Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | LL1597 | OT |
vaccine was expired when it was given with no reported adverse event; Initial information received on 25-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received expired poliomyelitis vaccine (inactivated) with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date in 2016, the patient received unknown dose of suspect poliomyelitis vaccine (inactivated) (Unknown strength, formulation) produced by unknown manufacturer with lot LL1597 and expiry date 2013 via oral route in unknown administration site for Immunization (expired product administered) (Latency same day). Reportedly, Based on their records, the vaccine was expired when it was given. She cannot confirm the brand name of the vaccine. She wanted to confirm if the expiration date on the record truly matches the lot number. Nurse checking on the information if the expiration date matches the lot number Unknown brand of Polio vaccine. 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.