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Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study.
Chui, Celine Sze Ling; Fan, Min; Wan, Eric Yuk Fai; Leung, Miriam Tim Yin; Cheung, Edmund; Yan, Vincent Ka Chun; Gao, Le; Ghebremichael-Weldeselassie, Yonas; Man, Kenneth K C; Lau, Kui Kai; Lam, Ivan Chun Hang; Lai, Francisco Tsz Tsun; Li, Xue; Wong, Carlos King Ho; Chan, Esther W; Cheung, Ching-Lung; Sing, Chor-Wing; Lee, Cheuk Kwong; Hung, Ivan Fan Ngai; Lau, Chak Sing; Chan, Joseph Yat Sun; Lee, Michael Kang-Yin; Mok, Vincent Chung Tong; Siu, Chung-Wah; Chan, Lot Sze Tao; Cheung, Terence; Chan, Frank Ling Fung; Leung, Anskar Yu-Hung; Cowling, Benjamin John; Leung, Gabriel Matthew; Wong, Ian Chi Kei.
Afiliación
  • Chui CSL; School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
  • Fan M; School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
  • Wan EYF; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China.
  • Leung MTY; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Cheung E; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China.
  • Yan VKC; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Gao L; Department of Family Medicine and Primary Care, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China.
  • Ghebremichael-Weldeselassie Y; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Man KKC; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Lau KK; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Lam ICH; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Lai FTT; Division of Health Sciences, Warwick Medical School, Gibbet Hill, University of Warwick, Warwick, Coventry, UK.
  • Li X; Research Department of Practice and Policy, School of Pharmacy, University College London, United Kingdom.
  • Wong CKH; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China.
  • Chan EW; The State Key Laboratory of Brain and Cognitive Sciences, The University of Hong Kong, Hong Kong SAR, China.
  • Cheung CL; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Sing CW; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China.
  • Lee CK; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Hung IFN; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China.
  • Lau CS; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Chan JYS; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China.
  • Lee MK; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China.
  • Mok VCT; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Siu CW; Department of Family Medicine and Primary Care, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China.
  • Chan LST; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China.
  • Cheung T; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Chan FLF; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China.
  • Leung AY; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Cowling BJ; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
  • Leung GM; Hong Kong Red Cross Blood Transfusion Service, Hospital Authority, Hong Kong, China.
  • Wong ICK; Expert Committee on Clinical Events Assessment Following COVID-19 Immunization, Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China.
EClinicalMedicine ; 50: 101504, 2022 Aug.
Article en En | MEDLINE | ID: mdl-35770253
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).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EClinicalMedicine Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EClinicalMedicine Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido