Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Macular degeneration; Bloodshot eyes; Hard to focus; Headache on the right side; Earache on the right side; Eye throbbing; Visual disturbances/ Vision problem/ cannot focus vision/ jumping vision/ Vision issues in both eyes; Cloudy; Bulge on the retina; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (Macular degeneration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2018 and Heart valve regurgitation since 01-Jan-2020. Concomitant products included HYDRALAZINE, LOSARTAN, CHLORTHALIDONE and AMLODIPINE for Blood pressure.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced EAR PAIN (Earache on the right side), EYE PAIN (Eye throbbing), VISUAL IMPAIRMENT (Visual disturbances/ Vision problem/ cannot focus vision/ jumping vision/ Vision issues in both eyes), VISION BLURRED (Cloudy), RETINAL DISORDER (Bulge on the retina) and HEADACHE (Headache on the right side). On an unknown date, the patient experienced MACULAR DEGENERATION (Macular degeneration) (seriousness criterion medically significant), OCULAR HYPERAEMIA (Bloodshot eyes) and PRESBYOPIA (Hard to focus). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Total 5 taken; ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for Dryness of eyes, at an unspecified dose and frequency; PREDNISOLONE ACETATE for Ear pain and Headache, at a dose of 1 percent; LOTEPREDNOL ETABONATE (INVELTYS) for Ear pain and Headache, at a dose of 1 percent and GABAPENTIN for Ear pain and Headache, at a dose of 300 mg once a day. At the time of the report, MACULAR DEGENERATION (Macular degeneration), EYE PAIN (Eye throbbing), VISUAL IMPAIRMENT (Visual disturbances/ Vision problem/ cannot focus vision/ jumping vision/ Vision issues in both eyes), VISION BLURRED (Cloudy), RETINAL DISORDER (Bulge on the retina), OCULAR HYPERAEMIA (Bloodshot eyes), PRESBYOPIA (Hard to focus) and HEADACHE (Headache on the right side) outcome was unknown and EAR PAIN (Earache on the right side) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         company comment: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.   This case was linked to MOD-2021-169094 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 26-MAY-2021 and does not contain any new information On 26-Jul-2021: Significant FU - contains Patient information, Medical history Provided and product treatment drug updated (A-REDS, Prednisolone Acetate 1% and Inveltys1%, and Gabapentin), laboratory data includes (Ultrasound on neck). Events were updated (macular degeneration, vision issues in both eyes, Bloodshot eyes ,and Hard to focus Presbyopia).; 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.