Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004043 | PO / MO |
Patient left Vivotif out of refrigeration (maximum temperature was unknown) on 28-Oct-2024 and took two affected doses; Patient left Vivotif out of refrigeration (maximum temperature was unknown) on 28-Oct-2024 and took two affected doses; Case reference number US-BN-2024-002702 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2864) on 30-Oct-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medications were not provided. On 28-Oct-2024, at 09:40 am on Monday, the patient left Vivotif out of refrigeration, maximum temperature was unknown, and as reported Vivotif was inside the house. On the same day, the patient took first dose of affected Vivotif, (batch number: 3004043) one capsule, orally for unknown indication (explicitly coded as 'product storage error' and 'product administration error'). On 30-Oct-2024, two days after administration of the first dose of Vivotif, reported as today, the patient took the second dose of Vivotif (batch number: 3004043), one capsule, orally (explicitly coded as 'product administration error'). As reported, the patient wanted to know if they could take Augmentin antibiotics prescribed by the otolaryngologist (ENT) and then resume Vivotif afterwards or if the patient had to retake it. 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-20241030-577011 to US-BAVARIAN NORDIC A/S-US-BN-2024-002702, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age left Vivotif out of refrigeration (maximum temperature was unknown) and Vivotif was inside the house. On the same day, the patient took first dose of affected Vivotif, one capsule, orally for unknown indication which is considered as product storage error and product administration error. Two days after administration of the first dose of Vivotif, the patient took the second dose of Vivotif, one capsule, orally 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 event due to Vivotif. The patient's medical history and concomitant medications were not provided. Product storage error and product administration 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 left Vivotif out of refrigeration (maximum temperature was unknown) and Vivotif was inside the house. On the same day, the patient took first dose of affected Vivotif, one capsule, orally for unknown indication which is considered as product storage error and product administration error. Two days after administration of the first dose of Vivotif, the patient took the second dose of Vivotif, one capsule, orally 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 event due to Vivotif. The patient's medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None