Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Allergy dermatitis; This spontaneous case (1 out of a cluster of 4 cases) initially received on 19-Nov-2025, was reported by a non-health professional and concerns a female patient. Medical history and concomitant medication reported as unknown. Administration of company suspect drugs: On an unknown date in 2020, the patient received Afluria (TIV) for Indication not reported, Dose regimen: Not reported, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: No batch number available. On an unknown date in 2021, the patient received Afluria (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 will be requested upon follow-up. On an unknown date in 2022, 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. On an unknown date in 2025, 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 will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Allergy dermatitis (outcome: Unknown). It was reported that the patient had allergy dermatitis and received the Afluria vaccine in 2020 and 2021 and received Flucelvax in 2022 and 2025. The patient was asked for the inactive ingredients of the vaccines to try to understand where de allergy might come from. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Unknown Reporter's assessment: The reporter assessed the seriousness of the event as unknown and causality assessment was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, the event(Allergy dermatitis) is considered related for reporting purposes.