Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site discharge, Product leakage
Clinical narrative: Jynneos was administered intradermally; Put the Jynneos shot in and it leaked; Case reference number US-BN-2022-004878 is a spontaneous case report initially received from a consumer via Communications (reference number: USBAV22-2109) on 13-Dec-2022 and concerns a 52 years-old male patient.   The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at unknown dose, site and route of administration for monkeypox.  On 12-Dec-2022, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with second dose of Jynneos vaccine (batch number: SDP000005), at unknown dose intradermally, at unknown site of administration (explicitly coded as 'intradermal injection'). On the same day, when the shot was put in it leaked. The patient could see where the needle went in and nothing else, there was no wheel, and no treatment was given to the patient.  At the time of this report, outcome of the event 'put the Jynneos shot in and it leaked' was unknown.  The reporter did not provide seriousness or causality assessment for the event 'put the Jynneos shot in and it leaked'.  Additional information received on 14-Dec-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A 52 years-old male patient was vaccinated with the first dose of Jynneos vaccine at unknown dose, site and route of administration for monkeypox. An unspecified amount of time after the first Jynneos dose, the patient was vaccinated with second dose of Jynneos vaccine at unknown dose intradermally, at unknown site of administration. On the same day, when the shot was put in it leaked. Injection site discharge is unlisted for MVA-BN according to RA version 1 and RA, whilst intradermal injection is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. The causality for injection site discharge is assessed as not related to the pharmacological properties of Jynneos vaccine, but to the technique of intradermal application. Intradermal injection is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A 52 years-old male patient was vaccinated with the first dose of Jynneos vaccine at unknown dose, site and route of administration for monkeypox. An unspecified amount of time after the first Jynneos dose, the patient was vaccinated with second dose of Jynneos vaccine at unknown dose intradermally, at unknown site of administration. On the same day, when the shot was put in it leaked. Injection site discharge is unlisted for MVA-BN according to RA version 1 and Ra, whilst intradermal injection is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. The causality for injection site discharge is assessed as not related to the pharmacological properties of Jynneos vaccine, but to the technique of intradermal application. Intradermal injection is not related to Jynneos, but to a human factor. The case is non-serious.