Received Jan 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) | SANOFI PASTEUR | 1 | — | OT |
experienced altered mental status; dizziness; shakes/chills; shakes/chills; too weak to get her to the ER on their own; This is a spontaneous report received from an Other HCP from License Party. Other Case identifier(s): 2025SA388326 (SANOFI Patient Safety & Pharmacovigilance), AE-022371 (Biontech). Initial information received on 28Dec2025 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 10Oct2024 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 10Oct2024 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/hills a few hours after receiving the vaccines. Patient's family member came to help but patient was two weak to get her to the ER on their own. Patent 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. Company comment: company comment dated 30Dec2025: 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 as 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. Case serious: Yes; Company Agent Causal: Yes; Case Listedness: Unlisted; Case Outcome: unknown. Batch/lot number is not provided, and it cannot be obtained. COMIRNATY (2024-2025 FORMULA) is under agreement with BIONTECH SE.; Sender's Comments: Based on a plausible drug-event temporal relationship, a contributory role of Comirnaty to the occurrence of the reported events Mental status changes, Dizziness Shaking, Chills and Weakness cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate