chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Smear test, Ultrasound scan normal
Clinical narrative: Neurological disorder; Like my hands get tired quickly; Woke up several time at night; My feet and toes are cold; Weakness/I don't have much energy to keep my hands up a long time; Numbness and Pins and needles on legs and foots/numbness on my wrist and fingers; Numbness and Pins and needles on legs and foots/Pins and needles on my leap; This is a spontaneous case received from a contactable consumer (patient herself). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO158), via an unspecified route of administration on 09Apr2021 at 14:45 (age at vaccination 31-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history, known allergies and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 14:50, the patient experienced numbness and pins and needles on legs and foot all the time when she sits down or lay down on her bed. On 10Apr2021 04:00, the patient woke up several time at night because of numbness/pins and needles. The patient stated that she had same symptoms and additional weakness, her feet and toes were cold, pins and needles on her leap that last few seconds. On 13Apr2021, the patient experienced numbness on her wrist and fingers. On 17Apr2021, the patient stated she had pins and needles at night, it was stronger, and she do not have much energy to keep hands up a long time, like her hands get tired quickly. On 02Sep2021, the patient stated she still have same problems. The Next EMG exam was scheduled on 10Sep. She had visited several Allergists, Neurologists but no health issue was found except neurological disorder caused by the vaccine. On 20Apr2021, the patient visited emergency room. The patient underwent lab test and procedures which included CTA Head W/WO Contrast and lumbar puncture and the results was no health problems found. The treatment for the events was unknown. Seriousness of the events was reported as disabling/incapacitating. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Asthenia, Electromyogram, Fatigue, Hypoaesthesia
Clinical narrative: Neurological disorder; Like my hands get tired quickly; Woke up several time at night; My feet and toes are cold; Weakness/I don't have much energy to keep my hands up a long time; Numbness and Pins and needles on legs and foots/numbness on my wrist and fingers; Numbness and Pins and needles on legs and foots/Pins and needles on my leap; This is a spontaneous case received from a contactable consumer (patient herself). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO158), via an unspecified route of administration on 09Apr2021 at 14:45 (age at vaccination 31-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history, known allergies and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 14:50, the patient experienced numbness and pins and needles on legs and foot all the time when she sits down or lay down on her bed. On 10Apr2021 04:00, the patient woke up several time at night because of numbness/pins and needles. The patient stated that she had same symptoms and additional weakness, her feet and toes were cold, pins and needles on her leap that last few seconds. On 13Apr2021, the patient experienced numbness on her wrist and fingers. On 17Apr2021, the patient stated she had pins and needles at night, it was stronger, and she do not have much energy to keep hands up a long time, like her hands get tired quickly. On 02Sep2021, the patient stated she still have same problems. The Next EMG exam was scheduled on 10Sep. She had visited several Allergists, Neurologists but no health issue was found except neurological disorder caused by the vaccine. On 20Apr2021, the patient visited emergency room. The patient underwent lab test and procedures which included CTA Head W/WO Contrast and lumbar puncture and the results was no health problems found. The treatment for the events was unknown. Seriousness of the events was reported as disabling/incapacitating. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Nervous system disorder, Paraesthesia, Peripheral coldness, Sleep disorder
Clinical narrative: Neurological disorder; Like my hands get tired quickly; Woke up several time at night; My feet and toes are cold; Weakness/I don't have much energy to keep my hands up a long time; Numbness and Pins and needles on legs and foots/numbness on my wrist and fingers; Numbness and Pins and needles on legs and foots/Pins and needles on my leap; This is a spontaneous case received from a contactable consumer (patient herself). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO158), via an unspecified route of administration on 09Apr2021 at 14:45 (age at vaccination 31-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history, known allergies and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 14:50, the patient experienced numbness and pins and needles on legs and foot all the time when she sits down or lay down on her bed. On 10Apr2021 04:00, the patient woke up several time at night because of numbness/pins and needles. The patient stated that she had same symptoms and additional weakness, her feet and toes were cold, pins and needles on her leap that last few seconds. On 13Apr2021, the patient experienced numbness on her wrist and fingers. On 17Apr2021, the patient stated she had pins and needles at night, it was stronger, and she do not have much energy to keep hands up a long time, like her hands get tired quickly. On 02Sep2021, the patient stated she still have same problems. The Next EMG exam was scheduled on 10Sep. She had visited several Allergists, Neurologists but no health issue was found except neurological disorder caused by the vaccine. On 20Apr2021, the patient visited emergency room. The patient underwent lab test and procedures which included CTA Head W/WO Contrast and lumbar puncture and the results was no health problems found. The treatment for the events was unknown. Seriousness of the events was reported as disabling/incapacitating. The outcome of the events was not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture positive, Cardiac operation, Cerebrovascular accident, Chills, Computerised tomogram
Clinical narrative: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization.  Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Endocarditis bacterial, Exercise tolerance decreased, Intensive care, Laboratory test
Clinical narrative: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization.  Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Malaise, Mass, Mitral valve replacement, Myocardial infarction
Clinical narrative: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization.  Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pathology test, Pyrexia, Spleen disorder, Upper respiratory tract infection
Clinical narrative: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization.  Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Chills, Endocarditis bacterial, Exercise tolerance decreased
Clinical narrative: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization.  Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise, Pyrexia, SARS-CoV-2 test, Syncope
Clinical narrative: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization.  Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization.  Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eczema asteatotic, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome, Urticaria
Clinical narrative: Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; I have developed hives on my stomach and itching; I have developed hives on my stomach and itching; This is a spontaneous report from a contactable other health care professional, (the patient reported for self). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EYO584), dose 1 via an unspecified route of administration, administered in arm left on 08Aug2021 13:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. Medical history included lyme disease, mast cell activation syndrome, Vestibular Migraines, Postural Orthostatic Tachycardia syndrome (POTS) and Known allergies includes: allergy to Sulfa based drugs and foods. Concomitant medications (Other medications in two weeks) includes: loratadine (CLARITINE), multivitamin and mineral taken for unspecified indication from unknown dates. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior to the vaccination. On 09Aug2021 08:00, the patient developed hives on stomach and itching. Mast Cell Activation syndrome and POTS returned after the vaccine when it had previously been gone. The events resulted in doctor or other healthcare professional office/clinic visit. Post vaccination, on 01Sep2021, the patient underwent lab test and procedures which includes: Nasal Swab/ PCR, covid test which showed negative result. The patient received mast cell stabalizer and antihistamines as treatment for the events. The outcome of the events was not recovered.  No follow-up attempts were needed. No further information was expected. ; Sender's Comments: Based on the temporal relation, the association between the events of Mast Cell activation Syndrome and Postural Orthostatic Tachycardia Syndrome and the suspect product of BNT162B2 cannot be completely ruled out. The patient's medical history of the reported events is a confounding factor  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 ad-verse 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: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome, Pruritus, SARS-CoV-2 test
Clinical narrative: Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; I have developed hives on my stomach and itching; I have developed hives on my stomach and itching; This is a spontaneous report from a contactable other health care professional, (the patient reported for self). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EYO584), dose 1 via an unspecified route of administration, administered in arm left on 08Aug2021 13:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. Medical history included lyme disease, mast cell activation syndrome, Vestibular Migraines, Postural Orthostatic Tachycardia syndrome (POTS) and Known allergies includes: allergy to Sulfa based drugs and foods. Concomitant medications (Other medications in two weeks) includes: loratadine (CLARITINE), multivitamin and mineral taken for unspecified indication from unknown dates. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior to the vaccination. On 09Aug2021 08:00, the patient developed hives on stomach and itching. Mast Cell Activation syndrome and POTS returned after the vaccine when it had previously been gone. The events resulted in doctor or other healthcare professional office/clinic visit. Post vaccination, on 01Sep2021, the patient underwent lab test and procedures which includes: Nasal Swab/ PCR, covid test which showed negative result. The patient received mast cell stabalizer and antihistamines as treatment for the events. The outcome of the events was not recovered.  No follow-up attempts were needed. No further information was expected. ; Sender's Comments: Based on the temporal relation, the association between the events of Mast Cell activation Syndrome and Postural Orthostatic Tachycardia Syndrome and the suspect product of BNT162B2 cannot be completely ruled out. The patient's medical history of the reported events is a confounding factor  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 ad-verse 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: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; I have developed hives on my stomach and itching; I have developed hives on my stomach and itching; This is a spontaneous report from a contactable other health care professional, (the patient reported for self). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EYO584), dose 1 via an unspecified route of administration, administered in arm left on 08Aug2021 13:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. Medical history included lyme disease, mast cell activation syndrome, Vestibular Migraines, Postural Orthostatic Tachycardia syndrome (POTS) and Known allergies includes: allergy to Sulfa based drugs and foods. Concomitant medications (Other medications in two weeks) includes: loratadine (CLARITINE), multivitamin and mineral taken for unspecified indication from unknown dates. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior to the vaccination. On 09Aug2021 08:00, the patient developed hives on stomach and itching. Mast Cell Activation syndrome and POTS returned after the vaccine when it had previously been gone. The events resulted in doctor or other healthcare professional office/clinic visit. Post vaccination, on 01Sep2021, the patient underwent lab test and procedures which includes: Nasal Swab/ PCR, covid test which showed negative result. The patient received mast cell stabalizer and antihistamines as treatment for the events. The outcome of the events was not recovered.  No follow-up attempts were needed. No further information was expected. ; Sender's Comments: Based on the temporal relation, the association between the events of Mast Cell activation Syndrome and Postural Orthostatic Tachycardia Syndrome and the suspect product of BNT162B2 cannot be completely ruled out. The patient's medical history of the reported events is a confounding factor  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 ad-verse 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: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Feeling abnormal, Headache, Rhinovirus infection
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-02) via an unspecified route of administration on 20Aug2021 at 10:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) 5mg daily and prenatal vitamins (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. On an unknown date in 2021, the patient experienced loss of taste and smell for 2 weeks after vaccine, extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prescriptions (unspecified) and ear nose and throat (ENT) referrals. Since the vaccination, the patient had been tested for COVID-19. On 25Aug2021, the patient underwent Polymerase Chain Reaction (PCR) test for COVID and the result was negative, test type was Nasal Swab. The clinical outcome of the events loss of taste and loss of smell was resolved on an unknown date in 2021; while that of the events extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis was not resolved at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-02) via an unspecified route of administration on 20Aug2021 at 10:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) 5mg daily and prenatal vitamins (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. On an unknown date in 2021, the patient experienced loss of taste and smell for 2 weeks after vaccine, extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prescriptions (unspecified) and ear nose and throat (ENT) referrals. Since the vaccination, the patient had been tested for COVID-19. On 25Aug2021, the patient underwent Polymerase Chain Reaction (PCR) test for COVID and the result was negative, test type was Nasal Swab. The clinical outcome of the events loss of taste and loss of smell was resolved on an unknown date in 2021; while that of the events extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis was not resolved at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Ear pain, Eye pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-02) via an unspecified route of administration on 20Aug2021 at 10:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) 5mg daily and prenatal vitamins (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. On an unknown date in 2021, the patient experienced loss of taste and smell for 2 weeks after vaccine, extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prescriptions (unspecified) and ear nose and throat (ENT) referrals. Since the vaccination, the patient had been tested for COVID-19. On 25Aug2021, the patient underwent Polymerase Chain Reaction (PCR) test for COVID and the result was negative, test type was Nasal Swab. The clinical outcome of the events loss of taste and loss of smell was resolved on an unknown date in 2021; while that of the events extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis was not resolved at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, SARS-CoV-2 test, Vertigo, Vestibular neuronitis, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-02) via an unspecified route of administration on 20Aug2021 at 10:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) 5mg daily and prenatal vitamins (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. On an unknown date in 2021, the patient experienced loss of taste and smell for 2 weeks after vaccine, extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prescriptions (unspecified) and ear nose and throat (ENT) referrals. Since the vaccination, the patient had been tested for COVID-19. On 25Aug2021, the patient underwent Polymerase Chain Reaction (PCR) test for COVID and the result was negative, test type was Nasal Swab. The clinical outcome of the events loss of taste and loss of smell was resolved on an unknown date in 2021; while that of the events extreme headaches, blurred vision in left eye, dizziness/ vertigo sensations, inner ear pain and pain behind eye which the patient believed to be vestibular neuritis was not resolved at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blindness, Migraine, Presyncope, Urticaria
Clinical narrative: Anaphylactic shock; Hives; Vasovagal response; migraines; mild vision loss; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left, at the age of 43-year-old, on 31Aug2021 16:00 as single dose for COVID-19 immunisation. Known allergies: penicillin, sulfonamide (SULFA). There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination, and no COVID tested post vaccination. The patient experienced anaphylactic shock, hives, vasovagal response, migraines, mild vision loss, vertigo, all on 31Aug2021 16:30 with outcome of recovered with sequelae in 2021. Seriousness criteria of the events was reported as life threatening. The events resulted in Emergency room visit. The patient received EpiPen Benadryl for the events. Treatment received for the events.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Anaphylactic shock; Hives; Vasovagal response; migraines; mild vision loss; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left, at the age of 43-year-old, on 31Aug2021 16:00 as single dose for COVID-19 immunisation. Known allergies: penicillin, sulfonamide (SULFA). There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination, and no COVID tested post vaccination. The patient experienced anaphylactic shock, hives, vasovagal response, migraines, mild vision loss, vertigo, all on 31Aug2021 16:30 with outcome of recovered with sequelae in 2021. Seriousness criteria of the events was reported as life threatening. The events resulted in Emergency room visit. The patient received EpiPen Benadryl for the events. Treatment received for the events.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blindness, Migraine, Presyncope, Urticaria
Clinical narrative: Anaphylactic shock; Hives; Vasovagal response; migraines; mild vision loss; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left, at the age of 43-year-old, on 31Aug2021 16:00 as single dose for COVID-19 immunisation. Known allergies: penicillin, sulfonamide (SULFA). There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination, and no COVID tested post vaccination. The patient experienced anaphylactic shock, hives, vasovagal response, migraines, mild vision loss, vertigo, all on 31Aug2021 16:30 with outcome of recovered with sequelae in 2021. Seriousness criteria of the events was reported as life threatening. The events resulted in Emergency room visit. The patient received EpiPen Benadryl for the events. Treatment received for the events.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Computerised tomogram, Echocardiogram, Pericarditis
Clinical narrative: acute pericarditis; My HR was over 100 resting, I am an athlete and normally my HR is 60 at rest; chest pain; SOB; This is a spontaneous report from a non-contactable consumer or other non hcp. A 54-years-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 17Apr2021 as 2nddose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute pericarditis on an unspecified date, chest pain on 06Sep2021, sob on 06Sep2021, my HR was over 100 resting, I am an athlete and normally my HR is 60 at rest on an unspecified date. Patient stated I was in the hospital with pericarditis, asked me if I had received the Pfizer BT Covid vaccine. Patient states he may have gotten the pericarditis, maybe it was the vaccine. The patient underwent lab tests and procedures which included heart rate over 100 resting on. Therapeutic measures were taken as a result of acute pericarditis, chest pain, sob, my hr was over 100 resting, am an athlete and normally my hr is 60 at rest. Outcome of the patient experienced acute pericarditis, chest pain, sob was unknown, my hr was over 100 resting, am an athlete and normally my hr is 60 at rest on was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Heart rate increased, Pericarditis
Clinical narrative: acute pericarditis; My HR was over 100 resting, I am an athlete and normally my HR is 60 at rest; chest pain; SOB; This is a spontaneous report from a non-contactable consumer or other non hcp. A 54-years-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 17Apr2021 as 2nddose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute pericarditis on an unspecified date, chest pain on 06Sep2021, sob on 06Sep2021, my HR was over 100 resting, I am an athlete and normally my HR is 60 at rest on an unspecified date. Patient stated I was in the hospital with pericarditis, asked me if I had received the Pfizer BT Covid vaccine. Patient states he may have gotten the pericarditis, maybe it was the vaccine. The patient underwent lab tests and procedures which included heart rate over 100 resting on. Therapeutic measures were taken as a result of acute pericarditis, chest pain, sob, my hr was over 100 resting, am an athlete and normally my hr is 60 at rest. Outcome of the patient experienced acute pericarditis, chest pain, sob was unknown, my hr was over 100 resting, am an athlete and normally my hr is 60 at rest on was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cystitis
Clinical narrative: developed a possible bladder infection; but has pain "down there", though no other symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. She was scheduled for her second injection this coming Saturday, but in the meantime has developed a possible bladder infection. She stated she was doing things around the house and possibly strained herself, but has pain "down there", though no other symptoms.  She wanted to know if she were put on a course of antibiotics if this would interfere with the efficacy of the second vaccination. Caller declined transfer to safety as she was not sure she has a bladder infection as of yet. The outcome of the events was unknown.  Information on Lot/Batch Number has been Requested.  Follow-up attempts are completed. No further information is expected.