Received Mar 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK363AA | IM / LL |
sterile water diluent was used to reconstitute ACTHIB instead of the included diluent with no AE; Initial information received on 11-Mar-2026 regarding an unsolicited valid non-serious case received from nurse. This case involves a 3-week-old female patient who received HIB (PRP/T) Vaccine [Act-Hib] which was reconstituted with sterile water diluent instead of the included diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid [Pediarix], Pneumococcal vaccine conj 20v (CRM197) [PCV-20], and Rotavirus vaccine live oral 1v [Rotarix] all for Prophylactic vaccination [immunisation]. On 11-Mar-2026, the patient received 0.5ml, dose 1 of HIB (PRP/T) Vaccine, Powder and solvent for solution for injection, (strength: standard) batch: UK363AA, expiry date: 31-Dec-2026 via intramuscular route in left thigh for immunization, which was reconstituted with sterile water diluent instead of the included diluent with no reported adverse event [Product preparation error] (latency: same day). 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.
Pediarix; Pneumococcal vaccine conj 20v (CRM197); Rotarix