Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
felt very ill; headaches; nausea; Case reference number US-BN-2025-001196 is a spontaneous case initially received from a healthcare professional via Communication (reference number: USBAV25-1697) on 11-Jul-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as yesterday which was the 11th at 8:32, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, route, or site of administration, for typhoid fever. On an unspecified date, an unknown amount of time after the first dose, the patient experienced headaches, nausea and felt ill. At the time of the initial report, it was unknown if the patient recovered from the events 'headache'' 'nausea' and 'Ill feeling'. The reporter assessed events the of 'headache', 'nausea' and 'illness' as non-serious and did not provide a causality assessment. No further information was provided.; Reporter's Comments: A female patient of unspecified age took the first dose of Vivotif for typhoid fever. On an unspecified date, an unknown amount of time after the first dose, the patient experienced non-serious events of headaches, nausea and felt ill. Headache and nausea are listed and expected for Vivotif per CCDS v8 and USPI, whilst malaise is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, known vaccine safety profile 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 took the first dose of Vivotif for typhoid fever. On an unspecified date, an unknown amount of time after the first dose, the patient experienced non-serious events of headaches, nausea and felt ill. Headache and nausea are listed and expected for Vivotif per CCDS v8 and USPI, whilst malaise is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, known vaccine safety profile 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