Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19 immunisation, Cardiac failure congestive, Interchange of vaccine products, Pneumothorax
Clinical narrative: Congestive heart failure; Atrial fibrillation; Collapsed lung; interchange of vaccine products; revaccination with different COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure), ATRIAL FIBRILLATION (Atrial fibrillation) and PNEUMOTHORAX (Collapsed lung) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TAFAMIDIS (VYNDAMAX) for an unknown indication.    The patient's past medical history included Transthyretin-mediated amyloidosis (WILD-TYPE TRANSTHYRETINRELAT ATTR  AMYLOIDOSIS). Concurrent medical conditions included Allergy (VENOM TREATMENT KIT). Concomitant products included APIXABAN (ELIQUIS), FUROSEMIDE, ZOLPIDEM TARTRATE (ZOLPIDEM TARTATE), HYDROXYZINE HCL, LATANOPROST, OMEPRAZOLE, METOPROLOL TARTRATE and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TAFAMIDIS (VYNDAMAX) (Oral) 61 milligram once a day. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria hospitalization and medically significant), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant), PNEUMOTHORAX (Collapsed lung) (seriousness criteria hospitalization and medically significant), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID 19 vaccine). At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure), ATRIAL FIBRILLATION (Atrial fibrillation), PNEUMOTHORAX (Collapsed lung), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states she can only go a block then gets short of breath. she has heart failure with preserved ejection fraction. 03/2021 she got sick from the covid vaccine and ended up in the hospital for congestive heart failure. On 07/12/2021, patient was treated for atrial fibrillation. 08/2021 she got the covid booster and went to the hospital for 5 days and had a partial collapsed lung. Vyndamax start date was unknown,reported as 1.5 years ago. No additional information available.  Company comment: This regulatory authority case concerns a 86-year-old, female patient with no medical history information reported, who experienced the unexpected serious (hospitalization) events of cardiac failure congestive, atrial fibrillation and pneumothorax(collapsed lung). The events occurred approximately on an unknown date after a dose of mRNA-1273. No information about vaccination schedule or dose number was provided as well as exact onset dates in relation to vaccine administered. It was described that patient also received Tozinameran, hence revaccination with different COVID 19 vaccine and interchange of vaccine product was also noted. As reported, patient can only go a block then gets short of breath. Patient has heart failure with preserved ejection fraction. The patient got sick from the covid vaccine and ended up in the hospital for congestive heart failure. Four months later the patient was treated for atrial fibrillation, and 5 months after getting sick form COVID vaccine patient got the covid booster and went to the hospital for 5 days and had a partial collapsed lung. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.