Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
This situation is pre-assessed as an off-label use as per local labelling due to a possible off-label dosing schedule, by receiving only one dose rather than the complete series of three doses with no adverse event.; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age male patient who experienced this situation is pre-assessed as an off-label use as per local labelling due to a possible off-label dosing schedule, by receiving only one dose rather than the complete series of three doses with no adverse event. while receiving vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown month in 2024, the patient received a dose of suspect IPV (VERO); Suspension for injection (lot number, dose, strength and expiry date not reported) via unknown route in unknown administration site for Immunization; an off-label use as per local labelling due to a possible off-label dosing schedule, by receiving only one dose rather than the complete series of three doses with no adverse event. (off label use) (latency: same day) Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly:Pharmacist stated that he has a male patient who was administered one dose of IPOL polio vaccine last year. He is now going through an immigration process, and when his file was reviewed, he was told that his polio immunization is not up to date. His polio vaccination history, other than the one dose he received last year, is unknown. Pharmacist asked what the IPOL vaccination schedule would be to get this patient up to date. Additional Description of event Adverse events :This situation is pre-assessed as an off-label use as per local labelling due to a possible off-label dosing schedule, by receiving only one dose rather than the complete series of three doses. Action taken was not applicable.