Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004009 | PO / MO |
The patient did not take the fourth dose of Vivotif as the dog ate it; Case reference number US-BN-2024-001915 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-1039) on 14-May-2024 and concerns a *64-year-old female patient.* The patient's medical history and concomitant medication details were not provided. *On 09-May-2024,* the patient took the first dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule,* orally, for typhoid immunization. *On 11-May-2024, three days after the first dose of Vivotif,* the patient took the second dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule, orally.* *On 13-May-2024, five days after the first dose of Vivotif,* the patient took the third dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule, orally.* As reported, the patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it (explicitly coded as 'missed dose'). *As reported, the patient did not experience any adverse event due to Vivotif.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Additional information received from a nurse on 15-May-2024: New information included confirmation that the patient did not take the fourth dose of Vivotif. Follow up information received from a nurse on 28-May-2024: New information included added patient demographic details, Vivotif dosage information and confirmation on the fourth dose of Vivotif, and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 64-year-old female patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it, which is considered as missed dose. Reportedly, the patient did not experience any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue 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 64-year-old female patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it, which is considered as missed dose. Reportedly, the patient did not experience any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.