Number of cases of retinal vascular occlusion after mRNA-based COVID-19 vaccination in Japan

In August 2022, officials from the Japanese Ministry of Health, Labor and Welfare reported that the number of cases confirmed side effects or adverse events defined by the MedDRA PT (ver.24.0) in people who received the mRNA-based COVID-19 vaccine (total 23685319 cases). The breakdown of the mRNA-based COVID-19 vaccine administered to Japanese people was BNT162b2 (Pfizer/BioNTech) total 23245041 cases, and mRNA-1273 (Moderna) total 440278 cases.

As the number of cases suspected of developing side effects and adverse events as defined by MedDRA PT (ver.24.0), BNT162b2 (Pfizer/BioNTech) total 4519 cases (male 659 cases, female 3829 cases, unknown 31 cases), and mRNA-1273 (Moderna) total 9 cases (male 3 cases, female 6 cases) were reported. In particular, as the number of cases in which eye disorders were observed after vaccination with the mRNA-based COVID-19 vaccine, six cases of retinal hemorrhage (0.0000253%), two cases of retinal vein occlusion (0.0000084%), one case of retinal detachment (0.0000042%), and one case of retinal tear (0.0000042%) were reported. On the other hand, the number of patients diagnosed with anaphylactic shock was 1407 cases (0.00594%).

Among those who received the influenza vaccine in 2021-2022 (total 50.29 million), the number of cases of eye disorders was one case of uveitis, one case of ocular hyperemia, one case of eyelid edema, and one case of visual acuity decline. However, the development of retinal vascular occlusion after influenza vaccination has not been reported.

By a report from the Ministry of Health, Labor and Welfare in Japan, it was clarified that the number of cases with eye problems after vaccination with mRNA-based COVID-19 vaccine was slightly higher than the number of cases with eye problems after influenza vaccination. However, the protective effect of the mRNA-based COVID-19 vaccine against severe COVID-19 far outweighed the risk of developing eye damage. Therefore, Japan's Ministry of Health, Labor and Welfare recommends that Japanese citizens be vaccinated with the mRNA-based COVID-19 vaccine.

We do not have potential conflicts of interest.

Doctor specializing in cancer care.
Doctor specializing in emerging infectious diseases.

Published in JAMA on April 16, 2023 by Kyoto@takumah