Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | unknown | — |
The patient did not refrigerate the Vivotif and took entire course without refrigerating it; The patient did not refrigerate the Vivotif and took entire course without refrigerating it; The patient did not refrigerate the Vivotif and took entire course without refrigerating it; Case reference number US-BN-2025-000294 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0462) on 27-Feb-2025 and concerns an 11-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the entire course of Vivotif (batch number: unknown), at unknown dose, route or site of administration for unknown indication, as reported without refrigerating it (explicitly coded as 'product storage error', 'product temperature excursion issue' and '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: An 11-year-old female patient took the entire course of Vivotif, at unknown dose, route or site of administration for unknown indication, without refrigerating it which is considered as product storage error, product temperature excursion issue and product administration error. Product temperature excursion issue, product storage error 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 temperature excursion issue, product storage error 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: An 11-year-old female patient took the entire course of Vivotif, at unknown dose, route or site of administration for unknown indication, without refrigerating it which is considered as product storage error, product temperature excursion issue and product administration error. Product temperature excursion issue, product storage error 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 temperature excursion issue, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE