Received Aug 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT / LA |
female patient administered 0.1mL of IPOL intradermally rather than intramuscularly with no reported adverse event; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case is linked to this case US-SA-2025SA244517. This case involves a 39 years old female patient who was administered with 0.1 ml dose of IPV (VERO) [IPOL] intradermally rather than intramuscularly with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Aug-2025, the patient received 0.1 ml dose of suspect IPV (VERO), Suspension for injection, lot X1C891M, expiry date:31-Oct-2026, strength: standard, frequency: once, via intradermal route in the left arm for immunisation, intradermally rather than intramuscularly with no reported adverse event (incorrect route of product administration) (latency: same day). Reportedly, She is inquiring about the side effects, reactions, and adverse events that they should watch out for and the effects to the child of a nursing mother administered with IPOL. Medical Assistant also mentioned that the mother is unsure if she is unvaccinated or under vaccinated.No other vaccines, AE symptoms or no AE: None. 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-2025SA244517: