Reporte zur Charge UT7680NA/UT7761

Symptomtext

This situation is reported as a potential medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; Due to extended duration of excursion, the reporting nurse reported possible administration of the FLUZONE QUAD QIV with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case from other health professional. This case involves a 52 years old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and this situation is reported as a potential medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and due to extended duration of excursion, the reporting nurse reported possible administration of the fluzone quad qiv with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 11-Oct-2022 this situation is reported as a potential medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) Nature of Excursion was unsure, data logger showed excursion. No human error was there. Maximum/Minimum Reported Temperature was 52 F and Maximum Time Period Exposed was 14 DAYS. On 25-Oct-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UT7680NA/ UT7761NA and expiration date: 30-Jun-2023 in via intramuscular route at unknown administration site as Immunization. On 25-Oct-2022 due to extended duration of excursion, the reporting nurse reported possible administration of the fluzone quad qiv with no reported adverse event (poor quality product administered) same day following the administration of suspect vaccine. It was reported that the influenza vaccine given may have been ineffective. Action taken was not applicable. Outcome: Unknown for all. 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. Additional information received on 09-Nov-2022 from Other Health Care Professional: Therapy date added for suspect fluzone QIV accordingly event onset added for Poor quality product administered. Flublok captured incorrectly in this case deleted as separate case already create for same. Narrative updated.