Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004081 | PO / MO |
The patient took the first dose of Vivotif vaccine which was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit; The patient took the first dose of Vivotif vaccine which was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit; Case reference number US-BN-2024-002795 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-3063) on 19-Nov-2024 and concerns a 26-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 18-Nov-2024, reported as yesterday, the patient picked up Vivotif and forgot to put in the fridge. The Vivotif vaccine was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit and the vaccines were placed back in the fridge (explicitly coded as a 'product storage error'). On the same day, the patient took the first dose of the defected Vivotif capsule (batch number: 3004081) at dose of one capsule, orally, for indication typhoid immunization (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 the Vivotif vaccine. Non-significant follow up was downloaded from VAERS on 09-May-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241119-0cda6a to US-BAVARIAN NORDIC A/S-US-BN-2024-002795, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 26-year-old male patient picked up Vivotif and forgot to put in the fridge. The Vivotif vaccine was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit, and the vaccines were placed back in the fridge, which is considered as product storage error. On the same day, the patient took the first dose of the defected Vivotif capsule for indication typhoid immunization, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the 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 are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 26-year-old male patient picked up Vivotif and forgot to put in the fridge. The Vivotif vaccine was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit, and the vaccines were placed back in the fridge, which is considered as product storage error. On the same day, the patient took the first dose of the defected Vivotif capsule for indication typhoid immunization, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the 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 are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None