Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient received two doses of Vivotif which was stored at room temperature for 48 hours; The patient received two doses of Vivotif which was stored at room temperature for 48 hours; Case reference number US-BN-2025-000145 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-0142) on 20-Jan-2025 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. As reported, the patient stored Vivotif at room temperature for 48 hours since the first tablet (explicitly coded as product storage error temperature too high'). On unspecified date, reported as two days ago, the patient received first dose of Vivotif capsule without being refrigerated (batch number: unknown) at a dose of one tablet, orally, for indication typhoid vaccination (explicitly coded as 'product administration error'). On unspecified date, unknown amount of time after the first dose, reported as today, the patient received second dose of Vivotif capsule without being refrigerated (batch number: unknown) at a dose of one tablet, orally (explicitly coded as 'product administration error'). The patient stored remaining two doses in the refrigerator. 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 patient of unknown age and gender received the first dose of Vivotif capsule without being refrigerated and stored at room temperature for 48 hours for indication typhoid vaccination, which is considered as product storage error temperature too high and product administration error. On unspecified date, an unknown amount of time after the first dose, reported as today, the patient received second dose of Vivotif capsule without being refrigerated, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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 storage error and product administration error are considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender received the first dose of Vivotif capsule without being refrigerated and stored at room temperature for 48 hours for indication typhoid vaccination, which is considered as product storage error temperature too high and product administration error. On unspecified date, an unknown amount of time after the first dose, reported as today, the patient received second dose of Vivotif capsule without being refrigerated, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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 storage error and product administration error are considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None