chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: SARS-CoV-2 test positive, Ultrasound abdomen, Ultrasound scan, Ultrasound scan vagina, Urine ketone body present
Clinical narrative: pt is not vaccinated 08/20/23 59.4 kg (131 lb)     Physical Exam: General: Alert, well appearing and in no distress and speaking in full sentences. Appears tired but non toxic appearing.  Heart: regular rate and rhythm Lungs: clear to auscultation, no wheezes, rales or rhonchi, symmetric air entry Abdomen: soft, nontender, gravid Vertex confirmed by bedside ultrasound Transabdominal ultrasound: Presentation: cephalic, Fluid: normal appearing Transvaginal ultrasound: cervical length 4.05 cm   Cervical Exam:    deferred   The exam was chaperoned by RN.     Uterine Activity: Mode: TOCO DYNAMOMETER;MONITOR APPLIED  Uterine irritability noted  Fetal Assessment: Baseline Fetal Heart Rate (Baby A): 160     Membranes and Fluid:    intact     Urine dipstick shows positive for trace protein, moderate ketones.     Patient Assessment: Reassuring fetal status and Uterine contractions, rule-out labor  Active Hospital Problems   Diagnosis   ? (Principal) PRETERM UTERINE CONTRACTIONS       Plan: Observe, Reevaluate in about 2 hours COVID test sent IV Fluids (1 Liter) Pending Study Results at Discharge: None   Issues to be Addressed in Follow-up: COVID -19   Addendum: Pt received IV fluid bolus. UC's resolved. Informed pt of +COVID test. Discussed r/b of paxlovid-declines paxlovid. Reaction (sz) after tylenol use in childhood so listed as an allergy and declines. D/C home and sent message to clinic staff to arrange RN phone calls to check in given unvaccinated.                Note Details  Author (M.D.) File Time 8/21/2023  1:51 AM Author Type Physician Status Addendum Last Editor (M.D.) Specialty Obstetrics & Gynecology Hospital Acct # Admit Date 8/20/2023  Admission (Discharged) on 8/20/2023  Admission (Discharged) on 8/20/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  08/21   Discharged 0203
Sex: F
Vaccine: UNK
Symptoms: Uterine irritability
Clinical narrative: pt is not vaccinated 08/20/23 59.4 kg (131 lb)     Physical Exam: General: Alert, well appearing and in no distress and speaking in full sentences. Appears tired but non toxic appearing.  Heart: regular rate and rhythm Lungs: clear to auscultation, no wheezes, rales or rhonchi, symmetric air entry Abdomen: soft, nontender, gravid Vertex confirmed by bedside ultrasound Transabdominal ultrasound: Presentation: cephalic, Fluid: normal appearing Transvaginal ultrasound: cervical length 4.05 cm   Cervical Exam:    deferred   The exam was chaperoned by RN.     Uterine Activity: Mode: TOCO DYNAMOMETER;MONITOR APPLIED  Uterine irritability noted  Fetal Assessment: Baseline Fetal Heart Rate (Baby A): 160     Membranes and Fluid:    intact     Urine dipstick shows positive for trace protein, moderate ketones.     Patient Assessment: Reassuring fetal status and Uterine contractions, rule-out labor  Active Hospital Problems   Diagnosis   ? (Principal) PRETERM UTERINE CONTRACTIONS       Plan: Observe, Reevaluate in about 2 hours COVID test sent IV Fluids (1 Liter) Pending Study Results at Discharge: None   Issues to be Addressed in Follow-up: COVID -19   Addendum: Pt received IV fluid bolus. UC's resolved. Informed pt of +COVID test. Discussed r/b of paxlovid-declines paxlovid. Reaction (sz) after tylenol use in childhood so listed as an allergy and declines. D/C home and sent message to clinic staff to arrange RN phone calls to check in given unvaccinated.                Note Details  Author (M.D.) File Time 8/21/2023  1:51 AM Author Type Physician Status Addendum Last Editor (M.D.) Specialty Obstetrics & Gynecology Hospital Acct # Admit Date 8/20/2023  Admission (Discharged) on 8/20/2023  Admission (Discharged) on 8/20/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  08/21   Discharged 0203
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site mass, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: patient has raised itchy lump at injection site  no rash noted or warmth to site
Age: 5.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Wrong product administered
Clinical narrative: Child required DTaP vaccination per state and school protocol. The child was given the incorrect vaccine, Hep B, in error; the 5 rights of medication administration had not been followed regarding the right medication verification. The syringe used had been taken from the appropriate storage box and returned unused to the incorrect storage box. Once the error was discovered, the proper reporting was initiated, the father called, and the child brought back to the office for administration of the appropriate DTaP vaccine. At no time did the child experience an adverse reaction to either the Hep B vaccine or the DTaP vaccine after observation in the clinic. The child left in good and stable condition with his father after administration of the DTaP vaccine.
Age: 35.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Raised swollen red lump on left arm with localized itching and heat at site. Patient reported via electronic message system. Patient was contacted by triage nurse and scheduled with provider in clinic. Patient cancelled appt with provider.
Age: 35.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Pruritus
Clinical narrative: Raised swollen red lump on left arm with localized itching and heat at site. Patient reported via electronic message system. Patient was contacted by triage nurse and scheduled with provider in clinic. Patient cancelled appt with provider.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Alanine aminotransferase normal, Amylase normal, Anticoagulation drug level above therapeutic, Aspartate aminotransferase normal
Clinical narrative: Inpatient Pharmacy Warfarin Anticoagulation Therapy Protocol Progress Note  SUBJECTIVE: Patient is a 72 Y male admitted on 8/22/2023 for Acute Hypoxic Respiratory Failure/ Covid 19 / PNA+RT MOD Effusion/S/P Heart Transplant Allergies: Vaccine, Cyclosporine, Fluoxetine, Gabapentin, Lisinopril, and Spironolactone   OBJECTIVE: Medication: Warfarin New Start Warfarin?  No  Duration/Expected Duration: Indefinite   Indication: DVT   Goal INR: 2 - 3   Warfarin Tabs at Home: 2mg Home Dose:  Sunday (mg): 2 MG Monday (mg): 2 MG Tuesday (mg): 2 MG Wednesday (mg): 2 MG Thursday (mg): 2 MG Friday (mg): 2 MG Saturday (mg): 2 MG   Managed by/To be managed by: Anticoagulation Clinic   Labs: Estimated body mass index is 22.99 kg/m² as calculated from the following:   Height as of this encounter: 1.778 m (5' 10").   Weight as of 6/22/23: 72.7 kg (160 lb 3.2 oz).  Recent Labs   08/24/23 0605 08/23/23 0727 08/22/23 1154 PT 31.9* 31.8* 30.6* INR 3.2 3.2 3.0      Recent Labs   08/24/23 0605 08/22/23 1154 HGB 9.8* 10.6* HCT 33.4* 36.0* PLT CONFIRMD | 125* | NORMAL 119* CR 2.39* 2.48*    Lab Results Component Value Date   ALT 26 08/24/2023   AST 24 08/24/2023   GGT 22 07/15/2020   ALKALINE PHOSPHATASE 55 08/24/2023   Bilirubin, total 0.3 08/24/2023   Amylase 66 01/26/2023   Lipase 83 08/22/2023   Inpatient Warfarin Dosing History:    Date INR Warfarin (dose) Diet (note diet changes, ex: NPO, low intake, tube feeds, etc) Comments 8/22/23 3.0 HOLD Low Na   8/23/23 3.2 HOLD Low Na   8/24/23 3.2 HOLD Low Na                         Major Drug-Drug Interactions (include start/stop dates): Recent Vitamin K? No Ceftriaxone, dexamethasone, doxycycline, remdesivir, prednisone   Significant comorbidities or disease states: Renal failure   ASSESSMENT Today's INR is supratherapeutic Signs/symptoms of bleeding noted by RN/MD?: No, per chart review   Pt was on warfarin prior to admission       1. Education/re-education provided? No, will attempt to educate over phone today as patient is COVID +.   PLAN 1) Will hold warfarin tonight because supratherapeutic INR 2) No bridging at this time.       3) Recheck PT/INR with AM Labs  4) Pharmacy to continue to monitor Per Protocol 5) Discharge planning: None at this time.                        Cosigned by: (Pharm.D.) at 8/24/2023  2:23 PM  Note Details  File Time 8/24/2023 12:23 PM Author Type (none) Status Signed Last Editor (none) Admit Date 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023   Revision History   Detailed Report  Note viewed by patient Care Timeline  08/22   Admitted from ED 2144 08/25   Discharged 1644
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood creatinine increased, Blood sodium decreased, COVID-19
Clinical narrative: Inpatient Pharmacy Warfarin Anticoagulation Therapy Protocol Progress Note  SUBJECTIVE: Patient is a 72 Y male admitted on 8/22/2023 for Acute Hypoxic Respiratory Failure/ Covid 19 / PNA+RT MOD Effusion/S/P Heart Transplant Allergies: Vaccine, Cyclosporine, Fluoxetine, Gabapentin, Lisinopril, and Spironolactone   OBJECTIVE: Medication: Warfarin New Start Warfarin?  No  Duration/Expected Duration: Indefinite   Indication: DVT   Goal INR: 2 - 3   Warfarin Tabs at Home: 2mg Home Dose:  Sunday (mg): 2 MG Monday (mg): 2 MG Tuesday (mg): 2 MG Wednesday (mg): 2 MG Thursday (mg): 2 MG Friday (mg): 2 MG Saturday (mg): 2 MG   Managed by/To be managed by: Anticoagulation Clinic   Labs: Estimated body mass index is 22.99 kg/m² as calculated from the following:   Height as of this encounter: 1.778 m (5' 10").   Weight as of 6/22/23: 72.7 kg (160 lb 3.2 oz).  Recent Labs   08/24/23 0605 08/23/23 0727 08/22/23 1154 PT 31.9* 31.8* 30.6* INR 3.2 3.2 3.0      Recent Labs   08/24/23 0605 08/22/23 1154 HGB 9.8* 10.6* HCT 33.4* 36.0* PLT CONFIRMD | 125* | NORMAL 119* CR 2.39* 2.48*    Lab Results Component Value Date   ALT 26 08/24/2023   AST 24 08/24/2023   GGT 22 07/15/2020   ALKALINE PHOSPHATASE 55 08/24/2023   Bilirubin, total 0.3 08/24/2023   Amylase 66 01/26/2023   Lipase 83 08/22/2023   Inpatient Warfarin Dosing History:    Date INR Warfarin (dose) Diet (note diet changes, ex: NPO, low intake, tube feeds, etc) Comments 8/22/23 3.0 HOLD Low Na   8/23/23 3.2 HOLD Low Na   8/24/23 3.2 HOLD Low Na                         Major Drug-Drug Interactions (include start/stop dates): Recent Vitamin K? No Ceftriaxone, dexamethasone, doxycycline, remdesivir, prednisone   Significant comorbidities or disease states: Renal failure   ASSESSMENT Today's INR is supratherapeutic Signs/symptoms of bleeding noted by RN/MD?: No, per chart review   Pt was on warfarin prior to admission       1. Education/re-education provided? No, will attempt to educate over phone today as patient is COVID +.   PLAN 1) Will hold warfarin tonight because supratherapeutic INR 2) No bridging at this time.       3) Recheck PT/INR with AM Labs  4) Pharmacy to continue to monitor Per Protocol 5) Discharge planning: None at this time.                        Cosigned by: (Pharm.D.) at 8/24/2023  2:23 PM  Note Details  File Time 8/24/2023 12:23 PM Author Type (none) Status Signed Last Editor (none) Admit Date 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023   Revision History   Detailed Report  Note viewed by patient Care Timeline  08/22   Admitted from ED 2144 08/25   Discharged 1644
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Haematocrit decreased, Haemoglobin decreased, Infectious pleural effusion, International normalised ratio increased
Clinical narrative: Inpatient Pharmacy Warfarin Anticoagulation Therapy Protocol Progress Note  SUBJECTIVE: Patient is a 72 Y male admitted on 8/22/2023 for Acute Hypoxic Respiratory Failure/ Covid 19 / PNA+RT MOD Effusion/S/P Heart Transplant Allergies: Vaccine, Cyclosporine, Fluoxetine, Gabapentin, Lisinopril, and Spironolactone   OBJECTIVE: Medication: Warfarin New Start Warfarin?  No  Duration/Expected Duration: Indefinite   Indication: DVT   Goal INR: 2 - 3   Warfarin Tabs at Home: 2mg Home Dose:  Sunday (mg): 2 MG Monday (mg): 2 MG Tuesday (mg): 2 MG Wednesday (mg): 2 MG Thursday (mg): 2 MG Friday (mg): 2 MG Saturday (mg): 2 MG   Managed by/To be managed by: Anticoagulation Clinic   Labs: Estimated body mass index is 22.99 kg/m² as calculated from the following:   Height as of this encounter: 1.778 m (5' 10").   Weight as of 6/22/23: 72.7 kg (160 lb 3.2 oz).  Recent Labs   08/24/23 0605 08/23/23 0727 08/22/23 1154 PT 31.9* 31.8* 30.6* INR 3.2 3.2 3.0      Recent Labs   08/24/23 0605 08/22/23 1154 HGB 9.8* 10.6* HCT 33.4* 36.0* PLT CONFIRMD | 125* | NORMAL 119* CR 2.39* 2.48*    Lab Results Component Value Date   ALT 26 08/24/2023   AST 24 08/24/2023   GGT 22 07/15/2020   ALKALINE PHOSPHATASE 55 08/24/2023   Bilirubin, total 0.3 08/24/2023   Amylase 66 01/26/2023   Lipase 83 08/22/2023   Inpatient Warfarin Dosing History:    Date INR Warfarin (dose) Diet (note diet changes, ex: NPO, low intake, tube feeds, etc) Comments 8/22/23 3.0 HOLD Low Na   8/23/23 3.2 HOLD Low Na   8/24/23 3.2 HOLD Low Na                         Major Drug-Drug Interactions (include start/stop dates): Recent Vitamin K? No Ceftriaxone, dexamethasone, doxycycline, remdesivir, prednisone   Significant comorbidities or disease states: Renal failure   ASSESSMENT Today's INR is supratherapeutic Signs/symptoms of bleeding noted by RN/MD?: No, per chart review   Pt was on warfarin prior to admission       1. Education/re-education provided? No, will attempt to educate over phone today as patient is COVID +.   PLAN 1) Will hold warfarin tonight because supratherapeutic INR 2) No bridging at this time.       3) Recheck PT/INR with AM Labs  4) Pharmacy to continue to monitor Per Protocol 5) Discharge planning: None at this time.                        Cosigned by: (Pharm.D.) at 8/24/2023  2:23 PM  Note Details  File Time 8/24/2023 12:23 PM Author Type (none) Status Signed Last Editor (none) Admit Date 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023   Revision History   Detailed Report  Note viewed by patient Care Timeline  08/22   Admitted from ED 2144 08/25   Discharged 1644
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lipase normal, Platelet count decreased, Pneumonia, Prothrombin time prolonged, Renal failure
Clinical narrative: Inpatient Pharmacy Warfarin Anticoagulation Therapy Protocol Progress Note  SUBJECTIVE: Patient is a 72 Y male admitted on 8/22/2023 for Acute Hypoxic Respiratory Failure/ Covid 19 / PNA+RT MOD Effusion/S/P Heart Transplant Allergies: Vaccine, Cyclosporine, Fluoxetine, Gabapentin, Lisinopril, and Spironolactone   OBJECTIVE: Medication: Warfarin New Start Warfarin?  No  Duration/Expected Duration: Indefinite   Indication: DVT   Goal INR: 2 - 3   Warfarin Tabs at Home: 2mg Home Dose:  Sunday (mg): 2 MG Monday (mg): 2 MG Tuesday (mg): 2 MG Wednesday (mg): 2 MG Thursday (mg): 2 MG Friday (mg): 2 MG Saturday (mg): 2 MG   Managed by/To be managed by: Anticoagulation Clinic   Labs: Estimated body mass index is 22.99 kg/m² as calculated from the following:   Height as of this encounter: 1.778 m (5' 10").   Weight as of 6/22/23: 72.7 kg (160 lb 3.2 oz).  Recent Labs   08/24/23 0605 08/23/23 0727 08/22/23 1154 PT 31.9* 31.8* 30.6* INR 3.2 3.2 3.0      Recent Labs   08/24/23 0605 08/22/23 1154 HGB 9.8* 10.6* HCT 33.4* 36.0* PLT CONFIRMD | 125* | NORMAL 119* CR 2.39* 2.48*    Lab Results Component Value Date   ALT 26 08/24/2023   AST 24 08/24/2023   GGT 22 07/15/2020   ALKALINE PHOSPHATASE 55 08/24/2023   Bilirubin, total 0.3 08/24/2023   Amylase 66 01/26/2023   Lipase 83 08/22/2023   Inpatient Warfarin Dosing History:    Date INR Warfarin (dose) Diet (note diet changes, ex: NPO, low intake, tube feeds, etc) Comments 8/22/23 3.0 HOLD Low Na   8/23/23 3.2 HOLD Low Na   8/24/23 3.2 HOLD Low Na                         Major Drug-Drug Interactions (include start/stop dates): Recent Vitamin K? No Ceftriaxone, dexamethasone, doxycycline, remdesivir, prednisone   Significant comorbidities or disease states: Renal failure   ASSESSMENT Today's INR is supratherapeutic Signs/symptoms of bleeding noted by RN/MD?: No, per chart review   Pt was on warfarin prior to admission       1. Education/re-education provided? No, will attempt to educate over phone today as patient is COVID +.   PLAN 1) Will hold warfarin tonight because supratherapeutic INR 2) No bridging at this time.       3) Recheck PT/INR with AM Labs  4) Pharmacy to continue to monitor Per Protocol 5) Discharge planning: None at this time.                        Cosigned by: (Pharm.D.) at 8/24/2023  2:23 PM  Note Details  File Time 8/24/2023 12:23 PM Author Type (none) Status Signed Last Editor (none) Admit Date 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023   Revision History   Detailed Report  Note viewed by patient Care Timeline  08/22   Admitted from ED 2144 08/25   Discharged 1644
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Inpatient Pharmacy Warfarin Anticoagulation Therapy Protocol Progress Note  SUBJECTIVE: Patient is a 72 Y male admitted on 8/22/2023 for Acute Hypoxic Respiratory Failure/ Covid 19 / PNA+RT MOD Effusion/S/P Heart Transplant Allergies: Vaccine, Cyclosporine, Fluoxetine, Gabapentin, Lisinopril, and Spironolactone   OBJECTIVE: Medication: Warfarin New Start Warfarin?  No  Duration/Expected Duration: Indefinite   Indication: DVT   Goal INR: 2 - 3   Warfarin Tabs at Home: 2mg Home Dose:  Sunday (mg): 2 MG Monday (mg): 2 MG Tuesday (mg): 2 MG Wednesday (mg): 2 MG Thursday (mg): 2 MG Friday (mg): 2 MG Saturday (mg): 2 MG   Managed by/To be managed by: Anticoagulation Clinic   Labs: Estimated body mass index is 22.99 kg/m² as calculated from the following:   Height as of this encounter: 1.778 m (5' 10").   Weight as of 6/22/23: 72.7 kg (160 lb 3.2 oz).  Recent Labs   08/24/23 0605 08/23/23 0727 08/22/23 1154 PT 31.9* 31.8* 30.6* INR 3.2 3.2 3.0      Recent Labs   08/24/23 0605 08/22/23 1154 HGB 9.8* 10.6* HCT 33.4* 36.0* PLT CONFIRMD | 125* | NORMAL 119* CR 2.39* 2.48*    Lab Results Component Value Date   ALT 26 08/24/2023   AST 24 08/24/2023   GGT 22 07/15/2020   ALKALINE PHOSPHATASE 55 08/24/2023   Bilirubin, total 0.3 08/24/2023   Amylase 66 01/26/2023   Lipase 83 08/22/2023   Inpatient Warfarin Dosing History:    Date INR Warfarin (dose) Diet (note diet changes, ex: NPO, low intake, tube feeds, etc) Comments 8/22/23 3.0 HOLD Low Na   8/23/23 3.2 HOLD Low Na   8/24/23 3.2 HOLD Low Na                         Major Drug-Drug Interactions (include start/stop dates): Recent Vitamin K? No Ceftriaxone, dexamethasone, doxycycline, remdesivir, prednisone   Significant comorbidities or disease states: Renal failure   ASSESSMENT Today's INR is supratherapeutic Signs/symptoms of bleeding noted by RN/MD?: No, per chart review   Pt was on warfarin prior to admission       1. Education/re-education provided? No, will attempt to educate over phone today as patient is COVID +.   PLAN 1) Will hold warfarin tonight because supratherapeutic INR 2) No bridging at this time.       3) Recheck PT/INR with AM Labs  4) Pharmacy to continue to monitor Per Protocol 5) Discharge planning: None at this time.                        Cosigned by: (Pharm.D.) at 8/24/2023  2:23 PM  Note Details  File Time 8/24/2023 12:23 PM Author Type (none) Status Signed Last Editor (none) Admit Date 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023   Revision History   Detailed Report  Note viewed by patient Care Timeline  08/22   Admitted from ED 2144 08/25   Discharged 1644
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Arthralgia, Arthritis, Asthenia, Blood test
Clinical narrative: nueroroligic damage throughout body manifests as inflamation of joints with debilitating pain and muscle spasms with electrical sensations affecting all major muscle areas - neck, upper back muscles, shoulder muscles, thighs, calves. Also the inflamation of joints at my extremities has resulted in me being unable to do basic self-care activites. I am home bound since April 2021 after the COVID-19 Phizer vaccine.  I also experienced about 5-6 months of delerium. Delirium is a serious change in mental abilities that results in confused thinking and a lack of awareness of someone?s surroundings.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carpal tunnel decompression, Computerised tomogram, Confusional state, Delirium, Elbow operation
Clinical narrative: nueroroligic damage throughout body manifests as inflamation of joints with debilitating pain and muscle spasms with electrical sensations affecting all major muscle areas - neck, upper back muscles, shoulder muscles, thighs, calves. Also the inflamation of joints at my extremities has resulted in me being unable to do basic self-care activites. I am home bound since April 2021 after the COVID-19 Phizer vaccine.  I also experienced about 5-6 months of delerium. Delirium is a serious change in mental abilities that results in confused thinking and a lack of awareness of someone?s surroundings.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Electrocardiogram, Housebound, Interleukin level, Loss of personal independence in daily activities
Clinical narrative: nueroroligic damage throughout body manifests as inflamation of joints with debilitating pain and muscle spasms with electrical sensations affecting all major muscle areas - neck, upper back muscles, shoulder muscles, thighs, calves. Also the inflamation of joints at my extremities has resulted in me being unable to do basic self-care activites. I am home bound since April 2021 after the COVID-19 Phizer vaccine.  I also experienced about 5-6 months of delerium. Delirium is a serious change in mental abilities that results in confused thinking and a lack of awareness of someone?s surroundings.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Myalgia, Neck pain, Nervous system disorder
Clinical narrative: nueroroligic damage throughout body manifests as inflamation of joints with debilitating pain and muscle spasms with electrical sensations affecting all major muscle areas - neck, upper back muscles, shoulder muscles, thighs, calves. Also the inflamation of joints at my extremities has resulted in me being unable to do basic self-care activites. I am home bound since April 2021 after the COVID-19 Phizer vaccine.  I also experienced about 5-6 months of delerium. Delirium is a serious change in mental abilities that results in confused thinking and a lack of awareness of someone?s surroundings.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Spinal nerve stimulator implantation, Thinking abnormal, X-ray
Clinical narrative: nueroroligic damage throughout body manifests as inflamation of joints with debilitating pain and muscle spasms with electrical sensations affecting all major muscle areas - neck, upper back muscles, shoulder muscles, thighs, calves. Also the inflamation of joints at my extremities has resulted in me being unable to do basic self-care activites. I am home bound since April 2021 after the COVID-19 Phizer vaccine.  I also experienced about 5-6 months of delerium. Delirium is a serious change in mental abilities that results in confused thinking and a lack of awareness of someone?s surroundings.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Resident was given a 2nd dose of the vaccine within an hour or 2
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: GIVEN ON 4/19/2023
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Electrocardiogram, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Noted to have red rash annular and expanding at injection site  Was warm to touch and painful with some swelling
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Rash erythematous
Clinical narrative: Noted to have red rash annular and expanding at injection site  Was warm to touch and painful with some swelling
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Small intestinal resection, Thrombectomy, Thrombosis
Clinical narrative: blood clot in abdomen 2 surgeries removal of blood clot and 4/5 of small intestine
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Investigation, Thrombosis
Clinical narrative: blood clot in abdomen 2 surgeries removal of blood clot and 4/5 of small intestine
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: blood clot in abdomen 2 surgeries removal of blood clot and 4/5 of small intestine
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: GIVEN AFTER 4/18/2023
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling & redness at injection site
Age: 12.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Patient received lower than authorized dose. Patient received Moderna COVID-19 vaccine, Bivalent for 6 months to 4 years of age. After error was identified, patient received Moderna COVID-19 vaccine, Bivalent for 12 years and older.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Brain fog, Deafness, Fatigue
Clinical narrative: A couple of days after the vaccine I woke up with terrible brain fog, muscle soreness, unable to move well, difficulty sitting up, getting out of bed.  Right hand was swollen and stiff.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: A couple of days after the vaccine I woke up with terrible brain fog, muscle soreness, unable to move well, difficulty sitting up, getting out of bed.  Right hand was swollen and stiff.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, PNC15, VARCEL
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Patient received an expired dose of ACTHIB vaccine on 08/29/2023. Upon reconciling vaccine inventory, Nurse Manager, discovered that the vaccine inventory count was not correct. After further review it was discovered that the incorrect lot number was selected for a vaccine administered on 08/29/2023. The actual vaccine lot that was administered was ACTHIB lot UJ796AA that expired on 08/12/2023. Sanofi has been contacted to determine if ACTHIB lot UJ796AA was still viable on 08/29/2023 and their response was no. Attempted to contact patient's mother on 08/30/2023 at 3pm using in house interpreter. Patient's mother did not answer, voicemail was left. Will continue to call patient's mother until contact is made.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given to patient who was 12 years old and not high risk
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: pain in arm
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given an adult dose of the hepatitis A vaccine, not pediatrics.
Age: 4.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: No adverse event
Clinical narrative: No signs and symptoms noted.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Headache, Injection site pain, Limb discomfort, Neck pain
Clinical narrative: I spoke with patient at 2:15 pm on 8/30/23, patient states that after she left clinic yesterday, her left arm started feeling full, as if her blood pressure was being taken. She also c/o pain/achiness to back of head and neck, left shoulder. She later felt as if she was chilled, so she took tylenol or ibuprofen, and went to bed. When she woke up on 8/30, she if feeling better.
Age: 4.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Vaccination site reaction
Clinical narrative: 3.5in circle around vaccine site
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial reaction was mild pain and swelling at the injection site.  That is normal for me; I took no medication.  However, by three days later pain and swelling had not subsided; I continued without medication.  By five days out, site remained swollen, red and was itching considerably; I used topical antihistamine.  Continues swollen and itching on sixth day; continue to use topical antihistamine.  This is totally abnormal for me.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Limb mass
Clinical narrative: lump on arm
Age: 66.0
Sex: M
Vaccine: FLU4, PNC20, TDAP
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Pain, X-ray
Clinical narrative: Difficulty rasing left arm in abduction and external rotation about 85 degrees. Pain began about 1 week after injection. Referred to orthopedic surgery. Orthopedic surgery referred to physical therapy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling in the right knee and upper thigh.
Age: 3.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event
Clinical narrative: Patient was given the pfizer bivalent covid vaccine for dose # 3. She had received the moderna vaccine for doses #1 and #2. She did not experience any adverse effects at time of administration.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient was in for a OB follow up and MA did not cross check all resources to see if patient had recieved Tdap prior. Patient had the Tdap vaccine at her 28 week OB appt. At the time of appt she was 32 weeks.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received initial dose 06/29/2022 at pharmacy, Second dose 11/01/2022 at pharmacy.  In error patient received additional dose 01/07/2023 at pharmacy. No adverse events have been reported. Error was discovered by utilizing database to search for recommended vaccinations.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Malaise, Nausea, Nervousness, Vomiting
Clinical narrative: The second dose was administered @ 1307 in the left deltoid. The employee initially experienced nausea. However, this symptom quickly recovered and she felt fine. Then the employee waited 15 minutes with no additional symptoms. At 1327 the employee became warm, shaky, nauseated and then began vomiting. She was provided with rest, ice packs, crackers and sports drink.  She continued to vomit and feel unwell. Therefore a call was placed @1452. We spoke with RN who recommended the employee apply self care at this.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Medical assistant reported that an expired PNEUMOVAX 23 was given to a patient on 8/15/2023.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 15-AUG-2023, the patient was administered with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) pre-filled syringe, lot number: U027357, expiration date: 25-MAR-2023 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AEs) were reported (no adverse event). No further information was provided. There was no product quality complaint (PQC).
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular, Varicella
Clinical narrative: diagnosed as Chickenpox; Severe vesicular rash started on face, neck, and arms, now everwhere.; pruritus; This non-serious case was reported by a consumer and described the occurrence of chickenpox in a 62-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had severe documented chickenpox at age 24.). Concomitant products included celecoxib (Celebrex), cetirizine and atenolol.   On 07-AUG-2023, the patient received Shingles vaccine. In AUG-2023, an unknown time after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: pruritus). On 16-AUG-2023, the patient experienced chickenpox (Verbatim: diagnosed as Chickenpox) and vesicular rash (Verbatim: Severe vesicular rash started on face, neck, and arms, now everwhere.).  The outcome of the chickenpox and vesicular rash were not resolved and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the chickenpox, vesicular rash and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the chickenpox, vesicular rash and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 20-AUG-2023 The Patient states that she had Severe vesicular rash started on face, neck, and arms, now everwhere,  The serious was reported as Intervention.  The patient had severe documented chickenpox at age 24.  The patient asked could not see how you could develop chickenpox from a dead virus.  The physician stated that the patient was contagious. No pain, but severe pruritus.  The reporter consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: limited range of motion in the injection site arm; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injected limb mobility decreased in a male patient who received Herpes zoster (Shingrix) (batch number YC5Y7) for prophylaxis.   On 27-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: limited range of motion in the injection site arm).  The outcome of the injected limb mobility decreased was not reported.   The reporter considered the injected limb mobility decreased to be possibly related to Shingrix.     The company considered the injected limb mobility decreased to be possibly related to Shingrix.   Additional Information: Receipt Date: 21-AUG-2023 It was reported that the patient had limited range of motion in the injection site arm. The patient said that it was a possibility but cannot be certain.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Papule, Pruritus, Rash
Clinical narrative: rash; Pruritic with erythematous fluid filled vesicle on right 4th digit; erythematous papules and vesicles on left side of shin, right cheek, and right side of chest; erythematous fluid filled vesicle on right 4th digit/vesicles on left side of shin, right cheek and right side of chest; erythematous papules; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix. In AUG-2023, less than a week after receiving Shingrix, the patient experienced pruritus (Verbatim: Pruritic with erythematous fluid filled vesicle on right 4th digit), papule (Verbatim: erythematous papules and vesicles on left side of shin, right cheek, and right side of chest), vesicles (Verbatim: erythematous fluid filled vesicle on right 4th digit/vesicles on left side of shin, right cheek and right side of chest) and erythema (Verbatim: erythematous papules ). On 17-AUG-2023, the patient experienced rash (Verbatim: rash).  The outcome of the rash, pruritus, papule, vesicles and erythema were not reported.   It was unknown if the reporter considered the rash, pruritus, papule, vesicles and erythema to be related to Shingrix.     It was unknown if the company considered the rash, pruritus, papule, vesicles and erythema to be related to Shingrix.   Additional Information: GSK receipt date: 21-Aug-2023 The patient received a dose of Shingirx at 8:30 am at local pharmacy (not in office).  The patient woke up next day of vaccination, with rash.  In August 2023, less than a week, pruritic with erythematous fluid filled vesicle on right 4th digit, erythematous papules and vesicles on left side of shin, right cheek, and right side of chest. Dose information was not given to the office. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Pain, Pain in extremity
Clinical narrative: Extremely fatigued; sore; Severe arm pain; Did not want to get out of bed; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue (Verbatim: Extremely fatigued), pain (Verbatim: sore), pain in arm (Verbatim: Severe arm pain) and bedridden (Verbatim: Did not want to get out of bed). The outcome of the fatigue, pain and bedridden were resolved (duration 2 days) and the outcome of the pain in arm was resolved (duration 36 hrs).   It was unknown if the reporter considered the fatigue, pain, pain in arm and bedridden to be related to Shingrix.     It was unknown if the company considered the fatigue, pain, pain in arm and bedridden to be related to Shingrix.   Additional Information: Receipt Date: 20-AUG-2023 The patient self reported severe arm pain for 24 to 36 hours following Shingrix vaccine. The patient stated that she was extremely fatigues and sore and did not want to get out of bed the day following her Shingrix vaccine. The patient was completely fine 2 days later.
Sex: U
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: had only a sore arm for 1 day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 18-AUG-2023, the patient received RSV vaccine. In AUG-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: had only a sore arm for 1 day).  In AUG-2023, the outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: Receipt Date: 20-AUG-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated on Friday and had only a sore arm for 1 day.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 21-AUG-2023 The pharmacist reported that a female patient received first dose of Shingrix in 2018 but never received the second dose. The first dose was administered at a different location, so exact date and lot number and expiration date information was not available to the pharmacist. No additional dosing had yet been administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo powder vial mixed with MMR Merck diluent vial or with sterile; received Menveo powder vial mixed with MMR Merck diluent vial or with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva9468, expiry date 31-JUL-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Menveo powder vial mixed with MMR Merck diluent vial or with sterile) and inappropriate dose of vaccine administered (Verbatim: received Menveo powder vial mixed with MMR Merck diluent vial or with sterile water ).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 22-Aug-2023 The reporter had just found it an empty box of Menveo with only one liquid conjugated component of Menveo left.  It looks like one unknown patient received Menveo powder vial mixed with MMR Merck diluent vial or with sterile water. The reporter consented to follow-up. The patient received Menveo vaccine which was reconstituted with non-approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix a few years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose few years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix a few years ago).The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 22-AUG-2023 The reporter called to report that a patient over 70 years of age received the first dose of Shingrix a few years ago, although they were unsure if it had been Zostavax and wished to know how to proceed.  The information about the event, vaccine and patient was scarce and was not provided as the provider mentioned they had not received consent from the patient. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 922YF, expiry date 07-MAY-2025) for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 97MR2, expiry date 11-OCT-2025) for prophylaxis.   In AUG-2023, the patient received Twinrix, Shingrix and Boostrix. In AUG-2023, an unknown time after receiving Twinrix, Shingrix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion).The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-AUG-2023 The reporter called to inform that on the month of August, Twinrix, Boostrix, and Shingrix were in an excursion where they were exposed to a temperature of 59.0 degree F that lasted 240 hours and all three products had been inadvertently administered to an unknown number of patients during the month , which led to incorrect storage of vaccine. The reporter was informed that GlaxoSmithKline had no data to support the stability of such products  Since in the facility they did not know that the products were not supported. The Vaccine Administration Facility was the same as primary reporter. The reporter did not have any details since the number of patients that received doses from the lot numbers that were in the excursion was unknown. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received first dose of Shingrix on 30May2018; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th May 2018, batch number:ZY3X4 and expiry date: 28th April 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received first dose of Shingrix on 30May2018).The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date:23-AUG-2023 The reporter reported that patient due to loss of insurance coverage did not receive the second dose of Shingrix. He would now like to receive another dose, but at the time of reporting it had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Possible late 2nd dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late 2nd dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: Receipt date: 23-AUG-2023 Possible late 2nd dose reported on behalf of provider by sales representative. The vaccine administration facility is the same as primary reporter. No other adverse event (AE) details made available. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.