Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased, Laboratory test, Necrosis, Oxygen saturation
Clinical narrative: CUTANEOUS VASCULITIS/LEUKOCYTOCLASTIC VASCULITIS; THROMBOSIS; NECROSIS; CELLULITIS; CONDITION AGGRAVATED; GAIT DISTURBANCE; ERYTHEMA; BLISTER; TENDERNESS; ALANINE AMINOTRANSFERASE NORMAL; ANTINEUTROPHIL CYTOPLASMIC ANTIBODY NEGATIVE; ANTINUCLEAR ANTIBODY NEGATIVE; ASPARTATE AMINOTRANSFERASE NORMAL; BIOPSY ABDOMINAL WALL NORMAL; BIOPSY MUSCLE ABNORMAL; BLOOD ALKALINE PHOSPHATASE NORMAL; BLOOD CREATININE NORMAL; DOUBLE STRANDED DNA ANTIBODY; FULL BLOOD COUNT NORMAL; HEPATITIS VIRAL TEST NEGATIVE; HIV ANTIGEN NEGATIVE; IMMUNOLOGY TEST; INTERNATIONAL NORMALISED RATIO INCREASED; RED BLOOD CELL SEDIMENTATION RATE INCREASED; RENAL FUNCTION TEST NORMAL; RHEUMATOID FACTOR NEGATIVE; SARS-COV-2 TEST NEGATIVE; WHITE BLOOD CELL COUNT NORMAL; X-RAY ABNORMAL; RASH MACULAR; RASH; RASH MACULOPAPULAR; ARTHRALGIA; This spontaneous report received from other health professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1209679) and from literature: This report concerned a 64 year old male. The objective of the study is to describe a case of cutaneous small-vessel vasculitis following vaccination with the JANSSEN COVID-19 VACCINE. The patient's height, and weight were not reported. The patient's past medical history included: depression, anxiety, obstructive sleep apnea, erectile dysfunction, and inflatable penile, prosthesis replaced (inflatable penile, prosthesis replaced 10/2020), and concurrent conditions included: acute recurrent sinusitis, upper respiratory infection, and deep vein thrombosis (dvt) of his left lower extremity and was on chronic anticoagulation, and other pre-existing medical conditions included: The patient had no known allergies to medication. The patient had no autoimmune disease or recent infections. The patient did not had prior complications with previous vaccines, including influenza vaccines. The patient was afebrile and denied any new or changes in supplements or medications. He was up to date on age-appropriate cancer screenings. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered at arm on 10-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 64 years old. Concomitant medications included amoxicillin for acute recurrent sinusitis, and warfarin for drug used for unknown indication.  On 17-MAR-2021, the patient felt a sting on his left lateral ankle. When he pulled up his pant leg, he saw the small little red spots that were exquisitely tender. He went immediately to his primary care physician's office, where he was prescribed Bactrim for suspected cellulitis. The rash steadily worsened with extension up his left leg and onto his right leg and blistering of some of the lesions most markedly in his groin. His rash initially presented on his feet bilaterally as palpable purpuric papules and plaques, which spread up his legs and thighs, with the newest lesions distributed over his arms, abdomen, buttocks, and back. The lesions were tender to palpation and were more pronounced, edematous, and tender on the left leg compared with the right. The patient also had pain associated with the rash increased and remained most severe on the lateral aspect of the left ankle. He presented back to his primary care physician's office, where he was given methylprednisolone 80 milligrams intravenous for pain, discharged with a prescription for prednisone 60 milligrams daily for the next few days. Pain worsened the point that he was unable to bear much weight on the left leg prompting his presentation to the emergency department.  The patient visited to the emergency department where vitals were notable for being afebrile, heart rate 111, blood pressure 162/104mmHg, normal oxygen saturation on room air. He was noted to have a maculopapular rash on bilateral lower extremities extending up the trunk to the chest. Laboratory workup showed a normal Complete blood count, creatinine 1.29 (baseline 1),Aspartate aminotransferase 34, Alanine aminotransferase 36, Blood alkaline phosphatase 117. International normalized ratio was 2.3 on. He denied any chills, night sweats, change in weight, myalgias, arthralgias, or genitourinary, gastrointestinal, or pulmonary symptoms. The patient experienced thrombosis, and was hospitalized (date unspecified). The patient also experienced necrosis, cutaneous vasculitis, cellulitis, condition aggravated, gait disturbance, erythema, blister, tenderness, alanine aminotransferase normal, antineutrophil cytoplasmic antibody negative, antinuclear antibody negative, aspartate aminotransferase normal, biopsy abdominal wall normal which was negative for specific immune deposits, biopsy muscle abnormal, blood alkaline phosphatase normal, blood creatinine normal, double stranded dna antibody, full blood count normal, hepatitis viral test negative, hiv antigen negative, immunology test, international normalized ratio increased, red blood cell sedimentation rate increased, renal function test normal, rheumatoid factor negative, sars-cov-2 test negative, white blood cell count normal, x-ray abnormal, rash macular, rash, rash maculopapular, arthralgia. Initiation of high-dose corticosteroids led to the rapid improvement of the patient's cutaneous symptoms and clinical appearance of the rash. The patient's vasculitis resolved and remained quiescent after the completion of his oral steroid course. On an unspecified date, the patient had post-inflammatory hyperpigmentation at sites of previously involved leukocytoclastic vasculitis, which are gradually improving in clinical appearance. Laboratory data (dates unspecified) included: Antineutrophil cytoplasmic antibody Negative, Antinuclear antibody Negative, Biopsy from the patient's thigh revealed fibrinoid necrosis of vessel walls with fibrin thrombi, extravasated erythrocytes, and neutrophilic inflammatory infiltrate with leukocytoclasia, Biopsy abdominal wall normal, Blood creatinine normal, Blood pressure (NR: not provided) 162/104 mmHg, Complement factor C3 normal limits, Complement factor C4 normal limits, Double stranded DNA antibody Negative, Full blood count normal, HIV antigen Negative, Heart rate 111 (unit not reported), Hepatitis viral test Negative, Immunology test not reported, Lab test Negative, Lab test normal limits, Oxygen saturation normal, Renal function test normal, Rheumatoid factor Negative, SARS-CoV-2 test Negative, White blood cell count normal, and X-ray abnormal. Treatment medications (dates unspecified) included: paracetamol, methylprednisolone, morphine, prednisone, hydrocodone bitartrate/paracetamol, and sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cutaneous vasculitis/leukocytoclastic vasculitis, and had not recovered from thrombosis, rash, arthralgia, alanine aminotransferase normal, antineutrophil cytoplasmic antibody negative, antinuclear antibody negative, aspartate aminotransferase normal, biopsy abdominal wall normal, biopsy muscle abnormal, blister, blood alkaline phosphatase normal, blood creatinine normal, cellulitis, condition aggravated, double stranded dna antibody, full blood count normal, gait disturbance, hepatitis viral test negative, hiv antigen negative, immunology test, international normalized ratio increased, red blood cell sedimentation rate increased, renal function test normal, rheumatoid factor negative, sars-cov-2 test negative, white blood cell count normal, x-ray abnormal, rash macular, rash maculopapular, erythema, necrosis, and tenderness. The authors emphasized that the temporal association between the patient's vaccination and subsequent development of vasculitis in the absence of other possible inciting etiologies suggests that the vaccine may have been the trigger. However, the authors cannot ascribe causation. While there have been cases of systemic illness in the setting of cutaneous vasculitis and our patient was not acutely ill and responded rapidly to appropriate treatment This report was serious (Hospitalization Caused / Prolonged).  Additional information was received form physician (author) via literature on 06-SEP-2022. The following information was updated and incorporated into the case narrative: source, reporters, patient medical history, DVT, event rrt cutaneous vasculitis was updated to cutaneous vasculitis/leukocytoclastic vasculitis, outcome of cutaneous vasculitis/leukocytoclastic vasculitis updated to recovered/resolved form not recovered, lab biopsy thigh, hepatic function, complement c3 and c4 level, extractable nuclear antigen panel was added and narrative updated.; Sender's Comments: V1:The new information was updated  into the case narrative. -Leukocytoclastic vasculitis( Cutaneous vasculitis),Rash, rash macular, rash maculopapular, blister, erythema, tenderness. Follow-up received Clinical Details. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS (Warfarin) Therefore, this event(s) is considered not related. Covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210500543 -COVID-19 VACCINE Ad26.COV2. S, cellulitis, necrosis, condition aggravated, gait disturbance,  alanine aminotransferase normal, antineutrophil cytoplasmic antibody negative, antinuclear antibody negative, aspartate aminotransferase normal, biopsy abdominal wall normal, biopsy muscle abnormal, blood alkaline phosphatase normal, blood creatinine normal, , double stranded dna antibody, full blood count normal, hepatitis viral test negative, hiv antigen negative, immunology test, international normalized ratio increased, red blood cell sedimentation rate increased, renal function test normal, rheumatoid factor negative, sars-cov-2 test negative, white blood cell count normal, x-ray abnormal. 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). 20210500543- COVID-19 VACCINE Ad26.COV2. S .arthralgia. This event(s) is labeled and is therefore considered potentially related.