Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3003852 | PO / MO |
Patient completed course with Vivotif vaccine that had expiration date in Mar-2024; Case reference number US-BN-2024-001921 is a spontaneous case report initially received from pharmacist via Med Communication (reference number: USBAV24-1060) on 16-May-2024 and concerns 52-year-old male patient. The patient's relevant medical history and concomitant medications were not provided. On 23-Apr-2024, pharmacist dispensed a prescription of Vivotif that was expired in March. *On an unspecified date (to be confirmed), the patient took the first dose of Vivotif* (batch number: 3003852; expiration date: Mar-2024), one capsule, orally, for indication reported as typhoid immunization (explicitly coded as 'expired vaccine used'). *On 24-Apr-2024, reported as approximately, unknown amount of time after the first dose, the patient took the second dose of Vivotif (batch number: 3003852; expiration date: Mar-2024), one capsule, orally (explicitly coded as 'expired vaccine used').* *On 26-Apr-2024, reported as approximately, two days after the second dose, the patient took the third dose of Vivotif (batch number: 3003852; expiration date: Mar-2024), one capsule, orally (explicitly coded as 'expired vaccine used').* *On 28-Apr-2024, reported as approximately, two days after the third dose, the patient took the fourth dose of Vivotif (batch number: 3003852; expiration date: Mar-2024), one capsule, orally. As reported, there were no deviation issues during the administration of Vivotif (explicitly coded as 'expired vaccine used')* *At the time of this follow up report, the patient did not experience any adverse event due to Vivotif*. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Non-significant case correction was received from reporter on 26-Jun-2024 included: reporter's email address. Follow up information received from a pharmacist on 27-Jun-2024: New information included added patient initials, Vivotif dosage information and confirmation of absence of deviation issues and adverse events during the administration of Vivotif.; Reporter's Comments: A 52-year-old male patient was vaccinated with four oral doses of Vivotif vaccine, each of which had expired in March 2024; for indication of typhoid immunization. This is considered as expired vaccine used, as on 23-Apr-2024, the pharmacist dispensed Vivotif with expiration date in March. No associated adverse events were reported. Expired product administered is listed per company conventions. The patient's relevant medical history and concomitant medications were not provided. Expired product administered is assessed as not related to suspect product but to human error. The case is non-serious.; Sender's Comments: A 52-year-old male patient was vaccinated with four oral doses of Vivotif vaccine, each of which had expired in March 2024; for indication of typhoid immunization. This is considered as expired vaccine used, as on 23-Apr-2024, the pharmacist dispensed Vivotif with expiration date in March. No associated adverse events were reported. Expired product administered is listed per company conventions. The patient's relevant medical history and concomitant medications were not provided. Expired product administered is assessed as not related to suspect product but to human error. The case is non-serious.
Comments: None