Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
Body pain; Vomited once; The patient had three doses of Vivotif that felt sick from them; Fever; Headache; Case reference number US-BN-2024-002208 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-1685) on 17-Jul-2024 and concerns a patient of an unspecified demographics. The patient's medical history and concomitant medication details are not provided. On 11-Jul-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for an unknown indication. On 13-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally. On 15-Jul-2024, two days after the second dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. On an unspecified date, as reported the patient had three doses and felt sick from them. The patient felt body pain, fever, and headache, and vomited once. As reported, the patient vomited the day after taking Vivotif so no capsule was vomited intact. At the time of the initial report, the outcome for the events of feeling sick, body pain, fever, headaches, and vomiting was unknown. The reporter assessed the events of feeling sick, body pain, fever, headaches, and vomiting as not serious, and possibly related to the Vivotif. 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-20240717-0044e8 to US-BAVARIAN NORDIC A/S-US-BN-2024-002208, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of an unspecified demographics felt body pain, fever, and headache, and vomited once, within approximately two days after three doses of Vivotif were administered, at an unknown dose, orally, for an unknown indication. Pain is unlisted and unexpected while vomiting, malaise, pyrexia and headache are all listed and expected according to CCDS v8 and USPI. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details are not provided. Causal relationship is assessed as related due to plausible temporal relationship, known product safety profile (for vomiting, malaise, pyrexia and headache), lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of an unspecified demographics felt body pain, fever, and headache, and vomited once, within approximately two days after three doses of Vivotif were administered, at an unknown dose, orally, for an unknown indication. Pain is unlisted and unexpected while vomiting, malaise, pyrexia and headache are all listed and expected according to CCDS v8 and USPI. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details are not provided. Causal relationship is assessed as related due to plausible temporal relationship, known product safety profile (for vomiting, malaise, pyrexia and headache), lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.
Comments: None.