TABLE 5.
Observed to Expected (O:E) Adverse Event Rates within 42 days of Inoculation for COVID Vaccines Compared to Background Rates in the U.S. Person‐years of Observation for all COVID Vaccines (N patients Who Received at Least One Vaccine Dose × [42 days/365.25 days) was 20,036,976 Person‐years; for Pfizer: 10,357,319 Person‐years; for Moderna: 8,361,094 Person‐years; and for Janssen: 1,318,563 Person‐years
| 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) |
|---|---|---|---|---|---|
| Cerebral venous thrombosis | Age, median (IQR) | 52 (38–63) | 55 (40–68) | 54 (37–67) | 47 (38–59) |
| Sex (% F) | 62% | 60% | 53% | 68% | |
| Days from vaccine, median (IQR) | 7 (3–16) | 4 (2–12) | 8 (4–16) | 10 (5–16) | |
| Observed N (% of doses) | 128 (0.00004%) | 40 (0.00002%) | 34 (0.00003%) | 53 (0.0005%) | |
| Expected N (background rate 2.08/100,000 person‐yr) | 400.7 | 207.1 | 167.2 | 26.4 | |
| O:E, (95% CI) | 0.32 (0.27–0.38) | 0.19 (0.14–0.26) | 0.20 (0.14–0.28) | 2.01 (1.51–2.63) | |
| Ischemic Stroke | Age, median (IQR) | 68 (56–78) | 66 (55–77) | 71 (59–79) | 62 (52–74) |
| Sex (% F) | 55% | 54% | 57% | 54% | |
| Days from vaccine, median (IQR) | 4 (1–13) | 4 (1–12) | 4 (1–14) | 7 (2–16) | |
| Observed N (% of doses) | 1704 (0.0006%) | 688 (0.0004%) | 750 (0.0006%) | 255 (0.002%) | |
| Expected N (background rate 32.48 /100,000 person‐yr) | 6491.9 | 3355.8 | 2709.0 | 427.2 | |
| O:E, (95% CI) | 0.26 (0.25–0.28) | 0.21 (0.19–0.22) | 0.28 (0.26–0.30) | 0.60 (0.53–0.67) | |
| Intracerebral Hemorrhage | Age, median (IQR) | 65 (54–78) | 70 (59–78) | 66 (52–81) | 57 (40–64) |
| Sex (% F) | 57% | 47% | 62% | 72% | |
| Days from vaccine, median (IQR) | 4 (1–12) | 3 (1–12) | 3 (1–9) | 11 (4–15) | |
| Observed N (% of doses) | 173 (0.00006%) | 77 (0.00005%) | 60 (0.00005%) | 36 (0.0003%) | |
| Expected N (background rate 7.18 /100,000 person‐yr) | 1422.6 | 735.4 | 593.6 | 93.6 | |
| O:E, (95% CI) | 0.12 (0.10–0.14) | 0.10 (0.08–0.13) | 0.10 (0.08–0.13) | 0.38 (0.27–0.53) | |
| Subarachnoid Hemorrhage | Age, median (IQR) | 61 (49–74) | 65 (52–81) | 56 (47–66) | 59 (45–66) |
| Sex (% F) | 65% | 70% | 55% | 74% | |
| Days from vaccine, median (IQR) | 5 (2–14) | 4 (1–12) | 7 (2–15) | 7 (2–18) | |
| Observed N (% of doses) | 72 (0.00002%) | 30 (0.00002%) | 22 (0.00002%) | 10 (0.00009%) | |
| Expected N (background rate 10.28 /100,000 person‐yr 3 , 12 ) | 2043.8 | 1056.4 | 852.8 | 134.5 | |
| O:E, (95% CI) | 0.04 (0.03–0.04) | 0.03 (0.02–0.04) | 0.03 (0.02–0.04) | 0.07 (0.04–0.14) | |
| Headache | Age, median (IQR) | 49 (36–61) | 49 (36–61) | 52 (38–64) | 44 (32–55) |
| Sex (% F) | 75% | 77% | 76% | 68% | |
| Days from vaccine, median (IQR) | 1 (0–1) | 1 (0–1) | 1 (0–1) | 0 (0–1) | |
| Observed N (% of doses) | 41,710 (0.01%) | 16,128 (0.01%) | 17,260 (0.01%) | 8,163 (0.01%) | |
| Expected N (background rate 7368.48/100,000 person‐yr) | 1,476,404.5 | 763,168.7 | 616,078.9 | 97,156.9 | |
| O:E, (95% CI) | 0.03 (0.03–0.03) | 0.02 (0.02–0.02) | 0.03 (0.03–0.03) | 0.08 (0.08–0.09) | |
| Seizure | Age, median (IQR) | 39 (26–58) | 37 (23–57) | 45 (30–64) | 34 (26–47) |
| Sex (% F) | 55% | 57% | 56% | 47% | |
| Days from vaccine, median (IQR) | 0 (0–1) | 0 (0–1) | 0 (0–2) | 0 (0–1) | |
| Observed N (% of doses) | 1933 (0.0006%) | 905 (0.0005%) | 680 (0.0005%) | 340 (0.003%) | |
| Expected N (background rate 13.88 /100,000 person‐yr) | 2765.1 | 1429.3 | 1153.8 | 181.9 | |
| O:E, (95% CI) | 0.699 (0.67–0.73) | 0.633 (0.59–0.68) | 0.59 (0.55–0.64) | 1.87 (1.68–2.08) |
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.