Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cardiac flutter, Feeding disorder, Heart rate increased, SARS-CoV-2 antibody test
Clinical narrative: Five days after the second dose i was hospitalized with fast heart rate/fluttering; I also had Gastrointestinal discomfort/disorders which caused trouble in eating; which caused trouble in eating; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Five days after the second dose i was hospitalized with fast heart rate/fluttering), ABDOMINAL DISCOMFORT (I also had Gastrointestinal discomfort/disorders which caused trouble in eating), FEEDING DISORDER (which caused trouble in eating) and HEART RATE INCREASED (fast heart rate) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus and Dysautonomia.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Five days after the second dose i was hospitalized with fast heart rate/fluttering) (seriousness criteria hospitalization and medically significant), ABDOMINAL DISCOMFORT (I also had Gastrointestinal discomfort/disorders which caused trouble in eating) (seriousness criterion hospitalization), FEEDING DISORDER (which caused trouble in eating) (seriousness criterion hospitalization) and HEART RATE INCREASED (fast heart rate) (seriousness criterion hospitalization). At the time of the report, CARDIAC FLUTTER (Five days after the second dose i was hospitalized with fast heart rate/fluttering), ABDOMINAL DISCOMFORT (I also had Gastrointestinal discomfort/disorders which caused trouble in eating), FEEDING DISORDER (which caused trouble in eating) and HEART RATE INCREASED (fast heart rate) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: high (High) showed her levels to be high.         No concomitant medication information was provided.  It was reported that five days after the second dose the patient was hospitalized with fast heart rate/fluttering along with Gastrointestinal discomfort/disorders which caused trouble in eating. The patient had trouble getting the results interpreted by her physicians for COVID-19 antibody test.  No treatment medications were provided.  Company comment: This spontaneous case concerns a  female patient with relevant concurrent medical conditions of lupus erythematous and dysautonomia, who experienced serious unexpected events of cardiac flutter, heart rate increased, abdominal discomfort and feeding disorder. The events occurred approximately 5 days after the second dose of the mRNA-1273 . Reportedly, the patient was hospitalized with fast heart rate and heart flutter, in addition to gastrointestinal discomfort and disorder that caused trouble eating. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  Patient's lupus erythematous and dysautonomia are possible confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-400130 (Patient Link).; Reporter's Comments: The patient has a history of lupus and dysautonomia. Five days after the second dose the patient was hospitalized with fast heart rate/fluttering along with Gastrointestinal discomfort/disorders which caused trouble in eating. The patient took a COVID-19 antiobody test which reportedly showed her levels to be high but she had trouble getting the results interpreted by her physicians. The symptoms are slowly resolving.; Sender's Comments: This spontaneous case concerns a  female patient with relevant concurrent medical conditions of lupus erythematous and dysautonomia, who experienced serious unexpected events of cardiac flutter, heart rate increased, abdominal discomfort and feeding disorder. The events occurred approximately 5 days after the second dose of the mRNA-1273 . Reportedly, the patient was hospitalized with fast heart rate and heart flutter, in addition to gastrointestinal discomfort and disorder that caused trouble eating. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  Patient's lupus erythematous and dysautonomia are possible confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.