Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004044 | PO / MO |
The patient took one dose of Vivotif, it was left out of the fridge for one week, reached a maximum temperature of 78F; The patient took one dose of Vivotif, it was left out of the fridge for one week, reached a maximum temperature of 78F; Case reference number US-BN-2024-002499 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2391) on 16-Sep-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the Vivotif vaccine was left out of the fridge for one week, reached a maximum temperature of 78-degree Fahrenheit (explicitly coded as 'product storage error'). On 16-Sep-2024, the patient took the first dose of Vivotif (batch number: 3004044), at an unknown dose, orally use for typhoid immunization (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. Non-significant follow-up was downloaded from VAERS on 09-May-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240916-e8c877 to US-BAVARIAN NORDIC A/S-US-BN-2024-002499, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif which was left out of the fridge for one week and reached a maximum temperature of 78-degree Fahrenheit (considered as product storage error) at an unknown dose, orally use for typhoid immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif which was left out of the fridge for one week and reached a maximum temperature of 78-degree Fahrenheit (considered as product storage error) at an unknown dose, orally use for typhoid immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.