Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK174AB | OT |
pentacel vaccine, but was only given the hib portion of the vaccine, which was reconstituted with sterile water with no reported adverse event; pentacel vaccine, but was only given the hib portion of the vaccine, which was reconstituted with sterile water with no reported adverse event; Initial information received on 31-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 weeks old female patient who was administered to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)],but was only given the hib portion of the vaccine, which 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 Pneumococcal vaccine conj 20v (CRM197) (Pneumococcal vaccine conj 20v (CRM197)); and Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 21-Jul-2025, the patient received 0.5 ml (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection(lot UK174AB, expiry date 21-Mar-2026, strength standard and frequency once) via intramuscular route in the left lateralis for Immunisation but was only given the hib portion of the vaccine, which was reconstituted with sterile water with no reported adverse event (product preparation error), (single component of a two-component product administered) (latency same day). Reportedly, patient started Pentacel vaccine, but was only given the HIB portion of the vaccine, which was reconstituted with sterile water. She was asking if they can continue the vaccine by giving the missing portion or if it needs to be restarted. 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.
Pneumococcal vaccine conj 20v (CRM197); Rotavirus vaccine