Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004007 | PO / MO |
The patient took second dose of Vivotif one day early, and the third dose one day late; Case reference number US-BN-2024-002242 is a spontaneous case initially received from nurse care professional via Med Communications (reference number USBAV24-1755) on 23-Jul-2024 and concerns a 41-year-old female patient. The patient's medical history and concomitant medication details were not provided. *On 18-Jul-2024,* the patient took the first dose of Vivotif (batch number: 3004007, *expiry date: 31-Oct-2024), one capsule,* orally, for immunization against disease caused by salmonella typhi *and travel.* *On 19-Jul-2024,* one day after the first dose of Vivotif, reported as one day early, the patient took the second dose of Vivotif (batch number: 3004007, *expiry date: 31-Oct-2024), one capsule, orally* (explicitly coded as 'Inappropriate schedule of vaccine administered'). *On 21-Jul-2024,* three days after the first dose of Vivotif, reported as one day late, the patient took the third dose of Vivotif (batch number: 3004007, *expiry date: 31-Oct-2024),* one capsule, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). *On 24-Jul-2024, six days after the first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024), one capsule, orally*. *As reported, the patient did not experience any adverse event due 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 a nurse on 04-Sep-2024: New information included added patient initials, Vivotif dosage information and confirmation on adverse events during the administration of Vivotif. Additional information received from a nurse on 09-Sep-2024: information included confirmation on the date of birth.; Reporter's Comments: A 41-year-old female patient took the second dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 1 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, the patient took the third dose of Vivotif, on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. 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 41-year-old female patient took the second dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 1 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, the patient took the third dose of Vivotif, on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. 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.