Received Mar 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID VI POLYSACCHARIDE (TYPHIM VI) | SANOFI PASTEUR | UNK | W1A441M | OT / LA |
administration of expired typhim VI vaccine with no reported adverse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 46 years old female patient who received expired typhoid VI polysaccharide vaccine [typhim VI] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Mar-2025, the patient received an expired unknown dose of suspect typhoid VI polysaccharide vaccine, Solution for injection (lot W1A441M and expiry date: 07-Mar-2025) (Frequency: once and strength: standard) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Patient tried to contact the HCP (health care professional) who gave the vaccine to confirm if it was a typographical error, but they haven't responded to her. She wanted to know if the expiration date is correct based on the lot number. She refused to provide address. MIS (Management Information System) advised to contact healthcare provider to confirm the information. Patient advised that she needs the information (with regards to the expiration date) urgently as she will be travelling, and that the HCP cannot be reached. 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.