chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Chills (no fever), sore throat, runny nose, cough, headache, muscle aches. All symptoms started shortly after 8 am and continued throughout the day until bedtime. Took DayQuil, Ibuprofen, Tylenol, slept, and increased fluids. Symptom management helped, especially extra sleep.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea
Clinical narrative: Chills (no fever), sore throat, runny nose, cough, headache, muscle aches. All symptoms started shortly after 8 am and continued throughout the day until bedtime. Took DayQuil, Ibuprofen, Tylenol, slept, and increased fluids. Symptom management helped, especially extra sleep.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Loss of smell
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: fever 102 degrees, headache, chills, nausea, fatigue, loss of appetite, 48 hours tylenol
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: fever 102 degrees, headache, chills, nausea, fatigue, loss of appetite, 48 hours tylenol
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Urticaria
Clinical narrative: Generalized hives. Lasting about 30 minutes when going away. Ranging from 1 inch to 4-5 inches. On eyes, shoulders,  thighs, legs, knees and elbows. Becoming more frequent for 24 hours
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Echocardiogram, Electrocardiogram
Clinical narrative: Nausea, fainting x 2
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Syncope
Clinical narrative: Nausea, fainting x 2
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Incorrect product formulation administered
Clinical narrative: Pt was given PFizer Bivalent on 10/11/22 and then was given a second Pfizer Bivalent on 11/7/22
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Diet refusal, Influenza virus test negative, Pyrexia
Clinical narrative: Developed low grade fever a couple of hours after vaccines. Refusal to eat and vomiting. Hospitalized, IV fluids and ton monitoring. Hospitalized until eating again and vomiting resolved.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Developed low grade fever a couple of hours after vaccines. Refusal to eat and vomiting. Hospitalized, IV fluids and ton monitoring. Hospitalized until eating again and vomiting resolved.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Anticoagulant therapy, Blood creatinine increased, COVID-19
Clinical narrative: Patient is a 82 y.o. male patient of MD presented with seizure, HTN, DM, CAD, s/p stent, CKD, lung cancer who presented with acute encephalopathy, needed to be intubated for airway protection and was admitted to ICU. Pt transferred to intermediate floor after extubation.   Acute on chronic respiratory failure - resolved Possible CAP Intubated for airway protection CXR on 10/24 showed streaked opacities in the RUL Extubated 10/25 to nasal cannula Doing well now on room air Sputum culture grew E coli, switched from cefepime to iv ampicillin. Changed to po amoxicillin  ID following   Covid-19 Virus Infection Date of onset of symptoms: unknown Symptoms present on admission: none Date of covid positive test: 10/22/2022 Vaccination status: vaccinated Imaging: CXR - streaky RUL opacities Oxygen requirements on admission: intubated for airway protection for seizures; quickly weaned to room air Current oxygen requirements: room air Medical therapy: steroids Consultants following: ID Special isolation to be discontinued today   Seizure-like activity Acute ischemic stroke Developed acute onset right hemiparesis 10/25 which rapidly improved MRI  of the brain was notable for a very small right corona radiata infarct which would not explain his symptoms of altered mental status or right hemiparesis No epileptiform changes on EEG Continue Keppra On Plavix and ASA for 21 days then discontinue ASA Cervical MRI shows no cervical stenosis; plan for outpatient EMG to better assess upper extremity weakness F/u outpatient in Stroke Prevention clinic    Acute metabolic encephalopathy Likely ICU/hospital-acquired delirium Delirium precautions in place improved   AKI on CKD - improving Fluid resuscitation Gabapentin may be affecting encephalopathy in AKI and reduced GFR Likely ATN from infection Avoid nephrotoxic medications Nephrology following. Cr 2.06<1.89<1.9<1.58 today ( baseline 1.5) Cr improving daily  DM type II, uncontrolled Accu-Cheks with coverage
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral infarction, Chest X-ray abnormal, Chronic kidney disease, Condition aggravated, Diabetes mellitus inadequate control
Clinical narrative: Patient is a 82 y.o. male patient of MD presented with seizure, HTN, DM, CAD, s/p stent, CKD, lung cancer who presented with acute encephalopathy, needed to be intubated for airway protection and was admitted to ICU. Pt transferred to intermediate floor after extubation.   Acute on chronic respiratory failure - resolved Possible CAP Intubated for airway protection CXR on 10/24 showed streaked opacities in the RUL Extubated 10/25 to nasal cannula Doing well now on room air Sputum culture grew E coli, switched from cefepime to iv ampicillin. Changed to po amoxicillin  ID following   Covid-19 Virus Infection Date of onset of symptoms: unknown Symptoms present on admission: none Date of covid positive test: 10/22/2022 Vaccination status: vaccinated Imaging: CXR - streaky RUL opacities Oxygen requirements on admission: intubated for airway protection for seizures; quickly weaned to room air Current oxygen requirements: room air Medical therapy: steroids Consultants following: ID Special isolation to be discontinued today   Seizure-like activity Acute ischemic stroke Developed acute onset right hemiparesis 10/25 which rapidly improved MRI  of the brain was notable for a very small right corona radiata infarct which would not explain his symptoms of altered mental status or right hemiparesis No epileptiform changes on EEG Continue Keppra On Plavix and ASA for 21 days then discontinue ASA Cervical MRI shows no cervical stenosis; plan for outpatient EMG to better assess upper extremity weakness F/u outpatient in Stroke Prevention clinic    Acute metabolic encephalopathy Likely ICU/hospital-acquired delirium Delirium precautions in place improved   AKI on CKD - improving Fluid resuscitation Gabapentin may be affecting encephalopathy in AKI and reduced GFR Likely ATN from infection Avoid nephrotoxic medications Nephrology following. Cr 2.06<1.89<1.9<1.58 today ( baseline 1.5) Cr improving daily  DM type II, uncontrolled Accu-Cheks with coverage
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Encephalopathy, Endotracheal intubation, Escherichia test positive, Glomerular filtration rate decreased
Clinical narrative: Patient is a 82 y.o. male patient of MD presented with seizure, HTN, DM, CAD, s/p stent, CKD, lung cancer who presented with acute encephalopathy, needed to be intubated for airway protection and was admitted to ICU. Pt transferred to intermediate floor after extubation.   Acute on chronic respiratory failure - resolved Possible CAP Intubated for airway protection CXR on 10/24 showed streaked opacities in the RUL Extubated 10/25 to nasal cannula Doing well now on room air Sputum culture grew E coli, switched from cefepime to iv ampicillin. Changed to po amoxicillin  ID following   Covid-19 Virus Infection Date of onset of symptoms: unknown Symptoms present on admission: none Date of covid positive test: 10/22/2022 Vaccination status: vaccinated Imaging: CXR - streaky RUL opacities Oxygen requirements on admission: intubated for airway protection for seizures; quickly weaned to room air Current oxygen requirements: room air Medical therapy: steroids Consultants following: ID Special isolation to be discontinued today   Seizure-like activity Acute ischemic stroke Developed acute onset right hemiparesis 10/25 which rapidly improved MRI  of the brain was notable for a very small right corona radiata infarct which would not explain his symptoms of altered mental status or right hemiparesis No epileptiform changes on EEG Continue Keppra On Plavix and ASA for 21 days then discontinue ASA Cervical MRI shows no cervical stenosis; plan for outpatient EMG to better assess upper extremity weakness F/u outpatient in Stroke Prevention clinic    Acute metabolic encephalopathy Likely ICU/hospital-acquired delirium Delirium precautions in place improved   AKI on CKD - improving Fluid resuscitation Gabapentin may be affecting encephalopathy in AKI and reduced GFR Likely ATN from infection Avoid nephrotoxic medications Nephrology following. Cr 2.06<1.89<1.9<1.58 today ( baseline 1.5) Cr improving daily  DM type II, uncontrolled Accu-Cheks with coverage
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiparesis, Infection, Intensive care, Intensive care unit delirium, Ischaemic stroke
Clinical narrative: Patient is a 82 y.o. male patient of MD presented with seizure, HTN, DM, CAD, s/p stent, CKD, lung cancer who presented with acute encephalopathy, needed to be intubated for airway protection and was admitted to ICU. Pt transferred to intermediate floor after extubation.   Acute on chronic respiratory failure - resolved Possible CAP Intubated for airway protection CXR on 10/24 showed streaked opacities in the RUL Extubated 10/25 to nasal cannula Doing well now on room air Sputum culture grew E coli, switched from cefepime to iv ampicillin. Changed to po amoxicillin  ID following   Covid-19 Virus Infection Date of onset of symptoms: unknown Symptoms present on admission: none Date of covid positive test: 10/22/2022 Vaccination status: vaccinated Imaging: CXR - streaky RUL opacities Oxygen requirements on admission: intubated for airway protection for seizures; quickly weaned to room air Current oxygen requirements: room air Medical therapy: steroids Consultants following: ID Special isolation to be discontinued today   Seizure-like activity Acute ischemic stroke Developed acute onset right hemiparesis 10/25 which rapidly improved MRI  of the brain was notable for a very small right corona radiata infarct which would not explain his symptoms of altered mental status or right hemiparesis No epileptiform changes on EEG Continue Keppra On Plavix and ASA for 21 days then discontinue ASA Cervical MRI shows no cervical stenosis; plan for outpatient EMG to better assess upper extremity weakness F/u outpatient in Stroke Prevention clinic    Acute metabolic encephalopathy Likely ICU/hospital-acquired delirium Delirium precautions in place improved   AKI on CKD - improving Fluid resuscitation Gabapentin may be affecting encephalopathy in AKI and reduced GFR Likely ATN from infection Avoid nephrotoxic medications Nephrology following. Cr 2.06<1.89<1.9<1.58 today ( baseline 1.5) Cr improving daily  DM type II, uncontrolled Accu-Cheks with coverage
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck, Mental status changes, Metabolic encephalopathy
Clinical narrative: Patient is a 82 y.o. male patient of MD presented with seizure, HTN, DM, CAD, s/p stent, CKD, lung cancer who presented with acute encephalopathy, needed to be intubated for airway protection and was admitted to ICU. Pt transferred to intermediate floor after extubation.   Acute on chronic respiratory failure - resolved Possible CAP Intubated for airway protection CXR on 10/24 showed streaked opacities in the RUL Extubated 10/25 to nasal cannula Doing well now on room air Sputum culture grew E coli, switched from cefepime to iv ampicillin. Changed to po amoxicillin  ID following   Covid-19 Virus Infection Date of onset of symptoms: unknown Symptoms present on admission: none Date of covid positive test: 10/22/2022 Vaccination status: vaccinated Imaging: CXR - streaky RUL opacities Oxygen requirements on admission: intubated for airway protection for seizures; quickly weaned to room air Current oxygen requirements: room air Medical therapy: steroids Consultants following: ID Special isolation to be discontinued today   Seizure-like activity Acute ischemic stroke Developed acute onset right hemiparesis 10/25 which rapidly improved MRI  of the brain was notable for a very small right corona radiata infarct which would not explain his symptoms of altered mental status or right hemiparesis No epileptiform changes on EEG Continue Keppra On Plavix and ASA for 21 days then discontinue ASA Cervical MRI shows no cervical stenosis; plan for outpatient EMG to better assess upper extremity weakness F/u outpatient in Stroke Prevention clinic    Acute metabolic encephalopathy Likely ICU/hospital-acquired delirium Delirium precautions in place improved   AKI on CKD - improving Fluid resuscitation Gabapentin may be affecting encephalopathy in AKI and reduced GFR Likely ATN from infection Avoid nephrotoxic medications Nephrology following. Cr 2.06<1.89<1.9<1.58 today ( baseline 1.5) Cr improving daily  DM type II, uncontrolled Accu-Cheks with coverage
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Renal tubular necrosis, SARS-CoV-2 test positive, Seizure, Seizure like phenomena
Clinical narrative: Patient is a 82 y.o. male patient of MD presented with seizure, HTN, DM, CAD, s/p stent, CKD, lung cancer who presented with acute encephalopathy, needed to be intubated for airway protection and was admitted to ICU. Pt transferred to intermediate floor after extubation.   Acute on chronic respiratory failure - resolved Possible CAP Intubated for airway protection CXR on 10/24 showed streaked opacities in the RUL Extubated 10/25 to nasal cannula Doing well now on room air Sputum culture grew E coli, switched from cefepime to iv ampicillin. Changed to po amoxicillin  ID following   Covid-19 Virus Infection Date of onset of symptoms: unknown Symptoms present on admission: none Date of covid positive test: 10/22/2022 Vaccination status: vaccinated Imaging: CXR - streaky RUL opacities Oxygen requirements on admission: intubated for airway protection for seizures; quickly weaned to room air Current oxygen requirements: room air Medical therapy: steroids Consultants following: ID Special isolation to be discontinued today   Seizure-like activity Acute ischemic stroke Developed acute onset right hemiparesis 10/25 which rapidly improved MRI  of the brain was notable for a very small right corona radiata infarct which would not explain his symptoms of altered mental status or right hemiparesis No epileptiform changes on EEG Continue Keppra On Plavix and ASA for 21 days then discontinue ASA Cervical MRI shows no cervical stenosis; plan for outpatient EMG to better assess upper extremity weakness F/u outpatient in Stroke Prevention clinic    Acute metabolic encephalopathy Likely ICU/hospital-acquired delirium Delirium precautions in place improved   AKI on CKD - improving Fluid resuscitation Gabapentin may be affecting encephalopathy in AKI and reduced GFR Likely ATN from infection Avoid nephrotoxic medications Nephrology following. Cr 2.06<1.89<1.9<1.58 today ( baseline 1.5) Cr improving daily  DM type II, uncontrolled Accu-Cheks with coverage
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Sputum culture positive
Clinical narrative: Patient is a 82 y.o. male patient of MD presented with seizure, HTN, DM, CAD, s/p stent, CKD, lung cancer who presented with acute encephalopathy, needed to be intubated for airway protection and was admitted to ICU. Pt transferred to intermediate floor after extubation.   Acute on chronic respiratory failure - resolved Possible CAP Intubated for airway protection CXR on 10/24 showed streaked opacities in the RUL Extubated 10/25 to nasal cannula Doing well now on room air Sputum culture grew E coli, switched from cefepime to iv ampicillin. Changed to po amoxicillin  ID following   Covid-19 Virus Infection Date of onset of symptoms: unknown Symptoms present on admission: none Date of covid positive test: 10/22/2022 Vaccination status: vaccinated Imaging: CXR - streaky RUL opacities Oxygen requirements on admission: intubated for airway protection for seizures; quickly weaned to room air Current oxygen requirements: room air Medical therapy: steroids Consultants following: ID Special isolation to be discontinued today   Seizure-like activity Acute ischemic stroke Developed acute onset right hemiparesis 10/25 which rapidly improved MRI  of the brain was notable for a very small right corona radiata infarct which would not explain his symptoms of altered mental status or right hemiparesis No epileptiform changes on EEG Continue Keppra On Plavix and ASA for 21 days then discontinue ASA Cervical MRI shows no cervical stenosis; plan for outpatient EMG to better assess upper extremity weakness F/u outpatient in Stroke Prevention clinic    Acute metabolic encephalopathy Likely ICU/hospital-acquired delirium Delirium precautions in place improved   AKI on CKD - improving Fluid resuscitation Gabapentin may be affecting encephalopathy in AKI and reduced GFR Likely ATN from infection Avoid nephrotoxic medications Nephrology following. Cr 2.06<1.89<1.9<1.58 today ( baseline 1.5) Cr improving daily  DM type II, uncontrolled Accu-Cheks with coverage
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Immunisation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: patient experienced numbness/pain and discomfort the day after vaccination (12/15/2021).  Symptoms persisted until late January 2022.  Patient re-experienced symptoms of stiffness/pain in September 2022.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: patient experienced numbness/pain and discomfort the day after vaccination (12/15/2021).  Symptoms persisted until late January 2022.  Patient re-experienced symptoms of stiffness/pain in September 2022.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Hypoaesthesia, Musculoskeletal stiffness, Pain
Clinical narrative: patient experienced numbness/pain and discomfort the day after vaccination (12/15/2021).  Symptoms persisted until late January 2022.  Patient re-experienced symptoms of stiffness/pain in September 2022.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain
Clinical narrative: She got her vaccine, it was real painful in her shoulder, squished the arm real tight, big guy.  It was like somebody had hit her in the shoulder.  Later in the day it would go to fire feeling, down her arm, inside of her arm and shoot through her lower arm into her thumb on the left side.  Now it does not go down to the thumb very often, now goes from shoulder area to elbow area.  If she turns her head to the right when she is having this reaction it eases up.  You cannot see anything physically wrong, electrical shock like feeling down her arm.  She did go to the doctor and he checked the area and felt it was a nerve in her neck that she injured 30 years ago, but feels like it was acting up again.  She cannot walk around with her head tilted to the right at all times.  It does come and go, and does have to grab her arm.  It is better, but it still comes on on occasion.    It is not her heart or any other area, just in the area where she got the vaccine.  She can move the arm all around, can use the hand, but has the shooting pain in the shoulder.  Feels he may have hit a nerve.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Electric shock sensation, Injection site pain, Pain
Clinical narrative: She got her vaccine, it was real painful in her shoulder, squished the arm real tight, big guy.  It was like somebody had hit her in the shoulder.  Later in the day it would go to fire feeling, down her arm, inside of her arm and shoot through her lower arm into her thumb on the left side.  Now it does not go down to the thumb very often, now goes from shoulder area to elbow area.  If she turns her head to the right when she is having this reaction it eases up.  You cannot see anything physically wrong, electrical shock like feeling down her arm.  She did go to the doctor and he checked the area and felt it was a nerve in her neck that she injured 30 years ago, but feels like it was acting up again.  She cannot walk around with her head tilted to the right at all times.  It does come and go, and does have to grab her arm.  It is better, but it still comes on on occasion.    It is not her heart or any other area, just in the area where she got the vaccine.  She can move the arm all around, can use the hand, but has the shooting pain in the shoulder.  Feels he may have hit a nerve.
Age: 55.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immunisation reaction, Myalgia, Pain, Tenderness
Clinical narrative: Generalized soreness deep in R arm developed approximately 1 week post vaccine. Vaccine given in left deltoid. Continues soreness after 3 weeks (4 weeks post vaccine) PCP diagnosed pain as post-vaccine reaction
Age: 55.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immunisation reaction, Pain in extremity
Clinical narrative: Generalized soreness deep in R arm developed approximately 1 week post vaccine. Vaccine given in left deltoid. Continues soreness after 3 weeks (4 weeks post vaccine) PCP diagnosed pain as post-vaccine reaction
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Ischaemic stroke, Lacunar stroke, Magnetic resonance imaging head abnormal, Muscular weakness
Clinical narrative: Right lacunar ischemic stroke - left arm, hand and leg weakness; Right lacunar ischemic stroke - left arm, hand and leg weakness; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 18:30 as dose 4 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Degenerative spinal disease" (unspecified if ongoing). Prior to vaccination, the patient did not have COVID. Concomitant medication(s) included: BENTYL; CALCIUM. The patient did not receive other vaccine within four weeks. Past drug history included: Celebrex, reaction(s): "Known allergies: Celebrex", notes: Known allergies: Celebrex. Vaccination history included: BNT162b2 (Dose Number: 1 (DOSE 1, SINGLE ), Batch/Lot No: EL8982, Location of injection: Arm Left), administration date: 22Jan2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2 (DOSE 2, SINGLE ), Batch/Lot No: FL9262, Location of injection: Arm Left), administration date: 12Feb2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3 (DOSE 3 (BOOSTER), SINGLE), Batch/Lot No: FC3184, Location of injection: Arm Left), administration date: 12Oct2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: LACUNAR STROKE (hospitalization), MUSCULAR WEAKNESS (hospitalization) all with onset 15Oct2022 at 09:00, outcome "recovering" and all described as "Right lacunar ischemic stroke - left arm, hand and leg weakness". The patient was hospitalized for lacunar stroke, muscular weakness (hospitalization duration: 4 day(s)). The events "right lacunar ischemic stroke - left arm, hand and leg weakness" required emergency room visit. Therapeutic measures were taken as a result of lacunar stroke, muscular weakness reported as medications and therapy. The patient was not tested for COVID post-vaccination.
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Lacunar stroke, Muscular weakness
Clinical narrative: Right lacunar ischemic stroke - left arm, hand and leg weakness; Right lacunar ischemic stroke - left arm, hand and leg weakness; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 18:30 as dose 4 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Degenerative spinal disease" (unspecified if ongoing). Prior to vaccination, the patient did not have COVID. Concomitant medication(s) included: BENTYL; CALCIUM. The patient did not receive other vaccine within four weeks. Past drug history included: Celebrex, reaction(s): "Known allergies: Celebrex", notes: Known allergies: Celebrex. Vaccination history included: BNT162b2 (Dose Number: 1 (DOSE 1, SINGLE ), Batch/Lot No: EL8982, Location of injection: Arm Left), administration date: 22Jan2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2 (DOSE 2, SINGLE ), Batch/Lot No: FL9262, Location of injection: Arm Left), administration date: 12Feb2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3 (DOSE 3 (BOOSTER), SINGLE), Batch/Lot No: FC3184, Location of injection: Arm Left), administration date: 12Oct2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: LACUNAR STROKE (hospitalization), MUSCULAR WEAKNESS (hospitalization) all with onset 15Oct2022 at 09:00, outcome "recovering" and all described as "Right lacunar ischemic stroke - left arm, hand and leg weakness". The patient was hospitalized for lacunar stroke, muscular weakness (hospitalization duration: 4 day(s)). The events "right lacunar ischemic stroke - left arm, hand and leg weakness" required emergency room visit. Therapeutic measures were taken as a result of lacunar stroke, muscular weakness reported as medications and therapy. The patient was not tested for COVID post-vaccination.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event; Office manager reports that MMR II was administered to three patients after the product's expiration date. Office manager confirms the product was stored appropriately prior to administration and had no temperature excursions. HCP came onto the line; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II)  (expired product administered) 0.5 milliliter, lot #T029549, expiration date reported as 01-SEP-2022, but upon internal validation was established as 10-SEP-2022 (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. The reporter stated that the product was stored appropriately and had no temperature excursion prior administration. No adverse event was reported.  This is one of three cases reported by the same reporter.; Sender's Comments:  US-009507513-2210USA010243:AE report #: 02276158 US-009507513-2210USA010287:
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: "Patient started therapy with PNEUMOVAX 23 for pneumonia. Patient experienced swelling."; "Patient started therapy with PNEUMOVAX 23 for pneumonia.; This spontaneous report was received from a consumer and refers to a male patient. The patients' medical history, concurrent conditions, concomitant therapies were not provided.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for pneumonia (strength, dose description, lot number, expiry date, and route of administration were not provided) (product use in unapproved indication).  On an unknown date, the patient experienced swelling. The outcome of the event was reported as unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and swelling was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 on  AUG2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for COVID-19 on  AUG2022) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 011M20A, 012L20A and 064FC21A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Dust allergy and Allergy.   On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In August 2022, the patient experienced COVID-19 (Patient tested positive for COVID-19 on  AUG2022). At the time of the report, COVID-19 (Patient tested positive for COVID-19 on  AUG2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Positive.         No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided. Patient had received all Moderna doses in the past and never had any issues Patient said that she had a history of asthma, but she has never had a reaction like this to anything. No treatment medications were reported.   This case was linked to MOD-2022-669812 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Temperature excursion product administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     The patient had no allergies.  It was unknown that the patient ever been diagnosed or tested positive for COVID-19.     On 26-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient).    No concomitant medication was provided.  On an unknown date, the patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses.  The patient had received dose 4 on deltoid body site.   Date vial was moved from freezer to refrigerator on 7-Sep-2022.  The refrigeration excursions identified; state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic where was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2022 at 5:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    It was unknown if the patient ever been diagnosed with or tested positive for COVID-19. No concomitant medication were reported.  Patient took second, third and fourth dose through intramuscularly at deltoid region. The vaccines were stored in the Refrigerator. There were 2 unbroken cartons with 20 vials. The vials of both monovalent vaccines were moved from freezer to refrigerator on 07-Sep-2022. All the vials were not visualized. The patient administered the vaccine in the deltoid (unspecified location) muscle. Refridgeration excursions identified, state vaccine was housed in these units. There were excursions noted.         No treatment information was provided by the reporter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; Patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022 at 2:13 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Sep-2022 at 2:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    Concomitant product use was not provided by the reporter.  Dose 4 anatomical site was also reported as deltoid.  It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the local department was made aware of the situation.  No adverse reactions were reported for patient at the time of the report.  Treatment information was not provided.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient was administered vaccine which had undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; Dose/volume:0.25; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), ACCIDENTAL UNDERDOSE (Dose/volume:0.25) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Sep-2022 at 4:02 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and ACCIDENTAL UNDERDOSE (Dose/volume:0.25). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), ACCIDENTAL UNDERDOSE (Dose/volume:0.25) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and ACCIDENTAL UNDERDOSE (Dose/volume:0.25).    No concomitant medication was provided.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  Date vial was moved from freezer to refrigerator on 7-Sep-2022.   It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Decreased appetite, Myalgia, Nasopharyngitis
Clinical narrative: Felt cold; No appetite through the weekend/Didn't eat for 3 days.; stayed in bed on Saturday and Sunday; Muscles ached; chills; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Felt cold), DECREASED APPETITE (No appetite through the weekend/Didn't eat for 3 days.), BEDRIDDEN (stayed in bed on Saturday and Sunday), MYALGIA (Muscles ached) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced NASOPHARYNGITIS (Felt cold), DECREASED APPETITE (No appetite through the weekend/Didn't eat for 3 days.), BEDRIDDEN (stayed in bed on Saturday and Sunday), MYALGIA (Muscles ached) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (Felt cold), DECREASED APPETITE (No appetite through the weekend/Didn't eat for 3 days.), BEDRIDDEN (stayed in bed on Saturday and Sunday), MYALGIA (Muscles ached) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. On 10-MAR-2021, the patient received first dose of Moderna vaccine (Lot number 001B21A). Patient reported no Adverse Reactions. On 7-APR-2021, the patient received second dose of Moderna vaccine (Lot number 026B21A). Patient reported no Adverse Reactions. On 21-DEC-2021, the patient received first Moderna COVID 19 vaccine booster dose(Lot number 069H21A). Patient reported no Adverse Reactions. On 02-JUN-2022, the patient received second Moderna COVID 19 vaccine booster dose(Lot number 056M21A). Patient reported no Adverse Reactions. No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient was administered vaccine which had undergone several temperature excursions.; No Adverse Event; patient was administered vaccine which had undergone several temperature excursions.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No Adverse Event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if  the patient ever been diagnosed with/ tested positive for COVID-19.     On 23-Sep-2022 at 11:54 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.).    Concomitant product use was not provided by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Vials were moved from freezer to refrigerator on 7SEP2022 It was reported that Refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation.  The vial size was reported as 5.5ml.  Treatment information was not provided.