Reporte zur Charge UJ136AA

Symptomtext

12 month old male patient administered expired dose of ActHib, with no adverse event; Initial information received on 28-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old male patient who was administered expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMR II) for Immunisation. On 28-Apr-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Hib portion lot UJ136AA and expiry date: 05-Mar-2021, diluent vial lot U6574AA and expiry date: 25-Mar-2021) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that the caller reported that ActHIB was administered to a patient today. The caller stated that the product expired on 05 MAR 2021. The caller would like know if the patient must be re-vaccinated and if there will be any potential adverse effects for the patient. Reporter relationship: health care professional (HCP) Product used: used still using product: no At the time of report no adverse event was reported. 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.