Sex: U
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: The Jynneos vaccine was left in freezer, freezer malfunctioned and the final temperature reached 30 degrees Fahrenheit for six hours, vials were half melted and was moved to different freezer; The Jynneos vaccine was left in freezer, freezer malfunctioned and the final temperature reached 30 degrees Fahrenheit for six hours, vials were half melted and was moved to different freezer; The patient received the Jynneos vaccine which temperature reached 30 degrees Fahrenheit for six hours; Case reference number US-BN-2025-000014 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0025) on 06-Jan-2025 and concerns a patient with unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, eight vials of Jynneos vaccine had temperature excursion, as reported freezer malfunctioned and the final temperature reached 30 degrees F for six hours, vials were half melted, and vaccine was moved to different freezer at that point (explicitly coded as 'product storage error too high' and 'product temperature excursion issue')  On unspecified date, as reported five days later, the patient received defected dose of Jynneos vaccine (batch number: #96867; expiration date: 04/2024), at unknown dose, route or site of administration for unknown indication (explicitly coded as 'product administration error').   At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos.  No further information was provided.; Reporter's Comments: A patient with unspecified age and gender received defected dose of Jynneos vaccine for unknown indication. Reportedly, Jynneos vaccine had temperature excursion, freezer malfunctioned, and the final temperature reached 30 degrees F for six hours, vials were half melted, and vaccine was moved to different freezer at that point, which is considered as product storage error too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due Jynneos. 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. Product storage error, product temperature excursion issue 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 patient with unspecified age and gender received defected dose of Jynneos vaccine for unknown indication. Reportedly, Jynneos vaccine had temperature excursion, freezer malfunctioned, and the final temperature reached 30 degrees F for six hours, vials were half melted, and vaccine was moved to different freezer at that point, which is considered as product storage error too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due Jynneos. 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. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.