Table 2.
Onset (a) and resolution (b) of adverse events following the first vaccine injection
| (a) Onset | ≤ 1 h N (%) |
1-4 h N (%) |
4-12 h N (%) |
12-24 h N (%) |
24-48 h N (%) |
> 48 h N (%) |
Missing data N (%) |
|---|---|---|---|---|---|---|---|
| Mild | |||||||
| Pain, redness and swelling at the injection site (n = 265) | 30 (11.3) | 68 (25.7) | 109 (41.1) | 50 (18.9) | 7 (2.6) | 1 (0.4) | |
| Fatigue (n = 66) | 3 (4.5) | 12 (18.2) | 20 (30.3) | 17 (25.8) | 7 (10.6) | 3 (4.5) | 4 (6.1) |
| Headache (n = 52) | 10 (19.2) | 10 (19.2) | 13 (25.0) | 12 (23.1) | 5 (9.7) | 1 (1.9) | 1 (1.9) |
| Fever ≤ 38 °C (n = 5) | 2 (40.0) | 3 (60.0) | |||||
| Chills (n = 20) | 1 (5.0) | 3 (15.0) | 4 (20.0) | 11 (55.0) | 1 (5.0) | ||
| Abdominal pain (n = 3) | 1 (33.3) | 1 (33.3) | 1 (33.3) | ||||
| Nausea (n = 7) | 1 (14.3) | 3 (42.8) | 2 (28.6) | 1 (14.3) | |||
| Insomnia (n = 5) | 3 (60.0) | 2 (40.0) | |||||
| Sleep disorders (n = 8) | 6 (75.0) | 1 (12.5) | 1 (12.5) | ||||
| Moderate | |||||||
| Lymphadenopathy (n = 8) | 1 (12.5) | 2 (25.0) | 1 (12.5) | 1 (12.5) | 2 (25.0) | 1 (12.5) | |
| Myalgia/Arthralgia (n = 31) | 2 (6.4) | 1 (3.2) | 7 (22.6) | 11 (35.6) | 3 (9.7) | 6 (19.3) | 1 (3.2) |
| Local urticaria (n = 2) | 2 (100) | ||||||
| Diarrhoea (n = 7) | 1 (14.3) | 1 (14.3) | 1 (14.3) | 1 (14.3) | 3 (42.8) | ||
| Severe | |||||||
| Paraesthesia (n = 11) | 8 (72.7) | 1 (9.1) | 2 (18.2) | ||||
| Generalized urticaria (n = 3) | 3 (100) | ||||||
| (b) Resolution | < 12 h N (%) |
12-24 h N (%) |
24-48 h N (%) |
48-72 h N (%) |
> 72 h N (%) |
Missing data N (%) |
|---|---|---|---|---|---|---|
| Mild | ||||||
| Pain, redness and swelling at the injection site (n = 265) | 44 (16.6) | 85 (32.1) | 82 (30.9) | 38 (14.3) | 15 (5.7) | 1 (0.4) |
| Fatigue (n = 66) | 7 (10.6) | 25 (37.9) | 14 (21.2) | 7 (10.6) | 9 (13.6) | 4 (6.1) |
| Headache (n = 52) | 19 (36.5) | 14 (26.9) | 8 (15.4) | 5 (9.6) | 6 (11.6) | |
| Fever ≤ 38 °C (n = 5) | 2 (40.0) | 2 (40.0) | 1 (20.0) | |||
| Chills (n = 20) | 8 (40.0) | 3 (15.0) | 4 (20.0) | 3 (15.0) | 2 (10.0) | |
| Abdominal pain (n = 3) | 1 (33.3) | 2 (66.7) | ||||
| Nausea (n = 7) | 2 (28.6) | 1 (14.2) | 2 (28.6) | 2 (28.6) | ||
| Insomnia (n = 5) | 4 (80.0) | 1 (20.0) | ||||
| Sleep disorders (n = 8) | 6 (75.0) | 1 (12.5) | 1 (12.5) | |||
| Moderate | ||||||
| Lymphadenopathy (n = 8) | 1 (12.5) | 1 (12.5) | 2 (25.0) | 3 (37.5) | 1 (12.5) | |
| Myalgia/Arthralgia (n = 31) | 2 (6.4) | 10 (32.2) | 7 (22.6) | 4 (12.9) | 7 (22.6) | 1 (3.3) |
| Local urticaria (n = 2) | 2 (100) | |||||
| Diarrhoea (n = 7) | 1 (14.2) | 2 (28.6) | 2 (28.6) | 2 (28.6) | ||
| Severe | ||||||
| Paraesthesia (n = 11) | 8 (72.7) | 1 (9.1) | 1 (9.1) | 1 (9.1) | ||
| Generalized urticaria (n = 3) | 1 (33.3) | 1 (33.3) | 1 (33.4) | |||
The higher frequencies among the listed options are reported in bold