Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
retinal hemorrhage; macular degeneration; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL HAEMORRHAGE (retinal hemorrhage) and MACULAR DEGENERATION (macular degeneration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 29-Nov-2021, the patient experienced RETINAL HAEMORRHAGE (retinal hemorrhage) (seriousness criteria disability and medically significant) and MACULAR DEGENERATION (macular degeneration) (seriousness criteria disability and medically significant). The patient was treated with Aflibercept (Eylea hd) at an unspecified dose and frequency and Aflibercept (Eylea) at an unspecified dose and frequency. At the time of the report, RETINAL HAEMORRHAGE (retinal hemorrhage) and MACULAR DEGENERATION (macular degeneration) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medications were reported. On 29-Nov-2021, patient experienced temporary blurry vision, so patient did not think too much about it. Patient was busy during holidays and had minor symptoms. The blurry vision recurred on 25-Dec-2021 during a drive and worsened upon arrival. Patient made an appointment with an ophthalmologist and was told she had a retinal hemorrhage and macular degeneration. Ophthalmologist sent patient to a retinal specialist who began eye injections. patient received injections every month eventually getting to every 12 weeks. patient did not associate this problem with the vaccine until almost 2 years later when patient had lunch with a friend, and she mentioned she also had these same issues and her doctor told her it was from the Moderna vaccine. It was reported that they had both eye exams shortly before receiving the vaccine. Her friend had an exam 1 month before and patient had her eye exam 5 months before and both had not any of these issues and both had 1st symptoms approximately 2 weeks after injections and did think this was a coincidence. Patient mentioned that this has been a very inconvenient experience and reported that she would probably need to be receive this treatment for life. She had to drive 3 hours each way to visit the retinal specialist and patient received the Eylea HD at the university but she went to another Doctor at winter there was only given the Eylea and it was not as effective. Patient needed the injections more often. She stated that it was too expensive to get the Eylea HD. Also, patient was told she could no longer legally drive until her vision improved. It was mentioned that she felt like Moderna was responsible for her issue as they were not given any warning regarding eye problem when the vaccine was made available, and it was Moderna responsibility to report those side effects to the public. This case was linked to US-MODERNATX, INC.-MOD-2025-787620 (E2B Linked Report).; Reporter's Comments: Based on information provided, the causality cannot be excluded and both events are assessed as related to the suspect product. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787620:Patient 2