Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient did not receive dose of Vivotif about 48 hours after the last dose; Case reference number US-BN-2024-000004 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV24-0008) on 02-Jan-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 29-Dec-2023, the patient received a dose of Vivotif (batch number), at an unknown dose or route of administration, for unknown indication. As reported, the patient was scheduled to receive the next dose of Vivotif on On 31-Dec-2023, however the patient did not receive dose of Vivotif about 48 hours after the last dose (explicitly coded as 'missed dose'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from Emergent BioSolutions on 03-Jan-2024 and included local case reference ID and confirmation of patient's gender.; Reporter's Comments: A male patient of unspecified age was scheduled to receive the next dose of Vivotif, however the patient did not receive dose of Vivotif about 48 hours after the last dose, which is considered as missed dose. It was unknown if the patient experienced 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 male patient of unspecified age was scheduled to receive the next dose of Vivotif, however the patient did not receive dose of Vivotif about 48 hours after the last dose, which is considered as missed dose. It was unknown if the patient experienced 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