Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Electrocardiogram, Exposure to SARS-CoV-2, Injection site swelling, Myocardial infarction, Restlessness
Clinical narrative: Diabetes; Coagulation disorder; RESTLESNESS; Exposure to COVID-19; COVID-19 respiratory infection; Injection site warmth; injection site pain; injection site swelling; Heart attack; Coronary Artery Occlusion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a physician and describes the occurrence of CORONARY ARTERY OCCLUSION (Coronary Artery Occlusion), MYOCARDIAL INFARCTION (Heart attack) and DIABETES MELLITUS (Diabetes) in a 55-year-old female 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 products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and PREDNISONE for Rheumatoid arthritis.    Previously administered products included for Product used for unknown indication: NSAIDS. Past adverse reactions to the above products included Itching with NSAIDS. Concurrent medical conditions included Non-tobacco user, Diabetes mellitus and Rheumatoid arthritis. Concomitant products included CETIRIZINE for Allergy, LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure increased, SEMAGLUTIDE (OZEMPIC) for Diabetes, VITAMIN D3 for Nutritional supplement, IBUPROFEN for Pain, ROSUVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PREDNISONE (unknown route) dosage form. In March 2021, the patient experienced CORONARY ARTERY OCCLUSION (Coronary Artery Occlusion) (seriousness criterion medically significant). On 20-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PAIN (injection site pain) and INJECTION SITE SWELLING (injection site swelling). On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), COAGULOPATHY (Coagulation disorder), RESTLESSNESS (RESTLESNESS), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and COVID-19 (COVID-19 respiratory infection). In March 2021, CORONARY ARTERY OCCLUSION (Coronary Artery Occlusion), VACCINATION SITE WARMTH (Injection site warmth) and INJECTION SITE SWELLING (injection site swelling) had resolved. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) was resolving, DIABETES MELLITUS (Diabetes), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and COVID-19 (COVID-19 respiratory infection) outcome was unknown, COAGULOPATHY (Coagulation disorder) had not resolved and RESTLESSNESS (RESTLESNESS) and VACCINATION SITE PAIN (injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: unknown (abnormal) Diabetes.. In March 2021, Electrocardiogram: unknown (abnormal) Heart attack.. In March 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unspecified date, 3 weeks prior to the heart attack, the patient reported that she had covid-19 infection and she possibly contacted the infection from her husband.  On an unspecified date, treatment included stent placement, metoprolol, prasugrel and Ativan (lorazepam).  Based on the current available information and temporal association between the use of the product and the start dates of the events as (EXPOSURE TO SARS-COV-2 ,COVID-19 respiratory infection, VACCINATION SITE WARMTH  VACCINATION SITE PAIN, and VACCINATION SITE SWELLING , a causal relationship cannot be excluded. Based on reporter's causality (On 20-Mar-2021, the patient experienced MYOCARDIAL INFARCTION  and On 24-Mar-2021, the patient received dose of mRNA-1273 ) the events as CORONARY ARTERY OCCLUSION ,MYOCARDIAL INFARCTION, COAGULOPATHY,DIABETES MELLITUS, RESTLESSNESS and Rheumatoid Arthritis does not have temporal relationship with the vaccine and assessed as unlikely related to mRNA-1273. All these events are part of medical history of the patient.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Followup received on 07-JUN-2021 and contains NNI.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events as (EXPOSURE TO SARS-COV-2 ,COVID-19 respiratory infection, VACCINATION SITE WARMTH  VACCINATION SITE PAIN, and VACCINATION SITE SWELLING , a causal relationship cannot be excluded. Based on reporter's causality (On 20-Mar-2021, the patient experienced MYOCARDIAL INFARCTION  and On 24-Mar-2021, the patient received dose of mRNA-1273 ) the events as CORONARY ARTERY OCCLUSION ,MYOCARDIAL INFARCTION, COAGULOPATHY,DIABETES MELLITUS, RESTLESSNESS and Rheumatoid Arthritis does not have temporal relationship with the vaccine and assessed as unlikely related to mRNA-1273. All these events are part of medical history of the patient.