Received Mar 25, 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 had temperature excursion for seven hours, maximum temperature was 74 Fahrenheit degrees; The patient took first dose of Vivotif vaccine which had temperature excursion for seven hours, maximum temperature was 74 Fahrenheit degrees; Case reference number US-BN-2024-002753 is a spontaneous case initially received from a other health care professional via Med Communications (reference number: USBAV24-2940) on 07-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date, reported as yesterday, one box (four doses) of the Viviotif vaccine was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, as reported was not instructed to put in refrigerator (explicitly coded as 'product storage error'). On 06-Nov-2024, the patient took the first dose of the affected Vivotif vaccine (batch number: unknown) at one dose, orally for typhoid prophylaxis (explicitly coded as '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-20241107-101dae to US-BAVARIAN NORDIC A/S-US-BN-2024-002753, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took the first dose of the affected Vivotif vaccine for typhoid prophylaxis, which was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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 female patient of unknown age took the first dose of the affected Vivotif vaccine for typhoid prophylaxis, which was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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.