Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient took second and third dose of Vivotif which were not refrigerated; The patient took second and third dose of Vivotif which were not refrigerated and did not take first three doses on an empty stomach; Case reference number US-BN-2024-001853 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0894) on 01-May-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 18-Apr-2024, the patient took first dose of Vivotif (batch number: unknown), orally, at unknown dose, for unknown indication. As reported, the patient did not take vaccine on empty stomach (explicitly coded as 'Product administration error'). On an unspecified date, the patient did not refrigerate Vivotif vaccine. On unspecified dates, unknown amount of time after first dose of Vivotif, the patient took second and third dose of Vivotif (batch number: unknown), orally, at unknown dose, as reported the patient did not take vaccine on empty stomach. As reported the product of Vivotif was out of refrigerator over a week (explicitly coded as 'Product administration error' and 'Product storage 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 was provided.; Reporter's Comments: A male patient of unspecified age took all three doses of Vivotif on an empty stomach, which is considered as product administration error. Additionally it was reported that the product of Vivotif was out of refrigerator over a week, which is considered as product storage error. No associated adverse events were reported. Product administration error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product administration error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age took all three doses of Vivotif on an empty stomach, which is considered as product administration error. Additionally it was reported that the product of Vivotif was out of refrigerator over a week, which is considered as product storage error. No associated adverse events were reported. Product administration error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product administration error are not related to Vivotif, but to a human factor. The case is non-serious.
Comments: None