Table 4.
AEs distribution according to the vaccines in IIM group
| BNT162b2 (Pfizer) | ChadOx1 nCOV-19 (Oxford/ AstraZeneca) | mRNA-1273 (Moderna) | ChAdOx1 nCoV-19 (Covishield Serum Institute India) | Sinovac-CoronaVac | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N (883) | % (100) | N (175) | % (100) | N (555) | % (100) | N (15) | % (100) | N (29) | % (100) | |
| Minor AEs | 136 | 15.4 | 38* | 21.7 | 84 | 15.1 | 4 | 26.7 | 9* | 31.0 |
| Injection site (arm) pain and soreness | 65*# | 7.4 | 22 | 12.6 | 10 | 1.8 | 1 | 6.7 | 6* | 20.7 |
| Myalgia | 59 | 6.7 | 18 | 10.3 | 8 | 1.4 | 1 | 6.7 | 5* | 17.2 |
| Body ache | 59* | 6.7 | 20 | 11.4 | 8 | 1.4 | 2 | 13.3 | 6* | 20.7 |
| Joint pain | 52 | 5.9 | 17 | 9.7 | 8 | 1.4 | 2 | 13.3 | 5*# | 17.2 |
| Fever | 41 | 4.6 | 15 | 8.6 | 5 | 0.9 | 2 | 13.3 | 5* | 17.2 |
| Chills | 44 | 5.0 | 13 | 7.4 | 6 | 1.1 | 1 | 6.7 | 3 | 10.3 |
| Cough | 13 | 1.5 | 1 | 0.6 | 1 | 0.2 | 1 | 6.7 | 3***# | 10.3 |
| Difficulty in breathing or shortness of breath | 22 | 2.5 | 4 | 2.3 | 4 | 0.7 | 2* | 13.3 | 2 | 6.9 |
| Nausea/vomiting | 13 | 1.5 | 5 | 2.9 | 1 | 0.2 | 0 | 0.0 | 0 | 0.0 |
| Headache | 55 | 6.2 | 17*# | 9.7 | 5 | 0.9 | 0 | 0.0 | 3 | 10.3 |
| Rash | 24# | 2.7 | 3 | 1.7 | 4 | 0.7 | 3***# | 20.0 | 2 | 6.9 |
| Fatigue | 71 | 8.0 | 21 | 12.0 | 6 | 1.1 | 2 | 13.3 | 4 | 13.8 |
| Diarrhea | 16 | 1.8 | 6 | 3.4 | 2 | 0.4 | 1 | 6.7 | 1 | 3.4 |
| Abdominal pain | 10 | 1.1 | 4 | 2.3 | 2 | 0.4 | 1 | 6.7 | 3***# | 10.3 |
| High pulse rate or palpitations | 25 | 2.8 | 5 | 2.9 | 1 | 0.2 | 2* | 13.3 | 4***# | 13.8 |
| Rise in blood pressure | 13 | 1.5 | 6*# | 3.4 | 1 | 0.2 | 0 | 0.0 | 1 | 3.4 |
| Fainting | 2 | 0.2 | 2 | 1.1 | 1 | 0.2 | 1** | 6.7 | 2***# | 6.9 |
| Dizziness | 29 | 3.3 | 8 | 4.6 | 2 | 0.4 | 1 | 6.7 | 4**# | 13.8 |
| Chest pain | 10 | 1.1 | 3 | 1.7 | 1 | 0.2 | 0 | 0.0 | 1 | 3.4 |
| Swelling in the extremities | 13 | 1.5 | 6 | 3.4 | 2 | 0.4 | 1 | 6.7 | 2* | 6.9 |
| Weakness and tingling in the feet and legs | 27 | 3.1 | 10 | 5.7 | 2 | 0.4 | 1 | 6.7 | 4**# | 13.8 |
| Pricking or pins and needles sensations in the hands and feet | 21 | 2.4 | 8 | 4.6 | 1 | 0.2 | 1 | 6.7 | 5***# | 17.2 |
| Visual disturbances (loss of vision, blurring of vision, etc.) | 10 | 1.1 | 5 | 2.9 | 2 | 0.4 | 1 | 6.7 | 2*# | 6.9 |
| Bleeding/bruising on the body | 10 | 1.1 | 6*# | 3.4 | 1* | 0.2 | 1 | 6.7 | 2* | 6.9 |
| Petechial rash | 3*# | 0.3 | 2 | 1.1 | 1 | 0.2 | 1* | 6.7 | 2*** | 6.9 |
| Major AEs | 72**# | 8.2 | 22 | 12.6 | 61 | 11.0 | 7***# | 46.7 | 10***# | 34.5 |
| Anaphylaxis | 11* | 1.2 | 5 | 2.9 | 9 | 1.6 | 3***# | 20.0 | 5***# | 17.2 |
| Marked difficulty in breathing | 26 | 2.9 | 7 | 4.0 | 10 | 1.8 | 5***# | 33.3 | 4** | 13.8 |
| Throat closure | 13** | 1.5 | 6 | 3.4 | 9 | 1.6 | 3***# | 20.0 | 5***# | 17.2 |
| Severe rashes | 19**# | 2.2 | 6 | 3.4 | 10 | 1.8 | 4***# | 26.7 | 6***# | 20.7 |
| Hospitalization | 21** | 2.4 | 8 | 4.6 | 11 | 2.0 | 4***# | 26.7 | 5***# | 17.2 |
Bold indicates increased odds ratio vs. the remaining vaccines. Bold + Underlined indicates decreased odds ratio vs. remaining vaccines. AE adverse events, AID autoimmune disease, HC healthy control, IIM idiopathic inflammatory myopathy
#Significant according to binary logistic regression adjusted for age, gender, ethnicity, and immunosuppressant dose, and stratified by country. *p < .05, **p < .005, ***p < .001