Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004043 | PO / MO |
Patient left fourth dose of Vivotif on kitchen counter for 72 hours; Patient left fourth dose of Vivotif on kitchen counter for 72 hours; The patient received fourth dose of Vivotif, 14 days after the first dose; Patient received four capsules of Vivotif as a fourth dose; Case reference number US-BN-2024-002190 is a spontaneous case initially received from health care professional via agency (reference number: USBAV24-1640) on 12-Jul-2024 and concerns a *71-year-old* female patient. The patient's medical history and concomitant medication details were not provided. *On 02-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004043, expiry date: 30-Nov-2024), one capsule*, orally, for typhoid immunization. *On 04-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004043, expiry date: 30-Nov-2024), one capsule, orally.* *On 06-Jul-2024, four days after the first dose, the patient took the third dose of Vivotif (batch number: 3004043, expiry date: 30-Nov-2024), one capsule, orally.* *On 16-Jul-2024, 14 days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004044, expiry date: 31-Jul-2024), at a dose reported as four capsules, orally. As reported, the patient left fourth dose of Vivotif on kitchen counter for 72 hours (explicitly coded as 'vaccine overdose', 'product storage error', 'product administration error' and 'inappropriate schedule of vaccine administered')*. At the time of follow up report, the patient did not experience any adverse event due to Vivotif. Follow up information received from a health care professional on 26-Jul-2024: New information included patient demographic details (patient initials and age), Vivotif dosage information, and confirmation that the patient did not experience any adverse event due to Vivotif. Non-significant follow up was downloaded from VAERS on 09-May-2025 included new reference number Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240712-b2271c to US-BAVARIAN NORDIC A/S-US-BN-2024-002190, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 71-year-old female patient took the fourth dose of Vivotif on day 14 from the first one, which is considered inappropriate schedule of vaccine administered. The patient received four doses on this day, which is considered overdose. The capsules had been kept at room temperature for 72 hours, which is considered product storage error and product administration error. No associated adverse events were reported. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are not related to the suspect vaccine, but to human factor. This case is considered as non-serious.; Sender's Comments: A 71-year-old female patient took the fourth dose of Vivotif on day 14 from the first one, which is considered inappropriate schedule of vaccine administered. The patient received four doses on this day, which is considered overdose. The capsules had been kept at room temperature for 72 hours, which is considered product storage error and product administration error. No associated adverse events were reported. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are not related to the suspect vaccine, but to human factor. This case is considered as non-serious.
Comments: None.