Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
a bit of a stomach pain; Case reference number US-BN-2026-000010 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: CASE-001336) on 22-Dec-2025 and concerns female patient of unknown age. The patient's medical history and concomitant medication details were not provided. The patient recently got her wisdom teeth removed and had to take amoxicillin for 10 days. The patient reported that there were power outages at her residence over a period of two days. She stated that the vaccine had been stored in the refrigerator during this time; however, it is unknown whether the refrigerator maintained the required storage temperature (to be confirmed). On an unknown date, reported as three weeks ago, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, route of administration for an unknown indication. On an unknown date, unknown time after the first dose, the patient experienced stomach pain. At the time of the initial report, it was unknown if the patient recovered from the event of stomach pain. The reporter did not provide the seriousness and causality assessment for the event of stomach pain. Additional information received from the reporter on 05-Jan-2025: New information included details about stomach pain, confirmation that vaccine was stored in the fridge and patient took one dose.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of stomach pain on an unknown date, unknown time after the patient took the first dose of Vivotif for an unknown indication. Abdominal pain upper is considered as listed and expected for Vivotif per CCDS v9 and USPI. The patient's medical history and concomitant medication details were not provided. The patient recently got her wisdom teeth removed and had to take amoxicillin for 10 days. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the causality is assessed as related to the suspect vaccine. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A female patient of unknown age experienced a non-serious event of stomach pain on an unknown date, unknown time after the patient took the first dose of Vivotif for an unknown indication. Abdominal pain upper is considered as listed and expected for Vivotif per CCDS v9 and USPI. The patient's medical history and concomitant medication details were not provided. The patient recently got her wisdom teeth removed and had to take amoxicillin for 10 days. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the causality is assessed as related to the suspect vaccine. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Medical History/Concurrent Conditions: Wisdom teeth removal