Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: The patients took the first and the second doses of Vivotif which were out of refrigerator, total duration 75 hours, maximum temperature was 73 Fahrenheit degrees; The patients took the first and the second doses of Vivotif which were out of refrigerator, total duration 75 hours, maximum temperature was 73 Fahrenheit degrees; Case reference number US-BN-2024-002066 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-1403) on 18-Jun-2024 and concerns two patients 16-years-old and 18-years-old of unspecified gender.  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, as reported last Friday at 5 PM, eight pills of Vivotif vaccine were purchased and were out of the refrigerator, maximum temperature was 73 Fahrenheit degree (explicitly coded 'product storage error').  On 14-Jun-2024, as reported last Friday at 7:30 PM, as reported two hours after purchase and not refrigerated, patients took the first dose of Vivotif (batch number: 3004044), at unknown dose, orally, for an unknown indication (explicitly coded as 'product administration error').  On 16-Jun-2024, as reported on Sunday, three days after the first dose of Vivotif, patients took the second dose of Vivotif  (batch number: 3004044), at unknown dose, orally (explicitly coded as 'product administration error'). As reported, total duration of excursion was 75h.  At the time of the initial report, it was unknown if any of the patients experienced any adverse event due to Vivotif vaccine.  Additional information received from consumer on 18-Jun-2024 via Med Communications (reference number: USBAV24-1408) included: age for second patient, and an additional reference number.; Reporter's Comments: Two patients, a 16-year-old and 18-year-old of unspecified gender took the first and the second dose of Vivotif, after Vivotif vaccines were out of the refrigerator, maximum temperature was 73 Fahrenheit degree, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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: Two patients, a 16-year-old and 18-year-old of unspecified gender took the first and the second dose of Vivotif, after Vivotif vaccines were out of the refrigerator, maximum temperature was 73 Fahrenheit degree, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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.