Table 1.
Adverse reactions | Women ( n = 1107) | Men ( n = 290) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
After first dose | After second dose | After first dose | After second dose | |||||||||
No. | Frequency (%) | Proportion (%) | No. | Frequency (%) | Proportion (%) | No. | Frequency (%) | Proportion (%) | No. | Frequency (%) | Proportion (%) | |
Total adverse reactions | 178 | 16.1 | 100 | 169 | 15.3 | 100 | 23 | 7.9 | 100 | 35 | 12.1 | 100 |
Solicited adverse reactions | ||||||||||||
Injection site adverse reactions (Pain,induration,redness,swelling, or itch) | 116 | 10.5 | 65.2 | 124 | 11.2 | 73.4 | 13 | 4.5 | 56.5 | 25 | 8.6 | 71.4 |
Systemic adverse reactions | ||||||||||||
Muscle pain | 98 | 8.9 | 55.1 | 93 | 8.4 | 55.0 | 10 | 3.4 | 43.5 | 16 | 5.5 | 45.7 |
Fatigue | 96 | 8.7 | 53.9 | 78 | 7.0 | 46.2 | 9 | 3.1 | 39.1 | 13 | 4.5 | 37.1 |
Headache, Dizziness | 69 | 6.2 | 38.8 | 40 | 3.6 | 23.7 | 7 | 2.4 | 30.4 | 8 | 2.8 | 22.9 |
Fever | 29 | 2.6 | 16.3 | 9 | 0.8 | 5.3 | 3 | 1.0 | 13.0 | 5 | 1.7 | 14.3 |
Vomiting, Diarrhea | 16 | 1.4 | 9.0 | 9 | 0.8 | 5.3 | 3 | 1.0 | 13.0 | 4 | 1.4 | 11.4 |
Appetite impaired, Nausea | 15 | 1.4 | 8.4 | 11 | 1.0 | 6.5 | 0 | 0 | 0 | 2 | 0.7 | 5.7 |
Allergic reaction, urticaria, rash | 10 | 0.9 | 5.6 | 0 | 0 | 0 | 2 | 0.7 | 8.7 | 0 | 0 | 0 |
Stuffy, runny nose | 9 | 0.8 | 5.1 | 5 | 0.5 | 3.0 | 1 | 0.3 | 4.3 | 0 | 0 | 0 |
Cough, Throat pain | 8 | 0.7 | 4.5 | 6 | 0.5 | 3.6 | 2 | 0.7 | 8.7 | 1 | 0.3 | 2.9 |
Lymphadenopathy | 2 | 0.2 | 1.1 | 3 | 0.3 | 1.8 | 1 | 0.3 | 4.3 | 1 | 0.3 | 2.9 |
Non-solicited adverse reactions | ||||||||||||
(Menstruation, chest pain, numbness of limbs) | 6 | 0.5 | 3.4 | 3 | 0.3 | 1.8 | 0 | 0 | 0 | 1 | 0.3 | 2.9 |