Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient took all the treatment of Vivotif without being refrigerated; The patient picked up Vivotif vaccine but did not keep it refrigerated; The patient picked up Vivotif vaccine but did not keep it refrigerated; Case reference number US-BN-2025-000381 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV25-0605) on 18-Mar-2025 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient picked up Vivotif vaccine but did not keep it refrigerated (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On unspecified date, patient took all the treatment of Vivotif without being refrigerated (batch number: unknown) at an unknown dose, route, for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unknown age picked up Vivotif vaccine but did not keep it refrigerated, which is considered as product storage error and product temperature excursion issue. On unspecified date, patient took all the treatment of Vivotif without being refrigerated for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error, product storage error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product storage error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age picked up Vivotif vaccine but did not keep it refrigerated, which is considered as product storage error and product temperature excursion issue. On unspecified date, patient took all the treatment of Vivotif without being refrigerated for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error, product storage error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product storage error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None