Retinal vascular occlusion following SARS-CoV-2 vaccination: A VAERS database analysis.

Purpose: To evaluate the cases of retinal vessel occlusion following COVID-19 vaccination and evaluate the onset interval and clinical presentations in patients diagnosed with vaccine associated retinal artery occlusion (RAO) and retinal vein occlusion (RVO). Design: Retrospective study of the cases reported to the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS) between December 11, 2020 and July 1, 2022. Participants: Patients diagnosed with retinal vessel occlusion following vaccination with BNT162b2, mRNA-1273, and Ad26.COV2.S globally. Methods: We performed a descriptive analysis of the patient demographics and clinical presentation in patients with retinal vessel occlusion. The correlation between the vaccines and continuous and categorical variables were assessed. We performed the post-hoc analysis to evaluated the association between RAO and RVO onset post-vaccination, and vaccine and dosage. Finally, a 30-day reverse analysis for RAO and RVO onset following administration of vaccine. A major limitation in the methods of this study is the lack of control group for assessing the risk of retinal vessel occlusive disease in patients who received the vaccine compared to the patients who were unvaccinated. Main Outcome Measures: The crude reporting rate of retinal vessel occlusion following SARS-CoV-2 vaccine. The ocular and systemic presentations, onset duration and short term risk of RAO and RVO following vaccination. Results: During the study period, 1351 retinal vessel occlusion cases were reported globally. The crude reporting rates of retinal vessel occlusion for BNT162b2, mRNA-1273, and Ad26.COV2.S were 0.36, 0.41, and 0.69, respectively. The majority of the retinal vessel occlusion cases were reported following 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. In the cohort, 817 and 433 patients were diagnosed with RVO and RAO, respectively. Most cases of RVO (41.12%) and RAO (48.27%) were reported within the first week post-vaccination. We observed that the mean onset interval for RVO was significantly longer in patients who received Ad26.Cov2.S (54.07 ± 88.98 days) compared to BNT162b2 (18.07 ± 28.66 days) and mRNA-1273 (22.85 ± 38.13 days) vaccines (p<0.0001). This was further confirmed by post-hoc analysis, which revealed a significantly longer onset duration for the Ad26.Cov2.S compared to BNT162b2 and mRNA 1273 vaccines (p<0.0001). The reverse Kaplan Meier 30-day risk analysis showed a significant a higher risk of RVO onset following BNT162b2 compared to other vaccines(p<0.0001). Conclusions: The low crude reporting rate highlights a low safety concern for retinal vessel occlusion following SARS-CoV-2 vaccination. This study provides insights into possible temporal association between reported retinal vessel occlusion events with SARS-CoV-2 vaccines, however further insights are needed to understand the underlying immunopathological mechanisms that promote thrombosis of retinal vasculature on vaccine administration.