Symptomtext
Expired dose of FLUZONE HD QIV was administered to a patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Regulatory Authority (RA) (Reference number- 00839623) and transmitted to Sanofi on 02-Nov-2021. This case involves a 74 year old female patient who was received a expired dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 02-Nov-2021, the patient received a first 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ537AC, expiry: 30-Jun-2021, formulation: prefilled syringe) via unknown route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "Caller states an expired dose of FLUZONE HD QIV was administered to a patient. Caller is looking for information in regards to possible adverse effects as well as if they need to revaccinate. A nurse practitioner (NP) administered a dose of FLUZONE QUADRIVALENT HIGH DOSE today that expired on 30Jun2021. The NP plans to administer a dose of in-date vaccine to the patient as soon as possible." No other adverse event was reported. 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. 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.