Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient took third and fourth dose of Vivotif that were not refrigerated; The patient took third and fourth dose of Vivotif that were not refrigerated; The patient took third and fourth dose of Vivotif that were not refrigerated; Case reference number US-BN-2025-000887 is a spontaneous case initially received from physician via Communication (reference number: USBAV25-0964) on 29-Apr-2025 and concerns adult (also reported as about 20 years old), female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took first dose of Vivotif (batch number: unknown) orally, at unknown dose for typhoid immunization. On unspecified date, unknown amount of time from a first dose, the patient took second dose of Vivotif (batch number: unknown) orally, at unknown dose. On unspecified dates, unknown amount of time from a first dose, the patient took third and fourth dose of Vivotif (batch number: unknown) orally, at unknown dose, while doses were not refrigerated (explicitly coded as 'product administration error', 'product storage error' and 'product temperature excursion issue'). At the time of the initial report, it was unknown if patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: This case concerns an adult female patient (about 20 years), on unspecified date, who took first dose of Vivotif orally, for an indication of typhoid immunization. Later, on unspecified date, unknown amount of time from a first dose, the patient took second dose of Vivotif. As reported on unspecified dates, unknown amount of time from the first dose, the patient took third and fourth doses of Vivotif which were not refrigerated, which is considered as 'product temperature excursion issue', product administration error' and 'product storage error'. At the time of the initial report, it was unknown if patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed as per company convention. The patients' medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns an adult female patient (about 20 years), on unspecified date, who took first dose of Vivotif orally, for an indication of typhoid immunization. Later, on unspecified date, unknown amount of time from a first dose, the patient took second dose of Vivotif. As reported on unspecified dates, unknown amount of time from the first dose, the patient took third and fourth doses of Vivotif which were not refrigerated, which is considered as 'product temperature excursion issue', product administration error' and 'product storage error'. At the time of the initial report, it was unknown if patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed as per company convention. The patients' medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE