Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | — |
off label use as per local labelling due eceived IPOL on the following dates: 1st dose: 01JUL2025 and 2nd dose: 17NOV2025 with no AE; Initial information received on 19-May-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 30-year-old female patient who experienced off label use as per local labelling due to received POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] on the following dates: 1st dose: 01-JUL-2025 and 2nd dose: 17-NOV-2025 with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 01-Jul-2025, the patient received a 0.5 mL once (1X), dose 1 and on 17-Nov-2025, the patient received a 0.5 mL once (1X), dose 2 of POLIOMYELITIS VACCINE (INACTIVATED) suspension for injection (batch/lot number: unknown, expiry date: unknown) (strength: Standard) via unknown route in an unknown administration site for immunization [Immunisation] with no adverse event (Off label use) (Latency: same day) following the second dose. There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. It was reported, "There were no other immunizations. .Pharmacist called to ask about the spacing of dosing for IPOL. She stated that a patient received IPOL on the following dates: 1st dose: 01JUL2025 and 2nd dose: 17NOV2025. She would like to know if it is okay to still give the 3rd dose now or should she repeat the series. She also wanted to know since the spacing between the 1st and 2nd dose is greater than 2 months, if she would need to restart the series." Action taken: Not applicable.