Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
The Vivotif vaccine was unrefrigerated for about 24 hours; The Vivotif vaccine was unrefrigerated for about 24 hours; The patient took three doses of Vivotif after it was unrefrigerated for 24 hours; Case reference number US-BN-2025-000292 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-0445) on 27-Feb-2025 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient picked up Vivotif vaccine from the pharmacy and patient was not told that it needed to be refrigerated, so it was unrefrigerated for about 24 hours (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 22-Feb-2025, the patient took first dose of Vivotif capsule after it was unrefrigerated (batch number: unknown) at an unknown dose, route, for unknown indication (explicitly coded as 'product administration error'). On 24-Feb-2025, two days after the first dose, the patient took second dose of Vivotif capsule after it was unrefrigerated (batch number: unknown) at an unknown dose, route (explicitly coded as 'product administration error'). On 26-Feb-2025, four days after the first dose, the patient took third dose of Vivotif capsule after it was unrefrigerated (batch number: unknown) at an unknown dose, route (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unknown age picked up Vivotif vaccine from the pharmacy and patient was not told that it needed to be refrigerated, so it was unrefrigerated for about 24 hours, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first, second and the third dose of Vivotif capsule after it was unrefrigerated for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed 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: A female patient of unknown age picked up Vivotif vaccine from the pharmacy and patient was not told that it needed to be refrigerated, so it was unrefrigerated for about 24 hours, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first, second and the third dose of Vivotif capsule after it was unrefrigerated for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed 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