Received Mar 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No Batch number | — |
Tested positive for Flu B; Vaccination failure; This spontaneous case initially received on 05-Mar-2026, was reported by a non-health professional and concerns a patient of unknown age/gender. Relevant medical history and concomitant were unknown. Administration of company suspect drug: On 18-Oct-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: Not reported, 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 an unknown date, the patient had tested positive for Flu B (Medically Significant, outcome: Unknown) (intensity: mild), Vaccination failure (Medically Significant, outcome: Unknown) Case was upgraded to serious upon company assessment of the reported event (tested positive for Flu B) clinical significance The patient was reaching out to share that patient received Flucelvax 25/26 Seasonal Product on 18-Oct-2025 and had recently tested positive for Flu B. Symptoms were mild, but patient believed that they required to share per company policy, so please reached out if there was an alternate site/source where this information needs to be shared. Treatment measures associated with event was Unknown. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the causality assessment and seriousness was reported as unknown.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. For the events of Influenza B virus test positive and Vaccination failure, patient tested positive to Influenza within 21-to-180-day time period. Furthermore, a lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
Comments: None