Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Injection, Product administered at inappropriate site, Product administration error, Product storage error
Clinical narrative: Jynneos was administered intradermal; The second dose of Jynneos was administered 42 days after the first dose; The Jynneos was administered in the patient's midforearm; Vaccinations were administered after storage below recommended temperature; Vaccinations were administered after storage below recommended temperature; Case reference number US-BN-2022-003952 is a spontaneous case report initially received on 07-Oct-2022 from other health professional via agency (reference number: USBAV22-1651) and concerns *32-year-old male patient*.  The patient's medical history and concomitant medication details were not provided.  *On 24-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and mon-keypox vaccine, live, nonreplicating; batch number: FDP00002; expiration date: 30-Aug-2023) at a dose of 0.1 ml, administered intradermal in the left mid forearm for monkeypox prophylaxis after storage below recommended temperature (explicitly coded as 'product storage error', 'product administration error', 'Vaccine administered at inappropriate site' and 'intradermal injection').*  *On 05-Oct-2022, 42 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00003; expiration date: 01-Aug-2023) at a dose of 0.1 ml, administered intradermal in the left mid forearm after storage below recommended temperature (explicitly cod-ed as 'product storage error', 'product administration error', 'intradermal injection', 'Vaccine administered at inappropriate site' and 'inappropriate schedule of vaccine administered').*  At the time of this report, it was unknown if any patients experienced any adverse event due to Jynneos.  Additional information received on 07-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 pre-sented between asterisks (*).  Follow-up information received from the other health care professional via Bavarian Nordic on 17-Oct-2022: New information included details for the patient, confirmation that Jynneos was admin-istered and details for the administered dose of Jynneos.  Additional information received on 22-Oct-2022 from Bavarian Nordic included confirmation of the dates of vaccination.  Additional information received on 26-Oct-2022 from Bavarian Nordic included confirmation of the batch number, dosage, route of administration, anatomical location and expiration date.  This case is linked with US-BN-2022-004044 due to the same reporter.; Reporter's Comments: A 32-year-old male patient was vaccinated with the first dose of Jynneos vaccine on 24-Aug-22 at a dose of 0.1 ml, administered intradermal in the left mid forearm for monkeypox prophylaxis after storage below recommended temperature, which is considered product storage error, product administration error, vaccine administeredat inappropriate site and intradermal injection. 42 days after the first dose the patient was vaccinated with the second dose of Jynneos at a dose of 0.1 ml, administered intradermal in the left mid forearm after storage below recommended temperature, which is also considered product storage error, product administration error, vaccine administered at inappropriate site, intradermal injection and inappropriate schedule of vaccine administered. 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. Product storage error, product administration error, vaccine administered at inappropriate site, intradermal injection and inappropriate schedule of vaccine administered are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A 32-year-old male patient was vaccinated with the first dose of Jynneos vaccine on 24-Aug-22 at a dose of 0.1 ml, administered intradermal in the left mid forearm for monkeypox prophylaxis after storage below recommended temperature, which is considered product storage error, product administration error, vaccine administeredat inappropriate site and intradermal injection. 42 days after the first dose the patient was vaccinated with the second dose of Jynneos at a dose of 0.1 ml, administered intradermal in the left mid forearm after storage below recommended temperature, which is also considered product storage error, product administration error, vaccine administered at inappropriate site, intradermal injection and inappropriate schedule of vaccine administered. 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. Product storage error, product administration error, vaccine administered at inappropriate site, intradermal injection and inappropriate schedule of vaccine administered are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.