Table 3.
Adverse events | Healthy adults | Patients with underlying illnesses | Patients with malignancy | Patients with diabetes mellitus | Patients with autoimmune diseases | Patients with chronic renal diseases | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No. of events | No. of subjects (%) (95% CI) |
No. of events | No. of subjects (%) (95% CI) |
No. of events | No. of subjects (%) (95% CI) |
No. of events | No. of subjects (%) (95% CI) |
No. of events | No. of subjects (%) (95% CI) |
No. of events | No. of subjects (%) (95% CI) |
|
Subjects with HZ history | N = 155 | N = 49 | N = 11 | N = 28 | N = 1 | N = 9 | ||||||
Vaccine-related AEs | 198 | 87 (56%) (48–64%)* | 54 | 23 (47%) (33–62%) | 8 | 4 (36%) (11–69%) | 30 | 13 (46%) (28–66%) | 6 | 1 (100%) | 10 | 5 (56%) (21–86%) |
Injection-site AEs | 189 | 82 (53%) (45–61%)* | 54 | 23 (47%) (33–62%) | 8 | 4 (36%) (11–69%) | 30 | 13 (46%) (28–66%) | 6 | 1 (100%) | 10 | 5 (56%) (21–86%) |
Systemic AEs | 9 | 8 (5%) (2–10%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) |
Subjects without HZ history | N = 1045 | N = 251 | N = 38 | N = 152 | N = 9 | N = 52 | ||||||
Vaccine-related AEs | 1164 | 422 (40%) (37–43%) | 274 | 102 (41%) (35–47%) | 36 | 16 (42%) (26–59%) | 167 | 60 (39%) (32–48%) | 8 | 4 (44%) (14–79%) | 63 | 22 (42%) (29–57%) |
Injection-site AEs | 1117 | 409 (39%) (36–42%) | 260 | 95 (38%) (32–44%) | 33 | 14 (37%) (22–54%) | 161 | 58 (38%) (30–46%) | 6 | 3 (33%) (7–70%) | 60 | 20 (38%) (25–53%) |
Systemic AEs | 47 | 38 (4%) (3–5%) | 14 | 11 (4%) (2–8%) | 3 | 2 (5%) (0.6–18%) | 6 | 5 (3%) (1–8%) | 2 | 1 (11%) (0.3–48%) | 3 | 3 (6%) (1–16%) |
AE Adverse event, HZ Herpes zoster
*P < 0.05, **P < 0.1 (compared with the proportion of reported subjects without HZ history within the category of subjects)