Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3051995 | OT |
polymyalgia, rheumatica-like reactions; that was PMR; drenching sweats; severe myalgia; shaking chills; Initial information received on 10-Nov-2025 regarding an unsolicited valid serious case received from a physician. This case involves patient of unknown demographics who experienced polymyalgia, rheumatica-like reactions; that was pmr, drenching sweats, severe myalgia and shaking chills after receiving COVID-19 vaccine mRNA omicron (mRNA 1283) [Mnexspike 2024-2025 formula] and influenza USP trival A-B subvirion vaccine [Fluzone]. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were reported. No Medical History information was reported. On 21-Oct-2025, the patient received a 1 DF (dosage form) of suspect Influenza USP Trival A-B Subvirion Vaccine Suspension for injection (batch number, expiry date: not reported) via unknown route in unknown administration site for immunization and 10 microgram of suspect Mnexspike 2024-2025 formula not produced by Sanofi Pasteur injection of lot 3051995 (strength, expiry date: not reported) via intramuscular route in unknown administration site for Covid-19 prophylaxis. On 22-OCT-2025 the patient developed polymyalgia, rheumatica-like reactions; that was pmr (polymyalgia rheumatica), drenching sweats (hyperhidrosis), severe myalgia (myalgia) and shaking chills (chills) (latency: 1 day) Seriousness criteria: These events were assessed as medically significant. Relevant laboratory test results included: Red blood cell sedimentation rate - On an unknown date: [117 a sed (sedimentation) rate of over 100, that was PMR] Action taken was not applicable. No corrective treatment was received for the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the events.; Sender's Comments: Sanofi company comment dated 17-Nov-2025: This case involves patient of unknown demographics who experienced polymyalgia, rheumatica-like reactions; that was pmr, drenching sweats, severe myalgia and shaking chills after receiving COVID-19 vaccine mRNA omicron (mRNA 1283) [Mnexspike 2024-2025 formula] and influenza USP trival A-B subvirion vaccine [Fluzone]..The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed
Test Name: Red blood cell sedimentation rate; Result Unstructured Data: 117 a sed rate of over 100, that was PMR