Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / LA |
cardiomyopathy; Initial information received on 31-Dec-2025 regarding an unsolicited valid serious courtesy case received from a other health professional. This case involves a 76 years and 04 month old female patient who had cardiomyopathy after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] and Tozinameran [Pfizer Biontech Covid-19 Vaccine]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Sep-2024, the patient received unknown dose of suspect Influenza Usp TrivaL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknwon strength, lot and expiry date) and unknown dose of suspect pfizer biontech covid-19 vaccine (Unknown strength, formulation, lot and expiry date) not produced by Sanofi Pasteur, via intramuscular route in the left arm for prophylactic vaccination (Immunisation) On 19-Sep-2024 the patient developed cardiomyopathy (Latency 10 days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and pfizer biontech covid-19 vaccine. Action taken: Not applicable. Corrective treatment: defibrillator was given as a corrective treatment for the event. Outcome: Unknown for the event. Seriousness criteria; This event was assessed as medically significant. The patient was hospitalized on the same day this event occurred. The patient was discharged on 25-Sep-2024 (hospitalization during 6 days).; Sender's Comments: Sanofi company comment dated 06-Jan-2026: This case involves a 76 years and 04 month old female patient who had cardiomyopathy after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] and Tozinameran [Pfizer Biontech Covid-19 Vaccine]. Further information regarding allergic history, medical history, concomitant medication and tolerance, 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 suspect vaccine cannot be assessed.