Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: The patient did not take fourth dose of Vivotif on scheduled date; The finale capsule of Vivotif was unrefrigerated for 16 hours at potentially room temperature; Case reference number US-BN-2024-002002 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1297) on 06-Jun-2024 and concerns 18-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient received first, second and third dose of Vivotif (batch number: 3004041), at unknown dose, orally, for immunization against disease caused by salmonella typhi.  On an unspecified date, reported as yesterday, the patient was due for final fourth dose of Vivotif, and didn't take it (explicitly coded as 'Inappropriate schedule of vaccine administered').  As reported, the final capsule was unrefrigerated for 16 hours, and it was unknown if it was at room temperature, because the patient travelled and potentially that the temperature could be above room temperature (explicitly coded as 'Product storage 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: An 18-years-old female patient was due for final fourth dose of Vivotif, and didn't take it which is considered as inappropriate schedule of vaccine administered. Reportedly, the final capsule was unrefrigerated for 16 hours, and it was unknown if it was at room temperature, because the patient travelled and potentially that the temperature could be above room temperature which is considered as product storage error. Inappropriate schedule of product administration and product storage 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. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An 18-years-old female patient was due for final fourth dose of Vivotif, and didn't take it which is considered as inappropriate schedule of vaccine administered. Reportedly, the final capsule was unrefrigerated for 16 hours, and it was unknown if it was at room temperature, because the patient travelled and potentially that the temperature could be above room temperature which is considered as product storage error. Inappropriate schedule of product administration and product storage 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. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.