Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1A191M | OT / LL |
inappropriate use due to the administration of an expired dose of ipol to a patient with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 10 months old male patient where patient had inappropriate use of IPV (Vero) [IPOL] due to the administration of an expired dose of ipol to a patient 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 Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix); HIB vaccine conj (tet tox) (ACTHIB) and pneumococcal vaccine conj 20V (CRM197) for Immunisation. On 25-Feb-2025, inappropriate use due to the administration of 0.5 ml (once) dose of suspect IPV (VERO) Suspension for injection (Strength- standard) (lot- W1A191M and expiry date- 16-FEB-2025) via intramuscular route in the left thigh for immunization and expired dose of vaccine to a patient with no reported adverse event (expired product administered) (latency- same day). Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. 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; Acthib; PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)