Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004041 | PO / MO |
The patient took three of four doses of Vivotif, which did not refrigerate; The patient took three of four doses of Vivotif, which did not refrigerate; The patient did not take fourth dose of Vivotif; Case reference number US-BN-2024-001836 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0843) on 25-Apr-2024 and concerns a *53-years-old* male patient. The patient's medical history and concomitant medication details were not provided. On 17-Apr-2024, the patient picked Vivotif vaccine and did not refrigerate (explicitly coded as and 'product storage error'). On 19-Apr-2024, the patient took the first dose of Vivotif (batch number: 3004041, *expiration date: Oct-2024), at one capsule*, orally, for typhoid immunization (explicitly coded as 'product administration error'). On 21-Apr-2024, three days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004041, *expiration date: Oct-2024), at one capsule*, orally (explicitly coded as 'product administration error'). On 23-Apr-2024, five days after the first dose of Vivotif, the patient took the third dose of Vivotif (batch number: 3004041, *expiration date: Oct-2024), at one capsule*, orally (explicitly coded as 'product administration error'). *As reported, the patient did not take fourth dose of Vivotif, and the patient will be restarting the Vivotif course due to upcoming travel (explicitly coded as ' Incomplete course of vaccination '). * *At the time of follow up, 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 (*). Follow-up information received from investigator on 06-May-2024: New information included confirmation that the patient received three doses of Vivotif, dosing information for all doses of Vivotif, patient demographic information and conformation that the patient did not experience any adverse event.; Reporter's Comments: A 53-year-old male patient picked Vivotif vaccine and did not refrigerate, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif, at unknown dose, orally, for typhoid immunization, which is considered as product administration error. Three days after the first dose of Vivotif, the patient took the second dose of Vivotif, at unknown dose, which is also considered as product administration error. It was confirmed that the patient received only three doses of Vivotif, which is considered as incomplete course of vaccination. Product storage error, incomplete course of vaccination and product administration error are listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 53-year-old male patient picked Vivotif vaccine and did not refrigerate, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif, at unknown dose, orally, for typhoid immunization, which is considered as product administration error. Three days after the first dose of Vivotif, the patient took the second dose of Vivotif, at unknown dose, which is also considered as product administration error. It was confirmed that the patient received only three doses of Vivotif, which is considered as incomplete course of vaccination. Product storage error, incomplete course of vaccination and product administration error are listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.