Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The patient took seven days course of Vivotif which did not refrigerate; The patient took seven days course of Vivotif which did not refrigerate; Case reference number US-BN-2024-001892 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0988) on 09-May-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported the patient did not know Vivotif vaccine was supposed to be kept refrigerated (explicitly coded as 'Product storage error'). On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif (batch number: unknown), at unknown dose, route, or site administration, 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 patient of unspecified gender or age did not know Vivotif vaccine was supposed to be kept refrigerated, which is considered as product storage error. On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified gender or age did not know Vivotif vaccine was supposed to be kept refrigerated, which is considered as product storage error. On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None