Sex: U
Vaccine: SMALLMNK
Symptoms: Product use issue, Scar, Wrong technique in product usage process
Clinical narrative: The patient developed a permanent scar identified as dermatofibroma; The patient received the second dose of Jynneos vaccine 29 days after the first dose; The patient received vaccine in left forearm instead in upper arm (deltoid); Jynneos was administered through incompetent usage and improper handling of the needle when injected into the patients forearm; Case reference number US-BN-2024-002321 is a spontaneous case initially received from a lawyer via Bavarian Nordic (reference number: BN_2024_02928) on 06-Aug-2024 and concerns a patient of unspecified gender or age.  The patient's medical history and concomitant medication were not provided.  On 06-Sep-2022, the patient received the first dose of Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration, for unknown indication.  On 05-Oct-2022, 29 days after the first dose of Jynneos, the patient received the second dose of Jynneos (batch number: unknown), at unknown dose and route in left forearm. As reported, Jynneos was administered through incompetent usage and improper handling of the needle when injected into the patient's forearm (explicitly coded as 'inappropriate schedule of vaccine administered', 'vaccine administered at inappropriate site' and 'product use issue').  On an unspecified date, the patient developed a permanent scar identified as dermatofibroma.  On 13-Mar-2023, as reported, the physician confirmed condition of the patient.  On 25-May-2023, the patient started treatment with steroid injections and v-beam laser treatments.  On 22-Jun-2023, as reported again the patient started treatment with steroid injections and v-beam laser treatments.  On unspecified dates, as reported, between Aug-2023 and Dec-2023, the patient received scar treatment including micro-needling, injections, and permanent make-up treatment. As reported, throughout the course of patient's treatment, the patient had treatment with tri-luma, scar away, azelaic acid gel, and rosacea cream, as recommended by medical professionals.  At the time of initial report, the patient did not recover from event of 'Dermatofibroma', as reported despite diligent efforts, including various medical interventions and treatments recommended by medical professionals, patient's dermatofibroma remained resilient and permanent, causing significant physical injury, emotional distress, and financial strain.  The reporter did not provide seriousness assessment of 'Dermatofibroma', however the event was considered as serious, reported as causing significant physical injury, due to being reported as causing significant physical injury and emotional distress. Causality assessment for the event of 'Dermatofibroma' was considered as related, reported as a direct and proximate consequence of receiving Jynneos vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown demographics was vaccinated with two doses of Jynneos, 29 days apart (which is considered inappropriate schedule of vaccine administration). The second dose was given in the patient's forearm via, reportedly, improper handling and technique, which is considered vaccine administration at inappropriate site and product use issue. The patient developed dermatofibroma scar on an unspecified date. Treatment included laser beams, topical remedies and steroid injections. The case is considered serious due to medical significance and disabling (due to the physical injury, permanent scarring and emotional distress). Dermatofibroma (fibrous histiocytoma) is unlisted and unlabeled per CCDS v7.0 and PI for Jynneos. Vaccine administration at inappropriate site, product use issue and inappropriate schedule of vaccine administered are listed per company convention. Medical history and concomitant medications were unknown. It was unknown if the patient had had any other adverse events (systemic or local) immediately after the injection. Dermatofibroma can occur as a result of local trauma, insect bites, but the exact pathophysiology and etiology are not clear. Development of a scar usually depends on a multitude of factor, including genetics, individual skin reactivity, or inadvertent errors/pollution/trauma upon application. Noted that the route of administration in the forearm was not specified (e.g. subcutaneous or intradermal). It was unknown if the patient had previously developed similar skin reactions to other triggers. Considering the information available, a causal relationship cannot be excluded; however, more information about the nature of the technical error upon application would help to put the case into a clearer context. Vaccine administration at inappropriate site, product use issue and inappropriate schedule of vaccine administered are not related to Jynneos, but to human and technical factors.; Sender's Comments: A patient of unknown demographics was vaccinated with two doses of Jynneos, 29 days apart (which is considered inappropriate schedule of vaccine administration). The second dose was given in the patient's forearm via, reportedly, improper handling and technique, which is considered vaccine administration at inappropriate site and product use issue. The patient developed dermatofibroma scar on an unspecified date. Treatment included laser beams, topical remedies and steroid injections. The case is considered serious due to medical significance and disabling (due to the physical injury, permanent scarring and emotional distress). Dermatofibroma (fibrous histiocytoma) is unlisted and unlabeled per CCDS v7.0 and PI for Jynneos. Vaccine administration at inappropriate site, product use issue and inappropriate schedule of vaccine administered are listed per company convention. Medical history and concomitant medications were unknown. It was unknown if the patient had had any other adverse events (systemic or local) immediately after the injection. Dermatofibroma can occur as a result of local trauma, insect bites, but the exact pathophysiology and etiology are not clear. Development of a scar usually depends on a multitude of factor, including genetics, individual skin reactivity, or inadvertent errors/pollution/trauma upon application. Noted that the route of administration in the forearm was not specified (e.g. subcutaneous or intradermal). It was unknown if the patient had previously developed similar skin reactions to other triggers. Considering the information available, a causal relationship cannot be excluded; however, more information about the nature of the technical error upon application would help to put the case into a clearer context. Vaccine administration at inappropriate site, product use issue and inappropriate schedule of vaccine administered are not related to Jynneos, but to human and technical factors.