chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Extreme ongoing (10 weeks so far) nerve pain; muscle pain; joint pain; weakness  in all 4 extremities and hips and shoulders; numbness and tingling in all extremities with the right side being the worst; numbness and tingling in all extremities with the right side being the worst; I am unable to do activities that I used to do; This is spontaneous report from contactable nurse (patient). A 54-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Feb2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration administered in right arm on 05Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included asthma. The patient had known allergies with gluten, latex. Concomitant medication(s) received within 2 weeks of vaccination included vitamin d3; multi vitamin, b complex. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 13:15, the patient experienced extreme ongoing (10 weeks so far) nerve pain, muscle pain, joint pain and weakness in all 4 extremities and hips and shoulders with the right side being the worst. Also with numbness and tingling in all extremities with the right side being the worst. The pain and weakness are severe and debilitating. The patient unable to do activities that used to do and also had to cut down work hours as cannot tolerate the pain and adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone, labs, specialists, physiotherapy, acupuncture. The seriousness of the event was considered as disabling/incapacitating by reporter. Outcome of the events was not recovered.  Device Date : 05May2021 Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. 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: Arthralgia, Hypoaesthesia, Loss of personal independence in daily activities, Muscular weakness, Myalgia
Clinical narrative: Extreme ongoing (10 weeks so far) nerve pain; muscle pain; joint pain; weakness  in all 4 extremities and hips and shoulders; numbness and tingling in all extremities with the right side being the worst; numbness and tingling in all extremities with the right side being the worst; I am unable to do activities that I used to do; This is spontaneous report from contactable nurse (patient). A 54-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Feb2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration administered in right arm on 05Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included asthma. The patient had known allergies with gluten, latex. Concomitant medication(s) received within 2 weeks of vaccination included vitamin d3; multi vitamin, b complex. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 13:15, the patient experienced extreme ongoing (10 weeks so far) nerve pain, muscle pain, joint pain and weakness in all 4 extremities and hips and shoulders with the right side being the worst. Also with numbness and tingling in all extremities with the right side being the worst. The pain and weakness are severe and debilitating. The patient unable to do activities that used to do and also had to cut down work hours as cannot tolerate the pain and adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone, labs, specialists, physiotherapy, acupuncture. The seriousness of the event was considered as disabling/incapacitating by reporter. Outcome of the events was not recovered.  Device Date : 05May2021 Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. 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: Neuralgia, Paraesthesia
Clinical narrative: Extreme ongoing (10 weeks so far) nerve pain; muscle pain; joint pain; weakness  in all 4 extremities and hips and shoulders; numbness and tingling in all extremities with the right side being the worst; numbness and tingling in all extremities with the right side being the worst; I am unable to do activities that I used to do; This is spontaneous report from contactable nurse (patient). A 54-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Feb2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration administered in right arm on 05Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included asthma. The patient had known allergies with gluten, latex. Concomitant medication(s) received within 2 weeks of vaccination included vitamin d3; multi vitamin, b complex. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 13:15, the patient experienced extreme ongoing (10 weeks so far) nerve pain, muscle pain, joint pain and weakness in all 4 extremities and hips and shoulders with the right side being the worst. Also with numbness and tingling in all extremities with the right side being the worst. The pain and weakness are severe and debilitating. The patient unable to do activities that used to do and also had to cut down work hours as cannot tolerate the pain and adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone, labs, specialists, physiotherapy, acupuncture. The seriousness of the event was considered as disabling/incapacitating by reporter. Outcome of the events was not recovered.  Device Date : 05May2021 Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. 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: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood magnesium decreased, Cerebral haemorrhage, Computerised tomogram, Decreased appetite
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Delusion, Dizziness, Echocardiogram, Gait disturbance, Influenza like illness
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Lethargy, Magnetic resonance imaging abnormal, Malaise, Platelet count normal
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Decreased appetite, Delusion, Dementia, Dizziness
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, General physical health deterioration, Hypersomnia, Inflammation, Laboratory test normal
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Magnetic resonance imaging, Mobility decreased, Pain, Pain of skin
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Quadriplegia
Clinical narrative: she became more and more lethargic from day after shot not wanting to really get up or eat. We met with the doctor on zoom after labs who said it was okay at her age to sleep all the time. She was up each day previously from 7 a.m to 6 pm.She was dizzy and ate less but functioned. Finally, after continuing to go downhill she asked to go to Emergency. After 10 days they were unable to diagnose and released her to a nursing facility under the guise of dementia. She had never had dementia ever. the shot scrambled her entire muscular system including voice, tongue, etc all below the neck.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Condition aggravated, Dysphonia, Facial paresis, Headache
Clinical narrative: Very blurred vision, barely could talk, could not smile, couldnt blink or close my eyes. Facial paralasis. Labled by hospital with a variant of Guillain-Barre syndrome. Treated in hospital with IVIG for 5 days. slowly getting back to myself. im now just over amonth from when i showed symptoms. I can finally close my eyes. cant smile yet. speech is about normal. Absolutely horrific experience and I will never get a vaccine again.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Lumbar puncture normal, Magnetic resonance imaging normal, Neck pain, Paraesthesia
Clinical narrative: Very blurred vision, barely could talk, could not smile, couldnt blink or close my eyes. Facial paralasis. Labled by hospital with a variant of Guillain-Barre syndrome. Treated in hospital with IVIG for 5 days. slowly getting back to myself. im now just over amonth from when i showed symptoms. I can finally close my eyes. cant smile yet. speech is about normal. Absolutely horrific experience and I will never get a vaccine again.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Scan with contrast, Vision blurred, Visual impairment
Clinical narrative: Very blurred vision, barely could talk, could not smile, couldnt blink or close my eyes. Facial paralasis. Labled by hospital with a variant of Guillain-Barre syndrome. Treated in hospital with IVIG for 5 days. slowly getting back to myself. im now just over amonth from when i showed symptoms. I can finally close my eyes. cant smile yet. speech is about normal. Absolutely horrific experience and I will never get a vaccine again.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood test, Computerised tomogram, Eyelid function disorder, Facial paralysis
Clinical narrative: Very blurred vision, barely could talk, could not smile, couldnt blink or close my eyes. Facial paralasis. Labled by hospital with a variant of Guillain-Barre syndrome. Treated in hospital with IVIG for 5 days. slowly getting back to myself. im now just over amonth from when i showed symptoms. I can finally close my eyes. cant smile yet. speech is about normal. Absolutely horrific experience and I will never get a vaccine again.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Human herpesvirus 6 infection, Immunoglobulin therapy, Lumbar puncture abnormal, Magnetic resonance imaging
Clinical narrative: Very blurred vision, barely could talk, could not smile, couldnt blink or close my eyes. Facial paralasis. Labled by hospital with a variant of Guillain-Barre syndrome. Treated in hospital with IVIG for 5 days. slowly getting back to myself. im now just over amonth from when i showed symptoms. I can finally close my eyes. cant smile yet. speech is about normal. Absolutely horrific experience and I will never get a vaccine again.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Very blurred vision, barely could talk, could not smile, couldnt blink or close my eyes. Facial paralasis. Labled by hospital with a variant of Guillain-Barre syndrome. Treated in hospital with IVIG for 5 days. slowly getting back to myself. im now just over amonth from when i showed symptoms. I can finally close my eyes. cant smile yet. speech is about normal. Absolutely horrific experience and I will never get a vaccine again.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Echocardiogram, Laboratory test, Pulmonary embolism
Clinical narrative: BLOOD CLOTS IN BOTH LUNGS; LUNG COLLAPSED; PAIN, SORENESS ON RIGHT SIDE; HURT WHEN TOOK A DEEP BREATH; CONCERN CREEP IN (ANXIOUS); HEART RATE FAST; RIGHT HAND SIDE UNDER RIBS FELT SOME PAIN; GENERAL MALAISE, FELT MILDLY ILL; This spontaneous report received from a patient via a company representative concerned a 62 year old female of an unknown ethnicity and race. The patient's height, and weight were not reported. The patient had no heart problems, pulmonary problems and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, about a week later of vaccination patient felt mildly ill and experienced general malaise, soreness on right side, and while patient wasn't struggling to breathe, it hurt when took a deep breath. Patient stated that right-hand side, like under ribs, felt some pain; not a bad pain, not enough to took anything for it but just noticed it. The symptoms seemed minor, and at the time, no reports had linked the Johnson vaccine and blood clots. But the following week, when symptoms began cases started to emerge. The patient hadn't panic by reading the reports, but concern did creep in (anxious) and heart rate fast. The patient had never battled serious illness, certainly nothing related to blood clots. Patient thought, might have a reaction. On 21-APR-2021, patient still wasn't feeling well and decided to make an appointment at the urgent care center. Patient soon learned that she had developed blood clots in both lungs due to the vaccine, physician told one of the lungs also had collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, felt mildly ill, pain, soreness on right side, hurt when took a deep breath, concern creep in (anxious), heart rate fast, blood clots in both lungs, lung collapsed and right hand side under ribs felt some pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210531023-Covid-19 vaccine ad26.cov2.s.Blood clots in both lungs and lung collapsed . These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Laboratory test, Pulmonary embolism, Ultrasound scan
Clinical narrative: BLOOD CLOTS IN BOTH LUNGS; LUNG COLLAPSED; PAIN, SORENESS ON RIGHT SIDE; HURT WHEN TOOK A DEEP BREATH; CONCERN CREEP IN (ANXIOUS); HEART RATE FAST; RIGHT HAND SIDE UNDER RIBS FELT SOME PAIN; GENERAL MALAISE, FELT MILDLY ILL; This spontaneous report received from a patient via a company representative concerned a 62 year old female of an unknown ethnicity and race. The patient's height, and weight were not reported. The patient had no heart problems, pulmonary problems and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, about a week later of vaccination patient felt mildly ill and experienced general malaise, soreness on right side, and while patient wasn't struggling to breathe, it hurt when took a deep breath. Patient stated that right-hand side, like under ribs, felt some pain; not a bad pain, not enough to took anything for it but just noticed it. The symptoms seemed minor, and at the time, no reports had linked the Johnson vaccine and blood clots. But the following week, when symptoms began cases started to emerge. The patient hadn't panic by reading the reports, but concern did creep in (anxious) and heart rate fast. The patient had never battled serious illness, certainly nothing related to blood clots. Patient thought, might have a reaction. On 21-APR-2021, patient still wasn't feeling well and decided to make an appointment at the urgent care center. Patient soon learned that she had developed blood clots in both lungs due to the vaccine, physician told one of the lungs also had collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, felt mildly ill, pain, soreness on right side, hurt when took a deep breath, concern creep in (anxious), heart rate fast, blood clots in both lungs, lung collapsed and right hand side under ribs felt some pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210531023-Covid-19 vaccine ad26.cov2.s.Blood clots in both lungs and lung collapsed . These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: BLOOD CLOTS IN BOTH LUNGS; LUNG COLLAPSED; PAIN, SORENESS ON RIGHT SIDE; HURT WHEN TOOK A DEEP BREATH; CONCERN CREEP IN (ANXIOUS); HEART RATE FAST; RIGHT HAND SIDE UNDER RIBS FELT SOME PAIN; GENERAL MALAISE, FELT MILDLY ILL; This spontaneous report received from a patient via a company representative concerned a 62 year old female of an unknown ethnicity and race. The patient's height, and weight were not reported. The patient had no heart problems, pulmonary problems and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, about a week later of vaccination patient felt mildly ill and experienced general malaise, soreness on right side, and while patient wasn't struggling to breathe, it hurt when took a deep breath. Patient stated that right-hand side, like under ribs, felt some pain; not a bad pain, not enough to took anything for it but just noticed it. The symptoms seemed minor, and at the time, no reports had linked the Johnson vaccine and blood clots. But the following week, when symptoms began cases started to emerge. The patient hadn't panic by reading the reports, but concern did creep in (anxious) and heart rate fast. The patient had never battled serious illness, certainly nothing related to blood clots. Patient thought, might have a reaction. On 21-APR-2021, patient still wasn't feeling well and decided to make an appointment at the urgent care center. Patient soon learned that she had developed blood clots in both lungs due to the vaccine, physician told one of the lungs also had collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, felt mildly ill, pain, soreness on right side, hurt when took a deep breath, concern creep in (anxious), heart rate fast, blood clots in both lungs, lung collapsed and right hand side under ribs felt some pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210531023-Covid-19 vaccine ad26.cov2.s.Blood clots in both lungs and lung collapsed . These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Heart rate increased, Malaise, Musculoskeletal chest pain, Pain
Clinical narrative: BLOOD CLOTS IN BOTH LUNGS; LUNG COLLAPSED; PAIN, SORENESS ON RIGHT SIDE; HURT WHEN TOOK A DEEP BREATH; CONCERN CREEP IN (ANXIOUS); HEART RATE FAST; RIGHT HAND SIDE UNDER RIBS FELT SOME PAIN; GENERAL MALAISE, FELT MILDLY ILL; This spontaneous report received from a patient via a company representative concerned a 62 year old female of an unknown ethnicity and race. The patient's height, and weight were not reported. The patient had no heart problems, pulmonary problems and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, about a week later of vaccination patient felt mildly ill and experienced general malaise, soreness on right side, and while patient wasn't struggling to breathe, it hurt when took a deep breath. Patient stated that right-hand side, like under ribs, felt some pain; not a bad pain, not enough to took anything for it but just noticed it. The symptoms seemed minor, and at the time, no reports had linked the Johnson vaccine and blood clots. But the following week, when symptoms began cases started to emerge. The patient hadn't panic by reading the reports, but concern did creep in (anxious) and heart rate fast. The patient had never battled serious illness, certainly nothing related to blood clots. Patient thought, might have a reaction. On 21-APR-2021, patient still wasn't feeling well and decided to make an appointment at the urgent care center. Patient soon learned that she had developed blood clots in both lungs due to the vaccine, physician told one of the lungs also had collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, felt mildly ill, pain, soreness on right side, hurt when took a deep breath, concern creep in (anxious), heart rate fast, blood clots in both lungs, lung collapsed and right hand side under ribs felt some pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210531023-Covid-19 vaccine ad26.cov2.s.Blood clots in both lungs and lung collapsed . These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Painful respiration, Pneumothorax, Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN BOTH LUNGS; LUNG COLLAPSED; PAIN, SORENESS ON RIGHT SIDE; HURT WHEN TOOK A DEEP BREATH; CONCERN CREEP IN (ANXIOUS); HEART RATE FAST; RIGHT HAND SIDE UNDER RIBS FELT SOME PAIN; GENERAL MALAISE, FELT MILDLY ILL; This spontaneous report received from a patient via a company representative concerned a 62 year old female of an unknown ethnicity and race. The patient's height, and weight were not reported. The patient had no heart problems, pulmonary problems and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, about a week later of vaccination patient felt mildly ill and experienced general malaise, soreness on right side, and while patient wasn't struggling to breathe, it hurt when took a deep breath. Patient stated that right-hand side, like under ribs, felt some pain; not a bad pain, not enough to took anything for it but just noticed it. The symptoms seemed minor, and at the time, no reports had linked the Johnson vaccine and blood clots. But the following week, when symptoms began cases started to emerge. The patient hadn't panic by reading the reports, but concern did creep in (anxious) and heart rate fast. The patient had never battled serious illness, certainly nothing related to blood clots. Patient thought, might have a reaction. On 21-APR-2021, patient still wasn't feeling well and decided to make an appointment at the urgent care center. Patient soon learned that she had developed blood clots in both lungs due to the vaccine, physician told one of the lungs also had collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, felt mildly ill, pain, soreness on right side, hurt when took a deep breath, concern creep in (anxious), heart rate fast, blood clots in both lungs, lung collapsed and right hand side under ribs felt some pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210531023-Covid-19 vaccine ad26.cov2.s.Blood clots in both lungs and lung collapsed . These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: no antibodies shown on spike protein antibody test at day 60.  I did have chills, and muscle aches after....so what was injected????
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia
Clinical narrative: no antibodies shown on spike protein antibody test at day 60.  I did have chills, and muscle aches after....so what was injected????
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test
Clinical narrative: he got covid and is still recovering from it; he got covid and is still recovering from it; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled to take the second dose on the 08Apr2021. However, he got covid and is still recovering from it. The patient wanted to know if he can take the vaccine on the 8th or does he have to reschedule his second dose. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he got covid and is still recovering from it; he got covid and is still recovering from it; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled to take the second dose on the 08Apr2021. However, he got covid and is still recovering from it. The patient wanted to know if he can take the vaccine on the 8th or does he have to reschedule his second dose. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: Fever, chills, weakness, severe aches, deterioration of health, death on May 17, 2021. Never recovered from the shot on March 4.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Fever, chills, weakness, severe aches, deterioration of health, death on May 17, 2021. Never recovered from the shot on March 4.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autopsy, Chills, Death, General physical health deterioration
Clinical narrative: Fever, chills, weakness, severe aches, deterioration of health, death on May 17, 2021. Never recovered from the shot on March 4.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, weakness, severe aches, deterioration of health, death on May 17, 2021. Never recovered from the shot on March 4.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blindness unilateral, Chills, Fatigue, Headache
Clinical narrative: now she was losing vision in her left eye too; after first shot, I lost vision in my right eye overnight . . . eye doctor believes it is a cataract.  After second shot, right eye became worse and now I am losing vision in my left eye too; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 05Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single (at 56 years of age) and via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) 2nd dose, single (at 57 years of age) for COVID-19 immunisation. The patient's medical history included melon and coconut allergy and hay fever. The patient's concomitant medications were not reported. The patient previously took Darvon [betahistine mesilate] and Darvocet [dextropropoxyphene napsilate;paracetamol] and experienced drug hypersensitivity on both. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 post vaccination. On 09Apr2021, after the after first shot, the patient had lost vision in her right eye overnight in which the eye doctor believed it was a cataract. After second shot, right eye became worse and now she was losing vision in her left eye too.The outcome of the events was not recovered. Therapeutic measures were taken as a result of the event.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: now she was losing vision in her left eye too; after first shot, I lost vision in my right eye overnight . . . eye doctor believes it is a cataract.  After second shot, right eye became worse and now I am losing vision in my left eye too; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 05Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single (at 56 years of age) and via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) 2nd dose, single (at 57 years of age) for COVID-19 immunisation. The patient's medical history included melon and coconut allergy and hay fever. The patient's concomitant medications were not reported. The patient previously took Darvon [betahistine mesilate] and Darvocet [dextropropoxyphene napsilate;paracetamol] and experienced drug hypersensitivity on both. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 post vaccination. On 09Apr2021, after the after first shot, the patient had lost vision in her right eye overnight in which the eye doctor believed it was a cataract. After second shot, right eye became worse and now she was losing vision in her left eye too.The outcome of the events was not recovered. Therapeutic measures were taken as a result of the event.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cataract, Visual impairment
Clinical narrative: now she was losing vision in her left eye too; after first shot, I lost vision in my right eye overnight . . . eye doctor believes it is a cataract.  After second shot, right eye became worse and now I am losing vision in my left eye too; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 05Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single (at 56 years of age) and via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) 2nd dose, single (at 57 years of age) for COVID-19 immunisation. The patient's medical history included melon and coconut allergy and hay fever. The patient's concomitant medications were not reported. The patient previously took Darvon [betahistine mesilate] and Darvocet [dextropropoxyphene napsilate;paracetamol] and experienced drug hypersensitivity on both. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 post vaccination. On 09Apr2021, after the after first shot, the patient had lost vision in her right eye overnight in which the eye doctor believed it was a cataract. After second shot, right eye became worse and now she was losing vision in her left eye too.The outcome of the events was not recovered. Therapeutic measures were taken as a result of the event.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, COVID-19, Fall, Loss of consciousness, Migraine
Clinical narrative: lost vision in both eyes; passed out; dizzy; severe nausea set in with severe body pain; severe nausea set in with severe body pain; worst migraine of my life; low blood pressure; This is a spontaneous report received from a contactable consumer (patient).   A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 19-years-old), administered in Arm Left on 23Apr2021 13:00 (Lot Number: EW0169) as 1st dose, single for COVID-19 immunization. Medical history included anxiety, and allergies to mosquitoes, hotdogs, and sausage. The patient was not pregnant at the time of vaccination. Concomitant medications included citalopram and drospirenone, estradiol (EOS), IUD, daily supplements. The patient previously took oxycodone ("oxicodone") and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. The patient, 48 hrs later, lost vision in both eyes, became dizzy, passed out multiple times. Later severe nausea set in with severe body pain. Went to Urgent Care the following day and was told side effects. That night had worst migraine of her life, low blood pressure, and continued nausea. Given some meds and sent home to rest. Took 2 full days to feel okay again. Onset date and time of events reported as 25Apr2021 13:00. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Treatment received for the adverse events included Toradol, Benadryl, and Reglan. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 27Apr2021. The outcome of the events was recovered with sequelae. The events "lost vision in both eyes" and "passed out" were considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was  Clinic/facility. 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. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible, no further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: lost vision in both eyes; passed out; dizzy; severe nausea set in with severe body pain; severe nausea set in with severe body pain; worst migraine of my life; low blood pressure; This is a spontaneous report received from a contactable consumer (patient).   A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 19-years-old), administered in Arm Left on 23Apr2021 13:00 (Lot Number: EW0169) as 1st dose, single for COVID-19 immunization. Medical history included anxiety, and allergies to mosquitoes, hotdogs, and sausage. The patient was not pregnant at the time of vaccination. Concomitant medications included citalopram and drospirenone, estradiol (EOS), IUD, daily supplements. The patient previously took oxycodone ("oxicodone") and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. The patient, 48 hrs later, lost vision in both eyes, became dizzy, passed out multiple times. Later severe nausea set in with severe body pain. Went to Urgent Care the following day and was told side effects. That night had worst migraine of her life, low blood pressure, and continued nausea. Given some meds and sent home to rest. Took 2 full days to feel okay again. Onset date and time of events reported as 25Apr2021 13:00. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Treatment received for the adverse events included Toradol, Benadryl, and Reglan. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 27Apr2021. The outcome of the events was recovered with sequelae. The events "lost vision in both eyes" and "passed out" were considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was  Clinic/facility. 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. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible, no further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Dizziness, Hypotension, Loss of consciousness, Migraine
Clinical narrative: lost vision in both eyes; passed out; dizzy; severe nausea set in with severe body pain; severe nausea set in with severe body pain; worst migraine of my life; low blood pressure; This is a spontaneous report received from a contactable consumer (patient).   A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 19-years-old), administered in Arm Left on 23Apr2021 13:00 (Lot Number: EW0169) as 1st dose, single for COVID-19 immunization. Medical history included anxiety, and allergies to mosquitoes, hotdogs, and sausage. The patient was not pregnant at the time of vaccination. Concomitant medications included citalopram and drospirenone, estradiol (EOS), IUD, daily supplements. The patient previously took oxycodone ("oxicodone") and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. The patient, 48 hrs later, lost vision in both eyes, became dizzy, passed out multiple times. Later severe nausea set in with severe body pain. Went to Urgent Care the following day and was told side effects. That night had worst migraine of her life, low blood pressure, and continued nausea. Given some meds and sent home to rest. Took 2 full days to feel okay again. Onset date and time of events reported as 25Apr2021 13:00. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Treatment received for the adverse events included Toradol, Benadryl, and Reglan. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 27Apr2021. The outcome of the events was recovered with sequelae. The events "lost vision in both eyes" and "passed out" were considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was  Clinic/facility. 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. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible, no further information is expected.