Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient had taken all four doses, but did not realize that the product needed to be refrigerated; The patient had taken all four doses, but did not realize that the product needed to be refrigerated; The patient had taken all four doses, but did not realize that the product needed to be refrigerated; Case reference number US-BN-2025-001075 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV25-1423) on 16-Jun-2025 and concerns a male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, the patient had taken all four doses (batch number: unknown), orally at doses of one capsule every other day for typhoid fever prophylaxis, but did not realize that the product needed to be refrigerated, kept at room temperature, but exact temperature was unknown for greater than 24 hours (explicitly coded 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 related to Vivotif vaccine. No further information was provided.; Reporter's Comments: This case concerns a male patient of unspecified age, who had received all the four doses of vivotif vaccine for an indication of typhoid fever prophylaxis. As reported, vaccine was not refrigerated and kept at room temperature, 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 related 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 male patient of unspecified age, who had received all the four doses of vivotif vaccine for an indication of typhoid fever prophylaxis. As reported, vaccine was not refrigerated and kept at room temperature, 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 related 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.