Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
Patient took one Vivotif capsule, that was at a too warm temperature; Patient took one Vivotif capsule, that was at a too warm temperature; Patient took one Vivotif capsule, that was at a too warm temperature; Case reference number US-BN-2025-001168 is a spontaneous case initially received from a nurse via Communications (reference number: USBAV25-1650) on 09-Jul-2025 and a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took one dose of Vivotif vaccine, however, it was at a temperature that was too warm (batch number: unknown), at unknown dose, route or site of administration for unknown indication (explicitly coded as 'product temperature excursion issue', 'product storage error' 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 unknown age and gender took one dose of Vivotif vaccine for unknown indication, however, it was at a temperature that was too warm, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error 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 patient of unknown age and gender took one dose of Vivotif vaccine for unknown indication, however, it was at a temperature that was too warm, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error 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.