FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25946529 Type 1

Non-Serious

ZILRETTA

Report Version

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-ORG100016242-2025000050

Authority Number

Sender Organization

PACIRA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

83.0 yr

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Drug effect less than expected (v28.1) Not Recovered

Myalgia (v28.1) Not Recovered

Injection site pain (v28.1) Unknown

Drugs (1)

ZILRETTA (TRIAMCINOLONE ACETONIDE) Suspect

Route: 050 | Dosage: SINGLE DOSE BOTH KNEES | Form: Suspension for injection | Indication: Arthralgia | Action: Not Applicable

Start: 01/24/2025 | End: 01/24/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250124

Report Duplicates (1)

ProPharma (AE): 2025-0018855

Raw JSON (click to expand)

                            {
  "_id": "69d4356a3b3830196fa5395d",
  "safetyreportid": "25946529",
  "authoritynumb": null,
  "companynumb": "US-ORG100016242-2025000050",
  "duplicate": 1,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 83.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug effect less than expected",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Myalgia",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Injection site pain",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ZILRETTA",
        "drugauthorizationnumb": "208845",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "SINGLE DOSE BOTH KNEES",
        "drugdosageform": "Suspension for injection",
        "drugadministrationroute": "050",
        "drugindication": "Arthralgia",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-01-24T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-01-24T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "TRIAMCINOLONE ACETONIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250124"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "ProPharma (AE)",
      "duplicatenumb": "2025-0018855"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PACIRA"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25946531 Type 1

Non-Serious

ZILRETTA

Report Version

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-ORG100016242-2025000098

Authority Number

Sender Organization

PACIRA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

51.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

109.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Genital infection bacterial (v28.1) Recovered

Oral bacterial infection (v28.1) Recovered

Condition aggravated (v28.1) Recovered

Drugs (1)

ZILRETTA (TRIAMCINOLONE ACETONIDE) Suspect

Route: 030 | Dosage: -- | Form: Suspension for injection | Indication: Product used for unknown indication | Action: Dose Not Changed

Start: 02/17/2025 | End: 03/17/2025 | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250228

Report Duplicates (2)

ProPharma (AE): 2025-0040333

ProPharma (MI): 2025-0040349

Raw JSON (click to expand)

                            {
  "_id": "69d4356a3b3830196fa5395c",
  "safetyreportid": "25946531",
  "authoritynumb": null,
  "companynumb": "US-ORG100016242-2025000098",
  "duplicate": 1,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 51.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": 109.0,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Genital infection bacterial",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Oral bacterial infection",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Condition aggravated",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ZILRETTA",
        "drugauthorizationnumb": "208845",
        "drugbatchnumb": "24-9009",
        "drugstructuredosagenumb": 32.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Suspension for injection",
        "drugadministrationroute": "030",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-02-17T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-03-17T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "TRIAMCINOLONE ACETONIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250228"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "ProPharma (AE)",
      "duplicatenumb": "2025-0040333"
    },
    {
      "duplicatesource": "ProPharma (MI)",
      "duplicatenumb": "2025-0040349"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PACIRA"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25946530 Type 1

Non-Serious

ZILRETTA

Report Version

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-ORG100016242-2025000027

Authority Number

Sender Organization

PACIRA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

74.0 yr

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Gait inability (v28.1) Not Recovered

Drugs (1)

ZILRETTA (TRIAMCINOLONE ACETONIDE) Suspect

Route: 050 | Dosage: NORMALLY EVERY 3 MONTHS | Form: Suspension for injection | Indication: Osteoarthritis | Action: --

Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

Report Duplicates (2)

ProPharma (AE): 2025-0008514

ProPharma (non MI): 2025-0008511

Raw JSON (click to expand)

                            {
  "_id": "69d4356a3b3830196fa5395b",
  "safetyreportid": "25946530",
  "authoritynumb": null,
  "companynumb": "US-ORG100016242-2025000027",
  "duplicate": 1,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 74.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gait inability",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ZILRETTA",
        "drugauthorizationnumb": "208845",
        "drugbatchnumb": "Unk",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "NORMALLY EVERY 3 MONTHS",
        "drugdosageform": "Suspension for injection",
        "drugadministrationroute": "050",
        "drugindication": "Osteoarthritis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "TRIAMCINOLONE ACETONIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "ProPharma (AE)",
      "duplicatenumb": "2025-0008514"
    },
    {
      "duplicatesource": "ProPharma (non MI)",
      "duplicatenumb": "2025-0008511"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PACIRA"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25946527 Type 1

Serious

DUPIXENT, DUPIXENT

Report Version

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-SA-2025SA313043

Authority Number

Sender Organization

SANOFI AVENTIS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

29.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Choking (v28.1) Unknown

Vision blurred (v28.1) Unknown

Injection site swelling (v28.1) Unknown

Injection site erythema (v28.1) Unknown

Oesophageal dilation procedure (v28.1) Unknown

Drugs (2)

DUPIXENT (DUPILUMAB) Suspect

Route: 058 | Dosage: 300 MG, QW | Form: Solution for injection | Indication: Eosinophilic oesophagitis | Action: Withdrawn

Start: 07/01/2025 | End: 01/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

DUPIXENT (DUPILUMAB) Suspect

Route: 058 | Dosage: 300 MG, QW | Form: Solution for injection | Indication: -- | Action: Withdrawn

Start: 10/16/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4356a3b3830196fa53959",
  "safetyreportid": "25946527",
  "authoritynumb": null,
  "companynumb": "US-SA-2025SA313043",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 29.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Choking",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vision blurred",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Injection site swelling",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Injection site erythema",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Oesophageal dilation procedure",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DUPIXENT",
        "drugauthorizationnumb": "761055",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "300 MG, QW",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Eosinophilic oesophagitis",
        "drugstartdateformat": "610",
        "drugstartdate": "2025-07-01T00:00:00",
        "drugenddateformat": "602",
        "drugenddate": "2025-01-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "DUPILUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DUPIXENT",
        "drugauthorizationnumb": "761055",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "300 MG, QW",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-16T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "DUPILUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "SANOFI AVENTIS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25946525 Type 1

Serious

RITUXIMAB

Report Version

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Geymonat MA, Rojas I, Rama ME. NEUROPSYCHIATRIC LUPUS AS THE INITIAL PRESENTATION OF PEDIATRIC SYSTEMIC LUPUS ERYTHEMATOSUS: A CASE REPORT

Company Number

AR-CELLTRION INC.-2025AR037890

Authority Number

Sender Organization

CELLTRION

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Aphasia (v28.1) Unknown

Dyskinesia (v28.1) Unknown

Hallucination, auditory (v28.1) Unknown

Intentional product use issue (v28.1) Unknown

Drugs (1)

RITUXIMAB (RITUXIMAB) Suspect

Route: -- | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Systemic lupus erythematosus | Action: Unknown

Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4356a3b3830196fa53958",
  "safetyreportid": "25946525",
  "authoritynumb": null,
  "companynumb": "AR-CELLTRION INC.-2025AR037890",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "AR",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Aphasia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyskinesia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyskinesia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hallucination, auditory",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intentional product use issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RITUXIMAB",
        "drugauthorizationnumb": "761088",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Concentrate for solution for infusion",
        "drugadministrationroute": null,
        "drugindication": "Systemic lupus erythematosus",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "RITUXIMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "AR",
    "qualification": 3,
    "literaturereference": "Geymonat MA, Rojas I, Rama ME. NEUROPSYCHIATRIC LUPUS AS THE INITIAL PRESENTATION OF PEDIATRIC SYSTEMIC LUPUS ERYTHEMATOSUS: A CASE REPORT"
  },
  "primarysourcecountry": "AR",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "CELLTRION"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25946526 Type 1

Serious

BEYFORTUS, ROTARIX, PREVNAR 13 (+1 more)

Report Version

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

AU-GLAXOSMITHKLINE-AU2024APC093066

Authority Number

Sender Organization

SANOFI AVENTIS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Infant

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (12)

Cardiac failure (v28.1) Not Recovered

Hypophagia (v28.1) Not Recovered

Sterile pyuria (v28.1) Not Recovered

C-reactive protein increased (v28.1) Unknown

Insomnia (v28.1) Unknown

Vasculitis (v28.1) Not Recovered

Eye discharge (v28.1) Not Recovered

Kawasaki^s disease (v28.1) Not Recovered

Cardiac murmur (v28.1) Not Recovered

Staphylococcal infection (v28.1) Unknown

Pyrexia (v28.1) Not Recovered

Rash (v28.1) Not Recovered

Drugs (4)

BEYFORTUS (NIRSEVIMAB-ALIP) Suspect

Route: -- | Dosage: UNK | Form: Solution for injection in pre-filled syringe | Indication: Product used for unknown indication | Action: Not Applicable

Start: 05/27/2024 | End: 05/27/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: 4

Recurrences: --

ROTARIX (HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN) Suspect

Route: -- | Dosage: UNK | Form: Oral drops | Indication: Prophylaxis | Action: Not Applicable

Start: 05/27/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

PREVNAR 13 (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\) Suspect

Route: -- | Dosage: UNK | Form: -- | Indication: Prophylaxis | Action: Not Applicable

Start: 05/27/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

INFANRIX HEXA (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHI) Suspect

Route: -- | Dosage: UNK | Form: Solution for injection | Indication: Prophylaxis | Action: Not Applicable

Start: 05/27/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240501

Report Duplicates (4)

EMA: AU-EMA-2025211-AUTODUP-1739228972314

ASTRAZENECA: AU-ASTRAZENECA-240132683_071610_P_1

GLAXOSMITHKLINE: AU-GLAXOSMITHKLINE-AU2024APC093066

SA: AU-SA-2025SA023632

Raw JSON (click to expand)

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  "companynumb": "AU-GLAXOSMITHKLINE-AU2024APC093066",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "AU",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 2,
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    "patientsex": 2,
    "reaction": [
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        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hypophagia",
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      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Sterile pyuria",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "C-reactive protein increased",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Insomnia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vasculitis",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Eye discharge",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Kawasaki^s disease",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Cardiac murmur",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Staphylococcal infection",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pyrexia",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BEYFORTUS",
        "drugauthorizationnumb": "761328",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugdosagetext": "UNK",
        "drugdosageform": "Solution for injection in pre-filled syringe",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2024-05-27T00:00:00",
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        "drugtreatmentduration": 1.0,
        "drugtreatmentdurationunit": 804,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "NIRSEVIMAB-ALIP"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ROTARIX",
        "drugauthorizationnumb": null,
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        "drugdosagetext": "UNK",
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        "drugstartdateformat": "102",
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        "drugenddateformat": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PREVNAR 13",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Prophylaxis",
        "drugstartdateformat": "102",
        "drugstartdate": "2024-05-27T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\\"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "INFANRIX HEXA",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": null,
        "drugindication": "Prophylaxis",
        "drugstartdateformat": "102",
        "drugstartdate": "2024-05-27T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHI"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240501"
  },
  "primarysource": {
    "reportercountry": "AU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "AU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "EMA",
      "duplicatenumb": "AU-EMA-2025211-AUTODUP-1739228972314"
    },
    {
      "duplicatesource": "ASTRAZENECA",
      "duplicatenumb": "AU-ASTRAZENECA-240132683_071610_P_1"
    },
    {
      "duplicatesource": "GLAXOSMITHKLINE",
      "duplicatenumb": "AU-GLAXOSMITHKLINE-AU2024APC093066"
    },
    {
      "duplicatesource": "SA",
      "duplicatenumb": "AU-SA-2025SA023632"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "SANOFI AVENTIS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25946524 Type 1

Serious

TISLELIZUMAB, TISLELIZUMAB, TISLELIZUMAB (+29 more)

Report Version

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

CN-BEIGENE-BGN-2025-017869

Authority Number

Sender Organization

BEIGENE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

80.0 yr

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Interstitial lung disease (v28.1) Recovering