Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK367AA | OT / RL |
incorrect diluent used and DTaP-IPV components only given the ACT-HIB portion, and not the DTaP-IPV portion of the vaccine with no reported adverse event; Initial information received on 20-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case- US-SA-2025SA349511 This case involves a 4 months old female patient as the incorrect diluent used and dtap-ipv components only given the act-hib portion, and not the dtap-ipv portion of the vaccine with no reported adverse event for Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine live reassort oral 5v (Rotateq) Pneumococcal vaccine conj for Immunisation. On 19-Nov-2025, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine dose 0.5 ml 1x(once) Strength = standard lot UK367AA expiry date-31-Mar-2027 via intramuscular route in the right thigh for Immunization incorrect diluent used and dtap-ipv components only given the act-hib portion, and not the dtap-ipv portion of the vaccine with no reported adverse event (single component of a two-component product administered) (latency same day). It was reported "She is assuming the float nurse that prepared it mixed the ACT-HIB with a sterile diluent used in a Merck vaccine, and did not use the DTaP and IPV, as those blue-top vials are still unopened in the box unopened, but the adjacent green-top vial is gone. They have been unable to reach her to verify, and have not yet reached out to the parents of the patients." 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.; Sender's Comments: US-SA-2025SA349511:
Rotateq; Pneumococcal conjugate vaccine