Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004062 | — |
The patient took Vivotif vaccine which did not refrigerate, maximum reached temperature was 77 Fahrenheit degrees; The patient took Vivotif vaccine which did not refrigerate,maximum reached temperature was 77 Fahrenheit degrees; Case reference number US-BN-2024-002523 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2438) on 19-Sep-2024 and concerns a female patient of unspecified age, born in 1978. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as since 14-Sep-2024, the patient did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees (explicitly coded as 'Product storage error'). On 14-Sep-2024, the patient took the first dose of Vivotif vaccine (batch number: 3004062), at unknown dose, route or site of administration, for immunization (explicitly coded as 'Product administration error') At the time of 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-20240919-bce90f to US-BAVARIAN NORDIC A/S-US-BN-2024-002523, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unspecified age, born in 1978 did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees which is considered as product storage error. The patient took the first dose of Vivotif vaccine, at unknown dose, route or site of administration, for immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age, born in 1978 did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees which is considered as product storage error. The patient took the first dose of Vivotif vaccine, at unknown dose, route or site of administration, for immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None