Table 2.
Adverse event list after any vaccination
| Zagreb group (N = 600) |
Essen group (N = 598) |
Control group (N = 600) |
Total | p | |
|---|---|---|---|---|---|
| Total AEs, n (%) | 184 (30.7) | 220 (36.8) | 194 (32.3) | 598 (33.3) | 0.0677 |
| Solicited AEs, n (%) | 169 (28.2) | 205 (34.3) | 175 (29.2) | 549 (30.5) | 0.0498 |
| Local AEs, n (%) | 84 (14.0) | 100 (16.7) | 72 (12.0) | 256 (14.2) | 0.0658 |
| Pain | 78 (13.0) | 86 (14.4) | 60 (10.0) | 224 (12.5) | 0.0605 |
| Erythema | 16 (2.7) | 19 (3.2) | 14 (2.3) | 49 (2.7) | 0.6507 |
| Itch | 5 (0.8) | 19 (3.2) | 11 (1.8) | 35 (2.0) | 0.0140* |
| Swell | 8 (1.3) | 9 (1.5) | 5 (0.8) | 22 (1.2) | 0.5543 |
| Induration | 0 (0.0) | 1 (0.2) | 0 (0.0) | 1 (0.1) | 0.3326 |
| Systemic AEs, n (%) | 123 (20.5) | 151 (25.3) | 136 (22.7) | 410 (22.8) | 0.1478 |
| Fever | 94 (15.7) | 116 (19.4) | 108 (18.0) | 318 (17.7) | 0.2319 |
| Headache | 33 (5.5) | 37 (6.2) | 27 (4.5) | 97 (5.4) | 0.4146 |
| Fatigue | 20 (3.3) | 25 (4.2) | 22 (3.7) | 67 (3.7) | 0.7275 |
| Myalgia | 5 (0.8) | 11 (1.8) | 6 (1.0) | 22 (1.2) | 0.2621 |
| Arthralgia | 2 (0.3) | 7 (1.2) | 2 (0.3) | 11 (0.6) | 0.1077 |
| Nausea | 8 (1.3) | 8 (1.3) | 7 (1.2) | 23 (1.3) | 0.9660 |
| Allergy | 2 (0.3) | 6 (1.0) | 7 (1.2) | 15 (0.8) | 0.2286 |
| Unsolicited AEs, n (%) | 35 (5.8) | 45 (7.5) | 39 (6.5) | 119 (6.6) | 0.4982 |
*The incidence of itch: Essen group vs. control group p = 0.1440, Essen group vs. Zagreb group p = 0.0037.