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Tuesday Poster Session
Category: IBD
Angela Mujukian, MD
Cedars-Sinai Medical Center
Los Angeles, CA, United States
Table 1 |
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Adverse Events | Dose 1 Cohort Total (n=2324) | IBD Dose 1
(n=1391) | HCW Dose 1
(n=933) |
p-value |
| Dose 2 Cohort Total (n=2155) | IBD Dose 2
(n=1271) | HCW Dose 2
(n=884) |
p-value |
DEMOGRAPHICS |
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Age (mean (SD)) | 42.85 (13.5) | 43.04 (14.0) | 42.57 (12.7) | 0.41 | 42.95 (13.5) | 43.03 (14.1) | 42.84 (12.6) | 0.74 | |
Gender (% F) | 1493 (67.3) | 873 (67.4) | 620 (67.2) | 0.50 | 1396 (68) | 805 (68) | 591 (68) | -- | |
Non-white | 570 (25.6) | 112 (8.6) | 458 (49.5) | < 0.001 | 522 (25.2) | 100 (8.4) | 422 (48.0) | < 0.001 | |
Ethnicity (Hispanic) | 157 (7.1) | 43 (3.3) | 114 (12.4) | < 0.001 | 145 (7.0) | 39 (3.3) | 106 (12.1) | < 0.001 | |
mRNA-1273 Vaccine | 571 (24.6) | 563 (40.5) | 8 (0.9) | < 0.001 | 514 (23.9) | 507 (39.9) | 514 (23.9) | < 0.001 | |
Prior Covid Infection (n=%) | 130 (5.9) | 65 (5.1) | 65 (7.1) | 0.059 | 113 (5.5) | 57 (4.8) | 56 (6.4) | 0.14 | |
LOCAL INJECTION SITE REACTOGENICITY |
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Any injection site reaction | 1010 (43.5) | 483 (34.7) | 627 (56.5) | < 0.001 | 1277 (59.3) | 657 (51.7) | 620 (70.1) | < 0.001 | |
Local pain | 1006 (43.3) | 480 (34.5) | 526 (56.4) | < .001 | 1273 (59.1) | 654 (51.5) | 619 (70) | < 0.001 | |
Local Redness | 129 (5.6) | 81 (5.8) | 48 (5.2) | 0.56 | 211 (9.8) | 132 (10.4) | 79 (9.0) | 0.30 | |
Local Swelling | 175 (7.5) | 99 (7.1) | 76 (8.2) | 0.003 | 288 (13.4) | 173 (13.6) | 115 (13.1) | 0.79 | |
Any symptoms | 1052 (45.3) | 516 (37.1) | 536 (57.4) | < 0.001 | 1352 (62.7) | 705 (55.5) | 647 (73.2) | < 0.001 | |
SYSTEMIC SYMPTOMS |
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Fever or chills | 186 (8.0) | 88 (6.3) | 98 (10.5) | < 0.001 | 670 (31.1) | 322 (25.3) | 348 (39.4) | < 0.001 | |
Fatigue or malaise | 555 (23.9) | 297 (21.4) | 258 (27.7) | < 0.001 | 1070 (49.7) | 544 (42.8) | 526 (59.5) | < 0.001 | |
Headache, dizziness, or lightheadedness | 398 (17.1) | 199 (14.3) | 199 (21.3) | < 0.001 | 764 (35.5) | 386 (30.4) | 378 (42.8) | < 0.001 | |
Eye, ear, mouth or throat changes | 49 (2.1) | 24 (1.7) | 25 (2.7) | 0.15 | 73 (3.4) | 37 (2.9) | 36 (4.1) | 0.18 | |
Swollen lymph nodes, skin/nail or face changes | 41 (1.8) | 31 (2.2) | 10 (1.1) | 0.05 | 139 (6.5) | 83 (6.5) | 56 (6.3) | 0.93 | |
Cough, chest or breathing symptoms | 21 (0.9) | 9 (0.6) | 12 (1.3) | 0.17 | 46 (2.1) | 23 (1.8) | 23 (2.6) | 0.27 | |
Nausea, vomiting, diarrhea, or other GI symptoms | 110 (4.7) | 83 (6.0) | 27 (2.9) | < 0.001 | 266 (12.3) | 154 (12.1) | 112 (12.7) | 0.75 | |
Urinary or genital symptoms | 1 (0.0) | 1 (0.1) | 0 (0.0) | >.99 | 6 (0.3) | 3 (0.2) | 3 (0.3) | 0.97 | |
Muscle, bone, joint or nerve symptoms | 183 (7.9) | 77 (5.5) | 106 (11.4) | < 0.001 | 499 (23.2) | 210 (16.5) | 289 (32.7) | < 0.001 | |
Memory or mood changes | 22 (0.9) | 12 (0.9) | 10 (1.1) | 0.77 | 57 (2.6) | 39 (3.1) | 18 (2.0) | 0.18 | |
Sleep changes | 73 (3.1) | 40 (2.9) | 33 (3.5) | 0.44 | 203 (9.4) | 117 (9.2) | 86 (9.7) | 0.74 |