Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
patient was given 2 doses of ipv with no reported ae; Initial information received on 15-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who was given 2 doses of Poliomyelitis Vaccine (Inactivated) 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, Hib Vaccine Conj, Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediacel) for Immunisation. On an unknown date, the patient received 2DF (dosage form) of suspect Poliomyelitis Vaccine (Inactivated), produced by unknown manufacturer, (unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site, with no reported adverse event (extra dose administered) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, Nurse calling for a patient that received extra doses of IPV. Patient was first given Pediacel then was given 2 doses of IPV. 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.
PEDIACEL