chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Discomfort, Pain
Clinical narrative: afib (atrial fibrillation); felt pain; discomfort; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 22Dec2023, outcome "unknown"; PAIN (non-serious) with onset 22Dec2023, outcome "unknown", described as "felt pain"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "afib (atrial fibrillation)". The events "afib (atrial fibrillation)", "felt pain" and "discomfort" required physician office visit. Clinical course: The caller refers that he and his wife (both 81-year-old) got the Pfizer COVID-19 vaccine. They both felt pain and discomfort right after getting shot and he also felt dizziness and shortness of breath within two or three weeks after having the vaccine, he went to the doctor and was diagnosed with afib (atrial fibrillation).   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram, Fatigue, Pain
Clinical narrative: afib (atrial fibrillation); felt pain; discomfort; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 22Dec2023, outcome "unknown"; PAIN (non-serious) with onset 22Dec2023, outcome "unknown", described as "felt pain"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "afib (atrial fibrillation)". The events "afib (atrial fibrillation)", "felt pain" and "discomfort" required physician office visit. Clinical course: The caller refers that he and his wife (both 81-year-old) got the Pfizer COVID-19 vaccine. They both felt pain and discomfort right after getting shot and he also felt dizziness and shortness of breath within two or three weeks after having the vaccine, he went to the doctor and was diagnosed with afib (atrial fibrillation).   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: tired, pain, walking loosing breathe
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Discomfort, Pain
Clinical narrative: tired, pain, walking loosing breathe
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram, Fatigue, Pain
Clinical narrative: tired, pain, walking loosing breathe
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Arrhythmia, Blood glucose increased, Bradykinesia, Chest X-ray normal, Differential white blood cell count normal
Clinical narrative: He got his vaccine, he stayed 15 minutes felt OK.  Went home, arm was a little bit sore.  he started feeling something under his tongue, not painful but something.  Within a couple of hours his back teeth felt swollen and was almost like biting his tongue.  He then disregarded it and then by 9:30 it was too swollen, he was so fatigued, having a hard time breathing and called 9-1-1.  When the ambulance got there he went downstairs, they started an IV, she asked him questions, gave him Benadryl and his mind went crazy, could not think, could not concentrate and could not come up with answers.  She still cannot remember what happened, which was last night at 10:00 PM.  He was given Solu-Medrol at the hospital and his blood sugars a little high but not diagnosed as a diabetic, and possibly prediabetic.  I does not recall what happened after the Solu-Medrol, did not feel much of a difference.  He was on the gurney, did an EKG at the hospital, had lab tests done which were CBC/diff, CMP, lipase, troponin 1 high sensitivity, 2 chest x-rays.  He was informed that everything looked OK.  He was having an arrhythmia while he was at the hospital.  He was observed in the ER and then they put a pulse ox on him and walked him.  He was walking so slow that he did not know what it was supposed to show.  His pulse ox at home is 93-94, and sometimes lower.  They worked him in the ambulance, and was discharged home around 1:30 AM this morning.  He called his doctor and told him that he was having problems, and was told to stop the Benadryl and he has an APT today at 4:00 PM with him.   He is not really feeling any better, the swelling of his tongue got better, breathing is really difficult still, and feels that something is not working or kicking in.   He has had his pneumonia, flu and COVID vaccines with no reactions.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Disturbance in attention, Dyspnoea, Electrocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: He got his vaccine, he stayed 15 minutes felt OK.  Went home, arm was a little bit sore.  he started feeling something under his tongue, not painful but something.  Within a couple of hours his back teeth felt swollen and was almost like biting his tongue.  He then disregarded it and then by 9:30 it was too swollen, he was so fatigued, having a hard time breathing and called 9-1-1.  When the ambulance got there he went downstairs, they started an IV, she asked him questions, gave him Benadryl and his mind went crazy, could not think, could not concentrate and could not come up with answers.  She still cannot remember what happened, which was last night at 10:00 PM.  He was given Solu-Medrol at the hospital and his blood sugars a little high but not diagnosed as a diabetic, and possibly prediabetic.  I does not recall what happened after the Solu-Medrol, did not feel much of a difference.  He was on the gurney, did an EKG at the hospital, had lab tests done which were CBC/diff, CMP, lipase, troponin 1 high sensitivity, 2 chest x-rays.  He was informed that everything looked OK.  He was having an arrhythmia while he was at the hospital.  He was observed in the ER and then they put a pulse ox on him and walked him.  He was walking so slow that he did not know what it was supposed to show.  His pulse ox at home is 93-94, and sometimes lower.  They worked him in the ambulance, and was discharged home around 1:30 AM this morning.  He called his doctor and told him that he was having problems, and was told to stop the Benadryl and he has an APT today at 4:00 PM with him.   He is not really feeling any better, the swelling of his tongue got better, breathing is really difficult still, and feels that something is not working or kicking in.   He has had his pneumonia, flu and COVID vaccines with no reactions.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Full blood count normal, Lipase normal, Memory impairment, Metabolic function test normal, Mouth swelling
Clinical narrative: He got his vaccine, he stayed 15 minutes felt OK.  Went home, arm was a little bit sore.  he started feeling something under his tongue, not painful but something.  Within a couple of hours his back teeth felt swollen and was almost like biting his tongue.  He then disregarded it and then by 9:30 it was too swollen, he was so fatigued, having a hard time breathing and called 9-1-1.  When the ambulance got there he went downstairs, they started an IV, she asked him questions, gave him Benadryl and his mind went crazy, could not think, could not concentrate and could not come up with answers.  She still cannot remember what happened, which was last night at 10:00 PM.  He was given Solu-Medrol at the hospital and his blood sugars a little high but not diagnosed as a diabetic, and possibly prediabetic.  I does not recall what happened after the Solu-Medrol, did not feel much of a difference.  He was on the gurney, did an EKG at the hospital, had lab tests done which were CBC/diff, CMP, lipase, troponin 1 high sensitivity, 2 chest x-rays.  He was informed that everything looked OK.  He was having an arrhythmia while he was at the hospital.  He was observed in the ER and then they put a pulse ox on him and walked him.  He was walking so slow that he did not know what it was supposed to show.  His pulse ox at home is 93-94, and sometimes lower.  They worked him in the ambulance, and was discharged home around 1:30 AM this morning.  He called his doctor and told him that he was having problems, and was told to stop the Benadryl and he has an APT today at 4:00 PM with him.   He is not really feeling any better, the swelling of his tongue got better, breathing is really difficult still, and feels that something is not working or kicking in.   He has had his pneumonia, flu and COVID vaccines with no reactions.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity, Paraesthesia oral, Swollen tongue, Thinking abnormal, Troponin I
Clinical narrative: He got his vaccine, he stayed 15 minutes felt OK.  Went home, arm was a little bit sore.  he started feeling something under his tongue, not painful but something.  Within a couple of hours his back teeth felt swollen and was almost like biting his tongue.  He then disregarded it and then by 9:30 it was too swollen, he was so fatigued, having a hard time breathing and called 9-1-1.  When the ambulance got there he went downstairs, they started an IV, she asked him questions, gave him Benadryl and his mind went crazy, could not think, could not concentrate and could not come up with answers.  She still cannot remember what happened, which was last night at 10:00 PM.  He was given Solu-Medrol at the hospital and his blood sugars a little high but not diagnosed as a diabetic, and possibly prediabetic.  I does not recall what happened after the Solu-Medrol, did not feel much of a difference.  He was on the gurney, did an EKG at the hospital, had lab tests done which were CBC/diff, CMP, lipase, troponin 1 high sensitivity, 2 chest x-rays.  He was informed that everything looked OK.  He was having an arrhythmia while he was at the hospital.  He was observed in the ER and then they put a pulse ox on him and walked him.  He was walking so slow that he did not know what it was supposed to show.  His pulse ox at home is 93-94, and sometimes lower.  They worked him in the ambulance, and was discharged home around 1:30 AM this morning.  He called his doctor and told him that he was having problems, and was told to stop the Benadryl and he has an APT today at 4:00 PM with him.   He is not really feeling any better, the swelling of his tongue got better, breathing is really difficult still, and feels that something is not working or kicking in.   He has had his pneumonia, flu and COVID vaccines with no reactions.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Troponin I normal
Clinical narrative: He got his vaccine, he stayed 15 minutes felt OK.  Went home, arm was a little bit sore.  he started feeling something under his tongue, not painful but something.  Within a couple of hours his back teeth felt swollen and was almost like biting his tongue.  He then disregarded it and then by 9:30 it was too swollen, he was so fatigued, having a hard time breathing and called 9-1-1.  When the ambulance got there he went downstairs, they started an IV, she asked him questions, gave him Benadryl and his mind went crazy, could not think, could not concentrate and could not come up with answers.  She still cannot remember what happened, which was last night at 10:00 PM.  He was given Solu-Medrol at the hospital and his blood sugars a little high but not diagnosed as a diabetic, and possibly prediabetic.  I does not recall what happened after the Solu-Medrol, did not feel much of a difference.  He was on the gurney, did an EKG at the hospital, had lab tests done which were CBC/diff, CMP, lipase, troponin 1 high sensitivity, 2 chest x-rays.  He was informed that everything looked OK.  He was having an arrhythmia while he was at the hospital.  He was observed in the ER and then they put a pulse ox on him and walked him.  He was walking so slow that he did not know what it was supposed to show.  His pulse ox at home is 93-94, and sometimes lower.  They worked him in the ambulance, and was discharged home around 1:30 AM this morning.  He called his doctor and told him that he was having problems, and was told to stop the Benadryl and he has an APT today at 4:00 PM with him.   He is not really feeling any better, the swelling of his tongue got better, breathing is really difficult still, and feels that something is not working or kicking in.   He has had his pneumonia, flu and COVID vaccines with no reactions.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Employee was given expired Spikevax. Expired on 1/19/24. No other vaccinations were given that day. No adverse reactions noted. Monitored for 15 minutes.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Hypersensitivity, Local reaction, Pain in extremity
Clinical narrative: about 36 hrs later my arm became very sore.  Monday morning I noticed i had a very large red mark on my arm.  I marked it and within 6hrs it had spread.    I saw MD in urgent care on Monday, Jan 29.  Cellulits vs local allergic reaction.  today, Jan 31, redness is less, arm still sore.
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Pt developed a rash head to toe 11 days after vaccine
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Initially, the site was red and hard [after vaccines were given in R thigh], which has now turned to black and blue. Patient also c/o itching at the site.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Groin pain, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Severe headache. Swollen lymph nodes left arm. Elbow pain 3 days. Most is upper thigh pain with left leg pain in groin and hip. Won't go away
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Interpreted written directions incorrectly and administered Hep B when it should have been given as HPV
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: wrong dose given, patient is 5 years old and patient received 6mo-4yo Pfizer dose
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Biopsy muscle abnormal, Biopsy peripheral nerve, Blood test, Botulinum toxin injection
Clinical narrative: Intense Migraines 15+ Days a month (Ubrelvy 100mg, 200 units of Botox), Loss of feeling in left leg, weakness, dystonia type reactions, paralysis (temporary / stiffness/ rigidness), Fibromyalgia, Psoriatic Arthritis, Psoriasis, HLA-B27, Myopathy, Facet Joint Syndrome, Spinal Cord Damage, Neuropathy, Mild Denervation type changes skeletal muscle (left quadriceps), degenerating myelinated axon seen, a few regenerated clusters are present. The mild denervations type changes seen in this patients's muscle biopsy consist of occasional scattered esterase positive atrophic muscle fibers suggesting the presence of mild ongoing denervation.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cytogenetic analysis, Demyelination, Dystonia, Electromyogram
Clinical narrative: Intense Migraines 15+ Days a month (Ubrelvy 100mg, 200 units of Botox), Loss of feeling in left leg, weakness, dystonia type reactions, paralysis (temporary / stiffness/ rigidness), Fibromyalgia, Psoriatic Arthritis, Psoriasis, HLA-B27, Myopathy, Facet Joint Syndrome, Spinal Cord Damage, Neuropathy, Mild Denervation type changes skeletal muscle (left quadriceps), degenerating myelinated axon seen, a few regenerated clusters are present. The mild denervations type changes seen in this patients's muscle biopsy consist of occasional scattered esterase positive atrophic muscle fibers suggesting the presence of mild ongoing denervation.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facet joint syndrome, Fibromyalgia, HLA-B*27 assay, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Intense Migraines 15+ Days a month (Ubrelvy 100mg, 200 units of Botox), Loss of feeling in left leg, weakness, dystonia type reactions, paralysis (temporary / stiffness/ rigidness), Fibromyalgia, Psoriatic Arthritis, Psoriasis, HLA-B27, Myopathy, Facet Joint Syndrome, Spinal Cord Damage, Neuropathy, Mild Denervation type changes skeletal muscle (left quadriceps), degenerating myelinated axon seen, a few regenerated clusters are present. The mild denervations type changes seen in this patients's muscle biopsy consist of occasional scattered esterase positive atrophic muscle fibers suggesting the presence of mild ongoing denervation.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Muscle rigidity, Musculoskeletal stiffness, Myopathy, Neuropathic muscular atrophy
Clinical narrative: Intense Migraines 15+ Days a month (Ubrelvy 100mg, 200 units of Botox), Loss of feeling in left leg, weakness, dystonia type reactions, paralysis (temporary / stiffness/ rigidness), Fibromyalgia, Psoriatic Arthritis, Psoriasis, HLA-B27, Myopathy, Facet Joint Syndrome, Spinal Cord Damage, Neuropathy, Mild Denervation type changes skeletal muscle (left quadriceps), degenerating myelinated axon seen, a few regenerated clusters are present. The mild denervations type changes seen in this patients's muscle biopsy consist of occasional scattered esterase positive atrophic muscle fibers suggesting the presence of mild ongoing denervation.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Paralysis, Psoriasis, Psoriatic arthropathy, Spinal cord injury
Clinical narrative: Intense Migraines 15+ Days a month (Ubrelvy 100mg, 200 units of Botox), Loss of feeling in left leg, weakness, dystonia type reactions, paralysis (temporary / stiffness/ rigidness), Fibromyalgia, Psoriatic Arthritis, Psoriasis, HLA-B27, Myopathy, Facet Joint Syndrome, Spinal Cord Damage, Neuropathy, Mild Denervation type changes skeletal muscle (left quadriceps), degenerating myelinated axon seen, a few regenerated clusters are present. The mild denervations type changes seen in this patients's muscle biopsy consist of occasional scattered esterase positive atrophic muscle fibers suggesting the presence of mild ongoing denervation.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pain, Rash
Clinical narrative: painful at injection site, slight rash. Advised to give motrin as directed, use ice packs and monitor for additional symptoms and to call back if worsening
Age: 21.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: patient was 37w0d at time of Abrysvo administration
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Full blood count abnormal, Myelodysplastic syndrome
Clinical narrative: Beginning August 2021, reported labwork showed decreasing blood cell levels suddenly with no known cause. After extensive testing I was diagnosed with Myelodysplatic Syndrome (bone marrow cancer) in Feb 2022. I am in progressive end stage of life as of this date 1/31/2024. I believe this cancer may be a result of this vaccine as I had a clean bill of health prior to the vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Erythema at both injection sites (left anterior thigh and right anterior thigh)
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: all 4 vaccines given 10 days too early.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Patient became dizzy within 1 minute after vaccine administration. Lied on floor to let pass over.  Gave ice pack and cold water.  Did no lose consciousness at any point according to mother who was with her.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Night of vaccine, noticed sore arm, itching, and very hot. Placed ice pack and took Tylenol. About a week later took oral Benadryl and no relief.  January 19th went to Dr. Gave a steroid shot and prescribed oral abx
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Computerised tomogram abdomen, Computerised tomogram thorax, Culture urine
Clinical narrative: Hospitalized for COVID-19 on 1/26/2024
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Haemoglobin, Influenza A virus test, Influenza B virus test, Metabolic function test
Clinical narrative: Hospitalized for COVID-19 on 1/26/2024
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Renal function test, SARS-CoV-2 test, Staphylococcus test, Urine analysis
Clinical narrative: Hospitalized for COVID-19 on 1/26/2024
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cellulitis, Incorrect route of product administration, Injection site erythema, Injection site pain, Needle issue
Clinical narrative: Patient had redness and pain at injection site (tried warm compresses, ice, and mixture of Tylenol and ibuprofen). Patient went to Urgent Care and has diagnosed with cellulitis (prescribed Keflex 500 mg - take one capsule po bid for 10 days). Prescriber said the medication did not go through the muscle and was found in the subcutaneous space. Patient was given vaccine with 25 G x 1 inch needle (same as RSV vaccine and flu vaccine). Spoke with patient and arm is completely healed.
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: Autopsy, Death, Respiratory arrest, Resuscitation
Clinical narrative: According to the mother, the patient departed the clinic at 1 pm after the vaccine was administered. Subsequently, the patient took a nap and at approximately 8 pm, the father observed that the patient was not breathing. The parents attempted CPR but it was unsuccessful. Shortly thereafter, the parents called both ambulance and police assistance. Upon the paramedics' arrival, the patient had already deceased; The causes of death are unknown, An autopsy is presently in the process of being investigated. The mother has not yet reported the exact cause of death, information was given via a telephone call.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Staff discovered the Shingrix vaccine expired on 11/24/2023 when she documented the shot after administration.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Angiogram, Cardiac disorder, Chest X-ray, Dyspnoea exertional, Echocardiogram
Clinical narrative: Patient has sinusitis, had seen PCP in followup on 12/18, off antibiotics. Received seasonal flu and COVID vaccine that day. About 10-12 days after vaccination, reports onset of dyspnea with exertion. Had attributed to it at the time for new medication, metoprolol ER, which was started on 12/1/24. Saw cardiology who prescribed it. Dyspnea acutely worsened a week later, and was ultimately admitted to hospital, found to have bilateral pulmonary embolism with right heart strain
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Full blood count, International normalised ratio, Metabolic function test, Pulmonary embolism
Clinical narrative: Patient has sinusitis, had seen PCP in followup on 12/18, off antibiotics. Received seasonal flu and COVID vaccine that day. About 10-12 days after vaccination, reports onset of dyspnea with exertion. Had attributed to it at the time for new medication, metoprolol ER, which was started on 12/1/24. Saw cardiology who prescribed it. Dyspnea acutely worsened a week later, and was ultimately admitted to hospital, found to have bilateral pulmonary embolism with right heart strain
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Arthralgia, Chills, Malaise, Mobility decreased, Pain
Clinical narrative: SORE ARMS AND SHOULDERS THE NEXT MORNING, DIFFICULTY LIFTING ARMS, BODYACHES/JOINT ACHES, FEELS LIKE GETTING SICK/CHILLS
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pain in extremity
Clinical narrative: SORE ARMS AND SHOULDERS THE NEXT MORNING, DIFFICULTY LIFTING ARMS, BODYACHES/JOINT ACHES, FEELS LIKE GETTING SICK/CHILLS
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: arm in excruciating pain that radiates to shoulder and elbow and has caused limited ROM. began with severe pain on day of injection and persisted over a month after.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: It was discovered that the Shingrix vaccine expired on 11/24/2023 when the MA documented the shot after administration.
Age: 89.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given a second dose of Abrysvo. They had already received a dose on 09/12/2023. However, they came to office walk-in clinic and requested to be vaccinated for RSV. RSV was given on both 09/12/2023 and 11/14/2023. Patient does not report any adverse effects.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Culture negative, Culture wound negative, Cytogenetic analysis normal, Drainage, Flow cytometry
Clinical narrative: Greater than 8 month history of nonhealing chronic intermittently draining of fluid collections in bilateral thighs requiring antibiotics, surgical drainage and hospitalization
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Fluid retention, Fungal test, Fungal test negative, Immunoglobulins, Impaired healing
Clinical narrative: Greater than 8 month history of nonhealing chronic intermittently draining of fluid collections in bilateral thighs requiring antibiotics, surgical drainage and hospitalization
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Laboratory test normal, Mycobacterium test negative, Neutrophil count, Oedema peripheral
Clinical narrative: Greater than 8 month history of nonhealing chronic intermittently draining of fluid collections in bilateral thighs requiring antibiotics, surgical drainage and hospitalization
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Facial pain, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient had father call clinic on 1/30/24 at 11:49 to report that she woke that morning with pain so bad in her right arm that she couldn't even move it. Stated the pain radiated into her side, neck and cheek
Age: 30.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth, Skin texture abnormal
Clinical narrative: Patient sent picture of erythema around injection site. "localized swelling has increased to a firm lump, skin textured, very hot to touch, and localized pain, tender to touch"
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Patient received an extra dose of TDAP vaccine. No reaction or adverse side effects noted at this time. Patient was 31weeks 3 days along in her pregnancy on the date of incident (01/31/2024). She has an estimated delivery date of 03/31/2024.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Patient said he was unable to move arm and was in pain. Went to ER and the next day can now move arm a little better but stil stiff
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: had vaccine around 3:45 - 4pm 01/30/2024, and by 5:15 parents were taking patient to the ER. I'm not sure what has happened since.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Presyncope
Clinical narrative: Patient vasovagal reaction and bumped plaster wall as did so. He had not eaten breakfast. He was moved to the cot and no injuries noted. He came around and was a bit diaphoretic but okay. Cool pack to neck and apple juice given. Rested and observed. Vital signs done. Disposition to home at 1038 am. VS: @1025 99/64, 65, 18  @1028 103/62, 76, 18  @1031 113/71, 80, 18  @1033 106/68, 81, 18
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Diarrhoea, Facial pain, Pyrexia
Clinical narrative: I had the vaccine on 1/5/2024 and got Covid on 1/24/24 . High fever, cough, diarrhea, pain in the left side of my face
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus - bilateral but much worse in left ear - sudden onset
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Malaise, Nasal congestion, Respiratory tract congestion
Clinical narrative: chest congestion, stuffy nose, weakness, general malaise feeling.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received RSV (Arexvy) twice. first dose was 9/21/23 and second dose was 12/19/23. Pharmacy notified patient after receiving second dose to inquire about adverse effects. Patient did not report any adverse events.
Age: 17.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK, UNK, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received early vaccine
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Eyelid rash, Rash
Clinical narrative: I did not have issues at the injection site or physical location. I did receive the shot and then a month later developed a raw rash on my lip, chin and face that is raw and peels skin. Note: I put the incorrect date on the first slide. Vaccine dates were 03/18/21 and 04/15/21. My screen would not allow me to go backwards
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal distension, Lip swelling, Swelling face
Clinical narrative: Swollen face (specifically cheeks and lips) -- has improved since this morning as of 11 am
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Nausea, Pallor, Skin warm, Syncope, Vomiting
Clinical narrative: During post vaccination observation phase, at approximately 1128, client with syncopal episode, color pale, while seated with mother.  Ammonia inhalant administered; client aroused, awake, and oriented to person.  Moved to nursing station/module for observation/monitoring.  Episodes of nausea with vomiting commenced while seated.  Remained awake and oriented to person; color pink, skin warm; BP 85/52.   Observed for additional fifteen minutes, no further vomiting.  Released with mother.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: patient was given COVID vaccine and he already had one in November.2023
Age: 78.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Death, Lethargy, Pain, Somnolence
Clinical narrative: This is a friend who found out that her friend who was a doctor died and wanted it documented.  She had talked to him on 12/9/23 and he mentioned that he had had two vaccines, a COVID vaccine and a flu vaccine.   She talked to one of his staff members said that when he got his shot that it felt like a truck had run over him.  He was lethargic, and was falling asleep and felt that he could tough it out.  An ambulance was called, unknown who called and he was taken to Hospital, does not know how long he was there but was informed on 1/25/24 by his staff that he had passed away on 1/13/24.  She called to see why he was not answering his phone as she was always in close contact with him, and that's what they informed her of.   She called the funeral home and was informed that his son was taking care of the arrangements that that he was cremated and there were no services.   She had called him on 12/30/23 and it sounded like he picked up the phone, then it was dropped or he hung up, she does not know which, but did not speak to him after that.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Abscess, Erythema, Incisional drainage, Oedema, Pyrexia
Clinical narrative: Patient states that after receiving his flu shot he had redness, swelling and fever for about two weeks. After third week he developed edema and abscess and had to visit MD. MD cleared abscess with incision and started antibiotic treatment. Patient says he has a lot of scar tissue due to gun-shot wounds and this happens occasionally. Patient is better now.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Swelling
Clinical narrative: Patient states that after receiving his flu shot he had redness, swelling and fever for about two weeks. After third week he developed edema and abscess and had to visit MD. MD cleared abscess with incision and started antibiotic treatment. Patient says he has a lot of scar tissue due to gun-shot wounds and this happens occasionally. Patient is better now.
Age: 23.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Exposure during pregnancy, Pallor, Vomiting
Clinical narrative: 32wk 0d gestation patient weighing 234lbs 3.2oz  Estimated due date: 03/27/2024. Patient recieved the vaccine in her left deltoid, tolerated procedure well. 10 minutes after vaccine was given, patient started feeling faint, looking pale and vomited all over her clothes and the exam table. Laid patient down on the exam table on her left side, placed a cool washrag on her forehead, gave her water and sprite to drink, crackers to eat. Patient felt better about 20minutes later.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Starting on 1/19/24, one day after vaccination, patient reported starting to experience intermittent headaches, at times severe, with home systolic blood pressure readings between 150-190 through 1/27/24 AM. No nausea, vomiting, no vision, speech or hearing changes, no gait problems. No tingling or  numbness or weakness except for left arm numbness for 2 minutes when he woke up on 1/27/24. No chest pain, shortness of breath or palpitations.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Pain, Pain in extremity, Tenderness, Vision blurred
Clinical narrative: Patient stated a couple of days after getting the shot she couldn't see as well.  She said her eyes felt like there was an oily film and she had blurred vision and double vision.  She insists it was because she received the Moderna vaccine insted of Pfizer (like she had for the 4 previous vaccinations.)  She also stated she had a sore arm whenever she tried to move it or rubbed it (like in the shower.)
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given 12/18/2023 but had expired 12/13/2023 based on 10-week refrigerator stability. No adverse events noted as a result. Patient contacted and does not want to be revaccinated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administered vaccine on 12/18/2023 but vaccine had expired on 12/13/2023 based on 10-week refrigerator stability. No ADRs noted, patient will be re-vaccinated
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm turned red and swelling to double the size of normal arm.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 12/23/23 but vaccine had expired 12/13/2023 based on 10-week refrigerator stability. Patient contacted and does not want to be revaccinated
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 12/30/23 but vaccine had expired 12/13/23 based on 10-week refrigerator stability. Patient currently hospitalized. Will be offered re-vaccination when appropriate.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Expired product administered
Clinical narrative: Patient vaccinated 12/29/23 but vaccine had expired 12/13/23 based on 10-week refrigerator stability.  Patient expired, not from COVID
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 1/15/2024 but vaccine expired 12/13/23 based on 10-week refrigerator stability. Patient re-vaccinated 1/29/2024
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone High-Dose was given to a 31 year-old adult
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Developed  Shingles (Herpes Zoster) on face within 72 hours of vaccine.  Symptoms progressed into right side top of head and back.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated 1/17/24 but vaccine expired 12/13/2023 based on 10-week refrigerator stability. Patient was offered re-vaccination but declined.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Tic
Clinical narrative: approximately 26 days after the covid Pfizer booster (in total 3 shots) My son developed a tic where he would uncontrollably moves his nose and mouth. That he continues to have to this day.
Age: 74.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Biopsy skin, Burning sensation, Foreign travel, Rash, Rash papular
Clinical narrative: Rash began on 10/27/2023 on the front and back of torso. Rash consists of random small raised bumps that are itchy and burnie, per client. Rash still continues to today. No antihistamines or steroid creams have worked on it. Client has seen a dermatologist and they have taken to separate samples to determine the cause. Client did also travel to another country and got in river water on 10/24/2023.
Age: 74.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Rash pruritic
Clinical narrative: Rash began on 10/27/2023 on the front and back of torso. Rash consists of random small raised bumps that are itchy and burnie, per client. Rash still continues to today. No antihistamines or steroid creams have worked on it. Client has seen a dermatologist and they have taken to separate samples to determine the cause. Client did also travel to another country and got in river water on 10/24/2023.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated on 1/18/24 but vaccine expired 12/13/23 based on 10-week refrigerator stability. Patient was called to offer vaccination but could not be contacted.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Blood glucose increased, C-reactive protein increased, Gait disturbance, Mobility decreased
Clinical narrative: Severe joint pain, concentrating on left hip.  Unable to walk or bend well.  Hospitalized for several days.   Very severe limitation of movement and severe pain.  Was administered antibiotics with little effect.  Given IV steroids, oral tylenol and strong NSAIDS.  Was able to resume almost normal ambulation.  .Still have mild pain.  Even though I am not a diabetic, blood sugar rose to 400 with steroids, now monitoring glucose and taking short term metformin.  Still have some GI issues related to administration of NSAIDS.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain
Clinical narrative: Severe joint pain, concentrating on left hip.  Unable to walk or bend well.  Hospitalized for several days.   Very severe limitation of movement and severe pain.  Was administered antibiotics with little effect.  Given IV steroids, oral tylenol and strong NSAIDS.  Was able to resume almost normal ambulation.  .Still have mild pain.  Even though I am not a diabetic, blood sugar rose to 400 with steroids, now monitoring glucose and taking short term metformin.  Still have some GI issues related to administration of NSAIDS.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated on 1/18/2024 but vaccine had expired on 12/13/23 due to 10-week refrigerator stability. Patient called to offer re-vaccination but could not be reached.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 1/19/24 but vaccine had expired 12/13/23 based on 10-week refrigerator stability. Patient contacted to offer re-vaccination but declined.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus
Clinical narrative: Patient noticed her skin has turned red after receiving the PNEUMOCOCCAL CONJUGATE PCV 20 vaccine at her last visit on 01/08/2024. Patient    has only been able to clean with soap and water, no fevers and ear in the am she states it started itching.  Apply a cool compress. Use tylenol/ibu and apply some hydrocortisone cream to the area if its itching.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 1/24/24 but vaccine expired 12/13/23 based on 10-week refrigerator stability. Patient called to offer re-vaccination but declined.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired x 3 days.  call to Merck, they never recommend use beyond expiration but report that the vaccine was effective and would not advise repeat.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: Patient called about 2 to 3 hours after the vaccine from home to ask about whether the vaccine can cause lightheadedness or dizziness as she believed she experienced that but she felt fine now. Patient stated she felt fine now and felt better knowing the vaccine can have that side effect.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 1/21/24 but vaccine expired 12/13/23 based on 10-week refrigerator stability. Patient remains admitted and attending MD notified. MD to discuss revaccination with family.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 1/24/2024 but vaccine had expired 12/13/23 due to 10-week refrigerator stability. Patient remains admitted and attending MD notified. MD to discuss revaccination with patient.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Intercepted product dispensing error
Clinical narrative: Patient was ordered for vaccine 1/25/24. Dispending pharmacist recognized that the vaccine about to be dispensed expired 12/13/23 based on 10-week refrigerator stability. Upon noticing the expired vaccine, in-date vaccine was provided to patient. However, on 1/29/24 it was suspected that the patient had received expired vaccine and was re-vaccinated. Ultimately patient received 2 in-date vaccines (1/25 and 1/29)
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 12/26/23 but vaccine expired 12/18/23 based on 10-week fridge stability. Patient/family will be contacted to offer re-vaccination.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 1/4/2024 but vaccine expired 12/18/23 based on 10-week refrigerator stability. Patient/family will be contacted to offer re-vaccination.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no report of medical concerns or symptoms related to the administration of the expired dose of PNEUMOVAX 23/No additional AE; HBP reporting that a patient at their practice was inadvertently administered an expired dose of PNEUMOVAX 23 today, 1/4/2024, with a labeled expiration date of 10/20/2023.; This spontaneous report was received from an office manager (health business professional [HBP]) and referred to a patient of unknown age and gender. The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported.  On 03-JAN-2024, the patient was inadvertently vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (0.5 milliliter/once, lot #W007035, expiration date: 20-OCT-2023, strength, anatomical site of administration and route of administration) administered for prophylaxis at office manager's practice by health professional (expired product administered). HBP confirmed no report of medical concerns or symptoms related to the administration of the expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). No additional adverse event (AE) (no AE). No additional information provided.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; 22-year-old female received a fourth dose of GARDASIL 9; This spontaneous report was received from a registered nurse (health care professional [HCP]) via an company employee (FBE) and referred to a 22-year-old female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 03-JAN-2024 (also reported as yesterday), the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dose, strength, exact dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) administered for prophylaxis (extra dose administered), but was not certain. The FBE reported she went to the HCP's office 03-JAN-2024 (today) to discuss. No additional details provided. No additional adverse event (AE) (no AE).
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; PROQUAD and VARIVAX were administered on 15-DEC-2022; HBP reported that VARIVAX and PROQUAD were administered to patients after a temperature excursion.; This spontaneous report was received from Assistant Immunizations Manager and refers to a 4-year-old male. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 15-DEC-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W024971, expiration date: 05-FEB-2024, administered into the right arm for prophylaxis (strength, dose, and route of administration were not provided); and with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # reported as W024971 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), administered into the right arm for prophylaxis (strength, dose, expiry date, and route of administration were not provided) (overdose, product storage error).  Digital Data logger was involved. Administered doses of vaccines experienced a temperature excursion of -14 degrees Celsius for 6 minutes. There were no previous temperature excursions. No additional adverse event was reported.; Sender's Comments:  US-009507513-2212USA006312:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Medical assistant called to report that an expired dose of MMR II was administered to a patient. Caller stated the product expired 12/16/2023 and was administered 1/11/2024.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.  The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 11-JAN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #U039909, expiration date: 16-DEC-2023 (strength, and route of administration were not provided), 1 dose, administered for prophylaxis (expired product administered). It was stated the product was never involved in a temperature excursion. The patient has not reported any symptoms. No additional adverse event (AE) was reported (no adverse event).