Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient experienced some abdominal pain with cramping; Case reference number US-BN-2024-001773 is a spontaneous case report initially received from other health care professional via Med Communications (reference number USBAV24-0671) on 05-Apr-2024 and concerns a 14-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 01-Apr-2024, the patient took first dose of Vivotif (batch number: unknown) at unknown dose, orally, for immunization against disease caused by Salmonella typhi. On 03-Apr-2024, two days after the first dose of Vivotif, the patient took second dose of Vivotif (batch number: unknown) at unknown dose, orally. On 05-Apr-2024, two days after the second dose of Vivotif, the patient took third dose of Vivotif (batch number: unknown) at unknown dose, orally. On unspecified date, the patient experienced some abdominal pain with cramping. The patient's treatment for abdominal pain with cramping included Tylenol. At the time of initial report, the outcome for the event of abdominal pain with cramping was unknown. The reporter assessed the abdominal pain with cramping as non-serious and possibly related to the product of Vivotif. No further information was provided.; Reporter's Comments: A 14-year-old male patient took three doses of Vivotif vaccine, for immunization against disease caused by Salmonella typhi. On unspecified date, the patient experienced some abdominal pain with cramping. Abdominal pain is listed/expected for Vivotif according to CCDS version 8.0 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome for the event of abdominal pain with cramping was unknown. Due to implied temporal relationship, product known safety profile and lack of alternative etiology at the moment, the causality for reported event is assessed as related to Vivotif. The case is non-serious.; Sender's Comments: A 14-year-old male patient took three doses of Vivotif vaccine, for immunization against disease caused by Salmonella typhi. On unspecified date, the patient experienced some abdominal pain with cramping. Abdominal pain is listed/expected for Vivotif according to CCDS version 8.0 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome for the event of abdominal pain with cramping was unknown. Due to implied temporal relationship, product known safety profile and lack of alternative etiology at the moment, the causality for reported event is assessed as related to Vivotif. The case is non-serious.
Comments: None