chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal X-ray, Abdominal tenderness, Acute kidney injury, Angiogram cerebral abnormal, Anion gap normal
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-glomerular basement membrane antibody, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Arteriogram carotid abnormal, Bacterial test negative
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy kidney, Biopsy skin abnormal, Bladder hydrodistension, Blood creatine phosphokinase increased, Blood creatinine increased
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactic acid increased, Blood pH decreased
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urea increased, CD4 lymphocytes decreased, CD4/CD8 ratio decreased, CD8 lymphocytes, CSF glucose increased
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF pressure normal, CSF white blood cell count, Cardiolipin antibody, Cerebellar infarction, Cerebral infarction
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Clostridium test, Complement factor C3, Complement factor C4, Complement factor normal, Computerised tomogram abdomen abnormal
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram pelvis abnormal, Condition aggravated, Conjunctivitis, Costovertebral angle tenderness
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cryptococcus test, Cytomegalovirus test negative, Deafness bilateral, Deafness neurosensory, Echocardiogram
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Flatulence, Fungal test negative, Giardia test negative, HIV test negative
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haematuria, Haemodialysis, Hepatitis B test negative, Hepatitis C test negative, Herpes simplex test negative
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperkalaemia, Illness, Inferior vena cava dilatation, Leukocytosis, Leukoplakia oral
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Light chain analysis, Light chain analysis abnormal, Light chain analysis increased, Magnetic resonance imaging head abnormal, Metabolic acidosis
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Natural killer cell count decreased, Nausea, Neutrophil count increased, Parasite stool test negative
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Periorbital oedema, Pleural effusion, Rash, Rash pustular, Red blood cells urine positive
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Renal failure, Renal haemorrhage, Renal impairment, Rhabdomyolysis, SARS-CoV-2 test negative
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Staphylococcus test positive, Streptococcus test, Subcapsular renal haematoma, Suprapubic pain, T-lymphocyte count decreased
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Treponema test negative, Ultrasound biliary tract, Ultrasound pelvis abnormal, Ureteric haemorrhage
Clinical narrative: Multi system organ failure; Renal failure; Shock; Cardiac tamponade; Multifocal small stroke; Systemic inflammation and hyperinflammation; Hearing loss; Pleural effusion; Neo pressure; This is a spontaneous report from a contactable Physician via medical information center. A male patient of an unspecified age (Age: 20; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Not reported) via unspecified route of administration on an unknown date as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced multi system organ failure, renal failure, shock, neo pressure (hypotension), cardiac tamponade, pleural effusion, multifocal small stroke (transient ischaemic attack), systemic inflammation (systemic inflammatory response syndrome), hearing loss (deafness). The outcome of the events was unknown.  Physician commented: HCP wanted to know reports of similar cases such as a male patient (20 years old) experienced after the first dose of the Pfizer covid vaccine. He experienced multi system organ failure, renal failure, shock, neo pressure, cardiac tamponade requiring pericardial window, pleural effusion requiring chest tube, hearing loss, multifocal small stroke, systemic inflammation and hyperinflammation. HCP is looking for guidance on treatment as well. Informed the physician that we can do some more research on their question to see if there was any additional information available.  Information related to batch/Lot no. was requested.; Sender's Comments: There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, concomitant medications,age of the patient, date of vaccine given, date on when the event started ,lab reports etc. The case will be reevaluated should additional information become 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.