Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
he went into heart failure; diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (he went into heart failure) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Family history included Heart rate low (slow heart rate, mother died from heart failure). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2024, the patient experienced COVID-19 (diagnosed with COVID). On an unknown date, the patient experienced CARDIAC FAILURE (he went into heart failure) (seriousness criteria death and medically significant). The patient died on an unknown date. The reported cause of death was he went into heart failure. It is unknown if an autopsy was performed. At the time of death, COVID-19 (diagnosed with COVID) had resolved. No concomitant medications provided by the reporter. Patient went to attend a family wedding on Dec-2024 and patient was fully vaccinated. He had been diagnosed with COVID after the wedding. That was because some person came to the wedding that apparently was not vaccinated and COVID was spread it to everyone. There were over 100 people at that wedding. Every single person at that wedding got COVID. Reporter had no information if other attendees were vaccinated or with what vaccine. It was reported that patient had all the vaccines that recommended for COVID but despite that patient got very, very sick and he was on a very extensive antibiotic as treatment medication to get over that COVID infection. Patient was recovered with an antibiotic treatment when he did get COVID. Patient had died from heart failure. Before that patient was taken to surgery to do a pacemaker, but he did not want it. It was reported that the reason he passed away was he refused to have the pacemaker. It was also reported that patient had a genetic propensity for a slow heart rate and death was not related with COVID. This case was linked to US-MODERNATX, INC.-MOD-2025-787904 (E2B Linked Report).; Reporter's Comments: Family history is a risk factor for the event. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787904:Patient 2 (Brother's case); Reported Cause(s) of Death: he went into heart failure
Medical History/Concurrent Conditions: Heart rate low (slow heart rate, mother died from heart failure)