chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Cervical radiculopathy, Cervical spinal stenosis, Cubital tunnel syndrome, Electromyogram abnormal, Exposure to SARS-CoV-2
Clinical narrative: On  February 1, 2022 I woke up with excruciating pain that extended from the lower right scapula down right arm and into hand. Within 3 days, I had dramatic muscle weakening and wasting in my right forearm, wrist, thenar area, and first dorsal interosseous. No trauma or unusual activity or event precipitated this episode. Last COVID vaccination prior to episode was November. At the time, many colleagues at work had COVID; if I did, I was asymptomatic. Pain subsided only after a steroid injection on 2/22/22.  After 2 EMGs and MRI/cervical and thoracic spine, the results:  EMGs x2 demonstrated C8 radiculopathy but in a setting of normal C8-T1 level with no foramina stenosis or nerve root compression at that level; mild cervical stenosis at c6/7 and c5/6, which one of the three neurosurgeons who weighed in on my case thought could be contributing to my symptoms. MRI of the brachial plexus on 3/23/22 revealed ?mild but definite thickening and edema in the right brachial plexus?possibly representing an inflammatory process. Saw another doctor for possible Thoracic Outlet Syndrome: negative Adson?s maneuver and East Roos test. Neurosurgeons concluded brachial plexitis, possibly due to COVID infection or vaccine. Fast forward to Fall 2022?after OT and PT?no noticeable improvement in hand strength. OT alarmed and recommended seeing hand surgeon (Dr.) who ordered another EMG and MRI. EMG showed slight improvement but still more consistent with C8 radiculopathy. In MRI, the hand surgeon anticipated finding hour-glass constrictions consistent with Parsonage Turner Syndrome but that was not the case. Hoping the sophisticated MRI at Hospital for Special Surgery could detect hour glass constriction, hand surgeon sent me for an eval there.  Jan 2023: I read that Hep E can cause peripheral nerve injury. Since I had been working closely with refugees during time of onset, I wondered if this was possible cause. On Feb 14, learned the Hep E test was positive but also learned that there is high incidence of false positive with this test. Feb 27, 2023, MRI at facility did not detect focal lesions (hour glass constrictions) but did reveal cubital tunnel syndrome for which hand surgeon offered surgery.  He performed cubital tunnel release in April 2023, after which I have not seen marked improvement.  Sept 2023:  Saw a neurologist for a neurology work up. No neurological findings revealed.   Two physicians thought it would be good for me to report this case on the VAERS site.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Hepatitis E virus test positive, Laboratory test, Magnetic resonance imaging spinal abnormal, Muscle atrophy, Muscular weakness
Clinical narrative: On  February 1, 2022 I woke up with excruciating pain that extended from the lower right scapula down right arm and into hand. Within 3 days, I had dramatic muscle weakening and wasting in my right forearm, wrist, thenar area, and first dorsal interosseous. No trauma or unusual activity or event precipitated this episode. Last COVID vaccination prior to episode was November. At the time, many colleagues at work had COVID; if I did, I was asymptomatic. Pain subsided only after a steroid injection on 2/22/22.  After 2 EMGs and MRI/cervical and thoracic spine, the results:  EMGs x2 demonstrated C8 radiculopathy but in a setting of normal C8-T1 level with no foramina stenosis or nerve root compression at that level; mild cervical stenosis at c6/7 and c5/6, which one of the three neurosurgeons who weighed in on my case thought could be contributing to my symptoms. MRI of the brachial plexus on 3/23/22 revealed ?mild but definite thickening and edema in the right brachial plexus?possibly representing an inflammatory process. Saw another doctor for possible Thoracic Outlet Syndrome: negative Adson?s maneuver and East Roos test. Neurosurgeons concluded brachial plexitis, possibly due to COVID infection or vaccine. Fast forward to Fall 2022?after OT and PT?no noticeable improvement in hand strength. OT alarmed and recommended seeing hand surgeon (Dr.) who ordered another EMG and MRI. EMG showed slight improvement but still more consistent with C8 radiculopathy. In MRI, the hand surgeon anticipated finding hour-glass constrictions consistent with Parsonage Turner Syndrome but that was not the case. Hoping the sophisticated MRI at Hospital for Special Surgery could detect hour glass constriction, hand surgeon sent me for an eval there.  Jan 2023: I read that Hep E can cause peripheral nerve injury. Since I had been working closely with refugees during time of onset, I wondered if this was possible cause. On Feb 14, learned the Hep E test was positive but also learned that there is high incidence of false positive with this test. Feb 27, 2023, MRI at facility did not detect focal lesions (hour glass constrictions) but did reveal cubital tunnel syndrome for which hand surgeon offered surgery.  He performed cubital tunnel release in April 2023, after which I have not seen marked improvement.  Sept 2023:  Saw a neurologist for a neurology work up. No neurological findings revealed.   Two physicians thought it would be good for me to report this case on the VAERS site.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal pain, Neuralgic amyotrophy, Neurological examination normal, Pain in extremity, Peripheral nerve decompression
Clinical narrative: On  February 1, 2022 I woke up with excruciating pain that extended from the lower right scapula down right arm and into hand. Within 3 days, I had dramatic muscle weakening and wasting in my right forearm, wrist, thenar area, and first dorsal interosseous. No trauma or unusual activity or event precipitated this episode. Last COVID vaccination prior to episode was November. At the time, many colleagues at work had COVID; if I did, I was asymptomatic. Pain subsided only after a steroid injection on 2/22/22.  After 2 EMGs and MRI/cervical and thoracic spine, the results:  EMGs x2 demonstrated C8 radiculopathy but in a setting of normal C8-T1 level with no foramina stenosis or nerve root compression at that level; mild cervical stenosis at c6/7 and c5/6, which one of the three neurosurgeons who weighed in on my case thought could be contributing to my symptoms. MRI of the brachial plexus on 3/23/22 revealed ?mild but definite thickening and edema in the right brachial plexus?possibly representing an inflammatory process. Saw another doctor for possible Thoracic Outlet Syndrome: negative Adson?s maneuver and East Roos test. Neurosurgeons concluded brachial plexitis, possibly due to COVID infection or vaccine. Fast forward to Fall 2022?after OT and PT?no noticeable improvement in hand strength. OT alarmed and recommended seeing hand surgeon (Dr.) who ordered another EMG and MRI. EMG showed slight improvement but still more consistent with C8 radiculopathy. In MRI, the hand surgeon anticipated finding hour-glass constrictions consistent with Parsonage Turner Syndrome but that was not the case. Hoping the sophisticated MRI at Hospital for Special Surgery could detect hour glass constriction, hand surgeon sent me for an eval there.  Jan 2023: I read that Hep E can cause peripheral nerve injury. Since I had been working closely with refugees during time of onset, I wondered if this was possible cause. On Feb 14, learned the Hep E test was positive but also learned that there is high incidence of false positive with this test. Feb 27, 2023, MRI at facility did not detect focal lesions (hour glass constrictions) but did reveal cubital tunnel syndrome for which hand surgeon offered surgery.  He performed cubital tunnel release in April 2023, after which I have not seen marked improvement.  Sept 2023:  Saw a neurologist for a neurology work up. No neurological findings revealed.   Two physicians thought it would be good for me to report this case on the VAERS site.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Spinal cord oedema
Clinical narrative: On  February 1, 2022 I woke up with excruciating pain that extended from the lower right scapula down right arm and into hand. Within 3 days, I had dramatic muscle weakening and wasting in my right forearm, wrist, thenar area, and first dorsal interosseous. No trauma or unusual activity or event precipitated this episode. Last COVID vaccination prior to episode was November. At the time, many colleagues at work had COVID; if I did, I was asymptomatic. Pain subsided only after a steroid injection on 2/22/22.  After 2 EMGs and MRI/cervical and thoracic spine, the results:  EMGs x2 demonstrated C8 radiculopathy but in a setting of normal C8-T1 level with no foramina stenosis or nerve root compression at that level; mild cervical stenosis at c6/7 and c5/6, which one of the three neurosurgeons who weighed in on my case thought could be contributing to my symptoms. MRI of the brachial plexus on 3/23/22 revealed ?mild but definite thickening and edema in the right brachial plexus?possibly representing an inflammatory process. Saw another doctor for possible Thoracic Outlet Syndrome: negative Adson?s maneuver and East Roos test. Neurosurgeons concluded brachial plexitis, possibly due to COVID infection or vaccine. Fast forward to Fall 2022?after OT and PT?no noticeable improvement in hand strength. OT alarmed and recommended seeing hand surgeon (Dr.) who ordered another EMG and MRI. EMG showed slight improvement but still more consistent with C8 radiculopathy. In MRI, the hand surgeon anticipated finding hour-glass constrictions consistent with Parsonage Turner Syndrome but that was not the case. Hoping the sophisticated MRI at Hospital for Special Surgery could detect hour glass constriction, hand surgeon sent me for an eval there.  Jan 2023: I read that Hep E can cause peripheral nerve injury. Since I had been working closely with refugees during time of onset, I wondered if this was possible cause. On Feb 14, learned the Hep E test was positive but also learned that there is high incidence of false positive with this test. Feb 27, 2023, MRI at facility did not detect focal lesions (hour glass constrictions) but did reveal cubital tunnel syndrome for which hand surgeon offered surgery.  He performed cubital tunnel release in April 2023, after which I have not seen marked improvement.  Sept 2023:  Saw a neurologist for a neurology work up. No neurological findings revealed.   Two physicians thought it would be good for me to report this case on the VAERS site.
Age: 75.0
Sex: M
Vaccine: COVID19, HEP, HEPA
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 60.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Discomfort, Mobility decreased, Swelling, Underdose
Clinical narrative: Nurse was not able to administer a full dose of MMR due to movement during the vaccine administration.  On 01/12/2024, the mother reported that the patient has some swelling/discomfort. Reports it is improving but patient does not want to move arm due to discomfort. Denied redness. During the follow up, the mother reported the patient is doing much better, he does not want anyone to touch his arm but is moving it.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rotateq vaccine series should not be started if infant is over 3 months of age. This infant is 4 months old and thus too old to start the Rotateq series.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swollen red hard bump
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Dizziness, Dyspnoea, Flushing, Heart rate increased
Clinical narrative: increase heart rate, flushed, dizziness, shortness of breath
Age: 74.0
Sex: F
Vaccine: COVID19, PNC20, RSV
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 86.0
Sex: M
Vaccine: COVID19, PNC20, RSV
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Blood test normal, Deafness, Dizziness
Clinical narrative: odd dizziness , profound hearing loss in right earloud noises in right ear, loss of balance, nausea, vomiting
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Nausea, Tinnitus, Vestibular disorder, Vomiting
Clinical narrative: odd dizziness , profound hearing loss in right earloud noises in right ear, loss of balance, nausea, vomiting
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: The patient received an extra dose of flu vaccine that was not needed.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: PREGNANT PATIENT 15 WEEKS OF GESTACION.SE IS GIVEN MENINGOCOCCAL MENQUADFI VACCINE. NOTIFIES THE NURSE AFTER THE ORIENTATION AND ADMINISTRATION OF THE SAME. AT THE MOMENT HE DID NOT PRESENT ANY REACTION.
Age: 83.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: No adverse event, Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: loss of range of motion for 3 days, consistent left arm pain for 3 weeks  when lifting arms up, bring around across chest area, arm pain waking patient from sleep on 17th day, tingling sensation of fingers.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Contusion, Erythema
Clinical narrative: pt had large circular bruise size of a softball that had red spots and lines through it.
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Delirium, Electroencephalogram normal, Encephalopathy
Clinical narrative: 7 days after vaccination resident was sent out to the hospital due to hypotension, resident has diagnosis history that includes orthostatic hypotension and idiopathic hypotension and essential hypertension. Resident was admitted to the ICU for orthostatic hypotension. On return from hospital 1/23/24 these are the hospital notes. Admitted for work up further work up of chronic orthostatic hypotension. Orthostatic etiology continued to be unclear. Condition C was called on 1/16/24 for acute encephalopathy and unresponsiveness. Found to have a hemorrhagic metastatic lesion vs acute intraparenchymal hemorrhage and transferred to ICU. CTH with 8mm hemorrhage in subcortical left frontal lobe thought 2/2 HTN or mets. Panscans reveal no metastatic disease although not pancreatic duct dilitation. C19-9 ordered and resulted normal at 14. Resident mental status returned to baseline. EEG no signs of seizure and extensive toxic metabolic workup was negative. NSGY consulted no surgical intervention and Okd restart of ASA. Resident was hypertensive IP with SBP 180-200's. Metoprolol was increased to 25 mg po daily, hydralazine prn for management. Encephalopathy spontaneously resolved and was likely thought to be due to components of delirium and dementia. Resident was deemed stable to return to facility1/23/24.
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Intensive care, Orthostatic hypotension, Scan normal, Toxicologic test normal, Unresponsive to stimuli
Clinical narrative: 7 days after vaccination resident was sent out to the hospital due to hypotension, resident has diagnosis history that includes orthostatic hypotension and idiopathic hypotension and essential hypertension. Resident was admitted to the ICU for orthostatic hypotension. On return from hospital 1/23/24 these are the hospital notes. Admitted for work up further work up of chronic orthostatic hypotension. Orthostatic etiology continued to be unclear. Condition C was called on 1/16/24 for acute encephalopathy and unresponsiveness. Found to have a hemorrhagic metastatic lesion vs acute intraparenchymal hemorrhage and transferred to ICU. CTH with 8mm hemorrhage in subcortical left frontal lobe thought 2/2 HTN or mets. Panscans reveal no metastatic disease although not pancreatic duct dilitation. C19-9 ordered and resulted normal at 14. Resident mental status returned to baseline. EEG no signs of seizure and extensive toxic metabolic workup was negative. NSGY consulted no surgical intervention and Okd restart of ASA. Resident was hypertensive IP with SBP 180-200's. Metoprolol was increased to 25 mg po daily, hydralazine prn for management. Encephalopathy spontaneously resolved and was likely thought to be due to components of delirium and dementia. Resident was deemed stable to return to facility1/23/24.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions noted. No treatment needed per primary care provider.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pt has had severe arm pain and had to do PT because of it. Pt is still experiencing this problem. Pt picked up a steroid at my location d/t complications with this problem.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse events occurred or resulted from these vaccinations. The patient was given a kinrix vaccine instead of an infanrix vaccine.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Computerised tomogram, Dysgraphia, Fall
Clinical narrative: Within 4 hours after the injection I went to the bank and I couldn't buckle, write my name legibly, I had numbness in my right arm from the elbow to the tips of my hand/finger. This lasted about 30 minutes. Then It disappeared. I did not have any other issues until 11am the following day and got the numbness in the right elbow and hand again. It went away again after 30 minutes. The 3rd day I had numbness in my right leg from below the knee to the tip of my toes. It has continued on and off ever since. Today (1/25/23) I drag my right foot and I am using a walker. It still comes and goes. a few times the right leg ends up behind me and I have no control over it and have to manually lift it and move it. My balance is not good. I can't walk normally. I have fallen a few times. There were a few periods of time where it goes away but then returns. It is the worst it has ever been at this point. I ended up in the hospital on December 16th after I fell. I was hospitalized 3 days.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging, Musculoskeletal disorder
Clinical narrative: Within 4 hours after the injection I went to the bank and I couldn't buckle, write my name legibly, I had numbness in my right arm from the elbow to the tips of my hand/finger. This lasted about 30 minutes. Then It disappeared. I did not have any other issues until 11am the following day and got the numbness in the right elbow and hand again. It went away again after 30 minutes. The 3rd day I had numbness in my right leg from below the knee to the tip of my toes. It has continued on and off ever since. Today (1/25/23) I drag my right foot and I am using a walker. It still comes and goes. a few times the right leg ends up behind me and I have no control over it and have to manually lift it and move it. My balance is not good. I can't walk normally. I have fallen a few times. There were a few periods of time where it goes away but then returns. It is the worst it has ever been at this point. I ended up in the hospital on December 16th after I fell. I was hospitalized 3 days.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Walking aid user
Clinical narrative: Within 4 hours after the injection I went to the bank and I couldn't buckle, write my name legibly, I had numbness in my right arm from the elbow to the tips of my hand/finger. This lasted about 30 minutes. Then It disappeared. I did not have any other issues until 11am the following day and got the numbness in the right elbow and hand again. It went away again after 30 minutes. The 3rd day I had numbness in my right leg from below the knee to the tip of my toes. It has continued on and off ever since. Today (1/25/23) I drag my right foot and I am using a walker. It still comes and goes. a few times the right leg ends up behind me and I have no control over it and have to manually lift it and move it. My balance is not good. I can't walk normally. I have fallen a few times. There were a few periods of time where it goes away but then returns. It is the worst it has ever been at this point. I ended up in the hospital on December 16th after I fell. I was hospitalized 3 days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient received Comirnaty 23-24 covid vaccine in right arm and Flucelvax QIV 23-24 in left arm. Initially she had a ?big knot? with pain at the injection site that went away later that day. The next day, she developed right shoulder pain with numbness and tingling. The pain was located on her shoulder blade on her back right side. Patient was evaluated 4 days later and physician prescribed meloxicam 15mg daily and tizanidine 4mg nightly at bedtime. She took the meloxicam for 7 days, but didn?t have any pain relief. She returned to her physician?s office and was prescribed prednisone 20mg 3 tabs daily for 5 days. Once the treatment was finished, her pain returned again. Her doctor prescribed a prednisone taper over 12 days, which relieved the pain again. Once she stopped, the pain returned. Patient went to an orthopedic clinic who gave a steroid injection. Patient is currently doing physical therapy because the pain hasn't resolved.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Already Listed.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Disability, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Following the vaccine the patient (myself) experienced a severe and prolonged disease flare which required significant NSAID and steroid use as well as temporary disability in the form of difficulty completing ADLs, and required a need to work from home. The flare required me to call my physicians office several times for steroid prescriptions and advice.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event but after shot was given patient informed us that she had gotten a flu shot a couple of months prior, but her employer could not find record so she decided to get it again.  Her pharmacy profile did not show that she had received a flu shot from Pharmacy and state IZ (immunization database) did not show history of any flu shots.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, PNC20, RV1
Symptoms: Extra dose administered
Clinical narrative: COMBINATION VACCINES PENTACEL (DTAP/IPV/HIB) AND COMBINATION VACCINE VAXELIS (DTAP/IPV/HIB/HEP B INADVERTANTLY ADMINISTERED ON THE SAME DAY THERFORE THE PATIENT RECEIVED TOO LARGE A DOSE OF VACCINE.  CDC NOTIFIED AND ADVISED TO REPORT TO VAERS VACCINE IS VALID AND DOES NOT NEED TO BE REPEATED.  BE AWARE THAT THE RISK OF A LOCAL REACTION COULD BE HIGHER, BUT MORE SERIOUS REACTIONS ARE UNLIKELY.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 34 days after my 6th vaccine for Covid-19 I came down with covid, for the first time ever!
Age: 29.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature separation of placenta
Clinical narrative: Placental abruption; healthy pregnancy; EDD 2/25/24; delivered; 3lbs 15oz at 32 weeks gestation
Age: 20.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Arthritis, Influenza like illness, Injection site pain, Injection site urticaria, Throat irritation
Clinical narrative: Varicella vaccine given at 9AM, Pt returned to clinic the following day at 12:30PM. Pt reported flu like symptoms, scratchy throat (no difficulty breathing), R upper arm/ shoulder pain and a red hive on the back of R arm at site of Varicella injection about 2x2 in. Pt was given cold compress and advised to take Benadryl and Tylenol. Instructed to go to urgent care if hive continues to grow past marked lines or ED if any difficulty breathing occurs. Unknown outcome at this time.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Plicated tongue
Clinical narrative: Tongue Fissures
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Given pediatric formulation vs adult formulation
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse reaction .
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Administered pediatric formulation vs adult formulation
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine fridge expiration was 1/20/24 but was administered on 1/23/24
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm
Clinical narrative: Patient was in HD for a follow up visit on 01/25/2024 for Pelvic Inflammatory Disease and showed me her Right arm. Arm was reddened and warm to touch. States the redness had increased since 01/23/2024 .  Denies any fever, pain, chills or nausea and vomiting.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine was diluted with the correct diluent but then the whole vial was administered instead of  the 0.3ml
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chest tube insertion, Culture, Fatigue, Full blood count
Clinical narrative: fever  hours after vaccine;still had fever 2 days later, upper resp infection, pneumonia 103 fever for 7 days, chest tube, fatigue
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pneumonia, Pyrexia, Upper respiratory tract infection
Clinical narrative: fever  hours after vaccine;still had fever 2 days later, upper resp infection, pneumonia 103 fever for 7 days, chest tube, fatigue
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I administered Dtap instead of Tdap, no adverse symptoms reported, parent will be contacted with plan
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: developed headache and then in 48h developed tinnitus in both ears.  Headache resolved but tinnitus is ongoing
Age: 65.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered DTap instead of TDAP. No adverse reaction reported.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given MMRV when aged out (14 years of age)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Child was in for IM injection. Interpreter utilized. Hep A vaccine given early. Mother informed will call with any concerns. No adverse reactions at time of visit noted.
Age: 49.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Acupuncture, Pruritus, Urticaria
Clinical narrative: I received both the flu shot as well as the Covid vaccine at a local pharmacy at the same time in the same left arm.  18 hours post injections, my legs and torso became itchy and I had formed significant hives in these areas. I took a Benadryl and went to bed and the next morning the hives were gone. However, the hives reappeared for the second time again the next night - Again, I?ll over my legs and a bit on my torso. Again I took Benadryl, went to bed, and woke up with no hives. I visited my acupuncturist the day, after the second hive event, received an acupuncture treatment to calm my histamines and cytokines, and had no more hives outbreaks.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: No symptoms reported. However, vaccine was past its 28d multidose vial expiration date.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt stated when he received the vaccine that it hurt more than other vaccines and that he had a sore and panful arm for about a week but that he has had about five episodes where the will feel sharp what he feels might be nerve pain that last for a while then goes a way.
Age: 21.0
Sex: F
Vaccine: EBZR
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: RSV vaccine ( 01/24/2024)   G2P0A1   EDD 03/12/2024 GA 33wks 1 days  Ordered RSV vacc:  Pfizer ( Abrysvo 0.5ML IM)  Administered RSV vacc: GSK ( Arexvy, 0.5 ml I.M. Left deltoid , Lot # G75S4, expiration date 07/05/2025,
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: PATIENT PULLED HER ARM AS INJECTION WAS BEING ADMINISTERED, HAD TO RESET TO INJECT MEDICATION INTO THE ARM.  NOT SURE IF INITIAL ATTEMPT ACTUALLY PUNCTURED ARM.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Awoke around 2 am with severe shivering, temperature elevated to 99.4. (normal 97.8-98.3) This felt like the shivering I experienced at night when I had COVID in March 2023. This resolved by the next morning
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash, Rash
Clinical narrative: This morning (1/25/24) I received a message from a patient that received both Trumenba and Tdap yesterday and woke up with a full upper body rash. She received Tdap (she had received a dose previously) and Trumenba (first dose on record). She reports the rash was worse to her right arm and this is where the Trumenba was administered. She was seen in the urgent care and reports they felt it was a reaction and encouraged her to use Benadryl for relief.
Sex: F
Vaccine: PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: Meningitis; This spontaneous report has been downloaded from Regulatory Authority concerning to an adult female patient (age: 50-54). The patient's medical history, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2010, the patient experienced Streptococcus pneumoniae meningitis. On an unknown date in 2010, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event Streptococcus pneumoniae meningitis was unknown.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae meningitis was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Laboratory test, Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report was received from database concerning an over 85-years-old male patient. His concurrent conditions, medical history, drug reactions, allergies or concomitant therapies were not provided.  In 2011, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) as prophylaxis (dose, dosage schedule, lot number, expiration date, route and site of administration were not reported).  In 2011, the patient experienced pneumococcal infection. His serotype was 19A. At the time of the report, the outcome of the event was unknown.  The reported did not provide a causality assessment between pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and the event.  Upon internal review, pneumococcal infection was considered medically significant.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumococcal infection
Clinical narrative: No data provided; This spontaneous report has been downloaded from Regulatory Authority and referring to an adult female patient (age: 60-64). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 3 times, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). Also on an unknown date, she received as suspect therapy Pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) (strength, dose, indication, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2021, the patient experienced Pneumococcal infection (reported as No data provided). On an unknown date in 2021, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not known.    The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of Pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority and refers to an adult (40-44-year-old) male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2021, the patient experienced pneumonia. On an unknown date in 2021, Streptococcus pneumoniae serotyping showed not available (also reported as vaccine not available for serotype). At the time of reporting, the outcome of the event was unknown.   The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Upon internal review, the event pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: pneumonia; This spontaneous report has been downloaded from regulatory authority and refers to an elderly male patient (between 80-84 years old). The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, lot #, expiration date, and route of administration were not provided).  On an unknown date in 2021, the patient experienced pneumonia (Pneumonia pneumococcal). The streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.  The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.   Upon internal review, the event pneumonia was determined to be medically significant.
Age: 39.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient was prescribed Vivotif (sent to pharmacy) for upcoming travel abroad. Patient emailed us 01/24/2024 reporting nausea, vomiting, diarrhoea, fatigue, feverish after 2 doses. I advised patient to stop Vivovif and reach out to us if symptoms do not resolve in 2 days, or if any worsening.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient reports pain and discomfort in right arm since vaccination.  She describes as a nagging, shooting pain.  Pain has progressively gotten worse.  Since January she reports trouble lifting her arm above her shoulder/ head.  Pain while sleeping causing her to wake up several times a night.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Trigeminal neuralgia
Clinical narrative: trigeminal neuralgia
Age: 43.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: The patient was given the Arexvy vaccine instead of the Abryvso
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects. Patient requested Novavax vaccine on 1/24/24. Patient did not remember or declare he had been given the Novavax vaccine the previous month on date 12/18/2023.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: We took our 2 year old in and he was to be given the flu vaccine. We just received a call from them stating that he was given the adult dosage rather than the infant dosage and immediately started looking for what to do including reporting it on this form. They stated that they were reporting it through the proper channels as well.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Exercise tolerance decreased, Full blood count normal, Herpes simplex test positive
Clinical narrative: Cut were not healing and extreme heart pains within 6 months of vaccine. (felt like he was going to die). First, sore on toe (size of dime) took 3 weeks for sore to heal, then sore on penis -- tested (+) for HSV2--doesn't believe this diagnosis b/c wife's test was negative. Reduced energy level started to notice this in January 2022 after an illness (thinks it could have been covid or bad food). No longer able to lift heavy during workouts (was working out for 1 hour at a time and now can only tolerate 10 minutes). Now needs more sleep - 01/2022. Stuffy sinuses got worse (unknown timeline). Cough started and has been continuous since 01/2021.  Lower sex drive started 2 years ago.  Sees PCP (NP) annually.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Impaired healing, Libido decreased, Malaise, Sinus congestion
Clinical narrative: Cut were not healing and extreme heart pains within 6 months of vaccine. (felt like he was going to die). First, sore on toe (size of dime) took 3 weeks for sore to heal, then sore on penis -- tested (+) for HSV2--doesn't believe this diagnosis b/c wife's test was negative. Reduced energy level started to notice this in January 2022 after an illness (thinks it could have been covid or bad food). No longer able to lift heavy during workouts (was working out for 1 hour at a time and now can only tolerate 10 minutes). Now needs more sleep - 01/2022. Stuffy sinuses got worse (unknown timeline). Cough started and has been continuous since 01/2021.  Lower sex drive started 2 years ago.  Sees PCP (NP) annually.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Cut were not healing and extreme heart pains within 6 months of vaccine. (felt like he was going to die). First, sore on toe (size of dime) took 3 weeks for sore to heal, then sore on penis -- tested (+) for HSV2--doesn't believe this diagnosis b/c wife's test was negative. Reduced energy level started to notice this in January 2022 after an illness (thinks it could have been covid or bad food). No longer able to lift heavy during workouts (was working out for 1 hour at a time and now can only tolerate 10 minutes). Now needs more sleep - 01/2022. Stuffy sinuses got worse (unknown timeline). Cough started and has been continuous since 01/2021.  Lower sex drive started 2 years ago.  Sees PCP (NP) annually.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Dysgeusia, Tongue rough
Clinical narrative: Patient stated 15 minutes after she received the vaccine she experienced "bitter taste" in mouth. Then a few minutes afterward she felt a rough sensation on her tongue that felt like "sandpaper." All the symptoms have resided after one day.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Nodule, Peripheral swelling, Pyrexia
Clinical narrative: patient got fluzone quad and prevnar 20 in same arm and arm starting swelling and turned red same day; patient has baseball size knot/swelling and fever at night; has not gone away yet
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Hypertension, Inflammation, Injection site pain, Joint range of motion decreased
Clinical narrative: Day 1 post injection patient complaints of arm swelling, tenderness, deep ache, and entire body aches. Seen on 1/3/24 and also added concern for SOB, radiaiting pain, decreased ROM, headaches and new onset HTN. Referred to ED.  Seen at ED 1/4/24 diagnosed with HTN, post injection inflammatory reaction.   Seen 1/25/24 dx with Brachial neuritis of left upper extremity.  patient states she is still having constant throbbing, decreased ROM, radiating left shoulder pain, difficulty with ADL's. No noted redness/swelling.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Peripheral swelling, Radiculitis brachial
Clinical narrative: Day 1 post injection patient complaints of arm swelling, tenderness, deep ache, and entire body aches. Seen on 1/3/24 and also added concern for SOB, radiaiting pain, decreased ROM, headaches and new onset HTN. Referred to ED.  Seen at ED 1/4/24 diagnosed with HTN, post injection inflammatory reaction.   Seen 1/25/24 dx with Brachial neuritis of left upper extremity.  patient states she is still having constant throbbing, decreased ROM, radiating left shoulder pain, difficulty with ADL's. No noted redness/swelling.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Day 1 post injection patient complaints of arm swelling, tenderness, deep ache, and entire body aches. Seen on 1/3/24 and also added concern for SOB, radiaiting pain, decreased ROM, headaches and new onset HTN. Referred to ED.  Seen at ED 1/4/24 diagnosed with HTN, post injection inflammatory reaction.   Seen 1/25/24 dx with Brachial neuritis of left upper extremity.  patient states she is still having constant throbbing, decreased ROM, radiating left shoulder pain, difficulty with ADL's. No noted redness/swelling.