Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient did not refrigerate the supply of Vivotif, and took three of the doses while they were not refrigerated; The patient did not refrigerate the supply of Vivotif, and took three of the doses while they were not refrigerated; The patient did not refrigerate the supply of Vivotif, and took three of the doses while they were not refrigerated; Case reference number US-BN-2025-000989 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-1227) on 27-May-2025 and concerns a 52-years-old female patient. The patient's relevant medical history and concomitant medications were not provided. As reported on unspecified date, the patient did not refrigerate her supply of Vivotif (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified dates, as reported every other day, the patient took three doses of defected Vivotif vaccine while they were not refrigerated (batch number: unknown) at an unknown dose, orally, for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 52-years-old female patient did not refrigerate her supply of Vivotif which is considered as product storage error and product temperature excursion issue. The patient took three doses of defected Vivotif vaccine while they were not refrigerated, at an unknown dose, orally, for unknown indication which is considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 52-years-old female patient did not refrigerate her supply of Vivotif which is considered as product storage error and product temperature excursion issue. The patient took three doses of defected Vivotif vaccine while they were not refrigerated, at an unknown dose, orally, for unknown indication which is considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None