Symptomtext
a patient was administered FLUZONE QUADRIVALENT sryinge which were not supposed to be used because of temperature excursion /No AE; shipment of pre-filled syringe FLUZONE QUADRIVALENT arrived late/ No AE; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a Pharmacy technician via consumer via phone via regulatory authority number: 00794935. This case is linked to case 2021SA310171(CLUSTER). This case involves a 60 years old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] syringe which were not supposed to be used because of temperature excursion and shipment of these pre-filled syringe arrived late (product storage error and product distribution issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylactic vaccination. On 30-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Injection lot number: UT7376LA, expiry date: 30-Jun-2022, frequency: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to incorrect product storage and product shipment delay (latency: same day). It was reported "Pharmacy technician called stating they had a shipment of pre-filled syringes FLUZONE QUADRIVALENT arrive late, after a temperature excursion was reported and it was determined that the syringes should not be used, 2 patients were accidentally given these vaccines. She asks if the vaccines were valid or if these patient's should be revaccinated. Caller states they had already reached to Pasteur Company Sanofi to find out if the vaccines were suitable, which they were told they were not and they were set to return them. Upon going to pack and return the shipment, caller realized one of the boxes set aside was incorrect, and the box that was supposed to be returned had been opened and two syringes used on patients." Product used: Used, first time product used: no, still using product: no and was device used: yes. No additional adverse event 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.