Received May 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK2018C | IM / LL |
administered expired ACTHIB to a patient with no reported adverse event; Initial information received on 05-May-2026 regarding an unsolicited valid non-serious case received from other or unknown health care professional. This case involves a 15-month-old male patient who was administered an expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and pneumococcal vaccine conj 7v CRM197 (Prevnar). On 05-May-2026, the patient received a 0.5 mL once of an expired HIB (PRP/T) vaccine powder and solvent for solution for injection (batch/lot number: UK2018C, expiry date: 30-Apr-2026) (strength: standard) via intramuscular route in the left thigh for immunization with no adverse event (Expired product administered, and latency: same day). No reported reaction was noted. Patient was monitored and they only found out the vaccine was expired when the patient had already left. No further information was provided by the reporter. 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 medication 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.
Dtap; Prevnar