Table 2.
Adverse events within 28 days after vaccination in healthy adults and patients with underlying illnesses
| Adverse events | Healthy adults (N = 1200) |
Patients with underlying illnesses (N = 300) |
Patients with malignancy (N = 49) |
Patients with diabetes mellitus (N = 180) |
Patients with autoimmune diseases (N = 10) |
Patients with chronic renal diseases (N = 61) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) |
|
| Any AEs | 1623 | 603 (50%) (47–53%) | 395 | 146 (49%) (43–54%) | 54 | 25 (51%) (36–66%) | 234 | 85 (47%) (40–55%) | 16 | 5 (50%) (19–81%) | 91 | 31 (51%) (38–64%) |
| SAEs | 2 | 2 (0.2%) (0–1%) | 1 | 1 (0.3%) (0–2%) | 0 | 0 (0%) | 1 | 1 (0.6%) (0–3.0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| Vaccine-related AEs | 1362 | 509 (42%) (40–45%) | 328 | 125 (42%) (36–47%) | 44 | 20 (41%) (27–56%) | 197 | 73 (41%) (33–48%) | 14 | 5 (50%) (19–81%) | 73 | 27 (44%) (32–58%) |
| Injection-site AEs | 1306 | 491 (41%) (38–44%) | 314 | 118 (39%) (34–45%) | 41 | 18 (37%) (23–52%) | 191 | 71 (39%) (32–47%) | 12 | 4 (40%) (12–74%) | 70 | 25 (41%) (29–54%) |
| Erythema | 405 | 405 (34%) (31–37%) | 94 | 94 (31%) (26–37%) | 14 | 14 (29%) (17–43%) | 52 | 52 (29%) (22–36%) | 4 | 4 (40%) (12–74%) | 24 | 24 (39%) (27–53%) |
| Itching | 244 | 243 (20%) (18–23%) | 60 | 59 (20%) (15–25%) | 8 | 8 (16%) (7–30%) | 39 | 38 (21%) (15–28%) | 2 | 2 (20%) (3–56%) | 11 | 11 (18%) (9–30%) |
| Swelling | 179 | 179 (15%) (13–17%) | 47 | 47 (16%) (12–20%) | 9 | 9 (18%) (9–32%) | 27 | 27 (15%) (10–21%) | 1 | 1 (10%) (0.3–45%) | 10 | 10 (16%) (8–28%) |
| Pain | 183 | 182 (15%) (13–17%) | 41 | 41 (14%) (10–18%) | 3 | 3 (6%) (1–17%)** | 28 | 28 (16%) (11–22%) | 2 | 2 (20%) (3–56%) | 8 | 8 (13%) (6–24%) |
| Warmth | 170 | 170 (14%) (12–16%) | 36 | 36 (12%) (9–16%) | 5 | 5 (10%) (3–22%) | 23 | 23 (13%) (8–19%) | 2 | 2 (20%) (3–56%) | 6 | 6 (10%) (4–20%) |
| Induration | 124 | 124 (10%) (9–12%) | 36 | 36 (12%) (9–16%) | 2 | 2 (4%) (0.5–14%) | 22 | 22 (12%) (8–18%) | 1 | 1 (10%) (0.3–45%) | 11 | 11 (18%) (9–30%)** |
| Eruption | 1 | 1 (0.1%) (0–0.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| Systemic AEs | 56 | 46 (4%) (3–5%) | 14 | 11 (4%) (2–6%) | 3 | 2 (4%) (0.5–14%) | 6 | 5 (3%) (0.9–6%) | 2 | 1 (10%) (0.3–45%) | 3 | 3 (5%) (1–14%) |
| Fever | 6 | 5 (0.4%) (0.1–1.0%) | 5 | 5 (2%) (0.5–4.0%)* | 2 | 2 (4%) (0.5–14%)* | 3 | 3 (2%) (0.3–5%)** | 0 | 0 (0%) | 0 | 0 (0%) |
| Headache | 8 | 8 (0.7%) (0.3–1.0%) | 2 | 2 (0.7%) (0.1–2.0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (10%) (0.3–45%)** | 1 | 1 (2%) (0.04–9%) |
| Fatigue | 5 | 5 (0.4%) (0.1–1.0%) | 3 | 3 (1%) (0.2–3.0%) | 1 | 1 (2%) (0.1–11%) | 1 | 1 (0.6%) (0–3.0%) | 1 | 1 (10%) (0.3–45%)* | 0 | 0 (0%) |
| Rash | 18 | 17 (1%) (0.8–2.0%) | 1 | 1 (0.3%) (0.008–2.0%) | 0 | 0 (0%) | 1 | 1 (0.6%) (0–3.0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| Others | 19 | 17 (1%) (0.8–3%) | 3 | 3 (1%) (0.2–3%) | 0 | 0 (0%) | 1 | 1 (0.6%) (0.01–3.0%) | 0 | 0 (0%) | 2 | 2 (3%) (0.4–11%) |
AE Adverse event, CI Confidence interval, SAE Severe adverse event
*P < 0.05, **P < 0.1 (compared with the proportion of subjects among healthy adults)