Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004008 | PO / MO |
The patient left Vivotif in the car for one hour and 40 minutes, the maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened; The patient left Vivotif in the car for one hour and 40 minutes, the maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened; Case reference number US-BN-2024-001926 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-1073) on 17-May-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened (explicitly coded as 'product storage error'). On an unspecified date, the patient took a first dose of Vivotif (batch number: 3004008) at an unknown dose, orally, for typhoid immunization (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first dose of Vivotif for typhoid immunization, after the patient left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown age and gender took the first dose of Vivotif for typhoid immunization, after the patient left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.