TABLE 5.
Listing of incidence solicited adverse events (for first and second vaccination combined) and serious adverse at least possibly related and not related to vaccination until 28 d after second vaccination
| Control (N = 191) | CKD G4/5 (N = 162) | P a | Dialysis (N = 159) | P a | KTR (N = 288) | P a | |
|---|---|---|---|---|---|---|---|
| Adverse events | |||||||
| Any adverse event, n (%) | 185 (96.9) | 156 (96.3) | 0.77 | 140 (88.0) | 0.001 | 280 (97.2) | 0.82 |
| Any systemic symptom, n (%) | 176 (92.1) | 146 (90.1) | 0.50 | 121 (76.1) | <0.001 | 231 (80.2) | <0.001 |
| Arthralgia, n (%) | 76 (39.8) | 72 (44.4) | 0.38 | 59 (37.1) | 0.61 | 99 (34.4) | 0.23 |
| Fatigue, n (%) | 136 (71.2) | 113 (69.7) | 0.77 | 93 (58.5) | 0.01 | 184 (63.9) | 0.10 |
| Fever, n (%) | 52 (27.2) | 44 (27.2) | 0.99 | 30 (18.9) | 0.07 | 24 (8.3) | <0.001 |
| Chills, n (%) | 97 (50.8) | 95 (58.6) | 0.14 | 65 (40.9) | 0.06 | 102 (35.4) | <0.001 |
| Headache, n (%) | 121 (63.3) | 80 (49.4) | 0.008 | 61 (38.4) | <0.001 | 147 (51.0) | 0.008 |
| Myalgia, n (%) | 130 (68.1) | 108 (66.7) | 0.78 | 89 (56.0) | 0.02 | 157 (54.5) | 0.003 |
| Nausea, n (%) | 60 (31.4) | 67 (41.4) | 0.05 | 39 (24.5) | 0.15 | 80 (27.8) | 0.39 |
| Any local symptom, n (%) | 172 (90.0) | 148 (91.4) | 0.67 | 132 (83.0) | 0.05 | 269 (93.4) | 0.18 |
| Erythema, n (%) | 67 (35.1) | 41 (25.3) | 0.05 | 36 (22.6) | 0.01 | 53 (18.4) | <0.001 |
| Induration, n (%) | 70 (36.6) | 54 (33.3) | 0.51 | 47 (29.6) | 0.16 | 85 (29.5) | 0.10 |
| Pain at injection side, n (%) | 170 (89.0) | 142 (87.6) | 0.69 | 130 (81.8) | 0.05 | 269 (93.4) | 0.09 |
| Serious adverse events | |||||||
| Any serious adverse event, n (%) | 0 | 6 (3.7) | 0.007 | 9 (5.7) | 0.001 | 12 (4.2) | 0.004 |
| Related to vaccination, n (%) | |||||||
| Exacerbation lichen sclerosis | – | 1 (0.6) | – | – | – | – | – |
| Cellulitis | – | – | – | – | – | 1 (0.3) | – |
| Malaise | – | 1 (0.6) | – | – | – | 1 (0.3) | – |
| Not related to vaccination, n (%) | |||||||
| Abdominal pain | – | – | – | 1 (0.6) | – | – | – |
| Cellulitis | – | 1 (0.6) | – | – | – | – | – |
| Chest pain | – | – | – | – | – | 1 (0.3) | – |
| Ischemic CVA | – | – | – | 1 (0.6) | – | 1 (0.3) | – |
| Cardiac decompensation | – | – | – | 1 (0.6) | – | 1 (0.3) | – |
| Fever | – | – | – | 1 (0.6) | – | 1 (0.3) | – |
| Bone fracture | – | 1 (0.6) | – | – | – | – | – |
| Hypomagnesemia | – | 1 (0.6) | – | – | – | – | – |
| Infection | – | – | – | 1 (0.6) | – | – | – |
| Kidney transplant rejection | – | – | – | 1 (0.6)b | – | – | – |
| Peritonitis | – | – | – | 2 (1.3) | – | – | – |
| Pneumonia | – | – | – | – | – | 1 (0.3) | – |
| Trauma | – | – | – | 1 (0.6) | – | – | – |
| Urinary tract infection | – | 1 (0.6) | – | – | – | 3 (1.2) | – |
| Enteritis | – | – | – | – | – | 1 (0.3) | – |
| Reanimation | – | – | – | – | – | 1 (0.3) | – |
Variables are given as number and percentage. P Value were calculated using chi-squared test.
aP values are given for the comparison between patient groups and controls.
bSubject received a kidney transplant after baseline visit.
CKD, chronic kidney disease; CVA, cerebrovascular accident; KTR, kidney transplant recipient.