Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered at inappropriate site
Clinical narrative: Jynneos was administered intradermally; No wheal observed with administration requiring secondary administration; Vaccine administered intradermally in the left forearm.; Case reference number US-BN-2022-003790 is a spontaneous case report initially received on 14-Sep-2022 from other health care professional via Communications (reference number: USBAV22-1401) and concerns a 51-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  *On 12-Aug-2022, the patient was vaccinated with the first dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number: Unknown), at a dose of 0.5 ml, administered subcutaneously in unknown anatomical location for unknown indication.*  On 09-Sep-2022, the patient was vaccinated with the *second dose* of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number: FDP00016), at an unknown dose or route of administration, in left forearm (explicitly coded as 'product administered at inappropriate site'), for monkeypox prevention. During the administration, no wheal was observed which required secondary administration (explicitly coded as 'Inappropriate schedule of product administration').  On 09-Sep-2022, the patient was vaccinated with the additional dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number: FDP00016) at dose of 0.1 milliliter, intradermally in the left arm, for monkeypox prevention (explicitly coded as 'Intradermal injection').   At the time of this report, the patient did not experience any adverse events due to Jynneos vaccination.  Additional information was received from Bavarian Nordic on 15-Sep-2022 and included the local BN case ID.  Additional information was downloaded via VAERS portal on 26-Sep-2022, and the information included route and site of administration for Jynneos.  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 02-Nov-2022 included vaccine details: batch number, date of vaccination, anatomical site location and indication for first dose and dosage for second dose of Jynneos vaccine. New non-event 'product administered at inappropriate site' was added.  Follow-up information received from nurse on 10-Nov-2022 included updated date when first dose of Jynneos was administered, dosage details and route of administration for the first dose and updated date when the second dose was administered.; Reporter's Comments: A 51-year-old male patient received the first dose of Jynneos, applied subcutaneously at an unknown site. 28 days later, the patient was vaccinated with the second dose of Jynneos at an unknown dose or route of administration, in left forearm, for monkeypox prevention (which is considered product administered at inappropriate site). On the same day, the patient was vaccinated with another dose of Jynneos administered intradermally in the left arm (which is considered intradermal injection), for monkeypox prevention (which is considered inappropriate schedule of product administration). No associated adverse events were reported. Intradermal injection, product administered at inappropriate site and inappropriate schedule of vaccine administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection, product administered at inappropriate site and inappropriate schedule of vaccine administered are not related to the suspect vaccine, but to a human factor. This case is non-serious.; Sender's Comments: A 51-year-old male patient received the first dose of Jynneos, applied subcutaneously at an unknown site. 28 days later, the patient was vaccinated with the second dose of Jynneos at an unknown dose or route of administration, in left forearm, for monkeypox prevention (which is considered product administered at inappropriate site). On the same day, the patient was vaccinated with another dose of Jynneos administered intradermally in the left arm (which is considered intradermal injection), for monkeypox prevention (which is considered inappropriate schedule of product administration). No associated adverse events were reported. Intradermal injection, product administered at inappropriate site and inappropriate schedule of vaccine administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection, product administered at inappropriate site and inappropriate schedule of vaccine administered are not related to the suspect vaccine, but to a human factor. This case is non-serious.