Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM / LA |
Body tremors; developed fever (101°F); Chills; Fatigue; a sore shoulder or sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body tremors), VACCINATION SITE PAIN (a sore shoulder or sore injection site), PYREXIA (developed fever (101°F)), FATIGUE (Fatigue) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (The patient had 9 Moderna shots since the COVID disease hit.). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. On 17-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, the patient experienced VACCINATION SITE PAIN (a sore shoulder or sore injection site) and FATIGUE (Fatigue). On 26-Sep-2025, the patient experienced TREMOR (Body tremors), PYREXIA (developed fever (101°F)) and CHILLS (Chills). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. In September 2025, TREMOR (Body tremors), VACCINATION SITE PAIN (a sore shoulder or sore injection site), PYREXIA (developed fever (101°F)), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F. No concomitant medications were reported. After the shot, the patient experienced common side effects like injection site pain and fatigue, which resolved quickly. The patient had mild side effects but then did not have any other side effects, nine days after the shot (26-Sep-2025), developed fever (101°F), chills, and body tremors, lasting less than 24 hours. By the next morning, on 27-Sep-2025, everything was gone, and he was fine. The side effects were pretty uneventful, regular side effects, but this was the first time that they gotten something really weird, had a fever and chills 9 days after was a little weird. The patient reported feeling fine with no lingering side effects. This case was linked to US-MODERNATX, INC.-MOD-2025-789766 (E2B Linked Report). This case was linked to MOD-2021-296625 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2025: Live non-significant follow-up received included: Event information, narrative was updated and reference ID added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789766:Patient brother case (Reporter) -Spikevax LP.8.1 PFS
Test Name: Body temperature; Result Unstructured Data: 101 F