Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 946624 | RA |
The patient tested positive for Flu A; Vaccination failure; This spontaneous case, initially received on 28-Feb-2025, was reported by a non health professional and concerns a female patient. Medical History and concomitant medication were reported as unknown. There was no allergy information reported. There was no product complaint associated with this case. Administration of company suspect drug: On 02-Oct-2024, the patient received Flucelvax (TIV) for Active immunization against influenza disease., Dose Regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Deltoid, Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 22-Feb-2025, The patient tested positive for Flu A (Medically Significant, outcome: Unknown). On an unknown date in 2025, the patient had Vaccination failure (Outcome: Not reported) On 22-Feb-2025, the patient went to urgent care where she tested positive for Flu. She was given the flu shot at work. Flu was not verified by nasal swab. Back to work by 25-Feb-2025. Didn't know how she got this, no one in the family had the flu. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event was reported as unknown. Reporter's assessment: The reporter assessed the seriousness as unknown and causality assessment was not reported for event The patient tested positive for Flu A. The reporter did not provide the seriousness and causality assessment of the event Vaccination failure.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. For influenza and vaccination failure, patient tested positive 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.