Table 1.
Safety and flare data of AIIRDs after receiving inactivated COVID-19 vaccines
| Variables | All AIIRDs | SLE | RA | BD | PsA/PsO | pSS |
| Participants (n) | 1507 | 614 | 434 | 122 | 76 | 74 |
| Female (n, %) | 1166 (77.4%) | 572 (93.2%) | 342 (78.8%) | 63 (51.6%) | 34 (44.7%) | 69 (93.2%) |
| Age (median, years) | 39 (31, 51) | 33 (27, 40) | 50 (39, 60) | 37 (30, 45) | 46 (36, 58) | 48 (39, 59) |
| Disease duration (median, years) | 5 (2, 10) | 5 (3, 10) | 4 (2, 10) | 6 (3, 10) | 10 (3, 20) | 3 (2, 5) |
| Allergic history (n, %)* | 209 (13.9%) | 127 (20.7%) | 36 (8.3%) | 21 (17.2%) | 4 (5.3%) | 6 (8.1%) |
| Complete two-dose vaccine (n, %) | 1197 (79.4%) | 436 (71.0%) | 407 (93.8%) | 87 (71.3%) | 63 (82.9%) | 62 (83.8%) |
| Inactivated vaccine band (n, %) | ||||||
| Sinopharm | 607 (40.3%) | 272 (44.3%) | 156 (35.9%) | 59 (48.4%) | 25 (32.9%) | 26 (35.1%) |
| Sinovac | 874 (58.0%) | 340 (55.4%) | 268 (61.8%) | 62 (50.8%) | 50 (65.8%) | 47 (63.5%) |
| Others/uncertain band | 26 (1.7%) | 2 (0.3%) | 10 (2.3%) | 1 (0.8%) | 1 (1.3%) | 1 (1.4%) |
| AEs (n, %) | 450 (29.9%) | 232 (37.8%) | 106 (24.4%) | 34 (27.9%) | 14 (18.4%) | 24 (32.4%) |
| Local (n, %) | 287 (19.0%) | 160 (26.1%) | 65 (15.0%) | 19 (15.6%) | 7 (9.2%) | 13 (17,6%) |
| Systemic (n, %) | 260 (17.3%) | 120 (19.5%) | 66 (15, 2%) | 28 (23.0%) | 8 (10.5%) | 15 (20.3%) |
| Rash | 55 | 28 | 13 | 9 | 2 | 3 |
| Fever/chills | 43 | 19 | 10 | 4 | 2 | 1 |
| Headache | 82 | 40 | 21 | 11 | 2 | 4 |
| Fatigue/sleepless | 123 | 57 | 31 | 14 | 2 | 7 |
| Nausea/vomiting | 26 | 15 | 10 | 3 | 0 | 1 |
| Diarrhoea | 10 | 7 | 0 | 1 | 1 | 1 |
| Others | 32 | 11 | 9 | 6 | 1 | 2 |
| Side effects after first vaccine (n, %) | 321/1507 (21.3%) | 179/614 (29.2%) | 69/434 (15.9%) | 32/122 (26.2%) | 10/76 (13.2%) | 18/74 (24.3%)‡ |
| Timing of onset, days (median) | 2 (1, 3) | 1 (1, 3) | 2 (1, 3) | 2 (1, 2) | 1 (1, 2) | 2 (1, 2) |
| Side effects after second vaccine (n, %) | 140/1210 (11.8%) | 68/436 (15.6%) | 44/302 (14.6%) | 9/87 (10.3%) | 5/63 (7.9%) | 4/62 (6.5%)‡ |
| Timing of onset, days (median) | 2 (1, 5) | 1 (1, 7) | 1 (1, 5) | 2 (1, 3) | 1 (1, 2) | 2 (1, 7) |
| Self-reported severe AE (n, %) | 28 (1.9%) | 11 (1.8%) | 4 (0.9%) | 8 (6.6%) | 0 (0%) | 1 (1.4%) |
| Fatal AE of interest (n, %)† | 0 | 0 | 0 | 0 | 0 | 0 |
| Self-reported flare after vaccine (n, %) | 158 (10.5%) | 65 (10.6%) | 41 (9.4%) | 14 (11.5%) | 3 (3.9%) | 5 (6.8%) |
| Flare required treatment escalation (n, %) | 53 (3.5%) | 19 (3.1%) | 11 (2.5%) | 7 (5.7%) | 1 (1.3%) | 2 (2.7%) |
*This question was described as ‘Have you ever been allergic to any food, drug or environmental substance etc before?’.
†Means anaphylactic shock, myocarditis, idiopathic thrombocytopenic purpura and death.
‡Three participants were not fully clear about that the side effects occured.after first or second vaccination.
AE, adverse event; AIIRDs, autoimmune inflammatory rheumatic diseases; BD, Behcet’s disease; PsA/PsO, psoriatic arthritis/psoriasis; pSS, primary Sjogren’s syndrome; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus.