Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient had cup of coffee about 15 minutes after administrating a dose of Vivotif on an empty stomach with cold water; Case reference number US-BN-2024-000016 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0024) on 04-Jan-2024 and concerns a patient of unspecified age or gender. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient received a dose of Vivotif (batch number: unknown), at an unknown dose and route of administration, for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee (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. Additional information received from Emergent BioSolutions on 05-Jan-2024 included additional reference number.; Reporter's Comments: A patient of unspecified age or gender received a dose of Vivotif for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee, 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 conventions. The patient's medical history and concomitant medications 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 unspecified age or gender received a dose of Vivotif for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee, 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 conventions. The patient's medical history and concomitant medications 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