Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK194AA | OT |
inappropriate use due to only the liquid portion of pentacel was administered to the patient with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse and processed together with live-follow up (10-Mar-2025). This case involves a 5 months old male patient who was administered inappropriately with the liquid portion of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Feb-2025, the patient received 0.5mL of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Suspension for injection (lot number UK194AA expiry date 01-Mar-2026 and strength standard) for immunisation and inappropriately only the liquid portion of pentacel was administered to the patient with no reported adverse event (single component of a two-component product administered) (latency same day). Action taken was not applicable. The age of the patient and dose description of the product was added. Narrative amended accordingly. Reportedly, nurse would like to know if the patient needs to be revaccinated with Pentacel (Vero) or can they administer the ActHib and the vaccination would be completed. 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. Based on data previously received, the following information (duplicate entry for pentacel vero #2 deleted) has been amended.
Premature baby
PREVNAR 20; ROTARIX