Table 3.
Females (n = 412) | Males (n = 369) | p-Value | |||
---|---|---|---|---|---|
AEFI | n | Reporting Rate (95%CI) × 100 Enrolled | n | Reporting Rate (95%CI) × 100 Enrolled | |
Local reaction | 240 | 58.3 (53.3–63.1) | 138 | 41.9 (36.6–47.5) | <0.0001 |
General malaise | 79 | 19.2 (15.5–23.3) | 35 | 10.6 (7.5–14.5) | 0.001 |
Neurological symptoms | 23 | 5.6 (3.6–8.3) | 13 | 4.0 (2.1–6.7) | 0.305 |
Fever/hyperpyrexia | 16 | 3.9 (2.2–6.2) | 5 | 1.5 (0.5–3.5) | 0.054 |
Gastrointestinal disorder | 6 | 1.5 (0.5–3.1) | 3 | 0.5 (0.2–2.6) | 0.501 |
Allergic reaction | 1 | 0.2 (0.0–1.3) | 1 | 0.3 (0.0–1.7) | 0.873 |
At least one AEFI | 270 | 65.5 (60.7–70.1) | 160 | 48.6 (43.1–54.2) | <0.0001 |