Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood fibrinogen, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood lactate dehydrogenase
Clinical narrative: CUTANEOUS SMALL VESSEL VASCULITIS; PURPURA; RASH; SERUM FERRITIN INCREASED; RHEUMATOID FACTOR POSITIVE; BIOPSY SKIN; BLOOD IMMUNOGLOBULIN A; TREPONEMA TEST; ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY NEGATIVE; ANTINEUTROPHIL CYTOPLASMIC ANTIBODY NEGATIVE; ANTINUCLEAR ANTIBODY NEGATIVE; BLOOD CULTURE NEGATIVE; HEPATITIS A ANTIBODY NEGATIVE; HEPATITIS B ANTIBODY NEGATIVE; HEPATITIS C ANTIBODY NEGATIVE; HIV TEST NEGATIVE; This spontaneous report was received from Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER ID: 1232026) and literature: Cutaneous small vessel vasculitis following single-dose Janssen Ad26.COV2.S vaccination. This report concerned a 65 year old male. The objective of the study was to describe cutaneous small vessel vasculitis following single-dose Janssen Ad26.COV2.S vaccination. The patient's height, and weight were not reported. The patient's past medical history included: aortic valve replacement with mechanical bi-leaflet prosthesis, stroke, and recovered hypertension, and concurrent conditions included: hyperlipidemia, and other pre-existing medical conditions included: He denied any prior vaccine. The patient experienced drug allergy when treated with gabapentin, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included warfarin. On 14-APR-2021 (one week after receiving vaccine), patient presented to the emergency department with painful and itchy purpuric rash involving arms, legs, and lower abdomen. A skin biopsy confirmed leukocytoclastic vasculitis. An extensive work-up was performed and was non-revealing for the most part. Rheumatology and Dermatology believed rash was caused by recently administered vaccine. Patient was started on Prednisone 60 mg daily along with Triamcinolone cream and (analgesics) pain medications (unspecified). His rash and pain gradually improved. Patient was hospitalized for 6 days (date unspecified). He was on oral Prednisone taper. The event latency was 7 days. Laboratory data included: Anti-cyclic citrullinated peptide antibody (NR: not provided) Negative, Antineutrophil cytoplasmic antibody (NR: not provided) Negative, Antinuclear antibody (NR: not provided) Negative, Biopsy skin (NR: not provided) consistent confirmed leukocytoclastic vasculitis, Blood culture (NR: not provided) Negative, Blood immunoglobulin A (NR: not provided) Within normal range, Cryoglobulins (NR: not provided) Negative, HIV test (NR: not provided) negative, Hepatitis A antibody (NR: not provided) Negative, Hepatitis B antibody (NR: not provided) Negative, Hepatitis C antibody (NR: not provided) Negative, Rheumatoid factor (NR: not provided) Positive Syphilis Abs, Serum ferritin (NR: not provided) Increased, and Treponema test (NR: not provided) Unknown. Complement factor C3 (NR: not provided) normal, Complement factor C4 (NR: not provided) normal, and Heparin-induced thrombocytopenia test (NR: not provided) Negative, Biopsy (NR: not provided) unknown, C-reactive protein (NR: not provided) 86 mg/ml, chest X-ray (NR: not provided) Were unremarkable, Complete blood count (NR: not provided) within the normal ranges, Fibrin D dimer (NR: not provided) 0.72 ug/mL, Erythrocyte sedimentation rate (NR: not provided) 34 mm/h, Fibrinogen (NR: not provided) 581 mg/dL, Haptoglobin (NR: not provided) 11 mg/dL, Antiglobulin test indirect (NR: not provided) normal, International normalized ratio (NR: not provided) Was therapeutic, Lactate dehydrogenase (NR: not provided) 407 IU/L, reactive syphilis antibody (NR: not provided) negative, SARS-CoV-2 PCR test (NR: not provided) negative, Serum immunoglobulin G (NR: not provided) 3310 mg d/L, Urinalysis (NR: not provided) were unremarkable, Serum immunoglobulin M (NR: not provided) 369 mg/dL, Venous Doppler (NR: not provided) were unremarkable, Hepatitis panel (NR: not provided) negative, Laboratory test (NR: not provided) exquisitely tender petechiae and purpura on the lower portions of bilateral extremities, scattered petechiae on the lower portion of the abdomen, and palpable purpura on the left arm. No mucosal or palmar/plantar involvement, livedo reticularis, skin ulcerations, skin nodules, or lymphadenopathy were apparent. All vital signs were within normal limits. Treatment medications (dates unspecified) included: prednisone, triamcinolone and analgesics. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cutaneous small vessel vasculitis, purpura, and rash, and had not recovered from anti-cyclic citrullinated peptide antibody negative, antineutrophil cytoplasmic antibody negative, antinuclear antibody negative, biopsy skin, blood culture negative, blood immunoglobulin A, hepatitis A antibody negative, hepatitis B antibody negative, hepatitis C antibody negative, HIV test negative, rheumatoid factor positive, serum ferritin increased, and treponema test. The authors emphasized that etiology of the patient's Cutaneous small vessel vasculitis was attributed to the Ad26.COV2.S vaccine and clinicians need to be aware of Ad26.COV2.S induced v as a potential complication of the adenoviral vaccine. Further investigation of any additional cases will be crucial for estimating the frequency and pathophysiology of Ad26.COV2.S induced Cutaneous small vessel vasculitis. Additional studies are needed to determine whether patients with severe adverse events to Ad26.COV2.S, including vaccine induced thrombotic thrombocytopenia, should avoid future inoculation with alternative COVID-19 vaccines. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20210857562 and 20211146237. This case, involving the same patient is linked to 20210809074.  Additional information was received from company representative on 19-NOV-2021. The following information was updated and incorporated into the case narrative: The patient's medical history updated. The event RRT was updated to cutaneous small vessel vasculitis.  It was determined that 20211146237 was a duplicate of this case. All relevant information regarding this case will be submitted under 20210706411.; Sender's Comments: V2: This version is created to update- medical history updated. The event RRT was updated to cutaneous small vessel vasculitis. All relevant information regarding duplicate case- 20211146237 submitted under 20210706411.  20210706411-Covid-19 vaccine ad26.cov2.s-. Follow-up received regarding Other Information: RRT updated. Cutaneous small vessel vasculitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210706411-Covid-19 vaccine ad26.cov2.s- Purpura, Serum ferritin increased Rheumatoid factor positive Biopsy skin,  Blood immunoglobulin A, Treponema test. Anti-cyclic citrullinated peptide antibody negative,  Antineutrophil cytoplasmic antibody negative,  Antinuclear antibody negative  Blood culture negative,  Hepatitis A antibody negative,  Hepatitis B antibody negative,  Hepatitis C antibody negative,  HIV test negative, rash. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).