Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / LA |
discomfort; muscle pain from her waist down the left side of her body; swelling at the injection site; sore arm; runny nose; difficulty sleeping due to the muscle pain and noted that she must sleep in a certain position due to the pain; Initial information received on 10-Nov-2025 regarding an unsolicited valid non-serious case (along with live follow-up processed together with csd dated: 10-Nov-2025) received from a patient. This case involves a 79 years old female patient who had difficulty sleeping due to the muscle pain and noted that she must sleep in a certain position due to the pain, discomfort, runny nose, muscle pain from her waist down the left side of her body, sore arm and swelling at the injection site 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 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 arm for Influenza [Immunisation]. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknow date In Oct-2025 the patient muscle pain from her waist down the left side of her body (myalgia) and discomfort (latency: few days approximately). On an unknown date In 2025 the patient had runny nose (rhinorrhoea), difficulty sleeping due to the muscle pain and noted that she must sleep in a certain position due to the pain (sleep disorder due to a general medical condition), sore arm (pain in extremity) and swelling at the injection site (vaccination site swelling) (latency: few days approximately). It is reported" Neither caller nor spouse have contacted their healthcare provider. However, they both have an appointment scheduled next week for their routine 6 month appointments". Action taken was not applicable. The patient was treated with Acetylsalicylic acid (Baby aspirin) for all the events. At time of reporting, the outcome was Unknown for all the events.; Sender's Comments: US-SA-2025SA337793:02718195, for patient (wife)