Reporte zur Charge U1C51M

Symptomtext

patient received IPOL, that was no longer suitable for use due to a temperature excursion, with no reported adverse event; Initial information received on 09-Mar-2022 regarding an unsolicited valid non-serious case received from another health professional. This case involves a 3-year-old child, male patient who experienced patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event while receiving vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation. On 08-Mar-2022, the patient received a dose of suspect IPV (VERO) suspension for injection, 1.5 ml, dose 5, lot U1C51M via subcutaneous route expiry date 17-June-2023 via subcutaneous route in the left thigh for Immunization. Patient has taken the vaccine previously. On 08-MAR-2022 the patient developed a non-serious event "patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event" (product storage error) following the administration of IPV (VERO) latency 1 day. Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable. It was not reported if the patient received a corrective treatment for the event (patient received IPOL, that was no longer suitable for use due to a temperature excursion, with no reported adverse event). At time of reporting, the outcome was Unknown for the event patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse 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.