Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diagnostic aspiration, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Difficulty breathing / Shortness of breath; Numbness and shooting pain per both feet; Bilateral tingling sensation in fingertips; Calf pain; Muffled sensation in her ears; Chest pain; Neck pain; Cough; Rhinorrhea; Weakness; Fatigue / Tired; Fever / Temperature of 102 / low grade temperature; Chills; Shoulder pain; Nausea; ANCA associated Vasculitis; granulomatosis with polyangiitis; This literature-non-study case was reported in a literature article and describes the occurrence of ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (ANCA associated Vasculitis), GRANULOMATOSIS WITH POLYANGIITIS (granulomatosis with polyangiitis), DYSPNOEA (Difficulty breathing / Shortness of breath), HYPOAESTHESIA (Numbness and shooting pain per both feet), PARAESTHESIA (Bilateral tingling sensation in fingertips), PAIN IN EXTREMITY (Calf pain), HYPOACUSIS (Muffled sensation in her ears), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), COUGH (Cough), RHINORRHOEA (Rhinorrhea), ASTHENIA (Weakness), FATIGUE (Fatigue / Tired), PYREXIA (Fever / Temperature of 102 / low grade temperature), CHILLS (Chills), ARTHRALGIA (Shoulder pain) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.   The patient's past medical history included Migraine (Gone after menopause.), pH (Negative) in 2006, Pulmonary function test (Normal) in June 2006, Colonoscopy (Follow-up in 5 years, normal.) on 12-Dec-2012, Stress test (Normal) in May 2006, Endoscopy gastrointestinal (Normal) in 2006, Baker's cyst excision (Bakers cyst) in 1957 and Endoscopy upper gastrointestinal tract (Normal) in 2006. Family history included DVT (Reports family history of DVT but denies any personal history DVT/PE). Concurrent medical conditions included Hyperlipidemia, Hypertension, Reflux esophagitis, Ex-tobacco user (Quit 35 years ago.), Wegeners granulomatosis and Alcohol use. Concomitant products included BIOTIN from an unknown date to 15-Mar-2021 for Hair growth increased, ACETAMINOPHEN for Pain, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) from an unknown date to 03-Mar-2021, CYANOCOBALAMIN (VITAMIN B-12), VITAMIN D3, ASCORBIC ACID, MULTIVITAMIN [VITAMINS NOS], ALENDRONATE SODIUM (FOSAMAX), FLUTICASONE, METOPROLOL SUCCINATE, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) and AVACOPAN for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing / Shortness of breath) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness and shooting pain per both feet) (seriousness criterion hospitalization), PARAESTHESIA (Bilateral tingling sensation in fingertips) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Calf pain) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), NECK PAIN (Neck pain) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), RHINORRHOEA (Rhinorrhea) (seriousness criterion hospitalization), ASTHENIA (Weakness) (seriousness criterion hospitalization), FATIGUE (Fatigue / Tired) (seriousness criterion hospitalization), PYREXIA (Fever / Temperature of 102 / low grade temperature) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), ARTHRALGIA (Shoulder pain) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). 05-Mar-2021, the patient experienced HYPOACUSIS (Muffled sensation in her ears) (seriousness criterion hospitalization). In 2021, the patient experienced ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (ANCA associated Vasculitis) (seriousness criteria hospitalization and medically significant) and GRANULOMATOSIS WITH POLYANGIITIS (granulomatosis with polyangiitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 15-Mar-2021 to 17-Mar-2021 due to ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS, ARTHRALGIA, ASTHENIA, CHEST PAIN, CHILLS, COUGH, DYSPNOEA, FATIGUE, GRANULOMATOSIS WITH POLYANGIITIS, HYPOACUSIS, HYPOAESTHESIA, NAUSEA, NECK PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PYREXIA and RHINORRHOEA. The patient was treated with PREDNISONE (oral) at a dose of 60 milligram once a day; PREDNISONE ongoing since an unknown date at a dose of 5 milligram once a day and RITUXIMAB at an unspecified dose and frequency. At the time of the report, ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (ANCA associated Vasculitis), GRANULOMATOSIS WITH POLYANGIITIS (granulomatosis with polyangiitis), DYSPNOEA (Difficulty breathing / Shortness of breath), HYPOAESTHESIA (Numbness and shooting pain per both feet), PARAESTHESIA (Bilateral tingling sensation in fingertips), PAIN IN EXTREMITY (Calf pain), HYPOACUSIS (Muffled sensation in her ears), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), COUGH (Cough), RHINORRHOEA (Rhinorrhea), ASTHENIA (Weakness), FATIGUE (Fatigue / Tired), PYREXIA (Fever / Temperature of 102 / low grade temperature), CHILLS (Chills), ARTHRALGIA (Shoulder pain) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Chest X-ray: abnormal (abnormal) Mild calcifications in aorta. Mild to moderate patchy nonspecific bilateral heterogenous opacities. Infectious or inflammatory etiology to be considered.. On 15-Mar-2021, Computerised tomogram thorax: abnormal (abnormal) Numerous bilateral pulmonary nodules and multiple bilateral pulmonary mass like opacities. On 15-Mar-2021, Electrocardiogram: abnormal (abnormal) Abnormal ECG when compared to ECG from 27FEB2020.. On 15-Mar-2021, Fibrin D dimer: 2.00 (abnormal) High / Positive. On 15-Mar-2021, Full blood count: normal (normal) Glucose, alkaline phosphatase and globulin slightly higher than normal range, but within acceptable normal range. A:G ratio lower than range but normal. On 15-Mar-2021, Haematocrit (35.1-45.6): 40.3 (normal) 40.3 Normal value low: 35.1 % Normal value high: 45.6 %. On 15-Mar-2021, Haemoglobin (11.7-15.7): 13.5 (normal) 13.5 Normal value low: 11.7 g/dL Normal value high: 15.7 g/dL. On 15-Mar-2021, Mean cell haemoglobin (26.4-33.0): 29.9 (normal) 29.9 Normal value low: 26.4 pg Normal value high: 33.0 pg. On 15-Mar-2021, Mean cell volume (80-97): 89.4 (normal) 89.4 Normal value low: 80 fL Normal value high: 97 fL. On 15-Mar-2021, Red blood cell count (3.90-5.11): 4.51 (normal) 4.51 Normal value low: 3.90 M/uL Normal value high: 5.11 M/uL. On 15-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 15-Mar-2021, Streptococcus test: negative (Negative) Negative. On 15-Mar-2021, Troponin: negative (Negative) Troponin I negative. On 15-Mar-2021, White blood cell count (3.8-10.8): 13.00 (High) 13.00 Normal value low: 3.8 K/uL Normal value high: 10.8 K/uL. On 17-Mar-2021, Chest X-ray: abnormal (abnormal) Increased opacities in lung. On 08-Apr-2021, Antineutrophil cytoplasmic antibody: 640 (Positive) c ANCA was positive. On 08-Apr-2021, Blood immunoglobulin G: 979 (Positive) Positive. On 08-Apr-2021, C-reactive protein: 4.54 (normal) Normal. On 08-Apr-2021, Electrocardiogram: normal (normal) Normal. On 08-Apr-2021, Fungal test: negative (Negative) Negative. On 08-Apr-2021, Hepatitis viral test: negative (Negative) Negative. On 21-Apr-2021, Chest X-ray: abnormal (abnormal) Multi focal patch pulmonary opacities some of which appear more conspicuous than prior and others.. On an unknown date, Antineutrophil cytoplasmic antibody: 1:640 with pr3 at 979 au/ml (Positive) ANCA serologic testing was strongly positive (1:640 with PR3 at 979 AU/ml; reference,<19). On an unknown date, Chest X-ray: abnormal (abnormal) During the evaluation for weight loss, a chest radiograph was obtained, which showed bilateral consolidated mass-like lesions. The largest lesion measured 7 cm in diameter and was located in the right lower lobe. and near resolution repeat radiographs also showed near resolution of mass-like lesions.. On an unknown date, Diagnostic aspiration: acute necrotizing granulomatous inflammation To rule out malignancy, a computed tomography-guided needle biopsy was done of the right lower lobe lesion, which showed acute necrotizing granulomatous infla mmation.. On an unknown date, Ultrasound Doppler: did not reveal deep venous thrombosis Doppler venous ultrasonography of both lower extremities did not reveal deep venous thrombosi. On an unknown date, Urine analysis: abnormal (abnormal) A urinalysis showed haematuria with a count of 10 red blood cells/high-power field..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (ANCA associated Vasculitis), GRANULOMATOSIS WITH POLYANGIITIS (granulomatosis with polyangiitis), DYSPNOEA (Difficulty breathing / Shortness of breath), HYPOAESTHESIA (Numbness and shooting pain per both feet), PARAESTHESIA (Bilateral tingling sensation in fingertips), PAIN IN EXTREMITY (Calf pain), HYPOACUSIS (Muffled sensation in her ears), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), COUGH (Cough), RHINORRHOEA (Rhinorrhea), ASTHENIA (Weakness), FATIGUE (Fatigue / Tired), PYREXIA (Fever / Temperature of 102 / low grade temperature), CHILLS (Chills), ARTHRALGIA (Shoulder pain) and NAUSEA (Nausea) to be related.    Treatment medication also included alka seltzer plus for pain relief.  Patient reports after second dose feeling achy and weak, low fever and continued to have fatigue, calf pain, chest pain on left side when she rolls over.  Her labs tested negative for COVID however, some of the tests show concerns for a possible pneumonia or COVID-19 but not confirmed. Patient feels much better since last follow up in terms of shortness of breath, still has some sinus congestion and residual numbness over right lower extremity.  Company Comment - This case concerns a 69 year old female patient with medical history of Wegener's granulomatosis,  who experienced the serious unexpected events of anti-neutrophil cytoplasmic antibody positive vasculitis, granulomatosis with polyangiitis, dyspnoea, hypoaesthesia, paraesthesia, pain in extremity, hypoacusis, chest pain, neck pain, cough, rhinorrhoea, asthenia, fatigue, pyrexia, chills, arthralgia and nausea. The events occurred 1 day after the second dose of mRNA-1273 vaccine, and were resolving at the time of the report. The patient was hospitalized 10 days from  the onset of the events. Chest x-ray revealed bilateral consolidated mass-like lesions, diagnostic aspiration revealed  acute necrotizing granulomatous inflammation. The patient was treated with Prednisone and Rituximab. Patient's medical history of Wegener's granulomatosis remains a confounder.  The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-447136.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant follow-up appended, Events are added ,lab data is added , concomitant and therapeutic drugs are added, medical history is added; Sender's Comments: This case concerns a 69 year old female patient with medical history of Wegener's granulomatosis,  who experienced the serious unexpected events of anti-neutrophil cytoplasmic antibody positive vasculitis, granulomatosis with polyangiitis, dyspnoea, hypoaesthesia, paraesthesia, pain in extremity, hypoacusis, chest pain, neck pain, cough, rhinorrhoea, asthenia, fatigue, pyrexia, chills, arthralgia and nausea. The events occurred 1 day after the second dose of mRNA-1273 vaccine, and were resolving at the time of the report. The patient was hospitalized 10 days from  the onset of the events. Chest x-ray revealed bilateral consolidated mass-like lesions, diagnostic aspiration revealed  acute necrotizing granulomatous inflammation. The patient was treated with Prednisone and Rituximab. Patient's medical history of Wegener's granulomatosis remains a confounder.  The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.