Received Jan 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Tiredness; racing heart which continued to escalate. Heart rate eventually reached 217; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and PALPITATIONS (racing heart which continued to escalate. Heart rate eventually reached 217) in a 71-year-old female patient 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. No Medical History information was reported. On 11-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 12-Oct-2025, the patient experienced FATIGUE (Tiredness) (seriousness criterion hospitalization) and PALPITATIONS (racing heart which continued to escalate. Heart rate eventually reached 217) (seriousness criterion hospitalization). On 12-Oct-2025, FATIGUE (Tiredness) had resolved. At the time of the report, PALPITATIONS (racing heart which continued to escalate. Heart rate eventually reached 217) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Oct-2025, Heart rate: 217. Concomitant medications were not reported. It was reported that patient experienced tiredness and racing heart which continued to escalate. The heart rate eventually reached at 217. Patient had two electro shocks 100j and 200j and spent 3 days in ICU. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.; Reporter's Comments: Elderly age is a risk factor for the events. The benefit-risk relationship of product is not affected by this report.
Test Date: 20251012; Test Name: Heart rate; Result Unstructured Data: 217