Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: nurse administered a dose of PENTACEL and did not reconstitute with the HIB portion of the vaccine; Nurse administered a dose of Pentacel and did not reconstitute with the HIB portion of the vaccine with no reported adverse event; Initial information received on 25-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient who experienced nurse administered a dose of pentacel and did not reconstitute with the hib portion of the vaccine and nurse administered a dose of pentacel and did not reconstitute with the hib portion of the vaccine 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE  (lot number, strength and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 25-JAN-2022 the patient developed a non-serious nurse administered a dose of pentacel and did not reconstitute with the hib portion of the vaccine (product administration error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  On 25-JAN-2022 the patient developed a non-serious nurse administered a dose of pentacel and did not reconstitute with the hib portion of the vaccine with no reported adverse event (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (nurse administered a dose of PENTACEL and did not reconstitute with the HIB portion of the vaccine, Nurse administered a dose of Pentacel and did not reconstitute with the HIB portion of the vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event nurse administered a dose of pentacel and did not reconstitute with the hib portion of the vaccine and was Unknown for the event nurse administered a dose of pentacel and did not reconstitute with the hib portion of the vaccine 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.