Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Respiratory distress; This spontaneous case initially received on 10-Apr-2025, was reported by a health professional and concerns a patient of unknown age/gender. At the time of the event the patient had alpha gal, other allergies. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for an Indication not reported., Dose regimen, route of administration, and 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 experienced Respiratory distress (Medically Significant, outcome: Not Reported). Case was upgraded to serious upon company assessment of the reported event clinical significance Reporter shared that a patient received Flucelvax and had respiratory distress. The reporter told that the patient had alpha gal and other allergies. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment of the event Respiratory distress.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events considered related for reporting purposes. There is insufficient information regarding the event for a meaningful causal assessment (event onset date, temporality, unclear etiology, relevant medical history). Of note, underlying condition of alpha gal can be considered as contributing factor.
Allergy; Alpha-gal allergy