chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin, Metabolic function test, Muscle spasms
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 19:18 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 at 02.30 patient experienced severe cramping on front and back of right leg; she was unable to stand and had to sit down on the floor. The patient then started feeling the left leg also  cramp and was rushed to the hospital. At 02:45 was in the hospital and received intravenous morphine and laboratory tests (hemoglobin and metabolic panel - test results not provided). At 04:24 patient received intravenous Valium. That same day, 10-APR-2021 at 05:07 Sodium Chloride (NaCl 0.9%) was stopped and the patient was released from hospital.  On 13-APR-2021 the patient received D-Dimer testing. She stated the levels were 0.95 (units unspecified) "which was elevated compared to average 0.5". Her doctor notified her not to fly anywhere and have an ultrasound. On 14-APR-20-21 ultrasound performed. Reports came back with no Deep vein thrombosis (DVT) but still blood clotting was present in unknown location. On 15-APR-20201 patient has requested  another D-Dimer test with her physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 50-year-old female patient was rushed to the hospital for severe cramping of right leg 2 days after receiving COVID-19 VACCINE AD26.COV2.S on right arm.  Hemoglobin and metaboic panel was awaiting results; D-Dimer was reported to elevated at 0.95; and ultrasound showed no deep vein thrombosis but was told that there was still blood clotting in an unknown location.  Additional work up is being done.  The patient was treated with Valium and IV fluid and was released from the hospital.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per the WHO causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism.  Considering temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Haemoglobin, Metabolic function test, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 19:18 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 at 02.30 patient experienced severe cramping on front and back of right leg; she was unable to stand and had to sit down on the floor. The patient then started feeling the left leg also  cramp and was rushed to the hospital. At 02:45 was in the hospital and received intravenous morphine and laboratory tests (hemoglobin and metabolic panel - test results not provided). At 04:24 patient received intravenous Valium. That same day, 10-APR-2021 at 05:07 Sodium Chloride (NaCl 0.9%) was stopped and the patient was released from hospital.  On 13-APR-2021 the patient received D-Dimer testing. She stated the levels were 0.95 (units unspecified) "which was elevated compared to average 0.5". Her doctor notified her not to fly anywhere and have an ultrasound. On 14-APR-20-21 ultrasound performed. Reports came back with no Deep vein thrombosis (DVT) but still blood clotting was present in unknown location. On 15-APR-20201 patient has requested  another D-Dimer test with her physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 50-year-old female patient was rushed to the hospital for severe cramping of right leg 2 days after receiving COVID-19 VACCINE AD26.COV2.S on right arm.  Hemoglobin and metaboic panel was awaiting results; D-Dimer was reported to elevated at 0.95; and ultrasound showed no deep vein thrombosis but was told that there was still blood clotting in an unknown location.  Additional work up is being done.  The patient was treated with Valium and IV fluid and was released from the hospital.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per the WHO causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism.  Considering temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a non-contactable Nurse. A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot Number: EP7533) at single dose for covid-19 immunization. The vaccine was administered in Public health clinic. Medical history included hypertension, allergies to PCN (Penicillin). The patient's concomitant medications were not reported. Patient reported for second dose of Pfizer BioNTech vaccine. Patient complained of headache during observation approximately 25 minutes after vaccination. The adverse events resulted in emergency department or urgent care. EMS was called. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event headache cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Cough, Headache, Heart rate, Respiratory rate
Clinical narrative: headache; This is a spontaneous report from a non-contactable Nurse. A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot Number: EP7533) at single dose for covid-19 immunization. The vaccine was administered in Public health clinic. Medical history included hypertension, allergies to PCN (Penicillin). The patient's concomitant medications were not reported. Patient reported for second dose of Pfizer BioNTech vaccine. Patient complained of headache during observation approximately 25 minutes after vaccination. The adverse events resulted in emergency department or urgent care. EMS was called. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event headache cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory rate increased
Clinical narrative: headache; This is a spontaneous report from a non-contactable Nurse. A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot Number: EP7533) at single dose for covid-19 immunization. The vaccine was administered in Public health clinic. Medical history included hypertension, allergies to PCN (Penicillin). The patient's concomitant medications were not reported. Patient reported for second dose of Pfizer BioNTech vaccine. Patient complained of headache during observation approximately 25 minutes after vaccination. The adverse events resulted in emergency department or urgent care. EMS was called. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event headache cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood test normal, Computerised tomogram normal, Echocardiogram, Echocardiogram normal
Clinical narrative: Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Gait disturbance, Magnetic resonance imaging normal, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Rash, Scan with contrast normal, Ultrasound Doppler
Clinical narrative: Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Facial paralysis, Gait disturbance, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Speech disorder
Clinical narrative: Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient recieved Moderna Vaccine dose 2 on March 18th.  He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21.  Flew from hometown to go to another state 4/6/21 to visit daughter.  Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma.  Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease.  Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak).  Neuro recommended restarting IVIG 4/19 x1-2 more days.  Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antibody test normal, Antinuclear antibody negative, Aphasia, Asthenia
Clinical narrative: Patient recieved Moderna Vaccine dose 2 on March 18th.  He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21.  Flew from hometown to go to another state 4/6/21 to visit daughter.  Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma.  Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease.  Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak).  Neuro recommended restarting IVIG 4/19 x1-2 more days.  Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ataxia, Back pain, Bilevel positive airway pressure, Borrelia test negative, C-reactive protein normal
Clinical narrative: Patient recieved Moderna Vaccine dose 2 on March 18th.  He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21.  Flew from hometown to go to another state 4/6/21 to visit daughter.  Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma.  Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease.  Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak).  Neuro recommended restarting IVIG 4/19 x1-2 more days.  Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: CSF immunoglobulin increased, CSF myelin basic protein normal, CSF test, Cranial nerve disorder, Dyspnoea
Clinical narrative: Patient recieved Moderna Vaccine dose 2 on March 18th.  He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21.  Flew from hometown to go to another state 4/6/21 to visit daughter.  Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma.  Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease.  Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak).  Neuro recommended restarting IVIG 4/19 x1-2 more days.  Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, HIV antibody negative, Hypoaesthesia, Immunoglobulin therapy, Intensive care
Clinical narrative: Patient recieved Moderna Vaccine dose 2 on March 18th.  He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21.  Flew from hometown to go to another state 4/6/21 to visit daughter.  Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma.  Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease.  Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak).  Neuro recommended restarting IVIG 4/19 x1-2 more days.  Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intervertebral disc degeneration, JC polyomavirus test negative, Magnetic resonance imaging head abnormal, Mobility decreased, Paraesthesia
Clinical narrative: Patient recieved Moderna Vaccine dose 2 on March 18th.  He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21.  Flew from hometown to go to another state 4/6/21 to visit daughter.  Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma.  Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease.  Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak).  Neuro recommended restarting IVIG 4/19 x1-2 more days.  Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid factor, SARS-CoV-2 test negative, Treponema test negative, Varicella virus test negative, Vitamin B12 normal
Clinical narrative: Patient recieved Moderna Vaccine dose 2 on March 18th.  He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21.  Flew from hometown to go to another state 4/6/21 to visit daughter.  Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma.  Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease.  Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak).  Neuro recommended restarting IVIG 4/19 x1-2 more days.  Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram head, Echocardiogram, Ischaemic stroke, Magnetic resonance imaging head abnormal
Clinical narrative: 74 year old left- handed female admitted emergently 4/9/21 with complaints of left hand and leg weakness with a headache. Onset of symptoms were 5:30pm  4/9.  Patient received Johnson& Johnson vaccine 4/9 at 1pm.    She was admitted for acute ischemic stroke.  She received TPA in the emergency department.  She was evaluated and followed by neurology.  She was placed on aspirin and high-dose atorvastatin.  She had slight improvement in her left-sided weakness with the treatments.  She was found to be hypertensive and was started on amlodipine 5 mg daily.  Blood pressure remains uncontrolled at the time of discharge.  She will need up titration of amlodipine and probably additional antihypertensive. She was transferred to acute rehab.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Computerised tomogram head normal, Computerised tomogram neck, Headache
Clinical narrative: 74 year old left- handed female admitted emergently 4/9/21 with complaints of left hand and leg weakness with a headache. Onset of symptoms were 5:30pm  4/9.  Patient received Johnson& Johnson vaccine 4/9 at 1pm.    She was admitted for acute ischemic stroke.  She received TPA in the emergency department.  She was evaluated and followed by neurology.  She was placed on aspirin and high-dose atorvastatin.  She had slight improvement in her left-sided weakness with the treatments.  She was found to be hypertensive and was started on amlodipine 5 mg daily.  Blood pressure remains uncontrolled at the time of discharge.  She will need up titration of amlodipine and probably additional antihypertensive. She was transferred to acute rehab.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hypertension, Ischaemic stroke, Muscular weakness, Musculoskeletal disorder
Clinical narrative: 74 year old left- handed female admitted emergently 4/9/21 with complaints of left hand and leg weakness with a headache. Onset of symptoms were 5:30pm  4/9.  Patient received Johnson& Johnson vaccine 4/9 at 1pm.    She was admitted for acute ischemic stroke.  She received TPA in the emergency department.  She was evaluated and followed by neurology.  She was placed on aspirin and high-dose atorvastatin.  She had slight improvement in her left-sided weakness with the treatments.  She was found to be hypertensive and was started on amlodipine 5 mg daily.  Blood pressure remains uncontrolled at the time of discharge.  She will need up titration of amlodipine and probably additional antihypertensive. She was transferred to acute rehab.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: NIH stroke scale, Sensory disturbance
Clinical narrative: 74 year old left- handed female admitted emergently 4/9/21 with complaints of left hand and leg weakness with a headache. Onset of symptoms were 5:30pm  4/9.  Patient received Johnson& Johnson vaccine 4/9 at 1pm.    She was admitted for acute ischemic stroke.  She received TPA in the emergency department.  She was evaluated and followed by neurology.  She was placed on aspirin and high-dose atorvastatin.  She had slight improvement in her left-sided weakness with the treatments.  She was found to be hypertensive and was started on amlodipine 5 mg daily.  Blood pressure remains uncontrolled at the time of discharge.  She will need up titration of amlodipine and probably additional antihypertensive. She was transferred to acute rehab.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral vein occlusion, Ultrasound Doppler, Ultrasound scan abnormal
Clinical narrative: Pt with right leg swelling 3 days prior to admission. Per ER note, pt without hx of recent surgery, long travel, blood clots. Pt did receive J&J vaccine on 3/12, former smoker and currently taking depo-provera (last shot 13 weeks ago). Pt had outpatient that confirmed DVT.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Pt with right leg swelling 3 days prior to admission. Per ER note, pt without hx of recent surgery, long travel, blood clots. Pt did receive J&J vaccine on 3/12, former smoker and currently taking depo-provera (last shot 13 weeks ago). Pt had outpatient that confirmed DVT.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral vein occlusion, Ultrasound Doppler, Ultrasound scan
Clinical narrative: Pt with right leg swelling 3 days prior to admission. Per ER note, pt without hx of recent surgery, long travel, blood clots. Pt did receive J&J vaccine on 3/12, former smoker and currently taking depo-provera (last shot 13 weeks ago). Pt had outpatient that confirmed DVT.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate increased, Hypertension, Malaise, Pain
Clinical narrative: days after J&J vaccine pt reported chills, headache, body aches and fatigue, BP became elevated just after vaccine but came down with rest and reassurance
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vital signs measurement
Clinical narrative: days after J&J vaccine pt reported chills, headache, body aches and fatigue, BP became elevated just after vaccine but came down with rest and reassurance
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Chills, Fatigue, Headache, Pain
Clinical narrative: days after J&J vaccine pt reported chills, headache, body aches and fatigue, BP became elevated just after vaccine but came down with rest and reassurance
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: After feeling no side effects from shot on Saturday my husband had a massive seizure in front of me that lasted about 6 minutes. Paramedics brought him to hospital breathing but unconscious. To our knowledge he had never had a seizure so I was incredibly scared and my children and I thought he may have died. My husband had been experiencing short small episodes that we thought were panic attacks for the last 5 years. Doctors had never suggested they could be epilepsy. Neurologist at Hospital that these episodes were small focal point seizures. It seems likely that the vaccine triggered a violent reaction that caused this grand mal seizure
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Loss of consciousness, Magnetic resonance imaging head
Clinical narrative: After feeling no side effects from shot on Saturday my husband had a massive seizure in front of me that lasted about 6 minutes. Paramedics brought him to hospital breathing but unconscious. To our knowledge he had never had a seizure so I was incredibly scared and my children and I thought he may have died. My husband had been experiencing short small episodes that we thought were panic attacks for the last 5 years. Doctors had never suggested they could be epilepsy. Neurologist at Hospital that these episodes were small focal point seizures. It seems likely that the vaccine triggered a violent reaction that caused this grand mal seizure
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pt received both a Johnson & Johnson as well as a Pfizer COVID 19 vaccines, 1 day apart. He started to have headache, "hot sweat" and fatigue 4-5 days after the 2nd vaccine and still affecting patient.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Incorrect dose administered
Clinical narrative: pt received both a Johnson & Johnson as well as a Pfizer COVID 19 vaccines, 1 day apart. He started to have headache, "hot sweat" and fatigue 4-5 days after the 2nd vaccine and still affecting patient.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Death, Dyspnoea, Foaming at mouth, Full blood count
Clinical narrative: SUSPECTED PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report received from a health care professional from a state immunization program concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included cancer, and concurrent conditions included overall poor health. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), date of administration was not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, approximately 24 hours post-vaccination, the patient was taken to the hospital after being found unresponsive. It was suspected that the patient had experienced a pulmonary embolism, resulting in his death.  Laboratory results revealed thrombocytopenia.  Reportedly, no heparin was used in his treatment. On an unspecified date, the subject died from suspected pulmonary embolism, and had not recovered from thrombocytopenia. An autopsy had not been performed at the time of the report, as it was pending family's approval. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a 60-year-old male patient, who died of a suspected pulmonary embolism approximately 24 hours after receipt of the Janssen COVID-19 vaccine. The patient had an unspecified cancer and was described as in overall poor health.  He was brought to a hospital, where it was suspected that he had died due to a pulmonary embolism.  He was also found to be thrombocytopenic.  The patient's cancer could provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: SUSPECTED PULMONARY EMBOLISM
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: HIV test, Haemoglobin decreased, Loss of consciousness, Malaise, Metabolic function test
Clinical narrative: SUSPECTED PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report received from a health care professional from a state immunization program concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included cancer, and concurrent conditions included overall poor health. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), date of administration was not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, approximately 24 hours post-vaccination, the patient was taken to the hospital after being found unresponsive. It was suspected that the patient had experienced a pulmonary embolism, resulting in his death.  Laboratory results revealed thrombocytopenia.  Reportedly, no heparin was used in his treatment. On an unspecified date, the subject died from suspected pulmonary embolism, and had not recovered from thrombocytopenia. An autopsy had not been performed at the time of the report, as it was pending family's approval. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a 60-year-old male patient, who died of a suspected pulmonary embolism approximately 24 hours after receipt of the Janssen COVID-19 vaccine. The patient had an unspecified cancer and was described as in overall poor health.  He was brought to a hospital, where it was suspected that he had died due to a pulmonary embolism.  He was also found to be thrombocytopenic.  The patient's cancer could provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: SUSPECTED PULMONARY EMBOLISM
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Sputum discoloured
Clinical narrative: SUSPECTED PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report received from a health care professional from a state immunization program concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included cancer, and concurrent conditions included overall poor health. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), date of administration was not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, approximately 24 hours post-vaccination, the patient was taken to the hospital after being found unresponsive. It was suspected that the patient had experienced a pulmonary embolism, resulting in his death.  Laboratory results revealed thrombocytopenia.  Reportedly, no heparin was used in his treatment. On an unspecified date, the subject died from suspected pulmonary embolism, and had not recovered from thrombocytopenia. An autopsy had not been performed at the time of the report, as it was pending family's approval. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a 60-year-old male patient, who died of a suspected pulmonary embolism approximately 24 hours after receipt of the Janssen COVID-19 vaccine. The patient had an unspecified cancer and was described as in overall poor health.  He was brought to a hospital, where it was suspected that he had died due to a pulmonary embolism.  He was also found to be thrombocytopenic.  The patient's cancer could provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: SUSPECTED PULMONARY EMBOLISM
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Coagulation test, Dyspnoea, Foaming at mouth, Heparin-induced thrombocytopenia test
Clinical narrative: SUSPECTED PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report received from a health care professional from a state immunization program concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included cancer, and concurrent conditions included overall poor health. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), date of administration was not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, approximately 24 hours post-vaccination, the patient was taken to the hospital after being found unresponsive. It was suspected that the patient had experienced a pulmonary embolism, resulting in his death.  Laboratory results revealed thrombocytopenia.  Reportedly, no heparin was used in his treatment. On an unspecified date, the subject died from suspected pulmonary embolism, and had not recovered from thrombocytopenia. An autopsy had not been performed at the time of the report, as it was pending family's approval. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a 60-year-old male patient, who died of a suspected pulmonary embolism approximately 24 hours after receipt of the Janssen COVID-19 vaccine. The patient had an unspecified cancer and was described as in overall poor health.  He was brought to a hospital, where it was suspected that he had died due to a pulmonary embolism.  He was also found to be thrombocytopenic.  The patient's cancer could provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: SUSPECTED PULMONARY EMBOLISM
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count, Sputum discoloured
Clinical narrative: SUSPECTED PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report received from a health care professional from a state immunization program concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included cancer, and concurrent conditions included overall poor health. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), date of administration was not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, approximately 24 hours post-vaccination, the patient was taken to the hospital after being found unresponsive. It was suspected that the patient had experienced a pulmonary embolism, resulting in his death.  Laboratory results revealed thrombocytopenia.  Reportedly, no heparin was used in his treatment. On an unspecified date, the subject died from suspected pulmonary embolism, and had not recovered from thrombocytopenia. An autopsy had not been performed at the time of the report, as it was pending family's approval. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a 60-year-old male patient, who died of a suspected pulmonary embolism approximately 24 hours after receipt of the Janssen COVID-19 vaccine. The patient had an unspecified cancer and was described as in overall poor health.  He was brought to a hospital, where it was suspected that he had died due to a pulmonary embolism.  He was also found to be thrombocytopenic.  The patient's cancer could provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: SUSPECTED PULMONARY EMBOLISM
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count, Pulmonary embolism, Thrombocytopenia
Clinical narrative: SUSPECTED PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report received from a health care professional from a state immunization program concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included cancer, and concurrent conditions included overall poor health. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), date of administration was not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, approximately 24 hours post-vaccination, the patient was taken to the hospital after being found unresponsive. It was suspected that the patient had experienced a pulmonary embolism, resulting in his death.  Laboratory results revealed thrombocytopenia.  Reportedly, no heparin was used in his treatment. On an unspecified date, the subject died from suspected pulmonary embolism, and had not recovered from thrombocytopenia. An autopsy had not been performed at the time of the report, as it was pending family's approval. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a 60-year-old male patient, who died of a suspected pulmonary embolism approximately 24 hours after receipt of the Janssen COVID-19 vaccine. The patient had an unspecified cancer and was described as in overall poor health.  He was brought to a hospital, where it was suspected that he had died due to a pulmonary embolism.  He was also found to be thrombocytopenic.  The patient's cancer could provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: SUSPECTED PULMONARY EMBOLISM