Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Catheterisation cardiac, Chest discomfort, Chest pain, Ejection fraction
Clinical narrative: heart attack, thrombosis, chest discomfort, hyperhidrosis, dyspnoea, hypoaesthesia; chest started to tighten; Chest pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack, thrombosis, chest discomfort, hyperhidrosis, dyspnoea, hypoaesthesia) and CHEST DISCOMFORT (chest started to tighten) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Weight loss (Lost 40 Ibs due to Ozempic and Invokana medications). Concurrent medical conditions included Type 2 diabetes mellitus (controlled with other medicines; A1c was 6.8 on 11-Mar-2021) since 05-Dec-2003. Concomitant products included ATORVASTATIN from 24-Mar-2019 to an unknown date for Cholesterol, METFORMIN from 24-May-2003 to an unknown date, CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) from 24-Mar-2019 to 23-Apr-2021 and SEMAGLUTIDE (OZEMPIC) from 24-Mar-2019 to an unknown date for Diabetes.   On 25-Feb-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021 at 8:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced CHEST PAIN (Chest pain) and FATIGUE (Tiredness). On 23-Apr-2021, the patient experienced CHEST DISCOMFORT (chest started to tighten) (seriousness criterion hospitalization). On 23-Apr-2021 at 11:15 AM, the patient experienced MYOCARDIAL INFARCTION (heart attack, thrombosis, chest discomfort, hyperhidrosis, dyspnoea, hypoaesthesia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Apr-2021 to 25-Apr-2021 due to CHEST DISCOMFORT and MYOCARDIAL INFARCTION. On 25-Mar-2021, CHEST PAIN (Chest pain) had resolved. On 26-Mar-2021, FATIGUE (Tiredness) had resolved. At the time of the report, MYOCARDIAL INFARCTION (heart attack, thrombosis, chest discomfort, hyperhidrosis, dyspnoea, hypoaesthesia) had not resolved and CHEST DISCOMFORT (chest started to tighten) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood cholesterol: below 100 (normal) good blood work related to cholesterol.. On 11-Mar-2021, Glycosylated haemoglobin: 6.8 (abnormal) 6.8. On an unknown date, Blood cholesterol: 250 (abnormal) More than doubled in a month. Cholesterol was shot up over 250 from under 100 and under 100 (abnormal) After vaccination,Cholesterol was under 100 had no symptoms of shortness of breath.. On an unknown date, Catheterisation cardiac: abnormal (abnormal) my "widowmaker" was 100% blocked. On an unknown date, Ejection fraction: 20-25% (abnormal) 20-25%.         Patient had good blood work related to cholesterol on 11-Mar-2021, however it was more than doubled in a month following administration of suspect drug.   Patient was taking 40mg of Atorvastatin, previously was taking 40mg of pravastatin with some results but my endocrinologist wanted patient to go even lower so he prescribed 40mg Atorvastatin which I take once per day and have been for over 2 years. Patient was concomitantly taking medications for type 2 diabetes. Patient had treated with blood thinners for the rest of my life.  On 25-MAR-2021 approximately 7 hours after in the evening patient had experienced some chest pain that lasted maybe 1 hour, could still breathe as normal and had took the next day off from work due to tiredness. Patient was released from the hospital 72 hours later and had required a life vest for release. Patient was sent to cardiac rehab for 6 weeks and was off the life vest due ejection fraction returning to normal levels. Patients  widow maker was 100% blocked and would placed a stent as per the cardiologist.  Company comment: This case concerns 49-year-old male patient with a history of Type 2 diabetes mellitus, who experienced the unexpected event of Myocardial Infarction. The event occurred approximately one month after the second dose of mRNA-1273. The rechallenge was not applicable as the events happened after the second dose. The medical history of Type 2 diabetes mellitus and patient´s age remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Added patient demographic details, start date of diabetes, medical history, lab data, concomitant medications, vaccine information, facility information ,added events, outcome of events- Heart attack, heart attack with 100% blockage updated from unknown to not recovered and Clot event from recovering to not recovered/resolved, added start date and stop date of hospitalization and updated narrative.; Sender's Comments: This case concerns 49-year-old male patient with a history of Type 2 diabetes mellitus, who experienced the unexpected event of Myocardial Infarction. The event occurred approximately one month after the second dose of mRNA-1273. The rechallenge was not applicable as the events happened after the second dose. The medical history of Type 2 diabetes mellitus and patient´s age remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.