Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Patient had reaction after first dose of Vivotif and patient will not complete vaccination; Patient had reaction after first dose of Vivotif and patient will not complete vaccination; Case reference number US-BN-2024-001969 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1154) on 28-May-2024 and concerns a patient of unspecified age and gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally for unknown indication. On unspecified date, unknown amount of time after taking the first dose of Vivotif, the patient experienced unspecified adverse reaction, and as reported the patient will not complete the vaccination (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, the outcome of the adverse reaction was unknown. The reporter assessed the adverse reaction as non-serious and related to Vivotif. No further information was provided.; Reporter's Comments: A patient of unspecified age and gender experienced unspecified adverse reaction, unknown time after taking the first dose of Vivotif and as reported the patient will not complete the vaccination which is considered as incomplete course of vaccination. Adverse reaction and incomplete course of vaccination are both considered listed per company conventions. The outcome of the adverse reaction was unknown. The patient's relevant medical history and concomitant medications were not provided. Adverse reaction is conservatively assessed as related due to lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender experienced unspecified adverse reaction, unknown time after taking the first dose of Vivotif and as reported the patient will not complete the vaccination which is considered as incomplete course of vaccination. Adverse reaction and incomplete course of vaccination are both considered listed per company conventions. The outcome of the adverse reaction was unknown. The patient's relevant medical history and concomitant medications were not provided. Adverse reaction is conservatively assessed as related due to lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None