Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) | SANOFI PASTEUR | 1 | U8830DA | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
patient was on AFib; elevated heart rate; blood pressure is still very low; chest pain; headache; chill; felt overall "very lousy/very weak; Initial information received on 30-Sep-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves a 74 years old male patient who was on afib (atrial fibrillation), blood pressure is still very low, chest pain, headache, chill and felt overall very lousy/very weak 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. At the time of the event, the patient had ongoing Cardiac amyloidosis. On 29-Sep-2025, the patient received an unknown dose of influenza USP TRIVAL A-b high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via intramuscular route in the arm NOS (not otherwise specified) for Immunization. On 29-Sep-2025 the patient was on afib (atrial fibrillation), blood pressure is still very low (hypotension), chest pain, headache, chill (chills), felt overall very lousy/very weak (asthenia) and elevated heart rate (heart rate increased) (latency- same day). Reportedly, the daughter explained that her father (patient) was given FLUZONE HD yesterday, 29-Sep-2025 and then that afternoon her mother sent her a message that the patient was shaking/ had a chill, elevated heart rate, headache and felt overall "very lousy". Reporter mentioned that the patient has cardiac amyloidosis. Reporter mentioned that the patient never had a reaction like this before. Patient was taken to the emergency room that same day. Reporter further explained that the patient felt okay (though he wasn't feeling great) but everything spiraled after getting the flu shot. Reporter was wondering if it was related. Reporter advised that as of the time of the report, the patient is still very weak and still has headache and blood pressure is still very low though the chest pain has gone and he is up and walking around. With the medication he was given his heart rate is low. Reporter mentioned that the cardiologist was scheduled to check the patient 30-Sep-2025. Action taken was not applicable. Patient was given different medications to regulate his heart rate (atrial fibrillation) and not reported for other events. At time of reporting, the outcome was Recovering / Resolving for the event patient was on afib, was Recovering / Resolving for the event chill, was Recovered / Resolved on an unknown date in 2025 for the event chest pain, was Not Recovered / Not Resolved for the event felt overall "very lousy/very weak, was Not Recovered / Not Resolved for the event headache and was Not Recovered / Not Resolved for the event blood pressure is still very low. Seriousness criteria: Medically significant for the event (atrial fibrillation and heart rate increased). Hospitalized on 29-Sep-2025 for all the events.; Sender's Comments: Sanofi company comment dated 03-Oct-2025: This case involves a 74 years old male patient who was on afib (atrial fibrillation), blood pressure is still very low after receiving influenza USP TRIVAL A-b high dose subvirion vaccine [Fluzone HD]. At the time of the event, the patient had ongoing Cardiac amyloidosis which could be a confounding factor. Further information regarding past relevant medical history,past treatments, and tolerance, family history, hospitalisation details, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Cardiac amyloidosis