Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004334 | PO / MO |
The patient did not refrigerate the Vivotif vaccine until 11-Jul-2025 and the patient took two doses; The patient did not refrigerate the Vivotif vaccine until 11-Jul-2025 and the patient took two doses; The patient did not refrigerate the Vivotif vaccine until 11-Jul-2025 and the patient took two doses; Case reference number US-BN-2025-001269 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-1742) on 16-Jul-2025 and concerns a patient of unspecified age and gender. The patient's relevant medical history and concomitant medications were not provided. On 22-Jun-2025, the patient picked up Vivotif vaccine and did not refrigerate the vaccine until July 11th (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 11-Jul-2025, the patient took first dose of affected Vivotif vaccine (batch number: 3004334), orally at unknown dose for unknown indication (explicitly coded as 'product administration error'). On 13-Jul-2025, two days after first dose, the patient took second dose of affected Vivotif vaccine (batch number: 3004334), orally at unknown dose (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: This case concerns a patient of unspecified age and gender. As reported, the patient took the first dose of Vivotif vaccine which was not refrigerated for approximately for more than 19 days, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a patient of unspecified age and gender. As reported, the patient took the first dose of Vivotif vaccine which was not refrigerated for approximately for more than 19 days, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.