Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004008 | PO / MO |
The patient took one dose of Vivotif vaccine which spent two weeks out of refrigerator, maximum temperature was 70 degrees Fahrenheit; The patient took one dose of Vivotif vaccine which spent two weeks out of refrigerator, maximum temperature was 70 degrees Fahrenheit; Case reference number US-BN-2024-002058 is a spontaneous case initially received from consumer via Communications (reference number USBAV24-1392) on 17-Jun-2024 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On 17-Jun-2024, as reported today, the patient took one dose of Vivotif vaccine (batch number: 3004008), at unknown dose, reported as one pill, orally, for typhoid fever immunisation. As reported, one box of Vivotif vaccine spent two weeks out of the refrigerator, maximum temperature was 70 Fahrenheit degree (explicitly coded 'Product storage error' and 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to 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-20240617-004d82 to US-BAVARIAN NORDIC A/S-US-BN-2024-002058, in accordance with ICH guidance on WWID formatting."; Reporter's Comments: A patient of unspecified age and gender took one dose of Vivotif vaccine for typhoid fever immunisation. As reported, one box of Vivotif vaccine spent two weeks out of the refrigerator, maximum temperature was 70 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: A patient of unspecified age and gender took one dose of Vivotif vaccine for typhoid fever immunisation. As reported, one box of Vivotif vaccine spent two weeks out of the refrigerator, maximum temperature was 70 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. USBAV24-1392:
Comments: None