Symptomtext
nurse gave 3 separate patient's an expired FLUZONE HD Quadrivalent vaccine, with no reported adverse event; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/Non-Healthcare Professional and physician via Regulatory authority (under reference 00794848). This case is linked to case 2021SA327336 (same reporter). This case involves a 68 years old male patient who accidentally received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [expired product administered]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 01-Oct-2021, the patient received a 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Prefilled Syringe, TOTAL, lot UJ482AA, expiration date: 30-Jun-2021) via intramuscular route in the upper arm for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (same day latency). It was reported "Practicing manager with provider's office is reporting they gave a patient an expired FLUZONE HD Quadrivalent vaccine. What shall we do from here? Caller repeated the above question. 2 HCP states that she saved back one box of FLUZONE HIGH DOSE because it had 1 month before it expired and the nurse accidentally pulled 3 prefilled syringes of FLUZONE HIGH DOSE from that box and gave them to 3 separate patients today 01-Oct-2021" At time of reporting, no 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 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.