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 had gastrointestinal illness; The patient vomited and saw Vivotif capsule in vomit; Case reference number US-BN-2024-001826 is a spontaneous case report initially received from nurse via Med Communications (reference number: USBAV24-0825) on 23-Apr-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication. On unspecified date, for unknow amount of time after first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: unknown), at an unknown dose, orally. On unspecified date, reported as eight hours after the last dose of Vivotif, the patient developed gastrointestinal illnesses, vomited and saw the capsule of Vivotif in vomit. At the time of initial repot it was unknown if the patient recovered form events of gastrointestinal illnesses and 'vomiting'. The reporter assessed the events of gastrointestinal illnesses and ' vomiting' as non-serious and possible related to the product of Vivotif. No further information was provided.; Reporter's Comments: A female patient developed non-serious events of gastrointestinal illnesses and vomiting reported as eight hours after the last dose of Vivotif for unknown indication. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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 developed non-serious events of gastrointestinal illnesses and vomiting reported as eight hours after the last dose of Vivotif for unknown indication. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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