Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient took one capsule of Vivotif and the box is not refrigerated since 08-Oct-2025; The patient took one capsule of Vivotif and the box is not refrigerated since 08-Oct-2025; The patient took one capsule of Vivotif and the box is not refrigerated since 08-Oct-2025; The patient was supposed to take Vivotif vaccine last night and forgot to announce; Case reference number US-BN-2025-001697 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-000376) on 21-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. Since 08-Oct-2025 also reported as 'over a weeks', the Vivotif box was not refrigerated (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, the patient took one dose of affected Vivotif (batch number: unknown), at a dose of one capsule, at unknown route of administration, for an unknown indication (explicitly coded as product administration error'). On 20-Oct-2025 reported as last night, the patient was supposed to take Vivotif but forgot to announce 4 AM (explicitly coded as missed dose'). At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A spontaneous case concerning, female patient of unspecified age experienced non serious events of product storage error, product temperature excursion issue, product administration error, and missed dose with Vivotif. These events are listed as per company conventions. The outcome was reported as unknown, with no adverse events experienced. Co suspect medications were not reported. The patient's relevant medical history, concurrent diseases, and concomitant/relevant past medications were not provided. For regulatory reporting purposes, causality is assessed as not related to the suspect vaccine but attributed to human factor and product handling. No associated adverse events have been reported with the reported medication error. This case is considered non serious.; Sender's Comments: A spontaneous case concerning, female patient of unspecified age experienced non serious events of product storage error, product temperature excursion issue, product administration error, and missed dose with Vivotif. These events are listed as per company conventions. The outcome was reported as unknown, with no adverse events experienced. Co suspect medications were not reported. The patient's relevant medical history, concurrent diseases, and concomitant/relevant past medications were not provided. For regulatory reporting purposes, causality is assessed as not related to the suspect vaccine but attributed to human factor and product handling. No associated adverse events have been reported with the reported medication error. This case is considered non serious.
Comments: None