Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1A191M | OT / LA |
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 10 years old male patient who had inappropriate use due to administration of an expired vaccine IPV (VERO) [IPOL] 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 Hepatitis B vaccine (Hepatitis B vaccine) and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for prophylactic vaccination (Immunisation). On 06-Mar-2025 at 11:00 hours, the patient received a dose of 0.5 ml of suspect IPV (VERO), Suspension for injection (lot W1A191M and expiry date 16-Feb-2025) (frequency: once and strength: standard) via intramuscular route in the left deltoid for immunisation with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Medical Assistant called to ask the validity of the administered expired IPOL to 2 patients. 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.; Sender's Comments: US-SA-2025SA070402:2nd patient
Hepatitis b vaccine; Mmr