Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site mass, Product administered at inappropriate site
Clinical narrative: the patient had a lump at the injection site; the patient received first dose of Jynneos in the forearm; Case reference number US-BN-2022-002539 is a spontaneous case report initially received on 19-Sep-22 from a consumer via Agency (reference number: USBAV22-1430) and concerns a male patient of unknown age.  The patient's concurrent medical history included mental illness.  The patient's concomitant medications details were not provided.  On unspecified date, as reported on Friday, 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, at the forearm, (explicitly coded as 'vaccine administered at inappropriate site'), for monkeypox.   On unspecified date, as reported on Sunday, the patient experienced a lump at the injection site. As reported, the patient stated that he had a bigger spot at the injection site than his spouse did. It was reported that the patient received second dose instead of first.  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-2022-002536 (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 male patient of unknown age was vaccinated with a first dose of Jynneos vaccine, at unknown dose, unknown route of administration, at the forearm, which is considered as vaccine administered at inappropriate site, for monkeypox. Reportedly, on unspecified date, the patient experienced a lump at the injection site. Injection site mass is unlisted for Jynneos according to the CCDS v1 and PI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's concurrent medical history included mental illness 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 fully excluded, the event of injection site mass has been considered as related to Jynneos. Product administered at inappropriate site has been considered as not related to Jynneos, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with a first dose of Jynneos vaccine, at unknown dose, unknown route of administration, at the forearm, which is considered as vaccine administered at inappropriate site, for monkeypox. Reportedly, on unspecified date, the patient experienced a lump at the injection site. Injection site mass is unlisted for Jynneos according to the CCDS v1 and PI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's concurrent medical history included mental illness 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 fully excluded, the event of injection site mass has been considered as related to Jynneos. Product administered at inappropriate site has been considered as not related to Jynneos, but to a human factor. This case is considered as non-serious.