Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident
Clinical narrative: strokes; covid 19; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (strokes) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 025L20A and 015M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products HYDRALAZINE for an unknown indication, METOPROLOL SUCCINATE for an unknown indication, FUROSEMIDE for an unknown indication, APIXABAN (ELIQUIS) for an unknown indication, FENOFIBRATE for an unknown indication, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication and ATORVASTATIN CALCIUM (ATORVASTIN) for an unknown indication.    It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Transient ischemic attacks (4 Transient Ischemic Attacks) in 2010 and Stroke (The patient had suffered 3 strokes. The patients first stroke was in 2020 before the patient had received any Moderna Covid-19 vaccine. The patient had the second stroke in at the end of 2020 before the first Moderna Covid-19 vaccine.) in 2020. Concurrent medical conditions included Diabetes, Blood pressure high, Anemic, Neuropathic pain (neuropathic pain at night) and Joint pain (joints hurt). Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]) for Joint pain, GABAPENTIN for Neuropathic pain, PREDNISONE, ACETAMINOPHEN;OXYCODONE HYDROCHLORIDE, FERROUS SULFATE, LEFLUNOMIDE, VITAMIN B COMPLEX (VITAMIN B CO) and ALLOPURINOL for an unknown indication.   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. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started HYDRALAZINE (unknown route) at an unspecified dose twice a day, METOPROLOL SUCCINATE (unknown route) 200 milligram once a day, FUROSEMIDE (unknown route) 40 milligram once a day, APIXABAN (ELIQUIS) (unknown route) 5 milligram twice a day, FENOFIBRATE (unknown route) 160 milligram once a day, CLOPIDOGREL BISULFATE (PLAVIX) (unknown route) 75 milligram once a day and ATORVASTATIN CALCIUM (ATORVASTIN) (unknown route) 40 milligram once a day. In 2021, the patient experienced CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant) and COVID-19 (covid 19). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes) and COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient will have back surgery later this year. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning an elderly male patient with relevant medical history / no reported medical history of Transient ischemic attacks (4 Transient Ischemic Attacks) in 2010, stroke (The patient had suffered 2 strokes), and concurrent medical conditions of Diabetes, Blood pressure high, Anemic, Neuropathic pain (neuropathic pain at night) and Joint pain (joints hurt), who experienced the serious (due to medically significant) unexpected, AESI of Cerebrovascular accident, and the non-serious unexpected event of COVID-19. The event Cerebrovascular accident occurred on an unknown date, in 2021, after a dose of mRNA-1273 vaccine. On 05-Feb-2021, the patient received first dose, on 05-Mar-2021 he received second dose, on 15-Nov-2021, he received third dose and on October 7, 2022, he received the fourth dose. Clinical course, supportive diagnostic procedures, and treatment were not provided. The outcome of the events was not reported. Age, gender, and mentioned medical history remain as confounders for the event cerebrovascular accident. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.