Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | — |
unintentional overdosage of ipol, administered 10 doses of ipol to a single patient (overdose) with no reported adverse event; Initial information received on 27-Mar-2026 regarding an unsolicited valid non-serious case received from a other healthcare professional (HCP). This case involves a patient of unknown age and unknown gender who was administered with the unintentional overdosage of 10 doses of suspect IPV (Vero) [IPOL], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history, and concomitant medications were not provided. On an unknown date, the patient received 10 ml doses of suspect IPV (Vero), Suspension for injection, strength: unknown, frequency: once via unknown route for immunization due to unintentional overdosage with no reported adverse event (overdose) (batch and expiry date not reported). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "This situation was pre-assessed as a medication error (unintentional) or inappropriate use (unknown intention) of IPOL. Clinic supervisor called to report that one of their medical assistants administered 10 doses of IPOL to a single patient. After the incident was reported to Sanofi, clinic supervisor spoke from the safety reporting department (SRD), medical information services (MIS) attempted to collect additional data, i.e., patient information. However, clinic supervisor stated that she had never reported an incident like this before and asked if it is standard for Sanofi to collect patient data. She also noted that, since she was working from a different site, she did not have any other information available". 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.
Comments: NONE