Table 5. HRs (95% CIs) for thrombotic and other outcomes 1–28 and >28 days postvaccination with BNT162b2 vaccine, compared with prevaccination rates.
All analyses were stratified on geographical region.
| Outcome | Age | 1–28 days postvaccination | >28 days postvaccination | ||||
|---|---|---|---|---|---|---|---|
| Unadjusted1 | Age and sex adjusted2 | Fully adjusted3 | Unadjusted1 | Age and sex adjusted2 | Fully adjusted3 | ||
| All venous events | <70 | 1.47 (1.35–1.61) | 1.01 (0.93–1.11) | 0.81 (0.74–0.88) | 1.14 (1.01–1.29) | 0.88 (0.77–1.00) | 0.73 (0.64–0.83) |
| ≥70 | 0.65 (0.60–0.71) | 0.56 (0.52–0.61) | 0.57 (0.53–0.62) | 0.68 (0.62–0.75) | 0.50 (0.46–0.55) | 0.50 (0.45–0.55) | |
| ICVT | <70 | 0.76 (0.31–1.85) | 0.72 (0.29–1.78) | 0.59 (0.24–1.45) | 0.65 (0.20–2.13) | 0.59 (0.18–1.93) | 0.51 (0.16–1.68) |
| ≥70 | 1.65 (0.64–4.29) | 1.25 (0.48–3.26) | 1.43 (0.55–3.75) | 1.13 (0.13–9.75) | 0.71 (0.08–6.56) | 0.88 (0.10–7.52) | |
| Portal vein thrombosis | <70 | 0.58 (0.15–2.30) | 0.44 (0.11–1.72) | 0.29 (0.07–1.17) | 3.06 (1.29–7.24) | 2.84 (1.19–6.74) | 2.19 (0.89–5.37) |
| ≥70 | 0.49 (0.10–2.28) | 0.43 (0.10–1.87) | 0.42 (0.09–1.91) | 0.67 (0.23–1.97) | 0.54 (0.19–1.56) | 0.48 (0.17–1.38) | |
| PE | <70 | 1.52 (1.36–1.71) | 0.99 (0.87–1.11) | 0.78 (0.69–0.88) | 1.20 (1.02–1.43) | 0.89 (0.75–1.06) | 0.71 (0.60–0.85) |
| ≥70 | 0.61 (0.55–0.68) | 0.53 (0.48–0.59) | 0.54 (0.49–0.60) | 0.61 (0.54–0.69) | 0.45 (0.40–0.51) | 0.45 (0.39–0.50) | |
| DVT | <70 | 1.38 (1.21–1.59) | 1.03 (0.89–1.18) | 0.82 (0.71–0.95) | 1.05 (0.86–1.28) | 0.85 (0.69–1.04) | 0.73 (0.59–0.89) |
| ≥70 | 0.69 (0.60–0.79) | 0.58 (0.51–0.67) | 0.61 (0.53–0.70) | 0.81 (0.69–0.96) | 0.59 (0.50–0.70) | 0.61 (0.52–0.73) | |
| Other | <70 | 2.16 (1.47–3.19) | 1.60 (1.07–2.37) | 1.18 (0.79–1.77) | 1.64 (0.93–2.90) | 1.34 (0.75–2.40) | 1.03 (0.57–1.87) |
| ≥70 | 1.13 (0.66–1.94) | 0.97 (0.58–1.64) | 1.01 (0.60–1.72) | 0.86 (0.39–1.88) | 0.66 (0.31–1.41) | 0.67 (0.30–1.47) | |
| All arterial events | <70 | 2.21 (2.12–2.31) | 1.31 (1.25–1.37) | 0.94 (0.90–0.99) | 1.45 (1.35–1.55) | 1.08 (1.01–1.16) | 0.88 (0.82–0.95) |
| ≥70 | 0.90 (0.87–0.93) | 0.69 (0.66–0.71) | 0.72 (0.70–0.75) | 1.15 (1.10–1.20) | 0.69 (0.66–0.72) | 0.71 (0.68–0.74) | |
| MI | <70 | 2.24 (2.12–2.37) | 1.39 (1.30–1.47) | 0.94 (0.88–1.00) | 1.42 (1.29–1.55) | 1.14 (1.04–1.26) | 0.88 (0.80–0.97) |
| ≥70 | 0.93 (0.88–0.98) | 0.74 (0.71–0.78) | 0.74 (0.70–0.78) | 1.19 (1.12–1.27) | 0.78 (0.73–0.83) | 0.75 (0.70–0.80) | |
| Ischaemic stroke4 | <70 | 2.18 (2.05–2.33) | 1.23 (1.14–1.31) | 0.90 (0.83–0.97) | 1.46 (1.32–1.62) | 1.00 (0.89–1.11) | 0.80 (0.72–0.90) |
| ≥70 | 0.88 (0.84–0.93) | 0.65 (0.63–0.68) | 0.71 (0.68–0.75) | 1.13 (1.06–1.19) | 0.64 (0.60–0.67) | 0.69 (0.66–0.73) | |
| Other arterial | <70 | 1.72 (1.28–2.31) | 0.95 (0.70–1.30) | 0.69 (0.50–0.94) | 1.63 (1.10–2.43) | 1.13 (0.74–1.72) | 0.85 (0.55–1.32) |
| ≥70 | 0.59 (0.46–0.76) | 0.51 (0.40–0.65) | 0.52 (0.41–0.67) | 0.64 (0.47–0.85) | 0.47 (0.35–0.62) | 0.46 (0.34–0.62) | |
| Haematological events | |||||||
| Any thrombocytopenia | <70 | 2.10 (1.60–2.77) | 1.48 (1.11–1.97) | 1.00 (0.75–1.34) | 2.03 (1.42–2.92) | 1.54 (1.07–2.23) | 0.97 (0.66–1.41) |
| ≥70 | 0.85 (0.64–1.13) | 0.72 (0.54–0.95) | 0.68 (0.51–0.90) | 1.22 (0.87–1.71) | 0.90 (0.64–1.25) | 0.79 (0.56–1.12) | |
| Other events | |||||||
| Haemorrhagic stroke5 | <70 | 1.39 (1.13–1.71) | 0.83 (0.67–1.03) | 0.77 (0.62–0.96) | 1.31 (1.00–1.73) | 0.90 (0.68–1.19) | 0.86 (0.65–1.15) |
| ≥70 | 0.80 (0.69–0.91) | 0.59 (0.52–0.68) | 0.65 (0.57–0.74) | 1.28 (1.09–1.50) | 0.72 (0.62–0.84) | 0.80 (0.68–0.94) | |
| Mesenteric thrombosis | <70 | 1.61 (1.10–2.36) | 0.84 (0.56–1.26) | 0.65 (0.43–0.97) | 1.77 (1.11–2.84) | 1.08 (0.66–1.75) | 0.83 (0.50–1.37) |
| ≥70 | 0.72 (0.57–0.90) | 0.54 (0.43–0.67) | 0.54 (0.44–0.68) | 1.06 (0.81–1.37) | 0.61 (0.48–0.78) | 0.59 (0.45–0.76) | |
| Lower limb fracture | <70 | 1.44 (1.31–1.59) | 1.03 (0.93–1.14) | 0.93 (0.84–1.02) | 1.24 (1.08–1.42) | 0.95 (0.83–1.09) | 0.89 (0.78–1.03) |
| ≥70 | 0.99 (0.93–1.05) | 0.65 (0.62–0.69) | 0.69 (0.66–0.73) | 1.48 (1.38–1.59) | 0.67 (0.63–0.72) | 0.71 (0.66–0.76) | |
| Death | <70 | 0.74 (0.69–0.79) | 0.35 (0.32–0.37) | 0.24 (0.22–0.26) | 0.91 (0.84–1.00) | 0.52 (0.48–0.57) | 0.33 (0.30–0.37) |
| ≥70 | 0.22 (0.22–0.23) | 0.16 (0.16–0.16) | 0.19 (0.19–0.20) | 0.30 (0.29–0.31) | 0.16 (0.16–0.16) | 0.19 (0.18–0.19) | |
1Stratifed by region.
2Adjusted for age, age2, sex, and stratified by region.
3Adjusted for age, age2, sex, ethnicity, deprivation, smoking, previous diagnosis of cancer, number of unique diseases in the last year, surgery in the last year, obesity, liver disease; additionally for women aged <70, history of depression and total number of types of medication (by BNF chapters); additionally for men aged <70, history of SARS-CoV2 infection and thrombocytopenia; and additionally for men and women aged ≥70, chronic kidney disease and dementia. Venous events adjusted for: anticoagulant medication, combined oral contraceptive medication, hormone replacement therapy medication, history of PE or DVT, and history of coronavirus infection. Arterial thromboses adjusted for: diabetes, hypertension, smoking, antiplatelet medication, blood pressure lowering medication, lipid lowering medication, anticoagulant medication, history of stroke, and history of MI. All analyses stratified by region.
4Ischaemic stroke: including ischaemic stroke, stroke of uncertain cause, and spinal stroke.
5Hemorrhagic stroke: including intracranial haemorrhage and subarachnoid haemorrhage.
BNF, British National Formulary; CI, confidence interval; DVT, deep vein thrombosis; HR, hazard ratio; ICVT, intracranial venous thrombosis; MI, myocardial infarction; PE, pulmonary embolism; SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2.