TABLE 6.
Observed to Expected Rates of Neurological events Reported after COVID Vaccination Compared to Rates of Neurological Events During the Acute Phase of SARS‐CoV‐2 Infection. Person‐years of Observation for all COVID Vaccines
Adverse event | Characteristic | All COVID vaccines^ (n = 306,907,697 doses) | Pfizer (n = 166,981,930 doses) | Moderna (n = 128,084,622 doses) | Janssen (n = 11,606,202 doses) |
---|---|---|---|---|---|
Any neurological event | Observed N | 105,214 | 44,896 | 42,368 | 17,622 |
Expected N (post‐COVID rate 69,41614‐324,10919/100,000 person‐yr) | 13,908,927‐64,941,552 | 7,189,668‐33,568,956 | 5,803,962‐27,099020 | 915,298‐4,273,575 | |
O:E, (95% CI) | 0.002 (0.002–0.002) to 0.008 (0.008–0.008) | 0.001 (0.001–0.001) to 0.006 (0.006–0.006) | 0.002 (0.002–0.002) to 0.007 (0.007–0.007) | 0.004 (0.004–0.004) to 0.02 (0.02–0.02) | |
Encephalo‐pathy | Observed N | 3,180 | 1,303 | 1,286 | 579 |
Expected N (post‐COVID rate 35,39514‐204,84419/100,000 person‐yr) | 7,092,176‐41,044,572 | 3,666,019‐21,216,361 | 2,959,446‐17,127,211 | 466,711‐2,700,999 | |
O:E, (95% CI) | 0.0004 (0.0004–0.0005) to 0.00008 (0.00008–0.00008) | 0.0004 (0.0003–0.0004) to 0.00006 (0.00006–0.00006) | 0.0004 (0.0004–0.0005) to 0.00008 (0.00007–0.00008) | 0.001 (0.001–0.001) to 0.0002 (0.0002–0.0002) | |
Guillain‐Barre Syndrome | Observed N | 265 | 115 | 87 | 61 |
Expected N (post‐COVID rate 34414/100,000 person‐yr) | 68,847 | 35,588 | 28,729 | 4,531 | |
O:E, (95% CI) | 0.004 (0.003–0.004) | 0.003 (0.003–0.004) | 0.003 (0.002–0.004) | 0.013 (0.01–0.02) | |
Bell's Palsy | Observed N | 1846 | 917 | 809 | 117 |
Expected N (post‐COVID rate 8217/100,000 person‐yr) | 16,430 | 8,493 | 6,856 | 1,081 | |
O:E, (95% CI) | 0.11 (0.11–0.12) | 0.11 (0.10–0.11) | 0.12 (0.11–0.13) | 0.11 (0.09–0.13) | |
Headache | Observed N | 41,710 | 16,128 | 17,260 | 8,163 |
Expected N (post‐COVID rate 97,35820/100,000 person‐yr) | 19,507,599 | 10,083,679 | 8,140,194 | 1,284,727 | |
O:E, (95% CI) | 0.002 (0.002–0.002) | 0.002 (0.002–0.002) | 0.002 (0.002–0.002) | 0.006 (0.006–0.006) | |
Anosmia/dysgeusia | Observed N | 1932 | 983 | 712 | 232 |
Expected N (post‐COVID rate 23,62120/100,000 person‐yr) | 4,732,934 | 2,446,502 | 1,974,974 | 311,458 | |
O:E, (95% CI) | 0.0004 (0.0004–0.0004) | 0.0004 (0.0004–0.0004) | 0.0004 (0.0003–0.0004) | 0.0007 (0.0007–0.0008) | |
Cerebral venous thrombosis | Observed N | 128 | 40 | 34 | 53 |
Expected N (post‐COVID rate 11218/100,000 person‐yr) | 22,441 | 11,600 | 9,364 | 1,477 | |
O:E, (95% CI) | 0.006 (0.005–0.007) | 0.003 (0.002–0.005) | 0.004 (0.003–0.005) | 0.04 (0.03–0.05) | |
Ischemic Stroke | Observed N | 1704 | 688 | 750 | 255 |
Expected N (post‐COVID rate 6987.414/100,000 person‐yr) | 1,400,064 | 723,707 | 584,223 | 92,133 | |
O:E, (95% CI) | 0.001 (0.001–0.001) | 0.001 (0.001–0.001) | 0.001 (0.001–0.001) | 0.003 (0.002–0.003) | |
Intracerebral Hemorrhage | Observed N | 173 | 77 | 60 | 36 |
Expected N (post‐COVID rate 2290.914/100,000 person‐yr) | 459,027 | 237,276 | 191,544 | 30,207 | |
O:E, (95% CI) | 0.0004 (0.0003–0.0004) | 0.0003 (0.0003–0.0004) | 0.0003 (0.0002–0.0004) | 0.001 (0.0008–0.001) | |
Subarachnoid Hemorrhage | Observed N | 72 | 30 | 22 | 10 |
Expected N (post‐COVID rate 343.614/100,000 person‐yr) | 68,847 | 35,588 | 28,729 | 4,531 | |
O:E, (95% CI) | 0.001 (0.0008–0.001) | 0.0008 (0.0006–0.001) | 0.0008 (0.0005–0.001) | 0.002 (0.001–0.004) | |
Seizure | Observed N | 1933 | 905 | 680 | 340 |
Expected N (post‐COVID rate 4,38719–847714/100,000 person‐yr) | 878,956‐1,698,454 | 454,341‐877,949 | 366,774‐708,737 | 57,841‐111,769 | |
O:E, (95% CI) | 0.001 (0.001–0.001) to 0.002 (0.002–0.002) | 0.001 (0.001–0.001) to 0.002 (0.002–0.002) | 0.001 (0.001–0.001) to 0.002 (0.002–0.002) | 0.003 (0.003–0.003) to 0.006 (0.005–0.007) |
O:E = observed to expected ratio; Bold represents O:E >1; ^note that the sum of events for Pfizer, Moderna and Janssen does not equal the total number of events because some entries did not specify COVID vaccine manufacturer.