Table 3. Local injection site and systemic reactions.
Number (%) of subjects a | ||||
---|---|---|---|---|
18–60 y | ≥61 y | Total | ||
(n = 63) | (n = 63) | (n = 126) | ||
Any | 45 (71%) | 31 (49%) | 76 (60%) | |
Injection site reactions (Day 1 – Day 4 post vaccination) | ||||
Any | 30 (48%) | 22 (35%) | 52 (41%) | |
Ecchymosis (mm) | Any | 1 (2%) | 4 (6%) | 5 (4%) |
>50 mm | 0 | 0 | 0 | |
Erythema (mm) | Any | 1 (2%) | 0 | 1 (1%) |
>50 mm | 0 | 0 | 0 | |
Induration (mm) | Any | 0 | 2 (3%) | 2 (2%) |
>50 mm | 0 | 0 | 0 | |
Swelling (mm) | Any | 1 (2%) | 2 (3%) | 3 (2%) |
>50 mm | 0 | 0 | 0 | |
Pain | Any | 29 (46%) | 17 (27%) | 46 (37%) |
Severe | 0 | 0 | 0 | |
Systemic reactions (Day 1–Day 4 post vaccination) | ||||
Any | 39 (62%) | 20 (32%) | 59 (47%) | |
Chills/ shivering | Any | 1 (2%) | 1 (2%) | 2 (2%) |
Severe | 0 | 0 | 0 | |
Malaise | Any | 5 (8%) | 2 (3%) | 7 (6%) |
Severe | 0 | 0 | 0 | |
Myalgia | Any | 27 (43%) | 12 (19%) | 39 (31%) |
Severe | 0 | 0 | 0 | |
Arthralgia | Any | 2 (3%) | 0 | 2 (2% |
Severe | 0 | 0 | 0 | |
Headache | Any | 13 (21%) | 4 (6%) | 17 (13%) |
Severe | 0 | 0 | 0 | |
Sweating | Any | 10 (16%) | 7 (11%) | 17 (13%) |
Severe | 0 | 0 | 0 | |
Fatigue | Any | 15 (24%) | 7 (11%) | 22 (17%) |
Severe | 0 | 0 | 0 | |
Fever | 0 | 0 | 0 | |
Other reactions | ||||
Temperature | <36 °C | 3 (5%) | 11 (17%) | 14 (11%) |
≥40 | 0 | 0 | 0 |
a Local injection site and systemic reactions were recorded for all subjects who provided post vaccination safety data (safety set)