Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Jaundice, Myocarditis, Renal failure, SARS-CoV-2 test
Clinical narrative: Renal failure: Yes; Arrhythmia: Yes; Myocarditis: Yes; Jaundice: Yes; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK9231), in arm, on 13Jan2021 as dose 2, single (Lot number: EL3249), in arm and on 22Nov2021 as dose 3 (booster) single (Lot number: FJ1611) at the age of 40 years, in arm, all subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "Renal failure: Yes"; ARRHYTHMIA (medically significant), outcome "unknown", described as "Arrhythmia: Yes"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis: Yes"; JAUNDICE (non-serious), outcome "unknown", described as "Jaundice: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive; (24May2022) Positive, notes: retested Positive Antigen (24May2021); (28May2022) Negative, notes: retested negative on 28May antigen.  Clinical course: It was reported that, patient had unknown SARS-CoV2 antibodies at diagnosis, Patient was not hospitalized, not admitted to an Intensive Care Unit, did not SARS-CoV2 antibodies at hospital discharge not display clinical signs at rest indicative of severe systemic illness. she not require supplemental oxygen (including high flow or ECMO) or received mechanical ventilation. Patient did not having Multiorgan failure, Tachypnea, Hypoxemia, Acute Respiratory Distress Syndrome (ARDS), Heart failure, Cardiogenic shock, acute myocardial infarction. Vomiting, Diarrhea, Abdominal pain, Acute liver failure, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Acute kidney injury, Altered consciousness, Convulsions/seizures, Encephalopathy, Meningitis, Cerebrovascular accident, Hematological, Thrombocytopenia, Disseminated intravascular coagulation, Chillblains, Erythema multiforme during the COVID-19 illness. Patient received Paxlovid therapies for COVID-19 started at 16May2022 and Stopped at 21May2022. Event not required the initiation of new medication or other treatment or procedure. patient had no smoker/former smoker patient not taking any medications routinely prior to the event being reported not pre-existing diseases worsened during the SARS-CoV2 infection. patient not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Pfizer product not had a causal effect to the adverse event.; Sender's Comments: Based on the available information in the case, the causal association between the events renal failure, arrhythmia, myocarditis and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.