Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Disorientation, Facial paralysis
Clinical narrative: blood clot going to his brain and disintegrated; one side of his face fell; disorientated; could not talk , very hard time talking; stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke), THROMBOSIS (blood clot going to his brain and disintegrated) and FACIAL PARALYSIS (one side of his face fell) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 053E21A, 010M2AA and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: pneumonia vaccine (pneumonia vaccine) in October 2021 and FLU VACCINE VII in October 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII and pneumonia vaccine. Concurrent medical conditions included Myasthenia gravis and High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol, PYRIDOSTIGMINE for Myasthenia gravis.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), FACIAL PARALYSIS (one side of his face fell) (seriousness criterion medically significant), DISORIENTATION (disorientated) and SPEECH DISORDER (could not talk , very hard time talking). On an unknown date, the patient experienced THROMBOSIS (blood clot going to his brain and disintegrated) (seriousness criterion medically significant). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at a dose of 81 milligram once a day; CLOPIDOGREL BISULFATE (PLAVIX) at a dose of 75 milligram once a day and PANTOPRAZOLE at a dose of 40 milligram once a day. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), THROMBOSIS (blood clot going to his brain and disintegrated), FACIAL PARALYSIS (one side of his face fell), DISORIENTATION (disorientated) and SPEECH DISORDER (could not talk , very hard time talking) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, Blood test: blood clot found in the brain Blood clot found in the brain. On 14-May-2022, Computerised tomogram: blood clot found in the brain Blood clot found in the brain. On 14-May-2022, Magnetic resonance imaging: blood clot found in the brain Blood clot found in the brain.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 14-May-2022, they brought him to the hospital where CAT Scans, MRIs and blood works were done. They said that patient had a blood clot which they did not know where it came from and went to his brain and it disintegrated.  Company Comment: This spontaneous case concerns a 77-year-old male patient with relevant medical history of high cholesterol and Myasthenia gravis, who reported unexpected serious (medically significant) events of cerebrovascular accident and facial paralysis, four days after the 4th dose of the mRNA-1273 (Spikevax). Concomitant products included atorvastatin for high cholesterol and pyridostigmine for Myasthenia gravis. Patient had a thromboembolism confirmed by CT and MRI, leading to stroke with facial paralysis, disorientation, and speech disorder. Elderly age and medical history of High cholesterol are strong risk factors for the event of cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-573299 (Patient Link).; Sender's Comments: This spontaneous case concerns a 77-year-old male patient with relevant medical history of high cholesterol and Myasthenia gravis, who reported unexpected serious (medically significant) events of cerebrovascular accident and facial paralysis, four days after the 4th dose of the mRNA-1273 (Spikevax). Concomitant products included atorvastatin for high cholesterol and pyridostigmine for Myasthenia gravis. Patient had a thromboembolism confirmed by CT and MRI, leading to stroke with facial paralysis, disorientation, and speech disorder. Elderly age and medical history of High cholesterol are strong risk factors for the event of cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.