Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK230AA | IM / LL |
inappropriate use due to hcp not reconstituting product with the correct diluent with no reported adverse event; Initial information received on 24-Apr-2026 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 1-year-old male patient who received only the saline diluent component of Hib (Prp/T) Vaccine [Act-Hib] without reconstitution with the lyophilized component with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. Concomitant medication(s) included pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20). On 17-Apr-2026, the patient received only the saline diluent component of 0.5 mL (once) dose 1 of Hib (Prp/T) Vaccine, powder and solvent for solution for injection of standard strength (batch/lot number: UK230AA, expiry date: 30-Jun-2026) via intramuscular route in left thigh for immunization, without reconstituting it with the lyophilized component (Product preparation issue) (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.
Prevnar 20