Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK196AA | OT |
pentacel components were administered separately and that the hib was reconstituted with sterile water with no reported adverse event; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] components separately and that the hib was reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine (Rotavirus vaccine) and Pneumococcal vaccine conj 15 V (CRM197) (Vaxneuvance) both for Prophylactic vaccination (Immunisation). On 24-Jun-2025, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine components separately and that the hib was reconstituted with sterile water (formulation: Suspension for injection) (lot UK196AA, strength: standard, frequency: once and expiry date: 30-Mar-2026) via intramuscular route (one on the left thigh, the other on the right thigh) for Immunization with no reported adverse event (wrong technique in product usage process) (Latency: same day). Reportedly, Pentacel was administered separately- reporter was unsure which side had the DTaP- IPV and which side had the Hib. 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.
Rotavirus vaccine; Vaxneuvance