Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Erythema, Fraction of inspired oxygen, Haematuria, Haemoglobin
Clinical narrative: ACUTE KIDNEY INJURY; HAEMATURIA; URINARY TRACT INFECTION; RASH ERYTHEMATOUS; COVID-19; COMPRESSION GARMENT APPLICATION; CONDITION AGGRAVATED; SARS-COV-2 TEST POSITIVE; ULTRASOUND KIDNEY NORMAL; URINE ANALYSIS ABNORMAL; CHEST X-RAY ABNORMAL; FRACTION OF INSPIRED OXYGEN; CULTURE URINE NEGATIVE; INFLAMMATORY MARKER TEST; LABORATORY TEST NORMAL; HYPERGLYCAEMIA; IRON DEFICIENCY ANAEMIA; LUNG DISORDER; LUNG OPACITY; MICROCYTIC ANAEMIA; OEDEMA; PAIN; POLYURIA; TENDERNESS; ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; TYPE 2 DIABETES MELLITUS; ABDOMINAL PAIN LOWER; DYSURIA; ERYTHEMA; AGEUSIA; ANOSMIA; COUGH; DYSPNOEA; HEADACHE; NAUSEA; CELLULITIS; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System); concerned a 55 year old female. The patient's past medical history included: history of gastric surgery, complications of gastric bypass surgery, cholecystectomy, frequent urination, and history of blood clots, and concurrent conditions included: iron deficiency anemia, type 2 diabetes mellitus with hyperglycemia, secondary hyperparathyroidism, morbid obesity, post traumatic stress disorder, moderate episode of recurrent major depressive disorder/anxiety depression, generalized anxiety disorder, degenerative disc disease cervical, pancreatic cyst, diabetes mellitus type 2 without retinopathy, senile nuclear cataract bilateral, myopia of both eyes, intraductal papillary mucinous neoplasm, chronic bilateral low back pain without sciatica, venous stasis of bilateral lower extremities, high serum parathyroid hormone, primary osteoarthritis of both knees, degenerative disc disease lumbosacral, primary osteoarthritis involving multiple joints, chronic deep vein thrombosis of proximal vein of lower extremity unspecified laterality, hypertension, obstructive sleep apnea moderate, pulmonary embolism, anemia, arthritis, congestive heart failure, and familial hypercholesterolemia, and other pre-existing medical conditions included: Patient had no known allergies. On 31-AUG-2020, Laboratory data included: Body mass index (NR: not provided) 50.0-59.9 adult. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 for an unspecified indication. The drug start period was 279 days. Concomitant medications included amitriptyline hydrochloride for anxiety depression, aripiprazole for anxiety depression, duloxetine hydrochloride for anxiety depression, rivaroxaban for deep vein thrombosis, and pulmonary embolism, atorvastatin calcium for hyperlipidemia, amlodipine besilate for hypertension, carvedilol for hypertension, hydrochlorothiazide/losartan for hypertension, cyanocobalamin, and escitalopram oxalate.  On 26-NOV-2021, the patient was hospitalized for cellulitis of left abdominal wall and was discharged on 03-DEC-2021. This has since improved. On 16-DEC-2021, the patient presented due to lower abdominal pain, erythema, edema erythematous skin and tenderness. She was diagnosed with pannus cellulitis and was started on parental antibiotics. She was diuresed with IV (intra venous) diuretics for 4-5 days and had significant improvement in her edema. She continued using lower extremity compression stockings (compression garment application) which also improved her edema (Oedema). She continued to have improvement in her pain and erythematous skin (Rash erythematous) and was discharged with oral antibiotics to complete a 10 days course for cellulitis. The patient also presented to hospital presented to the hospital with 4 days of shortness of breath (Dyspnoea), cough, nausea, headaches, loss of sense of taste (ageusia) and smell (anosmia). The patient tested positive for COVID-19. In the Emergency Department COVID PCR (polymerase chain reaction) test was positive, initially requiring 8L NC. Patient required venturi mask at 8 L to maintain her saturations. Labs were relatively unremarkable. The patient was treated with decadron and remdesivir and eventually weaned down to room air and remained stable. The patient did develop an Acute kidney injury after admission which was treated with fluids and resolved. The Renal Ultrasound was negative. The patient also endorsed new hematuria as well as dysuria. She was treated for urinary tract infection (UTI) with Ceftriaxone. Dysuria did improve but patient continued to have hematuria. The Urology was consulted and recommended obtaining Urine Analysis and culture through catheter UA showed some blood and culture has shown no growth to date. The Urology will follow up outpatient for outpatient computerized tomography (CT) urogram and cystoscopy if culture negative. The patient was given Urology office information at discharge. DGMS was also consulted for assistance with sugar control in setting id diabetes and steroids. The patient was reviewed General: She was not in acute distress, Appearance: She was obese HENT: Head: Normocephalic and atraumatic Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm, Heart sounds: Normal heart sounds, Pulmonary: Effort: Pulmonary effort was normal, No respiratory distress, Abdominal: General: There was no distension Palpations: Abdomen was soft, Tenderness: There was no abdominal tenderness, Musculoskeletal: Right lower leg: No edema, Left lower leg: No edema, Skin: General: Skin was warm and dry, Neurological: General: No focal deficit present, Mental Status: She was alert and oriented to person place and time Psychiatric: Mood and Affect: Mood normal. The patient had acute hypoxic respiratory failure, COVID19 pneumonia, and chest X-ray showed bilateral airspace disease (Lung opacity and lung disorder) which was treated with decadron 6 mg for 10 days, remdesivir and continuous pulse ox (pulse oximeter) monitoring prone position encouraged. Patient had daily inflammatory markers, currently on 8L via VM (virtual machine). Patient had insulin-dependent diabetes mellitus type 2(IDDM2) with hyperglycemia treated with victoza, glargine 40 units qhs and corrective insulin, suspect needs would be higher with steroids. She was discharged on increased 50 units Lantus daily and home victoza. She was provided with glucometer and diabetic supplies to check blood sugars at home and was given an education on how to check her sugars. The patient experienced Chronic microcytic anemia, IDA (Iron deficiency anaemia) and condition aggravated. On 16-DEC-2021, Patient had Chest X-Ray/ chest single view result were reported as mediastinum and hila were unremarkable. No pulmonary vascular congestion was present. There was perihilar airspace opacity new from previously No pleural effusion or pneumothorax was present (Bilateral perihilar airspace opacity pulmonary edema versus pneumonia). Patient underwent urine analysis (UA) and culture through catheter that urine analysis showed some blood and culture has shown no growth to date (negative). On 16-DEC-2021, the patient had Chest X-Ray/ chest single view result 1:24 PM TECHNIQUE: Single view chest INDICATION: shortness of breath COMPARISON: 30-NOV-2021 ENCOUNTER: Not applicable FINDINGS: Mediastinum and hila are unremarkable No pulmonary vascular congestion is present. There was perihilar airspace opacity new from previously. No pleural effusion or pneumothorax was present. (Bilateral perihilar airspace opacity pulmonary edema versus pneumonia). The patient underwent urine analysis (UA) and culture through catheter that urine analysis showed some blood and culture has shown no growth to date (negative). Laboratory data included: Chest X-ray (NR: not provided) Abnormal, Culture urine (NR: not provided) Negative, Fraction of inspired oxygen (NR: not provided) 40 percent Inflammatory marker test (NR: not provided) currently on 8L, Laboratory test (NR: not provided) Normal, SARS-CoV-2 test (NR: not provided) Positive, Ultrasound kidney (NR: not provided) Normal, and Urine analysis (NR: not provided) Abnormal. Other relevant diagnostics included: Impression: Bilateral perihilar airspace opacity pulmonary edema versus pneumonia DR CHEST SINGLE VIEW Result Date: 20-DEC-2021 Narrative: EXAMINATION: Single View Chest EXAM DATE: 20-DEC-2021 2:02 PM TECHNIQUE: Single view chest INDICATION: Covid COMPARISON: 16-DEC-2021 ENCOUNTER: Not applicable FINDINGS: Stable borderline prominent cardio mediastinal silhouette. There were mild ill-defined pulmonary opacities with perihilar distribution relatively stable in comparison to most recent exam. No pleural effusion or pneumothorax Impression: Little change in nonspecific perihilar predominant airspace opacities potentially reflecting pneumonia versus edema. Laboratory data included: Chest X-ray (NR: not provided) Abnormal. On 26-DEC-2021, Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 131/63 mmHg, 131/89 mmHg, Body height (NR: not provided) 1.651 m, Body mass index (NR: not provided) 55.69 kg/m2, 55.58 kg/m2, Body temperature (NR: not provided) 37.1 C, 37 C, Fraction of inspired oxygen (NR: not provided) 40 percent Haemoglobin (NR: not provided) stable at 10, Heart rate (NR: not provided) Regular, normal, Heart sounds (NR: not provided) Normal, O2 saturation (NR: not provided) 95 percent 98 percent Pulmonary function test (NR: not provided) coarse breath sounds, Normal, Pulse rate (NR: not provided) 88, 97, Respiratory rate (NR: not provided) 18, 21, and Weight (NR: not provided) 151.8 kg, 151.5 kg. On an unspecified date, the patient's heart rate was normal and heart rhythm showed no murmurs pulses 2plus and equal bilaterally. Patient had pulmonary test that showed coarse breath sounds throughout wearing venturi mask non labored. Gastrointestinal Examination showed soft non-distended non-tender. Musculoskeletal Examination showed 1plus (BLE) Bilateral Lower Extremity edema and no deformities. Neurological Examination showed alert oriented and 4 no focal deficits. Treatment medications (dates unspecified) included: ceftriaxone, insulin glargine, remdesivir, insulin, dexamethasone, and liraglutide. On 26-DEC-2021, patient was discharged home in stable condition. Patient was hospitalized for 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute kidney injury, acute respiratory failure, covid-19 pneumonia, cellulitis, type 2 diabetes mellitus, abdominal pain lower, ageusia, anosmia, covid-19, compression garment application, condition aggravated, cough, dyspnoea, dysuria, erythema, hyperglycaemia, iron deficiency anaemia, lung disorder, lung opacity, microcytic anaemia, oedema, pain, polyuria, tenderness, urinary tract infection, rash erythematous, headache, nausea, sars-cov-2 test positive, ultrasound kidney normal, urine analysis abnormal, chest x-ray abnormal, fraction of inspired oxygen, culture urine negative, inflammatory marker test, and laboratory test normal, and had not recovered from haematuria. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000210986. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 27-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: the event of confirmed clinical vaccination failure was deleted.; Sender's Comments: V1: This follow up adds information about Product quality complaint investigation result. The event of confirmed clinical vaccination failure was deleted. MAC updated.   20220112524-covid-19 vaccine ad26.cov2.s-acute kidney injury, acute respiratory failure, covid-19 pneumonia, cellulitis, abdominal pain lower, ageusia, anosmia, covid-19, compression garment application, condition aggravated, cough, dyspnoea, dysuria, erythema,  lung disorder, lung opacity, oedema, pain, polyuria, tenderness, urinary tract infection, sars-cov-2 test positive, ultrasound kidney normal, urine analysis abnormal, chest x-ray abnormal, fraction of inspired oxygen, culture urine negative, inflammatory marker test, laboratory test normal, rash erythematous, headache, nausea, haematuria,. 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). 20220112524-covid-19 vaccine ad26.cov2.s-type 2 diabetes mellitus, hyperglycaemia, iron deficiency anaemia, microcytic anaemia,. 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