Table 4.

Summary of adverse events following vaccination with PPSV23 by number of risk factors (Month 6–month 7).

n (%)	1 risk factor		≥2 risk factors
	V114 n = 561	PCV13 n = 190	V114 n = 211	PCV13 n = 69
Any AE	454 (80.9)	158 (83.2)	170 (80.6)	52 (75.4)
Injection-site†	428 (76.3)	142 (74.7)	167 (79.1)	49 (71.0)
Systemic	313 (55.8)	114 (60.0)	102 (48.3)	29 (42.0)
Any vaccine-relatedAE‡	446 (79.5)	149 (78.4)	169 (80.1)	50 (72.5)
Systemic	274 (48.8)	99 (52.1)	84 (39.8)	23 (33.3)
Any SAE	1 (0.2)	2 (1.1)	1 (0.5)	0 (0.0)
Any vaccine-relatedSAE†	0 (0.0)	1 (0.5)	0 (0.0)	0 (0.0)
Deaths	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Solicited AE	447 (79.7)	155 (81.6)	169 (80.1)	50 (72.5)
Solicited injection-site AE	427 (76.1)	142 (74.7)	166 (78.7)	49 (71.0)
Injection-site erythema	151 (26.9)	56 (29.5)	45 (21.3)	16 (23.2)
Injection-site pain	417 (74.3)	138 (72.6)	156 (73.9)	46 (66.7)
Injection-site swelling	190 (33.9)	71 (37.4)	68 (32.2)	21 (30.4)
Solicited systemic AE	293 (52.2)	107 (56.3)	100 (47.4)	26 (37.7)
Arthralgia	66 (11.8)	24 (12.6)	29 (13.7)	6 (8.7)
Fatigue	182 (32.4)	72 (37.9)	64 (30.3)	15 (21.7)
Headache	128 (22.8)	46 (24.2)	39 (18.5)	12 (17.4)
Myalgia	154 (27.5)	58 (30.5)	54 (25.6)	17 (24.6)

Pre-defined risk factors include chronic liver, lung, and heart disease, diabetes mellitus, tobacco use, and alcohol consumption. The risk factor of alcohol consumption is defined as an AUDIT-C score ≥5.

AE: adverse event; AUDIT-C: Alcohol Use Disorders Identification Test – Consumption; PCV13: 13-valent pneumococcal conjugate vaccine; PPSV23: 23-valent pneumococcal polysaccharide vaccine; SAE: serious adverse event; V114: 15-valent pneumococcal conjugate vaccine.

^†All injection-site AEs were considered related to the vaccine by the investigator.

^‡Determined by the investigator to be related to the vaccine.