Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site was warm; Injection site was slightly erythematous; Hurting on the injection site; Case reference number US-BN-2022-001805 is a spontaneous case report initially received on 08-Aug-2022 from other health care professional via Communications (reference number: USBAV22-0876) and concerns a male patient born in 1958.  The patient's medical history and concomitant medication details were not provided.  On 06-Aug-2022, around 4 pm, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 0.5 ml, administered subcutaneously, for monkeypox prophylaxis.  On 07-Aug-2022, 24 hours after the vaccination, the patient experienced hurting on the injection site.  On an unspecified date, reported also as 48 hours after the vaccination, the patient experienced warmth and slightly erythema on the injection site.  It was confirmed that the patient did not have previous vaccination reactions and that there were no other side effects.  At the time of this report, the outcome of the events was not resolved/ongoing.  The reporter assessed these events as non-serious and as possibly related to Jynneos.  Additional information received from Communications on 08-Aug-2022 included Communications report.  Additional information received on 09-Aug-2022 included confirmation of the country of occurrence.; Reporter's Comments: A male patient experienced a non-serious event of hurting on the injection site, as reported, 24 hours after the vaccination with Jynneos, for monkeypox prophylaxis. Reportedly, on an unspecified date, reported also as 48 hours after the vaccination, the patient experienced non-serious events of warmth and slightly erythema on the injection site. Injection site pain and injection site erythema are listed for Jynneos according to the guidelines, whilst injection site warmth is listed per guidelines but not listed per other guidelines. The patient's medical history and concomitant medication details were not provided. The outcome of the events was not resolved, as reported. Considering plausible temporal relationship, known product safety profile and since the contributory role of the suspect vaccine cannot be excluded, the events of injection site pain, injection site erythema and injection site warmth have been considered as related to Jynneos. This case is considered as non-serious.; Sender's Comments: A male patient experienced a non-serious event of hurting on the injection site, as reported, 24 hours after the vaccination with Jynneos, for monkeypox prophylaxis. Reportedly, on an unspecified date, reported also as 48 hours after the vaccination, the patient experienced non-serious events of warmth and slightly erythema on the injection site. Injection site pain and injection site erythema are listed for Jynneos according to the guidelines, whilst injection site warmth is listed per guidelines but not listed per other guidelines. The patient's medical history and concomitant medication details were not provided. The outcome of the events was not resolved, as reported. Considering plausible temporal relationship, known product safety profile and since the contributory role of the suspect vaccine cannot be excluded, the events of injection site pain, injection site erythema and injection site warmth have been considered as related to Jynneos. This case is considered as non-serious.