Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
Greater than 48 interval between third and fourth dose. Patient did not complete one week prior to exposure to S. Typhi.; he lost the last pill and wants another one; Case reference number US-BN-2025-001927 is a spontaneous case initially received from other health professional via Bavarian Nordic (reference number: CASE-001082) on 08-Dec-2025 and concerns a 25-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 29-Nov-2025, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose and route of administration, for the indication prophylactic vaccination. On 01-Dec-2025, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose and route of administration, for the indication prophylactic vaccination. On 03-Dec-2025, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose and route of administration, for the indication prophylactic vaccination. The reporter stated that the patient was supposed to take the fourth dose of Vivotif on 05-Dec-2025, but the patient lost the last pill and wanted another one. (explicitly coded as 'Missed dose') The reporter also stated that it was more than 48 hours interval between third and fourth dose and the patient did not complete one week prior to exposure to S. Typhi. (explicitly coded as 'Inappropriate schedule of product administration') At the time of the initial report, it was unknown if the patient experienced any adverse events due to the Vivotif vaccine. No further information was provided.; Reporter's Comments: A 25-year-old male patient was supposed to take the fourth dose of Vivotif on a certain date, but the patient lost the last pill and wanted another one, which is considered as missed dose. The reporter also stated that it was more than 48 hours interval between third and fourth dose and the patient did not complete one week prior to exposure to S. Typhi, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse events due to the Vivotif vaccine. Inappropriate schedule of product administration and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product dose omission issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 25-year-old male patient was supposed to take the fourth dose of Vivotif on a certain date, but the patient lost the last pill and wanted another one, which is considered as missed dose. The reporter also stated that it was more than 48 hours interval between third and fourth dose and the patient did not complete one week prior to exposure to S. Typhi, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse events due to the Vivotif vaccine. Inappropriate schedule of product administration and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product dose omission issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE.