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VAERS Report 2156672

Case Report Section

Détails du rapport Vaer

Âge: N/A

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: fn5254


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2022-02-01
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

fatigue/unusual tiredness; shortness of breath; heart palpitations; racing heart (tachycardia); back pain; pressing discomfort in the middle and towards left of the chest; myocarditis; pericarditis; confusion; light headedness; headache; pronounced joint aches; chest aching; off label use; booster; inappropriate dose of vaccine administered; this is a spontaneous report received from a contactable reporter (consumer) from the regulatory agency. regulatory number: gb-mhra-webcovid-202202020809043390-efl5y (ra). other case identifier(s): gb-mhra-adr 26550404 (ra). a 44-year-old female patient (not pregnant) received bnt162b2 (comirnaty), administration date 01feb2022 (lot number: fn5254) as dose 4 (booster), single for covid-19 immunisation. relevant medical history included: "antiphospholipid syndrome" (unspecified if ongoing); "discoid lupus erythematosis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "suspected covid-19" (unspecified if ongoing), notes: unsure when symptoms startedunsure when symptoms stopped; "steroid therapy" (unspecified if ongoing), notes: taking regular steroid treatment (e.g. orally or rectally); "immunodeficiency" (unspecified if ongoing), notes: taking other treatments or medicines, not listed above, known to lower the immune response; "systemic lupus erythematosus" (unknown if ongoing); "discoid lupus erythematosis" (unknown if ongoing); "fibromyalgia" (unknown if ongoing); "antiphospholipid syndrome" (unknown if ongoing). the patient's concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1; manufactuerer unknown), for covid-19 immunization; covid-19 vaccine (dose 2; manufactuerer unknown), for covid-19 immunization; comirnaty (dose 3 (booster), outcome: unknown), for covid-19 immunization, reaction(s): "confusion"; comirnaty (dose 3(booster), outcome: unknown), for covid-19 immunization, reaction(s): "pronounced joint aches", "back pain", "pressing discomfort in the middle and towards left of the chest", "chest aching", "chest pain", "light headedness", "shortness of breath", "breathlessness", "fatigue/unusual tiredness", "headache", "myocarditis", "heart palpitations", "palpitations", "pericarditis", "racing heart (tachycardia)". the following information was reported: off label use (medically significant) with onset 01feb2022, outcome "unknown", described as "off label use"; immunisation (medically significant) with onset 01feb2022, outcome "unknown", described as "booster"; incorrect dose administered (medically significant) with onset 01feb2022, outcome "unknown", described as "inappropriate dose of vaccine administered"; confusional state (medically significant), outcome "unknown", described as "confusion"; dizziness (medically significant), outcome "unknown", described as "light headedness"; headache (medically significant), outcome "unknown", described as "headache"; arthralgia (medically significant), outcome "unknown", described as "pronounced joint aches"; chest pain (medically significant) with onset 02feb2022, outcome "not recovered", described as "chest aching"; fatigue (medically significant), outcome "unknown", described as "fatigue/unusual tiredness"; dyspnoea (medically significant), outcome "unknown", described as "shortness of breath"; palpitations (medically significant), outcome "unknown", described as "heart palpitations"; tachycardia (medically significant), outcome "unknown", described as "racing heart (tachycardia)"; back pain (medically significant), outcome "unknown", described as "back pain"; chest discomfort (medically significant), outcome "unknown", described as "pressing discomfort in the middle and towards left of the chest"; myocarditis (medically significant), outcome "unknown", described as "myocarditis"; pericarditis (medically significant), outcome "unknown", described as "pericarditis". the patient underwent the following laboratory tests and procedures: chest x-ray: unknown results, notes: unknown results; computerised tomogram: unknown results, notes: unknown results; echocardiogram: unknown results, notes: unknown results; electrocardiogram: unknown results, notes: tests continue - had cardiogram, waiting 24 hours electrocardiogram (ecg); magnetic resonance imaging heart: unknown results, notes: unknown results; sars-cov-2 test: negative, notes: no - negative covid-19 test. therapeutic measures were taken as a result of confusional state, dizziness, headache, arthralgia, chest pain, fatigue, dyspnoea, palpitations, tachycardia, back pain, chest discomfort, myocarditis, pericarditis. clinical course: patient last menstrual period date: 15jan2022. patient was not currently breastfeeding. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. details of any relevant investigations or tests conducted: "investigations still ongoing after the last booster symptoms and steroids increased from 3 mg to 6 mg daily". it was unknown if the symptoms lead to a hospital stay. the diagnosis not made by a medical professional. treatment given because the symptoms: "tests continue - had cardiogram, waiting 24 hours electrocardiogram (ecg), steroids increased." imaging/s were carried out. it was unknown if any blood tests were taken. had a diagnosis of pericarditis / myocarditis. no follow-up attempts are possible. no further information is expected.; sender's comments: linked report(s) : gb-pfizer inc-202200312853 same patient, same product, different dose and different events

Données de laboratoire
test name: chest x-ray; result unstructured data: test result:unknown results; comments: unknown results; test name: chest computerised tomography (ct); result unstructured data: test result:unknown results; comments: unknown results; test name: echocardiogram; result unstructured data: test result:unknown results; comments: unknown results; test name: ecg; result unstructured data: test result:unknown results; comments: tests continue - had cardiogram, waiting 24 hours electrocardiogram (ecg); test name: cardiac mri; result unstructured data: test result:unknown results; comments: unknown results; test name: covid-19 virus test; test result: negative ; comments: no - negative covid-19 test
Liste des symptômes
back pain fatigue chest discomfort headache arthralgia chest pain dizziness pericarditis myocarditis dyspnoea tachycardia palpitations confusional state chest x-ray electrocardiogram computerised tomogram incorrect dose administered sars-cov-2 test immunisation echocardiogram off label use magnetic resonance imaging heart
Patient décédé?
Non
Date de décès
N/A
Anomalie congénitale
false
Vaccin administré par :
Other
Vaccin acheté par :
Inconnu
Visite d’un patient à l’urgence?
Non
Patient hospitalisé?
Non
Séjour à l’hôpital
Non
Nombre de jours à l’hôpital
Non spécifié
Invalidité permanente?
Non
Allergies:
na
Maladie actuelle
na