Received Apr 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UK333AA | IM / LL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK333AA | IM / LL |
ACTHIB component that was reconstituted with sterile water and administered to the patient and DTaP-IPV component was not given to the patient with no AE; Initial information received on 07-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15-month-old male patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine-(pentacel) in which that acellular pertussis (ACTHIB) component that was reconstituted with sterile water and administered and diphtheria toxoid-inactivated poliovirus (DTaP-IPV) component was not given to the patient with no adverse event (AE) The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Influenza vaccine (flu vaccine) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20). On 02-Apr-2026 the patient received (0.5 ml) dose 3 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine powder and suspension for suspension for injection (strength: Standard and Frequency: Once) (batch: UK333AA, expiry: 30-Sep-2026) via intramuscular in left vastus lateralis for immunization, in which stated that it was actually the acellular pertussis (ACTHIB) component that was reconstituted with sterile water and administered to the patient and diphtheria toxoid-inactivated poliovirus (DTaP-IPV) component was not given to the patient (Single component of a two-component product administered) (latency: same day). 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
Flu; Prevnar 20