Age: 76.0
Sex: M
Vaccine: HIBV, TTOX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product label on wrong product, Wrong product administered
Clinical narrative: The nurse who pulled the vaccine from stock saw conjugated with tetanus toxoid on the label of ActHIB and mistakenly thought that meant it was a vaccine against tetanus with no adverse event; ActHIB was administered in error to a 76 year old patient instead of a tetanus shot with no reported adverse event; ActHIB was administered in error to a 76 year old patient instead of a tetanus shot with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional (Reference number- 00674134) and transmitted to Sanofi on 08-Jul-2021.  This case involved 76 years old male patient who administered HIB (PRP/T) VACCINE [ACT-HIB] instead of a TETANUS VACCINE (wrong product administered and product administered to patient of inappropriate age) and it was reported as the nurse who pulled the vaccine from stock saw conjugated with tetanus toxoid on the label of acthib and mistakenly thought that meant it was a vaccine against tetanus (product label on wrong product)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 07-Jul-2021, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot UJ356AA) via unknown route in left deltoid site prophylactic vaccination.  On 07-JUL-2021,76 years old male patient administered HIB (PRP/T) VACCINE [ACT-HIB] instead of a TETANUS VACCINE (wrong product administered and product administered to patient of inappropriate age) (latency same day, non-serious)  On an unknown date it was reported as the nurse who pulled the vaccine from stock saw conjugated with tetanus toxoid on the label of HIB (PRP/T) VACCINE [ACT-HIB] and mistakenly thought that meant it was TETANUS VACCINE (product label on wrong product) (non-serious)  It was reported that, "The caller reports that ACTHIB was erroneously administered to a patient. The caller would like to know of any possible adverse events or side effects this may cause. The caller also would like to know what the next steps should be regarding the patient. Are there any contraindications or waiting period needed to give the correct vaccine, either (td) diphtheria tetanus or Tdap (tetanus, diphtheria, and acellular pertussis)? She currently only has Tdap in stock from both Sanofi and GSK (GlaxoSmithKline). Referred to non-Sanofi manufacturer for possibility of Boostrix. Adacel case for medical information provided for Adacel. There is no adverse event information in the Adacel case".  It was an actual medication error case (wrong vaccine administered, inappropriate age at vaccine administration and product label on wrong product)  At the time of reporting, no 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 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.  There will be no information available on the batch number for this case.