Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient did not refrigerate the Vivotif vaccine and took first capsule; The patient did not refrigerate the Vivotif vaccine and took first capsule; The patient did not refrigerate the Vivotif vaccine and took first capsule; Case reference number US-BN-2025-000966 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV25-1195) on 22-May-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, as reported the patient did not refrigerate the Vivotif vaccine. It was not refrigerated until just now. It has been about 24 hours since it was refrigerated (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 21-May-2025, reported as yesterday the patient took the first dose of defective Vivotif vaccine (batch number: unknown) at an unknown dose, orally for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age did not refrigerate the Vivotif vaccine. It has been about 24 hours since it was refrigerated, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of defective Vivotif vaccine for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications 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: A male patient of unspecified age did not refrigerate the Vivotif vaccine. It has been about 24 hours since it was refrigerated, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of defective Vivotif vaccine for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications 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.