Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA (VIMKUNYA) | BAVARIAN NORDIC | 1 | FDP00691 | IM / LA |
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004171 | PO / MO |
Patient received first dose of Vivotif on 07-Jun-2025, second dose on 09-Jun-2025, third dose on 11-Jun-2025, and fourth dose on 14-Jun-2025; Patient received Vimkunya vaccine at dose of 0.5 ml; "wringing/twisting" sensation accompanied by fever; "wringing/twisting" sensation accompanied by fever; Case reference number US-BN-2025-001458 is a spontaneous case initially received from a nurse via Bavarian Nordic (reference number: BN_2025_00257) on 26-Aug-2025 and concerns a 24-year-old female patient. The patient's medical history details and concomitant medication were not provided. The patient was healthy. On *07-Jun-2025*, the patient took the first dose of Vivotif (batch number: * 3004171, expiration date *31-Aug-2025*), at *1 dosage form (one capsule), oral for Typhoid fever prevention*. On *09-Jun-2025, 2 days* from the first dose, the patient took the second dose of Vivotif (* 3004171, expiration date *31-Aug-2025*), at *1 dosage form (one capsule), orally*. On *11-Jun-2025, 4 days* from the first dose, the patient took the third dose of Vivotif (* 3004171, expiration date *31-Aug-2025*), at *1 dosage form (one capsule), orally*. On *14-Jun-2025, 7 days* from the first dose, the patient took the fourth dose of Vivotif (* 3004171, expiration date *31-Aug-2025*), at *1 dosage form (one capsule), orally*. (explicitly coded as 'Inappropriate schedule of product administration') On *17-Jun-2025 at 12:10 pm, 3 days* after the fourth dose of Vivotif, the patient experienced "wringing/twisting" sensation accompanied by fever. On *19-Jun-2025*, the patient recovered from the events of 'abdominal discomfort' and 'fever'. *On 25-Jun-2025, the patient received co-suspect vaccine Vimkunya along side with constituent part prefilled syringe (batch number: FDP00691, expiration date: 31-Oct-2027) at dose of 0.5 cc, intramuscularly in left deltoid as Chikungunya prevention. (explicitly coded as 'vaccine underdose') * The reporter *assessed the events 'abdominal discomfort' and 'fever' as non-serious, and causality assessment for both events was provided as probably related to Vivotif*. *At the time of follow up version, patient recovered from events 'abdominal discomfort' and 'fever'. * The case is linked with the case ID US-BN-2025-001459 (the same reporter). Additional information received from Bavarian Nordic on 26-Aug-2025 included confirmation of the country of occurrence. Follow-up information received from nurse via Bavarian Nordic on 10-Nov-2025. New information included: administration details (date, dose, route), event details (onset date and stop date), two new events added, causality and intensity assessment.; Reporter's Comments: A 24-year-old female patient took the fourth dose of Vivotif for Typhoid fever prevention 7 days from the first dose, which is considered as inappropriate schedule of product administration. Reportedly, 3 days after the fourth dose of Vivotif, the patient experienced non-serious events of wringing/twisting sensation and pyrexia. Reportedly, the patient received co-suspect vaccine Vimkunya at dose of 0.5 cc, as Chikungunya prevention, which is considered as vaccine underdose. Pyrexia is listed and expected for Vivotif per Agency and Regulatory Agency, whilst abdominal discomfort is unlisted and unexpected. Inappropriate schedule of product administration and underdose are considered as listed per company convention. The patient's medical history details and concomitant medication were not provided, and the patient was healthy. The patient recovered. Considering plausible temporal relationship and biological plausibility, the reported events have been considered as related to Vivotif. Inappropriate schedule of product administration and underdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A 24-year-old female patient took the fourth dose of Vivotif for Typhoid fever prevention 7 days from the first dose, which is considered as inappropriate schedule of product administration. Reportedly, 3 days after the fourth dose of Vivotif, the patient experienced non-serious events of wringing/twisting sensation and pyrexia. Reportedly, the patient received co-suspect vaccine Vimkunya at dose of 0.5 cc, as Chikungunya prevention, which is considered as vaccine underdose. Pyrexia is listed and expected for Vivotif per Agency and Regulatory Agency, whilst abdominal discomfort is unlisted and unexpected. Inappropriate schedule of product administration and underdose are considered as listed per company convention. The patient's medical history details and concomitant medication were not provided, and the patient was healthy. The patient recovered. Considering plausible temporal relationship and biological plausibility, the reported events have been considered as related to Vivotif. Inappropriate schedule of product administration and underdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: NONE