Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
I get a cold/cold symptoms; I can't even breathe/difficulty breathing; I'm very frail; This spontaneous case, initially received on 18-Sep-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Indication not reported., Dose regimen: not reported, Route of administration: Unknown, Anatomical location: not reported, Lot number: No batch number available and will not be requested as no consent to follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced I get a cold/cold symptoms (outcome: Unknown), I can't even breathe/difficulty breathing (outcome: Unknown), I'm very frail (outcome: Not Reported). It had been reported that they (the poster) were off to a bad start. Before this happened, the patient had been getting the flu vaccine for a lifetime. Unfortunately, the patient was very frail and when the patient gets a cold, the patient can not even breathe. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter assessed the events I get a cold/cold symptoms, I can't even breathe/difficulty breathing as non-serious and causality was provided as unknown. The reporter did not provide seriousness and causality assessment for event I'm very frail.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes
Comments: None