Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient took two doses of Vivotif correctly, but third dose patient took 12 hours later; Case reference number US-BN-2024-001896 is a spontaneous case report initially received from nurse via Med Communications (reference number: USBAV24-0993) on 09-May-2024 and concerns patient of unspecified age and gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took two doses of Vivotif (batch number: unknown) at unknown doses, orally, for typhoid immunization, due to trip. On unspecified date, reported as 12 hours later than Vivotif should be taken, patient took third dose of Vivotif, at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A patient of unspecified age and gender took third dose of Vivotif, 12 hours later than Vivotif should have been taken which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender took third dose of Vivotif, 12 hours later than Vivotif should have been taken which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.