Received May 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK359AA | IM |
ACTHIB was incorrectly reconstituted and administered to a patient today/ACTHIB was reconstituted with a sterile diluent, with no reported adverse event; Initial information received on 11-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP - other or unknown). This case involves an unknown age patient of unknown gender who received Hib (Prp/T) Vaccine [ACT-HIB] which was incorrectly reconstituted with a sterile diluent 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 7v (CRM197) [Prevnar], Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [DTAP vaccine], Influenza vaccine (influenza vaccine). On 11-May-2026, the patient received an unknown dose (once) of Hib (Prp/T) Vaccine Powder and suspension for suspension for injection of standard strength (batch: UK359AA, expiry: 31-Aug-2026) via intramuscular route in an unknown administration site for Immunisation, which was incorrectly reconstituted with a sterile diluent with no reported adverse event. [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.
Comments: NONE
Prevnar; Dtap; Influenza vaccine