Table 3.
COVID-19 vaccination-associated AEs across different IIM subtypes
| DM (283) | IBM (249) | PM (185) | NM (60) | JM (4) | ASS (76) | OM (94) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | N | % | N | % | N | % | N | % | |
| Minor AEs | 47 | 16.6 | 18***# | 7.2 | 38 | 20.5 | 12 | 20 | 1 | 25.0 | 11 | 14.5 | 41***# | 43.6 |
| Injection site (arm) pain and soreness | 26 | 9.2 | 8*** | 3.2 | 17 | 9.2 | 9 | 15.0 | 0 | 0.0 | 6 | 7.9 | 17**# | 18.1 |
| Myalgia | 23 | 8.1 | 5***# | 2.0 | 18 | 9.7 | 4 | 6.7 | 0 | 0.0 | 5 | 6.6 | 18***# | 19.1 |
| Body ache | 27 | 9.5 | 6*** | 2.4 | 13 | 7.0 | 3 | 5.0 | 0 | 0.0 | 3 | 3.9 | 24***# | 25.5 |
| Joint pain | 22 | 7.8 | 3***# | 1.2 | 10 | 5.4 | 3 | 5.0 | 0 | 0.0 | 5 | 6.6 | 18***# | 19.1 |
| Fever | 16 | 5.7 | 4* | 1.6 | 6 | 3.2 | 1 | 1.7 | 0 | 0.0 | 4 | 5.3 | 14***# | 14.9 |
| Chills | 20* | 7.1 | 4* | 1.6 | 4 | 2.2 | 1 | 1.7 | 0 | 0.0 | 4 | 5.3 | 13***# | 13.8 |
| Cough | 5 | 1.8 | 0* | 0.0 | 0 | 0.0 | 0 | 0.0 | 1*** | 25.0 | 1 | 1.3 | 6***# | 6.4 |
| Difficulty in breathing or shortness of breath | 10 | 3.5 | 2* | 0.8 | 4 | 2.2 | 1 | 1.7 | 0 | 0.0 | 1 | 1.3 | 8***# | 8.5 |
| Nausea/vomiting | 8 | 2.8 | 1* | 0.4 | 1 | 0.5 | 1 | 1.7 | 0 | 0.0 | 1 | 1.3 | 7***# | 7.4 |
| Headache | 19 | 6.7 | 4*** | 1.6 | 13 | 7.0 | 3 | 5.0 | 0 | 0.0 | 3 | 3.9 | 18***# | 19.1 |
| Rash | 16 | 5.7 | 1**# | 0.4 | 8 | 4.3 | 0 | 0.0 | 0 | 0.0 | 1 | 1.3 | 11***# | 11.7 |
| Fatigue | 29 | 10.2 | 9*** | 3.6 | 14 | 7.6 | 5 | 8.3 | 0 | 0.0 | 7 | 9.2 | 23***# | 24.5 |
| Diarrhea | 7 | 2.5 | 0* | 0.0 | 2 | 1.1 | 1 | 1.7 | 0 | 0.0 | 0 | 0.0 | 5**# | 5.3 |
| Abdominal pain | 6 | 2.1 | 1 | 0.4 | 1 | 0.5 | 1 | 1.7 | 0 | 0.0 | 1 | 1.3 | 5**# | 5.3 |
| High pulse rate or palpitations | 10 | 3.5 | 1* | 0.4 | 1 | 0.5 | 0 | 0.0 | 0 | 0.0 | 3 | 3.9 | 9***# | 9.6 |
| Rise in blood pressure | 4 | 1.4 | 2 | 0.8 | 2 | 1.1 | 0 | 0.0 | 0 | 0.0 | 1 | 1.3 | 3 | 3.2 |
| Fainting | 1 | 0.4 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.1 |
| Dizziness | 10 | 3.5 | 3 | 1.2 | 5 | 2.7 | 0 | 0.0 | 0 | 0.0 | 2 | 2.6 | 8**# | 8.5 |
| Chest pain | 5* | 1.8 | 1 | 0.4 | 1 | 0.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.1 |
| Swelling in the extremities | 3 | 1.1 | 1 | 0.4 | 1 | 0.5 | 0 | 0.0 | 0 | 0.0 | 2* | 2.6 | 0 | 0.0 |
| Weakness and tingling in the feet and legs | 6 | 2.1 | 1* | 0.4 | 12** | 6.5 | 1 | 1.7 | 0 | 0.0 | 0 | 0.0 | 8**# | 8.5 |
| Pricking or pins and needles sensations in the hands and feet | 3 | 1.1 | 1* | 0.4 | 7 | 3.8 | 1 | 1.7 | 0 | 0.0 | 1 | 1.3 | 7***# | 7.4 |
| Visual disturbances (loss of vision, blurring of vision, etc.) | 4 | 1.4 | 1 | 0.4 | 3 | 1.6 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 3 | 3.2 |
| Bleeding/bruising on the body | 1 | 0.4 | 1 | 0.4 | 2 | 1.1 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.1 |
| Petechial rash | 2 | 0.7 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 4***# | 4.3 |
| Major AEs | 24 | 8.5 | 13*# | 5.2 | 17 | 9.2 | 6 | 10 | 1 | 25.0 | 3 | 3.9 | 23***# | 24.5 |
| Anaphylaxis | 4 | 1.4 | 3 | 1.2 | 2 | 1.1 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 3 | 3.2 |
| Marked difficulty in breathing | 11 | 3.9 | 4 | 1.6 | 7 | 3.8 | 1 | 1.7 | 1* | 25.0 | 1 | 1.3 | 7* | 7.4 |
| Throat closure | 5 | 1.8 | 4 | 1.6 | 3 | 1.6 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 4* | 4.3 |
| Severe rashes | 11 | 3.9 | 5 | 2.0 | 4 | 2.2 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 7*# | 7.4 |
| Hospitalization | 7 | 2.5 | 4 | 1.6 | 4 | 2.2 | 3 | 5.0 | 0 | 0.0 | 1 | 1.3 | 8***# | 8.5 |
Comparisons are between each IIM subtype vs. the rest of IIM subtypes. Bold indicates increased OR vs. the others. Bold + Underlined indicates decreased OR vs. the others. AE adverse events, ASS anti-synthetase syndrome, DM dermatomyositis, IBM inclusion body myositis, IIM idiopathic inflammatory myopathies, JDM juvenile dermatomyositis, NM necrotizing myositis, OM overlap myositis, PM polymyositis
#Significant in BLR (binary logistic regression) adjusted for age, gender, ethnicity, immunosuppressant dose, and stratified by country. *p < .05, **p < .005, ***p < .001