Table 4.
Comparison of vaccine adverse events between type1 diabetes patients and healthy controls of unmatched cohort (univariate and multivariate)
| Type 1 diabetes patients (n = 72) | HCs (n = 5,408) | Univariate | Multivariate † | |||
|---|---|---|---|---|---|---|
| OR (CI) | P‐value | OR (CI) | P‐value | |||
| n (%) | n (%) | |||||
| Any AE | 55 (76) | 4,176 (77) | 0.9 (0.5–1.6) | 0.868 | ||
| Injection site pain | 37 (51) | 3,401 (63) | 0.6 (0.3–0.9) | 0.045* | 0.6 (0.4–1.1) | 0.113 |
| Minor AEs to vaccine | ||||||
| Any minor AE | 54 (75) | 4,175 (77) | 0.8 (0.5–1.5) | 0.659 | ||
| Myalgia | 9 (12) | 829 (15) | 0.7 (0.3–1.5) | 0.508 | ||
| Body ache | 12 (16) | 1,149 (21) | 0.7 (0.3–1.3) | 0.345 | ||
| Fever | 17 (23) | 1,050 (19) | 1.2 (0.7–2.2) | 0.372 | ||
| Chills | 8 (11) | 694 (13) | 0.8 (0.4–1.7) | 0.664 | ||
| Nausea and vomiting | 5 (7) | 256 (5) | 1.5 (0.6–3.7) | 0.382 | ||
| Headache | 13 (18) | 1,266 (23) | 0.7 (0.3–1.3) | 0.286 | ||
| Rashes | 1 (1.4) | 64 (1) | 1.1 (0.1–8.5) | 0.873 | ||
| Fatigue | 17 (23) | 1,491 (27) | 0.8 (0.4–1.4) | 0.455 | ||
| Diarrhea | 4 (5) | 132 (2) | 2.3 (0.8–6.5) | 0.091 | ||
| Abdominal pain | 1 (1.4) | 83 (1.5) | 0.9 (0.1–6.5) | 0.920 | ||
| Rise in pulse rate | 0 (0) | 143 (3) | – | 0.162 | ||
| Rise in blood pressure | 0 (0) | 51 (1) | – | 0.408 | ||
| Fainting | 0 (0) | 22 (0.5) | – | 0.588 | ||
| Difficulty in breathing | 1 (1.4) | 65 (1) | 1.9 (0.8–4.5) | 0.885 | ||
| Dizziness | 6 (8) | 242 (4) | 1.9 (0.8–4.5) | 0.118 | ||
| Chest pain | 1 (1.4) | 69 (1) | 1.0 (0.1–7.9) | 0.932 | ||
| Others | 2 (3) | 354 (6) | 0.4 (0.1–1.6) | 0.212 | ||
| Major AEs | ||||||
| Any major AEs | 2 (3) | 128 (2) | 1.1 (0.2–4.8) | 0.820 | ||
| Anaphylaxis | 0 (0) | 5 (0.1) | – | 0.796 | ||
| Marked difficulty in breathing | 1 (1.4) | 34 (0.6) | 2.2 (0.3–16.4) | 0.421 | ||
| Throat closure | 0 (0) | 9 (0.2) | – | 0.729 | ||
| Severe rashes | 2 (3) | 20 (0.4) | 7.6 (1.7–33.5) | 0.001* | 7.4 (1.6–33.8) | 0.009* |
| Others | 0 (0) | 88 (1.6) | – | 0.536 | ||
| Hospitalization | 1 (1.4) | 12 (0.2) | 6.3 (0.8–49.3) | 0.158 | ||
AE, adverse effect; CI, confidence interval; HCs, healthy controls; OR, odds ratio.
*
Statistically significant.
†
Binary logistic regression adjusted for age, gender, ethnicity, vaccine type and stratified by country of origin.