Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Post procedural complication. Concurrent medical conditions included Spinal osteoarthritis (Spinal osteoarthritis symptoms included Back pain and inflammation.) and Nerve injury.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 06-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No concomitant medication information was provided.  The patient had four surgeries including fuse and custom spine and had more degeneration. She had a stroke after the second COVID-19 vaccine. She Had trigger shots in spine had problem walking and this did not do anything. On 06 Aug 2021, She had a stroke after the 2nd COVID-19. She was sick with the first vaccine and it did not end had a little cough when she laid down.  She had a surgery for a spinal fusion. She was off RINVOQ for a week due to having surgery. She had a complication from surgery, nerve damage. She had back surgery and was in extreme pain and she had a lot of inflammation. The symptoms of stroke included Gait disturbance and Mobility decreased.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  Company comment: This regulatory case concerns a 61-year-old female patient with relevant medical history of Spinal degenerative arthritis on Upadacitinib and multiple surgeries, who experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident, on an unspecified date after receiving the second dose of mRNA-1273 vaccine. Details of symptoms, clinical course, investigation reports and treatment were not provided. The outcome was reported as unknown. Age of the patient could be a risk factor. Medical history of Spinal degenerative arthritis with multiple surgeries could be a risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-586359 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Non-significant follow up was received on 28-Jan-2022. On 11-Apr-2022: Non-significant follow up was received on 11-Apr-2022. On 13-May-2022: Significant follow up was received on 13-May-2022, Added new events and narrative was updated. On 08-Jun-2022: Significant follow up was received on 08-Jun-2022., Added new events.; Sender's Comments: This regulatory case concerns a 61-year-old female patient with relevant medical history of Spinal degenerative arthritis on Upadacitinib and multiple surgeries, who experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident, on an unspecified date after receiving the second dose of mRNA-1273 vaccine. Details of symptoms, clinical course, investigation reports and treatment were not provided. The outcome was reported as unknown. Age of the patient could be a risk factor. Medical history of Spinal degenerative arthritis with multiple surgeries could be a risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.