Table 2.
1st Dose (n = 416) | 2nd Dose (n = 407) | |||||||
---|---|---|---|---|---|---|---|---|
Non-AIRD 1
(n = 134, 75.7%) |
AIRD (n = 173, 72.4%) |
p Value (0.499) | Total Adverse Events (n = 307) |
Non-AIRD (n = 125, 70.6%) |
AIRD (n = 148, 61.9%) |
p Value (0.076) | Total Adverse Events (n = 273) | |
Pain in injection site | 81 (45.3%) | 99 (41.4%) | 0.485 | 180 | 86 (48%) | 82 (34.3%) | 0.005 | 168 |
Local swelling | 9 (5%) | 6 (2.5%) | 0.192 | 15 | 6 (3.4%) | 4 (1.7%) | 0.338 | 10 |
Local redness | 22 (12.3%) | 23 (9.6%) | 0.427 | 45 | 8 (4.5%) | 7 (2.9%) | 0.435 | 15 |
Fatigue | 46 (25.7%) | 51 (21.3%) | 0.349 | 97 | 41 (22.9%) | 52 (21.8%) | 0.813 | 93 |
Headache | 33 (18.4%) | 44 (18.4%) | 1 | 77 | 24 (13.4%) | 25 (10.5%) | 0.361 | 49 |
Myalgia | 24 (13.4%) | 35 (14.6) | 0.777 | 59 | 25 (14%) | 25 (10.5%) | 0.289 | 50 |
New/increased joint pain | 25 (14%) | 35 (14.7%) | 0.888 | 60 | 10 (5.6%) | 20 (8.4%) | 0.340 | 30 |
Chills | 24 (13.4%) | 35 (14.6%) | 0.777 | 59 | 28 (15.6%) | 34 (14.5%) | 0.782 | 62 |
Fever | 8 (4.5%) | 13 (5.4%) | 0.822 | 21 | 22 (12.3%) | 24 (10%) | 0.528 | 46 |
Allergic reactions | 3 (1.7%) | 2 (0.8%) | 0.655 | 5 | 1 (0.6%) | 0 (0%) | 0.427 | 1 |
Skin rash | 3 (1.7%) | 3 (1.3%) | 1 | 6 | 1 (0.6%) | 0(0%) | 0.428 | 1 |
Anaphylactic shock | 0 (0%) | 0 (0%) | 0 | 0 | 0 (0%) | 1 (0.4%) | 1 | 1 |
Lymphadenopathy | 4 (2.2%) | 5 (2.1%) | 1 | 9 | 5 (2.9%) | 4 (1.7%) | 0.501 | 9 |
Paresthesia | 1 (0.6%) | 6 (2.5%) | 0.247 | 7 | 2 (1.2%) | 5 (2.1%) | 0.704 | 7 |
Digestive symptoms | 4 (2.2%) | 5 (2.1%) | 1 | 9 | 7 (4%) | 12 (5%) | 0.813 | 19 |
Dizziness | 2 (1.1%) | 7 (2.9%) | 0.311 | 9 | 6 (3.5%) | 6(2.5%) | 0.569 | 12 |
Cough | 3 (1.7%) | 0 (0%) | 0.078 | 3 | 1 (0.6%) | 0 (0%) | 0.420 | 1 |
1 AIRD—autoimmune rheumatic diseases. Statistical significant values are marked with Bold.