Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Injection
Clinical narrative: The second dose of Jynneos was administered on day 18 instead of day 28; The second dose of Jynneos was administered intradermally; Case reference number US-BN-2022-002181 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional via Agency (reference number: USBAV22-1237) and concerns a male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, *administered subcutaneously* at an unknown anatomical site, for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of *0.1 ml, administered intradermally* at an unknown anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered' *and 'Intradermal injection'*).  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local BN number.  All follow-up information is blended into the case narrative above, with the latest information pre-sented between asterisks (*).  Follow-up information was received from the other health care professional via Agency on 23-Sep-2022: New information included additional reporter, route of vaccine administration for the first and for the second dose of Jynneos and dosage regimen for the second dose.  The case is linked with US-BN-2022-002180, US-BN-2022-002182, US-BN-2022-002183, US-BN-2022-002184 due to the same reporter.; Reporter's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.1 ml, intradermally for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered and intradermal injection. Inappropriate schedule of product administration and intradermal injection are considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.1 ml, intradermally for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered and intradermal injection. Inappropriate schedule of product administration and intradermal injection are considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.