Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | — | PO / MO |
The patient had a cough and felt achy; The patient had a cough and felt achy; The patient had the flu and a fever; The patient had the flu and a fever; Case reference number US-BN-2024-002901 is a spontaneous case initially received from nurse via Med Communications (reference number: EUBAV24-3314) on 17-Dec-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 13-Dec-2024, reported as on day zero, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose reported as two out of four capsules, orally for unknown indication. On 15-Dec-2024, reported as on day two, the patient was vaccinated with the second dose of Vivotif (batch number: unknown) at unknown dose reported as two out of four capsules, orally. On 16-Dec-2024, reported as last night, one day after vaccination with second dose of Vivotif, the patient had the flu and a fever, as reported the patient also had a cough and felt achy since yesterday. At the time of the initial report, it was unknown if the patient recovered from the events of 'cough', 'pain', 'flu' and 'fever'. The reporter did not provide seriousness for events of 'cough', 'pain', 'flu' and 'fever'. The reporter did not provide causality assessment for the events of 'cough', 'pain', 'flu' and 'fever'. 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-20241217-8fe58a to US-BAVARIAN NORDIC A/S-US-BN-2024-002901, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of flu and a fever, as reported also cough and felt achy one day after vaccination with second dose of Vivotif for unknown indication. Pyrexia is listed and expected for Vivotif per CCDS v8 and USPI, whilst cough, pain and influenza are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, 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 experienced non-serious events of flu and a fever, as reported also cough and felt achy one day after vaccination with second dose of Vivotif for unknown indication. Pyrexia is listed and expected for Vivotif per CCDS v8 and USPI, whilst cough, pain and influenza are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
Comments: None.