Received Feb 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | GH9703 | — |
myocarditis; PVCs; short of breath; This is a spontaneous report received from a Physician. A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Pectus excavatum s/p repair" (unspecified if ongoing), notes: Pectus excavatum s/p repair; "restrictive lung diseaes" (unspecified if ongoing); "OSA" (unspecified if ongoing); "non-obstructive CAD" (unspecified if ongoing); "BRCA1+" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Start time: 11:15 AM, Anatomical location: Upper left arm, Lot No: ER8733), administration date: 25Mar2021, when the patient was 65-year-old, for Covid-19 immunization, reaction(s): "vaccination rash/itching occurred inner elbow right arm", "vaccination rash/itching occurred inner elbow right arm", "She experienced pain that lasted for about 3-4 days/pain at injection site last 3 days", "soft tissue of the underarm raised form on the right side", "This occurred on the left side the same areas and there were just like drying out of the skin", "Muscle pain", "red rash/raised bumps"; BNT162b2 (DOSE 2, SINGLE, Start time: 11:15, Anatomical location: left arm, Lot No: EW0161), administration date: 15Apr2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "Fever", "Pain", "Red rash". The following information was reported: DYSPNOEA (disability) with onset Oct2022, outcome "unknown", described as "short of breath"; VENTRICULAR EXTRASYSTOLES (disability) with onset 2025, outcome "recovering", described as "PVCs"; MYOCARDITIS (disability, medically significant) with onset 2025, outcome "recovering". The patient underwent the following laboratory tests and procedures: Workup: (2025) frequent PVCs; Magnetic resonance imaging heart: (2025) resolving myocarditis. It was unknown if therapeutic measures were taken as a result of myocarditis. Therapeutic measures were taken as a result of ventricular extrasystoles. Additional information: In Oct2022, The patient had the Pfizer COVID-19 vaccine and almost immediately afterwards became profoundly more short of breath with even the most minimal exertion. He went from being able to walk 2 miles a day to now being short of breath after walking about 5 minutes. Workup at that time found frequent PVCs and he was started on flecainide which did seem to help his symptoms somewhat; however, did not resolve entirely. Cardiac MRI revealed findings consistent with resolving myocarditis in late 2025.; Sender's Comments: Based on the temporal relationship between administration of BNT162b2 / BNT162b2 OMI BA.4-5 and the onset of dyspnoea, with subsequent confirmation of ventricular extrasystoles and myocarditis, and given that myocarditis is a recognized adverse event of mRNA COVID-19 vaccines, a reasonable possibility of a causal relationship 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
Medical History/Concurrent Conditions: BRCA1 gene mutation; Nonobstructive coronary artery disease; Obstructive sleep apnea; Pectus excavatum (Pectus excavatum s/p repair); Restrictive pulmonary disease
Test Date: 2025; Test Name: Workup; Result Unstructured Data: Test Result:frequent PVCs; Test Date: 2025; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:resolving myocarditis