Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
Patient having acid reflux coming up her throat after the second dose; The patient felt had a pretty good ringing in ears after first dose of Vivotif, ears were really ringing after the second dose of Viviotif; The patient felt kind of bad after first dose and felt really bad after the second dose of Vivotif; Case reference number US-BN-2025-001886 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-000979) on 01-Dec-2025 and concerns a female patient of an unknown age. The patient's history and concomitant medications details were provided. On 26-Nov-2025, the patient took the first dose of Vivotif (batch number: unknown) at dose of one capsule, at unknown route or site of administration for unknown indication. On an unspecified date, reported as on same day, about 10 to 15 minutes after patient took the first Vivotif capsule had a pretty good ringing in ears. On an unspecified date, reported as after the first night patient just felt kind of bad. On 28-Nov-2025, two days after first dose, the patient took the second dose of Vivotif (batch number: unknown) at dose of one capsule, at unknown route or site of administration. On an unspecified date, after the second capsule patient felt really bad and ears were really ringing. Patient also felt like was having acid reflux coming up her throat and felt bad from that pill. Those were very strong reactions. On 30-Nov-2025, two days after the second dose, the patient took the third dose of Vivotif (batch number: unknown) at dose of one capsule, at unknown route or site of administration. At the time of this report, it was unknown if the patient recovered from the events of 'ringing in ears' and 'feeling bad' after first and second dose of Vivotif and 'acid reflux (oesophageal)'. The reporter did not provide a serious assessment for the events of 'ringing in ears' and 'feeling bad' after first and second dose of Vivotif and 'acid reflux (oesophageal). The reporter assessed the event of 'feeling bad' after first and second dose of Vivotif as possibly related to the product, as reported patient felt bad from that pill, and the reporter did not provide causality assessment for the events of 'ringing in ears' after first and second dose of Vivotif and 'acid reflux (oesophageal)'. No further information was provided.; Reporter's Comments: A female patient of an unknown age experienced a non-serious event of ringing in ears reported as on same day, about 10 to 15 minutes after patient took the first Vivotif for unknown indication. On an unspecified date, reported as after the first night patient just felt kind of bad. On an unspecified date, after the second capsule patient felt like was having acid reflux coming up her throat. Gastrooesophageal reflux disease and tinnitus are unlisted and unexpected for Vivotif per CCDS v9 and USPI, whilst feeling abnormal is considered as listed per company convention. The patient's history and concomitant medications details were provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for feeling abnormal is assessed as related to the suspect vaccine. Considering weak biological plausibility, the causality for gastrooesophageal reflux disease and tinnitus is assessed as unlikely related to Vivotif. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A female patient of an unknown age experienced a non-serious event of ringing in ears reported as on same day, about 10 to 15 minutes after patient took the first Vivotif for unknown indication. On an unspecified date, reported as after the first night patient just felt kind of bad. On an unspecified date, after the second capsule patient felt like was having acid reflux coming up her throat. Gastrooesophageal reflux disease and tinnitus are unlisted and unexpected for Vivotif per CCDS v9 and USPI, whilst feeling abnormal is considered as listed per company convention. The patient's history and concomitant medications details were provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for feeling abnormal is assessed as related to the suspect vaccine. Considering weak biological plausibility, the causality for gastrooesophageal reflux disease and tinnitus is assessed as unlikely related to Vivotif. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.