Reporte zur Charge UP7683JA

Symptomtext

Products were out of range for a cumulative 2 hours, including high and low excursions with no adverse events; FLUZONE QUADRIVALENT NP was administered to a 60 year-old female post-excursion with no adverse event; Initial information receivedon 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves products diphtheria toxoid, poliomyelitis vaccine (inactivated), diphtheria and tetanus toxoids, meningococcal A-C-Y-W135 (D CONJ) vaccine [menactra], HIB (PRP/T) vaccine [act-hib] and influenza quadrival A-B vaccine [fluzone quadrivalent] that were out of range for a cumulative 2 hours, including high and low excursions with no adverse events and out of which fluzone quadrivalent np was administered to a 60 year-old female post-excursion with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B (MENB) for Immunisation. On 23-Jan-2023, the patient received a 0.5 dose of suspect influenza quadrival A-B vaccine (lot UP7683JA, expiry date- 30-Jun-2023 with unknown strength and form) via intramuscular route in unknown administration site as prophylactic vaccination. On an unknown date the products diphtheria toxoid, poliomyelitis vaccine (inactivated), diphtheria and tetanus toxoids, meningococcal A-C-Y-W135 (D CONJ) vaccine [menactra], HIB (PRP/T) vaccine [act-hib] and influenza quadrival A-B vaccine [fluzone quadrivalent] that were out of range for a cumulative 2 hours, including high and low excursions with no adverse events (product storage error) (unknown latency) and out of which on 23-Jan-2023 fluzone quadrivalent np was administered to a 60 year-old female post-excursion with no adverse event (poor quality product administered) (latency- same day). It was reported that "Products were exposed to a high of 47.4 and a low of 31.4. Nurse states that in the process of trying to get the refrigerator temperature to a stable, in-range level, both high and low temperature excursions occurred. Nurse states that on or before 23jan2023, the refrigerator temperature was getting too warm, the maximum temperature reached was 47.4F. Staff adjusted the thermostat and put "a couple more bottles of water" into the unit. Then, on 26jan2023, the refrigerator temperature became too cold, the temperature went down to 31.4F" Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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.