Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
severe muscle pain; joint aches; severe chills; severe headache; vomiting; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional). This case involves a 65 years old female patient who had severe muscle pain, joint aches, severe chills, severe headache and vomiting after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2025 at 05:00 hours, the patient received a dose of 0.5ml of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe standard strength, frequency-once (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 02-Oct-2025 the patient developed a severe muscle pain (myalgia), joint aches (arthralgia), severe chills (chills), headache (headache) and vomiting (latency-few hours). Reportedly- She had been taking the flu shots for years and have never had a reaction to any flu shot but she seems to have a very strong reaction to this vaccine yesterday. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.