Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient took four capsules of Vivotif every day rather than every other day.; Case reference number US-BN-2024-000175 is a spontaneous case report initially received from other health care professional via Med Communications (reference number: USBAV24-0292) on 09-Feb-2024 and concerns 18-years-old male. The patient's medical history and concomitant medications were not provided. On 01-Jan-2024, the patient took the first dose of Vivotif (batch number: unknown) *one capsule*, orally, as reported for Immunization against disease caused by salmonella typhi indication. On 02-Jan-2024, one day after first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown) *one capsule*, orally (explicitly codded as 'Inappropriate schedule of vaccine administered'). On 03-Jan-2024, two days after first dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown) *one capsule*, orally (explicitly codded as 'Inappropriate schedule of vaccine administered'). On 04-Jan-2024, three days after first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: unknown) *one capsule*, orally (explicitly codded as 'Inappropriate schedule of vaccine administered'). *At the time of the initial report, 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 nurse on 20-Feb-2024: volume for four doses of Vivotif updated, patient initials added and confirmation that patient did not experience any adverse event.; Reporter's Comments: An 18-year-old male patient took the second, third and the fourth dose of Vivotif vaccine for immunization against disease caused by salmonella typhi indication, on the days 1, 2 and 3 after the patient took the first dose of Vivotif, which is considered as inappropriate schedule of product administration. 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 medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An 18-year-old male patient took the second, third and the fourth dose of Vivotif vaccine for immunization against disease caused by salmonella typhi indication, on the days 1, 2 and 3 after the patient took the first dose of Vivotif, which is considered as inappropriate schedule of product administration. 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 medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None