Table 3.
Adverse events reported in Chu et al. (2016).
| AE | Grade 1 |
Grade 2 |
Grade 3 |
|||
|---|---|---|---|---|---|---|
| 15 mcg (n=119) | 30 mcg (n=120) | 15 mcg (n=119) | 30 mcg (n=120) | 15 mcg (n=119) | 30 mcg (n=120) | |
| Solicited local AE within 7 days of vaccination | ||||||
| Erythema/redness | 6 (5.4%) | 6 (5%) | 2 (1.7%) | 1 (0.8%) | 1 (0.8%) | 0 (0%) |
| Pain | 29 (24.4%) | 45 (37.5%) | 2 (1.7%) | 3 (2.5%) | 0 (0%) | 0 (0%) |
| Induration | 1 (0.8%) | 3 (2.5%) | 1 (0.8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Swelling | 1 (0.8%) | 1 (0.8%) | 2 (1.7%) | 4 (3.3%) | 0 (0%) | 0 (0%) |
| Pruritus | 1 (0.8%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Solicited systemic AEs within 7 days of vaccination | ||||||
| Fever | 7 (5.9%) | 10 (8.3%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Muscle pain | 2 (1.7%) | 3 (2.5%) | 1 (0.8%) | 0 (0.%) | 0 (0%) | 0 (0%) |
| Fatigue | 1 (0.8%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Headache | 1 (0.8%) | 3 (2.5%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Unsolicited AEs within 28 days of vaccination | 2 (1.7%) | 4 (3.3%) | 2 (1.7%) | 0 (0%) | 0 (0%) | 1 (0.8%) |
AE = adverse event.