Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac function test, Carditis, Cerebrovascular accident, Intracranial aneurysm
Clinical narrative: afib; stroke; brain aneurysms; multiple myeloma; He had heart issue, inflammation of the heart; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (afib), CEREBROVASCULAR ACCIDENT (stroke), INTRACRANIAL ANEURYSM (brain aneurysms), PLASMA CELL MYELOMA (multiple myeloma) and CARDITIS (He had heart issue, inflammation of the heart) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 019B21A) for COVID-19 prophylaxis.     Patient reported they did not any medical history or condition before receiving the vaccine. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), INTRACRANIAL ANEURYSM (brain aneurysms) (seriousness criterion medically significant), PLASMA CELL MYELOMA (multiple myeloma) (seriousness criterion medically significant) and CARDITIS (He had heart issue, inflammation of the heart) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (afib), CEREBROVASCULAR ACCIDENT (stroke), INTRACRANIAL ANEURYSM (brain aneurysms), PLASMA CELL MYELOMA (multiple myeloma) and CARDITIS (He had heart issue, inflammation of the heart) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: 30 percent of heart pumping.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He stated he was getting treatment for multiple myeloma, which was not curable. He had heart issue, inflammation of the heart. He was taking 5 different medications to help regulate his heart pumping. He only has 30 % of his heart pumping. He stated he did not have this problem before taking the Moderna virus shot.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 60-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Atrial fibrillation (AESI), Cerebrovascular accident (AESI), Carditis (AESI), Intracranial aneurysm and Plasma cell myeloma, which occurred on an unknown date after the second dose of mRNA-1273 vaccine. As reported, patient is getting treatment for multiple myeloma, which is not curable. He is also taking 5 different medications to help regulate his heart pumping. He only has 30% of his heart pumping. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.