Table 8. Incidence rates of potential COVID-19 associated complications in breakthrough patients.
The columns are: (1) Complications: phenotypes that are written with positive-sentiment in the clinical notes and occur −3 to +30 days relative to COVID diagnosis and do not occur −180 to −4 days relative to COVID diagnosis; (2) Incidence Rate of Complications in mRNA-1273 Breakthrough cases: the number of mRNA-1273-vaccinated individuals experiencing the complication divided by the number of at-risk patient days contributed by mRNA-1273-vaccinated breakthrough cases; (3) Incidence Rate of Complications in BNT162b2 Breakthrough cases: the number of BNT162b2-vaccinated individuals experiencing the complication divided by the number of at-risk patient days contributed by BNT162b2-vaccinated breakthrough cases; (4) IRR mRNA-1273 / BNT162b2: the IR of the complication in the mRNA-1273 breakthrough cohort divided by the IR of the complication in the BNT162b2 breakthrough cohort.
| Complication | Incidence Rate mRNA-1273 (n = 106) Events/Person-Days [Per 1000 Person-Days] |
Incidence Rate BNT162b2 (n = 220) Events/Person-Days [Per 1000 Person-Days] |
IRR mRNA-1273 / BNT162b2 (exact 95% CI) |
|---|---|---|---|
| ARD ALI | 4 / 2,206 [0.18%] | 10 / 4,335 [0.23%] | 0.79 (0.18, 2.73) |
| Acute kidney injury | 5 / 2,052 [0.24%] | 15 / 4,062 [0.37%] | 0.66 (0.19, 1.91) |
| Anemia | 9 / 1,729 [0.52%] | 8 / 3,853 [0.21 %] | 2.51 (0.86, 7.47) |
| Cardiac arrest | 1 / 2,230 [0.045%] | 2 / 4,521 [0.044%] | 1.01 (0.02, 19.47) |
| Cardiac arrhythmias | 9 / 1,686 [0.53%] | 20 / 3,216 [0.62%] | 0.86 (0.34, 1.97) |
| Chronic fatigue syndrome | 1 / 2,233 [0.045%] | 0 / 4,591 [0%] | inf (0.05, inf) |
| Disseminated intravascular coagulation | 0 / 2,238 [0%] | 0 / 4,591 [0%] | N/A |
| Encephalopathy Delirium | 2 / 2,148 [0.093%] | 4 / 4,360 [0.092%] | 1.01 (0.09, 7.08) |
| Heart failure | 5 / 2,043 [0.24%] | 7 / 4,149 [0.17%] | 1.45 (0.36, 5.31) |
| Hyperglycemia | 3 / 2,045 [0.15%] | 5 / 3,988 [0.13%] | 1.17 (0.18, 6.01) |
| Hypertension | 8 / 1,295 [0.62%] | 24 / 2,137 [1.1%] | 0.55 (0.21, 1.27) |
| Myocardial infarction | 2 / 2,143 [0.093%] | 5 / 4,364 [0.11%] | 0.81 (0.08, 4.98) |
| Numbness | 4 / 1,873 [0.21%] | 5 / 3,930 [0.13%] | 1.68 (0.33, 7.8) |
| Pleural effusion | 5 / 2,140 [0.23%] | 8 / 4,240 [0.19%] | 1.24 (0.32, 4.29) |
| Pulmonary embolism | 2 / 2,208 [0.091 %] | 5 / 4,393 [0.11%] | 0.8 (0.08, 4.86) |
| Respiratory failure | 5 / 2,199 [0.23%] | 10 / 4,335 [0.23%] | 0.99 (0.26, 3.17) |
| Sepsis | 3 / 2,142 [0.14%] | 2 / 4,418 [0.045%] | 3.09 (0.35, 37.04) |
| Septic shock | 1 / 2,217 [0.045%] | 0 / 4,557 [0%] | inf (0.05, inf) |
| Stroke | 0 / 2,204 [0%] | 5 / 4,307 [0.12%] | 0.0 (0, 2.13) |
| Venous thromboembolism | 3 / 2,173 [0.14%] | 3 / 4,382 [0.068%] | 2.02 (0.27, 15.06) |