Sex: M
Vaccine: SMALLMNK
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lethargy, Myalgia
Clinical narrative: Feeling Achy, fatigue, lethargy, muscle ache; Feeling Achy, fatigue, lethargy, muscle ache; Tinny size of a quarter, red rash, almost felt like it was given intramuscularly; Feeling Achy, fatigue, lethargy, muscle ache; Feeling Achy, fatigue, lethargy, muscle ache; Site of the injection was swollen and painful; Site of the injection was swollen and painful; Tenderness at an injection site; Case reference number US-BN-2022-001847 is a spontaneous case report initially received on 11-Aug-2022 from pharmacist (reference number: USBAV22-0961) and concerns 56-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 09-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) at a dose of 0.5 ml, administered subcutaneously, at right arm, for monkeypox prophylaxis. On the same day, the patient experienced injection site tenderness.  On 10-Aug-2022, one day after the vaccination, the patient feeling achy, experienced fatigue, lethargy and muscle ache. As reported, the patient got better and then started getting worse again,  took Tylenol (paracetamol) due to these events. On the same day, the patient experienced swollen and painful injection site (as reported worse shot the patient ever had) and tinny size of a quarter, red rash, almost felt like it was given intramuscularly.  On 11-Aug-2022, the patient still had the same symptoms but fatigue and lethargy were better.  At the time of this report, the outcome of the events ache', red rash', Injection site tenderness', Muscle ache', Injection site swelling' and Injection site pain' was not resolved, while the outcome of the events lethargy and fatigue was recovering.   The reporter assessed the events as non-serious and possibly related to the product.  Additional information received on 11-Aug-2022 included local case ID.; Reporter's Comments: A 56-year-old patient experienced injection site tenderness on the same day when he was vaccinated with the first dose of Jynneos, at a dose of 0.5 ml, administered subcutaneously, at right arm, for monkeypox prophylaxis. The patient was also feeling achy, experienced fatigue, lethargy, muscle ache, swollen and painful injection site and red rash, one day after he was vaccinated with Jynneos. Lethargy is unlisted and unexpected, pain is considered unlisted and unexpected while erythematous rash is considered listed however unexpected according to packet insert.  Injection site pain, fatigue, myalgia and injection site swelling are all listed and expected according to packet insert. The patient took Tylenol (paracetamol) due to reported events. Two days after the vaccination the patient still had the same symptoms but fatigue and lethargy were better. At this point, the outcome of the events pain, rash, injection site tenderness, muscle ache, injection site swelling and injection site pain was not resolved, while the outcome of the events lethargy and fatigue was recovering. The patient's medical history and concomitant medication details were not provided. Causality for all reported events is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is considered as non-serious.; Sender's Comments: A 56-year-old patient experienced injection site tenderness on the same day when he was vaccinated with the first dose of Jynneos, at a dose of 0.5 ml, administered subcutaneously, at right arm, for monkeypox prophylaxis. The patient was also feeling achy, experienced fatigue, lethargy, muscle ache, swollen and painful injection site and red rash, one day after he was vaccinated with Jynneos. Lethargy is unlisted and unexpected, pain is considered unlisted and unexpected while erythematous rash is considered listed however unexpected according to packet insert.  Injection site pain, fatigue, myalgia and injection site swelling are all listed and expected according to packet insert. The patient took Tylenol (paracetamol) due to reported events. Two days after the vaccination the patient still had the same symptoms but fatigue and lethargy were better. At this point, the outcome of the events pain, rash, injection site tenderness, muscle ache, injection site swelling and injection site pain was not resolved, while the outcome of the events lethargy and fatigue was recovering. The patient's medical history and concomitant medication details were not provided. Causality for all reported events is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is considered as non-serious.