convulsion/febrile convulsion	27 688	0.79
			Guillain-Barre syndrome	113	0.00
			Tremor	2755	0.08
Rash	511 090	14.53	Rash	511 090	14.53
Respiratory/miscellaneous	1 679 864	47.75	Acute conjunctivitis	311 701	8.86
			Acute coryza	55 489	1.58
			Cough	841 733	23.93
			Epistaxis	59 632	1.70
			Hoarse	4120	0.12
			Nasal airway obstruction	54 162	1.54
			Rhinorrhoea	14 579	0.41
			Sore mouth/throat pain	219 808	6.25
			Wheezing	118 640	3.37
Sensitivity/anaphylaxis	33 664	0.96	Adverse drug reaction/vaccine allergy	29 217	0.83
			Drug-induced anaphylaxis	1058	0.03
			Facial swelling	3389	0.10
Total	3 518 047	100%	Total	3 518 047	100.00