Symptomtext
The products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) with no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves unknown gender patient for whom it was reported the products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], HIB (PRP/T) VACCINE [ActHIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product storage error). The patient medical history, medical treatment(s), vaccination(s),concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot U7328AA, expiry date: 30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ496AAA, expiry date:09-Jul-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot UJ426AAA and expiry date:07-Mar-20222] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6828AB, expiry date: 09-Jan-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5765BA and expiry date: 28-Aug-2022] via an unknown route in unknown administration site for prophylactic vaccination. It was case of actual medication error due to product storage error [Latency: on the same day]. 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 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.
