Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Heart is weak; heart stop; collapsed in the kitchen; fever of 103°F; 2 inches redness around the shot site; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC DISORDER (Heart is weak), CARDIAC ARREST (heart stop) and LOSS OF CONSCIOUSNESS (collapsed in the kitchen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Exposure to COVID-19.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced PYREXIA (fever of 103°F) and VACCINATION SITE ERYTHEMA (2 inches redness around the shot site). On 01-Oct-2021, the patient experienced CARDIAC DISORDER (Heart is weak) (seriousness criterion hospitalization), CARDIAC ARREST (heart stop) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (collapsed in the kitchen) (seriousness criterion medically significant). The patient was hospitalized on 01-Oct-2021 due to CARDIAC DISORDER. The patient was treated with Manual therapy (CPR compressions on their chest till the paramedics arrived) for Cardiac arrest. At the time of the report, CARDIAC DISORDER (Heart is weak), CARDIAC ARREST (heart stop), LOSS OF CONSCIOUSNESS (collapsed in the kitchen), PYREXIA (fever of 103°F) and VACCINATION SITE ERYTHEMA (2 inches redness around the shot site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, Body temperature: 103 (High) 103°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient collapsed with stopped heart in kitchen, parent performed CPR compressions on chest till the paramedics arrived. Patient was now hospitalized and intubated doctor diagnosed as weak heart with no inflammation.  It was reported that the Patient was not on any medication and had not been diagnosed with any heart conditions before and has not had covid.19.  Patient has no history of COVID-19 and heart conditions. Concomitant medications were not provided. Treatment information was not provided.  Company Comment: This case concerns a 35 year-old female patient with no reported medical history, who experienced the unexpected serious events of Loss of consciousness, Cardiac arrest, and Cardiac disorder. The events occurred 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 35 year-old female patient with no reported medical history, who experienced the unexpected serious events of Loss of consciousness, Cardiac arrest, and Cardiac disorder. The events occurred 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.