chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mouth swelling, Myocarditis, Nausea, Oral pruritus, Pain in extremity
Clinical narrative: she had a reaction to PEG in the lipids of the vaccine; had Anaphylactic shock/anaphylactic reaction; a cardiovascular event /she had ventricular arrhythmias/Premature ventricular contractions; has High blood pressure sustained until today /Blood pressure still elevated to; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse (patient) reported a 55-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Feb2021 into right arm at a single dose for covid-19 immunisation. She reported having numerous allergies including fish, seafood, cats, sheep/lanolin, plants, and trees. The patient's concomitant medications were not reported. The patient usually doesn't have high blood pressure, but she had high blood pressure sustained until today, chest pains, hives immediately and itching on right arm where the shot was, felt welted and had different ventricular beats, short of breath. Doctors gave her Solumedrol- was given Morphine for blood pressure. The patient was admitted overnight and Blood pressure still elevated to and PVC (Premature ventricular contractions). The patient wanted to know what she can do to help this. The patient received the first Pfizer Covid vaccine dose on 03Feb2021. Within 1 minute experienced an anaphylactic reaction/shock and a cardiovascular event. She stated she had ventricular arrhythmias and is now on a beta-blocker for treatment. She thought that she had a reaction to PEG in the lipids of the vaccine. She wanted to know where the PEG is derived from.  The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain of skin, Painful respiration, Palpitations, Paraesthesia, Pharyngeal paraesthesia
Clinical narrative: she had a reaction to PEG in the lipids of the vaccine; had Anaphylactic shock/anaphylactic reaction; a cardiovascular event /she had ventricular arrhythmias/Premature ventricular contractions; has High blood pressure sustained until today /Blood pressure still elevated to; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse (patient) reported a 55-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Feb2021 into right arm at a single dose for covid-19 immunisation. She reported having numerous allergies including fish, seafood, cats, sheep/lanolin, plants, and trees. The patient's concomitant medications were not reported. The patient usually doesn't have high blood pressure, but she had high blood pressure sustained until today, chest pains, hives immediately and itching on right arm where the shot was, felt welted and had different ventricular beats, short of breath. Doctors gave her Solumedrol- was given Morphine for blood pressure. The patient was admitted overnight and Blood pressure still elevated to and PVC (Premature ventricular contractions). The patient wanted to know what she can do to help this. The patient received the first Pfizer Covid vaccine dose on 03Feb2021. Within 1 minute experienced an anaphylactic reaction/shock and a cardiovascular event. She stated she had ventricular arrhythmias and is now on a beta-blocker for treatment. She thought that she had a reaction to PEG in the lipids of the vaccine. She wanted to know where the PEG is derived from.  The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Pulmonary pain, Rash macular, Rash papular
Clinical narrative: she had a reaction to PEG in the lipids of the vaccine; had Anaphylactic shock/anaphylactic reaction; a cardiovascular event /she had ventricular arrhythmias/Premature ventricular contractions; has High blood pressure sustained until today /Blood pressure still elevated to; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse (patient) reported a 55-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Feb2021 into right arm at a single dose for covid-19 immunisation. She reported having numerous allergies including fish, seafood, cats, sheep/lanolin, plants, and trees. The patient's concomitant medications were not reported. The patient usually doesn't have high blood pressure, but she had high blood pressure sustained until today, chest pains, hives immediately and itching on right arm where the shot was, felt welted and had different ventricular beats, short of breath. Doctors gave her Solumedrol- was given Morphine for blood pressure. The patient was admitted overnight and Blood pressure still elevated to and PVC (Premature ventricular contractions). The patient wanted to know what she can do to help this. The patient received the first Pfizer Covid vaccine dose on 03Feb2021. Within 1 minute experienced an anaphylactic reaction/shock and a cardiovascular event. She stated she had ventricular arrhythmias and is now on a beta-blocker for treatment. She thought that she had a reaction to PEG in the lipids of the vaccine. She wanted to know where the PEG is derived from.  The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sensory disturbance, Skin burning sensation, Skin warm, Speech disorder, Supraventricular tachycardia
Clinical narrative: she had a reaction to PEG in the lipids of the vaccine; had Anaphylactic shock/anaphylactic reaction; a cardiovascular event /she had ventricular arrhythmias/Premature ventricular contractions; has High blood pressure sustained until today /Blood pressure still elevated to; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse (patient) reported a 55-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Feb2021 into right arm at a single dose for covid-19 immunisation. She reported having numerous allergies including fish, seafood, cats, sheep/lanolin, plants, and trees. The patient's concomitant medications were not reported. The patient usually doesn't have high blood pressure, but she had high blood pressure sustained until today, chest pains, hives immediately and itching on right arm where the shot was, felt welted and had different ventricular beats, short of breath. Doctors gave her Solumedrol- was given Morphine for blood pressure. The patient was admitted overnight and Blood pressure still elevated to and PVC (Premature ventricular contractions). The patient wanted to know what she can do to help this. The patient received the first Pfizer Covid vaccine dose on 03Feb2021. Within 1 minute experienced an anaphylactic reaction/shock and a cardiovascular event. She stated she had ventricular arrhythmias and is now on a beta-blocker for treatment. She thought that she had a reaction to PEG in the lipids of the vaccine. She wanted to know where the PEG is derived from.  The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Throat irritation, Tongue pruritus, Ventricular extrasystoles
Clinical narrative: she had a reaction to PEG in the lipids of the vaccine; had Anaphylactic shock/anaphylactic reaction; a cardiovascular event /she had ventricular arrhythmias/Premature ventricular contractions; has High blood pressure sustained until today /Blood pressure still elevated to; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse (patient) reported a 55-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Feb2021 into right arm at a single dose for covid-19 immunisation. She reported having numerous allergies including fish, seafood, cats, sheep/lanolin, plants, and trees. The patient's concomitant medications were not reported. The patient usually doesn't have high blood pressure, but she had high blood pressure sustained until today, chest pains, hives immediately and itching on right arm where the shot was, felt welted and had different ventricular beats, short of breath. Doctors gave her Solumedrol- was given Morphine for blood pressure. The patient was admitted overnight and Blood pressure still elevated to and PVC (Premature ventricular contractions). The patient wanted to know what she can do to help this. The patient received the first Pfizer Covid vaccine dose on 03Feb2021. Within 1 minute experienced an anaphylactic reaction/shock and a cardiovascular event. She stated she had ventricular arrhythmias and is now on a beta-blocker for treatment. She thought that she had a reaction to PEG in the lipids of the vaccine. She wanted to know where the PEG is derived from.  The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Blood pressure measurement, Hypertension, Reaction to excipient, Ventricular extrasystoles
Clinical narrative: she had a reaction to PEG in the lipids of the vaccine; had Anaphylactic shock/anaphylactic reaction; a cardiovascular event /she had ventricular arrhythmias/Premature ventricular contractions; has High blood pressure sustained until today /Blood pressure still elevated to; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse (patient) reported a 55-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Feb2021 into right arm at a single dose for covid-19 immunisation. She reported having numerous allergies including fish, seafood, cats, sheep/lanolin, plants, and trees. The patient's concomitant medications were not reported. The patient usually doesn't have high blood pressure, but she had high blood pressure sustained until today, chest pains, hives immediately and itching on right arm where the shot was, felt welted and had different ventricular beats, short of breath. Doctors gave her Solumedrol- was given Morphine for blood pressure. The patient was admitted overnight and Blood pressure still elevated to and PVC (Premature ventricular contractions). The patient wanted to know what she can do to help this. The patient received the first Pfizer Covid vaccine dose on 03Feb2021. Within 1 minute experienced an anaphylactic reaction/shock and a cardiovascular event. She stated she had ventricular arrhythmias and is now on a beta-blocker for treatment. She thought that she had a reaction to PEG in the lipids of the vaccine. She wanted to know where the PEG is derived from.  The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Headache, Hyperhidrosis, Metabolic function test, Muscle tightness
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Angiogram, Angiogram pulmonary abnormal, Aspartate aminotransferase increased, Atelectasis
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Blood culture negative, Blood urea increased, C-reactive protein normal, Computerised tomogram abdomen
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dehydration, Echocardiogram abnormal, Fatigue, Feeling hot
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Glomerular filtration rate decreased, Hyperhidrosis, Influenza virus test negative, Lipase increased
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Myalgia, Pericardial effusion, Pyrexia
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Respiratory viral panel, SARS-CoV-2 test negative, Urine analysis abnormal
Clinical narrative: Day after immunization:  sweating/feeling hot; Day 14 approx.:  myalgias that prevented usual exercise routine, fatigue, malaise, eventually loss of appetite to the point that patient became dehydrated, requiring IV fluids; fever to 102.9
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Head discomfort, Heart rate increased
Clinical narrative: head full; sinus dried up; light headed; spacey; feeling weak; Rapid pulse; felt as if she was going to pass out; Pale/ashy complexion; This is a spontaneous report from a contactable consumer(patient). A 68-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration on 06Feb2021 11:15 at single dose, left arm for covid-19 immunization. Patient was not pregnant. There were no other vaccines in four weeks. The patient medical history was not reported. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Concomitant medication included hydrochlorothiazide(HCTZ), lisinopril, atorvastatin (LIPITOR). On 06Feb2021 11:30 AM, the patient experienced head full, sinus dried up, light headed, spacey and feeling weak and rapid pulse, felt as if she was going to pass out, pale/ashy complexion. Events resulted in prolongation of existing hospitalization (vaccine received during existing hospitalization). Treatment received for the events. Treatment reported her pulse was checked 3-4 times. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Pallor, Paranasal sinus hyposecretion, Sinus congestion
Clinical narrative: head full; sinus dried up; light headed; spacey; feeling weak; Rapid pulse; felt as if she was going to pass out; Pale/ashy complexion; This is a spontaneous report from a contactable consumer(patient). A 68-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration on 06Feb2021 11:15 at single dose, left arm for covid-19 immunization. Patient was not pregnant. There were no other vaccines in four weeks. The patient medical history was not reported. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Concomitant medication included hydrochlorothiazide(HCTZ), lisinopril, atorvastatin (LIPITOR). On 06Feb2021 11:30 AM, the patient experienced head full, sinus dried up, light headed, spacey and feeling weak and rapid pulse, felt as if she was going to pass out, pale/ashy complexion. Events resulted in prolongation of existing hospitalization (vaccine received during existing hospitalization). Treatment received for the events. Treatment reported her pulse was checked 3-4 times. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Head discomfort, Heart rate
Clinical narrative: head full; sinus dried up; light headed; spacey; feeling weak; Rapid pulse; felt as if she was going to pass out; Pale/ashy complexion; This is a spontaneous report from a contactable consumer(patient). A 68-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration on 06Feb2021 11:15 at single dose, left arm for covid-19 immunization. Patient was not pregnant. There were no other vaccines in four weeks. The patient medical history was not reported. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Concomitant medication included hydrochlorothiazide(HCTZ), lisinopril, atorvastatin (LIPITOR). On 06Feb2021 11:30 AM, the patient experienced head full, sinus dried up, light headed, spacey and feeling weak and rapid pulse, felt as if she was going to pass out, pale/ashy complexion. Events resulted in prolongation of existing hospitalization (vaccine received during existing hospitalization). Treatment received for the events. Treatment reported her pulse was checked 3-4 times. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pallor, Presyncope, Sinus disorder
Clinical narrative: head full; sinus dried up; light headed; spacey; feeling weak; Rapid pulse; felt as if she was going to pass out; Pale/ashy complexion; This is a spontaneous report from a contactable consumer(patient). A 68-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration on 06Feb2021 11:15 at single dose, left arm for covid-19 immunization. Patient was not pregnant. There were no other vaccines in four weeks. The patient medical history was not reported. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Concomitant medication included hydrochlorothiazide(HCTZ), lisinopril, atorvastatin (LIPITOR). On 06Feb2021 11:30 AM, the patient experienced head full, sinus dried up, light headed, spacey and feeling weak and rapid pulse, felt as if she was going to pass out, pale/ashy complexion. Events resulted in prolongation of existing hospitalization (vaccine received during existing hospitalization). Treatment received for the events. Treatment reported her pulse was checked 3-4 times. The outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Oropharyngeal discomfort
Clinical narrative: Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM  56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies.  No evidence of anaphylaxis or airway compromise.  Discussed rebound potential; feel home observation reasonable.  Instructed on antigen avoidence.  Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved.  Patient feels better by 1pm and goes home.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Flushing, Heart rate increased
Clinical narrative: Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM  56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies.  No evidence of anaphylaxis or airway compromise.  Discussed rebound potential; feel home observation reasonable.  Instructed on antigen avoidence.  Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved.  Patient feels better by 1pm and goes home.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Throat irritation, Tremor
Clinical narrative: Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM  56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies.  No evidence of anaphylaxis or airway compromise.  Discussed rebound potential; feel home observation reasonable.  Instructed on antigen avoidence.  Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved.  Patient feels better by 1pm and goes home.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aplastic anaemia, Biopsy bone marrow abnormal, Packed red blood cell transfusion, Pancytopenia, Platelet transfusion
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aplastic anaemia, Full blood count, Pancytopenia, Petechiae, Platelet transfusion
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaemia, Anti-glomerular basement membrane antibody negative, Anti-platelet antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aplastic anaemia, Aspergillus test negative, Biopsy bone marrow abnormal, Blister, Blood beta-D-glucan negative
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Bone marrow myelogram abnormal, Complement factor C3, Complement factor C4, Computerised tomogram thorax abnormal
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Cytomegalovirus test negative, Dilatation intrahepatic duct acquired, Double stranded DNA antibody, Echocardiogram normal
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epstein-Barr virus antibody negative, Flow cytometry, Full blood count, HIV test negative, HTLV test
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemodialysis, Haemoglobin normal, Hepatitis viral test negative, Hepatobiliary scan abnormal, Histology
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Human herpes virus 6 serology negative, Hypertension, Hypothyroidism, Immunoglobulin therapy, Immunology test
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Light chain analysis normal, Lipase normal, Metabolic function test, Myelosuppression, Nephrotic syndrome
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neutropenia, Neutrophil count decreased, Pancytopenia, Parvovirus B19 test negative, Platelet count decreased
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet transfusion, Pulmonary calcification, Renal failure, Rheumatoid factor, T-lymphocyte count
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, Transaminases increased, Transfusion, Treponema test negative, Ultrasound abdomen abnormal
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound kidney abnormal, Urine electrophoresis normal, White blood cell count decreased
Clinical narrative: [Pfizer BioNtech COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): aplastic anemia. Patient states she received her vaccine and then 14 days later began to have small petechiae throughout her body. She reported this to her nephrologist who ordered a CBC and was advised to come to the ED. Hematology was consulted and she received decadron, platelets, and PRBC.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: 5:30 pm started with mild Headache. Progressed to nausea and more prnounced HA.  At 7:30 began having chills and fever. Slept all day. Awoke with HA and fatigue. My heart felt like it was beating fast with physical activity. Then developed a sorethroat.,
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: 5:30 pm started with mild Headache. Progressed to nausea and more prnounced HA.  At 7:30 began having chills and fever. Slept all day. Awoke with HA and fatigue. My heart felt like it was beating fast with physical activity. Then developed a sorethroat.,
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: 5:30 pm started with mild Headache. Progressed to nausea and more prnounced HA.  At 7:30 began having chills and fever. Slept all day. Awoke with HA and fatigue. My heart felt like it was beating fast with physical activity. Then developed a sorethroat.,
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: 5:30 pm started with mild Headache. Progressed to nausea and more prnounced HA.  At 7:30 began having chills and fever. Slept all day. Awoke with HA and fatigue. My heart felt like it was beating fast with physical activity. Then developed a sorethroat.,
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Balance test, Burning sensation, CSF pressure increased, Computerised tomogram
Clinical narrative: diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Very hard time focusing my eyes; Extreme burning and tingling sensation over his entire body; Extreme burning and tingling sensation over his entire body; extremely dizzy; confused; nauseous; uncontrollably shaking; Headache; This is a spontaneous report from a contactable consumer reporting for himself. A 33-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021 at 11:00 AM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient had no known allergies and did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. On 01Feb2021 at 12:00 PM the patient developed a headache. Over the next few hours the headache moved to the back of his neck and base of his skull. On 03Feb2021 the patient experienced very hard time focusing his eyes and extreme burning and tingling sensation over his entire body, he was extremely dizzy, confused, nauseous and uncontrollably shaking. Patient  went to his family doctor and was diagnosed with vertigo on 05Feb2021. Patient took meclizine with no relief. On 10Feb2021 the patient was visited by another doctor and went under two days of testing including acoustic stimulation tests, balance test, visual acuity tests, CT scan and MRI all with unknown result. The doctor said the vaccine shot caused an allergic reaction which elevated patient's spinal cord pressure and brain stem swelling. Therapeutic measures were taken as a result of spinal cord pressure and included treatment with Diamox. Outcome of the events was not resolved. The events were considered serious as life-threatening and as per disability. Patient was not tested positive for COVID-19 after vaccination.  The information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Confusional state, Disorientation, Dizziness, Head discomfort, Headache
Clinical narrative: diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Very hard time focusing my eyes; Extreme burning and tingling sensation over his entire body; Extreme burning and tingling sensation over his entire body; extremely dizzy; confused; nauseous; uncontrollably shaking; Headache; This is a spontaneous report from a contactable consumer reporting for himself. A 33-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021 at 11:00 AM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient had no known allergies and did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. On 01Feb2021 at 12:00 PM the patient developed a headache. Over the next few hours the headache moved to the back of his neck and base of his skull. On 03Feb2021 the patient experienced very hard time focusing his eyes and extreme burning and tingling sensation over his entire body, he was extremely dizzy, confused, nauseous and uncontrollably shaking. Patient  went to his family doctor and was diagnosed with vertigo on 05Feb2021. Patient took meclizine with no relief. On 10Feb2021 the patient was visited by another doctor and went under two days of testing including acoustic stimulation tests, balance test, visual acuity tests, CT scan and MRI all with unknown result. The doctor said the vaccine shot caused an allergic reaction which elevated patient's spinal cord pressure and brain stem swelling. Therapeutic measures were taken as a result of spinal cord pressure and included treatment with Diamox. Outcome of the events was not resolved. The events were considered serious as life-threatening and as per disability. Patient was not tested positive for COVID-19 after vaccination.  The information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Inner ear disorder, Magnetic resonance imaging, Nausea, Paraesthesia
Clinical narrative: diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Very hard time focusing my eyes; Extreme burning and tingling sensation over his entire body; Extreme burning and tingling sensation over his entire body; extremely dizzy; confused; nauseous; uncontrollably shaking; Headache; This is a spontaneous report from a contactable consumer reporting for himself. A 33-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021 at 11:00 AM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient had no known allergies and did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. On 01Feb2021 at 12:00 PM the patient developed a headache. Over the next few hours the headache moved to the back of his neck and base of his skull. On 03Feb2021 the patient experienced very hard time focusing his eyes and extreme burning and tingling sensation over his entire body, he was extremely dizzy, confused, nauseous and uncontrollably shaking. Patient  went to his family doctor and was diagnosed with vertigo on 05Feb2021. Patient took meclizine with no relief. On 10Feb2021 the patient was visited by another doctor and went under two days of testing including acoustic stimulation tests, balance test, visual acuity tests, CT scan and MRI all with unknown result. The doctor said the vaccine shot caused an allergic reaction which elevated patient's spinal cord pressure and brain stem swelling. Therapeutic measures were taken as a result of spinal cord pressure and included treatment with Diamox. Outcome of the events was not resolved. The events were considered serious as life-threatening and as per disability. Patient was not tested positive for COVID-19 after vaccination.  The information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Presyncope, Tremor, Vertigo, Vision blurred, Visual field tests
Clinical narrative: diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Very hard time focusing my eyes; Extreme burning and tingling sensation over his entire body; Extreme burning and tingling sensation over his entire body; extremely dizzy; confused; nauseous; uncontrollably shaking; Headache; This is a spontaneous report from a contactable consumer reporting for himself. A 33-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021 at 11:00 AM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient had no known allergies and did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. On 01Feb2021 at 12:00 PM the patient developed a headache. Over the next few hours the headache moved to the back of his neck and base of his skull. On 03Feb2021 the patient experienced very hard time focusing his eyes and extreme burning and tingling sensation over his entire body, he was extremely dizzy, confused, nauseous and uncontrollably shaking. Patient  went to his family doctor and was diagnosed with vertigo on 05Feb2021. Patient took meclizine with no relief. On 10Feb2021 the patient was visited by another doctor and went under two days of testing including acoustic stimulation tests, balance test, visual acuity tests, CT scan and MRI all with unknown result. The doctor said the vaccine shot caused an allergic reaction which elevated patient's spinal cord pressure and brain stem swelling. Therapeutic measures were taken as a result of spinal cord pressure and included treatment with Diamox. Outcome of the events was not resolved. The events were considered serious as life-threatening and as per disability. Patient was not tested positive for COVID-19 after vaccination.  The information on the lot/batch number has been requested.