chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Lipoma, Magnetic resonance imaging abnormal, Product administered at inappropriate site
Clinical narrative: The Tdap shot was administered 10/20/2020 by a pharmacy tech who injected into a site that was lower than typical on my right arm; rather than near the top where most of the muscle is, the shot site was approximately 6 inches below the top of the shoulder and caused significant pain at the time of the injection, and for a couple of days afterwards - not my usual experience taking vaccines.  (I also received shot one of the Shingrix vaccine on the same day on the left arm, but due to the nature of my report, do not think it is associated with the issue I am reporting.) A few months later, around July of 2021, my wife noticed a bulge in the back of my right arm, almost precisely where the Tdap shot was given.  As we were leaving for an extended two month vacation and I had no specific other symptoms, I planned to review it at my annual physical in November 2021.  By this time the bulge was quite large and no longer explainable merely as a difference in muscle mass.  Upon ultrasound and MRI, this was identified as a probable lipoma, but due to the location and my age thought to be a possible liposarcoma (cancerous), which required a special surgeon at the facility - Dr. - to remove on March 4, 2022.  It was approximately 10-12 cm in size.  Fortunately, it was found to be non-cancerous.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Ultrasound scan abnormal
Clinical narrative: The Tdap shot was administered 10/20/2020 by a pharmacy tech who injected into a site that was lower than typical on my right arm; rather than near the top where most of the muscle is, the shot site was approximately 6 inches below the top of the shoulder and caused significant pain at the time of the injection, and for a couple of days afterwards - not my usual experience taking vaccines.  (I also received shot one of the Shingrix vaccine on the same day on the left arm, but due to the nature of my report, do not think it is associated with the issue I am reporting.) A few months later, around July of 2021, my wife noticed a bulge in the back of my right arm, almost precisely where the Tdap shot was given.  As we were leaving for an extended two month vacation and I had no specific other symptoms, I planned to review it at my annual physical in November 2021.  By this time the bulge was quite large and no longer explainable merely as a difference in muscle mass.  Upon ultrasound and MRI, this was identified as a probable lipoma, but due to the location and my age thought to be a possible liposarcoma (cancerous), which required a special surgeon at the facility - Dr. - to remove on March 4, 2022.  It was approximately 10-12 cm in size.  Fortunately, it was found to be non-cancerous.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was mistakenly given the moderna primary dose for pediatric patients, as the bottle is still labeled "for booster dose only", but was supposed to get the moderna bivalent booster. The patient was informed of the mistake and did not have any adverse reactions. He decided to delay getting the bivalent booster in January after the holidays.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fear, Tinnitus
Clinical narrative: The Moderna COVID-19 primary vaccination series caused me to have tinnitus in spring 2021. The 1st dose of the Shingrix vaccine caused it to be much worse! I am so fearful now to get the 2nd dose!
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Underdose
Clinical narrative: The patient was mistakenly given the moderna primary dose for pediatric patients, as the bottle is still labeled "for booster dose only", but was supposed to get the moderna bivalent booster. The patient was informed of the mistake and did not have any adverse reactions. She received the correct moderna bivalent booster dose on 12/23/2022
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports having a swollen, warm to the touch, where the skin near the injection site also became hard to touch. Right arm in general has been quite painful for a week now.  The pain started right with the injection and was worse for the first two days following injection. Pt has been using a warm compress and taking Tylenol to help with the pain.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Bradyphrenia, Cognitive disorder, Crying, Fatigue
Clinical narrative: Within one hour: irritability, crying and fatigue. These symptoms are still present daily.   After invasive medical testing it was discovered that she now has inflammation throughout the body and specifically in digestive system.  Slower thinking and comprehension were noted. Stomach pain almost daily.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Inflammation, Irritability, Laboratory test abnormal
Clinical narrative: Within one hour: irritability, crying and fatigue. These symptoms are still present daily.   After invasive medical testing it was discovered that she now has inflammation throughout the body and specifically in digestive system.  Slower thinking and comprehension were noted. Stomach pain almost daily.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Bell's palsy, Pain, Pain in extremity
Clinical narrative: Extreme pain throughout like lighting up like a Christmas tree. Still happening, even after anti viral and steroid script. Systemic pain throughout lower back and legs especially. Then, 18 days later,, Bells Palsy
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given Fluzone High Dose indicated for 65 and older.  Patient is 58
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given Fluzone High Dose indicated for 65 and older.  Patient is 59 yo.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Echocardiogram, Electrocardiogram ambulatory, Heart rate decreased
Clinical narrative: Constant palpitations, chest pain, decreased heart rate. Currently on Metoprolol and being evaluated for an ablation.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Palpitations
Clinical narrative: Constant palpitations, chest pain, decreased heart rate. Currently on Metoprolol and being evaluated for an ablation.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Breast tenderness, Pain in extremity
Clinical narrative: sore arm discomfort in right breast (sore, tender)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: Got the second dose of a covid shot. The very next day I was having chronic shoulder pain, numbness, etc that radiates into my chest breastbone area.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was diluted with expired saline.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was diluted with expired saline.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was diluted with expired saline.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was diluted with expired saline.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was diluted with expired saline.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was diluted with expired saline.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: There are no adverse events reported
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was diluted with expired saline.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: Vaccine was diluted with expired saline.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 64 yo female patient given Fluzone HD indicated for 65 and older.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Hyperhidrosis, Pruritus
Clinical narrative: Patient received Covid19 vaccine booster (BioNTECH Bivalent) at 1352H today. At 1403 pt c/o being "Itchy and sweaty and feeling warm"  Patient denied SOB and no chest pain, administered o2 via mask at 10 lpm, administered normal saline 0.9% and Diphenhyramine 50mg IVP also given at 1407 per allergic reaction protocol. Patient was monitored closely and condition improved approximately at 1416 post intervention. No other allergy protocol medicine given after diphenhydramine. Patient stayed, observed for any changes in status for next 45 mins.   Patient was discharge with No new c/o voiced,AAOX3, standing b/p of 121/62 and pulse 77 Reg. Stable.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Rash pruritic
Clinical narrative: Swollen left occipital lymph node accompanied by small itchy bumps that come and go.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 64 yo male given Fluzone HD indicated for 65 years old and older
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fear, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: 11 pm day of vaccine, fever extreme chills.  Very bad muscle pain through the night (felt worse than the worst flu I had ever had) it hurt to move in the slightest.  Sweating alternating with freezing cold.  Next day fever 102 or 103.  Around noon, started VERY intense chills, causing extreme shaking.  Then started having muscle spasms with the shaking.  The spasms are intensely painful.  I have to lie down.  The cold  feeling is so bad blankets are piled on me and heating pad is put in the bed.  Hands shaking so bad I cannot hold phone to dial.  I am now starting to be fearful that something bad is going to happen to me, the spasms are so strong and painful.  These last several scary hours.  They subside and I have a fever for a week.  The headache probably started the second day.  I start taking tylenol around the clock.   I go to the doctor and get prescribed something.  I continue with tylenol around the clock.  Mid December I cut back to tylenol twice a day.  Christmas day was my first day without tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms, Myalgia, Pain, Pyrexia, SARS-CoV-2 antibody test positive
Clinical narrative: 11 pm day of vaccine, fever extreme chills.  Very bad muscle pain through the night (felt worse than the worst flu I had ever had) it hurt to move in the slightest.  Sweating alternating with freezing cold.  Next day fever 102 or 103.  Around noon, started VERY intense chills, causing extreme shaking.  Then started having muscle spasms with the shaking.  The spasms are intensely painful.  I have to lie down.  The cold  feeling is so bad blankets are piled on me and heating pad is put in the bed.  Hands shaking so bad I cannot hold phone to dial.  I am now starting to be fearful that something bad is going to happen to me, the spasms are so strong and painful.  These last several scary hours.  They subside and I have a fever for a week.  The headache probably started the second day.  I start taking tylenol around the clock.   I go to the doctor and get prescribed something.  I continue with tylenol around the clock.  Mid December I cut back to tylenol twice a day.  Christmas day was my first day without tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: 11 pm day of vaccine, fever extreme chills.  Very bad muscle pain through the night (felt worse than the worst flu I had ever had) it hurt to move in the slightest.  Sweating alternating with freezing cold.  Next day fever 102 or 103.  Around noon, started VERY intense chills, causing extreme shaking.  Then started having muscle spasms with the shaking.  The spasms are intensely painful.  I have to lie down.  The cold  feeling is so bad blankets are piled on me and heating pad is put in the bed.  Hands shaking so bad I cannot hold phone to dial.  I am now starting to be fearful that something bad is going to happen to me, the spasms are so strong and painful.  These last several scary hours.  They subside and I have a fever for a week.  The headache probably started the second day.  I start taking tylenol around the clock.   I go to the doctor and get prescribed something.  I continue with tylenol around the clock.  Mid December I cut back to tylenol twice a day.  Christmas day was my first day without tylenol.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient is experiencing hot, swollen, and itching at injection site.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Cognitive disorder, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: 11/19/22- woke up with severe dizziness and fatigue- improved slightly over the course of a week, but with progressive weakness (limb) and brain fog/cognitive impairment/vision  problems.  Started Methylprenisolone steroid pack on 11/25 and noted some improvement.  Dizziness continued to rapidly improve but weakness persisted/worsened.  Felt max improvement on day of 12/1, then took a serious turn.  By late evening of 12/1, developed numbness/tingling in both arms.  On 12/2 attempted a short walk and immediately both arms started to tingle and went numb and shortly after the soles of both feet began to tingle.  Attempted to drive later shortly after dark and was unable to focus eyes- called for assistance.  Became progressively weaker and woke on 12/5 pm with difficulty breathing.  Also unable to walk more than a few steps- needed assistance,  Went to ER on 12/6, EKG normal, MRI of brain and spine with and without contrast was normal, sent home in am of 12/7.  Saw PCP on 12/7 and started Prednisone 60 mg daily (1mg/kg).  Noted improvement second day and was able to walk with pole.  Continued to walk with pole for the next week.  Dizziness some better, but still not able to drive, eyes still out of focus.  Have tapered down on steroids, currently on 20 mg on 12/26/22.  Able to drive and walk without assistance, but still with some brain fog and severe fatigue.  Have not been able to work in 6 weeks.  Saw Neuro on 12/20 who stated exam was fine and problems were not neuro related.  Did not perform any evaluation of cognitive function- results were based on touching nose with finger and normal reflexes.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Hypoaesthesia, Impaired work ability
Clinical narrative: 11/19/22- woke up with severe dizziness and fatigue- improved slightly over the course of a week, but with progressive weakness (limb) and brain fog/cognitive impairment/vision  problems.  Started Methylprenisolone steroid pack on 11/25 and noted some improvement.  Dizziness continued to rapidly improve but weakness persisted/worsened.  Felt max improvement on day of 12/1, then took a serious turn.  By late evening of 12/1, developed numbness/tingling in both arms.  On 12/2 attempted a short walk and immediately both arms started to tingle and went numb and shortly after the soles of both feet began to tingle.  Attempted to drive later shortly after dark and was unable to focus eyes- called for assistance.  Became progressively weaker and woke on 12/5 pm with difficulty breathing.  Also unable to walk more than a few steps- needed assistance,  Went to ER on 12/6, EKG normal, MRI of brain and spine with and without contrast was normal, sent home in am of 12/7.  Saw PCP on 12/7 and started Prednisone 60 mg daily (1mg/kg).  Noted improvement second day and was able to walk with pole.  Continued to walk with pole for the next week.  Dizziness some better, but still not able to drive, eyes still out of focus.  Have tapered down on steroids, currently on 20 mg on 12/26/22.  Able to drive and walk without assistance, but still with some brain fog and severe fatigue.  Have not been able to work in 6 weeks.  Saw Neuro on 12/20 who stated exam was fine and problems were not neuro related.  Did not perform any evaluation of cognitive function- results were based on touching nose with finger and normal reflexes.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness, Neurological examination normal, Paraesthesia
Clinical narrative: 11/19/22- woke up with severe dizziness and fatigue- improved slightly over the course of a week, but with progressive weakness (limb) and brain fog/cognitive impairment/vision  problems.  Started Methylprenisolone steroid pack on 11/25 and noted some improvement.  Dizziness continued to rapidly improve but weakness persisted/worsened.  Felt max improvement on day of 12/1, then took a serious turn.  By late evening of 12/1, developed numbness/tingling in both arms.  On 12/2 attempted a short walk and immediately both arms started to tingle and went numb and shortly after the soles of both feet began to tingle.  Attempted to drive later shortly after dark and was unable to focus eyes- called for assistance.  Became progressively weaker and woke on 12/5 pm with difficulty breathing.  Also unable to walk more than a few steps- needed assistance,  Went to ER on 12/6, EKG normal, MRI of brain and spine with and without contrast was normal, sent home in am of 12/7.  Saw PCP on 12/7 and started Prednisone 60 mg daily (1mg/kg).  Noted improvement second day and was able to walk with pole.  Continued to walk with pole for the next week.  Dizziness some better, but still not able to drive, eyes still out of focus.  Have tapered down on steroids, currently on 20 mg on 12/26/22.  Able to drive and walk without assistance, but still with some brain fog and severe fatigue.  Have not been able to work in 6 weeks.  Saw Neuro on 12/20 who stated exam was fine and problems were not neuro related.  Did not perform any evaluation of cognitive function- results were based on touching nose with finger and normal reflexes.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Scan with contrast normal, Vision blurred, Visual impairment
Clinical narrative: 11/19/22- woke up with severe dizziness and fatigue- improved slightly over the course of a week, but with progressive weakness (limb) and brain fog/cognitive impairment/vision  problems.  Started Methylprenisolone steroid pack on 11/25 and noted some improvement.  Dizziness continued to rapidly improve but weakness persisted/worsened.  Felt max improvement on day of 12/1, then took a serious turn.  By late evening of 12/1, developed numbness/tingling in both arms.  On 12/2 attempted a short walk and immediately both arms started to tingle and went numb and shortly after the soles of both feet began to tingle.  Attempted to drive later shortly after dark and was unable to focus eyes- called for assistance.  Became progressively weaker and woke on 12/5 pm with difficulty breathing.  Also unable to walk more than a few steps- needed assistance,  Went to ER on 12/6, EKG normal, MRI of brain and spine with and without contrast was normal, sent home in am of 12/7.  Saw PCP on 12/7 and started Prednisone 60 mg daily (1mg/kg).  Noted improvement second day and was able to walk with pole.  Continued to walk with pole for the next week.  Dizziness some better, but still not able to drive, eyes still out of focus.  Have tapered down on steroids, currently on 20 mg on 12/26/22.  Able to drive and walk without assistance, but still with some brain fog and severe fatigue.  Have not been able to work in 6 weeks.  Saw Neuro on 12/20 who stated exam was fine and problems were not neuro related.  Did not perform any evaluation of cognitive function- results were based on touching nose with finger and normal reflexes.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was given Pfizer Covid booster dose on 9/1/22 and the recommendations had changed on 8/31/22 to use Bivalent boosters going forward.  Pharmacy was not aware of the changes that had gone in place yet and did not have the Bivalent Booster in stock.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antiacetylcholine receptor antibody, Blood thyroid stimulating hormone normal, Chest X-ray normal, Computerised tomogram head normal, Condition aggravated
Clinical narrative: Started with spike in Blood Pressure to 180/110.  Progressed to Dysarthria, Dysphagia, Increased and Irregular Heartbeat, Increased Repirations, Dizzy, and Fatigue.  Went to ER on 10/21.  Diagnostic tests ruled out Stroke, TIA, and Heart Attack.  Released for Outpatient Follow Ups and additional Testing indicated below.  All symptoms except Dysarthia & Dysphagia improved within several weeks.  Dysarthia & Dysphagia improving in Dec after starting Pyridostigmine for Myasthenia Gravis.  (No prior history of MG and no family history.) Symptoms were very slow in progressing for days.  Listed in when it became very evident.  Not sure which doctor is best.  Have names for Family/General Practice, ER doctor, Cardiologists, Otolarygologist, Neurologiests, etc.  Also available to me are doctor notes that appear in software.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Dysarthria, Dysphagia, Echocardiogram normal, Electrocardiogram ambulatory normal
Clinical narrative: Started with spike in Blood Pressure to 180/110.  Progressed to Dysarthria, Dysphagia, Increased and Irregular Heartbeat, Increased Repirations, Dizzy, and Fatigue.  Went to ER on 10/21.  Diagnostic tests ruled out Stroke, TIA, and Heart Attack.  Released for Outpatient Follow Ups and additional Testing indicated below.  All symptoms except Dysarthia & Dysphagia improved within several weeks.  Dysarthia & Dysphagia improving in Dec after starting Pyridostigmine for Myasthenia Gravis.  (No prior history of MG and no family history.) Symptoms were very slow in progressing for days.  Listed in when it became very evident.  Not sure which doctor is best.  Have names for Family/General Practice, ER doctor, Cardiologists, Otolarygologist, Neurologiests, etc.  Also available to me are doctor notes that appear in software.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram normal, Fatigue, Full blood count normal, Heart rate increased, Heart rate irregular
Clinical narrative: Started with spike in Blood Pressure to 180/110.  Progressed to Dysarthria, Dysphagia, Increased and Irregular Heartbeat, Increased Repirations, Dizzy, and Fatigue.  Went to ER on 10/21.  Diagnostic tests ruled out Stroke, TIA, and Heart Attack.  Released for Outpatient Follow Ups and additional Testing indicated below.  All symptoms except Dysarthia & Dysphagia improved within several weeks.  Dysarthia & Dysphagia improving in Dec after starting Pyridostigmine for Myasthenia Gravis.  (No prior history of MG and no family history.) Symptoms were very slow in progressing for days.  Listed in when it became very evident.  Not sure which doctor is best.  Have names for Family/General Practice, ER doctor, Cardiologists, Otolarygologist, Neurologiests, etc.  Also available to me are doctor notes that appear in software.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension, Laryngoscopy normal, Magnetic resonance imaging head normal, Metabolic function test, Myasthenia gravis
Clinical narrative: Started with spike in Blood Pressure to 180/110.  Progressed to Dysarthria, Dysphagia, Increased and Irregular Heartbeat, Increased Repirations, Dizzy, and Fatigue.  Went to ER on 10/21.  Diagnostic tests ruled out Stroke, TIA, and Heart Attack.  Released for Outpatient Follow Ups and additional Testing indicated below.  All symptoms except Dysarthia & Dysphagia improved within several weeks.  Dysarthia & Dysphagia improving in Dec after starting Pyridostigmine for Myasthenia Gravis.  (No prior history of MG and no family history.) Symptoms were very slow in progressing for days.  Listed in when it became very evident.  Not sure which doctor is best.  Have names for Family/General Practice, ER doctor, Cardiologists, Otolarygologist, Neurologiests, etc.  Also available to me are doctor notes that appear in software.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory rate increased, Thyroglobulin, Troponin normal, Ultrasound Doppler, Ultrasound scan normal
Clinical narrative: Started with spike in Blood Pressure to 180/110.  Progressed to Dysarthria, Dysphagia, Increased and Irregular Heartbeat, Increased Repirations, Dizzy, and Fatigue.  Went to ER on 10/21.  Diagnostic tests ruled out Stroke, TIA, and Heart Attack.  Released for Outpatient Follow Ups and additional Testing indicated below.  All symptoms except Dysarthia & Dysphagia improved within several weeks.  Dysarthia & Dysphagia improving in Dec after starting Pyridostigmine for Myasthenia Gravis.  (No prior history of MG and no family history.) Symptoms were very slow in progressing for days.  Listed in when it became very evident.  Not sure which doctor is best.  Have names for Family/General Practice, ER doctor, Cardiologists, Otolarygologist, Neurologiests, etc.  Also available to me are doctor notes that appear in software.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was given Pfizer Covid booster dose on 9/1/22 and the recommendations had changed on 8/31/22 to use Bivalent boosters going forward.  Pharmacy was not aware of the changes that had gone in place yet and did not have the Bivalent Booster is stock.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient wanted the Moderna Bivalent vaccine but received another dose of the monovalent series. According to the parent they had no reaction. This was an incorrect vaccine error.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administered 0.3 mls of undiluted monovalent pediatric pfizer vaccine to adult patient. calculated dose to be between 30 and 40 mcg (dependent on amount of overflow initially in vial). pt did not experience any negative effects or adverse effects from the vaccine. notified pcp of incident
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: This was an incorrect vaccine error. Patient has signed up for the bivalent vaccine but received the monovalent vaccine again. Patient did not experience and side effects.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administered 0.3 mls of undiluted monovalent pediatric pfizer vaccine to adult patient. calculated administered covid-19 dose to be between 30 and 40 mcg (dependent on amount of overflow initially in vial). pt did not experience any negative effects or adverse effects from the vaccine. notified pcp of incident
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Eye disorder, Eyeglasses therapy, Herpes simplex test positive, Herpes zoster disseminated
Clinical narrative: Activation of DISSEMINATED HERPES ZOSTER. As such, severe nerve pain has occurred along with eye and ear impairment. Started treatment of Valacyclovir with no resolve of symptoms. Gabapentin for treatment of postherpetic nerve pain. Prescription eye glasses for correction of visual impairment.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Post herpetic neuralgia, Varicella virus test positive, Visual impairment
Clinical narrative: Activation of DISSEMINATED HERPES ZOSTER. As such, severe nerve pain has occurred along with eye and ear impairment. Started treatment of Valacyclovir with no resolve of symptoms. Gabapentin for treatment of postherpetic nerve pain. Prescription eye glasses for correction of visual impairment.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Incorrect medication administered error. Patient had been signed up for the Moderna bivalent vaccine but was given the monovalent dose again. Parents reported no reaction to the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The pharmacy just received new vaccine which both the monovalent and bivalent vaccine were in the same box. The pharmacy also has labels premade to stick on the Vaccination Administration Record(VAR)s which are usually made for bivalent vaccine but this time only monovalent labels were present. The patient was the first patient for vaccination in the day and vaccine was taken out of the bag with open vaccine box. All six doses were drawn and put in a vial for the next vaccinations. The monovalent booster was mistakenly used instead of the bivalent booster. Pt does not have any adverse side effects at this time.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: Shoulder injury related to vaccine administration (SIRVA) reported by patient. Limited movement in right arm within a few hours of vaccine administration.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Nurse administered a dose of monovalent vaccine to patient instead of Bivalent Booster
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia, Wrong product administered
Clinical narrative: Patient was signed up for a Flu vaccine but received the bivalent Moderna vaccine. This was an incorrect vaccination administered error. The parent said that patient experienced low grade fever and arm soreness and that lasted 2 days. No other adverse effects were noticed.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphthous ulcer, Oral mucosal erythema, Rash, Stomatitis
Clinical narrative: oral mouth sores-red sores on oral mucosa. Pt was treated for aphthous ulcer of mouth with kenolog paste. At time of visit had rash for 4 days. No shortness of breath, angioedema, chest pain, difficulty swallowing, fever. Pt had similar reaction after 3rd dose of Moderna (booster) but never reported it as he didnt realize it could have been from the vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Nurse accidentally administered the monovalent booster instead of Bivalent  Booster. No adverse event reported by patient
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: Patient said he went to see doctor a little while after shot about left shoulder pain,  doctor said shot was giver a litter higher in the shoulder
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: This is an incorrect vaccine error. Patient signed up for the Moderna Bivalent pediatric dose and received the pediatric monovalent series. Patient did experience fever and missed 1 day of school due to it.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received ADACEL vaccine on 12/19/2022; she said the next day she started getting redness, swelling, and itchiness at the injected site. She started applying Neosporin and it seems to help; today 12/26/2022 she said the swelling is going down  but there is still some  itchiness; recommended benadryl pill but she said she does not want to get sleepy, so I recommended second option  as  claritin tablets
Sex: F
Vaccine: MMR
Symptoms: Biopsy skin abnormal, Blood immunoglobulin A, Blood immunoglobulin G increased, Blood immunoglobulin M normal, Granuloma skin
Clinical narrative: rubella virus granulomatosis disease; rubella virus granulomatosis disease;   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included asthma and seasonal allergies.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as two years after vaccination), the patient experienced a solitary papule that increased to several papules coalescing into a plaque localized to the left arm which was diagnosed initially as granulomatous dermatitis which was treated with methotrexate, bexarotene, hydrozychloroquine, topical clobetasol, and topical imiquimod, without benefit. After four years from the onset of the event, an skin biopsy was collected and histophatology results showed atypical CD8 lymphocytic infiltrate with associated granulomatosis inflammation, which due to similar rubella virus associated cutaneous granulomatosis dermatitis, plasma tests for rubella virus were performed with the following results: Blood immunoglobulin G: 688 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 851 mm3, CD3 CD4 T cells count: 470 mm3, CD3 CD8 T cells count: 345 mm3, CD19 B cells count: 345 mm3, CD56 CD16 NK cells count: 107 mm3, T-Cell mitogen proliferation: 7% (low), Rubella IgG titer: 580 IU/ml, Rubella neutralization titer: 1280 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA009517: US-009507513-2212USA009518:
Sex: F
Vaccine: MMR
Symptoms: Granulomatous dermatitis, Histology, Laboratory test, Nasopharyngeal swab, Papule
Clinical narrative: rubella virus granulomatosis disease; rubella virus granulomatosis disease;   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included asthma and seasonal allergies.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as two years after vaccination), the patient experienced a solitary papule that increased to several papules coalescing into a plaque localized to the left arm which was diagnosed initially as granulomatous dermatitis which was treated with methotrexate, bexarotene, hydrozychloroquine, topical clobetasol, and topical imiquimod, without benefit. After four years from the onset of the event, an skin biopsy was collected and histophatology results showed atypical CD8 lymphocytic infiltrate with associated granulomatosis inflammation, which due to similar rubella virus associated cutaneous granulomatosis dermatitis, plasma tests for rubella virus were performed with the following results: Blood immunoglobulin G: 688 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 851 mm3, CD3 CD4 T cells count: 470 mm3, CD3 CD8 T cells count: 345 mm3, CD19 B cells count: 345 mm3, CD56 CD16 NK cells count: 107 mm3, T-Cell mitogen proliferation: 7% (low), Rubella IgG titer: 580 IU/ml, Rubella neutralization titer: 1280 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA009517: US-009507513-2212USA009518:
Sex: F
Vaccine: MMR
Symptoms: Rubivirus test positive, Skin plaque
Clinical narrative: rubella virus granulomatosis disease; rubella virus granulomatosis disease;   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included asthma and seasonal allergies.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as two years after vaccination), the patient experienced a solitary papule that increased to several papules coalescing into a plaque localized to the left arm which was diagnosed initially as granulomatous dermatitis which was treated with methotrexate, bexarotene, hydrozychloroquine, topical clobetasol, and topical imiquimod, without benefit. After four years from the onset of the event, an skin biopsy was collected and histophatology results showed atypical CD8 lymphocytic infiltrate with associated granulomatosis inflammation, which due to similar rubella virus associated cutaneous granulomatosis dermatitis, plasma tests for rubella virus were performed with the following results: Blood immunoglobulin G: 688 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 851 mm3, CD3 CD4 T cells count: 470 mm3, CD3 CD8 T cells count: 345 mm3, CD19 B cells count: 345 mm3, CD56 CD16 NK cells count: 107 mm3, T-Cell mitogen proliferation: 7% (low), Rubella IgG titer: 580 IU/ml, Rubella neutralization titer: 1280 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA009517: US-009507513-2212USA009518:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Past lot that had also been expired that was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).    Patient age was reported as 70 Year 11 Month. No concomitant medication was provided. NDC ID number was reported as 80777027399. The lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose administered; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) had not resolved and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medication information was provided. It was reported that patient received additional booster 2 months after the first bivalent booster. All vials was thawed on 16-Dec-2022.  This case contains the information of 02 out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case 1 of 13
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Lot that had been expired was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient).    Person number was reported as 120798. Patient age was reported as 75 years 03 months. No concomitant medications were reported. Completion date was reported as 30-Jun-2022.     Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022 from the vial with lot number O70H21A.   No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). The patient was treated with CHLORAMPHENICOL (ANTIBIOTIC [CHLORAMPHENICOL]) for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. They stated that patient received has had 4 Moderna vaccines and scheduled to receive Bivalent vaccine but was on antibiotics for sinus infection.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Sore Shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore Shoulder) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore Shoulder). At the time of the report, ARTHRALGIA (Sore Shoulder) had resolved. Not Provided          Patient had all Pfizer vaccinations and boosters except the one for the Omicron booster which was Moderna. Patient never had a reaction to any of them except a sore shoulder for a day or two. concomitant and Treatment medications were not reported.