chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nervousness, Palpitations
Clinical narrative: About 10 mins after receiving the first dose of Pfizer vaccine - I experienced chest pounding tachycardia. They had me lay on the gurney and checked my pulse ox. My heart rate was 147 but my Sp02 100%.  After about 30 mins or so it naturally came down with no medical interventions.  Otherwise for the first dose my only other reaction was expected fatigue, injection site soreness and mild headache.   Of note - I did go ahead and get my second COVID19 vaccine after consulting with medical professionals on 1/24 and did not experience any chest pounding tachycardia. Maybe mild tachycardia but I was also nervous due to the previous first inject reaction.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: About 10 mins after receiving the first dose of Pfizer vaccine - I experienced chest pounding tachycardia. They had me lay on the gurney and checked my pulse ox. My heart rate was 147 but my Sp02 100%.  After about 30 mins or so it naturally came down with no medical interventions.  Otherwise for the first dose my only other reaction was expected fatigue, injection site soreness and mild headache.   Of note - I did go ahead and get my second COVID19 vaccine after consulting with medical professionals on 1/24 and did not experience any chest pounding tachycardia. Maybe mild tachycardia but I was also nervous due to the previous first inject reaction.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bursitis, Product administered at inappropriate site, X-ray
Clinical narrative: Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous report from a contactable physician. A 41-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3246), via an unspecified route of administration in the left leg on 06Jan2021 11:15 at a single dose for covid-19 immunisation. Medical history included eczema. Concomitant medication included spironolactone. The patient previously received first dose of BNT162B2 in the left leg on 16Dec2020 12:00 for covid-19 immunisation. On 06Jan2021 11:15, the patient experienced severe left arm pain unresolved. The patient received NSAIDS as treatment for the event. The patient has not tested positive for covid post vaccination. The outcome of the event severe left arm pain was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bursitis, Imaging procedure, Immediate post-injection reaction, Injected limb mobility decreased, Injection site extravasation
Clinical narrative: Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous report from a contactable physician. A 41-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3246), via an unspecified route of administration in the left leg on 06Jan2021 11:15 at a single dose for covid-19 immunisation. Medical history included eczema. Concomitant medication included spironolactone. The patient previously received first dose of BNT162B2 in the left leg on 16Dec2020 12:00 for covid-19 immunisation. On 06Jan2021 11:15, the patient experienced severe left arm pain unresolved. The patient received NSAIDS as treatment for the event. The patient has not tested positive for covid post vaccination. The outcome of the event severe left arm pain was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site reaction, Pain in extremity, SARS-CoV-2 antibody test negative, Tendonitis
Clinical narrative: Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous report from a contactable physician. A 41-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3246), via an unspecified route of administration in the left leg on 06Jan2021 11:15 at a single dose for covid-19 immunisation. Medical history included eczema. Concomitant medication included spironolactone. The patient previously received first dose of BNT162B2 in the left leg on 16Dec2020 12:00 for covid-19 immunisation. On 06Jan2021 11:15, the patient experienced severe left arm pain unresolved. The patient received NSAIDS as treatment for the event. The patient has not tested positive for covid post vaccination. The outcome of the event severe left arm pain was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous report from a contactable physician. A 41-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3246), via an unspecified route of administration in the left leg on 06Jan2021 11:15 at a single dose for covid-19 immunisation. Medical history included eczema. Concomitant medication included spironolactone. The patient previously received first dose of BNT162B2 in the left leg on 16Dec2020 12:00 for covid-19 immunisation. On 06Jan2021 11:15, the patient experienced severe left arm pain unresolved. The patient received NSAIDS as treatment for the event. The patient has not tested positive for covid post vaccination. The outcome of the event severe left arm pain was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Erythema, Fatigue, Feeling hot
Clinical narrative: within 5 minutes had itching at the site and burning sensation down arm to 4th and 5th digits, became flushed about neck and face area and was taken to the ED for evaluation by paramedic.  Within 20 minutes the adverse mild reaction had subsided without medications and the employee was discharged from the ED.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza like illness, Pruritus, Rash vesicular, Urticaria
Clinical narrative: within 5 minutes had itching at the site and burning sensation down arm to 4th and 5th digits, became flushed about neck and face area and was taken to the ED for evaluation by paramedic.  Within 20 minutes the adverse mild reaction had subsided without medications and the employee was discharged from the ED.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Flushing, Injection site pruritus
Clinical narrative: within 5 minutes had itching at the site and burning sensation down arm to 4th and 5th digits, became flushed about neck and face area and was taken to the ED for evaluation by paramedic.  Within 20 minutes the adverse mild reaction had subsided without medications and the employee was discharged from the ED.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Electroencephalogram normal, Fatigue, Headache, Hypoaesthesia
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Imaging procedure, Laboratory test normal, Pain, Pyrexia, Seizure like phenomena
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Rash, Seizure
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amnesia, Blindness, Computerised tomogram head, Computerised tomogram normal, Diplegia
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Feeling abnormal, Headache, Hypoaesthesia, Magnetic resonance imaging spinal normal
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Photopsia, Tremor
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Muscular weakness, SARS-CoV-2 test negative, Tremor
Clinical narrative: severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. 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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Approximately 2 weeks later I began to break out in hives every night. Have added benadryl up to 250-300mg  every day, allegra 24 hrs (2 doses) per day.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pain in extremity, Petechiae, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensation; foot blister; stubbed a toe; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284) at Left arm, intramuscular on 14Jan2021 16:45 at single dose for covid-19 immunisation. Medical history included Sjogren's, Raynaud, s/p Total abdominal hysterectomy (TAH)/Bilateral salpingo-oophorectomy (BSO) sex cord sclerosing stromal tumor, and known allergies: Sulfa. Patient did not have Covid prior vaccination. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), leflunomide, ciclosporin (RESTASIS), pilocarpine, colecalciferol (VITAMIN D), fish oil (OMEGA 3). Since the 14Jan2021 Pfizer COVID vaccine, the patient had left (L) 2nd Metatarsophalangeal (MTP) and right (R) 3rd MTP burning sensation on 15Jan2021 10:00 (like she had foot blister or stubbed a toe). Then, she had petechiae with discoloration on 16Jan2021 and 17Jan2021. No treatment was received for the events. The patient lab data included Covid PCR Test (Nasal Swab): negative on 15Jan2021. The outcome of events was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Limb injury, Petechiae, SARS-CoV-2 test
Clinical narrative: petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensation; foot blister; stubbed a toe; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284) at Left arm, intramuscular on 14Jan2021 16:45 at single dose for covid-19 immunisation. Medical history included Sjogren's, Raynaud, s/p Total abdominal hysterectomy (TAH)/Bilateral salpingo-oophorectomy (BSO) sex cord sclerosing stromal tumor, and known allergies: Sulfa. Patient did not have Covid prior vaccination. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), leflunomide, ciclosporin (RESTASIS), pilocarpine, colecalciferol (VITAMIN D), fish oil (OMEGA 3). Since the 14Jan2021 Pfizer COVID vaccine, the patient had left (L) 2nd Metatarsophalangeal (MTP) and right (R) 3rd MTP burning sensation on 15Jan2021 10:00 (like she had foot blister or stubbed a toe). Then, she had petechiae with discoloration on 16Jan2021 and 17Jan2021. No treatment was received for the events. The patient lab data included Covid PCR Test (Nasal Swab): negative on 15Jan2021. The outcome of events was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensation; foot blister; stubbed a toe; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284) at Left arm, intramuscular on 14Jan2021 16:45 at single dose for covid-19 immunisation. Medical history included Sjogren's, Raynaud, s/p Total abdominal hysterectomy (TAH)/Bilateral salpingo-oophorectomy (BSO) sex cord sclerosing stromal tumor, and known allergies: Sulfa. Patient did not have Covid prior vaccination. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), leflunomide, ciclosporin (RESTASIS), pilocarpine, colecalciferol (VITAMIN D), fish oil (OMEGA 3). Since the 14Jan2021 Pfizer COVID vaccine, the patient had left (L) 2nd Metatarsophalangeal (MTP) and right (R) 3rd MTP burning sensation on 15Jan2021 10:00 (like she had foot blister or stubbed a toe). Then, she had petechiae with discoloration on 16Jan2021 and 17Jan2021. No treatment was received for the events. The patient lab data included Covid PCR Test (Nasal Swab): negative on 15Jan2021. The outcome of events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Magnetic resonance imaging heart
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Heart rate
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Lip swelling, Paraesthesia oral, Throat irritation, Urticaria
Clinical narrative: The vaccine was administered on the following date: 1/19/21 and at approximately the following time: 1:00PM   The symptoms began 36 hours after administration of the vaccine.  The symptoms were: hives (itchy red raised rash - see photos), lip swelling and throat itching. Tried to treat at home with Benadryl but didn't improve so went to ED.  The treatment of the reaction was:   o Antihistamines: Benadryl  o Steroids: steroid in ED and 5 day course of prednisone o Epinephrine: 1x
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Throat irritation, Tryptase, Urticaria
Clinical narrative: The vaccine was administered on the following date: 1/19/21 and at approximately the following time: 1:00PM   The symptoms began 36 hours after administration of the vaccine.  The symptoms were: hives (itchy red raised rash - see photos), lip swelling and throat itching. Tried to treat at home with Benadryl but didn't improve so went to ED.  The treatment of the reaction was:   o Antihistamines: Benadryl  o Steroids: steroid in ED and 5 day course of prednisone o Epinephrine: 1x
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Nervousness, Swelling face, Swollen tongue
Clinical narrative: Shakes, tongue and lip sweeping, pain in stomach and headache
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Lip disorder, Tongue disorder, Tremor
Clinical narrative: Shakes, tongue and lip sweeping, pain in stomach and headache
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Catheterisation cardiac normal, Chest pain, Dizziness, Echocardiogram normal
Clinical narrative: chest pain; elevation of troponin level/increased levels of troponin; became weak and thought I was going to faint; became weak and thought I was going to faint; blood pressure was 171/ 104 or 114; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 21Jan2021 17:00 at single dose in left arm for covid-19 immunisation. Medical history included malignant melanoma; pernicious anemia, hypothyroidism, acute keratitis of both corneas of eye, osteopenia. Concomitant medication included nivolumab (OPDIVO). The patient had known allergies to doxycycline, tetracycline, erythromycin (reported as "erythromycin"), cefalexin (KEFLEX), hyoscine (SCOPOLAMINE), alendronate, ac cyclobenzaprin, influenza vaccine (FLUZONE) high dose (syr) in 2017 and retenol A. The patient had no Covid prior vaccination and did not underwent Covid test post vaccination. On 21Jan2021 17:30, the patient became weak and thought she was going to faint. She called the medical professional over and they brought her into a staged area for triage. She blood pressure was 171/104 or 114. She had chest pain. The EMT did and EKG, and started an IV. The ambulance was called and the patient was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. The patient was admitted to the hospital due to elevation of troponin level and chest pain for 2 days from 21Jan2021 to 23Jan2021. The following day on 22Jan2021, the patient saw her PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of troponin and chest pain. The cardiologist performed another EKG more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that the patient was given a nitro pill as her chest pain was between a 7 and a 8; a few minutes later the nurse asked about her pain level and it was a 3-4. The patient was given another nitro pill and her blood pressure drop. It result in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Troponin increased
Clinical narrative: chest pain; elevation of troponin level/increased levels of troponin; became weak and thought I was going to faint; became weak and thought I was going to faint; blood pressure was 171/ 104 or 114; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 21Jan2021 17:00 at single dose in left arm for covid-19 immunisation. Medical history included malignant melanoma; pernicious anemia, hypothyroidism, acute keratitis of both corneas of eye, osteopenia. Concomitant medication included nivolumab (OPDIVO). The patient had known allergies to doxycycline, tetracycline, erythromycin (reported as "erythromycin"), cefalexin (KEFLEX), hyoscine (SCOPOLAMINE), alendronate, ac cyclobenzaprin, influenza vaccine (FLUZONE) high dose (syr) in 2017 and retenol A. The patient had no Covid prior vaccination and did not underwent Covid test post vaccination. On 21Jan2021 17:30, the patient became weak and thought she was going to faint. She called the medical professional over and they brought her into a staged area for triage. She blood pressure was 171/104 or 114. She had chest pain. The EMT did and EKG, and started an IV. The ambulance was called and the patient was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. The patient was admitted to the hospital due to elevation of troponin level and chest pain for 2 days from 21Jan2021 to 23Jan2021. The following day on 22Jan2021, the patient saw her PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of troponin and chest pain. The cardiologist performed another EKG more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that the patient was given a nitro pill as her chest pain was between a 7 and a 8; a few minutes later the nurse asked about her pain level and it was a 3-4. The patient was given another nitro pill and her blood pressure drop. It result in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Troponin increased
Clinical narrative: chest pain; elevation of troponin level/increased levels of troponin; became weak and thought I was going to faint; became weak and thought I was going to faint; blood pressure was 171/ 104 or 114; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 21Jan2021 17:00 at single dose in left arm for covid-19 immunisation. Medical history included malignant melanoma; pernicious anemia, hypothyroidism, acute keratitis of both corneas of eye, osteopenia. Concomitant medication included nivolumab (OPDIVO). The patient had known allergies to doxycycline, tetracycline, erythromycin (reported as "erythromycin"), cefalexin (KEFLEX), hyoscine (SCOPOLAMINE), alendronate, ac cyclobenzaprin, influenza vaccine (FLUZONE) high dose (syr) in 2017 and retenol A. The patient had no Covid prior vaccination and did not underwent Covid test post vaccination. On 21Jan2021 17:30, the patient became weak and thought she was going to faint. She called the medical professional over and they brought her into a staged area for triage. She blood pressure was 171/104 or 114. She had chest pain. The EMT did and EKG, and started an IV. The ambulance was called and the patient was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. The patient was admitted to the hospital due to elevation of troponin level and chest pain for 2 days from 21Jan2021 to 23Jan2021. The following day on 22Jan2021, the patient saw her PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of troponin and chest pain. The cardiologist performed another EKG more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that the patient was given a nitro pill as her chest pain was between a 7 and a 8; a few minutes later the nurse asked about her pain level and it was a 3-4. The patient was given another nitro pill and her blood pressure drop. It result in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Blood test, Catheterisation cardiac normal, Chest pain
Clinical narrative: chest pain; elevation of troponin level/increased levels of troponin; became weak and thought I was going to faint; became weak and thought I was going to faint; blood pressure was 171/ 104 or 114; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 21Jan2021 17:00 at single dose in left arm for covid-19 immunisation. Medical history included malignant melanoma; pernicious anemia, hypothyroidism, acute keratitis of both corneas of eye, osteopenia. Concomitant medication included nivolumab (OPDIVO). The patient had known allergies to doxycycline, tetracycline, erythromycin (reported as "erythromycin"), cefalexin (KEFLEX), hyoscine (SCOPOLAMINE), alendronate, ac cyclobenzaprin, influenza vaccine (FLUZONE) high dose (syr) in 2017 and retenol A. The patient had no Covid prior vaccination and did not underwent Covid test post vaccination. On 21Jan2021 17:30, the patient became weak and thought she was going to faint. She called the medical professional over and they brought her into a staged area for triage. She blood pressure was 171/104 or 114. She had chest pain. The EMT did and EKG, and started an IV. The ambulance was called and the patient was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. The patient was admitted to the hospital due to elevation of troponin level and chest pain for 2 days from 21Jan2021 to 23Jan2021. The following day on 22Jan2021, the patient saw her PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of troponin and chest pain. The cardiologist performed another EKG more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that the patient was given a nitro pill as her chest pain was between a 7 and a 8; a few minutes later the nurse asked about her pain level and it was a 3-4. The patient was given another nitro pill and her blood pressure drop. It result in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram, Troponin increased
Clinical narrative: chest pain; elevation of troponin level/increased levels of troponin; became weak and thought I was going to faint; became weak and thought I was going to faint; blood pressure was 171/ 104 or 114; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 21Jan2021 17:00 at single dose in left arm for covid-19 immunisation. Medical history included malignant melanoma; pernicious anemia, hypothyroidism, acute keratitis of both corneas of eye, osteopenia. Concomitant medication included nivolumab (OPDIVO). The patient had known allergies to doxycycline, tetracycline, erythromycin (reported as "erythromycin"), cefalexin (KEFLEX), hyoscine (SCOPOLAMINE), alendronate, ac cyclobenzaprin, influenza vaccine (FLUZONE) high dose (syr) in 2017 and retenol A. The patient had no Covid prior vaccination and did not underwent Covid test post vaccination. On 21Jan2021 17:30, the patient became weak and thought she was going to faint. She called the medical professional over and they brought her into a staged area for triage. She blood pressure was 171/104 or 114. She had chest pain. The EMT did and EKG, and started an IV. The ambulance was called and the patient was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. The patient was admitted to the hospital due to elevation of troponin level and chest pain for 2 days from 21Jan2021 to 23Jan2021. The following day on 22Jan2021, the patient saw her PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of troponin and chest pain. The cardiologist performed another EKG more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that the patient was given a nitro pill as her chest pain was between a 7 and a 8; a few minutes later the nurse asked about her pain level and it was a 3-4. The patient was given another nitro pill and her blood pressure drop. It result in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Urticaria
Clinical narrative: Inflammation and skin welts noted in areas of clothing and watch contact with skin; Inflammation and skin welts noted in areas of clothing and watch contact with skin; acute swelling of lip without trauma; This is a spontaneous report from a contactable physician, the patient. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 12Jan2021 at 09:30 (at the age of 43-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, that patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received dose 1 of BNT162B2 on 29Dec2020 at 09:30, intramuscular in the right buttocks. On 15Jan2021 at 12:00, the patient experienced inflammation and skin welts in the areas of clothing and watch contact with skin; and developed acute swelling of the lip without trauma. Therapeutic measures were not taken and the events resulted in a physician or other healthcare professional office visit. The clinical outcome of the event skin inflammation, skin welts and lip swelling was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.