Reporte zur Charge UJ158AAA

Symptomtext

immunocompromised; expired ACT-HIB administered; Initial information regarding an unsolicited valid serious case was received from a other health professional via regulatory authority (Reference number- 00525503) and transmitted to Sanofi on 18-Mar-2021. This case involves a 65 year old female patient who had immunocompromised (immunodeficiency), while she received vaccine HIB (PRP/T) VACCINE [ACT-HIB]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ158AAA and expiry date 26-Nov-2020) via unknown route in right deltoid for prophylactic vaccination. On an unknown date, the patient developed a serious immunocompromised (immunodeficiency) unknown latency following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant. It was also medication error case due to expired ACT-HIB administered (expired product administered) (latency same day). No laboratory data was provided. It was not reported if the patient received a corrective treatment. At the time of reporting, the event outcome was unknown for immunocompromised . This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.; Sender's Comments: This case concerns 65 year old female patient who had immunodeficiency after vaccination with ACT-HIB. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.