Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
No energy; Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness; Headache; Nauseous; Fever of 101.5/Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), PYREXIA (Fever of 101.5/Fever), FATIGUE (Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness), HEADACHE (Headache) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 26-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced PYREXIA (Fever of 101.5/Fever). On 30-Sep-2025, the patient experienced ASTHENIA (No energy), FATIGUE (Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness), HEADACHE (Headache) and NAUSEA (Nauseous). On 02-Oct-2025, PYREXIA (Fever of 101.5/Fever) had resolved. At the time of the report, ASTHENIA (No energy) and FATIGUE (Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness) had not resolved and HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2025, Body temperature: fever of 101.5. On 27-Sep-2025, Body temperature: 100.5. On 28-Sep-2025, Body temperature: 100.5. On 29-Sep-2025, Body temperature: 100.5. On 30-Sep-2025, Body temperature: 100.5. On 01-Oct-2025, Body temperature: 99.8. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. Patient received over-65 Moderna COVID-19 vaccine on 25-Sep-2025. From 26-Sep-2025 patient had fever. Patient had no energy debilitating fatigue, exhausted headache, nauseous. On the reporting day (02-Oct-2025), fever was normal but still had extreme fatigue and tiredness. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.
Test Date: 20250926; Test Name: body temperature; Result Unstructured Data: fever of 101.5; Test Date: 20250927; Test Name: body temperature; Result Unstructured Data: 100.5; Test Date: 20250928; Test Name: body temperature; Result Unstructured Data: 100.5; Test Date: 20250929; Test Name: body temperature; Result Unstructured Data: 100.5; Test Date: 20250930; Test Name: body temperature; Result Unstructured Data: 100.5; Test Date: 20251001; Test Name: body temperature; Result Unstructured Data: 99.8