Report #2880827

Overview

Sex

Male

Age

64 yrs

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (3)

Symptom narrative

loss of his own heart's function; significant distress; frustration; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (loss of his own heart's function) in a 64-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Artificial heart device user (reliant on a mechanical heart due to the loss of his own heart's function). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (loss of his own heart's function) (seriousness criterion medically significant), EMOTIONAL DISTRESS (significant distress) and FRUSTRATION TOLERANCE DECREASED (frustration). At the time of the report, CARDIAC FAILURE (loss of his own heart's function), EMOTIONAL DISTRESS (significant distress) and FRUSTRATION TOLERANCE DECREASED (frustration) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that expressed significant distress and frustration over severe health issues that he had experienced following the administration of the Moderna COVID-19 vaccine. It was reported that he was currently awaiting a heart transplant, reliant on a mechanical heart due to the loss of his own heart's function. It was reported that patient emotional state was one of desperation and dissatisfaction, believing that the current system provided insufficient recourse for those affected. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-792971, US-MODERNATX, INC.-MOD-2025-792972 (E2B Linked Report).; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-792971:Invalid case for family (Multiple patients) US-MODERNATX, INC.-MOD-2025-792972:Case for family member

Current illness

Artificial heart device user (reliant on a mechanical heart due to the loss of his own heart's function)