Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Patient took the first dose of Vivotif with a full breakfast; Case reference number US-BN-2024-000158 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0283) on 07-Feb-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On 06-Feb-2024, but reported as health care professional not certain, the patient took the first dose of Vivotif (batch number: not reported) orally, at an unknown dose, for typhoid immunization. As reported, the patient took the first dose of Vivotif with a full breakfast, not on an empty stomach (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A patient of unknown demographics took the first dose of Vivotif for typhoid immunization with a full breakfast, not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error has been 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 demographics took the first dose of Vivotif for typhoid immunization with a full breakfast, not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.