Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Coronary artery disease, Pulmonary function test
Clinical narrative: They found out that there was blockage of greater than 70% in 5 areas of his heart/ the blood vessels were affected/ persistence of cardiac symptoms after bypass and 1st booster dose; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY DISEASE (They found out that there was blockage of greater than 70% in 5 areas of his heart/ the blood vessels were affected/ persistence of cardiac symptoms after bypass and 1st booster dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 959904, 015M20A and 038A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: hep B (more than one dose over a period of time) in September 2021 and flu (more than one dose over a period of time) in September 2021. Past adverse reactions to the above products included No adverse event with flu and hep B. Concurrent medical conditions included Drug allergy, Chest tightness since January 2021 and Breathlessness since January 2021.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CORONARY ARTERY DISEASE (They found out that there was blockage of greater than 70% in 5 areas of his heart/ the blood vessels were affected/ persistence of cardiac symptoms after bypass and 1st booster dose) (seriousness criterion hospitalization). The patient was hospitalized on 27-Oct-2021 due to CORONARY ARTERY DISEASE. The patient was treated with Surgery (quadruple bypass) for Coronary artery disease. At the time of the report, CORONARY ARTERY DISEASE (They found out that there was blockage of greater than 70% in 5 areas of his heart/ the blood vessels were affected/ persistence of cardiac symptoms after bypass and 1st booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Cardiac stress test: flunked the test (abnormal) flunked the test, there was blockage of greater than 70% in 5 areas of his heart but he was told that there was no heart damage and only the blood vessels were affected. On an unknown date, Pulmonary function test: he passed (normal) he passed.         Concomitant product use was not provided by the reporter. The patient was scheduled to get the stress test on 25-Oct-2021 for chest tightness and breathlessness that he started to experience in Jan2021. They found out that there was blockage of greater than 70 percent in 5 areas of his heart but he was told that there was no heart damage and only the blood vessels were affected. So they advised him to see a doctor right away and he was already scheduled for his first booster dose on 26-Oct-2021. So he went through with it before getting admitted. He was also told that his was a genetic progressive condition. He had a major issue after getting the first booster dose of the vaccine. On 27-Oct-2022, he got admitted in a hospital because he flunked the stress test. On 04-Nov-2021, he had a quadruple bypass. The chest tightness and breathlessness did not worsen after the vaccination. But he claimed that those were still present even after the by-pass so they did a pulmonary test which he passed. He was going to see his cardiologist for follow up regarding the persistence of those symptoms. He did not think that it was related to the vaccine. The patient had no related possible inflammation of the heart (myocarditis or pericarditis). The patient had chest pain/pressure/discomfort/angina pectoris and dyspnea/shortness of breath/pain with breathing. The patient had no palpitations/pericardial rub and syncope.  Company comment: This spontaneous case concerns a 71-year-old, male patient with prior vaccinations of mRNA-1273 as primary COVID-19 series, who was hospitalized for the unexpected event of Coronary artery disease (reported as They found out that there was blockage of greater than 70% in 5 areas of his heart/the blood vessels were affected/persistence of cardiac symptoms after bypass and 1st booster dose). The event initially presented as chest tightness and breathlessness which started during the first dose of mRNA-1273, and prior to receiving the first booster dose. The patient reportedly failed the stress test conducted a day prior to vaccination and imaging studies revealed 70% vessel blockage affecting multiple areas of his heart. He was advised hospital admission and opted to receive the first booster dose as an in-patient. He did not report of any worsening of the cardiac symptoms after. The patient underwent quadruple bypass surgery on an unknown date but observed persistence of the cardiac symptoms post-op. A pulmonary test was done but there were no abnormal findings noted. He was then scheduled for a cardiologist appointment for further evaluation. Earlier COVID-19 vaccine doses received remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-571142, MOD-2022-571162, MOD-2022-571165 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old, male patient with prior vaccinations of mRNA-1273 as primary COVID-19 series, who was hospitalized for the unexpected event of Coronary artery disease (reported as They found out that there was blockage of greater than 70% in 5 areas of his heart/the blood vessels were affected/persistence of cardiac symptoms after bypass and 1st booster dose). The event initially presented as chest tightness and breathlessness which started during the first dose of mRNA-1273, and prior to receiving the first booster dose. The patient reportedly failed the stress test conducted a day prior to vaccination and imaging studies revealed 70% vessel blockage affecting multiple areas of his heart. He was advised hospital admission and opted to receive the first booster dose as an in-patient. He did not report of any worsening of the cardiac symptoms after. The patient underwent quadruple bypass surgery on an unknown date but observed persistence of the cardiac symptoms post-op. A pulmonary test was done but there were no abnormal findings noted. He was then scheduled for a cardiologist appointment for further evaluation. Earlier COVID-19 vaccine doses received remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.