Age: 46.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Product administered at inappropriate site
Clinical narrative: Administered vaccines in wrong area with no adverse event; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case via Medical Information (under reference 00799338) from a pharmacist.  This case involves a 46-year-old female patient who was administered RABIES (HDC) VACCINE [IMOVAX RABIES], IMMUNOGLOBULIN HUMAN ANTI-RABIES and TETANUS VACCINE all in the wrong area (product administered at inappropriate site).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   The patient received a first dose of suspect RABIES (HDC) VACCINE on 22-Sep-2021, second dose on 25-Sep-2021 and third dose on 29-Sep-2021 (lot number and expiry date were not reported) via an unknown route in gluteal area for post-exposure immunisation.  On 22-Sep-2021, the patient received a dose of suspect TETANUS VACCINE not produced by Sanofi Pasteur (lot number and expiry date were not reported) via an unknown route in one thigh (otherwise not specified) for prophylactic vaccination.  On 22-Sep-2021, the patient received a dose IMMUNOGLOBULIN HUMAN ANTI-RABIES not produced by Sanofi Pasteur (lot number and expiry date were not reported) via an unknown route in the other thigh (otherwise not specified) for animal bite.  It was an actual case of medication error due to vaccine administered at inappropriate site (latency: same day).  It was reported "caller (pharmacist) requesting information regarding dosage of IMOVAX; caller states that her patient was administered IMOVAX on 22SEP2021 in the glute area; on 22SEP2021 the patient was also given an injection of tetanus medication in one thigh and the immunoglobin in the other thigh as well as antibiotics ;caller states the injection in the glute area was due to the small size of the patient and the other injections in her thighs; on 25SEP2021 the patient received dose 2 also in the glute area; on 29SEP2021 the patient received dose 3 also in the glute area; on 06OCT2021, the patient is due for her 4th injection; caller would like to know if there are adverse event that should be looked out for and how to safely administer the injection as the administration instructions do not suggest the glute area for the injections; caller is worried about the efficacy of the shots since they were all in the "wrong" area of the patient; The pharmacist would like to know if there is any information on repeating the series or doses. She is requesting a phone call back. She states that dose four is tomorrow and if they cannot give it in the deltoid she is going to recommend it be given in the thigh. She states that any advice or information she can be given beyond that for this patient would be appreciated because she is going to have to go to the medical directors at the health plan and present this to them."  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.  There will be no information available on the lot number for this case.