Symptomtext
On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event; On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2632257-1. The original narrative from the sender is the following: using vaxelis instead of giving act-hib as a stand-alone vaccine with no adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 months old female patient who had been administered VAXELIS instead of giving HIB (PRP/T) VACCINE [ACT-HIB] as a stand-alone vaccine with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 10-May-2023, the patient received a dose 1 at a dose of 0.5 ml suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (with an unknown frequency, strength, expiry date, lot UJ792AA) via intramuscular route in unknown administration site for immunization (immunisation). On an unknown date, the patient received suspect VAXELIS not produced by Sanofi Pasteur (with an unknown dosage, formulation, frequency, strength, expiry date, lot number) via unknown route in unknown administration site for prophylactic vaccination (immunization). On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event (wrong product administered) (latency: same day) . Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the 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 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. The causal relationship between Vaxelis and the event "On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event" was assessed as not applicable due to the nature of the reported event. No further information is expected. NI not working. Added state to Reporter State and Vaccine facility information.