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 Vivotif vaccine left unrefrigerated in the car (probably not above 60 degrees Fahrenheit); The Vivotif vaccine left unrefrigerated in the car (probably not above 60 degrees Fahrenheit); The female patient received second dose of Vivotif which was left unrefrigerated in the car (probably not above 60 degrees Fahrenheit); Case reference number US-BN-2025-000268 is a spontaneous case report initially received from consumer via Communication (reference number: USBAV25-0382) on 19-Feb-2025 concerns a female patient (wife) of unknown age. The patient relevant medical history and concomitant medications were not provided. As reported, the patient and her husband will be travelling in 10 days. The patient's husband picked up her prescription, but the pharmacy did not tell him it needed to be refrigerated. The patient's husband left the Vivotif vaccine in the car (probably not above 60 degrees Fahrenheit) (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too high'). On unspecified date, the patient took first dose of Vivotif without being refrigerated (batch number: unknown) at a dose of one capsule, orally, for indication reported as travelling. On 19-Feb-2025, reported as today, unknown amount of time after the first dose, the female patient took second dose of Vivotif without being refrigerated (batch number: unknown) at a dose of one capsule, orally (explicitly coded as 'product administration error'). As reported, the patient's husband had not taken dose yet, and picking up his prescription on 20-Feb-2025, reported as tomorrow. At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. Additional information received from a consumer via Communications on 19-Feb-2025 included: reference number (USBAV25-0383) and demographic information for husband.; Reporter's Comments: A female patient of unknown age took a dose of Vivotif without being refrigerated, namely the Vivotif vaccine was in the car (probably not above 60 degrees Fahrenheit), which is considered as product administration error, product temperature excursion issue and product storage error temperature too high. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient relevant medical history and concomitant medications were not provided. 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 female patient of unknown age took a dose of Vivotif without being refrigerated, namely the Vivotif vaccine was in the car (probably not above 60 degrees Fahrenheit), which is considered as product administration error, product temperature excursion issue and product storage error temperature too high. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient relevant medical history and concomitant medications were not provided. 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