Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
Two doses of Vivotif were taken with food and two on an empty stomach; Case reference number US-BN-2024-001947 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-1143) on 24-May-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took four doses of Vivotif (batch number: unknown) orally, at an unknown dose, for unknown indication. As reported, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two 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. No further information was provided.; Reporter's Comments: A female patient, took four doses of Vivotif orally, at an unknown dose, for unknown indication. Reportedly, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient, took four doses of Vivotif orally, at an unknown dose, for unknown indication. Reportedly, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.