Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004009 | PO / MO |
The patient received the second dose of Vivotif three days after the first dose; Case reference number US-BN-2024-001845 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0859) on 29-Apr-2024 and concerns a *22-year-old female patient.* The patient *had no relevant medical history and was not taking any concomitant medication.* On 26-Apr-2024, the patient took the first dose of Vivotif *(batch number: 3004009, expiration date: 31-Oct-2024)*, one capsule, orally, for typhoid immunization. As reported, patient was due to take the other dose on the 28th but forgot (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 29-Apr-2024, three days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004009, expiration date: 31-Oct-2024), one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). The patient was advised it is safe to continue the rest of the doses every other day. The reporter did not continue to follow-up if the patient took the last two doses on schedule and assumed that the patient did.* At the time of the *follow-up* report, it was unknown if the patient experienced any adverse event due to Vivotif. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow up information received from the reporter on 10-Jun-2024, new information included: patient details, Vivotif dosing information, medical history and concomitant medications information. Non-significant case correction performed for information received form the reporter on 24-Jun-2024 included confirmation that patient did not report anything back to the clinic.; Reporter's Comments: A 22-year-old female patient took the second dose of Vivotif on the day 3 after the patient took the first dose of Vivotif for typhoid immunization, 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. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 22-year-old female patient took the second dose of Vivotif on the day 3 after the patient took the first dose of Vivotif for typhoid immunization, 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. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None