Symptomtext
Low temperature reached: NEGATIVE 3.7? C / 1 HOUR AND 46 MINUTES she administered the Fluzone Hd Qiv to multiple patients with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old female patient and reporter reported temperature excursion for Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent]/ low temperature reached: negative 3.7? c / 1 hour and 46 minutes she administered the fluzone hd qiv to multiple patients with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot number: UT8137BA) (Expiry date: 30-Jun-2024) (with an unknown strength, formulation) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date, the reporter reported temperature excursion for Influenza Quadrival A-B High Dose Hv Vaccine/low temperature reached: negative 3.7? c / 1 hour and 46 minutes she administered the fluzone hd qiv to multiple patients with no reported adverse event (poor quality product administered) (latency: same day). It was reported, Caller provided inquiry number and she said she was advised that the vaccines was not suitable for use anymore. Caller was asking if we have any information on using ADACEL, FLUZONE QIV T, AND FLUZONE HD QIV after she was advised not to use it because of an excursion. Caller stated that she administered the Fluzone Qiv T And Fluzone Hd Qiv to multiple patients, but she only provided 1 patient for each vaccine, because she said it will take a lot of time if she would track all the product and patient information, and she stated that she only wants to know if we have any information on using ADACEL, FLUZONE QIV T, AND FLUZONE HD QIV after she was advised not to use it because of an excursion. Caller was in a hurry. This situation is reported to PV as medication errors due to the possible inappropriate administration of these products after the excursion occurred that were not supported by the extended stability information post excursion. Reason: Fridge malfunction Low temperature reached: NEGATIVE 3.7? C Duration out of labelled range: 1 HOUR AND 46 MINUTES If negative advice, have products been administered post excursion: YES, FLUZONE HD QIV WAS PUNCTURED AFTER EXCURSION Does extended stability data cover the excursion! NO Human Error! NO 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.; Sender's Comments: US-SA-2023SA353747:01836321, 01836324 US-SA-2023SA353804:01835076, 01836277, 01836324