Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Pruritus, Urticaria
Clinical narrative: The patient received the second dose of Jynneos intradermally and experienced a one and a half inch welt on forearm and it was itching; The patient received the second dose of Jynneos intradermally and experienced a one and a half inch welt on forearm and it was itching; The patient received the second dose of Jynneos intradermally; Case reference number US-BN-2022-001998 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV22-1112) on 22-Aug-2022 and concerns an adult male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided), at an unknown dose, site or route of administration, for unknown indication.  On an unspecified day, also reported as yesterday, an unknown amount of time after the first dose, the patient received the second dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) at an unknown dose or site of administration, intradermally, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').     On an unspecified date, the patient experienced a one and a half inch welt on forearm which was itching today (as reported). The patient wanted to know if he can apply cortisone cream.   At the time of this report, the outcome of the events 'welts' and 'Itching' was unknown.  The reporter assessed the events of 'welts' and 'Itching' as non-serious and possibly related to Jynneos.  Additional information received from Bavarian Nordic on 22-Aug-2022 included local BN case ID.; Reporter's Comments: An adult male patient was vaccinated with the second dose of Jynneos for unknown indication, intradermally which is considered as  inappropriate route of vaccination. The patient experienced a one and a half inch welt on forearm which was itching, unknown time after the vaccination. Urticaria and pruritus are listed/expected for MVA-BN vaccine according RA version 1, whilst unexpected per RA. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Due to implied temporal relationship and lack of information on alternative etiology the causality for urticaria and pruritus is assessed as related to Jynneos at the moment. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the second dose of Jynneos for unknown indication, intradermally which is considered as  inappropriate route of vaccination. The patient experienced a one and a half inch welt on forearm which was itching, unknown time after the vaccination. Urticaria and pruritus are listed/expected for MVA-BN vaccine according RA version 1, whilst unexpected per RA. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Due to implied temporal relationship and lack of information on alternative etiology the causality for urticaria and pruritus is assessed as related to Jynneos at the moment. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.