Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus, Injection site reaction, Rash maculo-papular
Clinical narrative: At the injection site, there was raised area of redness and itching and it looked like it was macular, papular in detail; At the injection site, there is and 8x3 raised area of redness and itching; At the injection site, there is and 8x3 raised area of redness and itching; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-001908 is a spontaneous case report initially received from a nurse practitioner via agency (reference number: USBAV22-1013) on 16-Aug-2022 and concerns an adult male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.   On an unknown date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) at an unknown dose or site of administration, intradermally, for unknown indication (explicitly coded as 'inappropriate route of vaccination').    On an unknown date, also reported as within 24 hours after the Jynneos vaccine, the patient had a reaction to the Jynneos injection, at the injection site, there was an 8x3 cm raised area of redness and itching and it looked like it was macular, popular in detail.   At the time of this report, the patient was recovering from all events.  The reporter did not provide seriousness and causality assessment for reported events.  Additional information received from Bavarian Nordic on 16-Aug-2022 included local BN case ID.; Reporter's Comments: An adult male patient of an unknown age developed non-serious events injection site redness, injection site pruritus and maculopapular rash 24 hours after Jynneos was administered intradermally, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. Maculopapular rash is unlisted, while injection site pruritus and injection site redness are listed per  agency 1 and the agency 2. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, maculopapular rash, injection site pruritus and injection site redness have been considered as related to Jynneos. Inappropriate route of vaccination is not related to Jynneos, but to a human factor.; Sender's Comments: An adult male patient of an unknown age developed non-serious events injection site redness, injection site pruritus and maculopapular rash 24 hours after Jynneos was administered intradermally, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. Maculopapular rash is unlisted, while injection site pruritus and injection site redness are listed per agency 1 and the agency 2. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, maculopapular rash, injection site pruritus and injection site redness have been considered as related to Jynneos. Inappropriate route of vaccination is not related to Jynneos, but to a human factor.