Itchy and mildly painful blisters; Itchy and mildly painful blisters; Itchy and mildly painful blisters; Rash; Case reference number US-BN-2022-001850 is a spontaneous case report initially received on 11-Aug-2022 from a consumer via agency (reference number: USBAV22-0963) and concerns a 31-year-old male patient.  The patient's current medical condition included cold sores, which the patient got every year.  The patient's medical history and concomitant medication details were not provided.  On 06-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: PDH00003) at an unknown dose, administered subcutaneously in the left arm, for unknown indication.  On 08-Aug-2022, two days after the first dose, the patient experienced blisters on the forearm on the opposite arm of the injection. There were about three blisters and they looked like cold sores, they were itchy and mildly painful. On the same day, the patient started to get a rash, a sample of the tissue was taken, and it came back negative for monkeypox.  On an unspecified date, reported also as day three, the patient had about 16 blisters, which were about five inches from the wrist, and above the elbow. The patient also saw a head developing on seven to 10 popping up, as reported. The blister seemed to be water filled, but as the sample was taken and the blisters were pressed hard, they did not burst.  On an unspecified date, reported also as day four, the patient developed a rash on the neck and on the upper arm. On the same date, at 12:10h pm, the blisters were getting bigger and some of them were almost bursting.  On an unspecified date, reported also as right now, the patient's blisters were in two clusters on the right forearm within five inches from the wrist. A cluster, which was expected to become a blister existed as a rash below the patient's right biceps and the patient had a rash on the neck and another one forming near the spine. The patient expected both to become blisters in the next day or two.  At the time of this report, the outcome of the events was not resolved/ongoing.  The reporter did not provide seriousness assessment for the events and assessed all events as possibly related to the product.  The product quality complaint number received for this case is QE-001893.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local BN case ID, PQC reference number, additional photos of the patient's blisters, and is blended in the case narrative above.; Reporter's Comments: A 31-year-old male patient experienced blisters two days after he was vaccinated with the first dose, on the opposite (right) forearm than Jynneos was administered (in the left arm) subcutaneously, for unknown indication and at an unknown dose. Reportedly, there were about three blisters which looked like cold sores, itchy and mildly painful. On the same day, the patient started to get a rash, a sample of the tissue was taken, and it came back negative for monkeypox. Blisters and pain are considered unlisted and unexpected while pruritus and rash are listed however unexpected according to agency 1 and agency 2 for Jynneos. At the time of this report, the outcome of the events was not resolved. The patient's current medical condition included cold sores (which the patient got every year) and medical history with concomitant medication details was not provided. All reported events are assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is considered as non-serious.; Sender's Comments: A 31-year-old male patient experienced blisters two days after he was vaccinated with the first dose, on the opposite (right) forearm than Jynneos was administered (in the left arm) subcutaneously, for unknown indication and at an unknown dose. Reportedly, there were about three blisters which looked like cold sores, itchy and mildly painful. On the same day, the patient started to get a rash, a sample of the tissue was taken, and it came back negative for monkeypox. Blisters and pain are considered unlisted and unexpected while pruritus and rash are listed however unexpected according to agency 1 and agency 2 for Jynneos. At the time of this report, the outcome of the events was not resolved. The patient's current medical condition included cold sores (which the patient got every year) and medical history with concomitant medication details was not provided. All reported events are assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is considered as non-serious.