Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: second dose of Jynneos vaccine administered on day 20 instead of day 28; third dose of Jynneos administered on day 35; second and third dose of Jynneos administered intradermally; Case reference number US-BN-2022-002577 is a spontaneous case report initially received on 20-Sep-2022 from a nurse via Company (reference number: USBAV22-1469) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not provided.  On 28-Jul-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at a dose of 0.1 ml, via an unknown route of administration, for monkeypox prophylaxis.  On 17-Aug-2022, 20 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00005), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  On 01-Sep-2022, 15 days after the second dose, the patient was vaccinated with the third dose of Jynneos (batch number: FDP00005), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 21-Sep-2022 included the local BN case ID.; Reporter's Comments: An adult male patient was vaccinated with the first dose of Jynneos, applied via unknown route of administration. 20 days later, the patient received the second dose of Jynneos, at a dose of 0.1 ml, applied intradermally (which is considered intradermal injection and inappropriate schedule of vaccine administered). On day 35, equivalent to 15 days after the second dose, the patient received a third dose of 0.1 ml Jynneos, applied intradermally (also considered intradermal injection). According to the CCDS V1.0 for MVA-BN, a booster dose can be applied to patients who have completed a full vaccination course (2 doses); however, data suggests that a booster dose is sufficient every two years. Hence, this is considered inappropriate schedule of vaccine administered. Inappropriate schedule of vaccine administered and intradermal injection are considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The events are assessed as not related to Jynneos, but to human error.; Sender's Comments: An adult male patient was vaccinated with the first dose of Jynneos, applied via unknown route of administration. 20 days later, the patient received the second dose of Jynneos, at a dose of 0.1 ml, applied intradermally (which is considered intradermal injection and inappropriate schedule of vaccine administered). On day 35, equivalent to 15 days after the second dose, the patient received a third dose of 0.1 ml Jynneos, applied intradermally (also considered intradermal injection). According to the CCDS V1.0 for MVA-BN, a booster dose can be applied to patients who have completed a full vaccination course (2 doses); however, data suggests that a booster dose is sufficient every two years. Hence, this is considered inappropriate schedule of vaccine administered. Inappropriate schedule of vaccine administered and intradermal injection are considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The events are assessed as not related to Jynneos, but to human error.