Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 4 | X1D141M | OT / RL |
inappropriate use due to the administration of 1 mL of IPOL to a patient instead of 0.5 mL with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 4 years old male patient who had inappropriate use due to the administration of 1 ml of IPV (VERO) [Ipol] to a patient instead of 0.5 ml 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 Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap); and Varicella zoster vaccine (Varicella vaccine) for Immunisation. On 22-Apr-2025, the patient received 1 ml Dose 4 of suspect IPV (VERO) Suspension for injection lot X1D141M and expiry date- 31-OCT-2026 via intramuscular route in the right thigh for Immunisation instead of 0.5 ml with no reported adverse event (extra dose administered) (latency- same day). Reportedly, the patient did not show any adverse events. 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.
Mmr; Dtap; Varicella vaccine