Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Injection site pruritus, Injection site swelling
Clinical narrative: Jynneos vaccine administered intradermally.; The second dose of Jynneos administered 56 days after the first dose.; With second dose of Jynneos injection site become very itchy.; With second dose of Jynneos injection site started swelling a bit; Case reference number US-BN-2022-002397 is a spontaneous case report initially received on 14-Sep-2022 from a consumer via Agency (reference number: USBAV22-1387) and concerns a male patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 17-Jul-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at an unknown dose or route of administration, reported as on the underarm, and for unknown indication.  On 11-Sep-2022, 56 days after the first dose, the patient was vaccinated with the second dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number unknown) at unknown dose, administered intradermally (explicitly coded as 'Intradermal injection' and 'inappropriate schedule of vaccine administered'), reported as top part on the arm for unknown indication.  On the same day, the patient developed injection site swelling.  On 12-Sep-2022, one day after the vaccination, the injection site became very itchy. The patient used Tylenol (paracetamol) to treat the symptoms.  At the time of this report, the outcome of the events 'injection site swelling' and 'injection site itching' was not recovered/not resolved.  The reporter assessed the events as non-serious. Causality assessment was not provided.   No further information was provided.  Additional information received from Bavarian Nordic on 14-Sep-2022 included local BN case ID.; Reporter's Comments: An adult male patient of an unknown age developed non-serious event injection site swelling on the day 0 and non-serious event injection site itching on the day 1 after the second dose of Jynneos was administered intradermally. The second dose was administered 56 days after the first dose of Jynneos which is considered inappropriate schedule of vaccine administered. Intradermal injection and inappropriate schedule of vaccine administered are listed by convention. Injection site pruritus and injection site swelling are listed per CCDS v1 and the PI. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, injection site pruritus and injection site swelling have been considered as related to Jynneos. Intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.; Sender's Comments: An adult male patient of an unknown age developed non-serious event injection site swelling on the day 0 and non-serious event injection site itching on the day 1 after the second dose of Jynneos was administered intradermally. The second dose was administered 56 days after the first dose of Jynneos which is considered inappropriate schedule of vaccine administered. Intradermal injection and inappropriate schedule of vaccine administered are listed by convention. Injection site pruritus and injection site swelling are listed per CCDS v1 and the PI. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, injection site pruritus and injection site swelling have been considered as related to Jynneos. Intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.