Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Retinal disorder, Visual impairment
Clinical narrative: macular degenration; ear ache on the right side; eye throbbing; vision problem/ can not fpocus vision/ jumping visionv; Bulge on the retina; Bloodshot eyes; vision issues in both eyes; headache on right side; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (macular degenration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2018 and Heart valve disorders since 01-Jan-2020. Concomitant products included HYDRALAZINE, LOSARTAN, CHLORTHALIDONE and AMLODIPINE for Blood pressure abnormal.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced MACULAR DEGENERATION (macular degenration) (seriousness criterion medically significant), EAR PAIN (ear ache on the right side), EYE PAIN (eye throbbing), VISUAL IMPAIRMENT (vision problem/ can not fpocus vision/ jumping visionv), RETINAL DISORDER (Bulge on the retina), OCULAR HYPERAEMIA (Bloodshot eyes), VISUAL IMPAIRMENT (vision issues in both eyes) and HEADACHE (headache on right side). The patient was treated with GABAPENTIN ongoing since an unknown date at a dose of 300 mg once a day; PREDNISOLONE ACETATE for Earache and Headache, at an unspecified dose and frequency and LOTEPREDNOL ETABONATE (INVELTYS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MACULAR DEGENERATION (macular degenration), EYE PAIN (eye throbbing), VISUAL IMPAIRMENT (vision problem/ can not fpocus vision/ jumping visionv), RETINAL DISORDER (Bulge on the retina), OCULAR HYPERAEMIA (Bloodshot eyes) and VISUAL IMPAIRMENT (vision issues in both eyes) outcome was unknown and EAR PAIN (ear ache on the right side) and HEADACHE (headache on right side) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient laboratory data was include ultrasoung on neck result was not given. The patient two eye doctors, one ear doctor and Neurologist.  Patient treatment information was received steroid shot.   This case was linked to MOD-2021-169315 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup received on 25-may-2021 non significant information was reported. On 26-Jul-2021: Patient Information, Events Added, Medical history was updated, treatment drug and outcome for headache and ear pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.