Table 2.
Reported thrombocytopenic, venous and arterial thromboembolic and hemorrhagic events for the BNT162b2 vaccine
| Time period after vaccination | Number of individualsa | Number of eventsb | Unadjusted RR (95% CI) | Number of risk groups adjusted RR (95% CI) | Fully adjusted RR (95% CI)c |
|---|---|---|---|---|---|
| Thrombocytopenia (excluding ITP) | |||||
| Unvaccinated | 2,343 | 207 (8.8%) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) |
| 0–6 d | 43 | ≤5 (≤11.6%) | 1.05 (0.29–3.78) | 0.89 (0.25–3.23) | 0.84 (0.23–3.08) |
| 7–13 d | 51 | 7 (14.6%) | 2.10 (0.71–6.18) | 1.71 (0.56–5.27) | 1.80 (0.59–5.50) |
| 14–20 d | 34 | 0 (0.0%) | 0.00 (0.00–Inf) | 0.00 (0.00–Inf) | 0.00 (0.00–Inf) |
| 21–27 d | 45 | ≤5 (≤11.1%) | 0.32 (0.05–1.94) | 0.35 (0.05–2.30) | 0.35 (0.05–2.28) |
| 28+ d | 250 | 21 (8.4%) | 1.06 (0.56–2.03) | 0.91 (0.47–1.75) | 0.80 (0.41–1.54) |
| 0–27 d | 173 | 13 (7.5%) | 0.79 (0.37–1.67) | 0.68 (0.32–1.45) | 0.67 (0.32–1.43) |
| ITP | |||||
| Unvaccinated | 702 | 58 (8.3%) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) |
| 0–6 d | ≤5 | 0 (0%) | 0.00 (0.00–Inf) | 0.00 (0.00–Inf) | 0.00 (0.00–Inf) |
| 7–13 d | 15 | ≤5 (≤33.3%) | 0.53 (0.04–8.05) | 0.54 (0.03–8.41) | 0.61 (0.04–9.28) |
| 14–20 d | 18 | 0 (0%) | 0.00 (0.00–Inf) | 0.00 (0.00–Inf) | 0.00 (0.00–Inf) |
| 21–27 d | 11 | ≤5 (≤45.5%) | 1.31 (0.16–10.45) | 1.41 (0.18–11.31) | 1.46 (0.18–12.01) |
| 28+ d | 49 | 5 (10.2%) | 1.52 (0.47–4.88) | 1.49 (0.45–4.91) | 1.68 (0.48–5.87) |
| 0–27 d | 45 | ≤5 (≤5.8%) | 0.44 (0.08–2.36) | 0.50 (0.09–2.76) | 0.54 (0.10–3.02) |
| Venous thromboembolic events (including CVST) | |||||
| Unvaccinated | 26,843 | 2,449 (9.1%) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) |
| 0–6 d | 460 | 26 (5.7%) | 0.46 (0.29–0.72) | 0.43 (0.27–0.67) | 0.40 (0.26–0.63) |
| 7–13 d | 589 | 38 (6.5%) | 0.54 (0.36–0.81) | 0.49 (0.33–0.74) | 0.45 (0.30–0.67) |
| 14–20 d | 547 | 37 (6.8%) | 0.59 (0.39–0.89) | 0.52 (0.34–0.79) | 0.48 (0.32–0.73) |
| 21–27 d | 448 | 36 (8.0%) | 0.80 (0.52–1.22) | 0.72 (0.47–1.10) | 0.64 (0.42–0.97) |
| 28+ d | 2,299 | 203 (8.8%) | 1.02 (0.83–1.25) | 0.88 (0.72–1.08) | 0.73 (0.60–0.90) |
| 0–27 d | 2,044 | 137 (6.7%) | 0.58 (0.47–0.73) | 0.53 (0.42–0.66) | 0.48 (0.39–0.61) |
| Arterial thromboembolic events | |||||
| Unvaccinated | 26,843 | 2,449 (9.1%) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) |
| 0–6 d | 460 | 26 (5.7%) | 0.46 (0.29–0.72) | 0.43 (0.27–0.67) | 0.40 (0.26–0.63) |
| 7–13 d | 589 | 38 (6,5%) | 0.54 (0.36–0.81) | 0.49 (0.33–0.74) | 0.45 (0.30–0.67) |
| 14–20 d | 547 | 37 (6.8%) | 0.59 (0.39–0.89) | 0.52 (0.34–0.79) | 0.48 (0.32–0.73) |
| 21–27 d | 448 | 36 (8.0%) | 0.80 (0.52–1.22) | 0.72 (0.47–1.10) | 0.64 (0.42–0.97) |
| 28+ d | 2,299 | 203 (8.8%) | 1.02 (0.83–1.25) | 0.88 (0.72–1.08) | 0.73 (0.60–0.90) |
| 0–27 d | 2,044 | 137 (6.7%) | 0.58 (0.47–0.73) | 0.53 (0.42–0.66) | 0.48 (0.39–0.61) |
| Hemorrhagic events | |||||
| Unvaccinated | 8,972 | 785 (8.7%) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) | 1.00 (1.00–1.00) |
| 0–6 d | 132 | 16 (12.1%) | 1.69 (0.92–3.09) | 1.40 (0.76–2.58) | 1.10 (0.59–2.06) |
| 7–13 d | 157 | 13 (8.3%) | 1.08 (0.56–2.09) | 0.93 (0.47–1.81) | 0.76 (0.39–1.50) |
| 14–20 d | 189 | 21 (11.1%) | 1.62 (0.91–2.88) | 1.40 (0.79–2.50) | 1.27 (0.71–2.27) |
| 21–27 d | 169 | 11 (6.5%) | 0.79 (0.39–1.57) | 0.70 (0.35–1.41) | 0.60 (0.30–1.22) |
| 28+ d | 762 | 76 (10%) | 1.44 (1.04–2.00) | 1.26 (0.90–1.76) | 1.07 (0.76–1.51) |
| 0–27 d | 647 | 61 (9.4%) | 1.25 (0.89–1.77) | 1.08 (0.77–1.53) | 0.92 (0.64–1.30) |
Inf, infinity.
aNumber of individuals in the vaccine exposure group. bNumber of events is the number of individuals with an incident consultation in the post-vaccination period. Percent is the number of events divided by n and should be equal to 9.1% if there is no association between vaccination and the event representing the 10:1 ratio of controls to cases. cAdjusted for number of clinical risk group, socioeconomic status and number of RT–PCR tests an individual had before 8 December 2020. n ≤ 5 denotes minimum allowable reported value.