Sex: F
Vaccine: COVID19
Symptoms: Investigation, Off label use, Pain in extremity, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Dyspnoea; Deep vein thrombosis; Fibrin D dimer increased; Peripheral swelling; ultrasound Doppler abnormal; Fall; Pain in extremity; Chest pain; Contusion; Dermatitis; Erythema; received Covid-19 vaccine ad26..cov2.s (dose number in series 1) and BNT162 (dose number in series 2); received Covid-19 vaccine ad26..cov2.s (dose number in series 1) and BNT162 (dose number in series 2); This is a spontaneous report received from contactable reporter(s) (Other HCP) from Regulatory Authority. Other Case identifier(s): 20220141867 (Janssen).  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Nov2021 (Lot number: FJ1620) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergy: Amoxicillin allergy" (ongoing), notes: Allergy reaction to antibiotics; "Tendonitis related to Lupus Plantar Fascitis" (ongoing), notes: related to Lupus plantar fasciitis received injections in her feet; "Bipolar I Disorder" (ongoing); "Chronic Sinusitis" (ongoing); "Colagenous Colitis" (ongoing); "Eczema" (ongoing); "Hypertension" (ongoing); "Fibromyalgia" (ongoing); "Hyperlipidemia" (ongoing); "Hypothyroidism" (ongoing); "Obstructive Sleep Apnea" (ongoing); "Post-Traumatic Stress Disorder" (ongoing); "Schmorl's Nodes of Thoracic region" (ongoing); "Type 2 Diabetes Mellitus" (ongoing); "Occlusive and adhesive tape allergy" (ongoing); "Migraine" (ongoing); "Necrobiosis lipoidica Diabeticorum" (ongoing); "Lupus" (ongoing); "known allergy: Latex Allergy" (ongoing). Concomitant medication(s) included: ACETYLCYSTEINE; ACETYLSALICYLIC ACID; BUSPIRONE; CETIRIZINE; COLECALCIFEROL; CLONIDINE; CYANOCOBALAMIN; DIPHENHYDRAMINE; TRULICITY; STEGLATRO; FAMOTIDINE; CYCLOBENZAPRINE. Vaccination history included: Janssen covid-19 vaccine (dose 1;batch number: 1805022; Intramuscular), administration date: 19Mar2021. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 28Dec2021, outcome "recovering", described as "Deep vein thrombosis"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 30Nov2021, outcome "unknown" and all described as "received Covid-19 vaccine ad26..cov2.s (dose number in series 1) and BNT162 (dose number in series 2)"; FIBRIN D DIMER INCREASED (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Fibrin D dimer increased"; PERIPHERAL SWELLING (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Peripheral swelling"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Pain in extremity"; CHEST PAIN (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Chest pain"; CONTUSION (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Contusion"; DERMATITIS (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Dermatitis"; DYSPNOEA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Dyspnoea"; ERYTHEMA (non-serious) with onset 05Dec2021, outcome "not recovered", described as "Erythema"; FALL (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Fall"; ULTRASOUND DOPPLER ABNORMAL (non-serious) with onset 28Dec2021, outcome "not recovered", described as "ultrasound Doppler abnormal". The patient underwent the following laboratory tests and procedures: angiogram pulmonary normal: (30Dec2021) negative, notes: negative for PE.Classification: UNK; investigation: (28Dec2021) elevated at 1.54, notes: elevated at 1.54.Classification: UNK; (30Dec2021) no evidence of dvt, notes: no evidence of DVT. Classification: UNK; (28Dec2021) dvt, notes: Classification: UNK; ultrasound doppler abnormal: (28Dec2021) abnormal. Clinical course: On 06Dec2021, the patient fell in the shower while at PT (fall) and sustained a bruise on right shin (contusion). The injured area became red and inflamed (erythera and dermatitis). The patient has pain in extremity. So, on 22Dec2021, she was seen in emergency department and was prescribed doxycycline for 10 days for treatment of cellulitis. Imaging  was not done at that time. On 28Dec2021, she was seen in primary care for failure to improve with antibiotics. Pain and swelling of the calf were worsening- (peripheral swelling). Fibrin D Dimer was elevated at 1.54 (Fibrin D Dimer increased) and ultrasound was positive for DVT (Deep Vein Thrombosis) of the right peroneal vein (ultrasound doppler abnormal); questionable right medial thigh saphenous branch varicosity nonocclusive thrombosis. On 30Dec2021, she was sent back to emergency department after her ultrasound resulted and she reported chest pain and shortness of breath (dysponea). No evidence for pulmonary embolism on computed tomography angiography (angiography pulmonary normal). She was started on Eliquis (apixaban. anticoagulant therapy) and discharged to home, where she had been recovering. The patient was still having right lower Extremity pain (Pain in Extremity) and swelling. At emergency department, follow-up visit on 05Jan2021 (sic.). The patient visited emergency room and physicians' office (dose number in series 2). The action taken with COVID019 vaccine ad26.cov2.s was not applicable. The result of causality for Deep Vein Thrombosis, Fibrin D Dimer increased, Peripheral swelling, Ultrasound Doppler Abnormal, Pain in Extremity, Chest Pain, Contusion, Dermatitis, Dysponea, Erythema and fall was possible. No follow-up attempts are possible. No further information is expected.  Follow-Up (16Feb2022): Follow-up attempts are completed. No further information is expected.