Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site nodule, Injection site pain
Clinical narrative: Jynneos vaccine administered intramuscularly; The subcutaneous one was tender; I had a node in my arm for days; The intramuscular one was very painful; Case reference number US-BN-2022-004643 is a spontaneous case initially received on 09-Nov-2022 from consumer via Communication (reference number: USBAV22-1913) and concerns a 71-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 12-Oct-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox vaccine, Live, Nonreplicating; batch number: Unknown), at unknown dose, administered intramuscularly (explicitly coded as 'Inappropriate route of vaccination'), at unknown anatomical location for monkeypox prophylaxis.  On 09-Nov-2022, the patient was vaccinated with the second dose of Jynneos vaccine (Smallpox and Monkeypox vaccine, Live, Nonreplicating; batch number: Unknown), at unknown dose, administered subcutaneously, at unknown anatomical location for monkeypox prophylaxis.  As reported, the patient received first dose intramuscularly and second dose subcutaneously. The intramuscular one was very painful, and the patient had a node in his arm for days. If it was pressed, it would hurt. The patient stated that subcutaneous one was tender, but OK and inquired if the vaccine can be given intramuscularly as well.  At the time of this report, the outcome of events was unknown.   The reporter assessed all reported events as non-serious and related to Jynneos vaccine.  Additional information received from Bavarian Nordic on 09-Nov-2022 included local BN case ID.; Reporter's Comments: A 71-year-old male patient was vaccinated with the first dose of Jynneos (at unknown dose, unknown anatomical location, for monkeypox prophylaxis), administered intramuscularly (considered as inappropriate route of vaccination) which was very painful and the patient had a nodule in his arm for days. Approximately one month after the first dose the patient was vaccinated with the second dose of Jynneos (at unknown dose, unknown anatomical location, for monkeypox prophylaxis), administered subcutaneously which was tender. Nodule is considered unlisted and unexpected according to RA v1 and RA for Jynneos while injection site pain is listed and expected. Incorrect route of product administration is considered listed per company convention. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details were not provided. Nodule and injection site pain are assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 71-year-old male patient was vaccinated with the first dose of Jynneos (at unknown dose, unknown anatomical location, for monkeypox prophylaxis), administered intramuscularly (considered as inappropriate route of vaccination) which was very painful and the patient had a nodule in his arm for days. Approximately one month after the first dose the patient was vaccinated with the second dose of Jynneos (at unknown dose, unknown anatomical location, for monkeypox prophylaxis), administered subcutaneously which was tender. Nodule is considered unlisted and unexpected according to RA v1 and RA for Jynneos while injection site pain is listed and expected. Incorrect route of product administration is considered listed per company convention. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details were not provided. Nodule and injection site pain are assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.