Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004044 | PO / MO |
Patient had severe stomach cramps; Patient felt very sick; Very nauseated; Case reference number US-BN-2024-002382 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-2087) on 22-Aug-2024 and concerns a 46-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 21-Aug-2024 at 05:30 PM, as reported an hour before the meal, the patient took the first dose of Vivotif (batch number: 3004044), at an unknown dose, via oral use for immunization against disease caused by salmonella typhi. On the same day, as reported two to three hours after the dose, the patient experienced severe stomach cramps, felt very nauseated, felt very sick and did not receive any treatment for the events. At the time of the initial report, it was unknown if the patient recovered from the events 'stomach cramps', 'nausea' and 'feeling sick'. The reporter assessed the events 'stomach cramps', 'nausea' and 'feeling sick' as non-serious and causality was assessed as possible for the events 'stomach cramps', 'nausea' and 'feeling sick'. 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-20240822-1f2f76 to US-BAVARIAN NORDIC A/S-US-BN-2024-002382, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 46-year-old female patient experienced non-serious events of stomach cramps, felt very nauseated and very sick on the day 0 after the patient took the first dose of Vivotif for immunization against disease caused by salmonella typhi. Malaise is listed for Vivotif per CCDS v8 and unexpected per USPI, nausea is listed per both CCDS v8 and USPI, whilst abdominal pain upper is considered as listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering suggestive 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 46-year-old female patient experienced non-serious events of stomach cramps, felt very nauseated and very sick on the day 0 after the patient took the first dose of Vivotif for immunization against disease caused by salmonella typhi. Malaise is listed for Vivotif per CCDS v8 and unexpected per USPI, nausea is listed per both CCDS v8 and USPI, whilst abdominal pain upper is considered as listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering suggestive 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.