Table 3.

Overview of Solicited Adverse Events and Other Indicators of Reactogenicity During a 7-Day Period After Vaccination

	Adult Subjects				Elderly Subjects
	(Age 18–64 y, n = 944)				(Age ≥65 y, n = 1376)
	First Vaccination		Second Vaccination		First Vaccination		Second Vaccination
	Full-Dose	Half-Dose	Full-Dose	Half-Dose	Full-Dose	Half-Dose	Full-Dose	Half-Dose
	(n = 468)	(n = 469)	(n = 450)	(n = 443)	(n = 692)	(n = 681)	(n = 676)	(n = 665)
Any reaction, %	72	56	53	43	52	39	39	28
Local reactions, No. of subjects	460–462	464–466	445–448	439–442	677–685	667–673	672–674	660–662
Local reactions, %	63	43	48	34	38	22	29	17
Pain (% severe), %	63 (<1)	43 (1)	48 (0)	34 (<1)	38 (0)	21 (0)	29 (<1)	16 (<1)
Ecchymosis (% severe), %	1 (0)	<1 (0)	1 (0)	1 (0)	<1 (0)	1 (0)	1 (0)	1 (0)
Erythema (% severe), %	1 (0)	0	0	0	2 (0)	<1 (0)	1 (0)	<1 (0)
Induration (% severe), %	3 (<1)	1 (0)	1 (0)	<1 (0)	2 (0)	1 (0)	2 (0)	<1 (0)
Systemic reactions, No. of subjects	452–457	452–460	439–446	432–438	668–688	656–677	663–676	652–664
Systemic reactions, %	43	38	27	23	28	26	19	17
Fatigue (% severe), %	23 (1)	19 (1)	13 (<1)	11 (0)	12 (<1)	11 (<1)	9 (<1)	9 (<1)
Nausea (% severe), %	7 (1)	8 (<1)	6 (<1)	4 (0)	4 (<1)	4 (<1)	3 (0)	3 (<1)
Malaise (% severe), %	21 (2)	16 (1)	12 (<1)	9 (0)	12 (<1)	12 (<1)	8 (<1)	8 (<1)
Myalgia (% severe), %	19 (1)	14 (<1)	10 (0)	8 (0)	10 (0)	10 (0)	7 (<1)	5 (0)
Arthralgia (% severe), %	12 (1)	9 (1)	6 (0)	5 (0)	6 (<1)	8 (<1)	5 (<1)	4 (<1)
Headache (% severe), %	21 (1)	20 (<1)	14 (<1)	11 (0)	10 (<1)	10 (<1)	6 (<1)	6 (0)
Loss of appetite (% severe), %	8 (<1)	7 (<1)	5 (<1)	3 (0)	4 (0)	5 (<1)	4 (0)	2 (0)
Temperature, % ≥38°C (% ≥40°C)	2 (<1)	2 (0)	1 (0)	<1 (0)	2 (0)	<1 (0)	1 (0)	<1 (0)
Other reactions, No. of subjects	458–465	456–462	434–449	429–438	678–688	671–677	673–676	657–664
Prevention of pain/fever (% severe), %	3 (1)	8 (2)	4 (1)	6 (1)	10 (1)	18 (3)	11 (2)	8 (1)
Treatment of pain/fever (% severe), %	34 (7)	24 (5)	15 (3)	7 (2)	36 (5)	29 (4)	23 (3)	19 (3)