Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004338 | — |
The patient took the first capsule of Vivotif after it was kept at approximately 65-70 degrees Fahrenheit for 12 hours.; The patient took the first capsule of Vivotif after it was kept at approximately 65-70 degrees Fahrenheit for 12 hours.; The patient took the first capsule of Vivotif after it was kept at approximately 65-70 degrees Fahrenheit for 12 hours.; Case reference number US-BN-2025-001635 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-000057) on 02-Oct-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, a box of Vivotif (batch number: 3004338) containing four capsules was left out of the refrigerator at approximately 65 to 70 degrees Fahrenheit for 12 hours, reported as the first temperature excursion (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On an unspecified date, the patient took the first dose of Vivotif (batch number: 3004338), for an unknown dose, route, or site of administration for an unknown indication (explicitly coded '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 male patient of unspecified age. As reported, the patient took the first dose of Vivotif vaccine for an unknown indication, which was left out of the refrigerator at approximately 65 to 70 degrees Fahrenheit for 12 hours, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue 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 male patient of unspecified age. As reported, the patient took the first dose of Vivotif vaccine for an unknown indication, which was left out of the refrigerator at approximately 65 to 70 degrees Fahrenheit for 12 hours, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue 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.