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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)