Symptomtext
three patients received Pentacel vaccine which was in transit one day too long outside of the delivery window and should not be used/ No AE; three patients received Pentacel vaccine which was in transit one day too long outside of the delivery window and should not be used/ No AE; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves three patients of an demographics who received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was in transit one day too long outside of the delivery window and should have not be used (batch number: UJ403AAA, expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination on 25-Mar-2021, around 11:45 am (Product storage error and Product distribution issue). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included SODIUM (NA). It was an actual medication error due to incorrect product storage and product shipment delay (latency: same day). Potential Product Technique Complain: No, Caller stated that they received their vaccines one day outside of the delivery window and that the staff did not catch it and her facility administered three doses of Pentacel to three patients on 25-Mar-2021. Caller asked what, if anything, needs to be done. Addressed the question, then the caller asks to be transferred back to Pasteur Customer Service to discuss replacement of the product that was in transit too long. The doses arrived in a shipment at the facility around 11:00 am that same morning. After the doses were given, the facility received an urgent email from Sanofi Pasteur alerting that the Pentacel was in transit one day too long and should not be used. The vaccine was supposed to arrive on Wednesday, 24-Mar-2021 and instead arrived on Thursday, 25-Mar-2021. As soon as they received the email, the facility checked their stock and removed the product. The caller noted that one time in the past this happened with a shipment too long in transit. At that time, someone from Sanofi was calling repeatedly to be sure the facility got the urgent notification. Yesterday there was no phone notification from Sanofi only the email. The caller is not currently at the office and does not have patient specific details with her at the time of the call. The batch number was available from her email, but there was no expiry listed in the email. She agrees to call back with the patient information for Adverse Event (AE) reporting. She was provided with the case number. The AE template was not completed because of limited information available at the time of call. 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.