Flares and AEs stratified by inflammatory RMD disease group
| Inflammatory joint diseases (n=2977) | Connective tissue diseases (n=928) | Vasculitis (n=593) | ||
| Flare following vaccination | Yes | 151 (5) | 29 (3) | 19 (3) |
| No | 2260 (76) | 784 (85) | 561 (95) | |
| Unknown/missing | 566 (19) | 115 (12) | 13 (2) | |
| Severity of flare | Mild/minor | 51 (2) | 13 (1) | 5 (1) |
| Moderate | 77 (3) | 12 (1) | 8 (1) | |
| Severe/major without hospitalisation | 15 (1) | 1 (<1) | 3 (1) | |
| Severe/major with hospitalisation | 1 (<1) | 2 (<1) | 3 (1) | |
| Unknown/missing | 7 (<1) | 1 (<1) | ||
| New medication or dosage increase due to flare | 44 (1) | 10 (1) | 11 (2) | |
| Vaccine-related AEs | Yes | 1092 (37) | 382 (41) | 175 (30) |
| No | 1885 (63) | 546 (59) | 418 (70) | |
| AE severity (only collected for AEs of special interest) | Non-serious | 55 (2) | 21 (2) | 13 (2) |
| Severe – important medical event | 4 (1) | 4 (1) | ||
| Severe – hospitalisation (or prolongation of existing hospitalisation) | 4 (1) | 2 (<1) | ||
| Severe – life threatening | 2 (<1) | 1 (<1) | ||
| Unknown/missing | 2 (<1) | |||
All values are n (%) unless stated otherwise.
AEs, adverse events; RMD, rheumatic and musculoskeletal disease.