Symptomtext
a patient was inadvertently given a dose of Act-Hib, reconstituted with sterile water/no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (MI) (Reference number- 00798637) and transmitted to Sanofi on 05-Oct-2021. This case involves a 7 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] which was inadvertently reconstituted with sterile water. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); POLIO VACCINE INACT (IPV); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On 27-Sep-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ545AA, expiry date-22-Jul-22 via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to product preparation error (latency same day). 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 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.