Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Visual impairment
Clinical narrative: Vision problems; Stroke; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782589) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, 40MG/0.4ML. In September 2021, the patient experienced COVID-19 (COVID-19). In September 2022, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Vision problems). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) was resolving, VISUAL IMPAIRMENT (Vision problems) had not resolved and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. No treatment medication information was reported.  In Sep 2022, the patient had stroke while riding a bike, eight miles in. She still had vision problems. In Sep 2021, she got covid. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter causality for the events of Covid and Vision problems with Adalimumab Solution for Injection was Not Provided The reporter causality for the event of Stroke with Adalimumab Solution for Injection was No Reasonable Possibility.  Company Comment: This spontaneous case concerns a 59-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) AESI of cerebrovascular accident, and the unexpected, non-serious events of COVID-19 and visual impairment. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving an unspecified dose of the mRNA-1273 original vaccine. The event COVID-19 occurred on an unspecified date in Sep2021 and the event cerebrovascular accident occurred on an unspecified date in Sep2022. The start date of the event visual impairment was not provided. Of note, the administration date of Humira and the vaccination date of the mRNA-1273 original vaccine were not reported, hence, the onset latency could not be assessed. No COVID-19 symptoms were reported and treatment information was not provided. On an unknown date, the event COVID-19 had resolved. About a year later, the patient had stroke while riding a bicycle, 8 miles in. No further clinical information (including details about consultation, diagnostic test/s and treatment) was available for medical review. The event cerebrovascular accident was resolving at the time of the report. However, it was reported that the patient still had vision problems. The history of co-suspect administration of Humira remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) AESI of cerebrovascular accident, and the unexpected, non-serious events of COVID-19 and visual impairment. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving an unspecified dose of the mRNA-1273 original vaccine. The event COVID-19 occurred on an unspecified date in Sep2021 and the event cerebrovascular accident occurred on an unspecified date in Sep2022. The start date of the event visual impairment was not provided. Of note, the administration date of Humira and the vaccination date of the mRNA-1273 original vaccine were not reported, hence, the onset latency could not be assessed. No COVID-19 symptoms were reported and treatment information was not provided. On an unknown date, the event COVID-19 had resolved. About a year later, the patient had stroke while riding a bicycle, 8 miles in. No further clinical information (including details about consultation, diagnostic test/s and treatment) was available for medical review. The event cerebrovascular accident was resolving at the time of the report. However, it was reported that the patient still had vision problems. The history of co-suspect administration of Humira remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.