Sex: F
Vaccine: SMALLMNK
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: After the excursion a vial was given to one patient; After the excursion a vial was given to one patient; Case reference number US-BN-2022-004176 is a spontaneous case report initially received on 20-Oct-2022 from other healthcare professional via Agency (reference number: USBAV22-1746) and concerns a 36-year-old female patient.  The patient's medical history and concomitant medication details were not provided. * There were not known drug allergies. *  On 18-Oct-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00020), at dose of 0.5 milliliters, administered subcutaneously in *left upper arm*, for monkeypox prophylaxis.  As reported, after the temperature excursion a vial was given to a patient. The vials reached a temperature of -2.1 degrees Celsius for 2 hours and 53 minutes (explicitly coded as 'Product temperature excursion issue' and 'Product administration error').  *At the time of this report, the patient did not experience any adverse event due to Jynneos vaccination. *   Additional information received on 20-Oct-2022 from Bavarian Nordic included local BN 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 a nurse on 14-Nov-2022 included patient's initials, allergy status, details for administered dose of Jynneos: anatomical location and expiration date, and information that patient did not experience any adverse event due to Jynneos vaccination.; Reporter's Comments: A 36-year-old female patient was vaccinated with the first dose of Jynneos vaccine at dose of 0.5 milliliters, administered subcutaneously, for monkeypox prophylaxis. Reportedly, after exposed to the temperature excursion a vial was given to the patient. The vials reached a temperature of -2.1 degrees Celsius for 2 hours and 53 minutes, which is considered product temperature excursion issue and product administration error. The patient did not experience any adverse events due to Jynneos vaccination. Product temperature excursion issue and product administration error are listed per company convention. Patient's medical history and concomitant medications were not provided. Product temperature excursion issue and product administration error are assessed as not related to Jynneos, but related to a human factor. The case is non-serious.; Sender's Comments: A 36-year-old female patient was vaccinated with the first dose of Jynneos vaccine at dose of 0.5 milliliters, administered subcutaneously, for monkeypox prophylaxis. Reportedly, after exposed to the temperature excursion a vial was given to the patient. The vials reached a temperature of -2.1 degrees Celsius for 2 hours and 53 minutes, which is considered product temperature excursion issue and product administration error. The patient did not experience any adverse events due to Jynneos vaccination. Product temperature excursion issue and product administration error are listed per company convention. Patient's medical history and concomitant medications were not provided. Product temperature excursion issue and product administration error are assessed as not related to Jynneos, but related to a human factor. The case is non-serious.