Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3003851 | PO / MO |
The patient took four doses of Vivotif vaccine every day instead of every other day; Case reference number US-BN-2024-000057 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0082) on 12-Jan-2024 and concerns an adult male patient. The patient's medical history and concomitant medication details were not provided. *On 09-Jan-2024, the patient took the first dose of Vivotif vaccine (batch number: 3003851, expiry date: 31-Mar-2024), orally for typhoid vaccine*. *On 10-Jan-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: 3003851, expiry date: 31-Mar-2024), orally*. As reported, the patient was instructed to take 1 capsule every other day, but the patient reported they took 1 capsule every day instead (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 11-Jan-2024, two days after the first dose, the patient took the third dose of Vivotif # (batch number: 3003851, expiry date: 31-Mar-2024), orally* (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 12-Jan-2024, three days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3003851, expiry date: 31-Mar-2024), orally* (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the follow up 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 (*). Additional information received on 15-Jan-2024 from a pharmacist included confirmation of patient's date of birth. Follow-up information received from a pharmacist on 29-Jan-2024: New information included information about Vivotif dosing information, dates of administration, expiration date and indication, and confirmation that medical history was not available.; Reporter's Comments: An adult male patient took the first dose of Vivotif vaccine reportedly for typhoid vaccine. Reportedly, the patient received the second, the third and the fourth dose of Vivotif on the days 1, 2, and 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. 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: An adult male patient took the first dose of Vivotif vaccine reportedly for typhoid vaccine. Reportedly, the patient received the second, the third and the fourth dose of Vivotif on the days 1, 2, and 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. 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.