Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient ate after first and second dose of Vivotif, and did not wait an hour; Case reference number US-BN-2024-002918 is a spontaneous case initially received from physician via Med Communications (reference number: USBAV24-3321) on 17-Dec-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose on Vivotif (batch number: unknown), at a dose of one capsule, orally, for unknown indication. On unspecified date, unknown amount of time after the first dose, the patient took the second dose on Vivotif (batch number: unknown), at a dose of one capsule, orally. As reported, the patient ate after the first and second dose of Vivotif and did not wait an hour (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age ate after the first and second dose of Vivotif and did not wait an hour, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is 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 unspecified age ate after the first and second dose of Vivotif and did not wait an hour, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None