Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004085 | PO / MO |
Patient took first dose of unrefrigerated Vivotif vaccine; Patient took first dose of unrefrigerated Vivotif vaccine; Patient took first dose of unrefrigerated Vivotif vaccine; Case reference number US-BN-2024-002902 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3324) on 17-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as on Friday, patient picked up Vivotif vaccine. On an unspecified date, the patient took first dose of Vivotif (batch number: 3004085; expiration date: Mar-2025), at unknown dose, orally for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate. (explicitly coded as 'product storage error', 'product administration error' and 'product temperature excursion issue'). 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-20241217-ea08e7 to US-BAVARIAN NORDIC A/S-US-BN-2024-002902 , in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took the first dose of Vivotif for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate, which is considered as product storage error, product administration error and product temperature excursion issue. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and product temperature excursion issue 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 product temperature excursion issue 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 dose of Vivotif for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate, which is considered as product storage error, product administration error and product temperature excursion issue. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and product temperature excursion issue 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 product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.