Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Rash; Case reference number US-BN-2024-001970 is a spontaneous case report initially received from a pharmacist via Emergent BioSolutions (reference number: EMG2024-621) on 26-May-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patent took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication. On an unspecified date, the patient developed rash. At the time of initial report, it was unknown if the patient recovered from the event of rash. The reporter did not provide seriousness and causality assessment for event of rash. No further information was provided.; Reporter's Comments: A patient of unspecified gender or age developed rash, unknown time after taking the first dose of Vivotif, at unknown dose, orally, for unknown indication. Rash is listed and expected according to CCDS v8 and USPI for Vivotif. At this point, it was unknown if the patient recovered from the event of rash. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of unspecified gender or age developed rash, unknown time after taking the first dose of Vivotif, at unknown dose, orally, for unknown indication. Rash is listed and expected according to CCDS v8 and USPI for Vivotif. At this point, it was unknown if the patient recovered from the event of rash. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.
Comments: None