Table 2.
Adverse events following immunization (AEFIs) for the first dose. AEFIs: adverse events following immunization. * Fisher’s exact test, significantly higher (p < 0.05) than the second dose (Table 3). † Other local AEFIs include numbness, sore throat, eye irritation, and others. ‡ Other systemic AEFIs include irregular bleeding, anorexia, cerebral anemia, and others. Day 0 is defined as the day of immunization.
| Day 0 (n = 301) |
Day 1 (n = 259) |
Day 3 (n = 196) |
Day 7 (n = 143) |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Any AEFI | 252 | (83.7%) | 235 | (90.7%) | 78 | (39.8%) | 28 | (19.6%) * | |
| Local | Injection-site pain | 237 | (78.7%) | 227 | (87.6%) | 59 | (30.1%) | 7 | (4.9%) |
| Localized warmth | 39 | (13.0%) | 54 | (20.8%) | 6 | (3.1%) | 3 | (2.1%) | |
| Exanthema | 2 | (0.7%) | 1 | (0.4%) | 0 | 1 | (0.7%) | ||
| Erythema | 1 | (0.3%) | 3 | (1.2%) | 9 | (4.6%) | 8 | (5.6%) * | |
| Swelling | 30 | (10.0%) | 46 | (17.8%) | 10 | (5.1%) | 10 | (7.0%) * | |
| Itchiness | 0 | 6 | (2.3%) | 10 | (5.1%) | 11 | (7.7%) | ||
| Red eye | 1 | (0.3%) | 1 | (0.4%) | 0 | 0 | |||
| Others † | 15 | (5.0%) | 15 | (5.8%) | 4 | (2.0%) | 11 | (7.7%) * | |
| Systemic | Malaise | 47 | (15.6%) | 99 | (38.2%) | 16 | (8.2%) | 1 | (0.7%) |
| Fever | 40 | (13.3%) | 80 | (30.9%) | 11 | (5.6%) | 0 | ||
| Fatigue | 29 | (9.6%) | 46 | (17.8%) | 7 | (3.6%) | 1 | (0.7%) | |
| Myalgia | 49 | (16.3%) | 59 | (22.8%) | 10 | (5.1%) | 0 | ||
| Arthralgia | 17 | (5.6%) | 29 | (11.2%) | 2 | (1.0%) | 1 | (0.7%) | |
| Nausea/Vomiting | 9 | (3.0%) | 9 | (3.5%) | 2 | (1.0%) | 0 | ||
| Diarrhea | 1 | (0.3%) | 10 | (3.9%) | 2 | (1.0%) | 0 | ||
| Chills | 6 | (2.0%) | 26 | (10.0%) | 2 | (1.0%) | 0 | ||
| Headache | 28 | (9.3%) | 62 | (23.9%) | 11 | (5.6%) | 4 | (2.8%) | |
| Rash | 0 | 1 | (0.4%) | 0 | 0 | ||||
| Others ‡ | 6 | (2.0%) | 3 | (1.2%) | 5 | (2.6%) | 0 | ||
| Medical Care Sought | Doctor visit | 1 | (0.3%) | 0 | 1 | (0.5%) | 0 | ||
| Use of analgesics | 30 | (10.0%) | 62 | (23.9%) | 8 | (4.1%) | 2 | (1.4%) | |