Table 1.
Vaccine-related adverse events | I dose N (%) |
II dose N (%) |
P-value* |
---|---|---|---|
Mild | 275 (80.9) | 273 (80.3) | 0.845 |
Pain, redness and swelling at the injection site | 265 (77.9) | 223 (65.6) | < 0.001 |
Fatigue | 66 (19.4) | 135 (39.7) | < 0.001 |
Headache | 52 (15.3) | 98 (28.8) | < 0.001 |
Fever ≤ 38 °C | 5 (1.5) | 46 (13.5) | < 0.001 |
Chills | 20 (5.9) | 90 (26.5) | < 0.001 |
Abdominal pain | 3 (0.9) | 26 (7.6) | < 0.001 |
Nausea | 7 (2.1) | 33 (9.7) | < 0.001 |
Insomnia | 5 (1.5) | 8 (2.4) | 0.401 |
Sleep disorders | 8 (2.4) | 20 (5.9) | 0.020 |
Moderate | 40 (11.8) | 126 (37.1) | < 0.001 |
Fever > 38 °C and < 39 °C | 0 (0) | 23 (6.7) | < 0.001 |
Lymphadenopathy | 8 (2.4) | 23 (6.7) | < 0.001 |
Myalgia/Arthralgia | 31 (9.1) | 115 (33.8) | < 0.001 |
Local urticaria | 2 (0.6) | 2 (0.6) | Not computable |
Vomit | 0 (0) | 3 (0.8) | 0.082 |
Diarrhoea | 7 (2.1) | 21 (6.2) | 0.007 |
Severe | 13 (3.8) | 16 (4.7) | 0.569 |
Dyspnoea | 0 (0) | 1 (0.3) | 0.317 |
Paraesthesia | 11 (3.2) | 11 (3.2) | Not computable |
Generalized urticaria | 3 (0.9) | 0 (0) | 0.082 |
Fever ≥ 39 °C | 0 (0) | 4 (1.2) | 0.045 |
*Chi-square test; significant results (p < 0.05) are indicated in bold