Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient took Vivotif and didn't notice that it should be refrigerated, it had been inside the house but not refrigerated; The patient took Vivotif and didn't notice that it should be refrigerated, it had been inside the house but not refrigerated; The patient took Vivotif and didn't notice that it should be refrigerated, it had been inside the house but not refrigerated; Case reference number US-BN-2025-001473 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-2154) on 27-Aug-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported, the patient didn't notice that Vivotif should be refrigerated and stated that it has been inside the house but not refrigerated (explicitly coded as 'product temperature excursion issue' and 'product storage error'). On an unspecified date, reported as yesterday, the patient took Vivotif (batch number: unknown) at an unknown dose and route of administration, for an 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. No additional information was provided.; Reporter's Comments: This case concerns a female patient of unspecified age. As reported, the patient took Vivotif vaccine, for unknown indication, which the patient didn't notice that Vivotif should be refrigerated and stated that it has been inside the house but not refrigerated, 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 events due to Vivotif. 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 female patient of unspecified age. As reported, the patient took Vivotif vaccine, for unknown indication, which the patient didn't notice that Vivotif should be refrigerated and stated that it has been inside the house but not refrigerated, 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 events due to Vivotif. 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