Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UJ983AA | OT / LL |
administered a dose of PENTACEL yesterday, but did not realize that it had expired on 12Feb2025 with no reported AE; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves a 1 years old male patient who administered a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)].yesterday, but did not realize that it had expired on 12feb2025 with no reported ae [adverse event]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine and Pneumococcal vaccine conj 15v (CRM197) for Immunisation. On 04-Mar-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(PRP/T) Vaccine,Suspension for injection, lot UJ983AA, expiry date: 12-feb-2025, via intramuscular route in the left thigh for Immunization with no adverse event expired product administered) (latency: same day). 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. Sender's Comments:Reporter can be contacted by Sanofi.
Mmr; Vaxneuvance