Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / LA |
discomfort; tiredness; muscle pain at the injection site; Initial information received on 10-Nov-2025 and live follow up received on same date both were processed together regarding an unsolicited valid non-serious case received from a patient. This case is linked to US-SA-2025SA335403. This case involves a 76 years old male patient who experienced discomfort, tiredness and muscle pain at the injection site after receiving vaccine 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 21-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number and expiry date not reported) strength: high dose, via unknown route in the left upper arm for immunisation. Information on the batch number was requested corresponding to the one at time of event occurrence. On a unknown date in 2025 the patient developed discomfort, tiredness (fatigue) (latency few days) and muscle pain at the injection site (vaccination site pain) (latency unknown). Reportedly:-Caller noted that they have both had adverse symptoms (peculiar) symptoms that they are not happy with. Neither caller nor spouse have contacted their healthcare provider. However, they both have an appointment scheduled next week for their routine 6 month appointments. They plan to discuss this with the provider at that time. Caller noted that their discomfort is not unbearable but it is noticeable. Complained of tiredness and muscle pain at the injection site in his left upper arm. The discomfort and fatigue started a couple of days after he received FLUZONE HD.He has taken a baby aspirin once in a while. Action taken was not applicable. The patient was treated with ACETYLSALICYLIC ACID [ASPIRIN] for (discomfort, tiredness and vaccination site pain). At time of reporting, the outcome was Unknown for all events.; Sender's Comments: US-SA-2025SA335403:02718195, for patient (wife)