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 took the first, second and third dose of Vivotif vaccine and realized that did not refrigerated vaccines; The patient took the first, second and third dose of Vivotif vaccine and realized that did not refrigerated vaccines; Case reference number US-BN-2024-002344 is a spontaneous case initially received from a consumer via Emergent BioSolutions (reference number: EMG2024-874) on 13-Aug-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the doses of Vivotif were not refrigerated (explicitly coded as 'product storage error'). On an unspecified date, the patent took the first dose of Vivotif (batch number: unknown), at a dose of pill, orally, for typhoid immunization (explicitly coded as 'product administration error'). On an unspecified date, unknown amount of time after first dose of Vivotif, the patent took the second dose of Vivotif (batch number: unknown), at a dose of pill, orally (explicitly coded as 'product administration error'). On an unspecified date, unknown amount of time after second dose of Vivotif, the patent took the third dose of Vivotif (batch number: unknown), at a dose of pill, orally (explicitly coded as 'product administration error'). As reported, the patient took three pills of Vivotif out of the four pills due to travel and realised that did not refrigerate Vivotif. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. Additional information received from consumer via Med Communication (reference number: USBAV24-1970) on 14-Aug-2024: Information included patient details and Vivotif dosing information. Non-significant case correction received from Emergent on 27-Aug-2024 included confirmation of initial receipt date.; Reporter's Comments: A female patient received three doses of Vivotif, after not refrigerating them, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A female patient received three doses of Vivotif, after not refrigerating them, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Vivotif, but to a human error. The case is non-serious.
Comments: NONE