Reporte zur Charge U6615AB

Symptomtext

Patient was administered with Pentacel vaccine which was expired with no reported AE; instead of Adacel patient administered Pentacel with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00544726) and transmitted to Sanofi on 01-Apr-2021. This case involves a 53 year old female patient who instead of adacel administered pentacel (Wrong product administered) and also was administered with pentacel vaccine which was expired (Expired product administered), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. Patient received no concomitant vaccines. Medical history, medical treatment, vaccination and family history were not provided. On 01-Apr-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot U6615AB and expiry date: 29-Mar-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. It was reported that, they intended to administer Adacel (Tdap) to the patient today (01-Apr-2021), but instead Pentacel, but only the DTaP-IPV component and not the Hib component, was inadvertently administered intramuscularly to the patient. In addition to that, the DTaP-IPV component of the Pentacel had expired on 29-Mar-2021. Facility was planning to re-vaccinate patient with Adacel. Reporter did not know the injection/administration site on the body where the vaccine was administered. Product used : Used. First time product used: Yes Still using product: No It was a case actual medication error due wrong product administered and expired product administered. [latency: at the same time of vaccination] . At the time of reporting, patient had no 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 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. There will be no information available on the batch number for this case.