Received Mar 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
weak; irregular heart beating; feel tired, fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), HEART RATE IRREGULAR (irregular heart beating) and FATIGUE (feel tired, fatigued) in a male patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Lung transplant (fifteen months ago). On 05-Nov-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASTHENIA (weak), HEART RATE IRREGULAR (irregular heart beating) and FATIGUE (feel tired, fatigued). At the time of the report, ASTHENIA (weak), HEART RATE IRREGULAR (irregular heart beating) and FATIGUE (feel tired, fatigued) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal. On an unknown date, Heart rate: irregular. Concomitant medication was not reported. It was reported that, patient took Covid-19 vaccine Moderna (Spikevax 0.5 ml) which he believed needed Spikevax 0.25 for his medical case. However, after taking the vaccine and till now patient felt tired, fatigued, weak and irregular heart beating. The patient requested information regarding how to treat, heal, and alleviate these adverse effects. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.
Medical History/Concurrent Conditions: Lung transplant (fifteen months ago)
Test Name: ECG; Result Unstructured Data: normal; Test Name: heart beat; Result Unstructured Data: irregular