Table 3. Side effects after the first and the second doses of the vaccine.
| Characteristics | Patient group (n = 776) | Control group (n = 715) | p-value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Total (%) | Gr 1 (%) | Gr 2 (%) | Gr 3–4 (%) | Total (%) | Gr 1 (%) | Gr 2 (%) | Gr 3–4 (%) | ||
| First dose | 15.9 | 22.5 | 0.001† | ||||||
| Local pain | 5.7 | 5.3 | 0.4 | – | 9.7 | 8.3 | 1.1 | 0.3 | 0.005† |
| Erythema | 0.5 | 0.4 | 0.1 | – | 2.1 | 1.8 | 0.3 | – | 0.009† |
| Fever | 2.1 | 1.2 | 0.8 | 0.1 | 1.8 | 1.7 | – | 0.1 | 0.852 |
| Fatigue | 6.4 | 5.0 | 1.3 | 0.1 | 8.4 | 6.7 | 1.4 | 0.3 | 0.165 |
| Headache | 4.6 | 3.6 | 0.9 | 0.1 | 7.8 | 6.2 | 1.1 | 0.6 | 0.013† |
| Myalgia | 4.5 | 3.2 | 0.9 | 0.4 | 6.7 | 4.4 | 2.2 | 0.1 | 0.071 |
| Nausea | 1.8 | 1.7 | – | 0.1 | 1.4 | 1.4 | – | – | 0.681 |
| Diarrhea | 0.8 | 0.4 | 0.4 | – | 1.0 | 0.8 | 0.2 | – | 0.783 |
| Other | 0.9 | 0.9 | – | – | 2.6 | 2.6 | – | – | 0.269 |
| Second dose | 15.2 | 16.8 | 0.436 | ||||||
| Local pain | 5.0 | 4.6 | 0.4 | – | 7.7 | 6.2 | 1.3 | 0.3 | 0.042† |
| Fever | 1.3 | 1.0 | 0.3 | – | 2.1 | 2.0 | 0.1 | – | 0.234 |
| Fatigue | 6.7 | 4.9 | 1.5 | 0.3 | 6.4 | 5.1 | 1.0 | 0.3 | 0.917 |
| Headache | 4.5 | 3.7 | 0.8 | – | 4.8 | 3.5 | 0.7 | 0.6 | 0.902 |
| Myalgia | 4.9 | 3.4 | 1.0 | 0.5 | 5.9 | 4.3 | 1.0 | 0.6 | 0.422 |
| Nausea | 1.2 | 0.8 | 0.4 | 0.7 | 0.7 | – | – | 0.427 | |
| Diarrhea | 0.9 | 0.7 | 0.1 | 0.1 | 0.3 | 0.3 | – | – | 0.182 |
| Other | 1.1 | 1.1 | – | – | 1.3 | 1.3 | – | – | 0.647 |
†
Statistically significant results.
Gr: Grade.