TABLE 4.
Vaccine ADEs based on COVID‐19 vaccine received among IIM patients (vs rest of vaccines)
| BNT162b2 (Pfizer) (n = 634) | ChadOx1 nCOV‐19 (Oxford/AstraZeneca) (n = 124) | MRNA‐1273 (Moderna) (n = 360) | ChAdOx1 nCoV‐19 (Covishield Serum Institute India) (n = 43) | |
|---|---|---|---|---|
| Injection‐site pain | 398 (62) | 69 (55) a * | 273 (76) a *** | 25 (58) |
| Minor ADEs | ||||
| Any minor ADE | 456 (71) a *** | 96 (77) | 303 (85) a *** | 35 (81) |
| Myalgia | 55 (8) a *** | 23 (18) a * | 44 (12) | 15 (35) a *** |
| Body ache | 99 (15) a *** | 35 (28) a * | 76 (21) | 12 (28) |
| Fever | 49 (7) a *** | 26 (21) a * | 54 (15) | 18 (42) a *** |
| Chills | 72 (11) a *** | 29 (23) a * | 65 (18) *, a | 4 (9) |
| Nausea and vomiting | 22 (3) a *** | 15 (12) * | 31 (8) *, a | 5 (11) |
| Headache | 120 (18) a *** | 41 (33) a ** | 91 (25) | 10 (23) |
| Rashes | 10 (1.5) a ** | 5 (4) | 21 (6) a *** | 1 (2) |
| Fatigue | 178 (27) | 37 (29) | 120 (33)* | 7 (16)* |
| Diarrhea | 14 (2) | 8 (6) * | 8 (2) | 1 (2) |
| Abdominal pain | 12 (2) | 9 (7) a *** | 7 (2) | 2 (4) |
| High pulse rate or palpitations | 12 (2) | 8 (6) a ** | 7 (2) | 2 (4) |
| Rise in blood pressure | 7 (1) | 3 (2) | 1 (0.2) | 1 (2) |
| Fainting | 5 (0.7) | 1 (1) | 1 (0.2) | 1 (2) |
| Difficulty in breathing | 7 (1) | 1 (1) | 4 (1) | 2 (4) |
| Dizziness | 21 (3) a ,* | 9 (7) | 25 (6)* | 3 (7) |
| Chest pain | 10 (1.5) | 2 (1.6) | 4 (1) | 2 (4) |
| Major ADEs | ||||
| Any major ADE | 22 (3.3) * | 11 (8.3) * | 17 (4.7) | 3 (7) |
| Anaphylaxis | 3 (0.4) | 3 (2) * | 1 (0.2) | 1 (2) |
| Marked difficulty in breathing | 6 (1) | 2 (1.6) | 4 (1) | 1 (2) |
| Throat closure | 1 (0.1) * | 2 (1.6) | 2 (0.5) | 1 (2) |
| Severe rashes | 6 (1) | 3 (2) | 2 (0.5) | 1 (2) |
| Hospitalization | 2 (0.2) | 1 (1) | 3 (0.8) | 1 (2) |
Notes: Chi‐square test used for categorical variables and Mann‐Whitney U test used for scale variables. Bold indicates increased odds ratio vs the remaining vaccines. Bold+underlined indicates decreased odds ratio vs remaining vaccines.
Abbreviations: ADE, adverse drug event; AID, autoimmune disease; HC, healthy control; IIM, idiopathic inflammatory myopathy.
*P < .05, ** P < .005, *** P < .001.
a
Significant according to binary logistic regression adjusted for age, gender, ethnicity, and immunosuppressant dose, and stratified by country.