Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The patient took first and second dose of Vivotif vaccine with hot coffee; Case reference number US-BN-2024-001963 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 28-May-2024 and concerns a 32-years-old female patient. The patient's medical history and concomitant medication details were not provided. On *11-May-2024*, the patent took *the first* dose of Vivotif (batch number: *3004008; expiration date 31-Oct-2024), one capsule*, orally *through mouth*, for typhoid immunization, reported as prevention of typhoid fever. As reported, the patent took Vivotif vaccine with hot coffee (explicitly coded as 'Product administration error'). *On 13-May-2024, two days after first dose of Vivotif, the patent took the second dose of Vivotif (batch number: 3004008; expiration date 31-Oct-2024), one capsule, orally through mouth, As reported, the patent took Vivotif vaccine with hot coffee (explicitly coded as 'Product administration error').* * On an unspecified date, unknown amount of time after second dose of Vivotif, the patent took the third dose of Vivotif (batch number: unknown), at unknown dose, route or site administration.* *On 14-May-2024, unknown amount of time after third dose of Vivotiv, the patent took the fourth dose of Vivotif (batch number: 3004008; expiration date 31-Oct-2024), one capsule, orally through mouth.* *At the time of the follow up report, the patient did not experience any adverse event due to Vivotif vaccine.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Additional information received form Bavarian Nordic on 28-May-2024 included indication for Vivotif vaccine and local BN case ID (BN_2024_02850). Additional information received from reporter on 29-May-2024 included demographic information of patient, gender and age, and confirmation that the patient took Vivotif vaccine with hot coffee. Follow up information received from nurse on 14-Jun-2024 included: patent's initial, dosing information for first, second and fourth dose of Vivotif, dates, route, volume, batch number and expiration date and confirmation that the patient did not experience any adverse events.; Reporter's Comments: A 32-year-old female patient took Vivotif for typhoid immunization. Reportedly, the patent took the first and the second dose of Vivotif vaccine with hot coffee which is considered as product administration error. Product administration error is considered listed per company convention. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 32-year-old female patient took Vivotif for typhoid immunization. Reportedly, the patent took the first and the second dose of Vivotif vaccine with hot coffee which is considered as product administration error. Product administration error is considered listed per company convention. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None