Table II.
Systematic reviews, surveillance and population-based studies on hemorrhagic risk in recipients of COVID-19 vaccines
| First author, JournalRef Type of study | Date of publication | Vaccine | Risk of bleeding events | Type of bleeding | Other information |
|---|---|---|---|---|---|
|
Pottegard A, BMJ
12
Population-based |
May 2021 | Viral-vectored | Morbidity ratio for any bleeding 1.23 (0.97–1.55). | / | All venous and arterial thromboses and bleedings were eligible |
|
Simpson CR Nat Med
15
Population-based |
July 2021 | Viral-vectored and m-RNA | Adjusted RR 1.48 (95% CI 1.12–1.96) in viral-vector vaccine recipients | (ITP) in viral-vector vaccine recipients: adjusted RR 5.77 (95% CI 2.41–13.83) | Nested-incident-matched case-control Self-controlled case-series analysis Males are predicted to develop thrombotic and hemorrhagic events (included ITP) with adjusted RR 1.31 (95% CI 1.23–1.39) |
|
Cari L J Autoimm
13
Eudra Vigilance European database |
August 2021 | Viral-vectored and m-RNA | 33 and 151 SAEs/1 million doses in mRNA-and viral-vector vaccine recipients, respectively | Increase in SAE rate in subjects 18–64 years vs >64 years Viral vector recipients mRNA recipients Gastrointestinal bleeding Viral vector recipients 1.6 (1.5–1.8) mRNA recipients 1.6 (1.3–1.8) Cerebral bleeding Viral vector recipients 1.4 (1.3–1.5) mRNA recipients 0.6 (0.6–0.7) |
|
|
Trogstad L Vaccine
17
Population-based (self-reported side-effects) |
September 2021 | Viral-vectored and m-RNA | 0.2% recipients of single dose mRNA vaccine reported skin bleeding vs 3.2% recipients of a single-dose viral-vectored vaccine. OR 16.0, 95% CI 7.5–34.1) | ORs for nose and gingival bleeding 8.0 (4.0–15.8) and 9.3 (4.3–20.0), respectively | Among recipients of viral-vectored vaccine, 3.5% (152/4,365) women reported skin bleeding as opposed to 1.4% (11/767) among men, OR 2.5 (95% CI 1.3–4.6) |
|
Alghamdi AN, Frontiers in Med
18
Questionnaire-based |
October 2021 | Viral-vectored and m-RNA | Some details on hormonal status | ||
|
Uaprasert N, Thromb J
28
Systematic review and meta-analysis |
November 2021 | Viral-vectored and m-RNA | n.a. | n.a. | 8 RCTs included No increased risk of hemorrhage, and death from hemorrhage No sex-disaggregated data |
CI: confidence interval; VTE: venous thromboembolism; ITP: idiopathic thrombocytopenic purpura; RCT: randomized controlled trials, n.a.: not applicable.