Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The patient left Vivotif outside of refrigerator in the paper bag on desk, and over the next week the patient took all four doses every other day as indicated; The patient left Vivotif outside of refrigerator in the paper bag on desk, and over the next week the patient took all four doses every other day as indicated; The patient left Vivotif outside of refrigerator in the paper bag on desk, and over the next week the patient took all four doses every other day as indicated; Case reference number US-BN-2025-000153 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: BN_2025_00023) on 22-Jan-2025 and concern a patient with unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif outside the refrigerator in the paper bag on desk (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified dates, as reported over next week, the patient took four doses every other day as indicated of Vivotif vaccine (batch number: unknown) at unknown dose, route or site of administration for upcoming trip to (withheld) (explicitly coded as '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: This case concerns a patient of unspecified age and gender who left Vivotif outside the refrigerator in the paper bag on desk which is considered as product storage error and product temperature excursion issue. On an unspecified dates (as reported over next week) the patient took four doses every other day as indicated of Vivotif vaccine at unknown dose, route or site of administration for upcoming trip to (withheld) which is considered as product administration error. Product storage error, product temperature excursion issue and product administration error are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. At this point, it was unknown if the patient experienced any adverse events due Vivotif. Product storage error, product temperature excursion issue 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: This case concerns a patient of unspecified age and gender who left Vivotif outside the refrigerator in the paper bag on desk which is considered as product storage error and product temperature excursion issue. On an unspecified dates (as reported over next week) the patient took four doses every other day as indicated of Vivotif vaccine at unknown dose, route or site of administration for upcoming trip to (withheld) which is considered as product administration error. Product storage error, product temperature excursion issue and product administration error are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. At this point, it was unknown if the patient experienced any adverse events due Vivotif. Product storage error, product temperature excursion issue and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE