Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3003908 | PO / MO |
The patient received third Vivotif capsule on day 7 and fourth capsule on day 12; Case reference number US-BN-2024-000194 is a spontaneous case report initially received from a nurse via Med Communication on 19-Feb-2024 and concerns a *17-years-old* female patient. The patient's medical history and concomitant medication details were not provided. On 27-Jan-2024, the patient took a first dose of Vivotif (batch number: 3003908; *expiration date: Jun-2024), at a dose of one capsule* via oral route, for typhoid immunization. On 29-Jan-2024, two days after the first dose, the patient took a second dose of Vivotif (batch number: 3003908, *expiration date: Jun-2024), at a dose of one capsule* via oral route. On 02-Feb-2024, on day seven instead on day five, the patient took a third dose of Vivotif (batch number: 3003908; *expiration date: Jun-2024), at a dose of one capsule* via oral route (explicitly coded as inappropriate schedule of vaccine administered'). On 07-Feb-2024, on day 12 instead on day seven, the patient took a fourth dose of Vivotif (batch number: 3003908; *expiration date: Jun-2024), at a dose of one capsule* via oral route (explicitly coded as inappropriate schedule of vaccine administered'). *At the time of follow up report, the patient did not experience any adverse event due to Vivotif vaccine.* Additional information received from a nurse via Med Communication on 21-Feb-2024: New information included additional reporter (nurse) and additional reference number. 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 05-Apr-2024: New information included patient's demographic information, expiration date and dose for four doses of Vivotif vaccines and conformation that the patient did not experience any adverse event due to Vivotif.; Reporter's Comments: A 17-year-old female patient of unknown age took the third (one capsule) and the fourth (one capsule) dose of Vivotif on the days 7 and 12, which is considered as inappropriate schedule of vaccine administered. It was confirmed that 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 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: A 17-year-old female patient of unknown age took the third (one capsule) and the fourth (one capsule) dose of Vivotif on the days 7 and 12, which is considered as inappropriate schedule of vaccine administered. It was confirmed that 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.