TABLE 2.
Comparison of vaccination‐related ADEs among active and inactive IIM cases
| Active IIM a (n = 855) | Inactive IIM a (n = 352) | Univariate | Multivariable | |||
|---|---|---|---|---|---|---|
| OR (95% CI) | P value | OR (95% CI) | P value | |||
| Any ADE | 681 (79.6) | 242 (68.8) | 1.7 (1.3‐2.3) | <.001 | 1.6 (1.1‐2.2) | .006 |
| Injection site pain | 557 (65) | 216 (61) | .213 | |||
| Minor ADEs | ||||||
| Any minor ADE | 679 (79.4) | 242 (68.8) | 1.7 (1.3‐2.3) | <.001 | 1.5 (1.1‐2.2) | .007 |
| Myalgia | 117 (13.7) | 25 (7) | 2 (1.3‐3.2) | .001 | 2.2 (1.3‐3.8) | .002 |
| Body ache | 178 (21) | 49 (14) | 1.6 (1.1‐2.2) | .005 | 1.5 (1.07‐2.3) | .020 |
| Fever | 112 (13) | 37 (10.5) | ‐‐‐ | .214 | ||
| Chills | 134 (15.7) | 38 (10.8) | 1.5 (1.04‐2.2) | .028 | 1.3 (0.8‐2.1) | .162 |
| Nausea and vomiting | 60 (7) | 12 (3.4) | 2.1 (1.1‐4) | .016 | 1.7 (0.8‐3.6) | .107 |
| Headache | 212 (25) | 55 (15.6) | 1.7 (1.2‐2.4) | <.001 | 1.5 (1.04‐2.1) | .028 |
| Rashes | 25 (2.9) | 9 (2.6) | .726 | |||
| Fatigue | 266 (31.1) | 73 (20.7) | 1.7 (1.2‐2.3) | <.001 | 1.5 (1.08‐2.1) | .015 |
| Diarrhea | 22 (2.6) | 5 (1.4) | .218 | |||
| Abdominal pain | 24 (2.8) | 3 (0.9) | .051 | |||
| High pulse rate or palpitations | 21 (2.5) | 6 (1.7) | .422 | |||
| Rise in blood pressure | 5 (0.6) | 3 (0.9) | .603 | |||
| Fainting | 2 (0.2) | 2 (0.6) | .358 | |||
| Difficulty in breathing | 9 (1.1) | 1 (0.3) | .181 | |||
| Dizziness | 51 (6) | 7 (2) | 3.1 (1.4‐6.9) | .003 | 2.5 (1.08‐5.9) | .031 |
| Chest pain | 14 (1.6) | 2 (0.6) | .140 | |||
| Major ADEs | ||||||
| Any major ADE | 49 (5.7) | 6 (1.7) | 3.5 (1.4‐8.2) | .002 | 2.7 (1.04‐7.3) | .040 |
| Anaphylaxis | 5 (0.6) | 0 (0) | .151 | |||
| Marked difficulty in breathing | 5 (0.6) | 3 (0.9) | .603 | |||
| Throat closure | 4 (0.5) | 0 (0) | .199 | |||
| Severe rashes | 7 (0.8) | 1 (0.3) | .298 | |||
| Hospitalization | 5 (0.6) | 2 (0.6) | .972 | |||
Notes: Chi‐square test was used for categorical variables and Mann‐Whitney U test used for continuous variables.
Factors adjusted in multivariable analysis (binary logistic regression) include age, gender, ethnicity, vaccine received, number of vaccine doses received, and immunosuppressants received.
Abbreviations: ADE, adverse drug event; CI, confidence interval; IIM, idiopathic inflammatory myopathy; OR, odds ratio.
a
Data expressed as number (%).