Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004081 | PO / MO |
The patient did not put Vivotif in fridge until 24 hours, maximum temperature was 68 Fahrenheit, the patient took the first dose the day it was picked up and then left remaining doses on counter; The patient did not put Vivotif in fridge until 24 hours, maximum temperature was 68 Fahrenheit, the patient took the first dose the day it was picked up and then left remaining doses on counter; Patient took first dose of Vivotif which was unrefrigerated; Case reference number US-BN-2025-000209 is a spontaneous case initially received from a nurse via Communication (reference number: USBAV25-0306) on 10-Feb-2025 and concerns a 21-years-old, female patient. The patient's medical history and concomitant medication details were not provided. On 06-Feb-2025, the patient took the first dose of Vivotif (batch number: 3004081), orally, for pre travel. The patient did not put medication in fridge until 24 hours later, the first dose was taken by patient the day it was picked up but then the remaining doses were left on the counter, maximum temperature was 68 Fahrenheit (explicitly coded as 'Product storage error temperature too high', 'Product temperature excursion issue', 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due Vivotif. No further information was provided.; Reporter's Comments: A 21-years-old female patient did not put medication in fridge until 24 hours later (the first dose was taken by patient the day it was picked up but then the remaining doses were left on the counter) and the maximum temperature was 68 Fahrenheit which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. Product storage error, product temperature excursion issue and product administration error are all considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 21-years-old female patient did not put medication in fridge until 24 hours later (the first dose was taken by patient the day it was picked up but then the remaining doses were left on the counter) and the maximum temperature was 68 Fahrenheit which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. Product storage error, product temperature excursion issue and product administration error are all considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE