{"id":"birv","safety":{"commonSideEffects":[{"effect":"Injection site pain (PAIN)","drugRate":"63.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":46,"totalAffected":29,"trialsReporting":2},{"effect":"Fatigue (FATIGUE)","drugRate":"43.5%","organSystem":"General disorders","placeboRate":"","totalAtRisk":46,"totalAffected":20,"trialsReporting":2},{"effect":"Headache (HEADACHE)","drugRate":"39.1%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":46,"totalAffected":18,"trialsReporting":2},{"effect":"Myalgia (MUSCLE PAIN)","drugRate":"37.0%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":46,"totalAffected":17,"trialsReporting":2},{"effect":"Chills (CHILLS)","drugRate":"34.8%","organSystem":"General disorders","placeboRate":"","totalAtRisk":46,"totalAffected":16,"trialsReporting":2},{"effect":"Injection site swelling (SWELLING)","drugRate":"10.9%","organSystem":"General disorders","placeboRate":"","totalAtRisk":46,"totalAffected":5,"trialsReporting":2},{"effect":"Arthralgia (JOINT PAIN)","drugRate":"10.9%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":46,"totalAffected":5,"trialsReporting":2},{"effect":"Injection site erythema (REDNESS)","drugRate":"8.7%","organSystem":"General disorders","placeboRate":"","totalAtRisk":46,"totalAffected":4,"trialsReporting":2},{"effect":"Pyrexia (FEVER)","drugRate":"8.7%","organSystem":"General disorders","placeboRate":"","totalAtRisk":46,"totalAffected":4,"trialsReporting":2},{"effect":"Diarrhoea (DIARRHEA)","drugRate":"8.7%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":46,"totalAffected":4,"trialsReporting":2},{"effect":"Vomiting (VOMITING)","drugRate":"4.3%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":46,"totalAffected":2,"trialsReporting":2},{"effect":"Lymphopenia","drugRate":"6.2%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":16,"totalAffected":1,"trialsReporting":1},{"effect":"Ventricular extrasystoles","drugRate":"6.2%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":16,"totalAffected":1,"trialsReporting":1},{"effect":"Dermatitis contact","drugRate":"2.2%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":46,"totalAffected":1,"trialsReporting":2},{"effect":"Iron deficiency anaemia","drugRate":"0.0%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Normocytic anaemia","drugRate":"0.0%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Atrial fibrillation","drugRate":"0.0%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Bundle branch block right","drugRate":"0.0%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Sinus bradycardia","drugRate":"0.0%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Cataract","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Diarrhoea","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Gastrooesophageal reflux disease","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Nausea","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Abdominal pain","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Gastritis","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Haemorrhoids","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Hiatus hernia","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Large intestine polyp","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Vomiting","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Chest discomfort","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Chills","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Fatigue","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Chest pain","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":46,"totalAffected":0,"trialsReporting":2},{"effect":"Diarrhoea infectious","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Gastroenteritis viral","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Nasopharyngitis","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Vulvovaginal mycotic infection","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Arthropod sting","drugRate":"0.0%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Fall","drugRate":"0.0%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Body temperature increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"C-reactive protein increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Haemoglobin decreased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Decreased appetite","drugRate":"0.0%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Vitamin B12 deficiency","drugRate":"0.0%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Back pain","drugRate":"0.0%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":46,"totalAffected":0,"trialsReporting":2},{"effect":"Myalgia","drugRate":"0.0%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Dizziness","drugRate":"0.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":46,"totalAffected":0,"trialsReporting":2},{"effect":"Pruritus","drugRate":"0.0%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Rash","drugRate":"0.0%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1},{"effect":"Haematoma","drugRate":"0.0%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":16,"totalAffected":0,"trialsReporting":1}],"seriousAdverseEvents":[{"event":"Rib fracture","detail":"Injury, poisoning and procedural complications. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Hip fracture","detail":"Injury, poisoning and procedural complications. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Suicidal ideation","detail":"Psychiatric disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cholelithiasis","detail":"Hepatobiliary disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Pneumonia","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Sepsis","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Viral infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Osteoarthritis","detail":"Musculoskeletal and connective tissue disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Appendicitis","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Gastric ulcer","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cervical spinal stenosis","detail":"Musculoskeletal and connective tissue disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cholecystitis infective","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cervical vertebral fracture","detail":"Injury, poisoning and procedural complications. 1 trial(s).","severity":"serious","incidence":"0.0%"}]},"_chembl":null,"_fixedAt":"2026-03-30T11:24:54.757159","_sources":{"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T08:45:28.374378+00:00"}},"_dailymed":null,"_scrapedAt":"2026-03-28T01:47:42.474Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T08:45:35.588891+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_fixedFields":["pubmed(2)"],"trialDetails":[{"nctId":"NCT05596734","phase":"PHASE2","title":"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza","status":"COMPLETED","sponsor":"BioNTech SE","startDate":"2022-10-28","conditions":"Influenza, Human, COVID-19","enrollment":1019},{"nctId":"NCT05052697","phase":"PHASE1, PHASE2","title":"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-09-13","conditions":"Influenza, Human","enrollment":1158}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"recentPublications":[{"date":"2025 Nov 12","pmid":"41305520","title":"Biya River Virus, a Novel Hantavirus of the Eurasian Water Shrew (Neomys fodiens) in Russia.","journal":"Viruses"},{"date":"2018 Oct","pmid":"30091805","title":"Comparison of ischaemia-reperfusion-induced acute kidney injury by clamping renal arteries, veins or pedicles in anaesthetized rats.","journal":"Experimental physiology"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"bIRV","genericName":"birv","companyName":"Pfizer Inc.","companyId":"pfizer","modality":"","firstApprovalDate":"","aiSummary":"","enrichmentLevel":5,"visitCount":9,"trialStats":{"total":2,"withResults":2},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T08:45:35.588891+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":true,"trials":true,"score":2}}