Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3030368 | IM |
stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore; she had a stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (she had a stroke) and VISUAL IMPAIRMENT (stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis. Concurrent medical conditions included Blood pressure abnormal and Allergy (unspecified allergies). On 03-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 10-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced CEREBROVASCULAR ACCIDENT (she had a stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced VISUAL IMPAIRMENT (stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore) (seriousness criterion hospitalization). At the time of the report, CEREBROVASCULAR ACCIDENT (she had a stroke) and VISUAL IMPAIRMENT (stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore) outcome was unknown. Concomitant products included blood pressure medications for blood pressure, and allergy medications for unspecified allergies. It was reported that, prior to the stroke, patient wore glasses but since the stroke patient was now visually impaired. The reporter stated that, medical professionals had told that the stroke damaged the area of brain responsible for vision. The patient did not have accurate distance or depth perception or contrast of colors anymore. When the patient was looking at something, she could not see the whole picture, there were holes in her vision. The patient had been doing everything on her own and had not been given any help. The patient was seriously frustrated all the time because every day, all day, she was struggling to see. The patient honestly believed this was directly related to the vaccine and that she has no proof of that and would likely never have proof of that. It was stated that patient would never again get COVID shot, regardless of brand. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.; Reporter's Comments: Underlying blood pressure abnormal could be a risk factor for the events. The benefit-risk relationship of product is not affected by this report.
Allergy (unspecified allergies); Blood pressure abnormal