Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK371A | LL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK371AA | IM / LL |
received the ACTHIB component from a PENTACEL, which was reconstituted with sterile diluent, with no reported adverse event; Initial information received on 20-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 2 month old female patient who received only the Act-Hib component from a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine- (Pentacel), which was reconstituted with sterile diluent, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Prevnar 20. On 18-Mar-2026, the patient received a 0.5 mL of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine, powder and suspension for suspension for injection (batch: UK371AA, expiry: 31-Mar-2027) (strength: unknown) via intramuscular route in left thigh for immunization (Immunisation). Nurse called to ask if they could administer just the diphtheria, tetanus, acellular pertussis, inactivated poliovirus (DTaP-IPV) component of Pentacel to a 1-month-old baby. Nurse stated that the baby already received the Act-Hib component from a Pentacel, which was reconstituted with sterile diluent (Product preparation error, onset: 18-Mar-2026 and 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.
Comments: NONE
Prevnar 20