Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Ultrasound scan
Clinical narrative: Heart attack/Chest pain; Surgical failure; Arterial occlusion; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack/Chest pain), SURGICAL FAILURE (Surgical failure) and ARTERIAL OCCLUSIVE DISEASE (Arterial occlusion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included Triple vessel bypass graft. Concurrent medical conditions included Heart failure, Abstains from alcohol, Non-tobacco user, Ulcerative colitis (Moderate to severe), Drug allergy (ANTIBIOTICS ALLERGY) and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, ALFUZOSIN HYDROCHLORIDE (UROXATRAL), ESOMEPRAZOLE and GABAPENTIN for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Once in two weeks,Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 28-Nov-2021, the patient experienced ARTERIAL OCCLUSIVE DISEASE (Arterial occlusion) (seriousness criterion medically significant). On 15-Dec-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack/Chest pain) (seriousness criterion medically significant) and SURGICAL FAILURE (Surgical failure) (seriousness criterion medically significant). The patient was treated with Surgery (Triple vessel bypass graft) for Myocardial infarction. On 18-Dec-2021, SURGICAL FAILURE (Surgical failure) had resolved. At the time of the report, MYOCARDIAL INFARCTION (Heart attack/Chest pain) had resolved and ARTERIAL OCCLUSIVE DISEASE (Arterial occlusion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Arteriogram: Showed 3 massive/extensive blockages arteries. On an unknown date, Electrocardiogram: Heart function normal. On an unknown date, Ultrasound scan: Normal heart function.   Indication for use of concomitant drug UROXATRAL was PROSTATE. No treatment medications were reported. Patient had triple bypass and one of the bypass was failed. The patient had open heart bypass surgery on 24 Nov 2021.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case, reported by a consumer, concerning a 70-year-old male patient with relevant medical condition of genetic heart failure and with current medication of Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Myocardial infarction, and unexpected serious (medically significant) events of Surgical failure and Arterial occlusive disease. Myocardial infarction and Surgical failure occurred approximately 1 month and 2 weeks after the third mRNA-1273 vaccination, and the event Arterial occlusive disease occurred 34 days after receiving the third/booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 31 days which falls within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination. It was reported that the patient had chest pain shortly after the third vaccination. Patient had an Arteriogram and showed three massive and extensive blockages in the arteries. Patient underwent open heart bypass surgery after 30 days, in which the patient had a triple bypass, however one of the bypasses failed. Eventually, patient experienced a heart attack. No further details about the treatments were provided. It was reported that the events Myocardial infarction and Surgical failure have resolved, while the outcome of the event Arterial occlusive disease was unknown. The medical condition of genetic heart failure and current medication of Adalimumab remain as confounders for the event Myocardial infarction. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 70-year-old male patient with relevant medical condition of genetic heart failure and with current medication of Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Myocardial infarction, and unexpected serious (medically significant) events of Surgical failure and Arterial occlusive disease. Myocardial infarction and Surgical failure occurred approximately 1 month and 2 weeks after the third mRNA-1273 vaccination, and the event Arterial occlusive disease occurred 34 days after receiving the third/booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 31 days which falls within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination. It was reported that the patient had chest pain shortly after the third vaccination. Patient had an Arteriogram and showed three massive and extensive blockages in the arteries. Patient underwent open heart bypass surgery after 30 days, in which the patient had a triple bypass, however one of the bypasses failed. Eventually, patient experienced a heart attack. No further details about the treatments were provided. It was reported that the events Myocardial infarction and Surgical failure have resolved, while the outcome of the event Arterial occlusive disease was unknown. The medical condition of genetic heart failure and current medication of Adalimumab remain as confounders for the event Myocardial infarction. The benefit-risk relationship of mRNA-1273 is not affected by this report.