Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient took first dose of Vivotif within 24 hours of picking up the medication, reaching a maximum temperature of 70 degrees Fahrenheit and the second dose was taken two days later and unrefrigerated.; The patient took first dose of Vivotif within 24 hours of picking up the medication, reaching a maximum temperature of 70 degrees Fahrenheit and the second dose was taken two days later and unrefrigerated.; The patient took first dose of Vivotif within 24 hours of picking up the medication, reaching a maximum temperature of 70 degrees Fahrenheit and the second dose was taken two days later and unrefrigerated.; The patient did not complete the course because they assumed it was not good anymore.; Case reference number US-BN-2025-000312 is a spontaneous case report initially received from other healthcare professional via Communication (reference number: USBAV25-0492) on 04-Mar-2025 concerns a 17-years-old male patient. The patient relevant medical history and concomitant medications were not provided. On unspecified date, the patient was prescribed with Vivotif but did not refrigerate it. On unspecified date, reported as within 24 hours of picking up the medication, the patient took first dose of Vivotif, which reached a maximum temperature of 70 degrees Fahrenheit (batch number: unknown) at an unknown dose, orally, for indication reported as typhoid immunization (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too high' and 'product administration error'). On unspecified date, reported as two days later, the patient took second dose of Vivotif (batch number: unknown) at an unknown dose, orally and unrefrigerated (explicitly coded as 'product administration error'). As reported, the patient did not complete the course because they assumed it was not good anymore (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 17-year-old male patient took first dose of Vivotif, which reached a maximum temperature of 70 degrees Fahrenheit for indication reported as typhoid immunization, which is considered as product temperature excursion issue, product storage error temperature too high and product administration error. On unspecified date, reported as two days later, the patient took second dose of Vivotif unrefrigerated, which is considered as product administration error. As reported, the patient did not complete the course because it was assumed it was not good anymore, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error, product temperature excursion issue, product administration error and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue, product administration error and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 17-year-old male patient took first dose of Vivotif, which reached a maximum temperature of 70 degrees Fahrenheit for indication reported as typhoid immunization, which is considered as product temperature excursion issue, product storage error temperature too high and product administration error. On unspecified date, reported as two days later, the patient took second dose of Vivotif unrefrigerated, which is considered as product administration error. As reported, the patient did not complete the course because it was assumed it was not good anymore, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error, product temperature excursion issue, product administration error and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue, product administration error and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None