Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No Batch number | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Flucelvax package insert was hard to read; Last year was not that effective; Very sick, very very sick; This spontaneous case, initially received on 24-Sep-2025, was reported by a health professional and concerns an elderly patient. Administration of company suspect drugs: On an unknown date, the patient received INN Flu Vaccine Seasonal for indication not reported, Dosage regimen: not reported, Route of administration: not reported, Lot number: No batch number available and would not be requested as the reporter did not provide consent for follow-up. On an unknown date in 2024, the patient received Flucelvax (TIV) for indication not reported, Dosage regimen: not reported, Route of administration: not reported, Lot number: No batch number available and would not be requested as the reporter did not provide consent for follow-up No additional suspect drugs. On an unknown date in 2024, the patient received Flucelvax (TIV) for RSV vaccine (RSV vaccine), Indication: Not reported. Dosage regimen: not reported, Route of administration: not reported, Lot number: No batch number available Adverse reactions/events and outcomes: On an unknown date in 2024, the patient experienced last year was not that effective (Medically Significant, outcome: Not Reported), Very sick, very very sick (outcome: Not Reported). On an unknown date, the patient experienced Flucelvax package insert was hard to read (outcome: Not Reported). Pharmacist stated, It was very confusing because nurses in different areas were putting out pamphlets that said it was quadrivalent. Reporter followed this very closely; last year (2024) it was not that effective. Reporter hoped that it would be effective this year 2025. Also, the Flucelvax package insert was hard to read. Reporter liked the flu vaccine. Reporter thought reporter was going to get the COVID vaccine also. Last year (2024) he got RSV and the doctors did not pay much attention. Reporter was very sick, very very sick. Patient could not get an appointment with the doctor in the country unless patient was dying, so it was kind of sad, not that summer, but last year 2024. Patient was 87 at home, and they did not pay attention. INN Flu Vaccine Seasonal action taken: Not Applicable Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter did not provide seriousness and causality assessment for the events.; Reporter's Comments: INN Flu vaccine seasonal- Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. A lack of effect can generally be expected for any medicinal/drug/vaccine product as a 100% success rate cannot be reasonably assumed in every patient treated. However, further information required on exact etiology (whether due to Flu vaccines or any other suspect product), temporality, onset latency, etc. for meaningful causal assessment. The event illness is probably attributed to RSV vaccine administered. Flucelvax (TIV)- Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. A lack of effect can generally be expected for any medicinal/drug/vaccine product as a 100% success rate cannot be reasonably assumed in every patient treated. However, further information required on exact etiology (whether due to Flu vaccines or any other suspect product), temporality, onset latency, etc. for meaningful causal assessment. The event illness is probably attributed to RSV vaccine administered.
Comments: None