Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Patient was due to take second dose of Vivotif at 2PM, patient was approximately 3 hours overdue, second dose not yet taken; Patient had gastrointestinal (GI) side effects; Vomited; Case reference number US-BN-2024-000200 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0352) on 20-Feb-2024 and concerns a 28-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 18-Feb-2024, at 02:00 pm. the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose via oral route, for unknown indication. On 19-Feb-2024, around 09:30 am, one day after the first dose, the patient had gastrointestinal side effects and vomited. As reported no fever occurred. On 20-Feb-2024, two days after the first dose of Vivotif, the patient was supposed to take the second dose of Vivotif at 2 pm, however the patient was approximately 3 hours overdue, and the reporter asked should the schedule be continued if the patient decides to continue with Vivotif series as the second dose was not yet taken (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, the outcome for the events of gastrointestinal side effects and vomited was unknown. The reporter did not provide seriousness or causality assessment for the events gastrointestinal side effects and vomited. No further information was provided.; Reporter's Comments: A 28-year-old female patient had gastrointestinal side effects and vomited on the day 1 after the patient took the first dose of Vivotif for unknown indication. On the day 2 after the first dose, the patient was supposed to take the second dose of Vivotif at 2 pm, however the patient was approximately 3 hours overdue, and the reporter asked should the schedule be continued if the patient decides to continue with Vivotif series as the second dose was not yet taken, which is considered as inappropriate schedule of vaccine administered. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and known vaccine safety profile, the events of gastrointestinal disorder and vomiting have been considered as related to Vivotif. Inappropriate schedule of product administration has 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 28-year-old female patient had gastrointestinal side effects and vomited on the day 1 after the patient took the first dose of Vivotif for unknown indication. On the day 2 after the first dose, the patient was supposed to take the second dose of Vivotif at 2 pm, however the patient was approximately 3 hours overdue, and the reporter asked should the schedule be continued if the patient decides to continue with Vivotif series as the second dose was not yet taken, which is considered as inappropriate schedule of vaccine administered. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and known vaccine safety profile, the events of gastrointestinal disorder and vomiting have been considered as related to Vivotif. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.