Reporte zur Charge UJ215AAA

Symptomtext

The patient was administered with an expired PENTACEL vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via consumer/non-health care professional via Medical Information (Reference number- 00752586) and transmitted to Sanofi on 02-Sep-2021. This case involves a 3-month-old patient (gender unspecified) who was administered an expired DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] [Expired product administered]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for prophylactic vaccination. On 02-Sep-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (lot UJ215AAA, expiry: 30-Apr-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). No adverse event was reported. It was reported, "Stated that they injected an expired Pentacel and want to know what to do. Lot UJ215AAA Exp 04/30/2021. Call transferred from Manufacturing Authorization (MIA). Physician Assistant (PA) states that a patient was injected with Pentacel on 02Sep2021 that expired on 4/30/2021. The PA asks if the expired Pentacel dose is valid and needs to reinjected. The PA reports an AE. The patient did not experience any adverse events as a result of this. 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.