Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Condition aggravated, Diabetes mellitus, Hidradenitis, Myocardial infarction
Clinical narrative: Mild hidradenitis suppurativa; Condition aggravated; heart attack/heart problem; Diabetes; Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and DIABETES MELLITUS (Diabetes) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis.    Concurrent medical conditions included Non-smoker, Blood pressure high, Abstains from alcohol, Abstains from recreational drugs, Hidradenitis suppurativa (Moderate to severe) and Diabetes.   On 05-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled, Citrate free. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced CARDIOVASCULAR DISORDER (heart attack/heart problem). In January 2022, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant). On an unknown date, the patient experienced HIDRADENITIS (Mild hidradenitis suppurativa) and CONDITION AGGRAVATED (Condition aggravated). In 2022, CARDIOVASCULAR DISORDER (heart attack/heart problem) had resolved. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) had resolved, DIABETES MELLITUS (Diabetes) had not resolved and HIDRADENITIS (Mild hidradenitis suppurativa) and CONDITION AGGRAVATED (Condition aggravated) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. On 1-Jan-2022 patient experienced heart attack/heart problem, on an unknown date in 2022 heart attack and heart problem was resolved. On 17-Dec-2021 patient had heart attack with severe angina. The patient had a four flares hidradenitis suppurativa after visiting the doctor but was seemed to be improving. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. The reporter's causality for the event(s) of heart attacks/heart problems, heart attacks, diabetes and mild hidradenitis suppurativa flare ups with respect to Humira was not provided. 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 62-year-old male patient, with relevant medical conditions of high blood pressure and diabetes, who experienced the unexpected and serious (due to medically significant) AESI of Myocardial infarction, and the unexpected and serious (due to medically significant) event of Diabetes mellitus. Myocardial infarction occurred 12 days after the first dose of mRNA-1273 vaccine, and Diabetes mellitus occurred approximately 1 month after the same dose. Co-suspect product includes non-company product Adalimumab for hidradenitis. At the time of the report, Myocardial infarction had resolved and Diabetes mellitus had not resolved. Underlying high blood pressure and diabetes could be contributory factors for Myocardial infarction, and diabetes could be a confounding factor for Diabetes mellitus. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 62-year-old male patient, with relevant medical conditions of high blood pressure and diabetes, who experienced the unexpected and serious (due to medically significant) AESI of Myocardial infarction, and the unexpected and serious (due to medically significant) event of Diabetes mellitus. Myocardial infarction occurred 12 days after the first dose of mRNA-1273 vaccine, and Diabetes mellitus occurred approximately 1 month after the same dose. Co-suspect product includes non-company product Adalimumab for hidradenitis. At the time of the report, Myocardial infarction had resolved and Diabetes mellitus had not resolved. Underlying high blood pressure and diabetes could be contributory factors for Myocardial infarction, and diabetes could be a confounding factor for Diabetes mellitus. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.