Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cardiac amyloidosis, Cerebrovascular accident, Menstrual disorder, Myocarditis
Clinical narrative: myocarditis; thrombosis; cerebrovascular accident; amyloidogenesis; arthralgia; menstrual disorders; reproductive concerns; This case has been considered invalid as Duplicate Case.  This is a literature report from License Party for the following literature source(s):   An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; THROMBOSIS (medically significant), outcome "unknown"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown"; CARDIAC AMYLOIDOSIS (medically significant), outcome "unknown", described as "amyloidogenesis"; ARTHRALGIA (non-serious), outcome "unknown"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "menstrual disorders"; REPRODUCTIVE TRACT DISORDER (non-serious), outcome "unknown", described as "reproductive concerns".  Synthetic mRNA vaccines have introduced a novel platform in human immunization by encoding viral antigens Within lipid nanoparticle encapsulated, chemically modified mRNA molecules. While initially promoted for their rapid production and strong immunogenicity, a growing body of evidence has identified a range of adverse events, including myocarditis, thrombosis, cerebrovascular accidents, amyloidogenesis, arthralgia, menstrual disorders, reproductive concerns, and new-onset malignancies. These events have prompted renewed scrutiny of the molecular mechanisms triggered by synthetic mRNA constructs and their intracellular fate. Unlike endogenous mRNA, vaccine-derived transcripts incorporate non-natural features such as NI-methylpseudouridine substitution, extended poly(A) tails, and optimized untranslated regions (UTRs) to enhance stability and translational efficiency. These same modifications may alter RNA metabolism and surveillance, contributing to ribosomal infidelity, +1 frameshifting, and defective protein folding. Independent studies have reported reverse transcription of vaccine mRNA into DNA via endogenous LINE-I elements, highlighting issues over genomic integration and persistent expression. Recent analyses of BNT162b2 vaccine vials revealed residual plasmid DNA, including SV40 enhancer and antibiotic resistance genes, raising concerns over potential oncogenic risk from unintended genomic exposure. Moreover, recent research has shown that spike protein translated from mRNA vaccines can persist in the circulation for extended periods, far beyond initial pharmacokinetic expectations, potentially sustaining Inflammatory signalling and Immune activation. Finally, some studies suggest that SARS-CoV-2 bears molecular signatures consistent with synthetic genome assembly, raising further concerns about engineered RNA platforms and their unforeseen biological consequences. These features collectively raise concerns regarding unintended cellular consequences of synthetic mRNA exposure.   To address this gap, the authors conducted a comparative transcriptomic analysis using bulk RNA-sequencing data from whole blood of patients with new-onset adverse events (Group 1) and patients with new-onset cancers (Group 2) following COVID-19 mRNA vaccination, alongside healthy controls. Differential expression analysis and Gene Set Enrichment Analysis (GSEA) were performed to identify hallmark-specific molecular pathways perturbed in each group. By comparing these two profiles, this study aims to highlight potential transcriptomic disturbances associated with vaccine-related pathology and explore whether distinct or shared molecular hallmarks may underlie different post-vaccination clinical trajectories.  The authors enrolled adult participants (ages 18-70) who developed either new-onset symptoms following administration of mRNA-based COVID-19 vaccines (BNT162b2 [Pfizer] or mRNA-1273 [Moderna]). All participants provided written informed consent prior to inclusion in the study. Among the symptomatic individuals with nonmalignant adverse events, reported manifestations included cardiovascular injury, thrombosis, chronic fatigue, and neurological dysfunction, emerging shortly after vaccination. Another group of participants was diagnosed with cancer as a new-onset condition within a short time frame following mRNA vaccine administration. The study population was divided into two groups: the first consisted of three individuals who developed new-onset post-vaccination symptoms (group 1), and the second included seven individuals with new-onset cancer diagnoses (group 2). A cohort of 803 healthy individuals was used as the reference control group. Peripheral blood samples were collected in accordance with institutional biosafety guidelines by licensed nurses at clinical sites affiliated with Neo7Bioscience. Venipuncture was performed using standard sterile technique. Whole blood was drawn into pre-labelled Streck tubes, stored at 4 degree C, and transported the same day in cooled containers to the Genomics Center at the University for processing.  No follow-up attempts are possible.  Follow-up (11Aug2025): This is a literature report for the following literature source(s): This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  Updated information: Market Authorization Holder of MODERNA COVID-19 VACCINE added, Digital Object Identifier updated, Causality assessment updated, and case downgraded to invalid as it was inclusion criteria for this study.  Follow-up (18Aug2025): This is a follow-up report to notify that the case PV202500092384 and 202500165734 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202500165734.  Amendment: case 202500165734 is being deleted from the database as erroneously submitted to certain regulators with no reportable ADRs and duplicate to 202500167447 (created for reporting to other regulators as well as aggregate and risk management purposes). All subsequent follow-up information will be reported under manufacturer report number 202500167447. This case is being deleted from the database for the following reason: duplicate case.  No further follow-up information has been received.