Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient took first dose of Vivotif vaccine which was out of refrigeration for 40-80 minutes; The patient took first dose of Vivotif vaccine which was out of refrigeration for 40-80 minutes; The patient took first dose of Vivotif vaccine which was out of refrigeration for 40-80 minutes; Case reference number US-BN-2025-000445 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV25-0790) on 08-Apr-2025 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On 08-Apr-2025, the patient took first dose of Vivotif vaccine (batch number: unknown) at an unknown dose, orally for unknown indication. The vaccine was out of refrigeration for 40 to 80mins (explicitly coded as 'product storage error', 'product administration error' and 'product temperature excursion issue'). 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: This case concerned a female patient of unspecified age/age group, who had received first dose of Vivotif vaccine at an unknown dose, orally for unknown indication. As reported, vaccine was out of refrigeration for 40 to 80 mins, 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 as 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: This case concerned a female patient of unspecified age/age group, who had received first dose of Vivotif vaccine at an unknown dose, orally for unknown indication. As reported, vaccine was out of refrigeration for 40 to 80 mins, 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 as 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.