Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3051995 | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | — |
polymyalgia, rheumatica-like reactions; that was PMR; drenching sweats; severe myalgia; shaking chills; This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia, rheumatica-like reactions; that was PMR), HYPERHIDROSIS (drenching sweats), MYALGIA (severe myalgia) and CHILLS (shaking chills) in a patient of an unknown age and gender who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3051995) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3051995) for COVID-19 prophylaxis and co-suspect non-company product included Influenza vaccine (Fluzone) for Immunization. No Medical History information was reported. On 21-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 10 microgram and dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Oct-2025, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia, rheumatica-like reactions; that was PMR) (seriousness criterion medically significant), HYPERHIDROSIS (drenching sweats) (seriousness criterion medically significant), MYALGIA (severe myalgia) (seriousness criterion medically significant) and CHILLS (shaking chills) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia, rheumatica-like reactions; that was PMR), HYPERHIDROSIS (drenching sweats), MYALGIA (severe myalgia) and CHILLS (shaking chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate: [117 a sed (sedimentation) rate of over 100, that was PMR]. 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 medications were not reported. The patient's past medical treatments, vaccinations and family history were not provided. On 21-Oct-2025, the patient received a 1 dosage form of suspect Influenza USP Trival A-B Subvirion Vaccine Suspension for injection. No corrective treatment was received for the events. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.; Reporter's Comments: Company comment: Concurrent administration of influenza vaccine is a confounder. The benefit-risk relationship of product is not affected by this report.
Test Name: Red blood cell sedimentation rate; Result Unstructured Data: [117 a sed (sedimentation) rate of over 100, that was PMR]