Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb injury, Myocardial fibrosis, Myocardial infarction, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in an elderly 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 product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant), SKIN PLAQUE (new plaques on arm), LIMB INJURY (felt foot was crushed), MYOCARDIAL FIBROSIS (scarring in heart), PYREXIA (Fever) and FATIGUE (fatigue and felt tired). At the time of the report, MYOCARDIAL INFARCTION (Heart attack), LIMB INJURY (felt foot was crushed), PYREXIA (Fever) and FATIGUE (fatigue and felt tired) outcome was unknown and SKIN PLAQUE (new plaques on arm) and MYOCARDIAL FIBROSIS (scarring in heart) had not resolved.            No concomitant medications were reported.  The patient had scarring in her heart and had a heart attack but did not recall it. patient had new plaques on her arm and wondered if it was due to the COVID vaccination. patient felt tired and lot of fatigued lately after receiving second covid vaccination and patient left foot felt crushed as if the bones were crushed.  The reporter causality for the events of heart attack, felt foot was crushed, scarring in heart, fatigue and felt tired and fever was not provided. the reporter's causality for the events of new plaques on arm with Humira(adalimumab) was a reasonable possibility.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  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 spontaneous case reported by a consumer, concerns an elderly female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Myocardial Infarction (Heart attack) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of Myocardial fibrosis and fatigue. It was reported that the patient had scarring in her heart and had a heart attack. On an unknown date, the patient had received ADALIMUMAB for Plaque psoriasis, which along with myocardial fibrosis could be considered as a risk factor for the event No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case reported by a consumer, concerns an elderly female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Myocardial Infarction (Heart attack) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of Myocardial fibrosis and fatigue. It was reported that the patient had scarring in her heart and had a heart attack. On an unknown date, the patient had received ADALIMUMAB for Plaque psoriasis, which along with myocardial fibrosis could be considered as a risk factor for the event No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.