Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT / LL |
administration of extra dose of IPOL with no adverse event; Initial information received on 18-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who was administered with an extra dose of poliomyelitis vaccine (INACTIVATED) [IPOL] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3) (MMR II) for Immunisation. On 13-Feb-2025, the patient received extra dose with 0.5 ml of IPV (VERO) Suspension for injection with standard strength (lot W1C831M and expiry date- 21-NOV-2025) via intramuscular route in the left thigh as Immunization with no adverse event (extra dose administered) (latency- same day). Reportedly, reporter said that the patient had already received the full series. They wanted to know what adverse events they should be expecting 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.
MMR II