Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Cardiac failure congestive, Computerised tomogram, Dyspnoea
Clinical narrative: Congestive heart failure; Difficulty breathing; Stomach pains; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure) and DYSPNOEA (Difficulty breathing) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Retardation mental (had a reaction to a vaccine in childhood which caused mild retardation), Emphysema (Early stage Emphysema) and Hypercholesterolaemia (He was on rosuvastatin 20 mg for high cholesterol). Concomitant products included ROSUVASTATIN for Hypercholesterolemia.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). The patient was treated with Surgery (Heart Mate III LVAD pump was implanted) for Cardiac failure congestive. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure) was resolving and DYSPNOEA (Difficulty breathing) and ABDOMINAL PAIN UPPER (Stomach pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) low. On an unknown date, Computerised tomogram: abnormal (abnormal) Diagnosed with congestive heart failure.         Treatment information provided included implantation of Heart Mate III LVAD pump. On 04-May-2021, the patient was having stomach pains and on an unknown date, the patient went to the hospital. The patient was admitted, and a CT scan was performed, and the patient was diagnosed with congestive heart failure. The patient remained hospitalized for 1-2 weeks and was then discharged. Reportedly, later the patient had difficulty in breathing and was admitted to another hospital where the patient underwent another CT scan, x-rays, and other tests. The patient also had a heart catheterization and their vessels were clear. The patient was considered ineligible for a heart transplant and a Heart Mate III LVAD pump was implanted. The patient was released and was recovering at home at the time of report. The reporter who was reporting on behalf of their brother also stated that the patient had a reaction to a vaccine in childhood which caused mild retardation and had early stage emphysema. It was also reported that the patient had normal low blood pressure.  Company Comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-060008 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.