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A Disproportionality Analysis for Association of Systemic Capillary Leak Syndrome with COVID-19 Vaccination Using the World Health Organization Pharmacovigilance Database
- Title
- A Disproportionality Analysis for Association of Systemic Capillary Leak Syndrome with COVID-19 Vaccination Using the World Health Organization Pharmacovigilance Database
- Authors
- Park, Jin; Kim, Dongyeop; Song, Tae-Jin
- Ewha Authors
- 송태진; 박진; 김동엽
- SCOPUS Author ID
- 송태진; 박진; 김동엽
- Issue Date
- 2022
- Journal Title
- VACCINES
- ISSN
- 2076-393X
- Citation
- VACCINES vol. 10, no. 6
- Keywords
- SARS-CoV-2; COVID-19 vaccination; adenoviral vector vaccine; mRNA-based vaccine; systemic capillary leak syndrome
- Publisher
- MDPI
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- Abstract
- Systemic capillary leak syndrome (SCLS) is a rare and potentially life-threatening disorder characterized by reversible plasma extravasation and vascular collapse. This study aimed to investigate the association between different types of COVID-19 vaccine and SCLS in a real-world setting. We used individual case safety reports of SCLS after COVID-19 vaccination from the WHO pharmacovigilance database, VigiBase. A disproportionality analysis of ChAdOx1 nCoV-19 and mRNA-based vaccines was performed. The information component (IC) and reporting odds ratio (ROR) were calculated from the entire database and viral vaccines data subset. A positive 95% lower end of the IC (IC025) value (>0) using Bayesian neural network analysis and lower end of the ROR 95% confidence interval (ROR025) >= 1 were defined as the ADR signal detection threshold. A total of 101 (0.004%) events of SCLS were identified. A significant potential signal of disproportionality of SCLS was noted in ChAdOx1 nCoV-19 when applied as the denominator for entire database (IC025 = 0.24, ROR025 = 1.23) and all viral vaccines (IC025 = 0.41, ROR025 = 1.59). No significant potential signal was noted for two mRNA-based vaccines as denominators for the entire database (IC025 = -0.49, ROR025 = 0.71) and all viral vaccines (IC025 = -0.32, ROR025 = 0.77). Contrary to ChAdOx1 nCoV-1, no safety signal for developing SCLS was identified for mRNA-based vaccines.
- DOI
- 10.3390/vaccines10060835
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
- Files in This Item:
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vaccines-10-00835.pdf(1.27 MB)
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