Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004045 | PO / MO |
The Vivotif vaccine was stored in the fridge, but the patient noticed uneven refrigeration, took two doses; The Vivotif vaccine was stored in the fridge, but the patient noticed uneven refrigeration, took two doses; Case reference number US-BN-2024-002292 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-1859) on 02-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. As reported the Vivotif vaccine was stored in the fridge, but the patient noticed uneven refrigeration, as the milk was starting to freeze, patient also stated that the duration of this first temperature excursion was unknown (explicitly coded as 'product storage error'). On 31-Jul-2024, the patient took the affected first dose of Vivotif (batch number: 3004045), at a dose of one capsule, orally, for indication reported as typhoid vaccine, travelling in about a month (explicitly coded as 'product administration error'). On 02-Aug-2024, two days after the first dose, the patient took the affected second dose of Vivotif (batch number: 3004045), at a dose of one capsule, orally (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-20240802-a813eb to US-BAVARIAN NORDIC A/S-US-BN-2024-002292, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age noticed uneven refrigeration when Vivotif vaccine was stored in the fridge as the milk was starting to freeze, patient also stated that the duration of this first temperature excursion was unknown which is considered as product storage error. The patient took the affected first dose of Vivotif, at a dose of one capsule, orally, for indication reported as typhoid vaccine, travelling in about a month which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of one capsule, orally which is also considered as product administration error. Product administration error and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age noticed uneven refrigeration when Vivotif vaccine was stored in the fridge as the milk was starting to freeze, patient also stated that the duration of this first temperature excursion was unknown which is considered as product storage error. The patient took the affected first dose of Vivotif, at a dose of one capsule, orally, for indication reported as typhoid vaccine, travelling in about a month which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of one capsule, orally which is also considered as product administration error. Product administration error and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.