Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Inappropriate schedule of product administration
Clinical narrative: congestive heart failure 2 weeks after the Moderna Covid booster.; Patient had dose 1 on 19 Feb 2021 and dose 2 on 16 Dec 2021; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure 2 weeks after the Moderna Covid booster.) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 013L20A and 012L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Carpal tunnel syndrome (diagnosed 8-10 years ago), Knee replacement (Right knee replaced 5-6 years ago.), Hip replacement (Right hip replaced 5-6 years ago.), Gallbladder removal (gallbladder has been gone a long time, since 1976) in 1976, Pacemaker insertion (cardiac), Parathyroidectomy and Thyroidectomy. Concurrent medical conditions included Heart murmur (had since childhood, 80 years ago), Cardiac amyloidosis and Retinal disorder. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), FUROSEMIDE (LASIX [FUROSEMIDE]), APIXABAN (ELIQUIS), LOSARTAN POTASSIUM (LOSARTAN K), SIMVASTATIN, BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) and BIMATOPROST (LUMIGAN) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 19 Feb 2021 and dose 2 on 16 Dec 2021). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure 2 weeks after the Moderna Covid booster.) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure 2 weeks after the Moderna Covid booster.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 19 Feb 2021 and dose 2 on 16 Dec 2021) outcome was unknown.            Concomitant medications also included Paxil, Eye drops, and Vitamins E, A, D3, C, turmeric, COQ10, omega 3, and multiple.  Patient had pacemaker placed a couple of years ago.  In Sep 2023, patient had thyroid removed and three quarters parathyroid removed.  Patient had problem with right eye retina diagnosed years ago.  Patient was diagnosed with congestive heart failure exactly 2 weeks after Moderna Covid booster. Had mentioned it to  cardiologist.  Patient was prescribed Vyndamax medication. Patient had issues with hearing, was hard of hearing. Patient clarified that the hard of hearing was well before starting the Vyndamax. Patient had started Vyndamax to be 90 days before and stopped on 16Oct2023, batch/lot number: 5022927A, Dose: 61mg once a day, 1 tablet by mouth per day. Expiry Date: Apr-2024. Patient was taking Vyndamax for ATT amyloidosis in the heart.  No treatment medications were reported. Company comment: This spontaneous case concerns an elderly patient of an unknown gender, with medical history of a cardiac pacemaker insertion in the past and cardiac amyloidosis, who experienced the unexpected and serious (medically significant) AESI of CARDIAC FAILURE CONGESTIVE, 2 weeks after the booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine. Previously, the patient received the first and the second dose of Moderna vaccine with 10 months apart: inappropriate schedule of product administration has been also reported. No further clinical information was available for medical review. Patient´s medical history of a cardiac pacemaker insertion suggestive of underlying cardiac disorder and cardiac amyloidosis remain as confounders for cardiac failure congestive. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine is not affected by this report.