Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | C4752BA | — |
pentacel possible administration post expiry with no AE; Initial information received on 24-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves an unknown age patient of unknown gender who was administered to Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis And Haemophilus Type B Vaccine [Pentacel]: post expiry with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date in 2017, the patient received an unknown expired dose of diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus type b vaccine, powder and suspension for suspension for injection (batch: C4752BA, expiry: 11-Sep-2016) (strength, dose, frequency and route: unknown) in an unknown administration site for immunization (Immunisation). They wanted to know if there was a way to check expiration and lot number for a product since they had a record for a patient's Pentacel that was given on 18-Aug-2017 but the expiration date was showing 11-Sep-2016. They wanted to verify if they needed to give the patient another dose. The caller explained that this was before they scanned things and they were just writing information on their records. Medical information services (MIS) consulted customer services and was told that they could not pull up a PENTACEL product with that lot number. The patient experienced pentacel possible administration post expiry with no adverse event (Expired product administered, onset: 2017, latency: same day). No adverse events were reported. The product was used. Action taken was not applicable. 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.
Comments: NONE