Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 30040009 | PO / MO |
The patient took one capsule of Vivotif which was approximately 48 hours at room temperature which reached about 70 Fahrenheit; The patient took one capsule of Vivotif which was approximately 48 hours at room temperature which reached about 70 Fahrenheit; Patient took only one dose of Vivotif; Case reference number US-BN-2024-001838 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0841) on 25-Apr-2024 and concerns a 19-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 22-Apr-2024, as reported, the typhoid was given to a patient, patient left Vivotif vaccine for approximately 48 hours at room temperature which reached about 70 degrees Fahrenheit (explicitly coded as 'product storage error'). On 24-Apr-2024, the patient took the first dose of affected Vivotif (batch number: 30040009, expiration date: 31-Oct-2024), at a dose reported as one tablet, orally for typhoid immunization (explicitly coded as 'product administration error', 'inappropriate schedule of vaccine'). *As reported, patient received a new Vivotif package and yet to begin with administration from 23-May-2024.* At the time of the follow up report, the patient did not experience any adverse event due to Vivotif vaccine. Non-significant case correction performed on 07-May-2024 for information received on 06-May-2024 included reporters email address. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from nurse on 08-May-2024: New information included dosing information for first dose of Vivotif, patient's demographic information and confirmation that the patient did not experience any adverse event. Follow-up information received from nurse on 21-May-2024: included it was confirmed that patient had received a new Vivotif package, and it is yet to administer.; Reporter's Comments: A 19-year-old male patient left Vivotif vaccine for approximately 48 hours at room temperature which reached about 70 degrees Fahrenheit which is considered as product storage error. Reportedly, the patient took the first dose of affected Vivotif, at a dose reported as one tablet, orally for typhoid immunization, which is considered as product administration error and inappropriate schedule of vaccine. Product storage error, inappropriate schedule of vaccine and product administration error are considered 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, inappropriate schedule of vaccine and product administration error are assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient left Vivotif vaccine for approximately 48 hours at room temperature which reached about 70 degrees Fahrenheit which is considered as product storage error. Reportedly, the patient took the first dose of affected Vivotif, at a dose reported as one tablet, orally for typhoid immunization, which is considered as product administration error and inappropriate schedule of vaccine. Product storage error, inappropriate schedule of vaccine and product administration error are considered 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, inappropriate schedule of vaccine and product administration error are assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None