Sex: F
Vaccine: SMALLMNK
Symptoms: Application site acne, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Jynneos vaccine was administered intradermally instead of prescribed subcutaneous route; After Jynneos vaccine, the bubble appeared at the injection site; After 24 hours of Jynneos vaccine, vaccination site started to get painful; After Jynneos vaccination, the patient experienced large red pimple that is sore to the touch; After Jynneos vaccination, the patient experienced large red pimple that is sore to the touch; Case reference number US-BN-2022-002324 is a spontaneous case report initially received on 09-Sep-2022 from a consumer via Communication (reference number: USBAV22-1330) and concerns a female patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 04-Sep-2022, the patient was vaccinated with first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) administered intradermally at an unreported dose and unknown anatomical site for monkeypox prophylaxis.  As reported, on 04-Sep-2022, the patient experienced bubble on the injection site and after 24 hours, pain at the injection site and large red pimple that is sore to the touch and when not touching it.  The reporter assessed events as related and non-serious.   At the time of this report, outcome of events was unknown.   No further information provided.; Reporter's Comments: A female patient of unknown age experienced bubble on the injection site on the same day she was vaccinated with first dose of Jynneos administered intradermally at an unreported dose and unknown anatomical site for monkeypox prophylaxis. After 24 hours, the patient also experienced pain at the injection site and large red pimple that is sore to the touch and even when not touching it. Application site acne is unlisted and unexpected, injection site vesicles are listed according to RA however unexpected per RA while injection site pain and injection site erythema are both listed and expected. Incorrect route of product administration is considered listed per company convention. The outcome of all reported events was unknown. Causality is assessed as related for all injection site reactions (vesicles, pain and erythema) and application site acne (pimple) due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Causality for 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 female patient of unknown age experienced bubble on the injection site on the same day she was vaccinated with first dose of Jynneos administered intradermally at an unreported dose and unknown anatomical site for monkeypox prophylaxis. After 24 hours, the patient also experienced pain at the injection site and large red pimple that is sore to the touch and even when not touching it. Application site acne is unlisted and unexpected, injection site vesicles are listed according to RA however unexpected per RA while injection site pain and injection site erythema are both listed and expected. Incorrect route of product administration is considered listed per company convention. The outcome of all reported events was unknown. Causality is assessed as related for all injection site reactions (vesicles, pain and erythema) and application site acne (pimple) due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Causality for incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.