Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Product storage error, Wrong technique in product usage process
Clinical narrative: Jynneos vaccine administered intradermaly; The vial has been opened for about 16.5 hours instead of the 8 hour limit in the refrigerator; The patient was administered with Jynneos vaccine whos vial was opened for about 16.5 hours in the refrigerator; The first dose was given on 08/22/2022; the patient's second dose given on 09/13/2022; Case reference number US-BN-2022-004223 is a spontaneous case report initially received on 06-Oct-2022 from nurse via Bavarian Nordic and concerns a *37-year-old male* patient.  The patient's medical history and concomitant medication details were not provided.  On 02-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at a dose reported as 0.5 mL, administered subcutaneously, at unknown site of administration, for an unknown indication.  On 13-Sep-2022, at 08:30 am, the patient was vaccinated with the second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at a dose reported as 0.1 mL, administered intradermally (explicitly coded as 'Intradermal injection' and 'inappropriate schedule of vaccine administered') at unknown site of administration, and for an unknown indication.  It was reported that, before the second dose was administered to the patient, the vaccine vial had been in the refrigerator at a controlled temperature but has been opened for about 16.5 hours instead of the 8-hour limit in the refrigerator (explicitly coded as 'Product administration error' and 'Product storage error').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 27-Oct-2022 from Bavarian Nordic included the country of occurrence.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from nurse on 03-Nov-2022: New information included the patient's details.; Reporter's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos vaccine on 02-Aug-22. On 13-Sep-22 the patient was vaccinated with the second dose of Jynneos vaccine, dose reported as 0.1ml administered intradermally which is coded as intradermal injection and inappropriate schedule of vaccine administered. Reportedly, before the second dose administration, the vaccine vial had been in the refrigerator at controlled temperature, but has been opened for about 16.5 hours instead of 8-hour limit. This is considered product storage error and product administration error. All events are listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos vaccine on 02-Aug-22. On 13-Sep-22 the patient was vaccinated with the second dose of Jynneos vaccine, dose reported as 0.1ml administered intradermally which is coded as intradermal injection and inappropriate schedule of vaccine administered. Reportedly, before the second dose administration, the vaccine vial had been in the refrigerator at controlled temperature, but has been opened for about 16.5 hours instead of 8-hour limit. This is considered product storage error and product administration error. All events are listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.