Reporte zur Charge UJ354ABA

Symptomtext

nurse gave a child ACT-HIB vaccine that was two weeks expired. with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Medical Information (Reference number- 00708642 and 00708732) and transmitted to Sanofi on 803-Aug-2021 in United States. This case involved 4-month-old male patient gave HIB (PRP/T) VACCINE [ACT-HIB] that was two weeks expired (expired product administered) The patient's past vaccination(s) included ACT-HIB on an unknown date in May-2021 with last dose. Relevant medical history, medical treatment(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination On 02-Aug-2021, the patient received second 0.5ml dose of suspect HIB (PRP/T) VACCINE [lot: UJ354ABA and expiry date: (two weeks expired) 18-Jul-2021] (Frequency = once) (Strength = standard) (Form: solution) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered) It was reported that, "Caller wanted to know if there was any time after an expired vaccine so that they do not have to repeat the vaccine". This was an actual medication error due to expired vaccine used (latency: same day) At the time of reporting, 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 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.