Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 4 | — | OT |
getting an extra dose of IPOL with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old female patient who experienced getting an extra dose of 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. On 20-Jan-2021 she also received a unknown (dose 4 ) dose of suspect IPV (VERO) Suspension for injection via unknown route in unknown administration site. On 06-May-2024, the patient received a 0.5 ml (dose 5) dose of suspect IPV (VERO) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization with no reported adverse event (extra dose administered) (latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken: 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.