Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient received four doses of Vivotif, three of those doses being taken were unrefrigerated; The patient received four doses of Vivotif, three of those doses being taken were unrefrigerated; Case reference number US-BN-2024-002391 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2092) on 23-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 16-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), one capsule, via oral use for unknown indication. On 18-Aug-2024, two days after the first dose, the patient was vaccinated with the second dose of Vivotif (batch number: unknown), one capsule, via oral use (explicitly coded as 'product storage error' and 'product administration error'). On 20-Aug-2024, four days after the first dose, the patient was vaccinated with the third dose of Vivotif (batch number: unknown), one capsule, via oral use (explicitly coded as 'product storage error' and 'product administration error'). On 22-Aug-2024, six days after the first dose, the patient was vaccinated with the fourth dose of Vivotif (batch number: unknown), one capsule, via oral use. As reported, three of those doses were taken unrefrigerated (explicitly coded as 'product storage error' and 'product administration error'). As reported, patient had no adverse reactions from administration of Vivotif vaccine. 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-20240823-14aec6 to US-BAVARIAN NORDIC A/S-US-BN-2024-002391, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took the first, second, third and the fourth dose of Vivotif for unknown indication. As reported, three of those doses were taken unrefrigerated, which is considered as product storage error and product administration error. The patient had no adverse reactions from administration of 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, second, third and the fourth dose of Vivotif for unknown indication. As reported, three of those doses were taken unrefrigerated, which is considered as product storage error and product administration error. The patient had no adverse reactions from administration of 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.