Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Catheterisation cardiac, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: Neurological issues; AFib; Premature ventricular contractions; Hair loss; Tremors; Exhausted; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a nurse.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Lot number: ER8733) at the age of 75 years intramuscular, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Asthma since childhood" (unspecified if ongoing), notes: Well controlled; "COPD", start date: 2011 (unspecified if ongoing), notes: Chronic; "Emphysema", start date: 2011 (unspecified if ongoing), notes: Chronic; "Pulmonary hypertension" (unspecified if ongoing), notes: Approximately 15 years; chronic but controlled; "Labile hypertension" (unspecified if ongoing), notes: Since approximately 40; EF 40-44; "Allergic to cat dander" (unspecified if ongoing); "Allergy to barbiturates and penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; LATANOPROST ophthalmic taken for glaucoma; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC] taken for routine health maintenance; SPIRIVA resp inhalation; XOPENEX HFA resp inhalation; PULMICORT resp inhalation. Past drug history included: Levofloxacin, reaction(s): "Allergy"; Morphine, reaction(s): "Allergy"; Ipratropium, reaction(s): "Allergy"; Cephalexin, reaction(s): "Allergy"; Pseudoephedrine, reaction(s): "Allergy"; Venlafaxine, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EL9266; afternoon; intramuscular in left upper arm), administration date: 11Feb2021, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Apr2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; ATRIAL FIBRILLATION (hospitalization, disability, medically significant) with onset 22Apr2021, outcome "not recovered", described as "AFib"; ALOPECIA (hospitalization, disability) with onset 22Apr2021, outcome "not recovered", described as "Hair loss"; NERVOUS SYSTEM DISORDER (hospitalization, disability) with onset 22Apr2021, outcome "not recovered", described as "Neurological issues"; VENTRICULAR EXTRASYSTOLES (hospitalization, disability) with onset 22Apr2021, outcome "not recovered", described as "Premature ventricular contractions"; TREMOR (hospitalization, disability) with onset 22Apr2021, outcome "not recovered", described as "Tremors"; FATIGUE (non-serious), outcome "not recovered", described as "Exhausted". The events "neurological issues", "afib", "premature ventricular contractions", "hair loss" and "tremors" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Unknown results. Therapeutic measures were taken as a result of nervous system disorder, atrial fibrillation, ventricular extrasystoles, alopecia, tremor. The patient did not receive any other vaccines within four weeks prior to the first administration of the suspect vaccine. The patient previously received the Pfizer suspect vaccine and had adverse events following these vaccinations. On 22Apr2021, the patient experienced neurological issues (not hospitalized specifically in neurology). But the patient also had atrial fibrillation (AFib), premature ventricular contractions (PVCs), hair loss, and tremors on 22Apr2021. The patient was hospitalized in cardiology electrophysiology (first time for 2 days, second time for three days, and third time for 5 days). The patient started with arrhythmias and then the arrhythmia become defined - it was atrial fibrillation. The patient developed another arrhythmia which is PVC. Since 22Apr2021, the patient was only partially functional as far as physically (and post hospitalization). The events also caused disability or permanent damage and required visit to physician's office and emergency room. Treatment was received for the adverse events or incidents which included chemical (diltiazem), electrical (R and L heart catheterization) but nothing was effective. The patient also had pacemaker and defibrillator placement on 22Jun2021. The patient's tremors worsened and was exhausted. The patient had not recovered from the events.; Sender's Comments: The events nervous system disorder, atrial fibrillation, ventricular extrasystoles, alopecia, and tremor are conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.,Linked Report(s) : US-PFIZER INC-202400186211 Same patient and product; different events and dose;