Received Apr 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004397 | PO / MO |
Anaphylactic reaction (closure of the throat, nausea, dizziness, fatigue and malaise); The patient took two doses of Vivotif on 09-Mar-2026 and 11-Mar-2026 and no additional doses taken; Skin peeling inside the mouth; Case reference number US-BN-2026-000448 is a spontaneous case report initially received from a consumer via Bavarian Nordic (reference number: CASE-002623) on 12-Mar-2026 and concerns an 18-years-old female patient. The patient's medical history and concomitant medication details were not reported. On 09-Mar-2026, reported as Monday, the patient took first dose of Vivotif (batch number: 3004397, expiration date: Oct-2026), at a dose of one capsule, orally for indication travelling abroad and *immunisation. * On 11-Mar-2026, two days after the first dose, the patient took second dose of Vivotif (batch number: 3004397, expiration date: Oct-2026), at a dose of one capsule, orally. *The patient received only two doses, and no additional doses were taken, just two doses (explicitly coded as 'incomplete course of vaccination). * *On the same day*, unknown time after the second dose, the patient had skin peeling inside her mouth. *On an unspecified date, the patient experienced anaphylactic reaction included closure of the throat, nausea, dizziness, fatigue and malaise. * *On 14-Mar-2026, the patient was recovered from the event of 'oral mucosal exfoliation'. * *At the time of follow up report, it was unknown if the patient was recovered from the event of 'anaphylactic reaction'. * *The reporter assessed event of oral mucosal exfoliation as serious due seriousness criteria of medically significant and with moderate intensity and causality as certainly related to Vivotif vaccine. The physician assessed the event as related and advised the patient to stop taking Vivotif. * *The reporter did not provide seriousness criteria for event of anaphylactic reaction and did not provide causality assessment; however the event anaphylactic reaction was considered as serious due to the criteria of medically significant. * All follow up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information was received from the consumer on 26-Mar-2026. New information included patient demographic details, dosing details, added start date, stop date, outcome and causality for event 'oral mucosal exfoliation' and new event anaphylactic reaction.; Reporter's Comments: This case concerns an 18-years-old female patient, who experienced a serious (medically significant) events of oral mucosal exfoliation and anaphylactic reaction, on unspecified date and time after receiving the second dose of Vivotif vaccine for an indication of travelling abroad and immunisation. As reported the patient received only two doses of Vivotif vaccine, which is considered as incomplete course of vaccination. Oral mucosal exfoliation is unlisted and unexpected for Vivotif per CCDS v9 and USPI, whilst anaphylactic reaction is listed and unexpected. Incomplete course of vaccination is consider as listed as per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown for anaphylactic reaction and recovered oral mucosal exfoliation. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as possibly related to the suspect vaccine. Event incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.; Sender's Comments: This case concerns an 18-years-old female patient, who experienced a serious (medically significant) events of oral mucosal exfoliation and anaphylactic reaction, on unspecified date and time after receiving the second dose of Vivotif vaccine for an indication of travelling abroad and immunisation. As reported the patient received only two doses of Vivotif vaccine, which is considered as incomplete course of vaccination. Oral mucosal exfoliation is unlisted and unexpected for Vivotif per CCDS v9 and USPI, whilst anaphylactic reaction is listed and unexpected. Incomplete course of vaccination is consider as listed as per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown for anaphylactic reaction and recovered oral mucosal exfoliation. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as possibly related to the suspect vaccine. Event incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.
Comments: None.