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 took 4-capsule course of Vivotif but did not store them in the fridge; The patient took 4-capsule course of Vivotif but did not store them in the fridge; The patient took 4-capsule course of Vivotif but did not store them in the fridge; Case reference number US-BN-2025-001068 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV25-1396) on 13-Jun-2025 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient completed four-capsule course of Vivotif, at an unknown dose (batch number: unknown) orally, for an unknown indication, but did not store Vivotif in the fridge. (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 events due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unspecified age and gender completed four-capsule course of Vivotif for an unknown indication, but did not store Vivotif in the fridge, which is considered as product storage error, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age and gender completed four-capsule course of Vivotif for an unknown indication, but did not store Vivotif in the fridge, which is considered as product storage error, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE