Retinal vascular occlusion after COVID-19 vaccination: Analysis of the French pharmacovigilance database.

Abstract

Retinal vein occlusions and central retinal artery occlusions have been reported with coronavirus disease 2019 (COVID-19) vaccines. We aim to provide a descriptive analysis of cases reported in France until mid-2023, and recorded in the French pharmacovigilance database. An independent ophthalmologist reviewed all cases. We analyzed 290 cases (228 retinal vein occlusions, 58 central retinal artery occlusions, and four combinations). Retinal vein occlusions occurred with mRNA vaccines (68.0%) and adenovirus-vectored vaccines (32%), with an 11-day median onset delay. Almost half of the patients had retinal vein occlusion risk factors, mainly hypertension, and five had a positive rechallenge. Considering the lower adenovirus-vectored vaccines exposure in France, their proportion of retinal vein occlusions appears high. Among the 58 central retinal artery occlusion cases, most occurred with mRNA vaccines in patients with retinal artery occlusion risk factors (mainly hypertension), with a 17-day median onset delay. In conclusion, there was a temporal association in almost half of cases, but few cases with positive rechallenge, and many cases were confounded by risk factors (e.g., cardiovascular disorders, diabetes), which are also COVID-19 risk factors. Therefore, the risk of retinal vascular occlusion does not challenge the benefit-risk ratio of the vaccination, especially for mRNA vaccines.