Sex: M
Vaccine: SMALLMNK
Symptoms: Pruritus, Skin exfoliation, Skin swelling, Vaccination site erythema, Vaccination site induration
Clinical narrative: Muscle pain; Painfull; Itching; Lump; Skin peeling; Puffed up; Swelling; Red; Case reference number US-BN-2022-001900 is a spontaneous case report initially received on 15-Aug-2022 from a consumer via agency (reference number: USBAV22-0985) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not reported.  On 03-Aug-2022, the patient received the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at an unknown dose or site of administration, subcutaneously for the unknown indication.  On an unspecified date, also reported as about a week after the vaccination, the patient developed a lump, itching, a little painful (as reported) and it started to spread. It has gotten down to the patient's elbow, which took about four days, and the patient had some skin peeling.  On an unspecified date, the patient went to urgent care where he was told that it looked like erythema (as reported). The patient stated that It has been painful and that this was in the same arm as the vaccine. It puffed up and started swelling. The patient also stated that the hardness, red, and swollen, were all connected to where the vaccination site was and that his pain felt like muscle pain. The patient took NyQuil which had an antihistamine and then did Benadryl cream as a treatment, and it seemed to have helped (as reported).  At the time of this report, the outcome of the events: 'muscle pain', ' painful arm', ' itching', 'mass', 'skin peeling', 'puffy skin', 'swelling arm', and 'redness' was reported as not resolved/ongoing.  The reporter considered the events as related to Jynneos, and did not provide seriousness assessment of the events.  Additional information received on 16-Aug-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: An adult male patient experienced non-serious events of mass, pruritus, pain in extremity and skin exfoliation also reported as about a week after the vaccination with the first dose of Jynneos, at an unknown dose or site of administration, subcutaneously for the unknown indication. Reportedly, on an unspecified date, the patient experienced non-serious events of myalgia, erythema, peripheral swelling and skin swelling. Myalgia is listed, pruritus and pain in extremity are listed and unlisted and skin exfoliation, mass, erythema, peripheral swelling and skin swelling are unlisted. The patient's medical history and concomitant medication details were not reported. The outcome of the events was reported as not resolved. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the events, all the events have been considered as related to Jynneos. This case is considered as non-serious.; Sender's Comments: An adult male patient experienced non-serious events of mass, pruritus, pain in extremity and skin exfoliation also reported as about a week after the vaccination with the first dose of Jynneos, at an unknown dose or site of administration, subcutaneously for the unknown indication. Reportedly, on an unspecified date, the patient experienced non-serious events of myalgia, erythema, peripheral swelling and skin swelling. Myalgia is listed, pruritus and pain in extremity are listed and unlisted and skin exfoliation, mass, erythema, peripheral swelling and skin swelling are unlisted. The patient's medical history and concomitant medication details were not reported. The outcome of the events was reported as not resolved. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the events, all the events have been considered as related to Jynneos. This case is considered as non-serious.