Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Deep vein thrombosis, Dyspnoea, Haemorrhage urinary tract, Kidney enlargement
Clinical narrative: arm swelling; went to ER - DVT rt arm - 2 Clots; small pulmonary embolism; Blood in urine turned to passing large clots/ Tremendous blood in urine. Passed huge clots; Blood in urine turned to passing large clots/ Tremendous blood in urine. Passed huge clots; feeling short of breath; large kidney stone blocking kidney; enlarged kidney; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via Regulatory Authority. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunization in public health department. Relevant medical history included: "Migraine in past" (unspecified if ongoing); "Had preeclampsia" (unspecified if ongoing). Patient reported she possibly took singular and Flonase on occasion in two weeks. Patient didn't receive other vaccine in 4 weeks. Past drug history included: Avelox, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (dose number=1, lot number unknown), administration date: 20Apr2021, when the patient was 43 years old, for Covid-19 immunization, reaction(s): "Hurt. Large red circle days later". The patient had no COVID-19 prior vaccination and she tested COVID-19 post vaccination. The following information was reported: NEPHROLITHIASIS (hospitalization, disability, medically significant, life threatening) with onset 25May2021, outcome "recovered with sequelae", described as "large kidney stone blocking kidney"; KIDNEY ENLARGEMENT (hospitalization, disability, medically significant, life threatening) with onset 25May2021, outcome "recovered with sequelae", described as "enlarged kidney"; DYSPNOEA (hospitalization, disability, medically significant, life threatening) with onset 28May2021, outcome "recovered with sequelae", described as "feeling short of breath"; PERIPHERAL SWELLING (hospitalization, disability, medically significant, life threatening) with onset 31May2021, outcome "recovered with sequelae", described as "arm swelling"; DEEP VEIN THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 31May2021, outcome "recovered with sequelae", described as "went to ER - DVT rt arm - 2 Clots"; PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening) with onset 31May2021, outcome "recovered with sequelae", described as "small pulmonary embolism"; HAEMORRHAGE URINARY TRACT (hospitalization, disability, medically significant, life threatening), BLOOD URINE PRESENT (hospitalization, disability, medically significant, life threatening) all with onset 31May2021, outcome "recovered with sequelae" and all described as "Blood in urine turned to passing large clots/ Tremendous blood in urine. Passed huge clots". The patient was hospitalized for nephrolithiasis, kidney enlargement, dyspnoea (hospitalization duration: 8 day(s)); for peripheral swelling, deep vein thrombosis, pulmonary embolism (discharge date: 02Jun2021); for haemorrhage urinary tract, blood urine present (discharge date: 11Jun2021). The events "large kidney stone blocking kidney", "feeling short of breath", "arm swelling", "went to er - dvt rt arm - 2 clots", "small pulmonary embolism", "blood in urine turned to passing large clots/ tremendous blood in urine. passed huge clots" and "blood in urine turned to passing large clots/ tremendous blood in urine. passed huge clots" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) negative, notes: Nasal swab; ultrasound scan: (15Jun2021) clot found, notes: arm ultrasound. Therapeutic measures were taken as a result of nephrolithiasis, kidney enlargement, dyspnoea, peripheral swelling, deep vein thrombosis, pulmonary embolism, haemorrhage urinary tract, blood urine present. It was also reported that "Adverse event: High level: got clots and PE following IVs in multiple hospital stays in a month. Right arm, PE, then left arm."  Clinical course:  11May2021: received dose 2 vaccine. 25May2021: Hospitalized - large kidney stone blocking kidney, enlarged kidney. IV placed. Stent placed. Released. 28May2021: saw dr - feeling short of breath. Dr thought from iv fluids. Prescribed diuretic. 31May2021: arm swelling, shortness of breath, went to ER - DVT rt arm - 2 Clots, small pulmonary embolism, both said to be related to IV from first hospital visit. Released 02Jun2021 on thinners. Blood in urine turned to passing large clots. 08Jun2021: Back in ER. Tremendous blood in urine. Passed huge clots. Thought from stent & thinners. Surgery to break and remove stone. IV in left arm. released on 11Jun2021. Quickly felt a 'marble' like bubble in eft arm. 15Jun2021: saw dr. Sent for arm ultrasound. Clot found.  The lot number for bnt162b2 was not provided and will be requested during follow up.