Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Condition aggravated, Feeling abnormal, Feeling hot, Gait disturbance
Clinical narrative: slowly got worse; felt like he put his foot in bucket of warm water; sensations that he was getting in his right foot was very strange; Sciatica was increased and got worse; veins in his foot again; uric acid was elevated in blood test/ blood uric acid increased; left eye was closed (swelling of eyelid); had a style (hordeolum); swelling in his right foot (peripheral swelling); swelled up and had a purple tint (skin discolouration); experience serve pain in hips and buttocks (gait inability); Pain in extremity; computerized tomogram abnormal; chest pain; pain in chest, more pain while inhaling (painful respiration); Bilateral pulmonary embolisms; Spinal Spondylosis and Disc herniations; magnetic resonance imaging spinal abnormal; back spine pain (Spinal pain); Lyme Disease; borrelia test positive; pinched nerve (nerve compression); back pain; pain in shoulders and hips; spinal osteoarthritis; could not walk; chiropractic; polymyalgia rheumatica; musculoskeletal pain; he really complained about his foot and sent a picture; limb discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. Regulatory number: 2132210. Other Case identifier(s): 20220312707(0) (Janssen Research & Development).  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FD0809) as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 06Mar2021 (Lot number: 1805022) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; SHINGRIX, administration date 04Aug2021. The following information was reported: POLYMYALGIA RHEUMATICA (hospitalization, medically significant) with onset Apr2021, outcome "not recovered", described as "polymyalgia rheumatica"; LYME DISEASE (hospitalization, medically significant) with onset 08Oct2021, outcome "unknown", described as "Lyme Disease"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 05Dec2021, outcome "not recovered", described as "Bilateral pulmonary embolisms"; MUSCULOSKELETAL PAIN (hospitalization) with onset Apr2021, outcome "not recovered", described as "musculoskeletal pain"; ARTHRALGIA (hospitalization) with onset 24May2021, outcome "not recovered", described as "pain in shoulders and hips"; SPINAL OSTEOARTHRITIS (hospitalization) with onset 09May2021, outcome "not recovered", described as "spinal osteoarthritis"; GAIT DISTURBANCE (hospitalization) with onset 09May2021, outcome "not recovered", described as "could not walk"; CONDITION AGGRAVATED (hospitalization), outcome "unknown", described as "slowly got worse"; FEELING HOT (hospitalization), outcome "unknown", described as "felt like he put his foot in bucket of warm water"; FEELING ABNORMAL (hospitalization), outcome "unknown", described as "sensations that he was getting in his right foot was very strange"; SPINAL PAIN (hospitalization) with onset 28Oct2021, outcome "not recovered", described as "back spine pain (Spinal pain)"; NERVE COMPRESSION (hospitalization) with onset Oct2021, outcome "not recovered", described as "pinched nerve (nerve compression)"; SCIATICA (hospitalization), outcome "not recovered", described as "Sciatica was increased and got worse"; INTERVERTEBRAL DISC PROTRUSION (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "Spinal Spondylosis and Disc herniations"; PAINFUL RESPIRATION (hospitalization) with onset 05Dec2021, outcome "not recovered", described as "pain in chest, more pain while inhaling (painful respiration)"; GAIT INABILITY (hospitalization) with onset 10Feb2022, outcome "not recovered", described as "experience serve pain in hips and buttocks (gait inability)"; LIMB DISCOMFORT (hospitalization) with onset 26Mar2021, outcome "not recovered", described as "he really complained about his foot and sent a picture"; SKIN DISCOLOURATION (hospitalization) with onset 17Feb2022, outcome "not recovered", described as "swelled up and had a purple tint (skin discolouration)"; BLOOD URIC ACID INCREASED (hospitalization) with onset 19Feb2022, outcome "not recovered", described as "uric acid was elevated in blood test/ blood uric acid increased"; SWELLING OF EYELID (hospitalization) with onset 19Feb2022, outcome "not recovered", described as "left eye was closed (swelling of eyelid)"; HORDEOLUM (hospitalization) with onset 19Feb2022, outcome "not recovered", described as "had a style (hordeolum)"; PERIPHERAL SWELLING (hospitalization) with onset 19Feb2022, outcome "not recovered", described as "swelling in his right foot (peripheral swelling)"; PERIPHERAL VASCULAR DISORDER (hospitalization), outcome "unknown", described as "veins in his foot again"; CHIROPRACTIC (hospitalization) with onset 09Apr2021, outcome "not recovered", described as "chiropractic"; BACK PAIN (hospitalization) with onset Aug2021, outcome "not recovered", described as "back pain"; CHEST PAIN (hospitalization) with onset 05Dec2021, outcome "not recovered", described as "chest pain"; BORRELIA TEST POSITIVE (hospitalization) with onset 08Oct2021, outcome "not recovered", described as "borrelia test positive"; COMPUTERISED TOMOGRAM ABNORMAL (hospitalization) with onset 05Dec2021, outcome "not recovered", described as "computerized tomogram abnormal"; MAGNETIC RESONANCE IMAGING SPINAL ABNORMAL (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "magnetic resonance imaging spinal abnormal"; LIMB DISCOMFORT (hospitalization) with onset 26Mar2021, outcome "not recovered", described as "limb discomfort"; PAIN IN EXTREMITY (hospitalization) with onset 13Jan2022, outcome "not recovered", described as "Pain in extremity". The patient was hospitalized for pulmonary embolism (start date: 06Dec2021). The events "polymyalgia rheumatica", "lyme disease", "bilateral pulmonary embolisms", "musculoskeletal pain", "pain in shoulders and hips", "spinal osteoarthritis", "could not walk", "slowly got worse", "felt like he put his foot in bucket of warm water", "sensations that he was getting in his right foot was very strange", "back spine pain (spinal pain)", "pinched nerve (nerve compression)", "sciatica was increased and got worse", "spinal spondylosis and disc herniations", "pain in chest, more pain while inhaling (painful respiration)", "experience severe pain in hips and buttocks (gait inability)", "he really complained about his foot and sent a picture", "swelled up and had a purple tint (skin discolouration)", "uric acid was elevated in blood test/ blood uric acid increased", "left eye was closed (swelling of eyelid)", "had a style (hordeolum)", "swelling in his right foot (peripheral swelling)", "veins in his foot again", "chiropractic", "back pain", "chest pain", "borrelia test positive", "computerized tomogram abnormal", "magnetic resonance imaging spinal abnormal", "limb discomfort" and "pain in extremity" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (09May2021) unknown results; blood uric acid: (19Feb2022) increased; borrelia test: (08Oct2021) positive; computerised tomogram: (05Dec2021) abnormal, notes: Show Bilateral Pulmonary embolism; laboratory test: (Oct2021) pinched nerve compression, notes: Indicated probably pinched nerve (nerve compression); magnetic resonance imaging spinal: (17Nov2021) abnormal, notes: MRI-Spinal Spondylosis and Disc herniation (intervertebral disc protrusion) at various levels; nerve conduction studies: (18Nov2021) unknown results. Therapeutic measures were taken as a result of polymyalgia rheumatica, lyme disease, pulmonary embolism, musculoskeletal pain, arthralgia, spinal osteoarthritis, gait disturbance, condition aggravated, feeling hot, feeling abnormal, spinal pain, nerve compression, sciatica, intervertebral disc protrusion, painful respiration, gait inability, limb discomfort, skin discolouration, blood uric acid increased, swelling of eyelid, hordeolum, peripheral swelling, peripheral vascular disorder, chiropractic, back pain, chest pain, borrelia test positive, computerised tomogram abnormal, magnetic resonance imaging spinal abnormal, limb discomfort, pain in extremity; patient was given Xarelto (Rivaroxaban) possibly 35 mg (milligram), 20 mg and 15 mg per day, gabapentin 300 mg per day increased to 600 mg per day, epidural steroid injection in back, methotrexate 12.5 mg once per week, folic acid 1 mg daily, prednisone from 10 mg (milligram) to 30 mg for 2 days, then taper down to 20 mg for 2 days and then back to 10 mg, allopurinol, cephalexin 500mg 2 times per day along with an eye ointment 4 times per day. Clinical Information: Causality for Janssen Covid-19 Vaccine and the events Polymyalgia Rheumatica, Pulmonary Embolism, Back pain, Chest pain, Chiropractic, Gait Disturbance, Gait Inability, Hordeolum, Intervertebral Disc Protrusion, Nerve Compression, Painful respiration, Peripheral Swelling, Sciatica, Skin Discolouration, Spinal Osteoarthritis, Spinal Pain, Swelling of eyelid, Borrelia Test Positive, Computerized Tomogram Abnormal, Blood Uric Acid Increased, Magnetic Resonance Imaging Spinal Abnormal, Arthralgia, Limb Discomfort, Pain Extremity and Musculoskeletal Pain per reporter and manufacturer was possible.  No follow-up attempts are possible. No further information is expected.