chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Neutrophil count increased, Pharyngeal oedema, Tachycardia
Clinical narrative: anaphylaxis; This is a spontaneous report from a contactable other healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. Pfizer covid vaccine caused anaphylaxis on 30Dec2020 and landed patient in hospital. Patient was an anesthesiologist and had high IgG to thyroid with hashimotos. Patient thought he/she had IgG/neutrophil mediated anaphylaxis (not the typical IgE) as absolute neutrophil count elevated but everything else normal in labs. Had tachycardia into 140-150s and mild facial and throat edema. Still having sudden bouts of elevated heart rate in the morning of 31Dec2020. Heart tests all normal. Outcome of event elevated heart rate was not recovered, and outcome of other events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Electrocardiogram normal, Hypoaesthesia
Clinical narrative: At about the 10 minute mark after receiving the vaccine my face started to become numb around the cheekbone area on my left side.  The numbness progressed to my right cheekbone area and to my forehead area above both eyes.  The EMT staff on site took my blood pressure and it was higher than what it usually is.   I have no history of high blood pressure.  They recored a reading of 148/89 the first read and it continued to climb to 169/98.  I was given a Benadryl tablet with water.  Since my blood pressure was not coming down after several readings an ambulance was called to transport me to the hospital where i could be monitored in the event my symptoms became worse.  An EKG and blood work were done and nothing came came back abnormal. My blood pressure came back down and the numbness in my face became better.  I think the Benadryl started working at this point.  I was in the ER for 2.5 hours and they released me since my symptoms got better.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Limb discomfort, Throat irritation, Throat tightness
Clinical narrative: felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue; arms and legs feel heavy; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek5730, expiration date: unknown), via an unspecified route of administration on the left arm on 30Dec2020 at 08:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included Hashimotos, Celiac, nonalcoholic fatty liver, and known allergies to gluten, eggs whites and eggs yolks, mustard seed, and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid (NATURE THROID), and an unspecified women's multivitamin. The patient was not pregnant at the time of vaccination. The 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. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 08:15, also reported as within 10 minutes, the patient felt flushed and at 20 minutes, she started to itch and felt tightness in her throat. The patient left after 30 minutes to go home and take diphenhydramine (BENADRYL). The patient worked at night and slept most of the day except to take BENADRYL and call out from work. Also on 30Dec2020, she noticed fatigue when she woke in the afternoon and her arms and legs felt heavy. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of itch and felt tightness in her throat. She had been on BENADRYL 50 mg every 4-6 hours. The itching and throat tightness remained unchanged. She had used an albuterol inhaler 3 times. The patient did not receive treatment for the other events. The patient was not recovered from the events "felt flushed, itch and felt tightness in her throat, fatigue, and arms and legs feel heavy."
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood pressure measurement, Chest discomfort, Chills, Dizziness
Clinical narrative: feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship.   The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Heart rate, Oxygen saturation
Clinical narrative: feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship.   The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Depressed level of consciousness, Dyspnoea
Clinical narrative: feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship.   The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Burning sensation, Cardiac monitoring, Chest discomfort
Clinical narrative: Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; 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 event Mental impairment cannot be totally excluded.  The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Heart rate increased, Peripheral coldness, Presyncope
Clinical narrative: Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; 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 event Mental impairment cannot be totally excluded.  The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Thinking abnormal, Throat irritation
Clinical narrative: Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; 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 event Mental impairment cannot be totally excluded.  The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Blood pressure increased, Burning sensation, Disturbance in attention
Clinical narrative: Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; 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 event Mental impairment cannot be totally excluded.  The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Mental impairment, Peripheral coldness, Speech disorder
Clinical narrative: Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; 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 event Mental impairment cannot be totally excluded.  The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; 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 event Mental impairment cannot be totally excluded.  The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Chills, Headache, Hypoaesthesia
Clinical narrative: Arm hurt after vaccine but developed numbness radiating from shoulder to fingers and around should to back. Arm is painful with tingling and numbness. Started 14 days after getting vaccine
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Arm hurt after vaccine but developed numbness radiating from shoulder to fingers and around should to back. Arm is painful with tingling and numbness. Started 14 days after getting vaccine
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypoaesthesia, Pain in extremity, Paraesthesia, SARS-CoV-2 test positive
Clinical narrative: Arm hurt after vaccine but developed numbness radiating from shoulder to fingers and around should to back. Arm is painful with tingling and numbness. Started 14 days after getting vaccine
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Site of injection became red, itchy, and warm with a hard spot
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Pain in extremity, White blood cell count increased
Clinical narrative: Site of injection became red, itchy, and warm with a hard spot
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Site of injection became red, itchy, and warm with a hard spot
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Hypoaesthesia
Clinical narrative: Within an hour of receiving the injection I lost 100% of my hearing in my right ear.  Starting with some ringing, vertigo and then just silence.  I called the Pfizer hotline, and they took down some information and then directed me to call the COVID hotline which resulted in pretty much the same.  As it was Christmas day and the weekend, I waited to contact my Primary Physician on 12/30/20.  She saw me immediately and sent me to a Specialist the next day to see Dr. for my hearing loss.  There I was given an audiological assessment where my right ear was found to have moderately severe to profound sensorineural hearing loss in the right ear.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Tinnitus, Vertigo
Clinical narrative: Within an hour of receiving the injection I lost 100% of my hearing in my right ear.  Starting with some ringing, vertigo and then just silence.  I called the Pfizer hotline, and they took down some information and then directed me to call the COVID hotline which resulted in pretty much the same.  As it was Christmas day and the weekend, I waited to contact my Primary Physician on 12/30/20.  She saw me immediately and sent me to a Specialist the next day to see Dr. for my hearing loss.  There I was given an audiological assessment where my right ear was found to have moderately severe to profound sensorineural hearing loss in the right ear.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody negative, C-reactive protein increased, Fibrin D dimer increased, Hepatitis C antibody negative, Pericarditis
Clinical narrative: acute pericarditis; This is a spontaneous report from the contactable physicians. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the left arm on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took recombinant zoster vaccine intramuscular in the left deltoid and diphtheria vaccine toxoid;pertussis vaccine acellular 3-component;tetanus vaccine toxoid (BOOSTRIX) intramuscular in the right deltoid; both on 11Dec2020; and diphtheria vaccine toxoid;pertussis vaccine acellular 5-component;tetanus vaccine toxoid (ADACEL) intramuscular in the right deltoid on 17Nov2010; all for immunization. The patient experienced acute pericarditis on 27Dec2020. The patient was admitted for acute pericarditis from 27Dec2020 to 28Dec2020. The cardiology team thinks the event was due to the vaccination. They were treating the patient with ibuprofen and colchicine. The reporter wants guidance on whether or not this patient should get the second dose of the vaccine. Outcome of the event was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event pericarditis cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Troponin T increased
Clinical narrative: acute pericarditis; This is a spontaneous report from the contactable physicians. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the left arm on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took recombinant zoster vaccine intramuscular in the left deltoid and diphtheria vaccine toxoid;pertussis vaccine acellular 3-component;tetanus vaccine toxoid (BOOSTRIX) intramuscular in the right deltoid; both on 11Dec2020; and diphtheria vaccine toxoid;pertussis vaccine acellular 5-component;tetanus vaccine toxoid (ADACEL) intramuscular in the right deltoid on 17Nov2010; all for immunization. The patient experienced acute pericarditis on 27Dec2020. The patient was admitted for acute pericarditis from 27Dec2020 to 28Dec2020. The cardiology team thinks the event was due to the vaccination. They were treating the patient with ibuprofen and colchicine. The reporter wants guidance on whether or not this patient should get the second dose of the vaccine. Outcome of the event was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event pericarditis cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: acute pericarditis; This is a spontaneous report from the contactable physicians. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the left arm on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took recombinant zoster vaccine intramuscular in the left deltoid and diphtheria vaccine toxoid;pertussis vaccine acellular 3-component;tetanus vaccine toxoid (BOOSTRIX) intramuscular in the right deltoid; both on 11Dec2020; and diphtheria vaccine toxoid;pertussis vaccine acellular 5-component;tetanus vaccine toxoid (ADACEL) intramuscular in the right deltoid on 17Nov2010; all for immunization. The patient experienced acute pericarditis on 27Dec2020. The patient was admitted for acute pericarditis from 27Dec2020 to 28Dec2020. The cardiology team thinks the event was due to the vaccination. They were treating the patient with ibuprofen and colchicine. The reporter wants guidance on whether or not this patient should get the second dose of the vaccine. Outcome of the event was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event pericarditis cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Pericarditis, Scan with contrast, Troponin increased
Clinical narrative: acute pericarditis; This is a spontaneous report from the contactable physicians. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the left arm on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took recombinant zoster vaccine intramuscular in the left deltoid and diphtheria vaccine toxoid;pertussis vaccine acellular 3-component;tetanus vaccine toxoid (BOOSTRIX) intramuscular in the right deltoid; both on 11Dec2020; and diphtheria vaccine toxoid;pertussis vaccine acellular 5-component;tetanus vaccine toxoid (ADACEL) intramuscular in the right deltoid on 17Nov2010; all for immunization. The patient experienced acute pericarditis on 27Dec2020. The patient was admitted for acute pericarditis from 27Dec2020 to 28Dec2020. The cardiology team thinks the event was due to the vaccination. They were treating the patient with ibuprofen and colchicine. The reporter wants guidance on whether or not this patient should get the second dose of the vaccine. Outcome of the event was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event pericarditis cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: acute pericarditis; This is a spontaneous report from the contactable physicians. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the left arm on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took recombinant zoster vaccine intramuscular in the left deltoid and diphtheria vaccine toxoid;pertussis vaccine acellular 3-component;tetanus vaccine toxoid (BOOSTRIX) intramuscular in the right deltoid; both on 11Dec2020; and diphtheria vaccine toxoid;pertussis vaccine acellular 5-component;tetanus vaccine toxoid (ADACEL) intramuscular in the right deltoid on 17Nov2010; all for immunization. The patient experienced acute pericarditis on 27Dec2020. The patient was admitted for acute pericarditis from 27Dec2020 to 28Dec2020. The cardiology team thinks the event was due to the vaccination. They were treating the patient with ibuprofen and colchicine. The reporter wants guidance on whether or not this patient should get the second dose of the vaccine. Outcome of the event was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event pericarditis cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Full blood count normal, Metabolic function test normal, Pericarditis
Clinical narrative: On 1/1/21 (4 days post dose 1), patient developed sudden onset substernal chest pain that resolved and recurred the next day on 1/2/21.  Patient was seen in the emergency department. VS were reported WNL, EKG with diffuse ST elevations and subtle PR depressions consistent with pericarditis. ECHO did not show evidence of effusion or tamponade. CXR and basic labs were unremarkable including troponin WNL. Patient sent home with colchicine and NSAIDS with plan for outpatient cardiology follow up. Of note, patient had COVID-19 in April 2020 with documented positive antibodies at that time.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: On 1/1/21 (4 days post dose 1), patient developed sudden onset substernal chest pain that resolved and recurred the next day on 1/2/21.  Patient was seen in the emergency department. VS were reported WNL, EKG with diffuse ST elevations and subtle PR depressions consistent with pericarditis. ECHO did not show evidence of effusion or tamponade. CXR and basic labs were unremarkable including troponin WNL. Patient sent home with colchicine and NSAIDS with plan for outpatient cardiology follow up. Of note, patient had COVID-19 in April 2020 with documented positive antibodies at that time.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation
Clinical narrative: On 1/1/21 (4 days post dose 1), patient developed sudden onset substernal chest pain that resolved and recurred the next day on 1/2/21.  Patient was seen in the emergency department. VS were reported WNL, EKG with diffuse ST elevations and subtle PR depressions consistent with pericarditis. ECHO did not show evidence of effusion or tamponade. CXR and basic labs were unremarkable including troponin WNL. Patient sent home with colchicine and NSAIDS with plan for outpatient cardiology follow up. Of note, patient had COVID-19 in April 2020 with documented positive antibodies at that time.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Laboratory test normal, Pericarditis, Troponin normal
Clinical narrative: On 1/1/21 (4 days post dose 1), patient developed sudden onset substernal chest pain that resolved and recurred the next day on 1/2/21.  Patient was seen in the emergency department. VS were reported WNL, EKG with diffuse ST elevations and subtle PR depressions consistent with pericarditis. ECHO did not show evidence of effusion or tamponade. CXR and basic labs were unremarkable including troponin WNL. Patient sent home with colchicine and NSAIDS with plan for outpatient cardiology follow up. Of note, patient had COVID-19 in April 2020 with documented positive antibodies at that time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Clumsiness, Computerised tomogram spine, Grip strength decreased, Hypoaesthesia, Impaired work ability
Clinical narrative: numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. 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: Muscular weakness, Neck pain, Neuralgic amyotrophy, Radiculitis brachial, Sensory loss
Clinical narrative: numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. 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.