Received May 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 388494 | — |
Patient had a severe reaction, which has continued since patient received flu vaccine, It has attached patient lungs; This spontaneous case, initially received on 22-May-2025, with additional information received on 26-May-2025 (being process together), was reported by a non-health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On 29-Jan-2025, the patient received INN Flu Vaccine Seasonal for Indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 388494. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Jan-2025, the Patient had a severe reaction, which has continued since patient received flu vaccine, It has attached patient lungs (outcome: Not Reported). Patient had a severe reaction, which has continued since patient received flu vaccine on 29-Jan-2025. Lot 388494. It has attached patient lungs. It happened within few hours after shot. Patient still have trouble which was never there before. 2 weeks before receiving shot patient had a complete check up with patient's cardiologist. All was fine. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment of event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Considered related due to plausible temporal relationship (same day within few hours after suspect).