Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 hours; The patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 hours; Case reference number US-BN-2024-000037 is a spontaneous case report initially received from a physician via Med Communication (reference number: USBAV24-0042) on 08-Jan-2024 and concerns female patient. The patient's relevant medical history and concomitant medications were not provided. The patient was not pregnant. On unspecified dates, the patient received the first, the second, the third and the fourth dose of Vivotif vaccine (batch number: unknown), all at unknown dose, orally, for indication reported as typhoid prophylaxis. As reported, the patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 hours (explicitly coded as 'product storage error' and '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 provided.; Reporter's Comments: A female patient received the first, the second, the third and the fourth dose of Vivotif vaccine for indication reported as typhoid prophylaxis. As reported, the patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 hours, which is considered as product storage error and 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 relevant medical history and concomitant medications were not provided. The patient was not pregnant. 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 female patient received the first, the second, the third and the fourth dose of Vivotif vaccine for indication reported as typhoid prophylaxis. As reported, the patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 hours, which is considered as product storage error and 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 relevant medical history and concomitant medications were not provided. The patient was not pregnant. 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