chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Rash morbilliform, Rash pruritic, Red blood cell sedimentation rate
Clinical narrative: pruritic morbilliform rash began within 48 hours of receipt appeared on trunk and extremities feels achy has not self treated
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN FREEZER AND NOT FRIDGE. NO TREATMENT.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Moderna 3/19/21 Lot# 006B21A;  Modern a4/16/21 Lot# 043B21A;  Moderna 2/8/21 Lot# 029H21B;  Moderna 4/13/22 Lot# 002M21A;  Pfizer 12/21/22 LOt# GJ3275
Age: 56.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED INFLUENZA VACCINE ON 10/04/2022. PATIENT HAD PREVIOUSLY RECEIVED AN INFLUENZA VACCINE ON 09/20/2022 AT ANOTHER FACILITY.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Medication error, No adverse event
Clinical narrative: IT WAS NOT AN ADVERSE EVENT , BUT A MEDICATION ERROR. THE COVID-19 BIVALENT ( 6MONTHS-4YEARS)  MISTAKENLY DILUTED INSTEAD OF THE MONOVALENT ( 6MONTHS - 4 YEARS) AND WAS ADMINISTERED TO PATIENT.  DR MADE PARENT AWARE , THE CHILD IS FINE. THE DR ALSO CALLED CDC , SHE WAS TOLD THAT THE CHILD DO NO NEED ANY MORE DOSES OF COVID-19 VACCINE.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/31/21 Lot# Ew0150;  Pfizer 4/21/21 Lot# Ew0169
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Two swollen knots formed on the thigh - one at injection site and one within an inch. It took about a week and a half for the swelling and knots to subside fully.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic
Clinical narrative: vaccine created a local breakout of atopic dermatitis right thigh For Atopic dermatitis  Use cream once or twice a day   Can use other emmollient creams
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/4/21 Lot# EN6206;  Pfizer 3/25/21 Lot# En6206
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN FREEZER AND NOT IN FRIDGE. NO TREATMENT.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: 3RD DOSE MODERNA COVID VACCINE GIVEN 11/17/21, #012F21A; 4TH DOSE MODERNA COVID VACCINE GIVEN 8/19/22, #060AA2A; pt resides in Healthcare and Rehab Center; pt had a positive COVID test in facility on 8/31/22 and passed away on the same day in the facility
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines' Pfizer 2/25/21 Lot# En6200;  Pfizer 3/18/21 Lot# EN6208
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Aspiration joint normal, Back pain, COVID-19, COVID-19 pneumonia
Clinical narrative: Clinical Summary Patient  is a 82 y.o. female with a history of CHF, COPD, HTN, Chronic Pain, Left Knee Arthritis, who presented to RMH 1/17/2023 with 3-4 days of left thigh pain, left hip pain, fevers, chills, rigors. Found to have (+)COVID test and L Iliopsoas tear with inflammation.    1. Left Ileopsoas Tear:  presented to St. Ann's 1/12/22 with left thigh pain (discharged home) 3-4 days of fevers, chills, rigors prior to admit. CT-A/P 1/18/23: left iliopsoas inflammation from L3 level to insertion on proximal femur with fluid-density. MRI L hip with acute near full thickness tear of L iliopsoas tendon without infectious process. Ortho followed and recommended conservative care with outpatient follow up. 2. Acute on Chronic Left Knee Pain: Known osteoarthritis of both knees s/p Right TKA 8/23/21 with Dr. Underwent L knee aspiration 1/18/2023 with no evidence of septic arthritis.   3. Acute on Chronic DDD: CT A/P 1/18/23: severe spinal canal stenosis at L2-L5.  MRI Lumbar-Spine 1/18/23 severe central canal stenosis throughout L spine. Given back pain at baseline and no neurologic symptoms, defer to outpatient workup. 4. COVID-19 Pneumonia: Vaccinated (Pfizer x4 last 10/2021) symptom onset 1/16/23, (+)test 1/18/23, admit CXR negative for airspace disease. Discharged with Paxlovid therapy. To hold home statin and trazodone until completion of therapy.    5. Hx of Post-Operative AFIB: Diagnosed during right TKA in 8/2021, not on long term systemic AC per PCP.   6. COPD: Stable  7. HTN: Continued home Losartan/hydrochlorothiazide 8. Abnormal Imaging: MRI 1/18/2023 noted indeterminate nodular lesions within uterus, outpatient follow up
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chills, Computerised tomogram abdomen abnormal, Condition aggravated, Inflammation
Clinical narrative: Clinical Summary Patient  is a 82 y.o. female with a history of CHF, COPD, HTN, Chronic Pain, Left Knee Arthritis, who presented to RMH 1/17/2023 with 3-4 days of left thigh pain, left hip pain, fevers, chills, rigors. Found to have (+)COVID test and L Iliopsoas tear with inflammation.    1. Left Ileopsoas Tear:  presented to St. Ann's 1/12/22 with left thigh pain (discharged home) 3-4 days of fevers, chills, rigors prior to admit. CT-A/P 1/18/23: left iliopsoas inflammation from L3 level to insertion on proximal femur with fluid-density. MRI L hip with acute near full thickness tear of L iliopsoas tendon without infectious process. Ortho followed and recommended conservative care with outpatient follow up. 2. Acute on Chronic Left Knee Pain: Known osteoarthritis of both knees s/p Right TKA 8/23/21 with Dr. Underwent L knee aspiration 1/18/2023 with no evidence of septic arthritis.   3. Acute on Chronic DDD: CT A/P 1/18/23: severe spinal canal stenosis at L2-L5.  MRI Lumbar-Spine 1/18/23 severe central canal stenosis throughout L spine. Given back pain at baseline and no neurologic symptoms, defer to outpatient workup. 4. COVID-19 Pneumonia: Vaccinated (Pfizer x4 last 10/2021) symptom onset 1/16/23, (+)test 1/18/23, admit CXR negative for airspace disease. Discharged with Paxlovid therapy. To hold home statin and trazodone until completion of therapy.    5. Hx of Post-Operative AFIB: Diagnosed during right TKA in 8/2021, not on long term systemic AC per PCP.   6. COPD: Stable  7. HTN: Continued home Losartan/hydrochlorothiazide 8. Abnormal Imaging: MRI 1/18/2023 noted indeterminate nodular lesions within uterus, outpatient follow up
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc degeneration, Lumbar spinal stenosis, Magnetic resonance imaging abnormal, Magnetic resonance imaging spinal abnormal, Malaise
Clinical narrative: Clinical Summary Patient  is a 82 y.o. female with a history of CHF, COPD, HTN, Chronic Pain, Left Knee Arthritis, who presented to RMH 1/17/2023 with 3-4 days of left thigh pain, left hip pain, fevers, chills, rigors. Found to have (+)COVID test and L Iliopsoas tear with inflammation.    1. Left Ileopsoas Tear:  presented to St. Ann's 1/12/22 with left thigh pain (discharged home) 3-4 days of fevers, chills, rigors prior to admit. CT-A/P 1/18/23: left iliopsoas inflammation from L3 level to insertion on proximal femur with fluid-density. MRI L hip with acute near full thickness tear of L iliopsoas tendon without infectious process. Ortho followed and recommended conservative care with outpatient follow up. 2. Acute on Chronic Left Knee Pain: Known osteoarthritis of both knees s/p Right TKA 8/23/21 with Dr. Underwent L knee aspiration 1/18/2023 with no evidence of septic arthritis.   3. Acute on Chronic DDD: CT A/P 1/18/23: severe spinal canal stenosis at L2-L5.  MRI Lumbar-Spine 1/18/23 severe central canal stenosis throughout L spine. Given back pain at baseline and no neurologic symptoms, defer to outpatient workup. 4. COVID-19 Pneumonia: Vaccinated (Pfizer x4 last 10/2021) symptom onset 1/16/23, (+)test 1/18/23, admit CXR negative for airspace disease. Discharged with Paxlovid therapy. To hold home statin and trazodone until completion of therapy.    5. Hx of Post-Operative AFIB: Diagnosed during right TKA in 8/2021, not on long term systemic AC per PCP.   6. COPD: Stable  7. HTN: Continued home Losartan/hydrochlorothiazide 8. Abnormal Imaging: MRI 1/18/2023 noted indeterminate nodular lesions within uterus, outpatient follow up
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Pyrexia, SARS-CoV-2 test positive, Tendon rupture
Clinical narrative: Clinical Summary Patient  is a 82 y.o. female with a history of CHF, COPD, HTN, Chronic Pain, Left Knee Arthritis, who presented to RMH 1/17/2023 with 3-4 days of left thigh pain, left hip pain, fevers, chills, rigors. Found to have (+)COVID test and L Iliopsoas tear with inflammation.    1. Left Ileopsoas Tear:  presented to St. Ann's 1/12/22 with left thigh pain (discharged home) 3-4 days of fevers, chills, rigors prior to admit. CT-A/P 1/18/23: left iliopsoas inflammation from L3 level to insertion on proximal femur with fluid-density. MRI L hip with acute near full thickness tear of L iliopsoas tendon without infectious process. Ortho followed and recommended conservative care with outpatient follow up. 2. Acute on Chronic Left Knee Pain: Known osteoarthritis of both knees s/p Right TKA 8/23/21 with Dr. Underwent L knee aspiration 1/18/2023 with no evidence of septic arthritis.   3. Acute on Chronic DDD: CT A/P 1/18/23: severe spinal canal stenosis at L2-L5.  MRI Lumbar-Spine 1/18/23 severe central canal stenosis throughout L spine. Given back pain at baseline and no neurologic symptoms, defer to outpatient workup. 4. COVID-19 Pneumonia: Vaccinated (Pfizer x4 last 10/2021) symptom onset 1/16/23, (+)test 1/18/23, admit CXR negative for airspace disease. Discharged with Paxlovid therapy. To hold home statin and trazodone until completion of therapy.    5. Hx of Post-Operative AFIB: Diagnosed during right TKA in 8/2021, not on long term systemic AC per PCP.   6. COPD: Stable  7. HTN: Continued home Losartan/hydrochlorothiazide 8. Abnormal Imaging: MRI 1/18/2023 noted indeterminate nodular lesions within uterus, outpatient follow up
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine disorder
Clinical narrative: Clinical Summary Patient  is a 82 y.o. female with a history of CHF, COPD, HTN, Chronic Pain, Left Knee Arthritis, who presented to RMH 1/17/2023 with 3-4 days of left thigh pain, left hip pain, fevers, chills, rigors. Found to have (+)COVID test and L Iliopsoas tear with inflammation.    1. Left Ileopsoas Tear:  presented to St. Ann's 1/12/22 with left thigh pain (discharged home) 3-4 days of fevers, chills, rigors prior to admit. CT-A/P 1/18/23: left iliopsoas inflammation from L3 level to insertion on proximal femur with fluid-density. MRI L hip with acute near full thickness tear of L iliopsoas tendon without infectious process. Ortho followed and recommended conservative care with outpatient follow up. 2. Acute on Chronic Left Knee Pain: Known osteoarthritis of both knees s/p Right TKA 8/23/21 with Dr. Underwent L knee aspiration 1/18/2023 with no evidence of septic arthritis.   3. Acute on Chronic DDD: CT A/P 1/18/23: severe spinal canal stenosis at L2-L5.  MRI Lumbar-Spine 1/18/23 severe central canal stenosis throughout L spine. Given back pain at baseline and no neurologic symptoms, defer to outpatient workup. 4. COVID-19 Pneumonia: Vaccinated (Pfizer x4 last 10/2021) symptom onset 1/16/23, (+)test 1/18/23, admit CXR negative for airspace disease. Discharged with Paxlovid therapy. To hold home statin and trazodone until completion of therapy.    5. Hx of Post-Operative AFIB: Diagnosed during right TKA in 8/2021, not on long term systemic AC per PCP.   6. COPD: Stable  7. HTN: Continued home Losartan/hydrochlorothiazide 8. Abnormal Imaging: MRI 1/18/2023 noted indeterminate nodular lesions within uterus, outpatient follow up
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given 0.2 ml of the 10 mcg/0.2 ml concentration (for ages 5-11) rather than 3 mcg/0.2 ml.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 2/9/21 Lot# EL9269;  Pfizer 3/2/21 Lot# EN6202;  Pfizer 11/6/21 Lot# FH8020
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Pt reports chills, headache, fatigue, and muscle aches
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction, but patient was given the vaccine outside of the recommended BUD.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental Improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event, but the vaccine was given to the patient beyond the recommended BUD.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN FREEZER AND NOT IN FRIDGE. NO TREATMENT.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory disturbance, Skin tightness, Tremor
Clinical narrative: I received a fu vaccine, but I don't know which one I got.  I felt a tightness around my upper arms and both hands shook.  It lasted about 30 minutes.  It happened about 4 hours after the injection.  I have a small amount of shaking today at about the same time as yesterday, but not as much movement as yesterday.  There is only a small amount of movement when holding something.  I also have a strange feeling in my arms and wrist.  This is mostly on the right side.  I have not had something like this happen before.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Crying, Poor quality sleep, Productive cough, Vomiting
Clinical narrative: Mom called. She states that patient had vaccine yesterday. Since then, he has been up wimpering or crying. Did not sleep well last night.  His rectal temp was 103.2. She is giving tylenol, but thinks that he spit up last dose. Patient is eating ok and having appropriate amount of wet diapers. She states that patient had a slight cough prior to getting the vaccinations, but now it's more phlegmy. Please advise.  Nurse Call  Per NP  Continue to monitor. We discussed normal for a slight temp. Lungs were clear on exam yesterday. Continue tylenol or ibuprofen every 6 hours. Should improve in the next 24 hours. If tylenol not working for temp, can try ibuprofen it is ok now that he is 6 months and sometimes works better.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Acute disseminated encephalomyelitis, Anaemia of chronic disease, Angiogram cerebral abnormal, Angiotensin converting enzyme decreased, Anti-GAD antibody negative
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Anti-NMDA antibody negative, Anti-ganglioside antibody negative, Anti-thyroid antibody, Antibody test negative, Antineutrophil cytoplasmic antibody negative
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Arteriogram carotid abnormal, Autoantibody negative, Autoimmune disorder, Barium swallow
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Biopsy brain abnormal, Blood copper, Blood folate normal, Blood immunoglobulin G normal, Blood iron abnormal
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Blood smear test abnormal, Brain oedema, Bronchial secretion retention, CD4 lymphocytes normal, CSF glucose increased
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: CSF immunoglobulin G index, CSF immunoglobulin increased, CSF lymphocyte count increased, CSF neutrophil count increased, CSF oligoclonal band absent
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: CSF pressure increased, CSF protein increased, CSF red blood cell count positive, CSF test abnormal, CSF white blood cell count increased
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebral infarction, Ceruloplasmin, Chest tube insertion, Computerised tomogram abdomen normal, Computerised tomogram thorax abnormal
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Cryptococcus test, Cytology abnormal, Depressed level of consciousness, Diffusion-weighted brain MRI abnormal
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Dysarthria, Echocardiogram abnormal, Ejection fraction decreased, Electroencephalogram abnormal, Encephalitis
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Encephalomyelitis, Epstein-Barr virus test negative, Fungal test negative, Gram stain negative, Gram stain positive
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Granulocytosis, Haemoglobinopathy, Headache, Hypermetabolism, Hyperthyroidism
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: IVth nerve paralysis, Imaging procedure artifact, Immunology test normal, Inflammation, Intracranial hypotension
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Intracranial pressure increased, Iron deficiency, Irritability, Laboratory test, Laboratory test normal
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Left ventricular dysfunction, Leukocytosis, Lumbar puncture abnormal, Lung consolidation, Lymphocytic infiltration
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Meningism, Meningitis aseptic
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Metastatic neoplasm, Microcytic anaemia, Mycobacterium tuberculosis complex test negative, Myoclonus, Opsoclonus myoclonus
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Optic nerve disorder, Papilloedema, Perfusion brain scan, Phonophobia, Photophobia
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Pituitary hyperplasia, Pituitary scan abnormal, Platelet morphology abnormal, Pleocytosis, Pneumomediastinum
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia, Pneumothorax, Positron emission tomogram abnormal, Post lumbar puncture syndrome, Pupillary reflex impaired
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Radiculopathy, Red blood cell count abnormal, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive, Scan with contrast abnormal
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Sexually transmitted disease test, Sideroblastic anaemia, Staphylococcus test positive, Thalassaemia, Thrombocytopenia
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Toxoplasma serology negative, Treponema test negative, VIth nerve paralysis, Venogram abnormal, Ventricular hypokinesia
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Viral test negative, Vitamin B1, Vitamin B12 normal, Vitamin B6, West Nile virus test negative
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell disorder, White matter lesion
Clinical narrative: 1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches, headaches, fatigue, chills, nausea
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sleep disorder, Tinnitus
Clinical narrative: 5/27/22 7 PM - Bad headache and  extremely loud ringing in ears 9 PM -  took 250mg Motrin; did not seem to alleviate either symptom; symptoms kept me awake most of the night 5/28/22 - both symptoms have mostly subsided by evening
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient reported needing a bivalent booster when seeing a provider in our office. Provider handed off to MA, who reviewed the chart and did not note any previous bivalent administrations. Vaccine was given. When trying to document, MA noticed bivalent vaccine had been pulled into chart (perhaps from local registry information) and noticed error. Provider informed patient of the error and that no harm was likely to occur. Event discussed with affected staff for prevention in future.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, Wrong dose given. Given Moderna Bi-valent .25
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest discomfort, Dysphagia, Dyspnoea, Electrocardiogram normal
Clinical narrative: Early morning around 2AM, I was feeling heaviness in the chest. I tried to drink water and had difficulty swallowing, I decided to go to the ER in the morning. They did an EKG, blood test and X-Ray, No heart issues. I was still having difficulty breathing and broke out in hives. I was given Benadryl, but it didn't help, I was prescribed Atrox for every 6 hours. Overtime things did get worst with the hives. February, I met the doctor again and she switched me from Atrox back to Benadryl. I use topical treatments like Benadryl spray. I'm still having the itching, so I use a moisturizer, it hasn't improved. Within the next few weeks, I will be going to an allergist for the next course of action.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria, X-ray normal
Clinical narrative: Early morning around 2AM, I was feeling heaviness in the chest. I tried to drink water and had difficulty swallowing, I decided to go to the ER in the morning. They did an EKG, blood test and X-Ray, No heart issues. I was still having difficulty breathing and broke out in hives. I was given Benadryl, but it didn't help, I was prescribed Atrox for every 6 hours. Overtime things did get worst with the hives. February, I met the doctor again and she switched me from Atrox back to Benadryl. I use topical treatments like Benadryl spray. I'm still having the itching, so I use a moisturizer, it hasn't improved. Within the next few weeks, I will be going to an allergist for the next course of action.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Mobility decreased, Swelling
Clinical narrative: pt developed red, painful area on her arm a few inches below injection site.  The redness and swelling has gone away, but the pain has not.  She still cannot fully lift her arm over her head.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: I had not been feeling well on the Saturday morning. By the evening I had gotten much worse and ended up taking a COVID-19 home test and it was positive. I was having a headache, fever, my body was aching, congestion, a cough, and I was so tired. I ended up reaching out to my doctor's office on Sunday and did a telehealth appointment with them. At this point I had taken two COVID-19 Home Tests and they were both positive. Due to my symptoms and the fever, they gave a prescription for Molnupiravir because I had not gone in and done blood work to get Paxlovid. I was really sick for about ten days and was very sick through this time and just miserable. The fever did come down, but I was so tired and unable to think clearly.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Mental impairment, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: I had not been feeling well on the Saturday morning. By the evening I had gotten much worse and ended up taking a COVID-19 home test and it was positive. I was having a headache, fever, my body was aching, congestion, a cough, and I was so tired. I ended up reaching out to my doctor's office on Sunday and did a telehealth appointment with them. At this point I had taken two COVID-19 Home Tests and they were both positive. Due to my symptoms and the fever, they gave a prescription for Molnupiravir because I had not gone in and done blood work to get Paxlovid. I was really sick for about ten days and was very sick through this time and just miserable. The fever did come down, but I was so tired and unable to think clearly.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had not been feeling well on the Saturday morning. By the evening I had gotten much worse and ended up taking a COVID-19 home test and it was positive. I was having a headache, fever, my body was aching, congestion, a cough, and I was so tired. I ended up reaching out to my doctor's office on Sunday and did a telehealth appointment with them. At this point I had taken two COVID-19 Home Tests and they were both positive. Due to my symptoms and the fever, they gave a prescription for Molnupiravir because I had not gone in and done blood work to get Paxlovid. I was really sick for about ten days and was very sick through this time and just miserable. The fever did come down, but I was so tired and unable to think clearly.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: As this was the patent's first dose of her primary series.  Pfizer COVID MONOVALENT for ages 12 and older should have been given.  However, Pfizer COVID BIVALENT for ages 12 and older was given by accident.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Hyperhidrosis, Palpitations
Clinical narrative: 1. Feelings of having a fast-beating and pounding heart in the night. 2. Sweet often during the day without excise.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arrhythmia, Chest X-ray, Condition aggravated, Dizziness
Clinical narrative: 2nd day post vaccine I started to feel really anxious, irritable, flushed skin, migraine and started to have tachycardia that would not go away. Felt like my skin was crawling increased SOB with how fast my heart rate was. + dizziness and lightheaded also. My resting heart rate was 180-200. when SX did not get better I was seen at the MD office and sent directly to the ER. I was admitted for OBS & treatment for the tachycardia. Advised to never receive the vaccine again. I was discharged home with new medications and a cardiac halter monitor to wear nonstop x 2 weeks. serial Troponin's, EKG's and cardiac ECHO/TEE also completed.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Echocardiogram abnormal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal
Clinical narrative: 2nd day post vaccine I started to feel really anxious, irritable, flushed skin, migraine and started to have tachycardia that would not go away. Felt like my skin was crawling increased SOB with how fast my heart rate was. + dizziness and lightheaded also. My resting heart rate was 180-200. when SX did not get better I was seen at the MD office and sent directly to the ER. I was admitted for OBS & treatment for the tachycardia. Advised to never receive the vaccine again. I was discharged home with new medications and a cardiac halter monitor to wear nonstop x 2 weeks. serial Troponin's, EKG's and cardiac ECHO/TEE also completed.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Formication, Heart rate increased, Irritability, Laboratory test
Clinical narrative: 2nd day post vaccine I started to feel really anxious, irritable, flushed skin, migraine and started to have tachycardia that would not go away. Felt like my skin was crawling increased SOB with how fast my heart rate was. + dizziness and lightheaded also. My resting heart rate was 180-200. when SX did not get better I was seen at the MD office and sent directly to the ER. I was admitted for OBS & treatment for the tachycardia. Advised to never receive the vaccine again. I was discharged home with new medications and a cardiac halter monitor to wear nonstop x 2 weeks. serial Troponin's, EKG's and cardiac ECHO/TEE also completed.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Tachycardia, Troponin
Clinical narrative: 2nd day post vaccine I started to feel really anxious, irritable, flushed skin, migraine and started to have tachycardia that would not go away. Felt like my skin was crawling increased SOB with how fast my heart rate was. + dizziness and lightheaded also. My resting heart rate was 180-200. when SX did not get better I was seen at the MD office and sent directly to the ER. I was admitted for OBS & treatment for the tachycardia. Advised to never receive the vaccine again. I was discharged home with new medications and a cardiac halter monitor to wear nonstop x 2 weeks. serial Troponin's, EKG's and cardiac ECHO/TEE also completed.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a dose of bivalent COVID vaccine after the Beyond Use date. No reported adverse effects
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a dose of the Bivalent Covid vaccine after the beyond use date. No reported adverse effects.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Chest X-ray normal, Chills, Cold sweat, Cough
Clinical narrative: On 01/02/2023 I started feeling extreme fatigue, malaise, cold sweats and chills for a few days. On day 5 my cough started progressing and was prescribed PAXLOVID. However my cough still lingered I had a chest x-ray and was negative for Pneumonia and Bronchitis. About a week later I was diagnosed with a UTI. I also had a rash and peeling skin on my feet. This may be due to having RA as this is one of the side effects.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Malaise, Rash, SARS-CoV-2 test positive, Skin exfoliation
Clinical narrative: On 01/02/2023 I started feeling extreme fatigue, malaise, cold sweats and chills for a few days. On day 5 my cough started progressing and was prescribed PAXLOVID. However my cough still lingered I had a chest x-ray and was negative for Pneumonia and Bronchitis. About a week later I was diagnosed with a UTI. I also had a rash and peeling skin on my feet. This may be due to having RA as this is one of the side effects.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Urinary tract infection
Clinical narrative: On 01/02/2023 I started feeling extreme fatigue, malaise, cold sweats and chills for a few days. On day 5 my cough started progressing and was prescribed PAXLOVID. However my cough still lingered I had a chest x-ray and was negative for Pneumonia and Bronchitis. About a week later I was diagnosed with a UTI. I also had a rash and peeling skin on my feet. This may be due to having RA as this is one of the side effects.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No symptomatic AEs reported during call. No additional AE details or PQC; Inbound call from HCP reporting a VARIVAX dose was inadvertently given intramuscularly instead of subcutaneously. No symptomatic AEs reported during call. No additional AE details or PQC.; This spontaneous report has been received from a medical assistant, regarding a 34-years-old female (also reported as 24-years-old, conflicting information). The patient's pertinent medical history included condylomas as current condition, previous drug reactions or allergies and concomitant medications were not reported.    On 16-JAN-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, (lot number: W003819, which was determined to be valid, with an expiration date on 02-FEB-2024), with an sterile diluent, Solution for injection/infusion (lot number: W010871, which was determined to be valid, with an expiration date on 17-NOV-2024), inadvertently given intramuscularly instead of subcutaneously in the left deltoid as prophylaxis (strength and, doses were not reported). (Incorrect route of product administration). The outcome of Incorrect route of product administration was reported as recovered.   It was reported that a repeat dose was not needed, and no adverse reactions were noted.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE information reported; 1 dose of PROQUAD and 1 dose of VARIVAX were accidentally administered to a patient concomitantly on 1/19/2023; This spontaneous report was received from a pediatrician and refers to a 1-year-old (reported as "1 year, 1 day old") patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 19-JAN-2023, the patient was accidentally administered one dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W006412, expiration date 23-FEB-2024 (exact dose, route of administration and anatomical location were not provided) concomitantly with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, lot # W024980, expiration date 05-FEB-2024 (exact dose, route of administration and anatomical location were not provided) as prophylaxis (accidental overdose). No additional adverse event information was reported (no adverse event).