Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
fever; pain at site of administration on arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (pain at site of administration on arm) in a 22-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 25-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 25-Oct-2025, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (pain at site of administration on arm). At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (pain at site of administration on arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2025, Body temperature: 102 degree fever. The concomitant medication was not reported by the reporter. The patient had 102-degree fever 4 to 5 hours after administration and had pain at site of administration on arm. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
Test Date: 20251025; Test Name: body temperature; Result Unstructured Data: 102 degree fever