Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took all four doses of Vivotif vaccine which were unrefrigerated; The patient took all four doses of Vivotif vaccine which were unrefrigerated; Flu like symptoms; Case reference number US-BN-2024-002129 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-1556) on 03-Jul-2024 and concerns a 19-years-old male patient.  The patient's medical history and concomitant medication details were not provided.  As reported, the patient did not refrigerate Vivotif vaccine (explicitly coded as 'Product storage error')  On 27-Jun-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally, for unknown indication (explicitly coded as 'Product administration error')  On 29-Jun-2024, two days after first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally (explicitly coded as 'Product administration error').  On 01-Jul-2024, two days after second dose of Vivotif, the patient took the third dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally (explicitly coded as 'Product administration error').  On 03-Jul-2024, two days after third dose of Vivotif, as reported, the patient started with flu like symptoms, but took the fourth dose of Vivotif regardless (batch number: unknown), at an unknown dose, orally (explicitly coded as 'Product administration error').  At the time of initial report, it was unknown if the patient recovered form event of flu like symptoms.  The reporter assessed the event of flu like illness as non-serious and did not provide causality assessment for the event flu like illness.   Additional information received on 03-Jul-2024 from Emergent BioSolutions included additional reference number (EMG224-751) and confirmation that the patient took Vivotif vaccine without it being under the refrigeration.; Reporter's Comments: A 19-years-old male patient did not refrigerate Vivotif vaccine which is considered as product storage error and took the first dose of Vivotif vaccine, at an unknown dose, orally, for unknown indication which is considered as product administration error. Two days after first dose of Vivotif, the patient took the second dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error.  Two days after second dose of Vivotif, the patient took the third dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Two days after third dose of Vivotif, as reported, the patient started with flu like symptoms, but took the fourth dose of Vivotif regardless, at an unknown dose, orally which is also considered as product administration error. At this point, it was unknown if the patient recovered form event of flu like symptoms. Influenza like illness is listed according to CCDS v8 and unexpected according to USPI while product administration error and product storage error are both considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Influenza like illness is assessed as related due to plausible temporal relationship and known product safety profile. Product administration error 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: A 19-years-old male patient did not refrigerate Vivotif vaccine which is considered as product storage error and took the first dose of Vivotif vaccine, at an unknown dose, orally, for unknown indication which is considered as product administration error. Two days after first dose of Vivotif, the patient took the second dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error.  Two days after second dose of Vivotif, the patient took the third dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Two days after third dose of Vivotif, as reported, the patient started with flu like symptoms, but took the fourth dose of Vivotif regardless, at an unknown dose, orally which is also considered as product administration error. At this point, it was unknown if the patient recovered form event of flu like symptoms. Influenza like illness is listed according to CCDS v8 and unexpected according to USPI while product administration error and product storage error are both considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Influenza like illness is assessed as related due to plausible temporal relationship and known product safety profile. Product administration error and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1556: