Report #2872010

Overview

Sex

Female

Age

Age unknown

State

MO

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Felt the vaccine was ineffective or did not work; This spontaneous case, initially received on 30-Oct-2025, was reported by a health professional and concerns a female patient. Medical history and concomitant medication was reported as unknown. Administration of company suspect drug: On an unknown date, 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 would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient felt the vaccine was ineffective or did not work (Medically Significant, outcome: Unknown). A patient received a flu vaccine but felt the vaccine was ineffective or did not work. The patient went to the pharmacy requested revaccination. Pharmacist inquired and tried to get some information about Flucelvax, and whether a patient could receive two doses. The patient who received immunization said she did not felt like going, so she was convinced she did not get it and wanted another one. The pharmacist just needed to know whether there's any guideline so she could have a second dose. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter did not provide causality assessment of the event and seriousness was assessed as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, the event vaccination failure is considered related for reporting purposes. However, the information provided is insufficient (vaccine administration date, whether patient actually developed influenza virus infection in the time frame of 21 to 180 days after vaccination and its confirmation with laboratory tests are not known) to perform a more in-depth analysis.