FDA FAERS Adverse Event Reports

25945546 Type 1

Serious

PAXLOVID, TRULICITY

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Physician

Literature Reference

--

Company Number

--

Authority Number

EU-MINISAL02-1062330

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

73.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hypertensive crisis (v28.1) Recovered

Headache (v28.1) Recovered

Drugs (2)

PAXLOVID (NIRMATRELVIR\RITONAVIR) Suspect

Route: 048 | Dosage: UNK | Form: Tablet | Indication: COVID-19 immunisation | Action: Dose Not Changed

Start: 10/02/2025 | End: 10/06/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: --

Recurrences: --

TRULICITY (DULAGLUTIDE) Interacting

Route: 058 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown

Start: 02/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251004

Report Duplicates (1)

MINISAL02: EU-MINISAL02-1062330

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53598",
  "safetyreportid": "25945546",
  "authoritynumb": "EU-MINISAL02-1062330",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 73.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hypertensive crisis",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Headache",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PAXLOVID",
        "drugauthorizationnumb": "217188",
        "drugbatchnumb": "MP9086",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "COVID-19 immunisation",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-02T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-10-06T00:00:00",
        "drugtreatmentduration": 5.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "NIRMATRELVIR\\RITONAVIR"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 3,
        "medicinalproduct": "TRULICITY",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "D866278",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "058",
        "drugindication": null,
        "drugstartdateformat": "610",
        "drugstartdate": "2025-02-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DULAGLUTIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251004"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MINISAL02",
      "duplicatenumb": "EU-MINISAL02-1062330"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "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"
}
                        

25945547 Type 1

Serious

IBRANCE

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

TW

Occurrence Country

TW

Reporter Country

TW

Reporter Qualification

Consumer

Literature Reference

--

Company Number

TW-PFIZER INC-PV202500124160

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hernia (v28.1) Unknown

Fall (v28.1) Unknown

Drugs (1)

IBRANCE (PALBOCICLIB) Suspect

Route: 048 | Dosage: 100 MG, 1X/DAY | Form: Capsule | Indication: -- | Action: Dose Not Changed

Start: 09/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53597",
  "safetyreportid": "25945547",
  "authoritynumb": null,
  "companynumb": "TW-PFIZER INC-PV202500124160",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "TW",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hernia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fall",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IBRANCE",
        "drugauthorizationnumb": "207103",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "100 MG, 1X/DAY",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-10T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "PALBOCICLIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "TW",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "TW",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "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"
}
                        

25945544 Type 1

Serious

VYNDAMAX

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/19/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Other Health Professional

Literature Reference

--

Company Number

US-PFIZER INC-202500207573

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

94.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

VYNDAMAX (TAFAMIDIS) Suspect

Route: -- | Dosage: UNK | Form: Capsule, soft | Indication: -- | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53594",
  "safetyreportid": "25945544",
  "authoritynumb": null,
  "companynumb": "US-PFIZER INC-202500207573",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 94.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VYNDAMAX",
        "drugauthorizationnumb": "212161",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Capsule, soft",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TAFAMIDIS"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945543 Type 1

Serious

VYNDAQEL

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

GB

Occurrence Country

GB

Reporter Country

GB

Reporter Qualification

Other Health Professional

Literature Reference

--

Company Number

GB-PFIZER INC-PV202500123914

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

79.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

VYNDAQEL (TAFAMIDIS MEGLUMINE) Suspect

Route: 048 | Dosage: 61 MG, 1X/DAY | Form: Capsule, soft | Indication: Cardiac amyloidosis | Action: Unknown

Start: 07/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53592",
  "safetyreportid": "25945543",
  "authoritynumb": null,
  "companynumb": "GB-PFIZER INC-PV202500123914",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": 79.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VYNDAQEL",
        "drugauthorizationnumb": "212161",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 61.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "61 MG, 1X/DAY",
        "drugdosageform": "Capsule, soft",
        "drugadministrationroute": "048",
        "drugindication": "Cardiac amyloidosis",
        "drugstartdateformat": "610",
        "drugstartdate": "2024-07-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TAFAMIDIS MEGLUMINE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945542 Type 1

Serious

LORBRENA

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

CN

Occurrence Country

CN

Reporter Country

CN

Reporter Qualification

Consumer

Literature Reference

--

Company Number

CN-PFIZER INC-PV202500124258

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

Elderly

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Cerebrovascular accident (v28.1) Unknown

Drugs (1)

LORBRENA (LORLATINIB) Suspect

Route: 048 | Dosage: 100 MG, 1X/DAY | Form: -- | Indication: -- | Action: Withdrawn

Start: 06/16/2025 | End: 10/17/2025 | Duration: 124.0 day | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53591",
  "safetyreportid": "25945542",
  "authoritynumb": null,
  "companynumb": "CN-PFIZER INC-PV202500124258",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CN",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Cerebrovascular accident",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "LORBRENA",
        "drugauthorizationnumb": "210868",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "100 MG, 1X/DAY",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2025-06-16T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-10-17T00:00:00",
        "drugtreatmentduration": 124.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "LORLATINIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CN",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "CN",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945541 Type 1

Serious

VYNDAQEL

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-PFIZER INC-202500207456

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

82.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

VYNDAQEL (TAFAMIDIS MEGLUMINE) Suspect

Route: -- | Dosage: UNK | Form: Capsule, soft | Indication: -- | Action: Unknown

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250930

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53590",
  "safetyreportid": "25945541",
  "authoritynumb": null,
  "companynumb": "US-PFIZER INC-202500207456",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 82.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VYNDAQEL",
        "drugauthorizationnumb": "211996",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Capsule, soft",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TAFAMIDIS MEGLUMINE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250930"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945540 Type 1

Serious

VYNDAQEL

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

GB

Occurrence Country

GB

Reporter Country

GB

Reporter Qualification

Consumer

Literature Reference

--

Company Number

GB-PFIZER INC-PV202500123354

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

77.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Renal failure (v28.1) Fatal

Drugs (1)

VYNDAQEL (TAFAMIDIS MEGLUMINE) Suspect

Route: -- | Dosage: -- | Form: Capsule, soft | Indication: -- | Action: Unknown

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250916

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5358f",
  "safetyreportid": "25945540",
  "authoritynumb": null,
  "companynumb": "GB-PFIZER INC-PV202500123354",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": 77.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Renal failure",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VYNDAQEL",
        "drugauthorizationnumb": "212161",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Capsule, soft",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
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        "drugenddateformat": null,
        "drugenddate": null,
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        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TAFAMIDIS MEGLUMINE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250916"
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "serious": 1,
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  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945538 Type 1

Serious

FLUCONAZOLE, OESTROGEL [ESTRADIOL]

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

GB

Occurrence Country

GB

Reporter Country

GB

Reporter Qualification

Consumer

Literature Reference

--

Company Number

--

Authority Number

GB-MHRA-MED-202510182151570400-TJRBK

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

59.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

60.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Lip swelling (v28.1) Recovered

Swollen tongue (v28.1) Unknown

Rash (v28.1) Recovering

Rash papular (v28.1) Not Recovered

Paraesthesia oral (v28.1) Recovered

Drugs (2)

FLUCONAZOLE (FLUCONAZOLE) Suspect

Route: -- | Dosage: 150MG ONCE AT NIGHT | Form: -- | Indication: Vulvovaginal candidiasis | Action: Withdrawn

Start: 10/16/2025 | End: 10/17/2025 | Duration: 2.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

OESTROGEL [ESTRADIOL] (--) Concomitant

Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --

Start: 08/08/2019 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251016

Report Duplicates (1)

MHRA: GB-MHRA-MED-202510182151570400-TJRBK

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5358e",
  "safetyreportid": "25945538",
  "authoritynumb": "GB-MHRA-MED-202510182151570400-TJRBK",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": 59.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 60.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Lip swelling",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Swollen tongue",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash papular",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Paraesthesia oral",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FLUCONAZOLE",
        "drugauthorizationnumb": "19949",
        "drugbatchnumb": "HX11024",
        "drugstructuredosagenumb": 150.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "150MG ONCE AT NIGHT",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Vulvovaginal candidiasis",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-16T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-10-17T00:00:00",
        "drugtreatmentduration": 2.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "FLUCONAZOLE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "OESTROGEL [ESTRADIOL]",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2019-08-08T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": null,
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251016"
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MHRA",
      "duplicatenumb": "GB-MHRA-MED-202510182151570400-TJRBK"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "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"
}
                        

25945539 Type 1

Serious

IBRANCE

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

GB

Occurrence Country

GB

Reporter Country

GB

Reporter Qualification

Consumer

Literature Reference

--

Company Number

GB-PFIZER INC-PV202500123966

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

46.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Coagulopathy (v28.1) Unknown

Drugs (1)

IBRANCE (PALBOCICLIB) Suspect

Route: 048 | Dosage: 100 MG, 1X/DAY | Form: Film-coated tablet | Indication: Breast cancer | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5358d",
  "safetyreportid": "25945539",
  "authoritynumb": null,
  "companynumb": "GB-PFIZER INC-PV202500123966",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": 46.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Coagulopathy",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IBRANCE",
        "drugauthorizationnumb": "212436",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "100 MG, 1X/DAY",
        "drugdosageform": "Film-coated tablet",
        "drugadministrationroute": "048",
        "drugindication": "Breast cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "PALBOCICLIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945533 Type 1

Serious

VYNDAMAX

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Other Health Professional

Literature Reference

--

Company Number

US-PFIZER INC-202500207757

Authority Number

--

Sender Organization

PFIZER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

75.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

VYNDAMAX (TAFAMIDIS) Suspect

Route: -- | Dosage: UNK | Form: Capsule, soft | Indication: -- | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5358c",
  "safetyreportid": "25945533",
  "authoritynumb": null,
  "companynumb": "US-PFIZER INC-202500207757",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 75.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VYNDAMAX",
        "drugauthorizationnumb": "212161",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Capsule, soft",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TAFAMIDIS"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        