Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | — |
administration of improperly stored PENTACEL to a patient with no reported adverse event; Initial information received on 22-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a patient with unknown age and gender who received administration of improperly stored Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5)/Hib(Prp/T) Vaccine [Pentacel], with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. On an unknown date, the patient received an unknown dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (batch: unknown, strength: unknown) via unknown route and unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence The patient received administration of improperly stored Pentacel (Poor quality product administered, onset date: unknown, latency: unknown). Action taken: not reported. 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