Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK107AB | OT / RL |
act-hib was reconstituted with a different diluent, only one of the vials was given with no reported adverse event; Initial information received on 04-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 months old female patient who received haemophilus type B (HIB) vaccine [ACT-HIB] was reconstituted with a different diluent, only one of the vials was given 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) (PREVNAR 20) for Immunisation; and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix) for Immunisation. On 31-Jan-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 30-SEP-2025 and lot UK107AB) once via intramuscular route in the right vastus lateralis as Immunization was reconstituted with a different diluent, only one of the vials was given with no reported adverse event (product preparation error) (latency- same day). Reportedly, they want to know if the vaccine was still valid or should the patient be revaccinated. Only the lyophilized vaccine was given. 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; Infanrix