Vaccine-Associated Uveitis after COVID-19 Vaccination: A CDC-VAERS database analysis

Rohan Bir Singh; Uday Pratap Singh Parmar; Francesca Kahale; Aniruddha Agarwal; Edmund Tsui

doi:10.1016/j.ophtha.2022.08.027

Vaccine-Associated Uveitis after COVID-19 Vaccination: A CDC-VAERS database analysis

Rohan Bir Singh, Uday Pratap Singh Parmar, Francesca Kahale, Aniruddha Agarwal^*, Edmund Tsui^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

PURPOSE: To assess the risk of vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination and evaluate uveitis onset interval and clinical presentations in the patients.

DESIGN: A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).

PARTICIPANTS: Patients diagnosed with VAU following administration of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccine, worldwide.

METHODS: A descriptive analysis of the demographics, clinical history and presentation was performed. We evaluated the correlation between the three vaccines and continuous and categorical variables. A post-hoc analysis was performed between uveitis onset-interval after vaccination, and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset post-vaccination was performed.

MAIN OUTCOME MEASURES: The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.

RESULTS: A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU for the cases reports from the United States was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n=853, 77.97%). The mean age of patients with VAU was 46.24±16.93 years, and 68.65% (n=751) were women. Most cases were reported after the first dose (n=452, 41.32%) and within the first week (n=591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22± 42.74 days) compared to BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (p<0.0001). The post-hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (p<0.0001) and the first dose compared to the second dose (p=0.0021). The 30-day risk analysis showed a significant difference between the three vaccines (p<0.0001).

CONCLUSIONS: The low crude reporting rate and observed-expected ratio suggests a low safety concern for VAU. This study provides insights into possible temporal association between reported VAU events and SARS-CoV-2 vaccines, however further investigations are required to delineate the associated immunological mechanisms.

Original language	English
Pages (from-to)	179-186
Number of pages	8
Journal	Ophthalmology
Volume	130
Issue number	2
Early online date	30 Aug 2022
DOIs	https://doi.org/10.1016/j.ophtha.2022.08.027
Publication status	Published - Feb 2023

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@article{1acbd4d720cf4dac93443432c948eb1a,

title = "Vaccine-Associated Uveitis after COVID-19 Vaccination: A CDC-VAERS database analysis",

abstract = "PURPOSE: To assess the risk of vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination and evaluate uveitis onset interval and clinical presentations in the patients.DESIGN: A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).PARTICIPANTS: Patients diagnosed with VAU following administration of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccine, worldwide.METHODS: A descriptive analysis of the demographics, clinical history and presentation was performed. We evaluated the correlation between the three vaccines and continuous and categorical variables. A post-hoc analysis was performed between uveitis onset-interval after vaccination, and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset post-vaccination was performed.MAIN OUTCOME MEASURES: The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.RESULTS: A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU for the cases reports from the United States was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n=853, 77.97%). The mean age of patients with VAU was 46.24±16.93 years, and 68.65% (n=751) were women. Most cases were reported after the first dose (n=452, 41.32%) and within the first week (n=591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22± 42.74 days) compared to BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (p<0.0001). The post-hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (p<0.0001) and the first dose compared to the second dose (p=0.0021). The 30-day risk analysis showed a significant difference between the three vaccines (p<0.0001).CONCLUSIONS: The low crude reporting rate and observed-expected ratio suggests a low safety concern for VAU. This study provides insights into possible temporal association between reported VAU events and SARS-CoV-2 vaccines, however further investigations are required to delineate the associated immunological mechanisms.",

author = "Singh, {Rohan Bir} and {Singh Parmar}, {Uday Pratap} and Francesca Kahale and Aniruddha Agarwal and Edmund Tsui",

note = "Copyright {\textcopyright} 2022. Published by Elsevier Inc.",

year = "2023",

month = feb,

doi = "10.1016/j.ophtha.2022.08.027",

language = "English",

volume = "130",

pages = "179--186",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier Science",

number = "2",

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TY - JOUR

T1 - Vaccine-Associated Uveitis after COVID-19 Vaccination

T2 - A CDC-VAERS database analysis

AU - Singh, Rohan Bir

AU - Singh Parmar, Uday Pratap

AU - Kahale, Francesca

AU - Agarwal, Aniruddha

AU - Tsui, Edmund

PY - 2023/2

Y1 - 2023/2

N2 - PURPOSE: To assess the risk of vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination and evaluate uveitis onset interval and clinical presentations in the patients.DESIGN: A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).PARTICIPANTS: Patients diagnosed with VAU following administration of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccine, worldwide.METHODS: A descriptive analysis of the demographics, clinical history and presentation was performed. We evaluated the correlation between the three vaccines and continuous and categorical variables. A post-hoc analysis was performed between uveitis onset-interval after vaccination, and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset post-vaccination was performed.MAIN OUTCOME MEASURES: The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.RESULTS: A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU for the cases reports from the United States was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n=853, 77.97%). The mean age of patients with VAU was 46.24±16.93 years, and 68.65% (n=751) were women. Most cases were reported after the first dose (n=452, 41.32%) and within the first week (n=591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22± 42.74 days) compared to BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (p<0.0001). The post-hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (p<0.0001) and the first dose compared to the second dose (p=0.0021). The 30-day risk analysis showed a significant difference between the three vaccines (p<0.0001).CONCLUSIONS: The low crude reporting rate and observed-expected ratio suggests a low safety concern for VAU. This study provides insights into possible temporal association between reported VAU events and SARS-CoV-2 vaccines, however further investigations are required to delineate the associated immunological mechanisms.

AB - PURPOSE: To assess the risk of vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination and evaluate uveitis onset interval and clinical presentations in the patients.DESIGN: A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).PARTICIPANTS: Patients diagnosed with VAU following administration of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccine, worldwide.METHODS: A descriptive analysis of the demographics, clinical history and presentation was performed. We evaluated the correlation between the three vaccines and continuous and categorical variables. A post-hoc analysis was performed between uveitis onset-interval after vaccination, and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset post-vaccination was performed.MAIN OUTCOME MEASURES: The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.RESULTS: A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU for the cases reports from the United States was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n=853, 77.97%). The mean age of patients with VAU was 46.24±16.93 years, and 68.65% (n=751) were women. Most cases were reported after the first dose (n=452, 41.32%) and within the first week (n=591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22± 42.74 days) compared to BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (p<0.0001). The post-hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (p<0.0001) and the first dose compared to the second dose (p=0.0021). The 30-day risk analysis showed a significant difference between the three vaccines (p<0.0001).CONCLUSIONS: The low crude reporting rate and observed-expected ratio suggests a low safety concern for VAU. This study provides insights into possible temporal association between reported VAU events and SARS-CoV-2 vaccines, however further investigations are required to delineate the associated immunological mechanisms.

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DO - 10.1016/j.ophtha.2022.08.027

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