Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Atrial fibrillation, Body temperature, Cardiac failure
Clinical narrative: Was admitted to the hospital with acute respiratory failure with hypoxia; Was admitted to the hospital with acute respiratory failure with hypoxia; Severe heart failure with acute decompensation and type unknown; Atrial fibrillation and non rheumatic mitral valve regurgitation; Atrial fibrillation and non rheumatic mitral valve regurgitation; After 4 days started to get a chest cold; After 4 days started to get a chest cold,shortness of breath; Fever on day 2 with temperature of 101.4 F; Weak; Took him to a walk in clinic because patient was coughing a lot; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Severe heart failure with acute decompensation and type unknown), ATRIAL FIBRILLATION (Atrial fibrillation and non rheumatic mitral valve regurgitation), MITRAL VALVE INCOMPETENCE (Atrial fibrillation and non rheumatic mitral valve regurgitation), ACUTE RESPIRATORY FAILURE (Was admitted to the hospital with acute respiratory failure with hypoxia) and HYPOXIA (Was admitted to the hospital with acute respiratory failure with hypoxia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 025A1A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Hyperlipidemia, AMLODIPINE and METOPROLOL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever on day 2 with temperature of 101.4 F). On 09-Nov-2021, the patient experienced LOWER RESPIRATORY TRACT INFECTION (After 4 days started to get a chest cold) and DYSPNOEA (After 4 days started to get a chest cold,shortness of breath). In November 2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation and non rheumatic mitral valve regurgitation) (seriousness criteria hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (Atrial fibrillation and non rheumatic mitral valve regurgitation) (seriousness criteria hospitalization and medically significant), ASTHENIA (Weak) and COUGH (Took him to a walk in clinic because patient was coughing a lot). On 16-Nov-2021, the patient experienced CARDIAC FAILURE (Severe heart failure with acute decompensation and type unknown) (seriousness criteria hospitalization and medically significant), ACUTE RESPIRATORY FAILURE (Was admitted to the hospital with acute respiratory failure with hypoxia) (seriousness criteria hospitalization and medically significant) and HYPOXIA (Was admitted to the hospital with acute respiratory failure with hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 16-Nov-2021 to 18-Nov-2021 due to ACUTE RESPIRATORY FAILURE, ATRIAL FIBRILLATION, CARDIAC FAILURE, HYPOXIA and MITRAL VALVE INCOMPETENCE. The patient was treated with OXYGEN for Adverse event, at an unspecified dose and frequency; APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency and FUROSEMIDE (LASIX [FUROSEMIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC FAILURE (Severe heart failure with acute decompensation and type unknown), ATRIAL FIBRILLATION (Atrial fibrillation and non rheumatic mitral valve regurgitation), MITRAL VALVE INCOMPETENCE (Atrial fibrillation and non rheumatic mitral valve regurgitation), ACUTE RESPIRATORY FAILURE (Was admitted to the hospital with acute respiratory failure with hypoxia), HYPOXIA (Was admitted to the hospital with acute respiratory failure with hypoxia), LOWER RESPIRATORY TRACT INFECTION (After 4 days started to get a chest cold), DYSPNOEA (After 4 days started to get a chest cold,shortness of breath), ASTHENIA (Weak), COUGH (Took him to a walk in clinic because patient was coughing a lot) and PYREXIA (Fever on day 2 with temperature of 101.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 101.4 (High) temperature of 101.4 F. In November 2021, Endoscopic ultrasound: no results provided no results provided. ultrasound esophageal scope to look at posterior side of heart. In November 2021, Laboratory test: no results provided no results provided. In November 2021, Oxygen saturation: normal (normal) Oxygen saturation was fine..         After 4 days of receiving third dose, patient started to get a chest cold, shortness of breath. Later, within 8 days, patient was admitted to the hospital with acute respiratory failure with hypoxia and severe heart failure with acute decompensation and type unknown. Patient also had atrial fibrillation and non rheumatic mitral valve regurgitation. Reporter also reported that patient had a fever on day 2 with a temperature of 101.4 F. Patient was taken to a walk in clinic because patient was coughing a lot and weak. And they said oxygen saturation was fine. Patient was admitted to the hospital on 16-Nov-2021 and was released on 18-Nov-2021.  Patient had no prior history of heart problems, and had just seen primary care doctor prior to receiving his booster dose, and there were no underlying issues.  Company Comment: This case concerns a 80-year-old, male patient with concomitant medications ATORVASTATIN for Hyperlipidemia, Amlodipine and Metoprolol, who experienced the unexpected serious events of Acute respiratory failure, Cardiac failure, Atrial fibrillation, Mitral valve incompetence, Hypoxia and other unexpected non-serious events. The events occurred approximately 8 days after the third dose of mRNA-1273 Vaccine which resulted in hospitalization. The patient was treated with APIXABAN (ELIQUIS), FUROSEMIDE (LASIX [FUROSEMIDE]) and OXYGEN. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of intake concomitant medications ATORVASTATIN for Hyperlipidemia, Amlodipine and Metoprolol remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-406117 (Patient Link).; Sender's Comments: This case concerns a 80-year-old, male patient with concomitant medications ATORVASTATIN for Hyperlipidemia, Amlodipine and Metoprolol, who experienced the unexpected serious events of Acute respiratory failure, Cardiac failure, Atrial fibrillation, Mitral valve incompetence, Hypoxia and other unexpected non-serious events. The events occurred approximately 8 days after the third dose of mRNA-1273 Vaccine which resulted in hospitalization. The patient was treated with APIXABAN (ELIQUIS), FUROSEMIDE (LASIX [FUROSEMIDE]) and OXYGEN. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of intake concomitant medications ATORVASTATIN for Hyperlipidemia, Amlodipine and Metoprolol remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.