Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: heart attack who were hospitalized; lupus flare up; Swelling around heart; high palpitations; severe hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack who were hospitalized), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up), PERICARDITIS (Swelling around heart), PALPITATIONS (high palpitations) and URTICARIA (severe hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack who were hospitalized) (seriousness criteria hospitalization, medically significant and life threatening), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) (seriousness criterion medically significant), PERICARDITIS (Swelling around heart) (seriousness criterion medically significant), PALPITATIONS (high palpitations) (seriousness criterion medically significant) and URTICARIA (severe hives) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack who were hospitalized), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up), PERICARDITIS (Swelling around heart), PALPITATIONS (high palpitations) and URTICARIA (severe hives) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.  Company Comment: This case concerns subject with no reported medical history, who experienced the unexpected events of myocardial infarction, systemic lupus erythematosus, urticaria and palpitations and the expected event of pericarditis. Time to onset from vaccination was not reported for the events. The rechallenge was unknown, as there's no information about vaccination doses, either dates or dose number. The event pericarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report. Further information is expected.; Sender's Comments: This case concerns subject with no reported medical history, who experienced the unexpected events of myocardial infarction, systemic lupus erythematosus, urticaria and palpitations and the expected event of pericarditis. Time to onset from vaccination was not reported for the events. The rechallenge was unknown, as there's no information about vaccination doses, either dates or dose number. The event pericarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report. Further information is expected.