Sex: M
Vaccine: SMALLMNK
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: It is now size of a dime and itchy.; The following day that lump started to get bigger, only hurts to the touch; Consumer noticed a small lump on the site where the vaccine was given; Case reference number US-BN-2022-002000 is a spontaneous case report initially received from a consumer via agency (reference number: USBAV22-1118) on 22-Aug-2022 and concerns a 60-year-old male patient    The patient's medical history was not provided.   The patient's concomitant medication details were not provided. It was reported that the patient received smallpox vaccine at the left arm as a kid.  On 17-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00018) administered subcutaneously in the left arm, at an unknown dose for monkeypox prophylaxis.     On the same day, the patient noticed a small lump on the site where the vaccine was given.  On 18-Aug-2022, one day after the first dose, the lump started to get bigger and hurt only on the touch, with no pressure it didn't hurt.  On an unspecified date, unknown amount of time after the first dose, the lump at the injection site was not getting worse, it was the size of a dime and itchy.   At the time of this report, the outcome of the events 'injection site mass', 'injection site pain' and 'injection site itching' was not resolved/ongoing.  The reporter assessed the events as non-serious and possibly related to Jynneos vaccine.   Additional information received from Bavarian Nordic on 22-Aug-2022 included local BN case ID.; Reporter's Comments: A 60-year-old male patient noticed a small lump on the site where the vaccine was given, on the same day when he was vaccinated with the first dose of Jynneos, administered subcutaneously in the left arm, at an unknown dose for monkeypox prophylaxis. One day after the first dose, the lump started to get bigger and hurt only on the touch and unknown time after the first dose, the lump at the injection site was not getting worse, but it was the size of a dime and itchy. Injection site mass in unlisted and unexpected according to agency 1and agency 2  for Jynneos, while injection site pain and injection site pruritus are both listed and expected. The outcome of the events was not resolved. The patient's medical history and concomitant medications were not provided. It was reported that the patient received smallpox vaccine at the left arm as a kid. Causality 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 60-year-old male patient noticed a small lump on the site where the vaccine was given, on the same day when he was vaccinated with the first dose of Jynneos, administered subcutaneously in the left arm, at an unknown dose for monkeypox prophylaxis. One day after the first dose, the lump started to get bigger and hurt only on the touch and unknown time after the first dose, the lump at the injection site was not getting worse, but it was the size of a dime and itchy. Injection site mass in unlisted and unexpected according to agency 1 and agency 2 for Jynneos, while injection site pain and injection site pruritus are both listed and expected. The outcome of the events was not resolved. The patient's medical history and concomitant medications were not provided. It was reported that the patient received smallpox vaccine at the left arm as a kid. Causality 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.