Table 2. Number and percentage of participants with reported solicited adverse events within the 7-days period after each vaccine dose (solicited safety set).
| 1st dose (n=128) | 2nd dose (n=128) | 3rd dose (n=127) | 4th dose (n=124) | |
|---|---|---|---|---|
| Local adverse event | ||||
| Erythema | 4 (3) | 6 (5) | 1 (1) | 6 (5) |
| Severe | 0 | 0 | 1 (1) | 2 (2) |
| Induration | 4 (3) | 9 (7) | 3 (2) | 6 (5) |
| Severe | 0 | 0 | 0 | 2 (2) |
| Tenderness | 17 (13) | 21 (16) | 14 (11) | 20 (16) |
| Severe | 0 | 0 | 3 (2) | 2 (2) |
| Systemic adverse event | ||||
| Change in eating habits | 29 (23) | 21 (16) | 21 (17) | 24 (19) |
| Severe | 2 (2) | 0 | 0 | 3 (2) |
| Sleepiness | 52 (41) | 31 (24) | 28 (22) | 20 (16) |
| Severe | 2 (2) | 0 | 0 | 4 (3) |
| Irritability | 58 (45) | 49 (38) | 47 (37) | 45 (36) |
| Severe | 2 (2) | 3 (2) | 4 (3) | 5 (4) |
| Vomiting | 26 (20) | 20 (16) | 15 (12) | 5 (4) |
| Severe | 0 | 1 (1) | 0 | 1 (1) |
| Diarrhea | 15 (12) | 13 (10) | 15 (12) | 17 (14) |
| Severe | 0 | 1 (1) | 0 | 0 |
| Fever (≥38℃) | 4 (3) | 10 (8) | 6 (5) | 15 (12) |
Values are presented as number (%).