Table 1.

Mean SF-36 PF Scale Scores at Baseline and Post-Dose 2 (Total Vaccinated Cohort)

		Baseline		Days 1–7 Post-Dose 2		Mean Change From Baseline to Post-Dose 2	SE of the Mean Change
		N	Mean Score	N	Mean Score
Overall		391	82.0	389	81.8	−0.4	0.53
Age category (y)	50–59	132	90.3	131	90.6	0.3	0.79
	60–69	130	81.8	130	81.3	−0.5	0.85
	≥70	129	73.7	128	73.2	−0.9	1.08
Reactogenicity grade	0	63	78.5	61	82.5	3.2	1.35
	1 and 2	267	82.6	267	81.9	−0.7	0.65
	3	61	82.8	61	80.4	−2.4	1.01
Adverse event type	None	59	79.0	57	82.1	2.2	1.24
	Local	302	82.7	302	81.9	−0.8	0.58
	Systemic	245	83.5	245	82.3	−1.2	0.60
Gender	Male	161	80.8	159	81.6	0.4	0.89
	Female	230	82.8	230	81.9	−0.9	0.64
Frailty status	Non-Frail	229	91.4	228	91.4	0.0	0.60
	Pre-Frail	141	72.4	140	71.9	−0.9	1.04
	Frail	21	43.7	21	43.7	0.0	2.39

Note: N = total number of participants; PF = physical functioning; SE = standard errors; ; SF-36 = Short Form Survey-36; high score represents high level of functioning/quality of life. Baseline is calculated as the mean of the Day −7, Day 0 (pre-dose 1) and Day 60 (pre-dose 2). Reactogenicity grading: 0 (none/normal); 1 (mild); 2 (moderate); 3 (severe; prevents normal activity); for swelling/redness; greatest surface diameter 0 (<20 mm); 1 (≥20 mm–≤50 mm); 2 (>50 mm–≤100 mm); 3 (>100 mm); for temperature: 0 (<37.5°C); 1 (37.5°C–38.0°C); 2 (38.1°C–39.0°C); 3 (>39.0°C).