Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | — |
The patient took two doses on Vivotif which were not refrigerated; The patient took two doses on Vivotif which were not refrigerated; The patient took Vivotif and was on unspecified antibiotics; Case reference number US-BN-2024-002893 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3306) on 16-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 13-Dec-2024 Friday, the patient took the first dose of Vivotif (batch number: unknown), at a dose of one capsule, via unknown route for indication reported as travel. On 15-Dec-2024 Sunday, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at a dose of one capsule, via unknown route. As reported, the patient took two doses on Vivotif which were not refrigerated and the patient was on unspecified antibiotics (explicitly coded as 'product storage error', 'product administration error' and 'labeled drug-drug interaction medication 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-20241216-891d19 to US-BAVARIAN NORDIC A/S-US-BN-2024-002893, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took two doses on Vivotif for indication reported as travel, which were not refrigerated, and the patient was on unspecified antibiotics, which is considered as product storage error, product administration error and labelled drug-drug interaction medication error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and labelled drug-drug interaction medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and labelled drug-drug interaction medication 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 two doses on Vivotif for indication reported as travel, which were not refrigerated, and the patient was on unspecified antibiotics, which is considered as product storage error, product administration error and labelled drug-drug interaction medication error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and labelled drug-drug interaction medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and labelled drug-drug interaction medication error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None