Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004085 | PO / MO |
Four patients took two doses of not refrigerated Vivotif, reaching 70 degrees Fahrenheit for ten days; Four patients took two doses of not refrigerated Vivotif, reaching 70 degrees Fahrenheit for ten days; Case reference number US-BN-2024-002913 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV24-3353) on 19-Dec-2024 and concerns a seven-year-old female patient, 10-year-old male patient, 11-year-old female patient and 14-year-old male patient. The patients medical history and concomitant medication details were not provided. On 16-Dec-2024, the patients took the first dose of Vivotif (batch number: 3004085) orally, at unknown dose, for typhoid immunisation. On 18-Dec-2024, two days after the first dose, the patients took the second dose of Vivotif (batch number: 3004085) orally, at unknown dose. Each patient took both doses while not refrigerated, maximum temperature was 70 Fahrenheits for ten days (explicitly coded as 'Product storage error' and 'Product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Vivotif. Additional information received from Med Communications on 19-Dec-2024 included additional reference numbers (USBAV24-3356, USBAV24-3357 and USBAV24-3359).; Reporter's Comments: This case report concerns a seven-year-old female patient, 10-year-old male patient, 11-year-old female patient and 14-year-old male patient. The patients took the first dose of Vivotif orally, at unknown dose, for typhoid immunisation and two days after the first dose, the patients took the second dose of Vivotif orally, at unknown dose. Each patient took both doses while not refrigerated, maximum temperature was 70 Fahrenheits for ten days which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Vivotif. The patients medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns a seven-year-old female patient, 10-year-old male patient, 11-year-old female patient and 14-year-old male patient. The patients took the first dose of Vivotif orally, at unknown dose, for typhoid immunisation and two days after the first dose, the patients took the second dose of Vivotif orally, at unknown dose. Each patient took both doses while not refrigerated, maximum temperature was 70 Fahrenheits for ten days which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Vivotif. The patients medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None