Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took four doses of Vivotif which were left unrefrigerated at the normal room temperature of 80 Fahrenheit; The patient took four doses of Vivotif which were left unrefrigerated at the normal room temperature of 80 Fahrenheit; Case reference number US-BN-2024-002506 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2402) on 17-Sep-2024 and concerns a 19-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as at the end of August, the doses of Vivotif were left unrefrigerated at a normal room temperature of 80 Fahrenheit (explicitly coded as 'product storage error'). As reported, the Vivotif vaccine was left out of the refrigerator the whole time after picking up the vaccine.  On 23-Aug-2024, the patient took the affected first dose of Vivotif (batch number: unknown), at a dose of a capsule, orally, for an indication reported as pre travel for mission trip (explicitly coded as 'product administration error').  On 25-Aug-2024, two days after the first dose, the patient took the affected second dose of Vivotif (batch number: unknown), at a dose of a capsule, orally (explicitly coded as 'product administration error').  On 27-Aug-2024, four days after the first dose, the patient took the affected third dose of Vivotif (batch number: unknown), at a dose of a capsule, orally (explicitly coded as 'product administration error').  On 29-Aug-2024, six days after the first dose, the patient took the affected fourth dose of Vivotif (batch number: unknown), at a dose of a capsule, orally (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 vaccine.  No further information was provided.; Reporter's Comments: A 19-year-old male patient took the affected first dose of Vivotif which were left unrefrigerated at a normal room temperature of 80 Fahrenheit (considered as product storage error), at a dose of a capsule, orally, for an indication reported as pre travel for mission trip which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Four days after the first dose, the patient took the affected third dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Six days after the first dose, the patient took the affected fourth dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient took the affected first dose of Vivotif which were left unrefrigerated at a normal room temperature of 80 Fahrenheit (considered as product storage error), at a dose of a capsule, orally, for an indication reported as pre travel for mission trip which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Four days after the first dose, the patient took the affected third dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Six days after the first dose, the patient took the affected fourth dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.