Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
Heart problem requiring pacemaker; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problem requiring pacemaker) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced CARDIAC DISORDER (Heart problem requiring pacemaker). At the time of the report, CARDIAC DISORDER (Heart problem requiring pacemaker) outcome was unknown. Not Provided For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient thought that it was more than a coincidence which occurred when the patient's heart problem started 2 weeks after second vaccine shot, due to which the patient required a pacemaker. Patient might not get booster doses. Paxlovid had worked well for patient. No specific treatment medication was reported. Agency reference ID was reported.