Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Sneezing; Rash in my back, neck and face, rash is worsening; Soar throat; This spontaneous case initially received on 12-Dec-2025, was reported by a non health professional and concerns an elderly male patient. Medical History and Concomitant Medications were reported as unknown. There was no product complaint associated with this case and no allergy information was reported. Administration of company suspect drug: On 04-Nov-2025, the patient received Fluad (TIV) for unknown indication, 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 Nov-2025, the patient experienced Rash in my back, neck and face, rash is worsening (outcome: Unknown), Soar throat (outcome: Unknown). On an unknown date, the patient experienced Sneezing (outcome: Unknown). The consumer had called and stated that previous month of the report he had been dealing with a rash, which had later spread to his back. He had received Prednisone treatment and two different steroid ointments, but the rash had continued worsening. He had been trying to determine what had caused the rash. On 04-Nov-2025, he had received a Fluad vaccine at their local Pharmacy, and about a week later he had begun developing a rash on his neck and face, along with a sore throat. He had initially assumed the sore throat was due to frequent sneezing. When the rash did not clear, he had visited a dermatologist, who had indicated that it would resolve after treatment. However, the treatment had worsened the rash, and the consumer planned to revisit the dermatologist the following week while trying to figure out the cause. He asked whether a rash could be a side effect of the flu shot, as there seemed to be no other contributory factors. Fluad (TIV) action taken: Not Applicable Treatment medication: Prednisone, Steroid ointments Reporter's assessment: The reporter did not provide the causality assessment of the events and seriousness criteria was reported as unknown for the events Rash in my back, neck and face, rash is worsening, Soar throat and Sneezing.; Reporter's Comments: Due to the spontaneous nature of the case, the events Rash in my back, neck and face, rash is worsening, Soar throat and Sneezing are considered related for reporting purposes.