Symptomtext
Received expired ACTHIB vaccinations with no reported adverse event; Initial information received on 25-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2021SA284000 (CLUSTER). This case involves a 1 years old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB]. Medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination. On 24-Aug-2021, the patient received a 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE lot UJ351AA, expiry date- 09-Aug-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). It was reported, "If baby was delivered: delivery date and if baby experienced an adverse event ? Inform that they will be receiving a follow up questionnaire ? If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA requirement. At time of reporting, 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. 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.