chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood testosterone decreased, Chills, Electrophoresis normal, Fatigue
Clinical narrative: Severe arthritis, ongoing now for weeks; Headaches; Difficulty concentrating; Severe lethargy; fatigue; Muscle weakness; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9662) via an unspecified route of administration in Arm Right on 26Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation at Nursing Home. Medical history included ADD (attention deficit hyperactivity disorder), allergies (unspecified), asthma, TBI (traumatic brain injury), sleep apnea, and hypogonadism. Patient had allergies to weed pollen, dust mites, and cockroach all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received other medications (unspecified) in two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EH9899) via an unspecified route of administration in Arm Left on 05Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation. On 26Jan2021 at 02:00 PM, the patient experienced severe arthritis, ongoing now for weeks, headaches, difficulty concentrating, severe lethargy, fatigue, muscle weakness. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Prednisone for the adverse events. The seriousness of the events was reported as disability or permanent damage. On 11Jun2021, post vaccination patient had Covid nasal swab test which result was pending. The clinical outcome of the events reported as not recovered.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events arthritis, headache, disturbance in attention, lethargy and fatigue and the suspect drug BNT162B2. 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: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Injection site hypersensitivity, Lethargy, Myalgia
Clinical narrative: Severe arthritis, ongoing now for weeks; Headaches; Difficulty concentrating; Severe lethargy; fatigue; Muscle weakness; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9662) via an unspecified route of administration in Arm Right on 26Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation at Nursing Home. Medical history included ADD (attention deficit hyperactivity disorder), allergies (unspecified), asthma, TBI (traumatic brain injury), sleep apnea, and hypogonadism. Patient had allergies to weed pollen, dust mites, and cockroach all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received other medications (unspecified) in two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EH9899) via an unspecified route of administration in Arm Left on 05Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation. On 26Jan2021 at 02:00 PM, the patient experienced severe arthritis, ongoing now for weeks, headaches, difficulty concentrating, severe lethargy, fatigue, muscle weakness. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Prednisone for the adverse events. The seriousness of the events was reported as disability or permanent damage. On 11Jun2021, post vaccination patient had Covid nasal swab test which result was pending. The clinical outcome of the events reported as not recovered.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events arthritis, headache, disturbance in attention, lethargy and fatigue and the suspect drug BNT162B2. 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: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative
Clinical narrative: Severe arthritis, ongoing now for weeks; Headaches; Difficulty concentrating; Severe lethargy; fatigue; Muscle weakness; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9662) via an unspecified route of administration in Arm Right on 26Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation at Nursing Home. Medical history included ADD (attention deficit hyperactivity disorder), allergies (unspecified), asthma, TBI (traumatic brain injury), sleep apnea, and hypogonadism. Patient had allergies to weed pollen, dust mites, and cockroach all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received other medications (unspecified) in two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EH9899) via an unspecified route of administration in Arm Left on 05Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation. On 26Jan2021 at 02:00 PM, the patient experienced severe arthritis, ongoing now for weeks, headaches, difficulty concentrating, severe lethargy, fatigue, muscle weakness. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Prednisone for the adverse events. The seriousness of the events was reported as disability or permanent damage. On 11Jun2021, post vaccination patient had Covid nasal swab test which result was pending. The clinical outcome of the events reported as not recovered.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events arthritis, headache, disturbance in attention, lethargy and fatigue and the suspect drug BNT162B2. 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: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthritis, Disturbance in attention, Fatigue, Headache, Lethargy
Clinical narrative: Severe arthritis, ongoing now for weeks; Headaches; Difficulty concentrating; Severe lethargy; fatigue; Muscle weakness; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9662) via an unspecified route of administration in Arm Right on 26Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation at Nursing Home. Medical history included ADD (attention deficit hyperactivity disorder), allergies (unspecified), asthma, TBI (traumatic brain injury), sleep apnea, and hypogonadism. Patient had allergies to weed pollen, dust mites, and cockroach all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received other medications (unspecified) in two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EH9899) via an unspecified route of administration in Arm Left on 05Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation. On 26Jan2021 at 02:00 PM, the patient experienced severe arthritis, ongoing now for weeks, headaches, difficulty concentrating, severe lethargy, fatigue, muscle weakness. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Prednisone for the adverse events. The seriousness of the events was reported as disability or permanent damage. On 11Jun2021, post vaccination patient had Covid nasal swab test which result was pending. The clinical outcome of the events reported as not recovered.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events arthritis, headache, disturbance in attention, lethargy and fatigue and the suspect drug BNT162B2. 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: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test
Clinical narrative: Severe arthritis, ongoing now for weeks; Headaches; Difficulty concentrating; Severe lethargy; fatigue; Muscle weakness; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9662) via an unspecified route of administration in Arm Right on 26Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation at Nursing Home. Medical history included ADD (attention deficit hyperactivity disorder), allergies (unspecified), asthma, TBI (traumatic brain injury), sleep apnea, and hypogonadism. Patient had allergies to weed pollen, dust mites, and cockroach all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received other medications (unspecified) in two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EH9899) via an unspecified route of administration in Arm Left on 05Jan2021 at 11:00 AM (at the age of 37 years old) as single dose for covid-19 immunisation. On 26Jan2021 at 02:00 PM, the patient experienced severe arthritis, ongoing now for weeks, headaches, difficulty concentrating, severe lethargy, fatigue, muscle weakness. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Prednisone for the adverse events. The seriousness of the events was reported as disability or permanent damage. On 11Jun2021, post vaccination patient had Covid nasal swab test which result was pending. The clinical outcome of the events reported as not recovered.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events arthritis, headache, disturbance in attention, lethargy and fatigue and the suspect drug BNT162B2. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: rash after her injection of the Pfizer covid vaccine over part of her body; Very itchy; Burning; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of age: 77 (Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash after her injection of the Pfizer covid vaccine over part of her body, very itchy and burning. The reporter would like to know if she should get the 2nd dose of the covid vaccine with her history of post-vaccine side effects. The reporter would like to know if she should take Benadryl prior to getting the 2nd dose of the covid vaccine, as recommended by her doctor. The reporter questioned: What if she takes an oral steroid, like prednisone, along with the covid vaccine and What was the percentage of efficacy after 1 dose? The reporter would like to know if she could get another company's covid vaccine as her 2nd dose of the covid vaccine series. The reporter would like to know how much protection she would get if she should take only 1 dose of the covid vaccine. Therapeutic measures were taken as a result of the events with topical steroids as directed by her dermatologist. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash after her injection of the Pfizer covid vaccine over part of her body; Very itchy; Burning; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of age: 77 (Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash after her injection of the Pfizer covid vaccine over part of her body, very itchy and burning. The reporter would like to know if she should get the 2nd dose of the covid vaccine with her history of post-vaccine side effects. The reporter would like to know if she should take Benadryl prior to getting the 2nd dose of the covid vaccine, as recommended by her doctor. The reporter questioned: What if she takes an oral steroid, like prednisone, along with the covid vaccine and What was the percentage of efficacy after 1 dose? The reporter would like to know if she could get another company's covid vaccine as her 2nd dose of the covid vaccine series. The reporter would like to know how much protection she would get if she should take only 1 dose of the covid vaccine. Therapeutic measures were taken as a result of the events with topical steroids as directed by her dermatologist. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: rash after her injection of the Pfizer covid vaccine over part of her body; Very itchy; Burning; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of age: 77 (Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash after her injection of the Pfizer covid vaccine over part of her body, very itchy and burning. The reporter would like to know if she should get the 2nd dose of the covid vaccine with her history of post-vaccine side effects. The reporter would like to know if she should take Benadryl prior to getting the 2nd dose of the covid vaccine, as recommended by her doctor. The reporter questioned: What if she takes an oral steroid, like prednisone, along with the covid vaccine and What was the percentage of efficacy after 1 dose? The reporter would like to know if she could get another company's covid vaccine as her 2nd dose of the covid vaccine series. The reporter would like to know how much protection she would get if she should take only 1 dose of the covid vaccine. Therapeutic measures were taken as a result of the events with topical steroids as directed by her dermatologist. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Odynophagia, Oral pruritus, Pharyngeal swelling
Clinical narrative: Anaphylaxis effect during first 15 minutes. After that, I went an urgent care with high blood pressure, tachycardia, breath shortness and stomach discomfort
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Anaphylactic reaction, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory
Clinical narrative: Anaphylaxis effect during first 15 minutes. After that, I went an urgent care with high blood pressure, tachycardia, breath shortness and stomach discomfort
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endoscopy, Hypertension, Laboratory test abnormal, Tachycardia
Clinical narrative: Anaphylaxis effect during first 15 minutes. After that, I went an urgent care with high blood pressure, tachycardia, breath shortness and stomach discomfort
Age: 72.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Blood glucose increased
Clinical narrative: Since receiving 2nd dose. Non specific cardiac abnormality, Hemoglobin A1C 7.1, RBC 5.45, Hemoglobin 16.3, Hematocrit 49.5,BUN 145, Calcium 10.8, Globulin 4.8,
Age: 72.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Blood calcium increased, Blood urea increased, Cardiac disorder, Globulins increased, Glycosylated haemoglobin increased
Clinical narrative: Since receiving 2nd dose. Non specific cardiac abnormality, Hemoglobin A1C 7.1, RBC 5.45, Hemoglobin 16.3, Hematocrit 49.5,BUN 145, Calcium 10.8, Globulin 4.8,
Age: 72.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Haematocrit increased, Haemoglobin increased, Laboratory test normal, Red blood cell count increased
Clinical narrative: Since receiving 2nd dose. Non specific cardiac abnormality, Hemoglobin A1C 7.1, RBC 5.45, Hemoglobin 16.3, Hematocrit 49.5,BUN 145, Calcium 10.8, Globulin 4.8,
Age: 72.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Blood calcium, Blood calcium increased, Blood cholesterol, Blood cholesterol abnormal, Blood glucose increased
Clinical narrative: Since receiving 2nd dose. Non specific cardiac abnormality, Hemoglobin A1C 7.1, RBC 5.45, Hemoglobin 16.3, Hematocrit 49.5,BUN 145, Calcium 10.8, Globulin 4.8,
Age: 72.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Blood test, Body temperature, Diabetes mellitus, Electrocardiogram, Malaise
Clinical narrative: Since receiving 2nd dose. Non specific cardiac abnormality, Hemoglobin A1C 7.1, RBC 5.45, Hemoglobin 16.3, Hematocrit 49.5,BUN 145, Calcium 10.8, Globulin 4.8,
Age: 72.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Myocardial infarction, Night sweats, Pyrexia, Renal disorder
Clinical narrative: Since receiving 2nd dose. Non specific cardiac abnormality, Hemoglobin A1C 7.1, RBC 5.45, Hemoglobin 16.3, Hematocrit 49.5,BUN 145, Calcium 10.8, Globulin 4.8,
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Syncope, Unresponsive to stimuli
Clinical narrative: Diagnosed with Myocarditis; administration_date=13/Apr/2021/number=1/vaccine_date=13/Apr/2021/number=2; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular at the age of 26-year-old administered in arm left on 13Apr2021 14:00 (Lot Number: 6314) at single dose, dose 2 via an unspecified route of administration at the age of 26-year-old administered in arm left on 13Apr2021 14:00 (Lot Number: 6314) single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Relevant past drug history was reported as cillins (unspecified). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. The patient diagnosed with myocarditis on 05May2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The event was serious for being medical significant. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was received the anti inflammatory and steroid for adverse events. The outcome of event was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Myocarditis
Clinical narrative: Diagnosed with Myocarditis; administration_date=13/Apr/2021/number=1/vaccine_date=13/Apr/2021/number=2; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular at the age of 26-year-old administered in arm left on 13Apr2021 14:00 (Lot Number: 6314) at single dose, dose 2 via an unspecified route of administration at the age of 26-year-old administered in arm left on 13Apr2021 14:00 (Lot Number: 6314) single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Relevant past drug history was reported as cillins (unspecified). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. The patient diagnosed with myocarditis on 05May2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The event was serious for being medical significant. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was received the anti inflammatory and steroid for adverse events. The outcome of event was recovering.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Cerebral haemorrhage, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report was received from an online literature/invited commentary article. This report concerned a 58 year old male. The patient's height, and weight were not reported. The patient had no significant medical history. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, anatomical injection site, batch number and expiry date not reported) once in total at an unspecified dose on an unspecified date for prophylactic vaccination. No concomitant medications were reported. On an unspecified date approximately 2 weeks after vaccination, the patient experienced Guillain-Barre syndrome and was hospitalized by the neurology service at a hospital. The patient had presented with marked bilateral facial weakness and modest appendicular weakness. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (caused hospitalization). This case, from Same Literature article is linked to 20210652112.; Sender's Comments: V0: This spontaneous report from an online article concerns a 58 year-old male who was hospitalized for Guillain-Barre syndrome (GBS) approximately 2 weeks after receiving Janssen Covid-19 vaccine. Presenting symptoms included marked bilateral facial weakness and modest appendicular weakness. Medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid analysis, MRI brain/spine, nerve conduction studies), corrective treatment, and outcome were not reported. Information regarding potential etiologies of GBS was also insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Inflammation
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report was received from an online literature/invited commentary article. This report concerned a 58 year old male. The patient's height, and weight were not reported. The patient had no significant medical history. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, anatomical injection site, batch number and expiry date not reported) once in total at an unspecified dose on an unspecified date for prophylactic vaccination. No concomitant medications were reported. On an unspecified date approximately 2 weeks after vaccination, the patient experienced Guillain-Barre syndrome and was hospitalized by the neurology service at a hospital. The patient had presented with marked bilateral facial weakness and modest appendicular weakness. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (caused hospitalization). This case, from Same Literature article is linked to 20210652112.; Sender's Comments: V0: This spontaneous report from an online article concerns a 58 year-old male who was hospitalized for Guillain-Barre syndrome (GBS) approximately 2 weeks after receiving Janssen Covid-19 vaccine. Presenting symptoms included marked bilateral facial weakness and modest appendicular weakness. Medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid analysis, MRI brain/spine, nerve conduction studies), corrective treatment, and outcome were not reported. Information regarding potential etiologies of GBS was also insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report was received from an online literature/invited commentary article. This report concerned a 58 year old male. The patient's height, and weight were not reported. The patient had no significant medical history. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, anatomical injection site, batch number and expiry date not reported) once in total at an unspecified dose on an unspecified date for prophylactic vaccination. No concomitant medications were reported. On an unspecified date approximately 2 weeks after vaccination, the patient experienced Guillain-Barre syndrome and was hospitalized by the neurology service at a hospital. The patient had presented with marked bilateral facial weakness and modest appendicular weakness. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (caused hospitalization). This case, from Same Literature article is linked to 20210652112.; Sender's Comments: V0: This spontaneous report from an online article concerns a 58 year-old male who was hospitalized for Guillain-Barre syndrome (GBS) approximately 2 weeks after receiving Janssen Covid-19 vaccine. Presenting symptoms included marked bilateral facial weakness and modest appendicular weakness. Medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid analysis, MRI brain/spine, nerve conduction studies), corrective treatment, and outcome were not reported. Information regarding potential etiologies of GBS was also insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report was received from an online literature/invited commentary article. This report concerned a 58 year old male. The patient's height, and weight were not reported. The patient had no significant medical history. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, anatomical injection site, batch number and expiry date not reported) once in total at an unspecified dose on an unspecified date for prophylactic vaccination. No concomitant medications were reported. On an unspecified date approximately 2 weeks after vaccination, the patient experienced Guillain-Barre syndrome and was hospitalized by the neurology service at a hospital. The patient had presented with marked bilateral facial weakness and modest appendicular weakness. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (caused hospitalization). This case, from Same Literature article is linked to 20210652112.; Sender's Comments: V0: This spontaneous report from an online article concerns a 58 year-old male who was hospitalized for Guillain-Barre syndrome (GBS) approximately 2 weeks after receiving Janssen Covid-19 vaccine. Presenting symptoms included marked bilateral facial weakness and modest appendicular weakness. Medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid analysis, MRI brain/spine, nerve conduction studies), corrective treatment, and outcome were not reported. Information regarding potential etiologies of GBS was also insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE  SYNDROME; HE IS BEING VERY DEPRESSED. COULDNT BE AT WORK; HARD TIME WALKING; MUSCLE ACHE; HEALTH DECLINE; This spontaneous report was received from a patient and concerned a 47 year old male.  The patient's weight, height, concurrent conditions, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 in left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 (5 days post vaccination), the patient was having health decline, couldn't walk, and muscle aches. The patient went to hospital on 02-MAY-2021 and was there for 5 days. The patient was told he had Guillain Barre syndrome. The patient was very depressed, he couldn't be at work. The patient also mentioned that he could not write due to this condition.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard time walking, Guillain Barre syndrome, muscle ache, he is being very depressed. couldn't be at work,  and health decline was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from the patient concerns a 47-year-old male who experienced onset of inability to walk, muscle aches, and unspecified health decline 5 days after receiving Janssen Covid-19 vaccine and was hospitalized 30 days post-vaccination for Guillain-Barre syndrome (GBS). He stayed in the hospital for 5 days. The patient was unable to work and was unable to write. No information regarding medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid tests, nerve conduction studies, MRI brain/spine), corrective treatment, or outcome was reported. Information regarding diagnostic testing and potential etiologies of GBS was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Feeling abnormal, Gait disturbance, General physical health deterioration, Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE  SYNDROME; HE IS BEING VERY DEPRESSED. COULDNT BE AT WORK; HARD TIME WALKING; MUSCLE ACHE; HEALTH DECLINE; This spontaneous report was received from a patient and concerned a 47 year old male.  The patient's weight, height, concurrent conditions, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 in left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 (5 days post vaccination), the patient was having health decline, couldn't walk, and muscle aches. The patient went to hospital on 02-MAY-2021 and was there for 5 days. The patient was told he had Guillain Barre syndrome. The patient was very depressed, he couldn't be at work. The patient also mentioned that he could not write due to this condition.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard time walking, Guillain Barre syndrome, muscle ache, he is being very depressed. couldn't be at work,  and health decline was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from the patient concerns a 47-year-old male who experienced onset of inability to walk, muscle aches, and unspecified health decline 5 days after receiving Janssen Covid-19 vaccine and was hospitalized 30 days post-vaccination for Guillain-Barre syndrome (GBS). He stayed in the hospital for 5 days. The patient was unable to work and was unable to write. No information regarding medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid tests, nerve conduction studies, MRI brain/spine), corrective treatment, or outcome was reported. Information regarding diagnostic testing and potential etiologies of GBS was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Mobility decreased
Clinical narrative: GUILLAIN BARRE  SYNDROME; HE IS BEING VERY DEPRESSED. COULDNT BE AT WORK; HARD TIME WALKING; MUSCLE ACHE; HEALTH DECLINE; This spontaneous report was received from a patient and concerned a 47 year old male.  The patient's weight, height, concurrent conditions, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 in left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 (5 days post vaccination), the patient was having health decline, couldn't walk, and muscle aches. The patient went to hospital on 02-MAY-2021 and was there for 5 days. The patient was told he had Guillain Barre syndrome. The patient was very depressed, he couldn't be at work. The patient also mentioned that he could not write due to this condition.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard time walking, Guillain Barre syndrome, muscle ache, he is being very depressed. couldn't be at work,  and health decline was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from the patient concerns a 47-year-old male who experienced onset of inability to walk, muscle aches, and unspecified health decline 5 days after receiving Janssen Covid-19 vaccine and was hospitalized 30 days post-vaccination for Guillain-Barre syndrome (GBS). He stayed in the hospital for 5 days. The patient was unable to work and was unable to write. No information regarding medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid tests, nerve conduction studies, MRI brain/spine), corrective treatment, or outcome was reported. Information regarding diagnostic testing and potential etiologies of GBS was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Loss of consciousness, Lumbar puncture
Clinical narrative: GUILLAIN BARRE  SYNDROME; HE IS BEING VERY DEPRESSED. COULDNT BE AT WORK; HARD TIME WALKING; MUSCLE ACHE; HEALTH DECLINE; This spontaneous report was received from a patient and concerned a 47 year old male.  The patient's weight, height, concurrent conditions, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 in left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 (5 days post vaccination), the patient was having health decline, couldn't walk, and muscle aches. The patient went to hospital on 02-MAY-2021 and was there for 5 days. The patient was told he had Guillain Barre syndrome. The patient was very depressed, he couldn't be at work. The patient also mentioned that he could not write due to this condition.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard time walking, Guillain Barre syndrome, muscle ache, he is being very depressed. couldn't be at work,  and health decline was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from the patient concerns a 47-year-old male who experienced onset of inability to walk, muscle aches, and unspecified health decline 5 days after receiving Janssen Covid-19 vaccine and was hospitalized 30 days post-vaccination for Guillain-Barre syndrome (GBS). He stayed in the hospital for 5 days. The patient was unable to work and was unable to write. No information regarding medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid tests, nerve conduction studies, MRI brain/spine), corrective treatment, or outcome was reported. Information regarding diagnostic testing and potential etiologies of GBS was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Neuropathy peripheral, Paraesthesia
Clinical narrative: GUILLAIN BARRE  SYNDROME; HE IS BEING VERY DEPRESSED. COULDNT BE AT WORK; HARD TIME WALKING; MUSCLE ACHE; HEALTH DECLINE; This spontaneous report was received from a patient and concerned a 47 year old male.  The patient's weight, height, concurrent conditions, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 in left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 (5 days post vaccination), the patient was having health decline, couldn't walk, and muscle aches. The patient went to hospital on 02-MAY-2021 and was there for 5 days. The patient was told he had Guillain Barre syndrome. The patient was very depressed, he couldn't be at work. The patient also mentioned that he could not write due to this condition.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard time walking, Guillain Barre syndrome, muscle ache, he is being very depressed. couldn't be at work,  and health decline was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from the patient concerns a 47-year-old male who experienced onset of inability to walk, muscle aches, and unspecified health decline 5 days after receiving Janssen Covid-19 vaccine and was hospitalized 30 days post-vaccination for Guillain-Barre syndrome (GBS). He stayed in the hospital for 5 days. The patient was unable to work and was unable to write. No information regarding medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid tests, nerve conduction studies, MRI brain/spine), corrective treatment, or outcome was reported. Information regarding diagnostic testing and potential etiologies of GBS was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Depression, Gait disturbance, General physical health deterioration, Guillain-Barre syndrome, Myalgia
Clinical narrative: GUILLAIN BARRE  SYNDROME; HE IS BEING VERY DEPRESSED. COULDNT BE AT WORK; HARD TIME WALKING; MUSCLE ACHE; HEALTH DECLINE; This spontaneous report was received from a patient and concerned a 47 year old male.  The patient's weight, height, concurrent conditions, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 in left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 (5 days post vaccination), the patient was having health decline, couldn't walk, and muscle aches. The patient went to hospital on 02-MAY-2021 and was there for 5 days. The patient was told he had Guillain Barre syndrome. The patient was very depressed, he couldn't be at work. The patient also mentioned that he could not write due to this condition.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard time walking, Guillain Barre syndrome, muscle ache, he is being very depressed. couldn't be at work,  and health decline was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from the patient concerns a 47-year-old male who experienced onset of inability to walk, muscle aches, and unspecified health decline 5 days after receiving Janssen Covid-19 vaccine and was hospitalized 30 days post-vaccination for Guillain-Barre syndrome (GBS). He stayed in the hospital for 5 days. The patient was unable to work and was unable to write. No information regarding medical history, concomitant medications, physical exam findings, diagnostic testing (e.g. cerebrospinal fluid tests, nerve conduction studies, MRI brain/spine), corrective treatment, or outcome was reported. Information regarding diagnostic testing and potential etiologies of GBS was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.