Symptomtext
The patient received an expired dose of the vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Regulatory Authority (RA) (Reference number- 00870596) and transmitted on 23-Nov-2021.. This case involves a 65 year old male patient who was received an expired dose of the 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), concomitant medication(s) and family history were not provided. On 22-Nov-2021, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ537AB, expiry: July2021, formulation: pre-filled syringe (PFS)) via intramuscular 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 "Registered Pharmacist (RPH) calling in on FLUZONE high dose (HD) PFS. Caller states that a patient received an expired dose of the vaccine and would like to know if they should revaccinate? Caller also asked what information should they provide to the patient? Patient mistakenly received expired FLUZONE HD from last year." 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.