Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient administrated a dose of Vivotif vaccine with food instead of one-hour prior meal; Case reference number US-BN-2024-000160 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0284) on 07-Feb-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient took a dose of Vivotif vaccine (batch number: unknown), at an unknown dose and route of administration, for unknown indication. As reported, the patient administrated a dose of Vivotif vaccine with food instead of one-hour prior meal (explicitly coded as 'product administration error'). At the time of 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 administrated a dose of Vivotif vaccine for unknown indication with food instead of one-hour prior meal, 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 administrated a dose of Vivotif vaccine for unknown indication with food instead of one-hour prior meal, 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