Reporte zur Charge U1C571N

Symptomtext

accidentally gave expired IPOL with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves 20 years old male patient who was accidentally given expired IPV (VERO) [IPOL] 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 hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (yeast) (Twinrix) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination. On 06-Jul-2023, the patient accidentally received a standard expired dose of suspect IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot U1C571N, expiry date- 17-JUN-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day). Action taken was not applicable. At time of reporting, the outcome was Unknown for the event 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 guidelines. 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.