Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004368 | — |
The patient took one Vivotif capsule after the vaccine had been left unrefrigerated for 15 hours; The patient took one Vivotif capsule after the vaccine had been left unrefrigerated for 15 hours; The patient took one Vivotif capsule after the vaccine had been left unrefrigerated for 15 hours; Case reference number US-BN-2025-001771 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: CASE-000619) on 06-Nov-2025 and concerns 63-years-old male patient. The patient's medical history and concomitant medication were not reported. On unspecified date, patient left Vivotif vaccine out of refrigeration for 15 hours. (explicitly coded as 'Product storage error' and 'Product temperature excursion issue') On 06-Nov-2025 patient took one capsule of left out Vivotif (batch number: 3004368), via an unknown route of administration, for unknown indication. (explicitly coded as and 'Product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event. No further information provided.; Reporter's Comments: This case concerns a 63-years-old male patient. As reported, patient took one capsule of Vivotif vaccine for unknown indication and left out of refrigeration for 15 hours, 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. 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 63-years-old male patient. As reported, patient took one capsule of Vivotif vaccine for unknown indication and left out of refrigeration for 15 hours, 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. 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