Report #2889677

Overview

Sex

Female

Age

Age unknown

State

WA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Vivotif was left out for over 50 hours at around 68-69ºF, and patient took two doses; Vivotif was left out for over 50 hours at around 68-69ºF, and patient took two doses; Vivotif was left out for over 50 hours at around 68-69ºF, and patient took two doses; Case reference number US-BN-2025-001752 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-000549) on 31-Oct-2025 and concerns a female patient of an unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif out for over 50 hours since it was picked up at around 68–69-degree F (explicitly coded as 'Product temperature excursion issue' and 'Product storage error') On unspecified date, the patient was vaccinated with dose of Vivotif (batch number: 3004337) at an unknown dose, and route of administration for an unknown indication. (explicitly coded as 'Product administration error') On unspecified date, the patient was vaccinated with another dose of Vivotif (batch number: 3004337) at an unknown dose, and route of administration At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received on 04-Nov-2025 from Bavarian Nordic included reference number. (BN-2025-00312); Reporter's Comments: A female patient of an unspecified age left Vivotif out for over 50 hours since it was picked up at around 68–69-degree F, which is considered as product temperature excursion issue and product storage error. On unspecified date, the patient was vaccinated with dose of Vivotif for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error, product temperature excursion issue and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product temperature excursion issue and product storage 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 an unspecified age left Vivotif out for over 50 hours since it was picked up at around 68–69-degree F, which is considered as product temperature excursion issue and product storage error. On unspecified date, the patient was vaccinated with dose of Vivotif for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error, product temperature excursion issue and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product temperature excursion issue and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.

Medical history

Comments: None.