Symptomtext
patient received an expired first-dose of DTaP-IPV/Hib with no reported adverse event; Initial information received on 23-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 2 months old male patient who received an expired first-dose of dtap-ipv/hib with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation. On 08-Nov-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at first dose of 0.5 mL 1X(once) via intramuscular route (lot UJ384AA, 09-Oct-2021) followed by second dose with (unknown administration site, strength) for prophylactic vaccination . On 08-NOV-2021 the patient developed a non-serious event "patient received an expired first-dose of dtap-ipv/hib with no reported adverse event" (expired product administered) (latency-Same day)following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was reported "Caller states that a two month old patient received an expired first-dose of DTaP-IPV/Hib that was manufactured by Sanofi in the office on 08NOV2021 and asked if the dose needed to be repeated. Caller states that the patient has received a second dose on 24NOV2021. Caller states that she does not have the brand name of the vaccine, only that it was manufactured by Sanofi and that her records show it as DTaP-IPV/Hib". Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for the event patient received an expired first-dose of dtap-ipv/hib with no reported 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.