Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral amyloid angiopathy, Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: itchiness on the arm of the vaccination; welts on the arm of the vaccination; Redness on the arm of the vaccination; lumps; high fever; cerebral amyloid angiopathy; This spontaneous case was reported by a nurse and describes the occurrence of CEREBRAL AMYLOID ANGIOPATHY (cerebral amyloid angiopathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced CEREBRAL AMYLOID ANGIOPATHY (cerebral amyloid angiopathy) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness on the arm of the vaccination), VACCINATION SITE URTICARIA (welts on the arm of the vaccination), VACCINATION SITE ERYTHEMA (Redness on the arm of the vaccination), VACCINATION SITE MASS (lumps) and PYREXIA (high fever). At the time of the report, CEREBRAL AMYLOID ANGIOPATHY (cerebral amyloid angiopathy), VACCINATION SITE PRURITUS (itchiness on the arm of the vaccination), VACCINATION SITE URTICARIA (welts on the arm of the vaccination), VACCINATION SITE ERYTHEMA (Redness on the arm of the vaccination), VACCINATION SITE MASS (lumps) and PYREXIA (high fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.No treatment drug was provided by reporter.  Patient stated in July of 2021 she was diagnosed with Cerebral Amyloid Angiopathy. Patient explained the condition of Cerebral Amyloid Angiopathy as it happened in brain where it causes to have stroke, the blood vessels in brain are weak, and cause blood to lay around in brain, and eventually causes stroke. Patient adds she was 2/3rds there and will eventually have a stroke.  Company comment: This case concerns a 75-year-old, female patient with no medical history reported, who experienced the unexpected serious event of cerebral amyloid angiopathy along with other non serious events. The event occurred approximately 5 months after the second dose of mRNA-1273. As reported, in July of 2021 the patient was diagnosed with Cerebral Amyloid Angiopathy. Patient explained the condition of Cerebral Amyloid Angiopathy as it happened in brain where it causes to have stroke, the blood vessels in brain are weak, and cause blood to lay around in brain, and eventually causes stroke. Patient adds she was 2/3rds there and will eventually have a stroke. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-456380, MOD-2021-016657 (Patient Link).; Sender's Comments: This case concerns a 75-year-old, female patient with no medical history reported, who experienced the unexpected serious event of cerebral amyloid angiopathy along with other non serious events. The event occurred approximately 5 months after the second dose of mRNA-1273. As reported, in July of 2021 the patient was diagnosed with Cerebral Amyloid Angiopathy. Patient explained the condition of Cerebral Amyloid Angiopathy as it happened in brain where it causes to have stroke, the blood vessels in brain are weak, and cause blood to lay around in brain, and eventually causes stroke. Patient adds she was 2/3rds there and will eventually have a stroke. The benefit-risk relationship of mRNA-1273 is not affected by this report.