Sex: U
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Rash macular, Vaccination site erythema, Vaccination site scab
Clinical narrative: Vaccination site never healed, it's just a giant, red scabby thing.; After getting the vaccination, I developed pox but they didn't hurt or scratch, the spots were purely cosmetic all over body and extremities, but not my face; Vaccine administered intradermally; First dose administrated "8 weeks before"; Case reference number US-BN-2022-004474, is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV22-1836) on a 01-Nov-2022 and concerns an adult patient of unknown age and gender.   The patient's medical history was, as reported, not immunocompromised and no active infection.  The patient's concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at an unknown dose, administered subcutaneously, on an unknown anatomical location, for monkeypox prophylaxis.  On 20-Sep-2022, 8 weeks after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) (explicitly coded as 'Inappropriate schedule of vaccine administered'), at an unknown dose, administered intradermally (explicitly coded as 'Intradermal injection'), at an unknown anatomical location, for monkeypox prophylaxis.  On an unspecified date, as reported, after the second vaccination, the patient developed pox that didn't hurt or scratch, the spots were purely cosmetic and all over the patient's body and extremities, but not on the patient's face. The dermatologist said that she didn't feel comfortable consulting because she didn't know enough about it. The patient was very afraid that the spots will scar. The patient stated that the vaccination site never healed and it's just a giant, red scabby thing, but it might be healing slowly. As reported, it's been 1.5 months since the second vaccination.  At the time of this report, the outcome of event 'Injection site scabbing' was not recovered/not resolved and the outcome of the event 'Spot-like rash' was unknown.  The reporter didn't provide seriousness assessment and did not provide a causality assessment.  Additional information received from Bavarian Nordic on 02-Nov-2022 included the local BN case ID and PQC Report.; Reporter's Comments: An adult patient of unknown age and gender was vaccinated with the second dose of Jynneos vaccine 8 weeks after the first dose, which is considered as inappropriate schedule of vaccine administered, at an unknown dose, administered intradermally, which is considered as intradermal injection, at an unknown anatomical location, for monkeypox prophylaxis. On an unspecified date, as reported, after the second vaccination, the patient developed non-serious events of injection site scab and rash macular. The events of injection site scab and rash macular are unlisted for Jynneos according to the RA v1 and RA. Inappropriate schedule of vaccine administered and intradermal injection are considered as listed per company convention. The patient's medical history was, as reported, not immunocompromised and no active infection, and concomitant medications were not provided. The outcome of event injection site scab was not resolved and the outcome of the event rash macular was unknown. Considering compatible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of injection site scab and rash macular have been considered as related to Jynneos. Inappropriate schedule of vaccine administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult patient of unknown age and gender was vaccinated with the second dose of Jynneos vaccine 8 weeks after the first dose, which is considered as inappropriate schedule of vaccine administered, at an unknown dose, administered intradermally, which is considered as intradermal injection, at an unknown anatomical location, for monkeypox prophylaxis. On an unspecified date, as reported, after the second vaccination, the patient developed non-serious events of injection site scab and rash macular. The events of injection site scab and rash macular are unlisted for Jynneos according to the RA v1 and RA. Inappropriate schedule of vaccine administered and intradermal injection are considered as listed per company convention. The patient's medical history was, as reported, not immunocompromised and no active infection, and concomitant medications were not provided. The outcome of event injection site scab was not resolved and the outcome of the event rash macular was unknown. Considering compatible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of injection site scab and rash macular have been considered as related to Jynneos. Inappropriate schedule of vaccine administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.