Received Mar 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Patient with Alpha Gal allergies had an allergic reaction to Flucelvax; This spontaneous case, initially received on 20-Mar-2026, was reported by a health professional and concerns a patient of unknown age/gender. The patient's concomitant medications and medical History were unknown. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for indication: Not reported, Dose regimen: not reported, Route of administration: not reported, Anatomical location: not reported, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the Patient with Alpha Gal allergies had an allergic reaction to Flucelvax (outcome: Unknown). Information was requested regarding Flucelvax and the potential for Alpha-Galrelated reactions, including details on the presence of mammalian proteins in the composition of Flucelvax. The concern raised was that patients with Alpha-Gal syndrome might experience an allergic reaction to Flucelvax, and clarification was sought on whether such reactions had been reported. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the seriousness as unknown and did not provide the causality assessment.; Reporter's Comments: The event is related due to temporal relationship plausibility.
Comments: None