Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052082 | IM |
Body temperature 96 degrees, but felt feverish; Burning pain in joints, neck, back, leg muscles; Burning pain in joints, neck, back, leg muscles; Burning pain in joints, neck, back, leg muscles; Burning pain in joints, neck, back, leg muscles; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Body temperature 96 degrees, but felt feverish), NECK PAIN (Burning pain in joints, neck, back, leg muscles), BACK PAIN (Burning pain in joints, neck, back, leg muscles), PAIN IN EXTREMITY (Burning pain in joints, neck, back, leg muscles) and ARTHRALGIA (Burning pain in joints, neck, back, leg muscles) in a 55-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052082) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052082) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Apr-2026, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 08-Apr-2026, the patient experienced PYREXIA (Body temperature 96 degrees, but felt feverish) (seriousness criterion hospitalization), NECK PAIN (Burning pain in joints, neck, back, leg muscles) (seriousness criterion hospitalization), BACK PAIN (Burning pain in joints, neck, back, leg muscles) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Burning pain in joints, neck, back, leg muscles) (seriousness criterion hospitalization) and ARTHRALGIA (Burning pain in joints, neck, back, leg muscles) (seriousness criterion hospitalization). At the time of the report, PYREXIA (Body temperature 96 degrees, but felt feverish), NECK PAIN (Burning pain in joints, neck, back, leg muscles), BACK PAIN (Burning pain in joints, neck, back, leg muscles), PAIN IN EXTREMITY (Burning pain in joints, neck, back, leg muscles) and ARTHRALGIA (Burning pain in joints, neck, back, leg muscles) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2026, Body temperature: 96 degree Celsius Body temperature. On 08-Apr-2026, White blood cell count: White blood cell count elevated far above normal levels. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. The patient had no concomitant disease or risk factor. Within 12 hours, the patient experienced burning pain in the joints, neck, back, and leg muscles, and had a body temperature of 96 degrees but felt feverish. Prednisone, acetaminophen, and ibuprofen were prescribed. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Test Date: 20260408; Test Name: Body temperature; Result Unstructured Data: Test Result:96 Cel;Body temperature; Test Date: 20260408; Test Name: White blood cell count; Result Unstructured Data: White blood cell count elevated far above normal levels