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Table 2 Ocurrence of AEFV in JDM patients and HC after each qHPV vaccine dose

From: Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study

  After the first dose After the second dose After the third dose Total
JDM HC p-valueb JDM HC p-valueb JDM HC p-valueb JDM HC p-valueb
Vaccinated patients during the study, n 42 39 NA 44 38 NA 42 35 NA 128 112 NA
Completed diaries after vaccine dose, n (%) 40 (95.2) 38 (97.4) NA 41 (93.2) 38 (100) NA 40 (95.2) 35 (100) NA 121 (94.5) 111 (99.1) NA
Local AEFV, n (%)
 Redness 5 (12.5) 4 (10.5) 1.000 2 (4.9) 3 (7.9) 0.667 0 (0.0) 2 (5.7) 0.214 7 (5.8) 9 (8.1) 0.601
 Bruise 0 (0.0) 0 (0.0) 1.000 1 (2.4) 1 (2.6) 1.000 0 (0.0) 5 (14.3) 0.019 1 (0.8) 6 (5.4) 0.058
 Edema 5 (12.5) 5 (13.2) 1.000 4 (9.8) 8 (21.1) 0.215 1 (2.5) 8 (22.9) 0.010 10 (8.3) 21 (18.9) 0.021
 Induration 6 (15.0) 9 (23.7) 0.396 4 (9.8) 4 (10.5) 1.000 4 (10.0) 5 (14.3) 0.726 14 (11.6) 18 (16.2) 0.346
 Pain 22 (55.0) 23 (60.5) 0.653 19 (46.3) 23 (60.5) 0.261 16 (40.0) 19 (54.3) 0.252 57 (47.1) 65 (58.6) 0.115
Systemic AEFV, n (%)
 Fever 1 (2.5) 0 (0.0) 1.000 1 (2.4) 0 (0.0) 1.000 0 (0.0) 1 (2.9) 0.467 2 (1.7) 1 (0.9) 1.000
 New cutaneous abnormalitiesa 2 (5.0) 0 (0.0) 0.494 1 (2.4) 0 (0.0) 1.000 1 (2.5) 0 (0.0) 1.000 4 (3.3) 0 (0.0) 0.052
 Itchiness 1 (2.5) 1 (2.6) 1.000 3 (7.3) 1 (2.6) 0.616 7 (17.5) 0 (0.0) 0.013 11 (9.1) 2 (1.8) 0.020
 Headache 9 (22.5) 10 (26.3) 0.794 10 (24.4) 10 (26.3) 1.000 6 (15.0) 7 (20.0) 0.761 25 (20.7) 27 (24.3) 0.534
 Nausea 9 (22.5) 1 (2.6) 0.014 1 (2.4) 2 (5.3) 0.606 2 (5.0) 4 (11.4) 0.409 12 (9.9) 7 (6.3) 0.346
 Vomiting 2 (5.0) 0 (0.0) 0.494 0 (0.0) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000 2 (1.7) 0 (0.0) 0.498
 Fatigue 6 (15.0) 7 (18.4) 0.767 4 (9.8) 7 (18.4) 0.338 4 (10.0) 5 (14.3) 0.726 14 (11.6) 19 (17.1) 0.263
 Fainting 0 (0.0) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000
 Initial or worsened muscular pain 2 (5.0) 1 (2.6) 1.000 2 (4.9) 1 (2.6) 1.000 0 (0.0) 0 (0.0) 1.000 4 (3.3) 2 (1.8) 0.685
 Initial or worsened articular pain 1 (2.5) 0 (0.0) 1.000 1 (2.4) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000 2 (1.7) 0 (0.0) 0.499
Severe AEFV, n (%)
 WHO definition 0 (0.0) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000 0 (0.0) 0 (0.0) 1.000
  1. JDM juvenile dermatomyositis, HC healthy controls, AEFV adverse events following vaccination, qHPV quadrivalent human papillomavirus vaccine, NA Not applicable, WHO World Health Organization
  2. aPatients described new rash on face or on body, that subsided in a maximum of 4 days
  3. bStatistical significance was defined as a p-value < 0.05