Report #2861948

Overview

Sex

Female

Age

52 yrs

State

MN

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

given immunization and it leaked back out of her arm after the injection. with no reported adverse event; given immunization and it leaked back out of her arm after the injection. with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 52 years old female patient who was given immunization with Influenza Trivalent Recombinant Vaccine [Flublok Tiv] and it leaked back out of her arm after the injection with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot U8832AA, Expiry: 31-May-2026, Strength: standard, Frequency: once) via unknown route in the arm nos (not otherwise specified) as immunization that leaked back out of her arm after the injection with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency: same day). Reportedly, reporter wanted to know if the patient should be given another dose. Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.