Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8764BB | OT / RA |
injection site soreness after the injection; experiencing symptoms at the injection site described as not hurting, but a sensation of a "jumping" feeling when the injection site area is touched or if he moves his arm in a certain way, like the nerves are affected, but it is not actual pain; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 87 years old male patient who had injection site soreness after the injection and experiencing symptoms at the injection site described as not hurting, but a sensation of a jumping feeling when the injection site area is touched or if he moves his arm in a certain way, like the nerves are affected, but it is not actual pain 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. Patient received no concomitant vaccines. On 10-Sep-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 U8764BB, expiry date:30-Jun-2026, strength not reported via intramuscular route in the right deltoid for Immunization. On an unknown date In 2025 the patient had injection site soreness after the injection (vaccination site pain) and symptoms at the injection site described as not hurting, but a sensation of a jumping feeling when the injection site area is touched or if he moves his arm in a certain way, like the nerves are affected, but it is not actual pain (vaccination site paraesthesia) (unknown latency). Action taken was Not Applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for the vaccination site pain after the injection and was Not Recovered / Not Resolved for the event vaccination site paraesthesia.