Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Macular degeneration, Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: right eye they may be the start of macular degeneration; vision was crazy/cannot see properly /issues with their eyes/not able to read; letters are shrunken and the edges are fussy and blurred; skin was peeling off, like sheets of skin peeling , worse than a sunburn.; right arm was itching like crazy; right arm was very red; arm was very swollen; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (right eye they may be the start of macular degeneration) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nerve damage, Numbness in leg, Cardiac arrest, Knee replacement (During which their heart stop in middle surgery.) and Cataract operation. Previously administered products included for Product used for unknown indication: XARELTO; for Operation NOS: Propofol. Past adverse reactions to the above products included Anaesthetic complication with Propofol; and No adverse event with XARELTO. Concurrent medical conditions included Autoimmune disorder NOS, Clot blood (Patient took Xarelto.), Gout, High cholesterol, Arthritis and Catastrophic reaction (Propofol were used during the operation and this always caused major catastrophes for the patient). Concomitant products included ALLOPURINOL and SPIRONOLACTONE for Gout, METOPROLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VISUAL IMPAIRMENT (vision was crazy/cannot see properly /issues with their eyes/not able to read), VISION BLURRED (letters are shrunken and the edges are fussy and blurred), SKIN EXFOLIATION (skin was peeling off, like sheets of skin peeling , worse than a sunburn.), PRURITUS (right arm was itching like crazy), ERYTHEMA (right arm was very red) and PERIPHERAL SWELLING (arm was very swollen). On an unknown date, the patient experienced MACULAR DEGENERATION (right eye they may be the start of macular degeneration) (seriousness criterion medically significant). The patient was treated with MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for Dry eye, at an unspecified dose and frequency and VITAMINS NOS for Adverse event, at an unspecified dose and frequency. In March 2021, PERIPHERAL SWELLING (arm was very swollen) had resolved. At the time of the report, MACULAR DEGENERATION (right eye they may be the start of macular degeneration), SKIN EXFOLIATION (skin was peeling off, like sheets of skin peeling , worse than a sunburn.), PRURITUS (right arm was itching like crazy) and ERYTHEMA (right arm was very red) outcome was unknown and VISUAL IMPAIRMENT (vision was crazy/cannot see properly /issues with their eyes/not able to read) and VISION BLURRED (letters are shrunken and the edges are fussy and blurred) had not resolved.            They still are not optimal with the glasses the Dr. indicated and cannot see properly. They wonder if they should get the booster vaccine or the third dose since they have some autoimmune diseases but do not want to risk loosing their sight completely. Patient thinks their PCP was useless and patient was not comfortable giving information not about themselves. Company Comment: This case concerns an 82-year-old, female patient with a history of Blood cholesterol increased, who experienced the unexpected non-serious events of visual impairment and Vision blurred approximately 2-3 weeks after the second dose of mRNA-1273 vaccine. She visited the ophthalmologist, with a possible diagnosis of the unexpected serious event of Macular degeneration (reported as: may be the start of macular degeneration). Patient´s age and Blood cholesterol increased remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419252, MOD-2021-418432, MOD-2021-418640, MOD-2021-418444, MOD-2021-419308 (Patient Link).; Sender's Comments: This case concerns an 82-year-old, female patient with a history of Blood cholesterol increased, who experienced the unexpected non-serious events of visual impairment and Vision blurred approximately 2-3 weeks after the second dose of mRNA-1273 vaccine. She visited the ophthalmologist, with a possible diagnosis of the unexpected serious event of Macular degeneration (reported as: may be the start of macular degeneration). Patient´s age and Blood cholesterol increased remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.