Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: The patient still has a bump, that doesn't hurt anymore; The patient still has bump, that doesn't hurt anymore; First dose of Jynneos administrated intradermally; Case reference number US-BN-2022-002440 is a spontaneous case report initially received on 15-Sep-22 from a consumer via Communications (reference number: USBAV22-1411) and concerns a male patient of unknown age.  The patient's medical history and concomitant medications details were not provided.  On unspecified date, over five weeks ago, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, or site of administration, administered intradermally, for monkeypox prophylaxis (explicitly coded as 'Intradermal injection').  On unspecified date, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose, site of administration or route of administration, for monkeypox prophylaxis.  The patient reported that he had received two doses of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating) from which the first one was administered over five weeks ago and that he still had a bump, that doesn't hurt anymore and was without scab.  At the time of this report, it was unknown rather there was treatment given to the patient due to any adverse event and if any laboratory tests have been performed.  At the time of this report, the outcome of the event of 'Injection site nodule' was unknown and the outcome of the event 'Injection site pain' was recovered/ resolved.  The Reporter assessed the events as non-serious and possible related to Jynneos.  Additional information received on 16-Sep-2022 from Bavarian Nordic included local BN case ID.  No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos, applied intradermally at an unknown site for monkeypox prophylaxis (explicitly coded as 'intradermal injection'). An unknown amount of time following the first dose, the patient experienced the non-serious events of injection site nodule and injection site pain. The patient received the second dose of Jynneos on an unknown date, applied on an unknown site, via unknown administration route. Injection site nodule is listed per RA V1.0 but unlisted per RA. Injection site pain is listed per RA and RA. Intradermal injection is considered listed per company conventions. The patient's medical history and concomitant medications were not reported. Based on the known safety profile of Jynneos, the events are assessed as related to the suspect vaccine. Intradermal injection is not related to Jynneos, but to human factor.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos, applied intradermally at an unknown site for monkeypox prophylaxis (explicitly coded as 'intradermal injection'). An unknown amount of time following the first dose, the patient experienced the non-serious events of injection site nodule and injection site pain. The patient received the second dose of Jynneos on an unknown date, applied on an unknown site, via unknown administration route. Injection site nodule is listed per RA V1.0 but unlisted per RA. Injection site pain is listed per RA and RA. Intradermal injection is considered listed per company conventions. The patient's medical history and concomitant medications were not reported. Based on the known safety profile of Jynneos, the events are assessed as related to the suspect vaccine. Intradermal injection is not related to Jynneos, but to human factor.