Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient had diarrhea after first two doses of Vivotif vaccine; The patient received three doses of Vivotif vaccine and did not want to take the fourth dose; Case reference number US-BN-2024-001760 is a spontaneous case report initially received from other health professional via Med Communications (reference number: USBAV24-0653) on 04-Apr-2024 and concerns an elderly female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication. On unspecified date, unknown amount of time after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication. On unspecified date, unknown amount of time after the second dose of Vivotif, the patient experienced diarrhea. On unspecified date, the patient recovered from the event of diarrhea. On unspecified date, unknown amount of time after the second dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. As reported, when the patient took third dose of Vivotif, the patient did not experience diarrhea but did not want to take the fourth dose as the fourth dose was close to travel (explicitly coded as 'incomplete course of vaccination'). The reporter assessed the event of diarrhea as non-serious and possibly related to Vivotif. No further information provided.; Reporter's Comments: An elderly female patient experienced diarrhea, unknown time after the second dose of Vivotif. Unknown time after the second dose, the patient took the third dose of Vivotif, at an unknown dose, orally. Reportedly, when the patient took third dose of Vivotif, the patient did not experience diarrhea but did not want to take the fourth dose as the fourth dose was close to travel which is considered as incomplete course of vaccination. Diarrhea is listed according to the CCDS v8 for Vivotif while incomplete course of vaccination is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of diarrhea was resolved. Causality assessment for diarrhea is related due to known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An elderly female patient experienced diarrhea, unknown time after the second dose of Vivotif. Unknown time after the second dose, the patient took the third dose of Vivotif, at an unknown dose, orally. Reportedly, when the patient took third dose of Vivotif, the patient did not experience diarrhea but did not want to take the fourth dose as the fourth dose was close to travel which is considered as incomplete course of vaccination. Diarrhea is listed according to the CCDS v8 for Vivotif while incomplete course of vaccination is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of diarrhea was resolved. Causality assessment for diarrhea is related due to known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None