Sex: U
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site mass, Product administered at inappropriate site
Clinical narrative: The patient has a lump at injection site; The patient has a redness at injection site; The patient received second dose of Jynneos vaccine in forearm; Case reference number US-BN-2022-002536 is a spontaneous case report initially received on 19-Sep-22 from a consumer via Communications (reference number: USBAV22-1429) and concerns a patient of an unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On unspecified date, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, unknown route of administration, for monkeypox.  On 16-Sep-2022, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at unknown dose, unknown route of administration, at forearm, (explicitly coded as 'vaccine administered at inappropriate site'), for monkeypox.   On unspecified date, the patient experienced a lump and redness at the injection site.  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.  The Reporter assessed the events as non-serious and did not provide causality assessment to Jynneos.  This case is linked to case US-BN-2022-002539 (same reporter).  Additional information received on 20-Sep-2022 from Bavarian Nordic included local BN case ID.  No further information was provided.; Reporter's Comments: A patient of an unknown age and gender was vaccinated with a second dose of Jynneos vaccine, at unknown dose, unknown route of administration, at forearm, which is considered as vaccine administered at inappropriate site, for monkeypox. Reportedly, on unspecified date, the patient experienced non-serious events of lump and redness at the injection site. Injection site erythema is listed for Jynneos, whilst injection site mass is unlisted according to the RA v1 and RA. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. The outcome was unknown. Considering the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded, the events of injection site erythema and injection site mass have been considered as related to Jynneos. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of an unknown age and gender was vaccinated with a second dose of Jynneos vaccine, at unknown dose, unknown route of administration, at forearm, which is considered as vaccine administered at inappropriate site, for monkeypox. Reportedly, on unspecified date, the patient experienced non-serious events of lump and redness at the injection site. Injection site erythema is listed for Jynneos, whilst injection site mass is unlisted according to the RA v1 and RA. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. The outcome was unknown. Considering the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded, the events of injection site erythema and injection site mass have been considered as related to Jynneos. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.