Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
flu; patient went to the emergency room last night around midnight with a 106F fever,; Patient received a Sanofi flu shot, and it did not work; Initial information received on 17-Mar-2025 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's mother). This case involves an unknown age male patient who received influenza vaccine flu shot, and it did not work and experienced flu. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date In September 2024, the patient received an unknown dose of suspect influenza vaccine, produced by unknown manufacturer, unknown formulation, Strength: standard, frequency: once, lot number not reported via unknown route in unknown administration site for Influenza (vaccination failure) (latency:same day). On 17-Mar-2025 the patient developed flu (influenza) and went to the emergency room last night around midnight with a 106f fever, (pyrexia) (latency: 6 months approximately) following the administration of influenza vaccine . Relevant laboratory test results included: Body temperature - On 17-March-2025: 106 F Influenza virus test - On 17-March-2025: [tested positive for flu] Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (influenza) (pyrexia) At time of reporting, the outcome was Unknown for the events (influenza) (pyrexia) Seriousness criteria: Medically significant for the event (vaccination failure); Sender's Comments: Sanofi company comment dated 19-Mar-2025:: This case involves an unknown age male patient who received influenza vaccine flu shot, and it did not work and experienced flu. Further information regarding allergic history, medical history, concomitant medication, any history of exposure to flu; are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Test Date: 20250317; Test Name: body temperature; Test Result: 106 {DF}; Test Date: 20250317; Test Name: Influenza virus test; Result Unstructured Data: tested positive for flu