Table 3.
The incidence and proportion of adverse events (AEs) in vaccinees after the 1st and 2nd dose of inactivated vaccine.
Type of AEs | After the 1st dose, N = 1392 |
After the 2nd dose, N = 1047 |
||||
---|---|---|---|---|---|---|
No of vaccinees | Incidence (%) | Proportion (%) | No of vaccinees | Incidence (%) | Proportion (%) | |
Total No of Any AEs | 532 | 38.2 | 100 | 325 | 31.0 | 100.0 |
Local AEs* | 398 | 28.6 | 74.8 | 272 | 26.0 | 83.7 |
With no other AEs | 256 | 18.4 | 48.1 | 219 | 20.9 | 67.4 |
With other AEs | 142 | 10.2 | 26.7 | 53 | 5.1 | 16.3 |
Headache, dizziness, insomnia | 137 | 9.8 | 25.8 | 50 | 4.8 | 15.4 |
With no other event | 79 | 5.7 | 14.9 | 31 | 3.0 | 9.5 |
With any other event | 58 | 4.2 | 10.9 | 19 | 1.8 | 5.9 |
Flu-like events | 87 | 6.3 | 16.4 | 34 | 3.2 | 10.5 |
Fever (ºC) | 30 | 2.15 | 5.64 | 9 | 0.9 | 2.8 |
≥39.0 | 1 | 0.07 | 0.19 | 0 | 0 | 0 |
38–38.9 | 2 | 0.14 | 0.38 | 1 | 0.1 | 0.3 |
<38 | 27 | 1.94 | 5.07 | 8 | 0.8 | 2.5 |
Loss of appetite, nausea, vomiting, abdominal pain, or diarrhea | 43 | 3.1 | 8.1 | 11 | 1.1 | 3.4 |
With no other event | 22 | 1.6 | 4.1 | 4 | 0.4 | 1.2 |
With any other event | 21 | 1.5 | 4.0 | 7 | 0.7 | 2.2 |
Cough, sputum, shortness of breath | 16 | 1.1 | 3.0 | 7 | 0.7 | 2.2 |
With no other event | 9 | 0.6 | 1.7 | 4 | 0.4 | 1.2 |
With any other event | 7 | 0.5 | 1.3 | 3 | 0.3 | 1.0 |
Skin allergic events | 19 | 1.4 | 3.6 | 8 | 0.8 | 2.5 |
With no other event | 8 | 0.6 | 1.5 | 6 | 0.6 | 1.9 |
With any other event | 11 | 0.8 | 2.1 | 2 | 0.2 | 0.6 |
Menstrual changes | 22 | 2.1† | 4.1 | 10 | 1.0† | 3.1 |
Menstruation delay | 15 | 1.4 | 2.8 | 6 | 0.6 | 1.9 |
Early menstruation | 4 | 0.4 | 0.7 | 3 | 0.3 | 0.9 |
Menorrhagia | 2 | 0.2 | 0.4 | 1 | 0.1 | 0.3 |
Prolonged period | 1 | 0.1 | 0.2 | 0 | 0.0 | 0.0 |
Severity of AEs | ||||||
Mild | 505 | 36.3 | 94.9 | 316 | 30.2 | 97.2 |
Moderate | 27 | 1.9 | 5.1 | 9 | 0.9 | 2.8 |
Severe | 0 | 0 | 0 | 0 | 0 | 0 |
*Pain, erythema, swelling, or itch on injection site. †The denominators were those women at the age of ≤50 y who were assumed to still have menstruation as the average age of menopause in China is around 50 y. 1073 and 943 women with the age ≤50 y accepted the 1st and 2nd vaccination respectively.