Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The Vivotif capsule kept at 60 degrees Fahrenheit for eight hours and the patient had three doses; The Vivotif capsule kept at 60 degrees Fahrenheit for eight hours and the patient had three doses; The Vivotif capsule kept at 60 degrees Fahrenheit for eight hours and the patient had three doses; Case reference number US-BN-2025-001090 is a spontaneous case report initially received from a pharmacist via regulatory authority (reference number: USBAV25-1447) on 18-Jun-2025 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, the Vivotif capsule kept at 60 degrees Fahrenheit for eight hours and the patient had three doses (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, the patient took first dose of affected Vivotif vaccine (batch number: unknown), orally at unknown dose for unknown indication (explicitly coded as 'product administration error'). On an unspecified date, the patient took second dose of affected Vivotif vaccine (batch number: unknown), orally at unknown dose. On an unspecified date, the patient took third dose of affected Vivotif vaccine (batch number: unknown), orally at unknown dose. At the time of the 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 spontaneous report involved a female patient who took three oral doses of improperly stored Vivotif vaccine. The capsules were kept at 60°F for eight hours, breaching storage conditions, and administration errors were noted. Patient's age, medical history, dose, and indication were unspecified; batch numbers were unknown. As of the report, no adverse events had been confirmed. The reported special situation events product administration error, product storage error and product temperature excursion issue are consider listed as per company conventions. The causality for events is assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A spontaneous report involved a female patient who took three oral doses of improperly stored Vivotif vaccine. The capsules were kept at 60°F for eight hours, breaching storage conditions, and administration errors were noted. Patient's age, medical history, dose, and indication were unspecified; batch numbers were unknown. As of the report, no adverse events had been confirmed. The reported special situation events product administration error, product storage error and product temperature excursion issue are consider listed as per company conventions. The causality for events is assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.