Table 2.
Symptoms | 23vPPV (N=2340), n (%) | Saline placebo (N=2332), n (%) | P value |
Any symptom | 805 (34.40) | 240 (10.30) | <.001 |
Any local symptoms | 660 (28.21) | 59 (2.53) | <.001 |
Redness at injection site | 146 (6.24) | 12 (0.51) | <.001 |
Swelling at injection site | 207 (8.85) | 12 (0.51) | <.001 |
Pain at injection site | 587 (25.09) | 49 (2.10) | <.001 |
Limited arm movement | 224 (9.57) | 11 (0.47) | <.001 |
Any systemic symptom | 438 (18.72) | 180 (7.72) | <.001 |
Fever (reported) | 81 (3.46) | 54 (2.32) | .02 |
Fatigue | 199 (8.50) | 103 (4.42) | <.001 |
Headache | 172 (7.35) | 98 (4.20) | <.001 |
Chills | 56 (2.39) | 30 (1.29) | <.001 |
Rash | 31 (1.32) | 3 (0.13) | <.001 |
Extensive arm swellinga | 13 (0.55) | 0 (0.0) | <.001 |
Generalized muscle pain | 217 (9.27) | 64 (2.74) | <.001 |
Generalized joint pain | 50 (2.14) | 32 (1.37) | .047 |
Medical advice sought (symptomatic patients)b | 15 (1.9) | 18 (7.5) | <.001 |
aDescribed as elbow joint to shoulder joint.
b23vPPV: N=790, saline placebo: N=240.