chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no ADE, just reporting this b/c an administration error occurred and we accidentally gave a Fluzone HD instead of the Pfizer bivalent that pt wanted. no ADEs reported by pt - she is doing just fine.
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Wheezing
Clinical narrative: redness,swelling,pain, in arm and possible face swelling,  wheezing
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Approximately one hour following influenza vaccination patient was found sitting upright in the elevator. 911 was called an ambulance came shortly thereafter. From what I could gather she fainted. She was sitting upright in the elevator holding her head and stating she received a flu shot earlier. I attempted to call the patient three times on different days at different times to find out more details about what happened after she was taken to the hospital, but the patient never picked up the phone or returned any of my calls.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza virus test, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: bad cough, sore throat, congestion...lasted 5 days...took over the counter meds...no r/x prescribed
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Skin warm, Swelling face
Clinical narrative: Facial swelling, warmth, and numbness affecting right side of face including around eye and inside ear; onset  was about 25-30 min after vaccination. Symptoms resolved within another 30 min after 50mg diphenhydramine
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Endometrial hyperplasia, Fatigue, Post-acute COVID-19 syndrome
Clinical narrative: Development of endometrial hyperplasia and chronic fatigue, later contracted COVID and was diagnosed with long haul COVID.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysgeusia, Injection site pruritus
Clinical narrative: Itching on site area, intense. Metallic taste in mouth
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal distension, Discomfort, Dyspepsia, Flatulence, Functional gastrointestinal disorder
Clinical narrative: Gastrointestinal issues; excessive bloating, painful gassiness, trouble passing waste, occasional nausea. Change in digestive issues - previously, was prone to painful diarrhea (possible IBS, was never diagnosed) that occurred in a pattern; it no longer happens (mostly because I've tried to stop eating certain foods but sometimes it would happen anyway). Have had symptoms of trapped gas since teenage years, but those symptoms were negligible. Have attempted changing and severely restricting diet; it does not completely alleviate the discomfort, but it does help (at first thought I'd developed gluten intolerance).  The symptoms came on very suddenly.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gastrointestinal disorder, Nausea
Clinical narrative: Gastrointestinal issues; excessive bloating, painful gassiness, trouble passing waste, occasional nausea. Change in digestive issues - previously, was prone to painful diarrhea (possible IBS, was never diagnosed) that occurred in a pattern; it no longer happens (mostly because I've tried to stop eating certain foods but sometimes it would happen anyway). Have had symptoms of trapped gas since teenage years, but those symptoms were negligible. Have attempted changing and severely restricting diet; it does not completely alleviate the discomfort, but it does help (at first thought I'd developed gluten intolerance).  The symptoms came on very suddenly.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test abnormal, Gait disturbance, Impaired work ability, Inflammatory marker increased
Clinical narrative: 2-3 weeks after the booster shot my hands swelled up and then my knees after some days and then my feet and ankles. All my joints (wrists, fingers, elbows, shoulders, jaw, knees and ankles and feet became very painful. By the end of the year (2021) the pain was so much that I started taking Advil to cope. That helped. The joint condition did not a bare and in February I had a video interview with Dr. He diagnosed me with Rheumatoid Arthritis. I have had no such problems before. He had me take a blood test and a week or two later when the results came in, he said the inflammation markers were very high, but the rheumatoid factor was normal. One subsequent blood test (a month or two later) confirmed the above. Dr. prescribed Prednisone at 40mg per day. I started that and it alleviated the pain and visible swelling. Problem is - 8 months later I have been unable to wean off the Prednisone. I have tried twice and whenever I get to the level of 10mg per day the pain in my joints comes back full force. I have tried Prednisone substitutes to no avail. The Prednisone causes side effects which I cannot tolerate (mainly problems breathing which disappear at the lower dosages ie 15 mg per day which I am now taking) At 15 mg the joint pain is high but somewhat tolerable, though I have difficulty walking and have reduced my work hours so as to get more sleep. 8-9 hours per day.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Rheumatoid arthritis, Rheumatoid factor negative
Clinical narrative: 2-3 weeks after the booster shot my hands swelled up and then my knees after some days and then my feet and ankles. All my joints (wrists, fingers, elbows, shoulders, jaw, knees and ankles and feet became very painful. By the end of the year (2021) the pain was so much that I started taking Advil to cope. That helped. The joint condition did not a bare and in February I had a video interview with Dr. He diagnosed me with Rheumatoid Arthritis. I have had no such problems before. He had me take a blood test and a week or two later when the results came in, he said the inflammation markers were very high, but the rheumatoid factor was normal. One subsequent blood test (a month or two later) confirmed the above. Dr. prescribed Prednisone at 40mg per day. I started that and it alleviated the pain and visible swelling. Problem is - 8 months later I have been unable to wean off the Prednisone. I have tried twice and whenever I get to the level of 10mg per day the pain in my joints comes back full force. I have tried Prednisone substitutes to no avail. The Prednisone causes side effects which I cannot tolerate (mainly problems breathing which disappear at the lower dosages ie 15 mg per day which I am now taking) At 15 mg the joint pain is high but somewhat tolerable, though I have difficulty walking and have reduced my work hours so as to get more sleep. 8-9 hours per day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin warm, Urticaria
Clinical narrative: Large rash, very itchy,  welts, red and warm to the touch.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaemia, Asthenia, Balance disorder, COVID-19, Chest X-ray normal
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chromaturia, Computerised tomogram head normal, Computerised tomogram spine, Condition aggravated, Confusional state
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Diarrhoea, Fall, Feeling abnormal, General physical health deterioration
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypotension, Hypoxia, Laboratory test abnormal, Leukopenia, Malaise
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Micturition urgency, SARS-CoV-2 test positive, Seizure, Tobacco user, Urinary incontinence
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urinary tract infection, Urine odour abnormal, X-ray limb
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Areflexia, Asthenia, COVID-19, Chest X-ray abnormal, Computerised tomogram head normal
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram spine, Condition aggravated, Confusional state, Cough, Culture urine positive
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electroencephalogram abnormal, Electromyogram, Fall, Immunoglobulin therapy, Lumbar puncture normal
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lung infiltration, Mental status changes, Muscular weakness, Plasmapheresis, Postictal state
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Procalcitonin normal, SARS-CoV-2 test positive, Seizure, Spinal osteoarthritis, Staphylococcus test positive
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tachycardia, Tachypnoea, Urinary tract infection
Clinical narrative: Patient with positive test on 10/25/22.  Patient tested due to cough, provider trying to determine if aspiration PNA.  Patient had COVID infection 07/02/2022, so this was just outside her 90 day window.  Case was previously submitted for her July infection  Provider d/c note:  "55 y/o F with history of DM2, tobacco use, recent COVID infection, depression/anxiety, recent DVT with completed Eliquis course (5/22), intracranial mass s/p resection in 2011 with localization related epilepsy presented to the ED following a witnessed seizure on 10/19/22. At ED, Upon arrival patient was still found to be post-ictal with AMS. Depakote level subtherapeutic, EEG showed generalized slowing, CT head  Negative for acute intracranial process. CT C-Spine was unremarkable except  Mild/moderate cervical spondylosis.    Neurology was consulted, and her seizures resolved.     Of note she was admitted to hospitals in July of 2022 with generalized weakness and frequent falls, with concern for Guillain-Barre syndrome or a demyelinating polyneuropathy.  At that time she received IVIG and plasmapheresis and her symptoms improved.  LP was unremarkable an electromyogram was not diagnostic at that time.  Recently since her hospitalization she has now developed recurrent progressive diffuse weakness, worse in the lower extremities, with decreased/absent reflexes in the bilateral lower extremities.  She has completed 5 days of IVIG infusions, and her weakness has not improved.  Our Neurology team now recommends transfer for  another course of plasmapheres.  She has also had intermittent confusion and altered mental status, which overall is improving.  She has been accepted by Dr. at hospital.   Pt also had UTI and antibx initiated, she has completed 3 days of doxy thus far, with urine culture revealing Staph epidermidis susceptible to tetracyclines.   Yesterday she did experience increased tachycardia and tachypnea, with increased cough.  I have some concerns she may have aspirated.  Chest x-ray revealed streaky infiltrates in the right lower lobe left upper lobe, of unclear significance.  A procalcitonin was not concerning.  Our speech and language pathologist cleared her for a general diet with thin liquids otherwise. Pt did have COVID in July, tested positive on 07/22/2022.  She did again test positive on 10/25/2022, and it is unclear if this is contributing to her current illness.  She has experienced no hypoxia, no fevers."
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLUA4, COVID19-2, FLUA4
Symptoms: Muscle spasms, Tremor
Clinical narrative: Resident had call light on, writer went into room and noted resident had tremors/body shakes. Resident stated that it started at about 11pm. No fever, no complaints of pain or feeling short of breath. Did go to hospital for evaluation. Came back from hospital early AM on 10/26/22; Got new orders from Dr prednisone 20 mg po BID x 3 days; Valium 2.50 mg po every 8 hours as needed for muscle spasms; Utilize prn tylenol order; Continue Baclofen and scheduled clonazepam; follow up with PCP in 1-2 days
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported from 01-SEP-2022 to 26-OCT-2022. No treatment information was provided. This case was reported for 15th patient out of 20 patients.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; RN calling to report that expired lot of ROTATEQ was administered to patient. Per caller, product expired on 10/18/22 and was administered on 10/25/22. No additional AEs, no PQCs.; This spontaneous report has been received from a nurse, concerning a 2-months-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not mentioned.  On 25-OCT-2022, the patient was vaccinated with expired Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml once orally for prophylaxis (lot#U006165 has been verified to be a valid lot, expiration date: 18-OCT-2022) (strength, dose regimen and frequency was not reported) (expired product administered). No additional adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received first dose of shingrix on October 28th 2019. Never got his 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th October 2019, from batch number 5482T, expiry date 11th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-OCT-2022 Reporters comment:  The patient received the first dose of shingrix and never got his 2nd dose. The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: breakthrough COVID infection after previous Moderna doses; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (breakthrough COVID infection after previous Moderna doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (breakthrough COVID infection after previous Moderna doses). At the time of the report, COVID-19 (breakthrough COVID infection after previous Moderna doses) outcome was unknown. Concomitant medications details were not reported by the reporter.  Patient stated that she received all Moderna COVID-19 vaccines in the past and had COVID 6 weeks ago.  Treatment details were not reported by the reporter.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received a booster dose of Monovalent Moderna COVID-19 vaccine instead of Bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a booster dose of Monovalent Moderna COVID-19 vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received a booster dose of Monovalent Moderna COVID-19 vaccine instead of Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a booster dose of Monovalent Moderna COVID-19 vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a booster dose of Monovalent Moderna COVID-19 vaccine instead of Bivalent booster).    No concomitant medication was reported.    No treatment information was reported.  The patient received a booster dose of monovalent Moderna COVID-19 vaccine instead of Bivalent booster.  Patient does not have the lot information.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion
Clinical narrative: I just had a pacemaker put in; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC PACEMAKER INSERTION (I just had a pacemaker put in) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2022, the patient experienced CARDIAC PACEMAKER INSERTION (I just had a pacemaker put in). At the time of the report, CARDIAC PACEMAKER INSERTION (I just had a pacemaker put in) outcome was unknown.            The concomitant medication was not reported by reporter. Patient enquired that will it hurt to get 5th booster because patient just had a pacemaker put in, the date was 18-Aug-2022. Patient's last booster of Moderna was May-2022. The treatment medication was not reported by reporter.