Table 2.
Comparison of vaccination-related AEs in patients with active vs inactive SLE
| Active SLE (n = 328) n (%) | Inactive SLE (n = 255) n (%) | Univariable |
Multivariable |
|||
|---|---|---|---|---|---|---|
| OR (95% CI) | P | OR (95% CI) | P | |||
| Any AEs | 277 (84.5) | 207 (81.2) | — | 0.296 | — | — |
| Injection site pain | 229 (69.8) | 186 (73.0) | — | 0.409 | — | — |
| Minor AEs | ||||||
| Any minor AEs | 277 (84.5) | 207 (81.2) | — | 0.296 | — | — |
| Myalgia | 55 (16.8) | 36 (14.1) | — | 0.382 | — | — |
| Body ache | 74 (22.6) | 46 (18.0) | — | 0.180 | — | — |
| Fever | 74 (22.6) | 38 (14.9) | 1.6 (1.1, 2.5) | 0.020 | 1.6 (1.1, 2.5) | 0.026 |
| Chills | 37 (11.3) | 29 (11.4) | — | 0.972 | — | — |
| Nausea and vomiting | 29 (8.8) | 15 (5.8) | — | 0.180 | — | — |
| Headache | 84 (25.6) | 63 (24.7) | — | 0.803 | — | — |
| Rashes | 12 (3.7) | 3 (1.2) | — | 0.060 | — | — |
| Fatigue | 102 (31) | 60 (23.5) | 1.4 (1.0, 2.1) | 0.043 | 1.5 (1.1, 2.3) | 0.025 |
| Diarrhoea | 9 (2.7) | 10 (3.9) | — | 0.427 | — | — |
| Abdominal pain | 9 (2.7) | 4 (1.6) | — | 0.340 | — | — |
| Tachycardia | 20 (6.0) | 2 (0.8) | 8.2 (1.9, 35) | 0.001 | 8.0 (1.8, 35) | 0.006 |
| Rise in blood pressure | 5 (1.5) | 3 (1.2) | — | 0.720 | — | — |
| Fainting | 0 (0.0) | 1 (0.4) | — | 0.256 | — | — |
| Difficulty in breathing | 6 (1.8) | 1 (0.4) | — | 0.114 | — | — |
| Dizziness | 26 (7.9) | 15 (5.8) | — | 0.338 | — | — |
| Chest pain | 10 (3.0) | 1 (0.4) | 7.9 (1.0, 62) | 0.019 | 7.7 (0.9, 62) | 0.054 |
| Major AEs | ||||||
| Any major AEs | 12 (3.7) | 3 (1.2) | — | 0.060 | — | — |
| Anaphylaxis | 2 (0.6) | 1 (0.4) | — | 0.716 | — | — |
| Marked dyspnoea | 1 (0.3) | 0 (0.0) | — | 0.378 | — | — |
| Throat closure | 1 (0.3) | 0 (0.0) | — | 0.378 | — | — |
| Severe rashes | 1 (0.3) | 0 (0.4) | — | 0.858 | — | — |
| Hospitalization | 0 (0.0) | 1 (0.4) | — | 0.256 | — | — |
Factors included as covariates in multivariable binary logistic regression analysis included age, gender, ethnicity, country by human development index. Bold text highlights significant P-values.
AEs: adverse events; OR: odds ratio.