Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Lichen sclerosus, Scleritis, Vitamin B12 deficiency
Clinical narrative: scleritis (ophthalmic); patient developed lichen sclerosis; patient experienced the destruction of parietal cells in her stomach lining; her body does not absorb B12 anymore; This spontaneous case was reported by a nurse and describes the occurrence of SCLERITIS (scleritis (ophthalmic)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SCLERITIS (scleritis (ophthalmic)) (seriousness criterion medically significant), LICHEN SCLEROSUS (patient developed lichen sclerosis), GASTROINTESTINAL DISORDER (patient experienced the destruction of parietal cells in her stomach lining) and VITAMIN B12 DEFICIENCY (her body does not absorb B12 anymore). The patient was treated with VITAMIN B12 [VITAMIN B12 NOS] at an unspecified dose and frequency. At the time of the report, SCLERITIS (scleritis (ophthalmic)), LICHEN SCLEROSUS (patient developed lichen sclerosis), GASTROINTESTINAL DISORDER (patient experienced the destruction of parietal cells in her stomach lining) and VITAMIN B12 DEFICIENCY (her body does not absorb B12 anymore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  It was reported that the patient had experienced the destruction of parietal cells in her stomach lining and took B12 shots.  Company Comment: This spontaneous case concerns a 66-year-old female patient, with no medical history reported, who experienced unexpected serious (medically Significant) event of Scleritis which occurred about 6 months after the second dose of mRNA-1273 vaccine. Patient also experienced non-serious event of Lichen sclerosus. Patient experienced the destruction of parietal cells in her stomach lining and took B12 shots. Reportedly, her body does not absorb B12 anymore. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the events reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old female patient, with no medical history reported, who experienced unexpected serious (medically Significant) event of Scleritis which occurred about 6 months after the second dose of mRNA-1273 vaccine. Patient also experienced non-serious event of Lichen sclerosus. Patient experienced the destruction of parietal cells in her stomach lining and took B12 shots. Reportedly, her body does not absorb B12 anymore. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the events reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.