Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
Patient took entire course of Vivotif without refrigerating; Patient took entire course of Vivotif without refrigerating; Case reference number US-BN-2024-001945 is a spontaneous case report initially received from other health care professional via Med Communication (reference number: USBAV24-1146) on 24-May-2024 and concerns male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On 17-May-2024, Vivotif vaccine was dispensed. As reported, patient was not aware that Vivotif should been kept in the fridge (explicitly coded as 'product storage error'). On unspecified dates, patient took entire course of Vivotif (brand name: unknown) without refrigerating, at unknown dose, route, or site of administration for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A male patient of unspecified age was not aware that Vivotif should been kept in the fridge which is considered as product storage error, and took entire course of Vivotif without refrigerating, at unknown dose, route, or site of administration 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. The patient's relevant medical history and concomitant medications 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 male patient of unspecified age was not aware that Vivotif should been kept in the fridge which is considered as product storage error, and took entire course of Vivotif without refrigerating, at unknown dose, route, or site of administration 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. The patient's relevant medical history and concomitant medications 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