chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Brain fog; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 05Apr2021 (10:30) as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), allopurinol, omeprazole (PRILOSEC) and lorazepam. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 15Mar2021 (when the patient was 40 years old) for COVID-19 immunization. On 05Apr2021 (14:00), the patient had brain fog and dizziness. The events had resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, and were reported to be serious (causing disability or permanent damage). The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Myalgia, Nausea
Clinical narrative: On the 3rd day after receiving dose #2, I developed tightness in my chest.  I went to the ER, and was admitted for observation.  I was diagnosed with pericarditis.  I was released after 1 day.  I have an autoimmune condition, Sjögren?s syndrome.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis, SARS-CoV-2 test
Clinical narrative: On the 3rd day after receiving dose #2, I developed tightness in my chest.  I went to the ER, and was admitted for observation.  I was diagnosed with pericarditis.  I was released after 1 day.  I have an autoimmune condition, Sjögren?s syndrome.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Computerised tomogram thorax, Electrocardiogram, Full blood count
Clinical narrative: On the 3rd day after receiving dose #2, I developed tightness in my chest.  I went to the ER, and was admitted for observation.  I was diagnosed with pericarditis.  I was released after 1 day.  I have an autoimmune condition, Sjögren?s syndrome.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: On the 3rd day after receiving dose #2, I developed tightness in my chest.  I went to the ER, and was admitted for observation.  I was diagnosed with pericarditis.  I was released after 1 day.  I have an autoimmune condition, Sjögren?s syndrome.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Skin culture positive, Skin exfoliation, Stevens-Johnson syndrome
Clinical narrative: rash with multiple lesions on trunk with hyperpigmented rash with bullae and patches.  mucosal involvement including penile rash and oral involvement.  diagnosed with Stevens-Johnson syndrome
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Mucosal erosion, Oral mucosa erosion, Penile rash, Rash
Clinical narrative: rash with multiple lesions on trunk with hyperpigmented rash with bullae and patches.  mucosal involvement including penile rash and oral involvement.  diagnosed with Stevens-Johnson syndrome
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin hyperpigmentation, Stevens-Johnson syndrome, Trunk injury
Clinical narrative: rash with multiple lesions on trunk with hyperpigmented rash with bullae and patches.  mucosal involvement including penile rash and oral involvement.  diagnosed with Stevens-Johnson syndrome
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: Coughing; high respiratory rate; Headache; This is a spontaneous report from a contactable consumer (RN). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EP7533 and expiry date was not provided), via an unspecified route of administration, in right arm, on 04Apr2021, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient's medical history included hypertension, and Hashimoto's. The patient was allergic to shellfish and penicillin. Concomitant medications included Losartan and levothyroxine sodium (LEVOTHYROXINE). It was reported that on 04Apr2021 (25 minutes after vaccination) patient complained of headache and during observation. Patient had coughing. Patient's vitals at 10:19 AM included blood pressure 157/86, heart rate (HR) 60, and respiratory rate 200298. At 10:24 AM blood pressure 155/98 HR 58, and respiratory rate 200296. At 10:29 AM blood pressure 159/92, HR 59, and respiratory rate 200295. At 10:34 AM blood pressure 154/90, HR 61, and respiratory rate 180298. At 10:39 AM blood pressure 163/91, HR 69, and respiratory rate 200297. At 10:44 AM blood pressure 176/100, HR 57, and respiratory rate 200297. At 10:49 AM blood pressure 174/102, HR 65, and respiratory rate 200296. At 10:54 AM blood pressure 180/111, HR 71, and respiratory rate 200296. Patient's headache was increased. Emergency medical service (EMS) called and arrived at 10:54 AM. EMS transported patient to hospital. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Headache, cough and increased respiratory rate cannot be excluded.The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Cough, Headache, Heart rate, Respiratory rate
Clinical narrative: Coughing; high respiratory rate; Headache; This is a spontaneous report from a contactable consumer (RN). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EP7533 and expiry date was not provided), via an unspecified route of administration, in right arm, on 04Apr2021, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient's medical history included hypertension, and Hashimoto's. The patient was allergic to shellfish and penicillin. Concomitant medications included Losartan and levothyroxine sodium (LEVOTHYROXINE). It was reported that on 04Apr2021 (25 minutes after vaccination) patient complained of headache and during observation. Patient had coughing. Patient's vitals at 10:19 AM included blood pressure 157/86, heart rate (HR) 60, and respiratory rate 200298. At 10:24 AM blood pressure 155/98 HR 58, and respiratory rate 200296. At 10:29 AM blood pressure 159/92, HR 59, and respiratory rate 200295. At 10:34 AM blood pressure 154/90, HR 61, and respiratory rate 180298. At 10:39 AM blood pressure 163/91, HR 69, and respiratory rate 200297. At 10:44 AM blood pressure 176/100, HR 57, and respiratory rate 200297. At 10:49 AM blood pressure 174/102, HR 65, and respiratory rate 200296. At 10:54 AM blood pressure 180/111, HR 71, and respiratory rate 200296. Patient's headache was increased. Emergency medical service (EMS) called and arrived at 10:54 AM. EMS transported patient to hospital. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Headache, cough and increased respiratory rate cannot be excluded.The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory rate increased
Clinical narrative: Coughing; high respiratory rate; Headache; This is a spontaneous report from a contactable consumer (RN). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EP7533 and expiry date was not provided), via an unspecified route of administration, in right arm, on 04Apr2021, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient's medical history included hypertension, and Hashimoto's. The patient was allergic to shellfish and penicillin. Concomitant medications included Losartan and levothyroxine sodium (LEVOTHYROXINE). It was reported that on 04Apr2021 (25 minutes after vaccination) patient complained of headache and during observation. Patient had coughing. Patient's vitals at 10:19 AM included blood pressure 157/86, heart rate (HR) 60, and respiratory rate 200298. At 10:24 AM blood pressure 155/98 HR 58, and respiratory rate 200296. At 10:29 AM blood pressure 159/92, HR 59, and respiratory rate 200295. At 10:34 AM blood pressure 154/90, HR 61, and respiratory rate 180298. At 10:39 AM blood pressure 163/91, HR 69, and respiratory rate 200297. At 10:44 AM blood pressure 176/100, HR 57, and respiratory rate 200297. At 10:49 AM blood pressure 174/102, HR 65, and respiratory rate 200296. At 10:54 AM blood pressure 180/111, HR 71, and respiratory rate 200296. Patient's headache was increased. Emergency medical service (EMS) called and arrived at 10:54 AM. EMS transported patient to hospital. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Headache, cough and increased respiratory rate cannot be excluded.The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Body temperature increased, C-reactive protein increased, Chest discomfort, Chills
Clinical narrative: chest tightness/pain; chest tightness/pain; short of breath; nausea; headache; lethargy; temp 102.6; hard swollen lymph node right axilla; elevated troponin peaked at 9.6; myocarditis; This is a spontaneous report from a contactable consumer.  A 19-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: ER 8727, via an unspecified route of administration, administered in right arm on 03Apr2021 18:00 as single dose for Covid-19 immunisation. Medical history included asthma. There were no concomitant medications. On 04Apr2021, the patient experienced headache, lethargy, temperature 102.6, hard swollen lymph node right axilla. On 05Apr2021, signs and symptoms persisted with addition of nausea. On 06Apr2021, the patient experienced chest tightness/pain and shortness of breath. The patient went to ER on an unspecified date in 2021 with elevated troponin peaked at 9.6 hence heparin drip was started. The patient was admitted to hospital. On 09Apr2021, the patient was discharged with diagnosis of myocarditis. The outcome of the events was recovering.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Headache, Lymphadenopathy
Clinical narrative: chest tightness/pain; chest tightness/pain; short of breath; nausea; headache; lethargy; temp 102.6; hard swollen lymph node right axilla; elevated troponin peaked at 9.6; myocarditis; This is a spontaneous report from a contactable consumer.  A 19-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: ER 8727, via an unspecified route of administration, administered in right arm on 03Apr2021 18:00 as single dose for Covid-19 immunisation. Medical history included asthma. There were no concomitant medications. On 04Apr2021, the patient experienced headache, lethargy, temperature 102.6, hard swollen lymph node right axilla. On 05Apr2021, signs and symptoms persisted with addition of nausea. On 06Apr2021, the patient experienced chest tightness/pain and shortness of breath. The patient went to ER on an unspecified date in 2021 with elevated troponin peaked at 9.6 hence heparin drip was started. The patient was admitted to hospital. On 09Apr2021, the patient was discharged with diagnosis of myocarditis. The outcome of the events was recovering.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Nausea, Pain in extremity, Troponin increased
Clinical narrative: chest tightness/pain; chest tightness/pain; short of breath; nausea; headache; lethargy; temp 102.6; hard swollen lymph node right axilla; elevated troponin peaked at 9.6; myocarditis; This is a spontaneous report from a contactable consumer.  A 19-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: ER 8727, via an unspecified route of administration, administered in right arm on 03Apr2021 18:00 as single dose for Covid-19 immunisation. Medical history included asthma. There were no concomitant medications. On 04Apr2021, the patient experienced headache, lethargy, temperature 102.6, hard swollen lymph node right axilla. On 05Apr2021, signs and symptoms persisted with addition of nausea. On 06Apr2021, the patient experienced chest tightness/pain and shortness of breath. The patient went to ER on an unspecified date in 2021 with elevated troponin peaked at 9.6 hence heparin drip was started. The patient was admitted to hospital. On 09Apr2021, the patient was discharged with diagnosis of myocarditis. The outcome of the events was recovering.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chest discomfort, Chest pain, Dyspnoea, Headache
Clinical narrative: chest tightness/pain; chest tightness/pain; short of breath; nausea; headache; lethargy; temp 102.6; hard swollen lymph node right axilla; elevated troponin peaked at 9.6; myocarditis; This is a spontaneous report from a contactable consumer.  A 19-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: ER 8727, via an unspecified route of administration, administered in right arm on 03Apr2021 18:00 as single dose for Covid-19 immunisation. Medical history included asthma. There were no concomitant medications. On 04Apr2021, the patient experienced headache, lethargy, temperature 102.6, hard swollen lymph node right axilla. On 05Apr2021, signs and symptoms persisted with addition of nausea. On 06Apr2021, the patient experienced chest tightness/pain and shortness of breath. The patient went to ER on an unspecified date in 2021 with elevated troponin peaked at 9.6 hence heparin drip was started. The patient was admitted to hospital. On 09Apr2021, the patient was discharged with diagnosis of myocarditis. The outcome of the events was recovering.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Lymphadenopathy, Myocarditis, Nausea, Pyrexia
Clinical narrative: chest tightness/pain; chest tightness/pain; short of breath; nausea; headache; lethargy; temp 102.6; hard swollen lymph node right axilla; elevated troponin peaked at 9.6; myocarditis; This is a spontaneous report from a contactable consumer.  A 19-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: ER 8727, via an unspecified route of administration, administered in right arm on 03Apr2021 18:00 as single dose for Covid-19 immunisation. Medical history included asthma. There were no concomitant medications. On 04Apr2021, the patient experienced headache, lethargy, temperature 102.6, hard swollen lymph node right axilla. On 05Apr2021, signs and symptoms persisted with addition of nausea. On 06Apr2021, the patient experienced chest tightness/pain and shortness of breath. The patient went to ER on an unspecified date in 2021 with elevated troponin peaked at 9.6 hence heparin drip was started. The patient was admitted to hospital. On 09Apr2021, the patient was discharged with diagnosis of myocarditis. The outcome of the events was recovering.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Troponin, Troponin increased
Clinical narrative: chest tightness/pain; chest tightness/pain; short of breath; nausea; headache; lethargy; temp 102.6; hard swollen lymph node right axilla; elevated troponin peaked at 9.6; myocarditis; This is a spontaneous report from a contactable consumer.  A 19-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: ER 8727, via an unspecified route of administration, administered in right arm on 03Apr2021 18:00 as single dose for Covid-19 immunisation. Medical history included asthma. There were no concomitant medications. On 04Apr2021, the patient experienced headache, lethargy, temperature 102.6, hard swollen lymph node right axilla. On 05Apr2021, signs and symptoms persisted with addition of nausea. On 06Apr2021, the patient experienced chest tightness/pain and shortness of breath. The patient went to ER on an unspecified date in 2021 with elevated troponin peaked at 9.6 hence heparin drip was started. The patient was admitted to hospital. On 09Apr2021, the patient was discharged with diagnosis of myocarditis. The outcome of the events was recovering.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Blood test, Cardiac monitoring, Cardiac stress test
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Condition aggravated, Dizziness, Dyspepsia
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Fatigue, Frequent bowel movements, Headache
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Heart rate irregular, Myalgia, Nausea, Neck pain
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachyarrhythmia, Visual impairment
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abnormal faeces, Arthralgia, Chest pain, Dizziness
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Dyspnoea, Fatigue, Headache, Heart rate
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Malaise, Myalgia, Nausea, Neck pain
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Visual impairment
Clinical narrative: chest pain; neck pain; general muscle pain; joint pain; headaches; fatigue/malaise; fatigue/malaise; shortness of breath; lightheadedness; nausea; severe heartburn flare up; abdominal pain; digestive issues (urgent, but small stools); heart racing/palpitations; elevated heartrate; vision changes in the left eye; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:45 (at the age of 36years) as single dose for Covid-19 immunization. Medical history included heartburn and known allergies: Penicillin, alcohol; all from an unknown date and unknown if ongoing. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Concomitant medication included Ritual Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 (06:00 am), the patient experienced chest pain, neck pain, general muscle pain, joint pain, headaches, fatigue/malaise, some shortness of breath, lightheadedness, nausea, severe heartburn flare up, abdominal pain, digestive issues (urgent, but small stools), heart racing/palpitations, elevated heartrate, and vision changes in the left eye. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization. The patient was hospitalized from an unspecified date for 1 day. Treatment was received for the adverse events. There were many tests done/are being done. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient presented to the ED and was subsequently hospitalized on 2/12/2021 and 3/21/2021. Patient presented to the ED on 3/29/2021 and 3/31/2021. On 3/31/2021 he was hospitalized, and on 4/8/2021 he died.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine, Cerebral haemorrhage, Computerised tomogram head abnormal, Contusion, Epistaxis
Clinical narrative: Patient developed gum bleeding and petechiae several hours after the second vaccine dose was given. The next day she had hematuria and worsening bleeding and severe headache. She presented to hospital on 4/11/2021 and was found to have ITP and intracerebral hemorrhage.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Mouth haemorrhage, Platelet count decreased, Thrombosis, Tongue haemorrhage
Clinical narrative: Patient developed gum bleeding and petechiae several hours after the second vaccine dose was given. The next day she had hematuria and worsening bleeding and severe headache. She presented to hospital on 4/11/2021 and was found to have ITP and intracerebral hemorrhage.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Differential white blood cell count normal, Gingival bleeding, Haematuria
Clinical narrative: Patient developed gum bleeding and petechiae several hours after the second vaccine dose was given. The next day she had hematuria and worsening bleeding and severe headache. She presented to hospital on 4/11/2021 and was found to have ITP and intracerebral hemorrhage.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin normal, Headache, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Patient developed gum bleeding and petechiae several hours after the second vaccine dose was given. The next day she had hematuria and worsening bleeding and severe headache. She presented to hospital on 4/11/2021 and was found to have ITP and intracerebral hemorrhage.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy Left Side of Face; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration into left arm on 23Mar2021 10:00 (at the age of 51-year-old) as single dose for COVID-19 immunisation. Medical history included depression, anxiety, diabetes and obesity. Concomitant medications included duloxetine (DULOXETINE). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) into left arm on 02Mar2021 11:00 AM (at the age of 51-year-old) for COVID-19 immunisation. The patient experienced bell's palsy left side of face on 13Apr2021 12:00 PM. The patient was brought to the emergency room and received prednisone and anti-viral medication as treatment. Outcome of event was not recovered.  Information about lot and batch number was requested.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Sweet's syndrome developed after 2 weeks of first shot; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on arm Left on 07Mar2021 19:45 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication and therapy dates.  It was stated that Sweet's syndrome developed on 24Mar2021 (approximately after 2 weeks of first shot) as the patient had fever followed by severe rashes all over the body. The patient had negative nasal swab for COVID-19 on 24Mar2021, 01Apr201 and 08Apr2021. The patient was treated with prednisone taper and the patient was recovering from the events.   Information about the Lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute febrile neutrophilic dermatosis, SARS-CoV-2 test
Clinical narrative: Sweet's syndrome developed after 2 weeks of first shot; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on arm Left on 07Mar2021 19:45 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication and therapy dates.  It was stated that Sweet's syndrome developed on 24Mar2021 (approximately after 2 weeks of first shot) as the patient had fever followed by severe rashes all over the body. The patient had negative nasal swab for COVID-19 on 24Mar2021, 01Apr201 and 08Apr2021. The patient was treated with prednisone taper and the patient was recovering from the events.   Information about the Lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Musculoskeletal chest pain, Pulmonary embolism
Clinical narrative: pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm left on 05Apr2021 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. On Wednesday, 07Apr2021, the patient started experiencing pain on her stomach upper right side and had difficulty breathing. Thursday, 08Apr2021 the symptoms worsened so Friday morning, 09Apr2021, she went to Urgent Care and they sent her to the hospital ER. Friday evening, 09Apr2021 she has been admitted to the hospital with pulmonary embolism. She was released from the hospital on Sunday, 11Apr2021. Currently taking warfarin and enoxaparin injections. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09Apr2021. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm left on 05Apr2021 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. On Wednesday, 07Apr2021, the patient started experiencing pain on her stomach upper right side and had difficulty breathing. Thursday, 08Apr2021 the symptoms worsened so Friday morning, 09Apr2021, she went to Urgent Care and they sent her to the hospital ER. Friday evening, 09Apr2021 she has been admitted to the hospital with pulmonary embolism. She was released from the hospital on Sunday, 11Apr2021. Currently taking warfarin and enoxaparin injections. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09Apr2021. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram thorax abnormal, Dyspnoea, Pulmonary embolism
Clinical narrative: pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm left on 05Apr2021 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. On Wednesday, 07Apr2021, the patient started experiencing pain on her stomach upper right side and had difficulty breathing. Thursday, 08Apr2021 the symptoms worsened so Friday morning, 09Apr2021, she went to Urgent Care and they sent her to the hospital ER. Friday evening, 09Apr2021 she has been admitted to the hospital with pulmonary embolism. She was released from the hospital on Sunday, 11Apr2021. Currently taking warfarin and enoxaparin injections. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09Apr2021. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis, X-ray
Clinical narrative: pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm left on 05Apr2021 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. On Wednesday, 07Apr2021, the patient started experiencing pain on her stomach upper right side and had difficulty breathing. Thursday, 08Apr2021 the symptoms worsened so Friday morning, 09Apr2021, she went to Urgent Care and they sent her to the hospital ER. Friday evening, 09Apr2021 she has been admitted to the hospital with pulmonary embolism. She was released from the hospital on Sunday, 11Apr2021. Currently taking warfarin and enoxaparin injections. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09Apr2021. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.