Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: cannot see anything further than 10 feet, near sided; vision blurry; pink eye; left eye felt swollen; migraine behind left eye; Loss of vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Loss of vision) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back disorder (lower back) in 2007 and Barrett's esophagus in 2017. Concurrent medical conditions included Allergy to arthropod sting (Bee's), Penicillin allergy and Nearsighted (Patient was nearsighted in both eyes). Concomitant products included OMEPRAZOLE for an unknown indication.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020 at 7:30 PM, the patient experienced BLINDNESS (Loss of vision) (seriousness criterion medically significant) and MIGRAINE (migraine behind left eye). On 23-Dec-2020, the patient experienced VISUAL IMPAIRMENT (cannot see anything further than 10 feet, near sided), VISION BLURRED (vision blurry), CONJUNCTIVITIS (pink eye) and EYE SWELLING (left eye felt swollen). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at a dose of 100 mg. On 23-Dec-2020, MIGRAINE (migraine behind left eye) had resolved. At the time of the report, BLINDNESS (Loss of vision) had not resolved and VISUAL IMPAIRMENT (cannot see anything further than 10 feet, near sided), VISION BLURRED (vision blurry), CONJUNCTIVITIS (pink eye) and EYE SWELLING (left eye felt swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BLINDNESS (Loss of vision) to be possibly related. No further causality assessments were provided for VISUAL IMPAIRMENT (cannot see anything further than 10 feet, near sided), VISION BLURRED (vision blurry), CONJUNCTIVITIS (pink eye), EYE SWELLING (left eye felt swollen) and MIGRAINE (migraine behind left eye).    Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-205675.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-Jul-2021 and included reporter address and postal code wad updated, New patient medical history, height, weight, race and ethnicity were added. Batch number of 1st dose of the vaccine was added. Concomitant medication was added. Treatment medication tylenol dose was updated. New Events blindness, vision blurred, conjunctivitis, eye swelling was added. Outcome of event migraine was updated to recovered. Onset date for the event migraine was updated from unknown to 22-Dec-2020, Case was upgraded from Non-serious to serious due to the event blindness. On 16-Aug-2021: Follow-up received on 16 Aug 2021 contains no new information. On 16-Aug-2021: Follow-up received on 16 Aug 2021, contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.