Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Mitral valve calcification, Pain, Pain in extremity, Pleural effusion
Clinical narrative: stridal wheezing; Ache; Arm was sore/Soreness left arm at site of injection; Low grade fever like a 100 or below/Mild fever 99.9; A-fib 40s was diagnosed, it started on Jan2021& echocardiogram: a-fib 140s, moderate mitral regurgitation a-fib on 23Mar2021; Heart failure; mild interstitial pulmonary edema; shortness of breath; I felt like I had the flu; computerised tomogram: pleural effusion; partial atelectasis; computerised tomogram: pleural effusion; partial atelectasis; Cardiomegaly; Heavy mitral calcifications; Mild coronary artery calcifications. Moderate Atherosclerotic disease; fatigue; This is a spontaneous report from a contactable other hcp. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection,Batch/Lot Number: EL3247), intramuscular, administered in Arm Left on 29Jan2021 10:30 (AM) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hodgkin's disease, alopecia, asthma, back pain, dyspepsia, heartburn, pulmonary embolism (patient had a 2 time history of pulmonary emboli, she was having pulmonary emboli starting 15Jan2021), oral surgery - 2 teeth extracted on 13Jan2021, low thyroid due to mantle radiation, constipation. Concomitant medication(s) included levothyroxine taken for hypothyroidism; biotin taken for alopecia; finasteride taken for alopecia areata; colecalciferol (VITAMIN D3) taken for supplementation therapy; calcium taken for supplementation therapy; ascorbic acid (VIT C) taken for supplementation therapy; salbutamol sulfate (ALBUTEROL) taken for asthma, clobetasol propionate taken for alopecia areata; paracetamol, tramadol hydrochloride (ULTRAM) taken for back pain; lorazepam taken for an sleep, amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3) taken for dyspepsia, rivaroxaban (XARELTO) taken for pulmonary embolism, calcium, colecalciferol (CALCIUM +D3) taken for supplementation therapy, docusate sodium, sennoside a+b (DOCUSATE SODIUM AND SENNA) taken for constipation; triamcinolone acetonide taken for rash pruritic and steroid Injections to scalp for alopecia areata. Previously she took bnt162b2 (Lot Number: EJ1686), intramuscular, administered in Arm Left on 09Jan2021 3:30 pm as dose 1, single for covid-19 immunisation and had experienced malaise, tachy irregular pulse, fatigue, shortness of breath (SOB), atrial fibrillation. The patient experienced heart failure, mild interstitial pulmonary edema, shortness of breath, patient felt like he had the flu, computerised tomogram: pleural effusion; partial atelectasis, cardiomegaly, heavy mitral calcifications, mild coronary artery calcifications. moderate atherosclerotic disease, fatigue on an unspecified date in 2021, A-fib (atrial fibrillation) 40s was diagnosed, it started on Jan2021& echocardiogram: a-fib 140s, moderate mitral regurgitation a-fib (on 23Mar2021) in Jan2021, low grade fever like a 100 or below/mild fever 99.9, arm was sore/soreness in left arm at site, ache on 30Jan2021, stridal wheezing on 18Mar2021. Reporter stated, "she received the COVID-19 Vaccine on January 9 and the second one on January 29 and about two weeks, she had an appointment with the cardiologist on (DATE). They said she was in A-fib and they put her on cardiac medications she knows to try and to get her medically to convert back into sinus rhythm and that was in February. In March she had an allergic reaction to Diltiazem they switched her to Metoprolol and then two and half months later she was still in A-fib, they sent her to electrophysiologist and Monday she had a cardioversion done. she was in sinus rhythm now but she had still having symptoms shortness of breath and fatigue. Reporter further stated, "When she did have the second vaccine which was on (DATE), she did have a few side effect that are normal. she had like a low grade fever like a 100 or below, you know the arm was sore she felt like she had the flu you know, when your body was reacting from having the vaccine so she mean in less than two days it was gone but those things are kind of normal." She took Metoprolol (treatment) because she was in A-fib they are trying to medically convert her and right now her dose had been tapered because she awasm back in sinus rhythm (Clarification unknown). So in a month she would be off of it. Dermatologist strong encouraged her to saw a Dr for symptoms of shortness of breath and fatigue and to report her symptoms to Pfizer. Diagnosed with A-Fib by cardiologist. Medications started to treat A-Fib none worked. Cardioversion 05May2021 not successful long term. Still do shortness of breath and fatigue. AV Node ablation with micra leadless pacemaker inserted into 26Apr2021 heart ventricle. Pacing. Still do shortness of breath and fatigue. CT scan with contrast done. Pleural effusion with partial bilateral atelectasis and heart failure. diuretics started and shortness of breath and fatigue improved. The patient underwent lab tests which included computerised tomogram: pleural effusion; partial atelectasis; on 05May2021 heart failure; negative for pulmonary emboli, Cardiomegaly with mild interstitial pulmonary edema and greater than left pleural effusions suggesting heart failure with atelectasis. Heavy mitral calcifications. Mild coronary artery calcifications. Moderate atherosclerotic disease. neg. PEs, echocardiogram: unknown, echocardiogram: a-fibration 140 on 18Mar2021 Lots of stridal wheezing when laying down, echocardiogram: moderate mitral regurgitation a-fib on 23Mar2021, electrocardiogram: a-fib 140's, pulmonary function test: unknown results on 01Jun2021. Therapeutic measures were taken as a result of a-fib (atrial fibrillation), shortness of breath and fatigue. Adverse event atrial fibrillation resulted in physician visit. The outcome of event stridal wheezing was not resolved, dyspnoea, fatigue was resolving, ache, pain in arm, pyrexia was resolved with 1 days duration, whereas unknown for all other events.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events Afib,Cardiac failure and pulmonary edema.,Linked Report(s) : US-PFIZER INC-2021411065 same patient/drug, different vaccine dose/event