Table 3.
New graft-versus-host disease (GVHD) events and grade 3 or higher adverse events possibly related to SARS-CoV-2 mRNA vaccination reported at each time point.
| Event | <4-month cohort |
4-12-month cohort |
||||||
|---|---|---|---|---|---|---|---|---|
| Post-V1 (n = 76) | Post-V2 (n = 73) | Post-V3 (n = 53) | End-of-study (n = 57) | Post-V1 (n = 96) | Post-V2 (n = 88) | Post-V3 (n = 65) | End-of-study (n = 76) | |
| New-onset GVHD | ||||||||
| Acute GVHD skin grade | ||||||||
| 1 | 1 | – | – | – | 1 | 1 | 3 | 1 |
| 2 | 1 | 3 | – | 2 | 1 | – | – | – |
| 3 | – | – | 1 | – | 1 | 1 | – | – |
| Acute GVHD upper GI | ||||||||
| No | 2 | 3 | 1 | 3 | 5 | 2 | 3 | 2 |
| Yes | – | 1 | 1 | 1 | 1 | – | – | – |
| Acute GVHD lower GI grade | ||||||||
| 1 | – | 1 | 1 | – | 1 | – | – | – |
| 3 | – | – | – | – | 1 | – | – | – |
| 4 | – | 1 | – | – | – | – | – | – |
| Acute GVHD liver grade | ||||||||
| 1 | – | – | – | – | 1 | 1 | – | – |
| 2 | – | – | – | 1 | – | – | – | – |
| Chronic GVHD severity | ||||||||
| Mild | 3 | 4 | 4 | 10 | 13 | 14 | 9 | 12 |
| Moderate | 1 | 6 | 5 | 6 | 5 | 8 | 4 | 3 |
| Severe | – | – | – | – | – | – | – | – |
| Chronic GVHD extent | ||||||||
| Limited | 4 | 4 | 4 | 10 | 16 | 14 | 7 | 10 |
| Extensive | 1 | 6 | 5 | 6 | 2 | 9 | 6 | 6 |
| Adverse events ≥ Grade 3 | ||||||||
| Fever | – | – | – | – | – | 2 | – | – |
| Fatigue | 1 | 1 | – | – | – | – | – | – |
| Allergic reaction | – | – | – | 1 | – | – | – | 1 |
| Nausea | – | – | – | 2 | – | 1 | – | – |
| Vomiting | – | – | – | 2 | – | – | – | – |
| Diarrhea | – | – | – | 1 | – | – | – | – |
| Cystitis noninfective | – | – | – | – | – | – | – | 1 |
| Acute kidney injury | – | – | – | 1 | – | – | – | – |
| Dialysis | – | – | – | – | – | 1 | – | – |
| Hypotension | – | – | – | – | – | – | – | 1 |
| Hypertension | – | 1 | – | – | 2 | 1 | – | – |
| Pericardial effusion | – | – | – | 1 | 1 | – | – | – |
| Thromboembolic event | – | 1 | – | – | – | – | – | – |
| Arthralgia (joint pain) | – | – | – | – | – | 1 | – | – |
| Myalgia (muscle pain) | – | 1 | – | – | – | 1 | – | 1 |
| Hypoxia | – | – | – | 1 | – | – | – | 2 |
| Dyspnea | – | – | – | 1 | – | – | 1 | – |
| Hyperglycemia | – | – | – | – | – | – | 1 | 1 |
| Hepatitis | 2 | 2 | – | – | 4 | 1 | – | – |
Adverse events (according to NCI CTCAE Version 5.0) are shown for those documented prior to the indicated time point. Participants may have the same adverse event in multiple visits. GVHD body site involvement did not correlate with adverse events at that site (e.g., rash did not correlate with skin GVHD).