Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient experienced nausea and vomiting about 12 hours after taking Vivotif, and it has been consistent since the first pill.; The patient experienced nausea and vomiting about 12 hours after taking Vivotif, and it has been consistent since the first pill.; Case reference number US-BN-2024-002734 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-2923) on 05-Nov-2024 and concerns a female patient of unspecified age, reported as around 14 to 15 years old. The patient's medical history and concomitant medication details were not provided. On 31-Oct-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid Immunization. On 02-Nov-2024, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally. On 04-Nov-2024, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, orally. Since the first dose of Vivotif, about 12 hours after taking Vivotif, the patient experienced nausea and vomiting, and it has been consistent since the first pill. The healthcare professional stated the patient was definitely ingesting the pill, and it was working. The HCP would like to know if the fourth dose could be postponed until finals are done, which would be on 06-Nov-2024, Saturday. At the time of the initial report, the patient was not recovered from the events of vomiting and nausea, reported as consistent since the first pill. The reporter assessed the events of vomiting and nausea as non-serious, and causality for the events of vomiting and nausea was reported as possible. Non-significant follow-up was downloaded from VAERS on 09-May-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241105-e94967 to US-BAVARIAN NORDIC A/S-US-BN-2024-002734, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unspecified age reported as around 14 to 15 years old experienced non-serious events of nausea and vomiting as reported about 12 hours after taking Vivotif for typhoid Immunization. Vomiting and nausea are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events. Considering suggestive temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age reported as around 14 to 15 years old experienced non-serious events of nausea and vomiting as reported about 12 hours after taking Vivotif for typhoid Immunization. Vomiting and nausea are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events. Considering suggestive temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
Comments: None