Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3051995 | IM / RA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | LA |
polymyalgia, rheumatica-like reactions; that was PMR; severe myalgia; drenching sweats; shaking chills; This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia, rheumatica-like reactions; that was PMR), MYALGIA (severe myalgia), HYPERHIDROSIS (drenching sweats) and CHILLS (shaking chills) in a 51-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3051995) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3051995) for COVID-19 prophylaxis and non-company co-suspect product included Influenza vaccine (Fluzone) for an unknown indication. 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). 22-Oct-2025, the patient experienced MYALGIA (severe myalgia) (seriousness criterion medically significant), HYPERHIDROSIS (drenching sweats) (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), MYALGIA (severe myalgia), HYPERHIDROSIS (drenching sweats) 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 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. No concomitant medications were reported. The 51-year-old male, healthy came in for annual physical exam and travels a lot for work, so he wanted to get both his flu shot and COVID and he received the mnexspike on 21-Oct-2025, and he also received a flu shot. 24 hours later, he had severe myalgia, drenching sweats, and shaking chills. It persisted for 10 days, and his labs were through the roof and his sed rate was 117. He might have polymyalgia, rheumatica-like reactions. The rheumatology and infectious disease involved seeing if need to put him on steroids. The myalgias were common, but myalgia to this extent with drenching sweat and a sed rate of over 100, that was PMR. The symptoms were severe. The patient travels a lot. He wanted to update it cause his last one was a year prior, and he's an international traveler and felt like he was exposed a lot, so he opted to take it. It was reported that the patient was in the office (for vaccine administration) for middle of the day and then it was the following evening (when symptoms showed up). They had persisted for these 10 days and symptoms were ongoing. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: Flu vaccine remains as a co-suspect vaccine. The benefit-risk relationship of product is not affected by this report.
Test Name: sed rate; Result Unstructured Data: 117, a sed rate of over 100, that was PMR