Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004061 | PO / MO |
The patient took the first dose of Vivotif which was left unrefrigerated for over a week; The patient took the first dose of Vivotif which was left unrefrigerated for over a week; Case reference number US-BN-2024-002509 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2407) on 17-Sep-2024 and concerns an adult female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the doses of Vivotif were left unrefrigerated for over a week (explicitly coded as 'product storage error'). On 15-Sep-2024, the patient took the affected first dose of Vivotif (batch number: 3004061), at an unknown dose, orally, for an unknown indication (explicitly coded as 'product administration error'). As reported, the patient ordered Vivotif again for the patient's husband and heard that Vivotif vaccine was supposed to be refrigerated. At the time of the initial report, it was unknown if the patient experienced any adverse events 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-20240917-1ec2ff to US-BAVARIAN NORDIC A/S-US-BN-2024-002509, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: An adult female patient took the affected first dose of Vivotif which were left unrefrigerated for over a week (considered as product storage error), at an unknown dose, orally, for an unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed ad not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient took the affected first dose of Vivotif which were left unrefrigerated for over a week (considered as product storage error), at an unknown dose, orally, for an unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed ad not related to suspect product but to human factor. The case is non-serious.
Comments: None.