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Table 2 Adverse events within 28 days after vaccination in healthy adults and patients with underlying illnesses

From: Safety of live attenuated varicella-zoster vaccine in patients with underlying illnesses compared with healthy adults: a prospective cohort study

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%)
  1. AE Adverse event, CI Confidence interval, SAE Severe adverse event
  2. *P < 0.05, **P < 0.1 (compared with the proportion of subjects among healthy adults)