Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Cystoid macular oedema, Injection site haemorrhage, Laboratory test, Macular fibrosis
Clinical narrative: Cataract; Cystoid macular edema; Could barely see from right eye; Blood on injection site; Uveitis; Vitreous degeneration; Epiretinal membrane; This spontaneous case was reported by a physician and describes the occurrence of CYSTOID MACULAR OEDEMA (Cystoid macular edema), CATARACT (Cataract), UVEITIS (Uveitis), VITREOUS DEGENERATION (Vitreous degeneration) and MACULAR FIBROSIS (Epiretinal membrane) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Rheumatoid arthritis.    The patient's past medical history included Tobacco user (Half a pack of cigarettes a day) from 1974 to 2011, Cataract from November 2020 to 14-Mar-2021, Dry eyes in November 2020, Poor vision from January 2021 to 14-Mar-2021, Swelling of retina on 20-Mar-2021, Abstains from alcohol, Cataract operation on 25-Feb-2021 and Cataract operation on 14-Mar-2021. Concomitant products included METOPROLOL for Blood pressure high, KETOROLAC for Cataract, ATORVASTATIN for Cholesterol, METFORMIN for Diabetes.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced VISUAL IMPAIRMENT (Could barely see from right eye) and INJECTION SITE HAEMORRHAGE (Blood on injection site). In May 2021, the patient experienced UVEITIS (Uveitis) (seriousness criterion medically significant), VITREOUS DEGENERATION (Vitreous degeneration) (seriousness criterion medically significant) and MACULAR FIBROSIS (Epiretinal membrane) (seriousness criterion medically significant). On 20-May-2021, the patient experienced CYSTOID MACULAR OEDEMA (Cystoid macular edema) (seriousness criterion medically significant). On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant). The patient was treated with DIFLUPREDNATE (DUREZOL) at an unspecified dose and frequency and NEPAFENAC (ILEVRO) at an unspecified dose and frequency. On 07-May-2021, INJECTION SITE HAEMORRHAGE (Blood on injection site) had resolved. At the time of the report, CYSTOID MACULAR OEDEMA (Cystoid macular edema), CATARACT (Cataract), UVEITIS (Uveitis), VITREOUS DEGENERATION (Vitreous degeneration), MACULAR FIBROSIS (Epiretinal membrane) and VISUAL IMPAIRMENT (Could barely see from right eye) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Laboratory test: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CYSTOID MACULAR OEDEMA (Cystoid macular edema), CATARACT (Cataract), UVEITIS (Uveitis), VITREOUS DEGENERATION (Vitreous degeneration), MACULAR FIBROSIS (Epiretinal membrane), VISUAL IMPAIRMENT (Could barely see from right eye) and INJECTION SITE HAEMORRHAGE (Blood on injection site) to be not related.    It was reported that, on an unknown date, patient took an unspecified steroid shot in her right eye before taking the co-suspect Humira.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. 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.; 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.