Received Jan 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 4 | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | OT |
experienced altered mental status and dizziness; shakes/chills a few hours after receiving the vaccines; experienced altered mental status and dizziness; patient was too weak to get her to the ER on their own; Initial information received on 28-Dec-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 78 years and 8 month old female patient who had altered mental status and dizziness, shakes/chills a few hours after receiving the vaccines, and was too weak to get her to the er on their own while receiving vaccines influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] and covid-19 vaccine The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2024 at 15:52 hours, the patient received Dose 1 of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength, lot and expiry date) and Dose 4 of suspect covid-19 vaccine (Unknown strength, formulation, lot and expiry date) not produced by Sanofi Pasteur, all via intramuscular route in the arm NOS (Not otherwise specified). On 10-Oct-2024 at 19:00 hours, the patient developed experienced altered mental status and dizziness (mental status changes) (dizziness), shakes/chills a few hours (chills) and patient was too weak to get her to the er on their own (asthenia) (Latency 3 hours 8 minutes) following the administration of influenza usp trival A-B high dose subvirion vaccine and Covid-19 vaccine. Reportedly, Patient reported having severe shakes/chills a few hours after receiving the vaccines. Patient's family member came to help but patient was too weak to get her to the ER on their own. Patient also experienced altered mental status and dizziness. Patient was taken to the ER via ambulance and was admitted and stayed overnight. Action taken: Not applicable. Corrective treatment: Not reported Outcome: Unknown for all the events. Seriousness criteria: The patient was hospitalized for all the events.; Sender's Comments: Sanofi company comment dated 30-Dec-2025: This case involves a 78 years old female patient who had altered mental status and dizziness, shakes/chills a few hours after receiving the vaccines, and was too weak to get her to the er on their own while receiving vaccines influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] and covid-19 vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. 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.