chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Neurologic neglect syndrome, Paraesthesia, Vertigo
Clinical narrative: a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Central nervous system lesion, Dizziness, Headache, Lumbar puncture
Clinical narrative: a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging brain abnormal, Nystagmus, Paraesthesia, SARS-CoV-2 test negative, Viral test negative
Clinical narrative: a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral, Aphasia, Arteriogram carotid, Blood magnesium, Blood thyroid stimulating hormone
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Chest X-ray, Computerised tomogram head, Culture urine
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Differential white blood cell count, Dyspnoea, Dyspnoea exertional, Electrocardiogram, Fibrin D dimer
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Glycosylated haemoglobin, Lipids, Magnetic resonance imaging brain, Metabolic function test
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Perfusion brain scan, Platelet count, Red blood cell sedimentation rate, Respiratory viral panel, SARS-CoV-2 test
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scan with contrast, Tachycardia, Tachypnoea, Troponin I, Ultrasound kidney
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Asthenia, Dysarthria, Dyspnoea, Vision blurred
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Cerebrovascular accident, Chest pain, Dyspnoea, Transient ischaemic attack
Clinical narrative: TIAStroke, Angina, SOB, chest pain. Narrative: Employee stated that the attending physician mentioned that the vaccine might have exacerbated employee's previous health condition.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Influenza like illness, Myalgia, Oropharyngeal pain
Clinical narrative: Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Cough, Nausea, Neck pain
Clinical narrative: Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Diarrhoea, Headache, Lacrimation increased
Clinical narrative: approx 2-4 hours after receiving the vaccine, developed HA, myalgias, nausea, vomiting, diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Retching, Vomiting
Clinical narrative: approx 2-4 hours after receiving the vaccine, developed HA, myalgias, nausea, vomiting, diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: approx 2-4 hours after receiving the vaccine, developed HA, myalgias, nausea, vomiting, diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: approx 2-4 hours after receiving the vaccine, developed HA, myalgias, nausea, vomiting, diarrhea
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Arm pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient).  A 54-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: unknown, unspecified route on 28DEC2020 12:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization.  Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included ergocalciferol (VIT D), calcium (CALCIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 03:45, the patient experienced arm pain at injection site. The event arm pain at injection site did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect.  No treatment was received for the event. Outcome of the event arm pain at injection site was recovered.  Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination = Nasal Swab, Covid test date on 30Dec2020 and result was negative.  Information on lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Arm pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient).  A 54-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: unknown, unspecified route on 28DEC2020 12:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization.  Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included ergocalciferol (VIT D), calcium (CALCIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 03:45, the patient experienced arm pain at injection site. The event arm pain at injection site did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect.  No treatment was received for the event. Outcome of the event arm pain at injection site was recovered.  Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination = Nasal Swab, Covid test date on 30Dec2020 and result was negative.  Information on lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Headache, Pyrexia, Syncope
Clinical narrative: drop in blood pressure resulting in fainting; drop in blood pressure resulting in fainting; Severe headache; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unspecified route of administration on 03Jan2021 at single dose at left arm for immunization. Medical history included allergies to Penicillins. The patient's concomitant medications within 2 weeks of vaccination included birth control pill, prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced severe headache, fever, and drop in blood pressure resulting in fainting the morning following receiving the vaccine on 04Jan2021 with outcome of recovering. Patient didn't receive treatment for events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. This report is considered non-serious.  No follow-up attempts are possible. Information about Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event fainting with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fine motor skill dysfunction, Hypoaesthesia, Magnetic resonance imaging spinal normal, Sensory loss
Clinical narrative: acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; This is a spontaneous report from a contactable physician (patient).  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: FK1730, via an unspecified route of administration at Left arm from 19Dec2020 09:15 to 19Dec2020 09:15 at SINGLE DOSE for COVID-19 immunization.  Medical history reported as none.  Concomitant medication included acetylcarnitine (ACETYL L CARNITIN), magnesium, colecalciferol (VITAMIN D), and probiotics. On 29Dec2020 16:30, the patient developed acute bilateral numbness in her thumb and first 3 fingers, with loss of dexterity. It lasted approximately 30-45 minutes, and then improved somewhat but it continues to be present in all digits. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fine motor skill dysfunction, Hypoaesthesia
Clinical narrative: acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; This is a spontaneous report from a contactable physician (patient).  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: FK1730, via an unspecified route of administration at Left arm from 19Dec2020 09:15 to 19Dec2020 09:15 at SINGLE DOSE for COVID-19 immunization.  Medical history reported as none.  Concomitant medication included acetylcarnitine (ACETYL L CARNITIN), magnesium, colecalciferol (VITAMIN D), and probiotics. On 29Dec2020 16:30, the patient developed acute bilateral numbness in her thumb and first 3 fingers, with loss of dexterity. It lasted approximately 30-45 minutes, and then improved somewhat but it continues to be present in all digits. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. The outcome of the events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: She has shortness of breath the next day
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: She has shortness of breath the next day
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature abnormal, Fatigue, Myalgia, Neck pain, Palpitations
Clinical narrative: neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Neck pain, Palpitations, Pyrexia
Clinical narrative: neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site mass
Clinical narrative: Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Chills; Headache; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 30Dec2020 14:45 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 20:00, the patient experienced injection site sore, red hot hard, chills, and headache. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Chills; Headache; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 30Dec2020 14:45 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 20:00, the patient experienced injection site sore, red hot hard, chills, and headache. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Chills; Headache; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 30Dec2020 14:45 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 20:00, the patient experienced injection site sore, red hot hard, chills, and headache. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Chills; Headache; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 30Dec2020 14:45 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 20:00, the patient experienced injection site sore, red hot hard, chills, and headache. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Dehydration, Dizziness, Fatigue
Clinical narrative: I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.   Information about Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Headache, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.   Information about Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Somnolence
Clinical narrative: I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.   Information about Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.   Information about Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.   Information about Lot/Batch number has been requested.