Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: The second dose of jynneos was administered intradermally; The injection site was red and raised about 25 mm in size. It looked like an indurated PPD; The injection site was red and raised about 25 mm in size. It looked like an indurated PPD; Case reference number US-BN-2022-001935 is a spontaneous case report initially received from other health professional via Agency (reference number: USBAV22-1014) on 16-Aug-2022 and concerns a 39-year-old male patient.  The patient's medical history and concomitant medication details were not reported.  On 15-Jul-2022, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), administered subcutaneously, at an unknown dose or site of administration for unknown indication.  On 12-Aug-2022, 28 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number unknown), administered intradermally, at an unknown dose or site of administration (explicitly coded as 'Inappropriate route of vaccination').  On the same day, the patient developed injection site redness, raised about 25 mm in size, as reported, it looked like an indurated PPD (purified protein derivative).  At the time of this report, the outcome of the events 'injection site redness' and 'injection site induration' was unknown.  The reporter did not provide a seriousness or causality assessment.  Additional information received from Bavarian Nordic on 16-Aug-2022 included the local BN case ID.; Reporter's Comments: A 39-year-old male patient developed injection site redness, raised about 25 mm in size which looked like an indurated PPD (purified protein derivative), on the same day when he was vaccinated with the second dose of Jynneos administered intradermally, at an unknown dose or site of administration which is considered as inappropriate route of vaccination. Injection site erythema and injection site induration are both listed and expected according to CCDS v1 and PI. Incorrect route of product administration is considered listed per company convention. The outcome for the reported events was unknown. The patient's medical history and concomitant medication details were not reported. Causality is assessed as related for injection site erythema and injection site induration 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 39-year-old male patient developed injection site redness, raised about 25 mm in size which looked like an indurated PPD (purified protein derivative), on the same day when he was vaccinated with the second dose of Jynneos administered intradermally, at an unknown dose or site of administration which is considered as inappropriate route of vaccination. Injection site erythema and injection site induration are both listed and expected according to CCDS v1 and PI. Incorrect route of product administration is considered listed per company convention. The outcome for the reported events was unknown. The patient's medical history and concomitant medication details were not reported. Causality is assessed as related for injection site erythema and injection site induration 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.