Received Dec 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT / LA |
TIA (Transient Ischaemic Attack); memory issues with the TIA; myocardial irritability; Initial information received on 26-Nov-2025 regarding an unsolicited valid serious case received from patient's wife (Non-Healthcare Professional). This case involves a 56 years old male patient who experienced TIA (transient ischaemic attack) after receiving vaccine Influenza vaccine. The patient's past medical history included Aortic valve replacement on 06-JUN-2023, Cardiac pacemaker insertion on 11-JAN-2023 and had frequent premature ventricular contractions with their myocarditis. The patient's past vaccination(s) included Covid19 Pfizer Vaccine in JUN-2021. The patient's past medical treatment(s) and family history were not provided. On 25-Oct-2025, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (dose, formulation, strength, lot and expiry: unknown) via intramuscular route in the left deltoid for Immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 27-OCT-2025 the patient developed TIA (transient ischaemic attack) (transient ischaemic attack) with symptom memory issues with the TIA (Memory impairment) and myocardial irritability (Cardiomyopathy) (latency 2 days). Reportedly: -Patient wife stated that the patient is a Covid19 Pfizer Vaccine myocarditis patient on Jun-2021 and since then, he had a prosthetic aortic valve replacement on 06-Jan-2023. Patient subsequently got a pacemaker on 11-Jan-2023. Patient also had frequent premature ventricular contractions with their myocarditis. Patient's wife mentioned that it was what was seen in the ER when the patient was having memory issues with the TIA, myocardial irritability. Patient's wife is open to receive follow ups and emails about the patient's condition if ever needed. Patient's wife mentioned that the patient would never have Covid19 vaccine ever. Patient is reasonably now okay. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2025 for the event TIA (transient ischaemic attack).; Sender's Comments: Sanofi company dated 02-DEC-2025:- This case involves a 56 years old male patient who experienced TIA (transient ischaemic attack) after receiving vaccine Influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, concurrent illnesses and concomitant medications. In addition patient past medical history could be a confounding factors.
Medical History/Concurrent Conditions: Aortic valve replacement; Pacemaker insertion (cardiac); Premature ventricular contractions