Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Immune system disorder, Inappropriate schedule of product administration, Vasculitis
Clinical narrative: Immune system response to Jynneos vaccine; The second dose of Jynneos vaccine was administered 30 days after the first one; Recurring vasculitis; Case reference number US-BN-2023-000637 is a spontaneous case report initially received on 04-Apr-2023 from a consumer via Bavarian Nordic (local BN case ID: BN_2023_00918) and concerns a male patient born on 09-Sep-1987.  The patient's medical history and concomitant medication details were not provided.  On 05-Aug-2022, the patient was vaccinated with the first dose of Jynneos (batch number: FDP00013; expiration date: 27-Oct-2022) at unknown dose, route or anatomical site of vaccination, for unknown indication.  On 04-Sep-2022, 30 days after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00013; expiration date: 27-Oct-2022) at unknown dose, route or anatomical site of vaccination (explicitly coded as 'inappropriate schedule of vaccine administered').  On an unspecified date in Oct-2022, an unknown time after the vaccination and also reported as since receiving the second dose, the patient experienced recurring vasculitis. After consulting and being monitored by dermatologist, it was believed that symptoms have been triggered as an adverse immune system response to Jynneos vaccine. The patient was receiving daily medication to manage the symptoms and being monitored of kidney function and blood pressure to ensure that there was not ongoing organ damage.  The patient wanted to know next steps in order to identify whether the Jynneos vaccine may caused this, as reported, and how to fix and manage symptoms.  At the time of the initial report, the outcome of the events 'recurring vasculitis' and 'immune system response to Jynneos vaccine' was unknown.  The reporter did not provide seriousness and causality assessment for the events 'recurring vasculitis' and 'immune system response to Jynneos vaccine'.  No further information provided.  Non-significant case correction received on 11-Apr-2023 from Manufacturer included additional reference number.; Reporter's Comments: A male patient born in 1987, experienced recurring vasculitis, within approximately two months after he was vaccinated with the second dose of Jynneos (administered 30 days after the first dose of Jynneos), at unknown dose, route or anatomical site of vaccination which is considered as inappropriate schedule of vaccine administered. Vasculitis is unlisted and unexpected according to RA vs and RA for Jynneos while immunization reaction is considered listed. Inappropriate schedule of product administration is considered listed per company convention. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Since contributory role of suspect product cannot be fully excluded at this point and due to compatible temporal relationship, vasculitis and immunization reaction are both assessed as related. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient born in 1987, experienced recurring vasculitis, within approximately two months after he was vaccinated with the second dose of Jynneos (administered 30 days after the first dose of Jynneos), at unknown dose, route or anatomical site of vaccination which is considered as inappropriate schedule of vaccine administered. Vasculitis is unlisted and unexpected according to RA vs and RA for Jynneos while immunization reaction is considered listed. Inappropriate schedule of product administration is considered listed per company convention. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Since contributory role of suspect product cannot be fully excluded at this point and due to compatible temporal relationship, vasculitis and immunization reaction are both assessed as related. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.