Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004085 | PO / MO |
The patient took two doses of Vivotif, went to take third dose and discovered that the final two pill capsules were left out of the refirgerator since the last dose was taken about 48 hours, temperature where left was 50 to 60 degrees; The patient took two doses of Vivotif, went to take third dose and discovered that the final two pill capsules were left out of the refirgerator since the last dose was taken about 48 hours, temperature where left was 50 to 60 degrees; The patient took Vivotif vaccine that was not refrigerated; Case reference number US-BN-2025-000197 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-0248) on 04-Feb-2025 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took 2 doses (first and second) of Vivotif (batch number: 3004085; expiration date: Mar-2025) at unknown dose, for unknown indication, and went to take third dose but discovered that the final two pill capsules were left out of the refrigerator since the last dose was taken, about 48 hours, temperature where left has been 50-60 degrees. (explicitly coded as 'Product storage error', 'Product temperature excursion error too high' and 'Product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse events due Vivotif. No further information was provided.; Reporter's Comments: A spontaneous case of a patient of unspecified age and gender took 2 doses of Vivotif (batch number: 3004085; expiration date: Mar-2025) and discovered the final two capsules were left out of the refrigerator for about 48 hours at 50-60 degrees. The event coded as product storage error, product temperature excursion error too high and product administration error is listed as per company convention. With the limited information about the event details and considering the possibility of human errors causality assessed as not related. No adverse events were reported at the time of the initial report. The case is non serious.; Sender's Comments: A spontaneous case of a patient of unspecified age and gender took 2 doses of Vivotif (batch number: 3004085; expiration date: Mar-2025) and discovered the final two capsules were left out of the refrigerator for about 48 hours at 50-60 degrees. The event coded as product storage error, product temperature excursion error too high and product administration error is listed as per company convention. With the limited information about the event details and considering the possibility of human errors causality assessed as not related. No adverse events were reported at the time of the initial report. The case is non serious.
Comments: NONE