Sex: U
Vaccine: SMALLMNK
Symptoms: Injection site nodule, Wrong technique in product usage process
Clinical narrative: Hard brown bump on the forearm where the intradermal injection was placed.; Jynneos vaccine administered intradermally.; Hard brown bump on the forearm where the intradermal injection was placed.; Case reference number US-BN-2022-004099 is a spontaneous case report initially received on 17-Oct-2022 via agency (reference number: USBAV22-1713) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, intradermally and at forearm for monkeypox/smallpox prophylaxis (explicitly coded as 'Intradermal injection' and 'Product administered at inappropriate site').  As reported, it's been approximately four weeks since patient's first dose and the patient still have a hard brown bump on forearm where the intradermal injection was placed.   The patient stated that it's slowly getting better with taking oral antihistamines as the leaflet says.  At the time of this report, the outcome of the event 'Injection site nodule' was unknown.  The reporter assessed the events as non-serious. The reporter did not provide causality assessment.  Additional information received on 17-Oct-2022 via agency (reference number: USBAV22-1713): new information included the local BN case ID which is BN_2022_02566.; Reporter's Comments: A patient of unknown demographics developed hard brown bump on forearm where the intradermal injection was placed, which was still present, approximately four weeks after he was vaccinated with Jynneos, at an unknown dose, intradermally and at forearm for monkeypox/smallpox prophylaxis which is considered as intradermal injection and vaccine administered at inappropriate site. Injection site nodule is listed according to  agency 1 however unexpected according to agency 2 while injection and product administered at inappropriate site are both considered listed per company conventions. The outcome of injection site nodule was unknown. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related for injection site nodule due to compatible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Injection and product administered at inappropriate site are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics developed hard brown bump on forearm where the intradermal injection was placed, which was still present, approximately four weeks after he was vaccinated with Jynneos, at an unknown dose, intradermally and at forearm for monkeypox/smallpox prophylaxis which is considered as intradermal injection and vaccine administered at inappropriate site. Injection site nodule is listed according to  agency 1 however unexpected according to agency 2 while injection and product administered at inappropriate site are both considered listed per company conventions. The outcome of injection site nodule was unknown. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related for injection site nodule due to compatible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Injection and product administered at inappropriate site are both assessed as not related to suspect product but to human factor. The case is non-serious.