Sex: M
Vaccine: SMALLMNK
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Today is day 5 after the Jynneos vaccine and the site is still very red. It is very tender and red; Today is day 5 after the Jynneos vaccine and the site is still very red. It is very tender and red; The site is beginning to itch. It is getting more itchy; I am also having fatigue; Case reference number US-BN-2022-001873 is a spontaneous case report initially received from a consumer via agency (reference number: USBAV22-0970) on 12-Aug-2022 and concerns a 52-year-old male patient.  The patient's medical history and concomitant medication details were not provided.   On 08-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) at an unknown dose, route or site of administration for unknown indication.    On an unspecified day, also reported as day five after the Jynneos vaccine, the patient's vaccinated site was still very red and it was beginning to itch. It was very tender and red. As reported, the patient works in healthcare and the doctor looked at the site. The doctor did not think it was infected but to keep an eye on it. It was getting more itchy and the patient also having fatigue.  At the time of this report the outcome of the events 'Injection site erythema', 'Injection site pain', 'Injection site pruritus' and 'Fatigue' was unknown.  The reporter assessed the events as possibly related to Jynneos. Seriousness of the events was not provided.   Additional information received from Bavarian Nordic on 15-Aug-2022 included local BN case ID.; Reporter's Comments: A 52-year-old male patient experienced vaccinated site redness, tenderness and itching, five days after he was vaccinated with the first dose of Jynneos, at an unknown dose, route or site of administration for unknown indication. It was getting more itchy and the patient was also having fatigue. Injection site erythema, injection site pruritus, injection site pain and fatigue are all listed and expected according to agency 1 and agency 2 for Jynneos. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details were not provided. Causal relationship is assessed as related for all reported events due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A 52-year-old male patient experienced vaccinated site redness, tenderness and itching, five days after he was vaccinated with the first dose of Jynneos, at an unknown dose, route or site of administration for unknown indication. It was getting more itchy and the patient was also having fatigue. Injection site erythema, injection site pruritus, injection site pain and fatigue are all listed and expected according to agency 1 and agency 2 for Jynneos. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details were not provided. Causal relationship is assessed as related for all reported events due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.