Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient took two capsules of Vivotif which were left at room temperature for almost three weeks; The patient took two capsules of Vivotif which were left at room temperature for almost three weeks; Case reference number US-BN-2024-001762 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0651) on 04-Apr-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 18-Mar-2024, the patient left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks (explicitly coded as and 'product storage error'). On unspecified dates, the patient took first and second dose of affected Vivotif (batch number: unknown), at unknown dose, orally for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks which is considered as product storage error. reportedly, the patient took first and second dose of affected Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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 male patient of unspecified age left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks which is considered as product storage error. reportedly, the patient took first and second dose of affected Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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