chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was found dead; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: DK9231 and expiry date unknown) via an unspecified route of administration in the right arm on 08Jan2021 09:00 (at 56 years old) at SINGLE DOSE for COVID-19 immunisation. The patient had no medical history and no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive other vaccines in four weeks prior to vaccination; has not had COVID prior to vaccination; and has not tested for COVID-19, post vaccination. It was reported that the patient was found dead on the morning of 07Mar2021. The cause of death was unknown. No real information is known at this time. An autopsy was performed, and it was unsure if results will be obtained. Autopsy remarks indicated "TBD (To be determined)."; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Patient was found dead
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute motor-sensory axonal neuropathy, Back pain, Chest pain, Gait inability, Guillain-Barre syndrome
Clinical narrative: Gullian-Barre Syndrome; Paralyzed from the waist down, lost use of both arms; Severe pain; A spontaneous report was received from a consumer (patient's brother) concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe pain, was paralyzed form waist down and was diagnosed with Guillan-Barre Syndrome.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date the patient received her first dose of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient experienced severe pain in a few hours and was taken to the emergency room, then, discharged. The patient was taken back to the emergency room on 25-Feb-2021 (Thursday night), and on 26-Feb-2021 (Friday), she was paralyzed from the waist down, losing use of both arms. The patient was tested at the hospital for transverse myelitis, which was negative. Spinal tap for GBS (Guillan Barre Syndrome) was protein positive and she was given a definitive diagnosis of GBS. There was movement in fingers but could not pick up objects.     Seriousness criteria for the events of Gullian-Barre Syndrome and paralyzed from the waist down, lost use of both arms was medically significant.  Action taken with mRNA-1273 in response to events was not applicable.  The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Hypoaesthesia, Musculoskeletal disorder, Nausea, Vomiting
Clinical narrative: Gullian-Barre Syndrome; Paralyzed from the waist down, lost use of both arms; Severe pain; A spontaneous report was received from a consumer (patient's brother) concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe pain, was paralyzed form waist down and was diagnosed with Guillan-Barre Syndrome.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date the patient received her first dose of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient experienced severe pain in a few hours and was taken to the emergency room, then, discharged. The patient was taken back to the emergency room on 25-Feb-2021 (Thursday night), and on 26-Feb-2021 (Friday), she was paralyzed from the waist down, losing use of both arms. The patient was tested at the hospital for transverse myelitis, which was negative. Spinal tap for GBS (Guillan Barre Syndrome) was protein positive and she was given a definitive diagnosis of GBS. There was movement in fingers but could not pick up objects.     Seriousness criteria for the events of Gullian-Barre Syndrome and paralyzed from the waist down, lost use of both arms was medically significant.  Action taken with mRNA-1273 in response to events was not applicable.  The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Muscular weakness
Clinical narrative: Gullian-Barre Syndrome; Paralyzed from the waist down, lost use of both arms; Severe pain; A spontaneous report was received from a consumer (patient's brother) concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe pain, was paralyzed form waist down and was diagnosed with Guillan-Barre Syndrome.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date the patient received her first dose of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient experienced severe pain in a few hours and was taken to the emergency room, then, discharged. The patient was taken back to the emergency room on 25-Feb-2021 (Thursday night), and on 26-Feb-2021 (Friday), she was paralyzed from the waist down, losing use of both arms. The patient was tested at the hospital for transverse myelitis, which was negative. Spinal tap for GBS (Guillan Barre Syndrome) was protein positive and she was given a definitive diagnosis of GBS. There was movement in fingers but could not pick up objects.     Seriousness criteria for the events of Gullian-Barre Syndrome and paralyzed from the waist down, lost use of both arms was medically significant.  Action taken with mRNA-1273 in response to events was not applicable.  The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Gullian-Barre Syndrome; Paralyzed from the waist down, lost use of both arms; Severe pain; A spontaneous report was received from a consumer (patient's brother) concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe pain, was paralyzed form waist down and was diagnosed with Guillan-Barre Syndrome.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date the patient received her first dose of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient experienced severe pain in a few hours and was taken to the emergency room, then, discharged. The patient was taken back to the emergency room on 25-Feb-2021 (Thursday night), and on 26-Feb-2021 (Friday), she was paralyzed from the waist down, losing use of both arms. The patient was tested at the hospital for transverse myelitis, which was negative. Spinal tap for GBS (Guillan Barre Syndrome) was protein positive and she was given a definitive diagnosis of GBS. There was movement in fingers but could not pick up objects.     Seriousness criteria for the events of Gullian-Barre Syndrome and paralyzed from the waist down, lost use of both arms was medically significant.  Action taken with mRNA-1273 in response to events was not applicable.  The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diplegia, Guillain-Barre syndrome, Lumbar puncture, Myelitis transverse, Pain
Clinical narrative: Gullian-Barre Syndrome; Paralyzed from the waist down, lost use of both arms; Severe pain; A spontaneous report was received from a consumer (patient's brother) concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe pain, was paralyzed form waist down and was diagnosed with Guillan-Barre Syndrome.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date the patient received her first dose of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient experienced severe pain in a few hours and was taken to the emergency room, then, discharged. The patient was taken back to the emergency room on 25-Feb-2021 (Thursday night), and on 26-Feb-2021 (Friday), she was paralyzed from the waist down, losing use of both arms. The patient was tested at the hospital for transverse myelitis, which was negative. Spinal tap for GBS (Guillan Barre Syndrome) was protein positive and she was given a definitive diagnosis of GBS. There was movement in fingers but could not pick up objects.     Seriousness criteria for the events of Gullian-Barre Syndrome and paralyzed from the waist down, lost use of both arms was medically significant.  Action taken with mRNA-1273 in response to events was not applicable.  The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Culture negative, Death, Dependence on respirator, Haemophagocytic lymphohistiocytosis
Clinical narrative: HLH (hemophagocyticlymphohistiocytosis); This is a spontaneous report from a contactable consumer.  A 59-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose on 05Feb2021 12:00 for COVID-19 immunisation, administered at hospital.  Medical history included type 2 diabetes mellitus. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) on 15Jan2021 12:00 for COVID-19 immunisation, administered at hospital. No other vaccine in four weeks. The patient experienced hemophagocyticlymphohistiocytosis (HLH) on 15Feb2021 05:30, considered serious as medically significant and fatal. Patient received treatment for the event: etoposide and steroids. COVID was tested post vaccination in 2021, result unknown. The patient died on 15Feb2021. Cause of death was HLH (hemophagocyticlymphohistiocytosis). An autopsy was not performed.; Reported Cause(s) of Death: HLH (hemophagocyticlymphohistiocytosis
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Mechanical ventilation
Clinical narrative: HLH (hemophagocyticlymphohistiocytosis); This is a spontaneous report from a contactable consumer.  A 59-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose on 05Feb2021 12:00 for COVID-19 immunisation, administered at hospital.  Medical history included type 2 diabetes mellitus. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) on 15Jan2021 12:00 for COVID-19 immunisation, administered at hospital. No other vaccine in four weeks. The patient experienced hemophagocyticlymphohistiocytosis (HLH) on 15Feb2021 05:30, considered serious as medically significant and fatal. Patient received treatment for the event: etoposide and steroids. COVID was tested post vaccination in 2021, result unknown. The patient died on 15Feb2021. Cause of death was HLH (hemophagocyticlymphohistiocytosis). An autopsy was not performed.; Reported Cause(s) of Death: HLH (hemophagocyticlymphohistiocytosis
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemophagocytic lymphohistiocytosis, SARS-CoV-2 test
Clinical narrative: HLH (hemophagocyticlymphohistiocytosis); This is a spontaneous report from a contactable consumer.  A 59-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose on 05Feb2021 12:00 for COVID-19 immunisation, administered at hospital.  Medical history included type 2 diabetes mellitus. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) on 15Jan2021 12:00 for COVID-19 immunisation, administered at hospital. No other vaccine in four weeks. The patient experienced hemophagocyticlymphohistiocytosis (HLH) on 15Feb2021 05:30, considered serious as medically significant and fatal. Patient received treatment for the event: etoposide and steroids. COVID was tested post vaccination in 2021, result unknown. The patient died on 15Feb2021. Cause of death was HLH (hemophagocyticlymphohistiocytosis). An autopsy was not performed.; Reported Cause(s) of Death: HLH (hemophagocyticlymphohistiocytosis
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Airway patency device insertion, Blood glucose increased, Cardiac arrest, Cardiac assistance device user, Cardiac disorder
Clinical narrative: Moderna COVID-19 (mRNA-1273) vaccine treatment under Emergency Use Authorization(EUA): Decedent received vaccine and felt fine. Three hours later he became short of breath and went unresponsive.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Death, Dyspnoea, Mechanical ventilation, Respiratory arrest
Clinical narrative: Moderna COVID-19 (mRNA-1273) vaccine treatment under Emergency Use Authorization(EUA): Decedent received vaccine and felt fine. Three hours later he became short of breath and went unresponsive.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Resuscitation, Syncope
Clinical narrative: Moderna COVID-19 (mRNA-1273) vaccine treatment under Emergency Use Authorization(EUA): Decedent received vaccine and felt fine. Three hours later he became short of breath and went unresponsive.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Unresponsive to stimuli
Clinical narrative: Moderna COVID-19 (mRNA-1273) vaccine treatment under Emergency Use Authorization(EUA): Decedent received vaccine and felt fine. Three hours later he became short of breath and went unresponsive.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF white blood cell count, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain Barre treated with IVIG.  Patient received 2nd dose Pfizer vaccine. 24 hours later experienced flu like symptoms which resolved.  Following Saturday, noticed fatigue and lower extremity weakness and sorness. Progressed to the point where walking around the block was difficult. Weakness progressed and patient was advised to go to the emergency department for evaluation. In ED, patient is absent lower extremity reflexes. Patient notes no significant upper extremity weakness. No recent illnesses including diarrheal illness.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Areflexia, CSF protein increased, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Guillain Barre treated with IVIG.  Patient received 2nd dose Pfizer vaccine. 24 hours later experienced flu like symptoms which resolved.  Following Saturday, noticed fatigue and lower extremity weakness and sorness. Progressed to the point where walking around the block was difficult. Weakness progressed and patient was advised to go to the emergency department for evaluation. In ED, patient is absent lower extremity reflexes. Patient notes no significant upper extremity weakness. No recent illnesses including diarrheal illness.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Influenza like illness, Magnetic resonance imaging head abnormal, Muscular weakness, Pain in extremity
Clinical narrative: Guillain Barre treated with IVIG.  Patient received 2nd dose Pfizer vaccine. 24 hours later experienced flu like symptoms which resolved.  Following Saturday, noticed fatigue and lower extremity weakness and sorness. Progressed to the point where walking around the block was difficult. Weakness progressed and patient was advised to go to the emergency department for evaluation. In ED, patient is absent lower extremity reflexes. Patient notes no significant upper extremity weakness. No recent illnesses including diarrheal illness.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Gait inability, General physical health deterioration, Immunoglobulin therapy, Plasmapheresis
Clinical narrative: Guillain Barre treated with IVIG.  Patient received 2nd dose Pfizer vaccine. 24 hours later experienced flu like symptoms which resolved.  Following Saturday, noticed fatigue and lower extremity weakness and sorness. Progressed to the point where walking around the block was difficult. Weakness progressed and patient was advised to go to the emergency department for evaluation. In ED, patient is absent lower extremity reflexes. Patient notes no significant upper extremity weakness. No recent illnesses including diarrheal illness.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, SARS-CoV-2 test
Clinical narrative: Guillain Barre treated with IVIG.  Patient received 2nd dose Pfizer vaccine. 24 hours later experienced flu like symptoms which resolved.  Following Saturday, noticed fatigue and lower extremity weakness and sorness. Progressed to the point where walking around the block was difficult. Weakness progressed and patient was advised to go to the emergency department for evaluation. In ED, patient is absent lower extremity reflexes. Patient notes no significant upper extremity weakness. No recent illnesses including diarrheal illness.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF white blood cell count, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Acute inflammatory demyelinating polyradiculoneuropathy; Guillain Barre Syndrome; This is a spontaneous report from a contactable Physician.   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Age at vaccination was 58 years. Relevant medical history included HIV (well controlled on ART) and allergy to Sulfa antibiotics. Concomitant medications were not reported. On 13Fwb2021 the patient experienced 'Guillain Barre Syndrome Acute inflammatory demyelinating polyradiculoneuropathy' leading to emergency room visit. Provided seriousness criteria were hospitalization, Life threatening, disability and medically significant. The patient underwent Nasal Swab SARS-CoV-2 test on 18Feb2021 which resulted negative. At the time of the reporting the patient had not yet recovered.     Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event Guillain Barre Syndrome with BNT162b2 can not 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Areflexia, CSF protein increased, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Acute inflammatory demyelinating polyradiculoneuropathy; Guillain Barre Syndrome; This is a spontaneous report from a contactable Physician.   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Age at vaccination was 58 years. Relevant medical history included HIV (well controlled on ART) and allergy to Sulfa antibiotics. Concomitant medications were not reported. On 13Fwb2021 the patient experienced 'Guillain Barre Syndrome Acute inflammatory demyelinating polyradiculoneuropathy' leading to emergency room visit. Provided seriousness criteria were hospitalization, Life threatening, disability and medically significant. The patient underwent Nasal Swab SARS-CoV-2 test on 18Feb2021 which resulted negative. At the time of the reporting the patient had not yet recovered.     Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event Guillain Barre Syndrome with BNT162b2 can not 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Influenza like illness, Magnetic resonance imaging head abnormal, Muscular weakness, Pain in extremity
Clinical narrative: Acute inflammatory demyelinating polyradiculoneuropathy; Guillain Barre Syndrome; This is a spontaneous report from a contactable Physician.   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Age at vaccination was 58 years. Relevant medical history included HIV (well controlled on ART) and allergy to Sulfa antibiotics. Concomitant medications were not reported. On 13Fwb2021 the patient experienced 'Guillain Barre Syndrome Acute inflammatory demyelinating polyradiculoneuropathy' leading to emergency room visit. Provided seriousness criteria were hospitalization, Life threatening, disability and medically significant. The patient underwent Nasal Swab SARS-CoV-2 test on 18Feb2021 which resulted negative. At the time of the reporting the patient had not yet recovered.     Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event Guillain Barre Syndrome with BNT162b2 can not 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Gait inability, General physical health deterioration, Immunoglobulin therapy, Plasmapheresis
Clinical narrative: Acute inflammatory demyelinating polyradiculoneuropathy; Guillain Barre Syndrome; This is a spontaneous report from a contactable Physician.   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Age at vaccination was 58 years. Relevant medical history included HIV (well controlled on ART) and allergy to Sulfa antibiotics. Concomitant medications were not reported. On 13Fwb2021 the patient experienced 'Guillain Barre Syndrome Acute inflammatory demyelinating polyradiculoneuropathy' leading to emergency room visit. Provided seriousness criteria were hospitalization, Life threatening, disability and medically significant. The patient underwent Nasal Swab SARS-CoV-2 test on 18Feb2021 which resulted negative. At the time of the reporting the patient had not yet recovered.     Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event Guillain Barre Syndrome with BNT162b2 can not 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, SARS-CoV-2 test
Clinical narrative: Acute inflammatory demyelinating polyradiculoneuropathy; Guillain Barre Syndrome; This is a spontaneous report from a contactable Physician.   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Age at vaccination was 58 years. Relevant medical history included HIV (well controlled on ART) and allergy to Sulfa antibiotics. Concomitant medications were not reported. On 13Fwb2021 the patient experienced 'Guillain Barre Syndrome Acute inflammatory demyelinating polyradiculoneuropathy' leading to emergency room visit. Provided seriousness criteria were hospitalization, Life threatening, disability and medically significant. The patient underwent Nasal Swab SARS-CoV-2 test on 18Feb2021 which resulted negative. At the time of the reporting the patient had not yet recovered.     Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event Guillain Barre Syndrome with BNT162b2 can not 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: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Haematemesis, Intensive care, Nausea, SARS-CoV-2 test negative
Clinical narrative: Pfizer vaccine exacerbated preexisting, medically controlled heart condition; vomiting blood; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (reporter's mother) received second dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 18Feb2021 01:00 P.M (Batch/Lot number was not reported) at single dose for an unspecified indication. Medical history included cardiac disorder and renal disorder. The patient did not have known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Right on 26Jan2021 11:00 A.M (Batch/Lot number was not reported) at single dose for an unspecified indication. The patient did not receive other vaccine in four weeks. The patient received her second Pfizer vaccine on 18Feb2021 and died on 21Feb2021, after developing an adverse reaction that got progressively worse, including vomiting blood. Upon being rushed to the emergencyt room, the patient was tested for COVID due to policy (negative result) and admitted to the intensive care unit. It was unfortunate that we were all advised, particularly those with preexisting conditions, to get vaccinated without the benefits of knowing when the vaccine can cause more harm than good. For obvious reasons, the approval of COVID vaccines was rushed and thus the Pfizer Studies are not thorough and lack in data to support an all call for everyone to get vaccinated in the name of herd immunity. Without the appropriate data, the patient was DEAD. While you have immunity from liability you still have a moral obligation to collect data and advise accordingly. The reporter stated the reporter's goal was to save lives by sharing with all the reporter know. Adverse event start date was 19Feb2021. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), death. Death cause was reported as Pfizer vaccine exacerbated preexisting, medically controlled heart condition. It was unknown if the patient received treatment for adverse events. The patient was hospitalized for the events for 1 days. The patient did not have COVID prior vaccination. The patient had COVID tested post vaccination on 21Feb2021 and result was Negative.  Facility type vaccine was Clinic. Outcome of event vomiting blood was unknown. The patient died on 21Feb2021. An autopsy was not performed.  Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Pfizer vaccine exacerbated preexisting, medically controlled heart condition
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Haematemesis, SARS-CoV-2 test
Clinical narrative: Pfizer vaccine exacerbated preexisting, medically controlled heart condition; vomiting blood; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (reporter's mother) received second dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 18Feb2021 01:00 P.M (Batch/Lot number was not reported) at single dose for an unspecified indication. Medical history included cardiac disorder and renal disorder. The patient did not have known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Right on 26Jan2021 11:00 A.M (Batch/Lot number was not reported) at single dose for an unspecified indication. The patient did not receive other vaccine in four weeks. The patient received her second Pfizer vaccine on 18Feb2021 and died on 21Feb2021, after developing an adverse reaction that got progressively worse, including vomiting blood. Upon being rushed to the emergencyt room, the patient was tested for COVID due to policy (negative result) and admitted to the intensive care unit. It was unfortunate that we were all advised, particularly those with preexisting conditions, to get vaccinated without the benefits of knowing when the vaccine can cause more harm than good. For obvious reasons, the approval of COVID vaccines was rushed and thus the Pfizer Studies are not thorough and lack in data to support an all call for everyone to get vaccinated in the name of herd immunity. Without the appropriate data, the patient was DEAD. While you have immunity from liability you still have a moral obligation to collect data and advise accordingly. The reporter stated the reporter's goal was to save lives by sharing with all the reporter know. Adverse event start date was 19Feb2021. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), death. Death cause was reported as Pfizer vaccine exacerbated preexisting, medically controlled heart condition. It was unknown if the patient received treatment for adverse events. The patient was hospitalized for the events for 1 days. The patient did not have COVID prior vaccination. The patient had COVID tested post vaccination on 21Feb2021 and result was Negative.  Facility type vaccine was Clinic. Outcome of event vomiting blood was unknown. The patient died on 21Feb2021. An autopsy was not performed.  Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Pfizer vaccine exacerbated preexisting, medically controlled heart condition
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Hypoaesthesia oral, Intensive care, Laboratory test normal, Stridor
Clinical narrative: Client expressed difficulty breathing; throat tightening.  EMT assessed at 9:31 am.  160/110, HR 90, Resp 23, O2 100%,  ACCV125, Temp 96.6.  Client was given Benadryl via IV at 9:34 am and epinephrine IM at 9:35 am.  Vitals at 9:38 am 157/100, HR 100m resp 26, O2 100% on Oxygen. Client stated an improvement of symptoms but has agreed to be transported to hospital.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Client expressed difficulty breathing; throat tightening.  EMT assessed at 9:31 am.  160/110, HR 90, Resp 23, O2 100%,  ACCV125, Temp 96.6.  Client was given Benadryl via IV at 9:34 am and epinephrine IM at 9:35 am.  Vitals at 9:38 am 157/100, HR 100m resp 26, O2 100% on Oxygen. Client stated an improvement of symptoms but has agreed to be transported to hospital.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Client expressed difficulty breathing; throat tightening.  EMT assessed at 9:31 am.  160/110, HR 90, Resp 23, O2 100%,  ACCV125, Temp 96.6.  Client was given Benadryl via IV at 9:34 am and epinephrine IM at 9:35 am.  Vitals at 9:38 am 157/100, HR 100m resp 26, O2 100% on Oxygen. Client stated an improvement of symptoms but has agreed to be transported to hospital.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Pharyngeal paraesthesia
Clinical narrative: I immediately stated that the injection made me feel hot.  Then my hands and face turned red.  The clinicians took my BP and it was over 170.  They called the ER and took me directly there.  The ER doctor administered Benadryl in IV.  The redness started to go away and BP returned to normal.  There was also a headache.  Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days.  Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure fluctuation, Erythema, Feeling hot, Headache
Clinical narrative: I immediately stated that the injection made me feel hot.  Then my hands and face turned red.  The clinicians took my BP and it was over 170.  They called the ER and took me directly there.  The ER doctor administered Benadryl in IV.  The redness started to go away and BP returned to normal.  There was also a headache.  Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days.  Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Erythema, Feeling hot, Headache, Hypertension
Clinical narrative: I immediately stated that the injection made me feel hot.  Then my hands and face turned red.  The clinicians took my BP and it was over 170.  They called the ER and took me directly there.  The ER doctor administered Benadryl in IV.  The redness started to go away and BP returned to normal.  There was also a headache.  Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days.  Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: I immediately stated that the injection made me feel hot.  Then my hands and face turned red.  The clinicians took my BP and it was over 170.  They called the ER and took me directly there.  The ER doctor administered Benadryl in IV.  The redness started to go away and BP returned to normal.  There was also a headache.  Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days.  Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Blood pressure increased, Diplopia, Dyspnoea
Clinical narrative: Had an anaphylactic reaction; SOB; lips and tongue numb; lips and tongue numb; swollen face and eyes; swollen face and eyes; throat tightening; nausea; weakness; elevated heartrate; diaphoretic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration into left arm on 10Mar2021 12:15 at single dose for COVID-19 immunisation in doctor's office/urgent care. Medical history included Asthma well controlled, fibromyalgia. Allergies to sulfa meds and cilantro. Patient was not pregnant. Concomitant medication included cyclobenzaprine, sertraline, gabapentin and levothyroxine. No other vaccine in four weeks. Patient previously had Paroxetine and mRNA vaccine and had allergies. Patient had an anaphylactic reaction. SOB, lips and tongue numb, swollen face and eyes, throat tightening, nausea, weakness elevated heartrate, diaphoretic on 10Mar2021 12:15 PM. events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No covid prior vaccination, No covid tested post vaccination. Treatment included Epinephrine, iv diphenhydramine, prednisone 50 mg. patient was recovering from the events.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded  based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia oral, Nausea, Oxygen saturation decreased
Clinical narrative: Had an anaphylactic reaction; SOB; lips and tongue numb; lips and tongue numb; swollen face and eyes; swollen face and eyes; throat tightening; nausea; weakness; elevated heartrate; diaphoretic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration into left arm on 10Mar2021 12:15 at single dose for COVID-19 immunisation in doctor's office/urgent care. Medical history included Asthma well controlled, fibromyalgia. Allergies to sulfa meds and cilantro. Patient was not pregnant. Concomitant medication included cyclobenzaprine, sertraline, gabapentin and levothyroxine. No other vaccine in four weeks. Patient previously had Paroxetine and mRNA vaccine and had allergies. Patient had an anaphylactic reaction. SOB, lips and tongue numb, swollen face and eyes, throat tightening, nausea, weakness elevated heartrate, diaphoretic on 10Mar2021 12:15 PM. events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No covid prior vaccination, No covid tested post vaccination. Treatment included Epinephrine, iv diphenhydramine, prednisone 50 mg. patient was recovering from the events.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded  based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Had an anaphylactic reaction; SOB; lips and tongue numb; lips and tongue numb; swollen face and eyes; swollen face and eyes; throat tightening; nausea; weakness; elevated heartrate; diaphoretic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration into left arm on 10Mar2021 12:15 at single dose for COVID-19 immunisation in doctor's office/urgent care. Medical history included Asthma well controlled, fibromyalgia. Allergies to sulfa meds and cilantro. Patient was not pregnant. Concomitant medication included cyclobenzaprine, sertraline, gabapentin and levothyroxine. No other vaccine in four weeks. Patient previously had Paroxetine and mRNA vaccine and had allergies. Patient had an anaphylactic reaction. SOB, lips and tongue numb, swollen face and eyes, throat tightening, nausea, weakness elevated heartrate, diaphoretic on 10Mar2021 12:15 PM. events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No covid prior vaccination, No covid tested post vaccination. Treatment included Epinephrine, iv diphenhydramine, prednisone 50 mg. patient was recovering from the events.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded  based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Dyspnoea, Eye swelling, Heart rate
Clinical narrative: Had an anaphylactic reaction; SOB; lips and tongue numb; lips and tongue numb; swollen face and eyes; swollen face and eyes; throat tightening; nausea; weakness; elevated heartrate; diaphoretic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration into left arm on 10Mar2021 12:15 at single dose for COVID-19 immunisation in doctor's office/urgent care. Medical history included Asthma well controlled, fibromyalgia. Allergies to sulfa meds and cilantro. Patient was not pregnant. Concomitant medication included cyclobenzaprine, sertraline, gabapentin and levothyroxine. No other vaccine in four weeks. Patient previously had Paroxetine and mRNA vaccine and had allergies. Patient had an anaphylactic reaction. SOB, lips and tongue numb, swollen face and eyes, throat tightening, nausea, weakness elevated heartrate, diaphoretic on 10Mar2021 12:15 PM. events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No covid prior vaccination, No covid tested post vaccination. Treatment included Epinephrine, iv diphenhydramine, prednisone 50 mg. patient was recovering from the events.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded  based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .