Reporte zur Charge UJ514AA

Symptomtext

product expired was given to a patient inadvertently, with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and non health care professional via regulatory authority. This case involves a 70 years old male patient who was vaccinated inadvertently with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], which was expired (expired product administered). The patient's past medical history, medical treatment, vaccination, concomitant medication and familyhistory were not provided. On 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Once, lot UJ514AA; expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.. It was an actual medication error due to expired vaccine used (same day latency). It was reported "FLUZONE HIGH DOSE was given to a patient inadvertently today, but the product expired on 06/30/2021. Lot: UJ514AA NDC: unavailable" Caller states that the pharmacy buyer is calling to report the event and ask what they should do from here. Pharmacy buyer transferred from Caller. Pharmacy buyer, states the following: Yes, I am calling about a patient who received a dose of FLUZONE HIGH DOSE today (05Oct2021) that had expired on 30Jun2021. I do not have the patient's initials or date of birth. The patient is 70 years old and is a male patient. I am wondering if the patient needs to be revaccinated. No further information was provided." At time of reporting, no adverse event was reported and the outcome of the event was unknown. 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.