Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
Patient left Vivotif capsules out the refrigerator for 48 hours at home, and took one dose after excursion; Patient left Vivotif capsules out the refrigerator for 48 hours at home, and took one dose after excursion; Patient left Vivotif capsules out the refrigerator for 48 hours at home, and took one dose after excursion; Case reference number US-BN-2025-001800 is a spontaneous case initially received from other health care professional on 14-Nov-2025 via Bavarian Nordic (reference number: CASE-000746) and concerns a 28-years-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif capsules (4 capsules) out the refrigerator for 48 hours at home. (explicitly coded as product storage error', and 'product temperature excursion error') On 11-Nov-2025, the patient administered one Vivotif capsule after excursion (batch number: unknown), at an unknown dose, or route of administration for an unknown indication. (explicitly coded as product administration error') At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: This case concerns a 28-years-old female patient. As reported patient took one Vivotif capsule, which was out of the refrigerator for 48 hours at home, for unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, 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 temperature excursion issue, 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: This case concerns a 28-years-old female patient. As reported patient took one Vivotif capsule, which was out of the refrigerator for 48 hours at home, for unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, 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 temperature excursion issue, 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