Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004009 | PO / MO |
The patient took first and the second dose of Vivotif which was left at room temperature at 65 Fahrenheit about four of five days; The patient took first and the second dose of Vivotif which was left at room temperature at 65 Fahrenheit about four of five days; The patient took second dose of Vivotif four days after the first dose; Case reference number US-BN-2024-000674 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0568) on 25-Mar-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. As reported, the product of Vivotif was left at room temperature at 65 Fahrenheit for about four of five days. On 21-Mar-2024, the patient took first dose of Vivotif (batch number: 3004009) at unknown dose, orally, for indication reported as immunization against disease caused by Salmonella typhi (explicitly coded as 'Product administration error' and 'Product storage error'). On 25-Mar-2024, four days after fist dose of Vivotif the patient received second dose of Vivotif (batch number: 3004009) at unknown dose, orally (explicitly coded as 'Product administration error', 'Product storage error' and 'Inappropriate schedule of vaccine administered'). 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 female patient of unspecified age took first dose of Vivotif that was left at room temperature at 65 Fahrenheit, at unknown dose, orally, for indication reported as immunization against disease caused by Salmonella typhi, which is considered as product administration error and product storage error. Four days later, the patient received second dose of Vivotif , which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered, product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took first dose of Vivotif that was left at room temperature at 65 Fahrenheit, at unknown dose, orally, for indication reported as immunization against disease caused by Salmonella typhi, which is considered as product administration error and product storage error. Four days later, the patient received second dose of Vivotif , which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered, product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.
Comments: None