Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT / LA |
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) | SANOFI PASTEUR | UNK | — | OT / LA |
kidney failure; worsening COPD; high blood sugar; consistently runny nose; Initial information received on 10-Dec-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 70 year old male patient who experienced kidney failure, worsening copd, high blood sugar and consistently runny nose after receiving COVID-19 vaccine and influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Sep-2021, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose HV Vaccine and an unknown dose of suspect COVID-19 vaccine not produced by Sanofi Pasteur (formulation, strength, expiry date, lot number not reported) via intramuscular route in the left arm for prophylactic vaccination (immunization). Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date the patient developed kidney failure (renal failure), worsening copd (chronic obstructive pulmonary disease), serious high blood sugar (blood glucose increased) and consistently runny nose (rhinorrhoea) (unknown latency). Seriousness criteria: The event renal failure was considered as medically significant. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.; Sender's Comments: Sanofi company comment dated 18-Dec-2025: This case involves a 70 year old male patient who experienced kidney failure, worsening copd, high blood sugar and consistently runny nose after receiving COVID-19 vaccine and influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed