Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Product is the one administered to patient; Looked milky white, instead of clear; This spontaneous case, initially received on 22-Sep-2025 (Including additional information received on 23-Sep-2025), was reported by a non-health professional and concerns an adult male patient. Relevant History and concomitant medication were reported as unknown. The patient was not immunocompromised. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Indication not reported, Dose regimen: not reported, Anatomical Location: not reported, Route of administration: 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 an unknown date, the Product is the one administered to patient (outcome: Unknown), Looked milky white, instead of clear (outcome: Unknown). Reporter mentioned that her father sent her a photo of a Seqirus vaccine. In the photo, the reporter noticed, it said for 3 years and older. It also looked milky white, instead of clear. The defect had been discovered after use. The batch number had not been reported, and follow-up was required. The dose had been administered, but it was unknown whether a full dose had been given. It was also unknown whether the complaint sample was available. Regarding the packaging, it was unknown whether it appeared damaged. The storage conditions of the product were also unknown, including whether it had been stored in its original packaging, blister trays removed from the box, or individual syringes stored separately. The temperature conditions under which the product had been stored, such as refrigerator, freezer, or room temperature were not reported. For the particle complaint, the number of visible particles was unknown, and it was unknown when the particles had been noticed. The particle had been described as having a milky white appearance. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter did not provide a seriousness or causality assessment for events.; Reporter's Comments: The events were assessed as not related due to nature of events (special situation).
Comments: None