Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
The patient took one dose and put it back in refrigerator, the maximum temperature was 70 degrees Fahrenheit for maximum 24 hours; The patient took one dose and put it back in refrigerator, the maximum temperature was 70 degrees Fahrenheit for maximum 24 hours; Case reference number US-BN-2024-002774 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2995) on 12-Nov-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date, the patient took the first dose dose of Vivotif (batch number: unknown), at a dose of one capsule, taken orally for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event 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-20241112-5d75cf to US-BAVARIAN NORDIC A/S-US-BN-2024-002774, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A male patient of unknown age took the first dose dose of Vivotif for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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 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 male patient of unknown age took the first dose dose of Vivotif for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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 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