Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered at inappropriate site
Clinical narrative: Vaccine administered at inappropriate site; Jynneos administered intradermally; No wheal observed with administration requiring secondary administration; Case reference number US-BN-2022-003784 is a spontaneous case report initially received on 14-Sep-2022 from nurse via Communications (reference number: USBAV22-1399) and concerns a 37-year-old male patient.  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number not provided), at an unknown dose, site or route of administration, for an unknown indication.  On 09-Sep-2022, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number FDP00016) administered at *0.1 milliliter*, intradermally (ID) (explicitly coded as 'intradermal injection'), *in the left forearm, explicitly coded as 'vaccine administered at inappropriate site'), for Smallpox and Monkeypox prevention*. During the administration, no wheal was observed which required secondary administration, therefore, on the same date, and additional dose (unspecified) was administered, via unspecified route of administration and at an unspecified anatomical location (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, *the patient did not experience any adverse events due to Jynneos vaccination*.  Additional information was received by Bavarian Nordic on 15-Sep-2022 and it included the local BN case ID.  Additional information was downloaded from Vaccine Adverse Event Reporting System (VAERS) on 26-Sep-2022 and included VAERS ID (2442881-1), batch number, dose number, route of administration, and anatomical site of administration. Mentioned additional information was blended in the narrative above.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Additional information was received from a nurse via Bavarian Nordic on 02-Nov-2022 and included dose and indication of vaccine, anatomical location and new non-event.; Reporter's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date. On 09-Sep-22, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine was administered intradermally in the left forearm, and it's coded as intradermal injection and vaccine administered at inappropriate site. During the administration, no wheal was observed which required secondary administration, therefore, on the same date, and additional dose was administered, and this is considered as inappropriate schedule of vaccine administered. All three events are listed as per the Company conventions. The patients' medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events due to Jynneos vaccination. The case is non-serious. Based on information provided, causality for all events is assessed as not related to the suspect vaccine, but to a human action.; Sender's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date. On 09-Sep-22, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine was administered intradermally in the left forearm, and it's coded as intradermal injection and vaccine administered at inappropriate site. During the administration, no wheal was observed which required secondary administration, therefore, on the same date, and additional dose was administered, and this is considered as inappropriate schedule of vaccine administered. All three events are listed as per the Company conventions. The patients' medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events due to Jynneos vaccination. The case is non-serious. Based on information provided, causality for all events is assessed as not related to the suspect vaccine, but to a human action.