Dataset Information

Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study.

ABSTRACT:

Background

This study aims to evaluate the association between thromboembolic events and hemorrhagic stroke following BNT162b2 and CoronaVac vaccination.

Methods

Patients with incident thromboembolic events or hemorrhagic stroke within 28 days of covid-19 vaccination or SARS-CoV-2 positive test during 23 February to 30 September 2021 were included. The incidence per 100,000 covid-19 vaccine doses administered and SARS-CoV-2 test positive cases were estimated. A modified self-controlled case series (SCCS) analysis using the data from the Hong Kong territory-wide electronic health and vaccination records. Seasonal effect was adjusted by month.

Findings

A total of 5,526,547 doses of BNT162b2 and 3,146,741 doses of CoronaVac were administered. A total of 334 and 402 thromboembolic events, and 57 and 49 hemorrhagic stroke cases occurred within 28 days after BNT162b2 and CoronaVac vaccination, respectively. The crude incidence of thromboembolic events and hemorrhagic stroke per 100,000 doses administered for both covid-19 vaccines were smaller than that per 100,000 SARS-CoV-2 test positive cases. The modified SCCS detected an increased risk of hemorrhagic stroke in BNT162b2 14-27 days after first dose with adjusted IRR of 2.53 (95% CI 1.48-4.34), and 0-13 days after second dose with adjusted IRR 2.69 (95% CI 1.54-4.69). No statistically significant risk was observed for thromboembolic events for both vaccines.

Interpretation

We detected a possible safety signal for hemorrhagic stroke following BNT162b2 vaccination. The incidence of thromboembolic event or hemorrhagic stroke following vaccination is lower than that among SARS-CoV-2 test positive cases; therefore, vaccination against covid-19 remains an important public health intervention.

Funding

This study was funded by a research grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (reference COVID19F01).

SUBMITTER: Chui CSL

PROVIDER: S-EPMC9233170 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study.

Chui Celine Sze Ling CSL Fan Min M Wan Eric Yuk Fai EYF Leung Miriam Tim Yin MTY Cheung Edmund E Yan Vincent Ka Chun VKC Gao Le L Ghebremichael-Weldeselassie Yonas Y Man Kenneth K C KKC Lau Kui Kai KK Lam Ivan Chun Hang ICH Lai Francisco Tsz Tsun FTT Li Xue X Wong Carlos King Ho CKH Chan Esther W EW Cheung Ching-Lung CL Sing Chor-Wing CW Lee Cheuk Kwong CK Hung Ivan Fan Ngai IFN Lau Chak Sing CS Chan Joseph Yat Sun JYS Lee Michael Kang-Yin MK Mok Vincent Chung Tong VCT Siu Chung-Wah CW Chan Lot Sze Tao LST Cheung Terence T Chan Frank Ling Fung FLF Leung Anskar Yu-Hung AY Cowling Benjamin John BJ Leung Gabriel Matthew GM Wong Ian Chi Kei ICK

EClinicalMedicine 20220625

<h4>Background</h4>This study aims to evaluate the association between thromboembolic events and hemorrhagic stroke following BNT162b2 and CoronaVac vaccination.<h4>Methods</h4>Patients with incident thromboembolic events or hemorrhagic stroke within 28 days of covid-19 vaccination or SARS-CoV-2 positive test during 23 February to 30 September 2021 were included. The incidence per 100,000 covid-19 vaccine doses administered and SARS-CoV-2 test positive cases were estimated. A modified self-contr ...[more]

PMID: 35770253

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Dataset Information

Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study.

Background

Methods

Findings

Interpretation

Funding

Publications

Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study.

Similar Datasets

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