Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus
Clinical narrative: Little redness at the injection site; Itching at the injection site; Patient received Jynneos just underneath the skin on the forearm; Case reference number US-BN-2022-002140 is a spontaneous case report initially received on 26-Aug-2022 from a consumer via Communications (reference number: USBAV22-1194) and concerns a 67-year-old male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 22-Aug-2022, the patient was vaccinated with Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose or route of administration, reported as just underneath the skin on the forearm, for unknown indication (explicitly coded as 'inappropriate route of vaccination').  On an unspecified date, an unknown amount of time after the vaccination, reported also as after the shot, the patient developed little redness at the injection site.  On an unspecified date, an unknown amount of time after the vaccination, the patient developed itching at the injection site.  At the time of this report, the outcome of the events 'injection site redness' and 'injection site itching' was unknown.   The reporter assessed the events as non-serious and related to the vaccine.   Additional information received from Bavarian Nordic on 26-Aug-2022 included the local BN case ID.; Reporter's Comments: A 67-year-old male patient was vaccinated with Jynneos vaccine, at an unknown dose or route of administration, reported as just underneath the skin on the forearm, for unknown indication which is considered as inappropriate route of vaccination. Unknown time after the vaccination, reported also as after the shot, the patient developed little redness and itching at the injection site. Injection site erythema and injection site pruritus are both listed and expected according to RA v1 and RA for Jynneos. Incorrect route of product administration is considered listed per company convention. The outcome for injection site itching and injection site erythema was unknown. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as related for injection site erythema and injection site pruritus 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 67-year-old male patient was vaccinated with Jynneos vaccine, at an unknown dose or route of administration, reported as just underneath the skin on the forearm, for unknown indication which is considered as inappropriate route of vaccination. Unknown time after the vaccination, reported also as after the shot, the patient developed little redness and itching at the injection site. Injection site erythema and injection site pruritus are both listed and expected according to RA v1 and RA for Jynneos. Incorrect route of product administration is considered listed per company convention. The outcome for injection site itching and injection site erythema was unknown. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as related for injection site erythema and injection site pruritus 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.