Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004211 | PO / MO |
Feeling quite nauseous; The patient had some abdominal pain did not really bad; Case reference number US-BN-2025-001121 is a spontaneous case initially received from consumer via Communications (reference number: USBAV25-1532) on 25-Jun-2025 and concerns a 66-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 23-Jun-2025, the patient took the first dose of Vivotif (batch number: 3004211), at unknown dose, orally, for indication typhoid immunization. On 25-Jun-2025, two days after first dose, the patient took the second dose of Vivotif (batch number: 3004211), at unknown dose, orally. On an unspecified date, unknown time after taking Vivotif, the patient had been feeling quite nauseous, the nausea was pretty bad, and had some abdominal pain was not really bad, but felt nauseated. At the time of the initial report, it was unknown if the patient recovered from the events of 'nausea' and 'abdominal pain'. The reporter assessed the events of 'nausea' and 'abdominal pain' as non-serious and possibly related to the related to product of Vivotif. No further information provided.; Reporter's Comments: This case concerns a 66-years-old female patient, who experienced non-serious events of nausea and abdominal pain after unspecified date and time after vaccination with the second dose of Vivotif for an indication of typhoid immunization. Nausea and abdominal pain are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, it was unknown if the patient recovered from the events. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported events has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: This case concerns a 66-years-old female patient, who experienced non-serious events of nausea and abdominal pain after unspecified date and time after vaccination with the second dose of Vivotif for an indication of typhoid immunization. Nausea and abdominal pain are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, it was unknown if the patient recovered from the events. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported events has been considered as related to Vivotif. This case is considered as non-serious.
Comments: None.