Received Nov 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8852NA | OT |
Left arm weakness; Left Arm discomfort; Initial information received on 18-Nov-2025 regarding an unsolicited valid serious case received from a nurse. This case involves 47 years old female patient (65.77 kg) who had left arm weakness and left arm discomfort after receiving Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2025, the patient received a Dose of 0.5 mL once of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8852NA) (unknown strength and expiry date) via intramuscular route in unknown administration site as Flu Vaccine (Influenza immunization). On 19-OCT-2025 the patient developed left arm weakness (muscular weakness) and left arm discomfort (limb discomfort) (latency- 4 days). Reportedly, patient had Left arm weakness, and discomfort persistent x 1 month. Relevant laboratory test results included: Ultrasound scan - On an unknown date in 2025: [revealed a mild development of a granuloma n between the deltoid musculatures] Action taken was not applicable. A corrective treatment with unknown medications was received for the events along with ER (Emergency Room) Evaluation. At time of reporting, the outcome was Unknown for the events. Seriousness criteria: medically significant for the events.; Sender's Comments: Sanofi Company Comment dated 25-NOV-2025: This case involves 47 years old female patient (65.77 kg) who had left arm weakness and arm discomfort after receiving Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone]. Further information regarding concurrent condition during vaccination, previous vaccination, and tolerance, allergic history, are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Test Date: 2025; Test Name: ultrasound; Result Unstructured Data: revealed a mild development of a granuloma n between the deltoid musculatures