Reporte zur Charge U1A45M

Symptomtext

11 patients received IPOL from the punctured multi-dose vial of IPOL after the first excursion with no adverse event; Initial information received on 28-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old female patient who 11 patients received ipol from the punctured multi-dose vial of ipol after the first excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (with an unknown batch number) for Immunization. On 10-Dec-2021, the patient received a dose of suspect IPV (VERO) with the dose of 0.5 ml (lot U1A45M) via intramuscular route in (unknown administration site, frequency, strength, and expiry date). On 10-DEC-2021 the patient received ipol from the punctured multi-dose vial of ipol after the first excursion with no adverse event (product temperature excursion issue) (unknown latency) following the first dose intake and (unknown latency following the administration of IPV (VERO). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (11 patients received IPOL from the punctured multi-dose vial of IPOL after the first excursion with no adverse event). At time of reporting, the outcome was Unknown for the event 11 patients received ipol from the punctured multi-dose vial of ipol after the first excursion with no 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 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.