Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Felt a little bit of upset stomach; The patient had taken one out of four Vivotif capsule after the meals, instead of one hour before the meals; Case reference number US-BN-2024-002760 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-2956) on 07-Nov-2024 and concerns a male patient of unknown age (reporter's husband). The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule after the meals instead of one hour before the meals (explicitly coded as 'drug administration error'). On specified date, unknown amount of time after taking Vivotif, the patient felt a little bit of upset stomach but nothing much. At the time of the initial report, the outcome of the event upset stomach was unknown. The reporter assessed the event of upset stomach as non-serious, while the causality assessment for the same event was not provided. This case is linked to case US-BN-2024-002758 (same reporter). 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-20241107-ada4a8 to US-BAVARIAN NORDIC A/S-US-BN-2024-002760, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule after the meals instead of one hour before the meals, which is considered as drug administration error. An unknown amount of time after taking Vivotif, the patient felt a little bit of upset stomach. Abdominal discomfort is unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event upset stomach was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule after the meals instead of one hour before the meals, which is considered as drug administration error. An unknown amount of time after taking Vivotif, the patient felt a little bit of upset stomach. Abdominal discomfort is unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event upset stomach was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None