Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 2 | X1C891M | — |
while administering a dose of IPOL to a patient, only one-fourth of the dose was given, and the rest was partially wasted due to the patient moving with no reported adverse event; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months 5 days old female patient who was administered IPV (Vero) [IPol] but only one-fourth of the dose was given, and the rest was partially wasted due to the patient moving with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid [Daptacel] for Immunisation. On an unknown date in Nov-2025, the patient received dose 1 of suspect IPV (Vero) (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation. On 23-Jul-2025, the patient was administered dose 2 of suspect IPV (Vero) (once) Suspension for injection, Strength Standard, lot X1C891M and expiry date Oct-2026 via intramuscular route in the right thigh for immunization but only one-fourth of the dose was given, and the rest was partially wasted due to the patient moving with no reported adverse event (incorrect dose administered) (Latency Same day). Reportedly, Patient had the first dose of IPol, and this was supposed to be second dose when she was 2 months old, the patient also received a full dose of Daptacel, today without any issues. Treatment - 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.
DAPTACEL