Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK341AA | OT / LL |
medication error (unintentional)/an inappropriate use (unknown intention) due to the administration of only the DTaP-IPV component of PENTACEL without the ACTHIB component with no reported adverse event; received the DTaP-IPV component twice with no adverse event; Initial information received on 07-Nov-2025 regarding an unsolicited valid non-serious case (along with live follow -up attached together with csd dated: 07-Nov-2025) received from a nurse. This case involves a 4 months old female patient who had medication error (unintentional)/an inappropriate use (unknown intention) due to the administration of only the dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] without the acthib component and received the dtap-ipv component twice with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation; and Rotavirus vaccine live oral 1v (Rotarix) for Immunisation. On 07-Nov-2025, the patient received 2 doses of 0.5 ml of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, lot UK341AA, expiry date: 31-Aug-2026, strength: standard and frequency: once, via intramuscular route in the left thigh for Immunization and had medication error (unintentional)/an inappropriate use (unknown intention) due to the administration of only the dtap-ipv component of pentacel without the acthib component twice with no adverse event (single component of a two-component product administered) (extra dose administered) (latency: same day). Reportedly,She clarifies that whenever she previously called, they thought that 2 patients received only the DTaP-IPV component of PENTACEL. After doing more investigation, they found out that it was only 1 patient who got 2 DTaP-IPV components. 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.
Prevnar 20; Rotarix