Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
After taking Vivotif the patient lost voice for five days; Case reference number US-BN-2025-001266 is a spontaneous case initially received from pharmacist via Bavarian Nordic on 10-Jul-2025 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took Vivotif (batch number: unknown), at an unknown dose, route, and site of administration, for indication trip. On an unspecified date, unknown amount of time after taking Vivotif, as reported the first day in the morning, the patient lost voice. It was only affected the patient. At the time of initial report, it was unknown if the patient recovered from event of 'loss of voice', continued for five days after. The reporter did not provide seriousness and causality assessment for the event of 'loss of voice' No further information provided.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of aphonia on an unspecified date, unknown amount of time after taking Vivotif, as reported the first day in the morning after the patient took Vivotif for indication trip. Aphonia is unlisted and unexpected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship, the lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of aphonia on an unspecified date, unknown amount of time after taking Vivotif, as reported the first day in the morning after the patient took Vivotif for indication trip. Aphonia is unlisted and unexpected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship, the lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
Comments: None.