Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004063 | PO / MO |
The patient took the pill of Vivotif vaccine which had temperature excursion for three days, maximum temperature reached 65 Fahrenheit; The patient took the pill of Vivotif vaccine which had temperature excursion for three days, maximum temperature reached 65 Fahrenheit; The patient took the pill of Vivotif vaccine which had temperature excursion for three days, maximum temperature reached 65 Fahrenheit; The patient received only first dose of Vivotf vaccine; Case reference number US-BN-2024-002815 is a spontaneous case initially received from a consumer via Communications (reference number: USBAV24-3124) on 26-Nov-2024 and concerns a 75-years-old female patient. The patient's medical history and concomitant medication details were not provided. On 22-Nov-2024, on Friday, as reported the Vivotif vaccine was put on the shelf for three days, the maximum temperature reached 65 Fahrenheit (explicitly coded as 'product storage error' and 'product temperature excursion issue'). As reported, the patient was not counselled that the medication should be stored in the refrigerator. On 25-Nov-2024, the patient took the first dose of the affected Vivotif vaccine, (batch number: 3004063), *at a dose of one pill*, orally. *As reported, the patient took only first dose of Vivotif* (explicitly coded as 'product administration error' and *'Incomplete course of vaccination'*). At the time of the follow-up report, the patient did not experience any adverse event due to Vivotif.. Additional information received from consumer via Med Communication (reference number: USBAV24-3136) on 26-Nov-2024 included: additional reference number, lot number for Vivotif vaccine, information about temperature and total length of excursion, and conformation that the patient took affected vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a consumer on 12-Jan-2025: New information included added patient age, information on Vivotif additional doses, and confirmed that patient did not experience any adverse event due to Vivotif and was not counselled that the medication should be stored in the refrigerator. Follow up information received from a consumer on 29-Jan-2025: New information included Vivotif dosing information. 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-20241126-3e70e1 to US-BAVARIAN NORDIC A/S-US-BN-2024-002815, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 75-year-old female patient took the affected dose of the Vivotif vaccine for indication Typhoid immunization four days after the first dose, which was put on the shelf for three days, the maximum temperature reached 65 Fahrenheit, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of the affected Vivotif vaccine, at a dose of one pill, orally and took only first dose of Vivotif which is considered as product administration error and incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration, product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination, product temperature excursion issue, 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 75-year-old female patient took the affected dose of the Vivotif vaccine for indication Typhoid immunization four days after the first dose, which was put on the shelf for three days, the maximum temperature reached 65 Fahrenheit, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of the affected Vivotif vaccine, at a dose of one pill, orally and took only first dose of Vivotif which is considered as product administration error and incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration, product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination, product temperature excursion issue, 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.