Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: We had a temperature excursion and it was given to one patient; We had a temperature excursion and it was given to one patient; Case reference number US-BN-2022-004313 is a spontaneous case report initially received on 25-Oct-2022 from other healthcare professional (reference number: USBAV22-1773) and concerns a patient of unknown gender and age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: Unknown), at unknown dose, administered via an unspecified route, in unknown anatomical location, for unknown indication.  As reported, the vaccine reached 35.2 degrees Fahrenheit for 1 minute and 35 seconds. It was given to one patient (explicitly coded as 'Product administration error' and 'Product temperature excursion issue').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 25-Oct-2022 from Bavarian Nordic included local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from an HCP on 26-Oct-2022 (reference number: USBAV22-1793): new information included* lot number: FDP00005 and information that eight vials involved, given one vial to one patient. *; Reporter's Comments: A patient of unknown gender or age was vaccinated with a dose of Jynneos vaccine on an unspecified date, dose reported as unknown, administered via unspecified route or site. Reportedly, the vaccine was exposed to temperature excursion of 35.2 degrees Fahrenheit for 1 min and 35 seconds and then administered to one patient, which is coded as product administration error and product temperature excursion issue. Both events are listed per company. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse event due to Jynneos vaccination. Product administration error and product temperature excursion issue are assessed as not related to the suspect vaccine but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown gender or age was vaccinated with a dose of Jynneos vaccine on an unspecified date, dose reported as unknown, administered via unspecified route or site. Reportedly, the vaccine was exposed to temperature excursion of 35.2 degrees Fahrenheit for 1 min and 35 seconds and then administered to one patient, which is coded as product administration error and product temperature excursion issue. Both events are listed per company convention. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse event due to Jynneos vaccination. Product administration error and product temperature excursion issue are assessed as not related to the suspect vaccine but related to a human factor. The case is non-serious.