Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Vaccination failure; tested positive for B-strain Flu; showing symptoms of viral pneumonia; Initial information received on 05-Mar-2026 regarding an unsolicited valid serious case received from a consumer (non-healthcare professional). This case involves a male patient of unknown age who had tested positive for B-strain flu after receiving influenza trivalent recombinant vaccine [FLUBLOK TIV]. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. In Oct-2025, the patient received a 1X dose once of influenza trivalent recombinant vaccine [FLUBLOK TIV] solution for injection (batch/lot number and expiry date: unknown) (strength: unknown) via unknown route in an unknown administration site for influenza. A Sanofi employee stated he was speaking with a co-worker (patient) and they mentioned receiving a FLUBLOK back in Oct-2025. On 03-Mar-2026, the patient tested positive for B-strain flu (Influenza, onset: 03-Mar-2026, latency: approximately 5 months) and he was showing symptoms of viral pneumonia (Pneumonia viral, onset: 2026, latency: unknown). The patient experienced vaccination failure (Vaccination failure, onset: unknown, latency: unknown). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Relevant laboratory test results included: Influenza B virus test - On 03-Mar-2026 with positive result; tested positive for B-strain flu. Action taken: Not applicable. Corrective treatment: Not reported. Event outcome: Unknown for influenza. Seriousness criteria: Medically significant for influenza
Comments: NONE
Test Date: 20260303; Test Name: Influenza B virus test; Result Unstructured Data: tested positive for B-strain Flu