Received Apr 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK370AA | — |
report that the Hib component of Pentacel was reconstituted with Merck sterile diluent (sterile water) with no adverse event; Initial information received on 15-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves an unknown age patient of unknown gender and Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine (Pentacel) was reconstituted with Merck sterile diluent (sterile water), with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history, and concomitant medications were not provided. On 14-Apr-2026, the patient received Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine (Pentacel), Powder and suspension for suspension for injection (batch: UK370AA, expiry date: 31-Mar-2027) (strength, dose, frequency, and route: unknown) for immunization (Immunisation). The Hib component of Pentacel was reconstituted with Merck sterile diluent (sterile water) (Product preparation error, onset: 14-Apr-2026, latency: same day) (batch: UK370AA, expiry date: 31-Mar-2027). The healthcare professional stated that she was aware that this was not a valid dose and that it had to be repeated. Action taken: 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