Reporte zur Charge UJ529A

Symptomtext

patient was given products that were exposed to highest temperature excursion at 49 fahrenheit and for 45 minutes/ No AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case received from a other health care professional via Agency. This case is linked to case 2021SA178936 (consumer case). This case involves an unknown age female patient who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] pre-filled syringe lot number: UJ562AA expiration date: 30-Jun-2021, lot number: UJ507AA expiration date: 30-Jun-2021, lot number: UJ471AA expiration date: 30-Jun-2021, lot number: UT7073KA expiration date: 30-Jun-2021, lot number: UT7115KA expiration date: 30-Jun-2021, INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] lot number: UJ507AA expiration date: 30-Jun-2021, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number: U676AA expiration date: 31-Jul-2022, lot number: U6900AA expiration date: 18-Nov-2022, lot number: U6927AA expiration date: 28-Jan-2023, MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number: U6827BB expiration date: 18-Feb-2022, lot number: U6827BA expiration date: 18-Feb-2022, IPV (VERO) [IPOL] MULTI DOSE VIAL lot number: T1D482N expiration date: 25-Jul-2022, DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot number: C5688AA expiration date: 26-Nov-2021 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] lot number: UJ529A expiration date: 22-Jul-2022 for prophylactic vaccination and was tested with TUBERCULIN TEST [TUBERSOL] lot number: C5804AA expiration date: 03-Feb-2023 for tuberculin test via an unknown route and administration site that was exposed to highest temperature excursion at 49 Fahrenheit and for 45 minutes (Product storage error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to incorrect product storage (latency: same day). Description: Clinical coordinator called to report stability information of vaccines exposed to temperature excursion. On 09-Apr-2021, the highest temperature was at 49 Fahrenheit and the excursion lasted 45 minutes. On 23-Apr-2021, the highest temperature was at 48.7 Fahrenheit and the excursion lasted 30 minutes. Reason for excursion is that the fridge was not closed correctly, it did not shut all the way. Product used. At the time of report, 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 holders compliance with the requirements set out in 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.