Table 3.

Incidence of solicited local and general symptoms reported during the 7-day period after each dose (Days 0–7 for dose 1, and Days 21–28 for dose 2), overall by participant (TVC)

					95% CI
Symptom	Type	N	n	%	LL	UL
Solicited local symptoms
Pain	All	50	46	92	80.8	97.8
	Grade 3	50	4	8	2.2	19.2
Redness	All	50	6	12	4.5	24.3
	Grade 3	50	0	0	0.0	7.1
Swelling	All	50	7	14	5.8	26.7
	Grade 3	50	0	0	0.0	7.1
Solicited general symptoms
Fatigue	All	50	27	54	39.3	68.2
	Grade 3	50	1	2	0.1	10.6
Gastrointestinal symptoms	All	50	12	24	13.1	38.2
	Grade 3	50	2	4	0.5	13.7
Headache	All	50	20	40	26.4	54.8
	Grade 3	50	2	4	0.5	13.7
Joint pain	All	50	14	28	16.2	42.5
	Grade 3	50	1	2	0.1	10.6
Muscle ache	All	50	33	66	51.2	78.8
	Grade 3	50	1	2	0.1	10.6
Shivering	All	50	10	20	10.0	33.7
	Grade 3	50	1	2	0.1	10.6
Sweating	All	50	7	14	5.8	26.7
	Grade 3	50	1	2	0.1	10.6
Temperature	All	50	1	2	0.1	10.6
	Grade 3	50	0	0	0.0	7.1
	Grade 4	50	0	0	0.0	7.1

N Number of participants with at least one documented dose, TVC Total vaccinated cohort

Symptom intensity was graded on a scale of 1 (mild) to 3 (severe) for all symptoms except for body temperature which was graded on a scale of 1 to 4. Grade 3 symptoms were defined as follows: for redness or swelling, a diameter > 100 mm; for fever, body temperature ≥ 39.0–40.0 °C (grade 4: > 40.0 °C); and for all other events, preventing normal activities