Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No wheal observed with administration requiring secondary administration; Jynneos administered intradernally; Case reference number US-BN-2022-003779 is a spontaneous case report initially received on 14-Sep-22 from a *nurse* via Communications (reference number: USBAV22-1397) and concerns a 26-year-old male patient.  The patient *had no medical history and concomitant medication. *  On 09-Sep-2022, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00016) at unknown dose, unknown route of administration, at the left arm, for *monkeypox prevention. *  As reported, there was no wheal observed with administration requiring secondary administration.  On the same day, the patient was vaccinated with a second dose of Jynneos vaccine (batch number: FPD00016), (explicitly coded as 'inappropriate schedule of vaccine administration'), *expiration date 31-Oct-2024*, at an unknown dose, administered intradermally (explicitly coded as 'intradermal injection'), at the left arm, for *monkeypox prevention. *  At the time of this report, *the patient did not experience any adverse event due to Jynneos. *  Additional information received on 15-Sep-2022 from Bavarian Nordic included local BN case ID.  Additional information downloaded from VAERS received from healthcare professional on 26-Sep-2022 included second dose details and VAERS ID (2442886-1) and is blended in the case narrative above.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information was received from a reporter via Bavarian Nordic email on 02-Nov-2022: New information included an update on reporter type, indication, expiration date for second dose of Jynneos, confirmation that the patient had no medical history and that he did not experience any adverse event.; Reporter's Comments: A 26-year-old male patient was vaccinated with first and second dose of Jynneos vaccine on the same day, which is considered as inappropriate schedule of vaccine administration. The second dose was administered intradermally (ID), at left arm, for monkeypox prevention, which is considered as intradermal injection. Inappropriate schedule of product administration and injection are both considered listed per company conventions. The patient did not experience any adverse event following vaccination. The patient had no medical history nor concomitant medications. Causality for inappropriate schedule of product administration and injection is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 26-year-old male patient was vaccinated with first and second dose of Jynneos vaccine on the same day, which is considered as inappropriate schedule of vaccine administration. The second dose was administered intradermally (ID), at left arm, for monkeypox prevention, which is considered as intradermal injection. Inappropriate schedule of product administration and injection are both considered listed per company conventions. The patient did not experience any adverse event following vaccination. The patient had no medical history nor concomitant medications. Causality for inappropriate schedule of product administration and injection is assessed as not related to suspect product but to human factor. The case is non-serious.