Symptomtext
product were exposed to -0.5 degrees celsius for 45 minutes/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Global Medical Information (GMI) (Reference number- 00708327) and transmitted to Sanofi on 03-Aug-2021. This case involves MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL] that were exposed to -0.5 degree Celsius for 45 minutes and a patient received a dose of received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (UJ542AA and expiry date: 10-JUL-2022), DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (C5863AA and expiry date: 13-APR-2023), TUBERSOL (TUBERCULIN TEST) (lot C65751AA and expiry date: 19-Sep-2022), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (06920AA and expiry date: 15-APR-2022) and IPV (VERO) (lot R1F973M and expiry date:30-Oct-2021) exposed to -0.5 degree Celsius for 45 minutes. On 02-Aug-2021, the patient received as dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE via unknown route at an unknown administration site for prophylactic vaccination. This was potential medication error case due to product storage error temperature too low (on same day). It was reported that "the refrigerator temperature went down and Caller states that excursion was caused by the door being left open." It was not reported if patient experienced any adverse event. 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 by the regulatory authority. 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.