chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: Neurologist Consultation Note dated 04/27/2021: I saw him in consultation on 04/13/2021 and to follow up yesterday on 04/26/2021.  Well until he had the second of 2 Pfizer COVID-19 vaccinations 03/03/2021 and about 2 weeks or so later, around the third week in March, he had onset over a day or two or several days of numbness of the bottom of the feet, spreading to the ankles and calves, affecting the hands.  Balance is affected and feet and hands are weak.  This numbness is also painful, affects sleep with symptoms of restlessness in the legs when he tries to sleep.   Prior to my evaluation, was seen at the ER and had CT scan of the head and CT angiogram probably of the chest as well as Doppler of the lower extremities.  He was given gabapentin 100 mg at bedtime, which was not helpful; and prescribed oxycodone 5/325 mg, which he did not start.   After consultation, referred for electrodiagnostic study, performed on 04/22/2021 of all 4 extremities by a doctor.  Findings were of absent or reduced amplitude with normal latencies of all sensory nerves.  Specifically, sural potentials were absent bilaterally.  Motor nerves showed absent or delayed F waves and reduced recruitment, disproportionate amplitude loss or acute denervation, consistent with proximal demyelination.  In my opinion, this confirms the presence of a demyelinating neuropathy.  Further, absent sural potentials are more consistent with chronic as opposed to acute inflammatory demyelinating peripheral neuropathy.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Neurologist Consultation Note dated 04/27/2021: I saw him in consultation on 04/13/2021 and to follow up yesterday on 04/26/2021.  Well until he had the second of 2 Pfizer COVID-19 vaccinations 03/03/2021 and about 2 weeks or so later, around the third week in March, he had onset over a day or two or several days of numbness of the bottom of the feet, spreading to the ankles and calves, affecting the hands.  Balance is affected and feet and hands are weak.  This numbness is also painful, affects sleep with symptoms of restlessness in the legs when he tries to sleep.   Prior to my evaluation, was seen at the ER and had CT scan of the head and CT angiogram probably of the chest as well as Doppler of the lower extremities.  He was given gabapentin 100 mg at bedtime, which was not helpful; and prescribed oxycodone 5/325 mg, which he did not start.   After consultation, referred for electrodiagnostic study, performed on 04/22/2021 of all 4 extremities by a doctor.  Findings were of absent or reduced amplitude with normal latencies of all sensory nerves.  Specifically, sural potentials were absent bilaterally.  Motor nerves showed absent or delayed F waves and reduced recruitment, disproportionate amplitude loss or acute denervation, consistent with proximal demyelination.  In my opinion, this confirms the presence of a demyelinating neuropathy.  Further, absent sural potentials are more consistent with chronic as opposed to acute inflammatory demyelinating peripheral neuropathy.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Cardiac electrophysiologic study, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram head, Computerised tomogram thorax
Clinical narrative: Neurologist Consultation Note dated 04/27/2021: I saw him in consultation on 04/13/2021 and to follow up yesterday on 04/26/2021.  Well until he had the second of 2 Pfizer COVID-19 vaccinations 03/03/2021 and about 2 weeks or so later, around the third week in March, he had onset over a day or two or several days of numbness of the bottom of the feet, spreading to the ankles and calves, affecting the hands.  Balance is affected and feet and hands are weak.  This numbness is also painful, affects sleep with symptoms of restlessness in the legs when he tries to sleep.   Prior to my evaluation, was seen at the ER and had CT scan of the head and CT angiogram probably of the chest as well as Doppler of the lower extremities.  He was given gabapentin 100 mg at bedtime, which was not helpful; and prescribed oxycodone 5/325 mg, which he did not start.   After consultation, referred for electrodiagnostic study, performed on 04/22/2021 of all 4 extremities by a doctor.  Findings were of absent or reduced amplitude with normal latencies of all sensory nerves.  Specifically, sural potentials were absent bilaterally.  Motor nerves showed absent or delayed F waves and reduced recruitment, disproportionate amplitude loss or acute denervation, consistent with proximal demyelination.  In my opinion, this confirms the presence of a demyelinating neuropathy.  Further, absent sural potentials are more consistent with chronic as opposed to acute inflammatory demyelinating peripheral neuropathy.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Electromyogram abnormal, Hypoaesthesia, Muscular weakness, Neurological examination
Clinical narrative: Neurologist Consultation Note dated 04/27/2021: I saw him in consultation on 04/13/2021 and to follow up yesterday on 04/26/2021.  Well until he had the second of 2 Pfizer COVID-19 vaccinations 03/03/2021 and about 2 weeks or so later, around the third week in March, he had onset over a day or two or several days of numbness of the bottom of the feet, spreading to the ankles and calves, affecting the hands.  Balance is affected and feet and hands are weak.  This numbness is also painful, affects sleep with symptoms of restlessness in the legs when he tries to sleep.   Prior to my evaluation, was seen at the ER and had CT scan of the head and CT angiogram probably of the chest as well as Doppler of the lower extremities.  He was given gabapentin 100 mg at bedtime, which was not helpful; and prescribed oxycodone 5/325 mg, which he did not start.   After consultation, referred for electrodiagnostic study, performed on 04/22/2021 of all 4 extremities by a doctor.  Findings were of absent or reduced amplitude with normal latencies of all sensory nerves.  Specifically, sural potentials were absent bilaterally.  Motor nerves showed absent or delayed F waves and reduced recruitment, disproportionate amplitude loss or acute denervation, consistent with proximal demyelination.  In my opinion, this confirms the presence of a demyelinating neuropathy.  Further, absent sural potentials are more consistent with chronic as opposed to acute inflammatory demyelinating peripheral neuropathy.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Restless legs syndrome, Sleep disorder, Treatment noncompliance, Ultrasound Doppler
Clinical narrative: Neurologist Consultation Note dated 04/27/2021: I saw him in consultation on 04/13/2021 and to follow up yesterday on 04/26/2021.  Well until he had the second of 2 Pfizer COVID-19 vaccinations 03/03/2021 and about 2 weeks or so later, around the third week in March, he had onset over a day or two or several days of numbness of the bottom of the feet, spreading to the ankles and calves, affecting the hands.  Balance is affected and feet and hands are weak.  This numbness is also painful, affects sleep with symptoms of restlessness in the legs when he tries to sleep.   Prior to my evaluation, was seen at the ER and had CT scan of the head and CT angiogram probably of the chest as well as Doppler of the lower extremities.  He was given gabapentin 100 mg at bedtime, which was not helpful; and prescribed oxycodone 5/325 mg, which he did not start.   After consultation, referred for electrodiagnostic study, performed on 04/22/2021 of all 4 extremities by a doctor.  Findings were of absent or reduced amplitude with normal latencies of all sensory nerves.  Specifically, sural potentials were absent bilaterally.  Motor nerves showed absent or delayed F waves and reduced recruitment, disproportionate amplitude loss or acute denervation, consistent with proximal demyelination.  In my opinion, this confirms the presence of a demyelinating neuropathy.  Further, absent sural potentials are more consistent with chronic as opposed to acute inflammatory demyelinating peripheral neuropathy.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal, Dyspnoea, Pulmonary embolism, Wheezing
Clinical narrative: Had vaccine on April 1st, 2021. Presented to the ER with shortness of breath on 4/14/21. Admitted to med surg as they suspected COPD exasperation.  Transferred to ICU 4/15/21 due to needing bipap machine. Imaging found a small pulmonary embolism: reported to VAERS by medical doctor: #1225381-1.  He was intubated because he went into respiratory failure, they did not understand why because the PE was small. Intubated around 2pm on 4/15/21.  Attempted sedation vacation per protocol and under orders of MD 4/17, 4/18, 4/19: BP became too high so they continued to keep sedated. Head CT done, found he had a stroke, did not know the extent, still expecting he would wake up. 4/22/21 MRI done after 24 hours of no sedation and not waking up. MRI showed severe CVA: the cause of respiratory failure and not able to wake up. Extubated at 7:30pm on 4/22/21. Passed away 10:45pm.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bilevel positive airway pressure, Cerebrovascular accident, Chronic obstructive pulmonary disease, Computerised tomogram head abnormal, Condition aggravated
Clinical narrative: Had vaccine on April 1st, 2021. Presented to the ER with shortness of breath on 4/14/21. Admitted to med surg as they suspected COPD exasperation.  Transferred to ICU 4/15/21 due to needing bipap machine. Imaging found a small pulmonary embolism: reported to VAERS by medical doctor: #1225381-1.  He was intubated because he went into respiratory failure, they did not understand why because the PE was small. Intubated around 2pm on 4/15/21.  Attempted sedation vacation per protocol and under orders of MD 4/17, 4/18, 4/19: BP became too high so they continued to keep sedated. Head CT done, found he had a stroke, did not know the extent, still expecting he would wake up. 4/22/21 MRI done after 24 hours of no sedation and not waking up. MRI showed severe CVA: the cause of respiratory failure and not able to wake up. Extubated at 7:30pm on 4/22/21. Passed away 10:45pm.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Endotracheal intubation, Extubation, Hypertension
Clinical narrative: Had vaccine on April 1st, 2021. Presented to the ER with shortness of breath on 4/14/21. Admitted to med surg as they suspected COPD exasperation.  Transferred to ICU 4/15/21 due to needing bipap machine. Imaging found a small pulmonary embolism: reported to VAERS by medical doctor: #1225381-1.  He was intubated because he went into respiratory failure, they did not understand why because the PE was small. Intubated around 2pm on 4/15/21.  Attempted sedation vacation per protocol and under orders of MD 4/17, 4/18, 4/19: BP became too high so they continued to keep sedated. Head CT done, found he had a stroke, did not know the extent, still expecting he would wake up. 4/22/21 MRI done after 24 hours of no sedation and not waking up. MRI showed severe CVA: the cause of respiratory failure and not able to wake up. Extubated at 7:30pm on 4/22/21. Passed away 10:45pm.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Magnetic resonance imaging head abnormal, Pulmonary embolism, Respiratory failure, Sedative therapy
Clinical narrative: Had vaccine on April 1st, 2021. Presented to the ER with shortness of breath on 4/14/21. Admitted to med surg as they suspected COPD exasperation.  Transferred to ICU 4/15/21 due to needing bipap machine. Imaging found a small pulmonary embolism: reported to VAERS by medical doctor: #1225381-1.  He was intubated because he went into respiratory failure, they did not understand why because the PE was small. Intubated around 2pm on 4/15/21.  Attempted sedation vacation per protocol and under orders of MD 4/17, 4/18, 4/19: BP became too high so they continued to keep sedated. Head CT done, found he had a stroke, did not know the extent, still expecting he would wake up. 4/22/21 MRI done after 24 hours of no sedation and not waking up. MRI showed severe CVA: the cause of respiratory failure and not able to wake up. Extubated at 7:30pm on 4/22/21. Passed away 10:45pm.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Headache, Transient ischaemic attack, Visual impairment
Clinical narrative: Admitted to hospital 18 hours after vaccine with acute CVA
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Admitted to hospital 18 hours after vaccine with acute CVA
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Neuropathy peripheral, Paraesthesia, Skin burning sensation, Sleep disorder
Clinical narrative: Tingling/numbness starting in left hand which moved to bilateral hands, headache on crown of head and on sides, watery eyes, stomach pain and constipation which started 10 days later. The paraesthesias stared to move around the body, up the arms, down the legs. Having joint pains and fasciulations. This all occured gradually over the course of one week. The constipation has resolved but stomach pain continues, paraesthesias continue. She is currently taking gabapentin 100 mg hs which helps her sleep and manages her pain.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Constipation, Gastrointestinal disorder, Headache
Clinical narrative: Tingling/numbness starting in left hand which moved to bilateral hands, headache on crown of head and on sides, watery eyes, stomach pain and constipation which started 10 days later. The paraesthesias stared to move around the body, up the arms, down the legs. Having joint pains and fasciulations. This all occured gradually over the course of one week. The constipation has resolved but stomach pain continues, paraesthesias continue. She is currently taking gabapentin 100 mg hs which helps her sleep and manages her pain.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lacrimation increased, Muscle contractions involuntary, Neuropathy peripheral, Paraesthesia
Clinical narrative: Tingling/numbness starting in left hand which moved to bilateral hands, headache on crown of head and on sides, watery eyes, stomach pain and constipation which started 10 days later. The paraesthesias stared to move around the body, up the arms, down the legs. Having joint pains and fasciulations. This all occured gradually over the course of one week. The constipation has resolved but stomach pain continues, paraesthesias continue. She is currently taking gabapentin 100 mg hs which helps her sleep and manages her pain.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Insomnia
Clinical narrative: Severe tinnitus ( ear ringing) started at 4:20 a.m. ,(woke me up), on Tuesday April 13th, 2021, less than 48 hours after receiving the 1st dose of the COVID Pfizer vaccine injection.  It's been so severe it's got to the point that I've contemplated considering suicide.  It has totally turned my life upside down as it relates to sleep, working, daily functioning and living. On a scale of "1 to 10" I'd rate my tinnitus a "7" in severity.   It's a very high pitched tone, it sounds like the test pattern the TV stations used to broadcast at midnight.  It's maddening. It's torture.   The first 4 weeks were really hell.  Now it vacillates between a 7 and a 4.  It gets worse at night when I lay down.   So as of today it's been 7 weeks and 1 day since the onset of this tinnitus.  I called Pfizer Thursday April 15th, they were no help.  I had a zoom call with an MD who recommended not taking the 2nd Pfizer dose and to see and ENT asap. I saw Dr. who prescribed Prednisone tablets.  I am still suffering greatly from this.   Never in my life have I had tinnitus.  Never in my life have I been around loud work environments.  This is a direct result of taking the Pfizer vaccine.  I am certain of this fact.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Sleep disorder, Tinnitus
Clinical narrative: Severe tinnitus ( ear ringing) started at 4:20 a.m. ,(woke me up), on Tuesday April 13th, 2021, less than 48 hours after receiving the 1st dose of the COVID Pfizer vaccine injection.  It's been so severe it's got to the point that I've contemplated considering suicide.  It has totally turned my life upside down as it relates to sleep, working, daily functioning and living. On a scale of "1 to 10" I'd rate my tinnitus a "7" in severity.   It's a very high pitched tone, it sounds like the test pattern the TV stations used to broadcast at midnight.  It's maddening. It's torture.   The first 4 weeks were really hell.  Now it vacillates between a 7 and a 4.  It gets worse at night when I lay down.   So as of today it's been 7 weeks and 1 day since the onset of this tinnitus.  I called Pfizer Thursday April 15th, they were no help.  I had a zoom call with an MD who recommended not taking the 2nd Pfizer dose and to see and ENT asap. I saw Dr. who prescribed Prednisone tablets.  I am still suffering greatly from this.   Never in my life have I had tinnitus.  Never in my life have I been around loud work environments.  This is a direct result of taking the Pfizer vaccine.  I am certain of this fact.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Burning sensation, Injection site pain, Mobility decreased, Pain
Clinical narrative: Left shoulder pain and limited range of motion, consistent with adhesive capsulitis
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Joint range of motion decreased, Periarthritis
Clinical narrative: Left shoulder pain and limited range of motion, consistent with adhesive capsulitis
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF cell count normal, Electromyogram abnormal, Endotracheal intubation, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient was diagnosed with Guillain-Barré syndrome ultimately requiring mechanical ventilation with tracheostomy/PEG tube placement.  He was treated with IVIG 2g/kg over 5 days from 4/12-4/16/2021. He received 5 plasmapheresis (PLEX) treatments on alternating days between 4/26/2021 and 5/5/2021. Then for evidence of incomplete improvement/worsening, he received another full course of IVIG given over 2 days as 1 g/kg/day from 5/132021-05/14/2021.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Muscular weakness, Paraesthesia, Quadriplegia, Subacute inflammatory demyelinating polyneuropathy
Clinical narrative: Patient was diagnosed with Guillain-Barré syndrome ultimately requiring mechanical ventilation with tracheostomy/PEG tube placement.  He was treated with IVIG 2g/kg over 5 days from 4/12-4/16/2021. He received 5 plasmapheresis (PLEX) treatments on alternating days between 4/26/2021 and 5/5/2021. Then for evidence of incomplete improvement/worsening, he received another full course of IVIG given over 2 days as 1 g/kg/day from 5/132021-05/14/2021.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient was diagnosed with Guillain-Barré syndrome ultimately requiring mechanical ventilation with tracheostomy/PEG tube placement.  He was treated with IVIG 2g/kg over 5 days from 4/12-4/16/2021. He received 5 plasmapheresis (PLEX) treatments on alternating days between 4/26/2021 and 5/5/2021. Then for evidence of incomplete improvement/worsening, he received another full course of IVIG given over 2 days as 1 g/kg/day from 5/132021-05/14/2021.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Intensive care, Lumbar puncture, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Patient was diagnosed with Guillain-Barré syndrome ultimately requiring mechanical ventilation with tracheostomy/PEG tube placement.  He was treated with IVIG 2g/kg over 5 days from 4/12-4/16/2021. He received 5 plasmapheresis (PLEX) treatments on alternating days between 4/26/2021 and 5/5/2021. Then for evidence of incomplete improvement/worsening, he received another full course of IVIG given over 2 days as 1 g/kg/day from 5/132021-05/14/2021.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis, Plasmapheresis, X-ray
Clinical narrative: Patient was diagnosed with Guillain-Barré syndrome ultimately requiring mechanical ventilation with tracheostomy/PEG tube placement.  He was treated with IVIG 2g/kg over 5 days from 4/12-4/16/2021. He received 5 plasmapheresis (PLEX) treatments on alternating days between 4/26/2021 and 5/5/2021. Then for evidence of incomplete improvement/worsening, he received another full course of IVIG given over 2 days as 1 g/kg/day from 5/132021-05/14/2021.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Albumin CSF increased, CSF immunoglobulin increased, Gastrostomy, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient was diagnosed with Guillain-Barré syndrome ultimately requiring mechanical ventilation with tracheostomy/PEG tube placement.  He was treated with IVIG 2g/kg over 5 days from 4/12-4/16/2021. He received 5 plasmapheresis (PLEX) treatments on alternating days between 4/26/2021 and 5/5/2021. Then for evidence of incomplete improvement/worsening, he received another full course of IVIG given over 2 days as 1 g/kg/day from 5/132021-05/14/2021.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mechanical ventilation, Plasmapheresis, Tracheostomy
Clinical narrative: Patient was diagnosed with Guillain-Barré syndrome ultimately requiring mechanical ventilation with tracheostomy/PEG tube placement.  He was treated with IVIG 2g/kg over 5 days from 4/12-4/16/2021. He received 5 plasmapheresis (PLEX) treatments on alternating days between 4/26/2021 and 5/5/2021. Then for evidence of incomplete improvement/worsening, he received another full course of IVIG given over 2 days as 1 g/kg/day from 5/132021-05/14/2021.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Severe swelling and armpit pain on injection side; Severe swelling and armpit pain on injection side; severe hip pain; overall pain and tingling in left side; overall pain and tingling in left side; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 05Apr2021 at 16:45 (at the age of 58-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN), vitamin c [ascorbic acid] (VITAMIN C) and vitamin d [vitamin d nos] (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient previously received first dose of BNT162B2 (Lot number was unknown), via an unspecified route of administration in arm left on 05Apr2021 at 16:45 for covid-19 immunization. On 29Apr2021 at 15:45, the patient experienced severe swelling and armpit pain on injection side, severe hip pain on injection side, overall pain and tingling in left side. The reporter classified the events as non-serious and stated the events result doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Pain, Paraesthesia, Swelling
Clinical narrative: Severe swelling and armpit pain on injection side; Severe swelling and armpit pain on injection side; severe hip pain; overall pain and tingling in left side; overall pain and tingling in left side; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 05Apr2021 at 16:45 (at the age of 58-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN), vitamin c [ascorbic acid] (VITAMIN C) and vitamin d [vitamin d nos] (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient previously received first dose of BNT162B2 (Lot number was unknown), via an unspecified route of administration in arm left on 05Apr2021 at 16:45 for covid-19 immunization. On 29Apr2021 at 15:45, the patient experienced severe swelling and armpit pain on injection side, severe hip pain on injection side, overall pain and tingling in left side. The reporter classified the events as non-serious and stated the events result doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acidosis, Acute hepatic failure, Acute kidney injury, Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood gases abnormal, Blood glucose increased, Blood lactic acid increased, Cardiac arrest, Chronic kidney disease
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Death, Diabetic ketoacidosis, Endotracheal intubation, Glucose tolerance test
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Insulin tolerance test, Intensive care, Metabolic function test, Nausea
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Resuscitation, Sedative therapy, Unresponsive to stimuli, Vomiting
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Atelectasis
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Blood ethanol normal, Blood gases abnormal, Blood glucose increased, Blood ketone body increased
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid, Cerebral atrophy, Cerebral small vessel ischaemic disease, Cholelithiasis, Computerised tomogram abdomen abnormal
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Hepatic steatosis, International normalised ratio increased, Liver function test normal, Malaise
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Nausea, Pleural effusion, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Felt ill shortly after getting the vaccine.  Weakness, nausea and vomiting.  Developed AMS.  Presented to the ER and was found to be in acute hepatic failure
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Anticoagulant therapy, Computerised tomogram thorax, Hypoxia, Pulmonary embolism
Clinical narrative: Pulmonary Embolism in both lungs
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary infarction, Right ventricular dysfunction
Clinical narrative: Pulmonary Embolism in both lungs
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pulmonary embolism, Ultrasound scan, X-ray
Clinical narrative: Pulmonary Embolism in both lungs
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Erythema, Heparin-induced thrombocytopenia test positive, Peripheral swelling
Clinical narrative: BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT  ARM; This spontaneous report received from a patient concerned a 26 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Subclavian vein thrombosis
Clinical narrative: BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT  ARM; This spontaneous report received from a patient concerned a 26 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram thorax abnormal, Electrocardiogram normal, Peripheral swelling, Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT  ARM; This spontaneous report received from a patient concerned a 26 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT  ARM; This spontaneous report received from a patient concerned a 26 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Peripheral swelling, Pulmonary thrombosis, Skin discolouration, Thrombosis
Clinical narrative: BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT  ARM; This spontaneous report received from a patient concerned a 26 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 40.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypertension, Hypoaesthesia oral
Clinical narrative: 39 y/o female c/o dizziness and tongue numbness 6 mins after receiving the 2nd dose of the vaccine. She reported Hx of anxiety disorder and that she had similar symptoms with the 1st dose and her BP was elevated. She was assessed and monitored by NP, EMT, and paramedic. BP - 145/78, 139/83, HR - 87, resp - 16, O2 sat 86% on RA, SR w/o ectopy, pupils size 5, PERRL, MAE, has mild anxiety. Instructed on relaxation techniques, given snacks and H2O, took outside for fresh air with mask off. She was kept at site until she reported that she felt better, had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911 and go to the ED, follow up with her PCP, register with V-safe. She verbalized understanding and willingness to comply. She left with husband and family members in no acute discuss, awake, alert, oriented to person place, time and situation.
Age: 40.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Condition aggravated, Dizziness, Hypoaesthesia oral
Clinical narrative: 39 y/o female c/o dizziness and tongue numbness 6 mins after receiving the 2nd dose of the vaccine. She reported Hx of anxiety disorder and that she had similar symptoms with the 1st dose and her BP was elevated. She was assessed and monitored by NP, EMT, and paramedic. BP - 145/78, 139/83, HR - 87, resp - 16, O2 sat 86% on RA, SR w/o ectopy, pupils size 5, PERRL, MAE, has mild anxiety. Instructed on relaxation techniques, given snacks and H2O, took outside for fresh air with mask off. She was kept at site until she reported that she felt better, had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911 and go to the ED, follow up with her PCP, register with V-safe. She verbalized understanding and willingness to comply. She left with husband and family members in no acute discuss, awake, alert, oriented to person place, time and situation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear pain, Head discomfort, Headache, Pain
Clinical narrative: head felt like it was going to pop off/pain; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included botulinum toxin type A (BOTOX) injections a week and a day before she received the second dose of the vaccine for headaches. The patient previously received dose 1 of BNT162B2 on an unknown date for COVID-19 immunization. On an unspecified date after the second dose of the vaccine the patient experienced a severe reaction where her head felt like it was going to pop off. The patient received treatment with a 10 day course of steroids to help with the pain. The outcome of head felt like it was going to pop off was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: head felt like it was going to pop off/pain; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included botulinum toxin type A (BOTOX) injections a week and a day before she received the second dose of the vaccine for headaches. The patient previously received dose 1 of BNT162B2 on an unknown date for COVID-19 immunization. On an unspecified date after the second dose of the vaccine the patient experienced a severe reaction where her head felt like it was going to pop off. The patient received treatment with a 10 day course of steroids to help with the pain. The outcome of head felt like it was going to pop off was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: head felt like it was going to pop off/pain; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included botulinum toxin type A (BOTOX) injections a week and a day before she received the second dose of the vaccine for headaches. The patient previously received dose 1 of BNT162B2 on an unknown date for COVID-19 immunization. On an unspecified date after the second dose of the vaccine the patient experienced a severe reaction where her head felt like it was going to pop off. The patient received treatment with a 10 day course of steroids to help with the pain. The outcome of head felt like it was going to pop off was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Endotracheal intubation, Fatigue, Lung assist device therapy
Clinical narrative: Patient presented to the emergency room on   5/9/2021, approximately 3 weeks after receiving the J&J vaccine due to progressively worsening shortness of breath.   She also had noted pain and swelling in the left calf and leg.  In the ED she underwent CTA of the chest showing  severe burden of acute PE (pulmonary embolism) with severe right heart strain, small early infarct posteromedial LLL, hepatic steatosis. Venous doppler 5/10/21 showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. She underwent urgent thrombectomy, however, the next morning she became more hypoxic and hypotensive. She was intubated and was urgently placed on  ECMO.  She developed multi-organ failure. She was started on CVVH for oliguric renal failure. CT scan of her head done 3 days later showed diffuse diffuse cerebral edema, which is most likely a result of hypoxic encephalopathy.  With no improvement in her mental status over the course of the next few days, she was taken off life support and died on 5/15/2021