Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
Patient took first and second dose of Vivotif, and forgot to take third dose; Case reference number US-BN-2024-001922 is a spontaneous case report initially received from pharmacist via Med Communication (reference number: USBAV24-1064) on 16-May-2024 and concerns male patient. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient was vaccinated with first dose of Vivotif vaccine (batch number: unknown), at unknown dose, reported as four capsules, at an unknown route of administration, for unknown indication. On unspecified date, the patient was vaccinated with second dose of Vivotif vaccine (batch number: unknown), at unknown dose, reported as four capsules, at an unknown route of administration. As reported, the patient took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later (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: This case concerns a male patient who took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later 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: This case concerns a male patient who took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later 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