Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004281 | PO / MO |
The patient received only three doses of Vivotif capsule; The patient developed a worsening rash on the face after first dose of Vivotif; Case reference number US-BN-2025-000007 is a spontaneous case initially received from *pharmacist* via Communication (reference number: USBAV25-0019) on 03-Jan-2025 and concerns a 12-year-old female patient. The patient's medical history and concomitant medication details were not provided. On *30-Dec-2024*, the patient took the first dose of Vivotif vaccine (batch number: *3004281; expiration date: Feb-2026) at a dose of one capsule* orally, for pretravel protection. On *31-Dec-2024, one day after the first dose, reported as upon waking, the patient developed a mild* worsening rash on face. On *01-Jan-2025, two days after the first dose*, the patient took the second dose of Vivotif vaccine (batch number: *3004281; expiration date: Feb-2026) at a dose of one capsule* orally. On *03-Jan-2025, four days after the first dose*, the patient took the third dose of Vivotif vaccine (batch number: *3004281; expiration date: Feb-2026) at a dose of one capsule* orally. *As reported, the patient received only three doses of Vivotif vacccine (explicitly coded as 'inappropriate schedule of vaccine administered') *. *On 05-Jan-2025, the patient was recovered from the event 'rash aggravated', as reported duration was five or six days*. The reporter *assessed the event of 'rash aggravated' as non-serious and probably related to Vivotif*. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a pharmacist on 20-Jan-2025: New information included added reporter details, patient initials, Vivotif dosing details, event onset date, stop date, outcome, severity, seriousness, causality and confirmation that patient did not receive any additional doses of Vivotif.; Reporter's Comments: A 12-year-old female patient developed a non-serious event of worsening rash on face on the day 1 after the first dose of Vivotif vaccine for pretravel protection. As reported, the patient received only three doses of Vivotif vaccine, which is considered as inappropriate schedule of vaccine administered. Rash is listed and expected for Vivotif per CCDS v8 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering plausible temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 12-year-old female patient developed a non-serious event of worsening rash on face on the day 1 after the first dose of Vivotif vaccine for pretravel protection. As reported, the patient received only three doses of Vivotif vaccine, which is considered as inappropriate schedule of vaccine administered. Rash is listed and expected for Vivotif per CCDS v8 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering plausible temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE