chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear congestion, Eustachian tube disorder, Head discomfort, Magnetic resonance imaging abnormal
Clinical narrative: ear congestion, sensation of fullness in head, dizziness, vertigo, and tinnitus
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: ear congestion, sensation of fullness in head, dizziness, vertigo, and tinnitus
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: fever, aches, sore throat
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Cough, Dizziness, Electrocardiogram
Clinical narrative: I received the NOVAVAX Booster on October 27, 2022.  Around the  20th of November, fatigue, upper respiratory symptoms, fever, sore throat, and severe pain in the throat were felt.  Some of the symptoms were not so problematic at first, but around end of Dec holiday time, I was rushed to the emergency room due to severe pain in the throat, on-and-off fever, fatigue,  severe coughing, and dizziness.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza virus test, Magnetic resonance imaging, Oropharyngeal pain, Pyrexia
Clinical narrative: I received the NOVAVAX Booster on October 27, 2022.  Around the  20th of November, fatigue, upper respiratory symptoms, fever, sore throat, and severe pain in the throat were felt.  Some of the symptoms were not so problematic at first, but around end of Dec holiday time, I was rushed to the emergency room due to severe pain in the throat, on-and-off fever, fatigue,  severe coughing, and dizziness.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory symptom, Respiratory syncytial virus test, SARS-CoV-2 test, Streptococcus test, Urine analysis
Clinical narrative: I received the NOVAVAX Booster on October 27, 2022.  Around the  20th of November, fatigue, upper respiratory symptoms, fever, sore throat, and severe pain in the throat were felt.  Some of the symptoms were not so problematic at first, but around end of Dec holiday time, I was rushed to the emergency room due to severe pain in the throat, on-and-off fever, fatigue,  severe coughing, and dizziness.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I received the NOVAVAX Booster on October 27, 2022.  Around the  20th of November, fatigue, upper respiratory symptoms, fever, sore throat, and severe pain in the throat were felt.  Some of the symptoms were not so problematic at first, but around end of Dec holiday time, I was rushed to the emergency room due to severe pain in the throat, on-and-off fever, fatigue,  severe coughing, and dizziness.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects--72 day temperature was 1/12/23 so vaccine was expired
Age: 9.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Flushing, Rash, Rhinorrhoea, Stridor
Clinical narrative: face/body rash, face flushing, rhinorrhea, mild stridor and shortness of breath
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event, Viral titre
Clinical narrative: Patient received 1 Hepatitis B vaccine however, patient is immune to hepatitis B.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects--72 day temperature was 1/12/23 so vaccine was expired
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Cyanosis, Dizziness, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Started feeling tinnitus, lightheadedness, blue lips, blurry vision, fainting. All occurred in less than 5 minutes. Gained consciousness in less than a minute. Blood pressure and oxygenation were monitored after fainting spell. Blood pressure remained low for about an hour after incident.
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Started feeling tinnitus, lightheadedness, blue lips, blurry vision, fainting. All occurred in less than 5 minutes. Gained consciousness in less than a minute. Blood pressure and oxygenation were monitored after fainting spell. Blood pressure remained low for about an hour after incident.
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Blood pressure measurement, Cyanosis, Syncope, Tinnitus
Clinical narrative: Started feeling tinnitus, lightheadedness, blue lips, blurry vision, fainting. All occurred in less than 5 minutes. Gained consciousness in less than a minute. Blood pressure and oxygenation were monitored after fainting spell. Blood pressure remained low for about an hour after incident.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Grabbed MMRV out of freezer instead of just MMR.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects--72 day temperature was 1/12/23 so vaccine was expired
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the Bivalent dose as the 1st dose in their primary series.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects--72 day temperature was 1/12/23 so vaccine was expired
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, COVID-19 pneumonia, Emphysematous cystitis
Clinical narrative: Patient received Moderna COVID vaccine on 4/3/21 (lot # 026B21A), 5/1/21 (lot # 021C21A), and Pfizer COVID vaccine on 12/7/21 (lot # 33030BD). On 2/9/23, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 pneumonia, leukocytosis and emphysematous cystitis related to her Crohn's disease, and AKI on CKD. Patient discharged home on 2/13/23.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Leukocytosis, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 4/3/21 (lot # 026B21A), 5/1/21 (lot # 021C21A), and Pfizer COVID vaccine on 12/7/21 (lot # 33030BD). On 2/9/23, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 pneumonia, leukocytosis and emphysematous cystitis related to her Crohn's disease, and AKI on CKD. Patient discharged home on 2/13/23.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Muscle tightness, Pain
Clinical narrative: Patient received a dose of pneumovax23 on 11/29/2022; She received another dose on 2/10/23. On 2/11/23 she started experiencing pain, redness and muscle tightness (says unable to move the arm) and the symptoms continued after. she says it doesnt seem to be getting worse but is not getting much better either.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Mistakenly given a second Pfizer Bivalent Booster on 2/15/2023 at 1:27pm AST. The original Pfizer bivalent booster was given in October of 2022.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Patient went to Pharmacy for Tdap and Varicella vaccine on 02/13/2023. patient  received only Tdap vaccine from Pharmacy on 02/13/2023. Pharmacy referred her to another Pharmacy for varicella vaccine however patient showed up at Pharmacy on 02/14/2023 and asked for Tdap vaccine Pharmacy gave her Tdap at this point and realized the next day that patient received Tdap twice. We called patient and she is feeling ok only arm site soreness. We will give her refund and will give her follow up call.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects--72 day temperature was 1/12/23 so vaccine was expired
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Lymphoma, Neck mass, Pain in extremity, Rash
Clinical narrative: My adverse event started on the same day. I had a rash across my chest along with  pain on my left arm. I have history of cancer such Breast Cancer on 2011 and Thyroid Cancer on 2004. After few months of my third dose I've noticed there was a nodule on my right part of the neck. Since I get evaluations every year for cancer they said I had a lymph node but it turned out to be a cancerous nodule. Every vaccine I  got rashes afterwards my doctor said it was related to the vaccine. I had a CT scan on 04/13/2021 which showed the nodule. As of today I am waiting to get another surgery done. The rash I had on my chest it spread all over my body. Now it's on my hands, neck, head, back, and arms. I took prednisone skin ointment, and ALLEGRA, the rash flared up after the 2nd booster shot more. I even changed detergents but no one is sure where the rash is from known cause.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: My adverse event started on the same day. I had a rash across my chest along with  pain on my left arm. I have history of cancer such Breast Cancer on 2011 and Thyroid Cancer on 2004. After few months of my third dose I've noticed there was a nodule on my right part of the neck. Since I get evaluations every year for cancer they said I had a lymph node but it turned out to be a cancerous nodule. Every vaccine I  got rashes afterwards my doctor said it was related to the vaccine. I had a CT scan on 04/13/2021 which showed the nodule. As of today I am waiting to get another surgery done. The rash I had on my chest it spread all over my body. Now it's on my hands, neck, head, back, and arms. I took prednisone skin ointment, and ALLEGRA, the rash flared up after the 2nd booster shot more. I even changed detergents but no one is sure where the rash is from known cause.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 11year old patient was administered incorrect dose of 0.3 ml of Pfizer Bivalent 12+. MD spoke with parent and will follow up with her in 24 hours. MD went over possible side effect and allergic reaction symptoms to look out for.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects--72 day temperature was 1/12/23 so vaccine was expired
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccination. After administration upon lot look up, the vaccine had expired on 2/6/2023, but administered 2/15/2023
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects--72 day temperature was 1/12/23 so vaccine was expired
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Daughter called and said her Mom (the patient) had a really sore arm, like burning sensation and had been having it almost ever since
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Atrial flutter, Blood test abnormal, Cardiac stress test normal
Clinical narrative: I started having shortness of breath and rapid heart beat with chest pain around July 2021 . EKG showed Atrial Flutter.  Further EKGs were clean. On and off chest pain  July 2022 blood test at ER for chest pain shortness of breath show high D Dimer no blood clots in chest/lung November 2022 test positive ANA speckled pattern also high D Dimer again.  All blood work ran again. Negative with all labs clean for auto immune disease but unexplained D Dimer still  Joint and muscle pain and stiffness
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Echocardiogram normal
Clinical narrative: I started having shortness of breath and rapid heart beat with chest pain around July 2021 . EKG showed Atrial Flutter.  Further EKGs were clean. On and off chest pain  July 2022 blood test at ER for chest pain shortness of breath show high D Dimer no blood clots in chest/lung November 2022 test positive ANA speckled pattern also high D Dimer again.  All blood work ran again. Negative with all labs clean for auto immune disease but unexplained D Dimer still  Joint and muscle pain and stiffness
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer increased, Heart rate increased, Musculoskeletal stiffness, Myalgia
Clinical narrative: I started having shortness of breath and rapid heart beat with chest pain around July 2021 . EKG showed Atrial Flutter.  Further EKGs were clean. On and off chest pain  July 2022 blood test at ER for chest pain shortness of breath show high D Dimer no blood clots in chest/lung November 2022 test positive ANA speckled pattern also high D Dimer again.  All blood work ran again. Negative with all labs clean for auto immune disease but unexplained D Dimer still  Joint and muscle pain and stiffness
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast normal
Clinical narrative: I started having shortness of breath and rapid heart beat with chest pain around July 2021 . EKG showed Atrial Flutter.  Further EKGs were clean. On and off chest pain  July 2022 blood test at ER for chest pain shortness of breath show high D Dimer no blood clots in chest/lung November 2022 test positive ANA speckled pattern also high D Dimer again.  All blood work ran again. Negative with all labs clean for auto immune disease but unexplained D Dimer still  Joint and muscle pain and stiffness
Age: 14.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Pt was given 4 vaccines including Dtap, Hep A, Hib, and PCV vaccines that was intended for another pt. PNP explained to mom that the error was made and apologized. Explained that pt needs Hep A, MCV4, Tdap, and Varicella vaccines. Mom was understanding and wanted to move forward with the vaccines pt does need. PNP explained since pt received Dtap today, we do not want to give Tdap. Pt received MCV4 and Varicella. Will come back another day for Tdap.
Age: 23.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Death, Laboratory test, Military service, T-cell type acute leukaemia
Clinical narrative: Acute T-Cell Lymphoblastic Leukemia resulting in death
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Pt had brief tonic clonic seizure approximately 30 mins after vaccines and visit. Of note, child had first afebrile seizure 1 week prior on 2/9 and had already been set up for neurology FU.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bile duct stone, Bladder neck operation, COVID-19, Computerised tomogram abdomen abnormal, Condition aggravated
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Constipation, Hypertransaminasaemia, International normalised ratio increased, Klebsiella infection, Laboratory test abnormal
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nodule, SARS-CoV-2 test positive, Urinary tract infection, Urine leukocyte esterase positive, Vitamin K
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Bile duct stone, Biliary dilatation, Biliary sphincterotomy
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cholelithiasis, Computerised tomogram abdomen abnormal, Constipation, Endoscopic retrograde cholangiopancreatography
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypertransaminasaemia, International normalised ratio increased, Klebsiella infection, Nodule, SARS-CoV-2 test positive
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urinary tract infection, Urine analysis abnormal, Urine leukocyte esterase positive
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Constipation, Device breakage, Dizziness, Heart rate increased, Migraine
Clinical narrative: Migraine headaches  Fast heart beat Muscle weakness Tinnitus   Constipation Dizzy  Breast implant ruptured
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Tinnitus
Clinical narrative: Migraine headaches  Fast heart beat Muscle weakness Tinnitus   Constipation Dizzy  Breast implant ruptured
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic increased, Full blood count, Hypertension, Laboratory test, Lipids
Clinical narrative: Unexplained and Sustained High Blood Pressure despite yearly lifestyle improvements.  Angiogram in 2013 showed no Atherosclerosis. Currently experiencing Systolic swings of up to 60 points in 24 hours. Unable to adequately control it with Medications
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Thyroid function test
Clinical narrative: Unexplained and Sustained High Blood Pressure despite yearly lifestyle improvements.  Angiogram in 2013 showed no Atherosclerosis. Currently experiencing Systolic swings of up to 60 points in 24 hours. Unable to adequately control it with Medications
Age: 12.0
Sex: F
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Blood electrolytes normal, Brain herniation, Brain oedema, Headache, Sudden death
Clinical narrative: Sudden Death after a headache episode Post shows Cerebellar tonsillar and bilateral uncal herniation in the setting of "mild" cerebral edema No fever No rash
Age: 12.0
Sex: F
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Toxicologic test normal
Clinical narrative: Sudden Death after a headache episode Post shows Cerebellar tonsillar and bilateral uncal herniation in the setting of "mild" cerebral edema No fever No rash
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial discomfort, Laboratory test, Muscle spasms, Neck pain
Clinical narrative: Pt experienced "touching" down the left side of the face. NO PAIN. Went to eye dr and couldn't find anything. Muscles of neck were cramping excruciating pain. Heat helped and it subsided. Went to ER a few times. Neurologist visit = couldn't find anything. Referred patient to spine clinic, pain clinic for nerve investigation. Lasted over a year until finding possible shingles from NP in PCP office.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Incorrect product formulation administered, Underdose, Vaccination error
Clinical narrative: 10/27/2022 patient was administered Monovalent Moderna for 6 mos- 5 yrs dark blue cap with magenta border (0.25 mL / 25 mcg) as a booster - Incorrect vaccine & half the dose. This was a vaccine error previously reported to VAERS under VAERS ID: 2506797; E-Report Number: 913219.  Recommended dose should have been a "bivalent" dose.  In January 2023, facility reported to Department of State Health Services (DSHS) Region 7 - patient died on 12/15/2022.  DSHS understands there was a COVID-19 outbreak in the facility, possibly in November or December 2022 (exact dates unknown.)  Cause of patient death unknown, including whether the patient was diagnosed with COVID infection and/or death had any relation to COVID-infection.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Incorrect product formulation administered
Clinical narrative: 10/27/2022 patient was administered Monovalent Pfizer grey cap (0.3 mL / 30 mcg) as a booster; this was a vaccine error previously reported to VAERS under VAERS ID: 2506821; E-Report Number: 913243.  Recommended dose should have been a "bivalent" dose.  In January 2023, Facility reported to Department of State Health Services (DSHS) Region 7 - patient died on 11/11/2022.  DSHS understands there was a COVID-19 outbreak in the facility, possibly in November or December 2022 (exact dates unknown.)  Cause of patient death unknown, including whether the patient was diagnosed with COVID infection and/or death had any relation to COVID-infection.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Incorrect product formulation administered
Clinical narrative: 10/27/2022 patient was administered Monovalent Pfizer grey cap (0.3 mL / 30 mcg) as a booster; this was a vaccine error previously reported to VAERS under VAERS ID: 2506840; E-Report Number: 913262.  Recommended dose should have been a "bivalent" dose.  In January 2023, facility reported to Department of State Health Services (DSHS) - patient died on 1/29/2023.  DSHS understands there was a COVID-19 outbreak in the facility, possibly in November or December 2022 (exact dates unknown.)  Cause of patient death unknown, including whether the patient was diagnosed with COVID infection and/or death had any relation to COVID-infection.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Exposure to SARS-CoV-2, Incorrect product formulation administered, Vaccination error, Wrong product administered
Clinical narrative: 10/27/2022 patient was administered Monovalent adult Moderna red cap (0.25 mL / 50 mcg) administered as a booster - Incorrect vaccine. This was a vaccine error previously reported to VAERS under VAERS ID: 2511660; E-Report Number: 915127.  Recommended dose should have been a "bivalent" dose.  In January 2023, facility reported to Department of State Health Services (DSHS) Region 7 - patient died on 1/08/2023.  DSHS understands there was a COVID-19 outbreak in the facility, possibly in November or December 2022 (exact dates unknown.)  Cause of patient death unknown, including whether the patient was diagnosed with COVID infection and/or death had any relation to COVID-infection.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Incorrect product formulation administered, Vaccination error
Clinical narrative: 10/27/2022 patient was administered Monovalent adult Moderna red cap (0.25 mL / 50 mcg) administered as a booster - Incorrect vaccine. This was a vaccine error previously reported to VAERS under VAERS ID: 2511674; E-Report Number: 915141.  Recommended dose should have been a "bivalent" dose.  In January 2023, facility reported to Department of State Health Services (DSHS) Region 7 - patient died on 1/25/2023.  DSHS understands there was a COVID-19 outbreak in the facility, possibly in November or December 2022 (exact dates unknown.)  Cause of patient death unknown, including whether the patient was diagnosed with COVID infection and/or death had any relation to COVID-infection.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Exposure to SARS-CoV-2, Incorrect product formulation administered, Wrong product administered
Clinical narrative: 10/27/2022 patient was administered Monovalent adult Moderna red cap (0.25 mL / 50 mcg) administered as a booster - Incorrect vaccine. This was a vaccine error previously reported to VAERS under VAERS ID: 2512453; E-Report Number: 915666.  Recommended dose should have been a "bivalent" dose.  In January 2023, facility reported to Department of State Health Services (DSHS) Region 7 - patient died on 2/05/2023.  DSHS understands there was a COVID-19 outbreak in the facility, possibly in November or December 2022 (exact dates unknown.)  Cause of patient death unknown, including whether the patient was diagnosed with COVID infection and/or death had any relation to COVID-infection.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: short lived apillary; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "atopic dermatitis", start date: 01Jan2012 (unspecified if ongoing), notes: Treated with narrow beam UVB. Concomitant medication(s) included: TRIAMCINOLONE; CETAPHIL [DIMETICONE;GLYCEROL]. Vaccination history included: BNT162b2 (Dose: 1st, Date: 11Jan2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 11Jan2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "short lived apillary"; BNT162b2 (Dose: 2nd , Date: 04Mar2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 04Mar2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "short lived apillary"; BNT162b2 (Dose: 3rd , Date: 28Sep2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: 301558A), administration date: 28Sep2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "short lived apillary"; BNT162b2 (Dose: 4th , Date: 04Apr2022, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: FK9895), administration date: 04Apr2022, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "short lived apillary". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "short lived apillary". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Only side effect from vaccine was short lived apillary adenopathy or the side of the injection.; Sender's Comments: Linked Report(s): PFIZER INC-202300066370 same patient and event, different dose number;
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: short lived apillary; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "atopic dermatitis", start date: 01Jan2012 (unspecified if ongoing), notes: Treated with narrow beam UVB. Concomitant medication(s) included: TRIAMCINOLONE; CETAPHIL [DIMETICONE;GLYCEROL]. Vaccination history included: BNT162b2 (Dose: 1st, Date: 11Jan2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 11Jan2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "short lived apillary"; BNT162b2 (Dose: 2nd , Date: 04Mar2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 04Mar2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "short lived apillary"; BNT162b2 (Dose: 3rd , Date: 28Sep2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: 301558A), administration date: 28Sep2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "short lived apillary"; BNT162b2 (Dose: 4th , Date: 04Apr2022, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: FK9895), administration date: 04Apr2022, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "short lived apillary". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "short lived apillary". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Only side effect from vaccine was short lived apillary adenopathy or the side of the injection.; Sender's Comments: Linked Report(s): PFIZER INC-202300066370 same patient and event, different dose number;
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: she needed to report 3 more Vaccine Administration errors; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors).    No concomitant medications were reported.  It was reported unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  This case contains information for the 3rd of 3 patients described by the reporter.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709405 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709405:Patient 1 out of 3 Adult patients
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs; CMA calling on behalf of satellite clinic for information re dosing schedule for GARDASIL 9. Caller reports that patient received 1st dose at 14 years and 2nd dose at 15 years. Date of administration is week of 1/30/2023.; This spontaneous report has been received from other health professional concerning to a 15-year-old female patient. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient received the first (1st) dose at the age of 14 years of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml),once, (strength, lot number, expiration date, and route of administration were not provided) for prophylaxis.   Then, on 30-JAN-2023, the patient received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) over 1.5 years later at 15.5 years of age, at a dose of 0.5 milliliter (strength, route of administration, lot number and expiration date was not provided)(inappropriate schedule of product administration). Therefore, "CMA" called for information regarding the dosing schedule for of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) specifically if patient required third (3rd) dose.   No additional adverse event (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Customer called and reported that a dose of PROQUAD expired on 02FEB2023 and was administered on 13FEB2023. The product had no temperature excursions. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report has been received from a medical assistant concerning a 4-years-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 13-FEB-2023, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (lot number U024509 has been verified to be valid; expiration date reported and established as 02-FEB-2023) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse events were reported.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered 4 doses of the bivalent booster which were beyond the 30 day BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     It was unknown if patient ever diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was unknown if patient had any chronic or long standing health conditions.  Concurrent medical conditions included Penicillin allergy (penicillin allergy) and Drug allergy (compazine allergy).    On 06-Feb-2023 at 4:20 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD).    Concomitant medications details were not reported by the reporter. It was reported that 2 doses were administered on 06-Feb-2023 and 2 doses on 07-Feb-2023. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710235, US-MODERNATX, INC.-MOD-2023-710238, US-MODERNATX, INC.-MOD-2023-710239 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2023: Follow up contains significant information: Patient details added. Medical history added. Suspect product details updated. narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710235:Patient  US-MODERNATX, INC.-MOD-2023-710238:Patient Male US-MODERNATX, INC.-MOD-2023-710239:Patient
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; That Monovalent administered to a patient after date of Expiry on 13Feb2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023).    Nurse supervisor reported that a Monovalent vaccine was administered to a patient after date of expiry on 13-Feb-2023.  Dose was administered after 30-day use by date or after manufacturer date of expiry. Patient was administered with an individual vial. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 01-Jan-2023. The vial did not undergo any temperature excursions.  No concomitant medication reported. No treatment medication reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.).    No Concomitant medication was reported.  It was reported that 2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2023-710068 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-710068:Master case