Sex: U
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: ADACEL was exposed to 65-70 degrees F for 2-3 days/ it might be over 72 hour with no reported ae; dose was administered to a patient after excursion occurred with no ae; Initial information received on 03-Feb-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered diphtheria-2/tetanus/5 ac pertussis vaccine [ADACEL] after being exposed to 65-70 degrees F for 2-3 days/ it might be over 72 hour with no ae (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (with an unknown formulation, strength, dose, lot number and expiry date) via unknown route in unknown administration site for prophylactic vaccination.   Caller stated that their refrigerator became disconnected, but they were unaware. Caller unsure of how long product was out of range and what temperatures were reached. Caller stated that a dose was administered to a patient after excursion occurred (poor quality product administered; latency same day; unknown date of onset) and would like to know if that patient would experience any adverse reactions. Upon probing, she estimated that ADACEL was exposed to 65-70 degrees F for 2-3 days. She also said it might be over 72 hours. (Product storage error; unknown latency and onset date).  Agent provided stability information, administration post-excursion, and confirmed that the possible adverse effects would be the same as what could be seen in the prescribing information. The agent tried to collect the product information but it was already disposed of and patient information, but it was unavailable since she was not in the clinic.  Batch/lot number requested. Unknown by caller. Product no longer available.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the events (ADACEL was exposed to 65-70 degrees F for 2-3 days/ it might be over 72 hour with no reported ae, dose was administered to a patient after excursion occurred with no ae).  At time of reporting, the outcome was Unknown for the event adacel was exposed to 65-70 degrees f for 2-3 days/ it might be over 72 hour with no reported ae and was Unknown for the event dose was administered to a patient after excursion occurred with no ae.  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 guidelines. 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.   Based on information previously received, the following information [Coding for event of "dose was administered to a patient after excursion occurred" was updated from "medication error" to "Poor quality product administered", Case classification was updated from "Non-case" to "Valid with no AE", as per the events captured in event tab and Seriousness captured as "medically significant" was removed from event of product storage error] has/have been amended