Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Hives returned much, much worse; Rash that got progressively worse; This spontaneous case, initially received on 04-Nov-2025, was reported by a non health professional and concerns an adult female patient. Medical history was reported as unknown and no concomitant medications were taken. Administration of company suspect drug: On 13-Oct-2025, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, 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 13-Oct-2025, the patient experienced Rash that got progressively worse (outcome: Not reported). On an unknown date, the patient experienced Hives returned much, much worse. (outcome: Not reported). On 13-Oct-2025, the individual received a flu vaccination at her local pharmacy. Approximately five days later, she began to notice a rash that progressively worsened over the course of the week. On 24-Oct-2025, she visited her doctor, who prescribed a course of corticosteroids. After completing the five-day course, the medication appeared to keep the hives under control for about another week. However, the hives returned the following night with significantly increased severity. She remained under the care of a physician and expressed concern about continuing corticosteroid treatment. She had no underlying health conditions and described herself as a healthy adult woman who took no medications, exercised regularly, practiced yoga, and taught meditation. She noted that this was the most serious health issue she had ever experienced, for which she was otherwise grateful. She offered to share a photo of the rash if needed and sought further insight, mentioning that her doctor had indicated similar reactions had been reported in post-marketing. She described the reaction as a severe allergic. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Corticosteroids Reporter's assessment: The reporter assessed the events non-serious and did not provide causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, events considered related for reporting purposes