Table 3.
Onset (a) and resolution (b) of adverse events following the second 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 = 223) | 37 (16.6) | 63 (28.2) | 87 (39.1) | 31 (13.9) | 4 (1.8) | 1 (0.4) | |
| Fatigue (n = 135) | 4 (2.9) | 19 (14.1) | 42 (31.1) | 49 (36.3) | 15 (11.1) | 6 (4.5) | |
| Headache (n = 98) | 3 (3.1) | 16 (16.3) | 34 (34.7) | 31 (31.6) | 9 (9.2) | 5 (5.1) | |
| Fever ≥ 38 °C (n = 46) | 2 (4.3) | 19 (41.3) | 18 (39.1) | 5 (10.9) | 1 (2.2) | 1 (2.2) | |
| Chills (n = 90) | 3 (3.3) | 9 (10.0) | 37 (41.1) | 33 (36.7) | 6 (6.7) | 2 (2.2) | |
| Abdominal pain (n = 26) | 2 (7.7) | 3 (11.5) | 2 (7.7) | 10 (38.5) | 5 (19.2) | 2 (7.7) | 2 (7.7) |
| Nausea (n = 33) | 1 (3.0) | 3 (9.1) | 8 (24.2) | 13 (39.4) | 4 (12.1) | 2 (6.1) | 2 (6.1) |
| Insomnia (n = 8) | 1 (12.5) | 7 (87.5) | |||||
| Sleep disorders (n = 20) | 2 (10.0) | 10 (50.0) | 6 (30.0) | 2 (10.0) | |||
| Moderate | |||||||
| Fever > 38 °C and < 39 °C (n = 23) | 1 (4.3) | 10 (43.5) | 10 (43.5) | 2 (8.7) | |||
| Lymphadenopathy (n = 23) | 1 (4.3) | 1 (4.3) | 12 (52.2) | 4 (17.4) | 3 (13.1) | 2 (8.7) | |
| Myalgia/Arthralgia (n = 115) | 10 (8.7) | 38 (33.0) | 50 (43.5) | 15 (13.0) | 1 (0.9) | 1 (0.9) | |
| Local urticaria (n = 2) | 1 (50.0) | 1 (50.0) | |||||
| Vomit (n = 3) | 3 (100) | ||||||
| Diarrhoea (n = 21) | 2 (9.5) | 1 (4.8) | 10 (47.7) | 4 (19.0) | 4 (19.0) | ||
| Severe | |||||||
| Dyspnoea (n = 1) | 1 (100) | ||||||
| Paraesthesia (n = 11) | 3 (27.3) | 1 (9.1) | 3 (27.3) | 2 (18.1) | 1 (9.1) | 1 (9.1) | |
| Fever ≥ 39 °C (n = 4) | 2 (50.0) | 2 (50.0) | |||||
| 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 = 223) | 42 (18.8) | 68 (30.5) | 57 (25.6) | 31 (13.9) | 24 (10.8) | 1 (0.4) |
| Fatigue (n = 135) | 13 (9.6) | 42 (31.1) | 26 (19.3) | 20 (14.8) | 33 (24.5) | 1 (0.7) |
| Headache (n = 98) | 18 (18.4) | 29 (29.6) | 18 (18.4) | 13 (13.2) | 21 (21.4) | |
| Fever ≥ 38 °C (n = 46) | 12 (26.1) | 15 (32.6) | 11 (23.9) | 3 (6.5) | 4 (8.7) | 1 (2.2) |
| Chills (n = 90) | 22 (24.4) | 27 (30.0) | 20 (22.3) | 10 (11.1) | 8 (8.9) | 3 (3.3) |
| Abdominal pain (n = 26) | 4 (15.4) | 4 (15.4) | 7 (26.9) | 2 (7.7) | 7 (26.9) | 2 (7.7) |
| Nausea (n = 33) | 7 (21.3) | 11 (33.3) | 8 (24.2) | 3 (9.1) | 3 (9.1) | 1 (3.0) |
| Insomnia (n = 8) | 3 (37.5) | 4 (50.0) | 1 (12.5) | |||
| Sleep disorders (n = 20) | 10 (50.0) | 3 (15.0) | 1 (5.0) | 5 (25.0) | 1 (5.0) | |
| Moderate | ||||||
| Fever > 38 °C and < 39 °C (n = 23) | 2 (8.7) | 8 (34.8) | 7 (30.4) | 5 (21.7) | 1 (4.4) | |
| Lymphadenopathy (n = 23) | 5 (21.7) | 4 (17.4) | 7 (30.4) | 6 (26.1) | 1 (4.4) | |
| Myalgia/Arthralgia (n = 115) | 17 (14.8) | 29 (25.2) | 28 (24.3) | 15 (13.0) | 25 (21.7) | 1 (0.8) |
| Local urticaria (n = 2) | 1 (50.0) | 1 (50.0) | ||||
| Vomit (n = 3) | 2 (66.7) | 1 (33.3) | ||||
| Diarrhoea (n = 21) | 6 (28.6) | 8 (38.0) | 3 (14.3) | 3 (14.3) | 1 (4.8) | |
| Severe | ||||||
| Dyspnoea (n = 1) | 1 (100) | |||||
| Paraesthesia (n = 11) | 3 (27.3) | 3 (27.3) | 2 (18.2) | 1 (9.0) | 2 (18.2) | |
| Fever ≥ 39 °C (n = 4) | 1 (25.0) | 2 (50.0) | 1 (25.0) | |||
The higher frequencies among the listed options are reported in bold