Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID VI POLYSACCHARIDE (TYPHIM VI) | SANOFI PASTEUR | UNK | X1A271M | OT |
administered typhim vi subcutaneously instead of the recommended intramuscular route with no reported ae; Initial information received on 12-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 36 years old male patient who was administered Typhoid Vi Polysaccharide Vaccine [Typhim Vi] subcutaneously instead of the recommended intramuscular route with no reported adverse event. The patient's past 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 (Tdap) and Tetanus Vaccine (Tetanus B) for Immunisation. On 12-May-2025, the patient received 0.5ml (once) dose of suspect Typhoid Vi Polysaccharide Vaccine, Solution for injection, Strength standard, lot X1A271M and expiry date 31-Mar-2026 for immunization via subcutaneous route in the left triceps instead of the recommended intramuscular route with no reported adverse event (incorrect route of product administration) (Latency same day). Action taken was not applicable. 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.
TDAP; TETANUS VACCINE