Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal white dots syndrome
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of RETINAL EXUDATES (vaccine aggravates the MEWDS, had the symptoms happen 4 times now after COVID-19 vaccine/Visual Impairment) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Retinal white dots syndrome (Was diagnosed right when COVID-19 hit). Since November 2019 and Drug allergy (Bactrim allergy). Concomitant products included FLECAINIDE, AMLODIPINE BESILATE (NORVASC) and VITAMINS NOS for an unknown indication. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RETINAL EXUDATES (vaccine aggravates the MEWDS, had the symptoms happen 4 times now after COVID-19 vaccine/Visual Impairment) (seriousness criterion medically significant). At the time of the report, RETINAL EXUDATES (vaccine aggravates the MEWDS, had the symptoms happen 4 times now after COVID-19 vaccine/Visual Impairment) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment details were reported.- It was reported that (MEWDS) which was inflammation in the eye, caused temporary blindness one in a lifetime. Patient received all 3 doses of Moderna COVID-19 vaccines. The vaccine aggravated the MEWDS condition. Patient was eligible for second booster dose and was anticipated her vision to be affected again. Patient was never tested positive for COVID-19. Company comment: This Spontaneous case concerns a 56-year-old, female patient, with current history of Multiple evanescent white dot syndrome (MEWDS), who experienced the unexpected, serious (Medically significant) event of retinal exudates after administration of the third dose of mRNA-1273 vaccine, exact date was not provided neither for the event nor for vaccination. Patient has received three doses of mRNA-1273 and reports that she has experienced visual compromise of MEWDS 4 times after vaccination; however, since vaccination nor symptom onset dates and outcomes were provided, latency and rechallenge cannot be properly assessed. No further clinical information was provided for medical reviewing. Current history of Multiple evanescent white dot syndrome (MEWDS) remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-551315 (Patient Link). Sender's Comments: This Spontaneous case concerns a 56-year-old, female patient, with current history of Multiple evanescent white dot syndrome (MEWDS), who experienced the unexpected, serious (Medically significant) event of retinal exudates after administration of the third dose of mRNA-1273 vaccine, exact date was not provided neither for the event nor for vaccination. Patient has received three doses of mRNA-1273 and reports that she has experienced visual compromise of MEWDS 4 times after vaccination; however, since vaccination nor symptom onset dates and outcomes were provided, latency and rechallenge cannot be properly assessed. No further clinical information was provided for medical reviewing. Current history of Multiple evanescent white dot syndrome (MEWDS) remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.