Received May 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | — |
confirmed the final diagnosis of CSVV due to COVID-19 vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) in a 55-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: Previously administered products included for COVID-19 prophylaxis: mRNA COVID-19 Moderna vaccines (Dose 1) and mRNA COVID-19 Moderna vaccines (Dose 2); for Drug use for unknown indication: Penicillin. Past adverse reactions to the above products included Allergic rash with Penicillin; and No adverse effect with mRNA COVID-19 Moderna vaccines and mRNA COVID-19 Moderna vaccines. Concurrent medical conditions included Chronic back pain. Concomitant products included Gabapentin for Chronic back pain. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) (seriousness criteria hospitalization and medically significant). The patient was treated with Hydroxyzine hydrochloride (Hydroxyzine) at an unspecified dose and frequency and Prednisone (oral use) at a dose of taper for a 30-day duration. At the time of the report, CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (10-30 U/L): 17 U/L. On an unknown date, Antineutrophil cytoplasmic antibody: Negative. On an unknown date, Antinuclear antibody: Negative. On an unknown date, Aspartate aminotransferase (10-36 U/L): 13 U/L. On an unknown date, Biopsy skin: Histopathology of Hematoxylin-eosin-stained skin biopsy with 20× (left) and 40× (right) magnification showed neutrophilic inflammation of dermal vessels with leukocytoclasia. On an unknown date, Blood alkaline phosphatase (32-104 U/L): 115 U/L. On an unknown date, Blood calcium (2.2-2.6 millimole per litre): 2.47 millimole per litre. On an unknown date, Blood chloride (98-105 millimole per litre): 101 millimole per litre. On an unknown date, Blood creatinine (61.9-115 micromole per litre): 70.72 micromole per litre. On an unknown date, Blood culture: Negative. On an unknown date, Blood potassium (3.5-5 millimole per litre): 4.5 millimole per litre. On an unknown date, Blood sodium (135-145 millimole per litre): 141 millimole per litre. On an unknown date, Blood test: Blood investigations revealed normal blood cell counts.. On an unknown date, Blood urea (2.9-7.1 millimole per litre): 6.78 millimole per litre. On an unknown date, C-reactive protein (0-5 milligram per litre): 4.29 milligram per litre. On an unknown date, Complement factor (30-75): 57 kU/L. On an unknown date, Cryoglobulins: Negative. On an unknown date, Dermatologic examination: revealed maculopapular, erythematous lesions on thighs and forearms, non-blanching lesions predominantly involving bilateral upper and lower extremities (day 2 since symptom onset). and coalescing erythematous patches with palpable purpura involving upper and lower extremities with areas of desquamation were observed at the time of hospital admission (day 5 since symptom onset).. On an unknown date, Eosinophil count (0-0.7 10^9/L): 0 10^9/L. On an unknown date, Fibrin D dimer (0-0.5 milligram per litre): 8.13 milligram per litre. On an unknown date, HIV test: Negative. On an unknown date, Haemoglobin (120-160 gram per litre): 127 gram per litre. On an unknown date, Hepatitis viral test: Negative. On an unknown date, Immunology test: unremarkable. On an unknown date, Inflammatory marker test: unremarkable. On an unknown date, Metabolic function test: unremarkable. On an unknown date, Platelet count (150-450 10^9/L): 473 10^9/L. On an unknown date, Urine analysis: unremarkable. On an unknown date, White blood cell count (4-11 10^9/L): 12.9 10^9/L. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) to be related. Patient presented to outpatient clinic with a diffuse pruritic rash that started 48 hours after vaccine. She did not report past or family history of neoplasm or autoimmune disease. There was no change in her medication use. Basic blood investigations and a 3-mm punch biopsy of a skin lesion on the leg were obtained. Patient was prescribed with topical steroid and hydroxyzine. The patient followed up 72 hours later (5 days since the onset of rash) with a worsening rash-larger in size with itching and burning pain associated with bilateral ankle pain. She was hospitalized, and intravenous steroid was initiated. There was no evidence of venous thrombosis on the lower extremities. Temporality of her symptoms post vaccination and exclusion of other differential diagnoses confirmed the final diagnosis of Cutaneous small-vessel vasculitis (CSVV) due to COVID-19 vaccine. The patient responded with decreasing erythema, pruritus, and pain within 48 hours. With no new lesions appearing, she was discharged on prednisone taper for a 30-day duration. She had significant improvement of her symptoms 1 week after discharge. The patient had improving violaceous patches on legs (day 10 since symptom onset) with near-complete resolution of rash on forearms (day 30 since symptom onset). It was reported that this case highlighted importance of keeping a strong suspicion to allow prompt recognition and appropriate treatment.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Chronic back pain
Gabapentin
Test Name: Alanine aminotransferase; Test Name: Anti-neutrophil cytoplasmic antibody panel; Test Result: Negative ; Test Name: Anti-nuclear antibody; Test Result: Negative ; Test Name: Aspartate aminotransferase; Test Name: 3-mm punch biopsy of skin; Result Unstructured Data: Histopathology of Hematoxylin-eosin-stained skin biopsy with 20× (left) and 40× (right) magnification showed neutrophilic inflammation of dermal vessels with leukocytoclasia; Test Name: Alkaline phosphatase; Test Name: Calcium; Test Name: Chloride; Test Name: Creatinine; Test Name: Blood culture; Test Result: Negative ; Test Name: Potassium; Test Name: Sodium; Test Name: Blood investigations; Result Unstructured Data: Blood investigations revealed normal blood cell counts.; Test Name: Blood urea nitrogen; Test Name: Complement level; Result Unstructured Data: 57 kU/L; Test Name: C-reactive protein; Test Name: Cryoglobulin; Test Result: Negative ; Test Name: skin examination; Result Unstructured Data: revealed maculopapular, erythematous lesions on thighs and forearms, non-blanching lesions predominantly involving bilateral upper and lower extremities (day 2 since symptom onset).; Test Name: skin examination; Result Unstructured Data: coalescing erythematous patches with palpable purpura involving upper and lower extremities with areas of desquamation were observed at the time of hospital admission (day 5 since symptom onset).; Test Name: Eosinophil count; Test Name: D-dimer; Test Name: Hemoglobin; Test Name: Hepatitis panel; Test Result: Negative ; Test Name: Human immunodeficiency virus test; Test Result: Negative ; Test Name: autoimmune markers; Result Unstructured Data: unremarkable; Test Name: inflammatory markers; Result Unstructured Data: unremarkable; Test Name: Comprehensive metabolic panel; Result Unstructured Data: unremarkable; Test Name: Platelet count; Test Name: urinalysis; Result Unstructured Data: unremarkable; Test Name: White blood cell count