Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004343 | PO / MO |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | unknown | — |
Bell's Palsy; Case reference number US-BN-2025-001795 is a spontaneous case initially received from a nurse via Bavarian Nordic (reference number: CASE-000709) on 12-Nov-2025 and concerns a 51-year-old female patient. The patient's medical history and concomitant medication details were not provided On 03-Nov-2025, the patient received a dose of Vivotif (batch number: 3004343) at *one capsule as a dose, orally, for travel vaccine as indication. * On the same day, the patient received a dose of the co-suspect shingles vaccine (brand name: unknown) (batch number: unknown) at an unknown dose, route, or site for administration for an unknown indication. On an unspecified date from vaccination with Vivotif, the patient experienced a reaction to the shingles vaccine, right side facial weakness and was tested for stroke and then diagnosed with Bell's Palsy. On an unspecified date, the patient started on immunosuppressant dose of steroids for sever days had not been able to finish the typhoid vaccine series. *On an unspecified dates, the patient took three adittional doses of Vivotif vaccine (batch number: 3004343) at capsule as a dose, orally. * At the time of *the follow up report, the patient was recovering from the event 'Bell's palsy'. * *The reporter assessed the event of 'Bell's palsy' as serious due to medical significance and not related to Vivotif vaccine. * All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow-up information received from the nurse on 01-Dec-2025 included: patients initials, volume, indication, route and expiration date for Vivotif vaccine, severity, outcome, seriousness and causality of the event 'Bell's palsy'.; Reporter's Comments: A 51-year-old female patient experienced serious (medically significant) event of Bell's palsy, on the unspecified date and time, after receiving the dose of Vivotif vaccine, for an unknown indication along with co-suspect shingles vaccine. Bell's palsy is unlisted as per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medications details were not provided. The patient was recovering from the event. Based on the available information, as the evaluation did not find enough evidence to suggest a reasonable possibility of a causal nor plausible biological mechanism of action between the reported event and suspect vaccine, therefore for regulatory reporting purposes the causality is assessed as not related. Co-suspect (Shingles vaccine) can be a confounding factor. This case is considered as serious due to medically significant criteria.; Sender's Comments: A 51-year-old female patient experienced serious (medically significant) event of Bell's palsy, on the unspecified date and time, after receiving the dose of Vivotif vaccine, for an unknown indication along with co-suspect shingles vaccine. Bell's palsy is unlisted as per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medications details were not provided. The patient was recovering from the event. Based on the available information, as the evaluation did not find enough evidence to suggest a reasonable possibility of a causal nor plausible biological mechanism of action between the reported event and suspect vaccine, therefore for regulatory reporting purposes the causality is assessed as not related. Co-suspect (Shingles vaccine) can be a confounding factor. This case is considered as serious due to medically significant criteria.
Test Name: test for stroke; Result Unstructured Data: Test Result:/ ;tested for stroke and then diagnosed with Bell's Palsy; Comments: /