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Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis

PURPOSE: To evaluate the cases of retinal artery occlusion (RAO) and retinal vein occlusion (RVO) after severe acute respiratory syndrome coronavirus (SARS-CoV-2) disease 2019 vaccination. DESIGN: Retrospective study of the cases reported to the Centers for Disease Control and Prevention Vaccine Adv...

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Autores principales: Singh, Rohan Bir, Parmar, Uday Pratap Singh, Gupta, Rudraksh, Garcia, Antonio Jacobo Vega, Cho, Wonkyung, Singh, Kanwar Partap, Agarwal, Aniruddha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10281033/
https://www.ncbi.nlm.nih.gov/pubmed/37362418
http://dx.doi.org/10.1016/j.xops.2023.100354
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author Singh, Rohan Bir
Parmar, Uday Pratap Singh
Gupta, Rudraksh
Garcia, Antonio Jacobo Vega
Cho, Wonkyung
Singh, Kanwar Partap
Agarwal, Aniruddha
author_facet Singh, Rohan Bir
Parmar, Uday Pratap Singh
Gupta, Rudraksh
Garcia, Antonio Jacobo Vega
Cho, Wonkyung
Singh, Kanwar Partap
Agarwal, Aniruddha
author_sort Singh, Rohan Bir
collection PubMed
description PURPOSE: To evaluate the cases of retinal artery occlusion (RAO) and retinal vein occlusion (RVO) after severe acute respiratory syndrome coronavirus (SARS-CoV-2) disease 2019 vaccination. DESIGN: Retrospective study of the cases reported to the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System between December 11, 2020 and July 1, 2022. PARTICIPANTS: Patients diagnosed with RVO after vaccination with BNT162b2, mRNA-1273, and Ad26.COV2.S, globally. METHODS: We performed a descriptive analysis of the demographics and presentation in patients with RVO. The correlations between the vaccines and continuous and categorical variables were assessed. We performed the post hoc analysis to evaluate the association between RAO, RVO onset postvaccination, and vaccine and dosage. A 30-day reverse Kaplan-Meier analysis was conducted for RAO and RVO onset after vaccination. MAIN OUTCOME MEASURES: The crude reporting rate of RVO after SARS-CoV-2 vaccine. The ocular and systemic presentations, onset duration, and short-term risk of RAO and RVO after vaccination. RESULTS: One thousand three hundred and fifty-one RVO cases were reported globally. The crude reporting rates for BNT162b2, mRNA-1273, and Ad26.COV2.S were 0.36, 0.41, and 0.69, respectively. The majority of the cases were reported after BNT162b2 (n = 606, 74.17%). The mean age of patients with RVO and RAO was 58.54 ± 16.06 years and 64.63 ± 16.16 years, respectively. Most cases of RVO (41.12%) and RAO (48.27%) were reported within the first week. The mean onset interval for RVO was significantly longer in patients who received Ad26.Cov2.S (54.07 ± 88.98 days) compared with BNT162b2 (18.07 ± 28.66 days) and mRNA-1273 (22.85 ± 38.13 days) vaccines (P < 0.0001). This was confirmed by post hoc analysis (P < 0.0001). The reverse Kaplan-Meier 30-day risk analysis showed a significant a higher risk of RVO onset after BNT162b2 compared with other vaccines (P < 0.0001). CONCLUSIONS: The low crude reporting rate highlights a low safety concern for RVO after SARS-CoV-2 vaccination. This study provides insights into possible temporal association between reported RVO events with SARS-CoV-2 vaccines; however, further insights are needed to understand the underlying immunopathologic mechanisms that promote thrombosis of retinal vasculature on vaccine administration. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
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spelling pubmed-102810332023-06-21 Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis Singh, Rohan Bir Parmar, Uday Pratap Singh Gupta, Rudraksh Garcia, Antonio Jacobo Vega Cho, Wonkyung Singh, Kanwar Partap Agarwal, Aniruddha Ophthalmol Sci Original Article PURPOSE: To evaluate the cases of retinal artery occlusion (RAO) and retinal vein occlusion (RVO) after severe acute respiratory syndrome coronavirus (SARS-CoV-2) disease 2019 vaccination. DESIGN: Retrospective study of the cases reported to the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System between December 11, 2020 and July 1, 2022. PARTICIPANTS: Patients diagnosed with RVO after vaccination with BNT162b2, mRNA-1273, and Ad26.COV2.S, globally. METHODS: We performed a descriptive analysis of the demographics and presentation in patients with RVO. The correlations between the vaccines and continuous and categorical variables were assessed. We performed the post hoc analysis to evaluate the association between RAO, RVO onset postvaccination, and vaccine and dosage. A 30-day reverse Kaplan-Meier analysis was conducted for RAO and RVO onset after vaccination. MAIN OUTCOME MEASURES: The crude reporting rate of RVO after SARS-CoV-2 vaccine. The ocular and systemic presentations, onset duration, and short-term risk of RAO and RVO after vaccination. RESULTS: One thousand three hundred and fifty-one RVO cases were reported globally. The crude reporting rates for BNT162b2, mRNA-1273, and Ad26.COV2.S were 0.36, 0.41, and 0.69, respectively. The majority of the cases were reported after BNT162b2 (n = 606, 74.17%). The mean age of patients with RVO and RAO was 58.54 ± 16.06 years and 64.63 ± 16.16 years, respectively. Most cases of RVO (41.12%) and RAO (48.27%) were reported within the first week. The mean onset interval for RVO was significantly longer in patients who received Ad26.Cov2.S (54.07 ± 88.98 days) compared with BNT162b2 (18.07 ± 28.66 days) and mRNA-1273 (22.85 ± 38.13 days) vaccines (P < 0.0001). This was confirmed by post hoc analysis (P < 0.0001). The reverse Kaplan-Meier 30-day risk analysis showed a significant a higher risk of RVO onset after BNT162b2 compared with other vaccines (P < 0.0001). CONCLUSIONS: The low crude reporting rate highlights a low safety concern for RVO after SARS-CoV-2 vaccination. This study provides insights into possible temporal association between reported RVO events with SARS-CoV-2 vaccines; however, further insights are needed to understand the underlying immunopathologic mechanisms that promote thrombosis of retinal vasculature on vaccine administration. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Elsevier 2023-06-20 /pmc/articles/PMC10281033/ /pubmed/37362418 http://dx.doi.org/10.1016/j.xops.2023.100354 Text en © 2023 by the American Academy of Ophthalmology. https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Original Article
Singh, Rohan Bir
Parmar, Uday Pratap Singh
Gupta, Rudraksh
Garcia, Antonio Jacobo Vega
Cho, Wonkyung
Singh, Kanwar Partap
Agarwal, Aniruddha
Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis
title Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis
title_full Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis
title_fullStr Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis
title_full_unstemmed Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis
title_short Retinal Vascular Occlusion after Severe Acute Respiratory Syndrome Coronavirus Vaccination: A Vaccine Adverse Events Reporting System Database Analysis
title_sort retinal vascular occlusion after severe acute respiratory syndrome coronavirus vaccination: a vaccine adverse events reporting system database analysis
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10281033/
https://www.ncbi.nlm.nih.gov/pubmed/37362418
http://dx.doi.org/10.1016/j.xops.2023.100354
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