chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram normal, Eye disorder, Facial paralysis, Hypoaesthesia
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer reported for herself. A 41-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 30Apr2021 10:00 for Covid-19 immunization. Medical history and concomitant drug were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 for Covid-19 immunization. The patient reported events diagnosed as Bell's Palsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye. The adverse event started since 14May2021. Treatment included prescription of a seven-day course of Prednisone, etc. The adverse event result in Emergency room/department or urgent care. Outcome of the event was not resolved. Since the vaccination, the patient has not been tested for COVID-19. The report was not assessed as serious.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test normal
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer reported for herself. A 41-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 30Apr2021 10:00 for Covid-19 immunization. Medical history and concomitant drug were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 for Covid-19 immunization. The patient reported events diagnosed as Bell's Palsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye. The adverse event started since 14May2021. Treatment included prescription of a seven-day course of Prednisone, etc. The adverse event result in Emergency room/department or urgent care. Outcome of the event was not resolved. Since the vaccination, the patient has not been tested for COVID-19. The report was not assessed as serious.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer reported for herself. A 41-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 30Apr2021 10:00 for Covid-19 immunization. Medical history and concomitant drug were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 for Covid-19 immunization. The patient reported events diagnosed as Bell's Palsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye. The adverse event started since 14May2021. Treatment included prescription of a seven-day course of Prednisone, etc. The adverse event result in Emergency room/department or urgent care. Outcome of the event was not resolved. Since the vaccination, the patient has not been tested for COVID-19. The report was not assessed as serious.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count normal, Full blood count normal, Loss of consciousness, Metabolic function test, Troponin I normal
Clinical narrative: I passed out; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER 8737), administered in right arm, on 13Apr2021 at 14:30 (at the age of 59-years-old) at unknown, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included known allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included paroxetine, ciclosporin (RESTASIS), fluticasone propionate (FLONASE), vitamins nos (MULTIVITAMIN); all reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies. The patient passed out on 14Apr2021 at 03:00. The event was reported as non-serious, required emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse event and included treatment with intravenous fluids. The patient was recovering from the event.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis normal
Clinical narrative: I passed out; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER 8737), administered in right arm, on 13Apr2021 at 14:30 (at the age of 59-years-old) at unknown, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included known allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included paroxetine, ciclosporin (RESTASIS), fluticasone propionate (FLONASE), vitamins nos (MULTIVITAMIN); all reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies. The patient passed out on 14Apr2021 at 03:00. The event was reported as non-serious, required emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse event and included treatment with intravenous fluids. The patient was recovering from the event.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: I passed out; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER 8737), administered in right arm, on 13Apr2021 at 14:30 (at the age of 59-years-old) at unknown, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included known allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included paroxetine, ciclosporin (RESTASIS), fluticasone propionate (FLONASE), vitamins nos (MULTIVITAMIN); all reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies. The patient passed out on 14Apr2021 at 03:00. The event was reported as non-serious, required emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse event and included treatment with intravenous fluids. The patient was recovering from the event.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Bacterial test negative, Elliptocytosis hereditary, Emergency care, Fatigue
Clinical narrative: hemolytic anemia; hereditary elliptocytosis; This is a spontaneous report from contactable consumer (patient) reported for himself that a 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included blood disorder, mild asthma. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA inhaler); montelukast sodium (SINGULAIR). Patient previously received flu shot on 26Feb2021 for immunization. Patient experienced hemalytic anemia on 13Mar2021 following the 1st dose of Pfizer covid vaccine. Required a 3-day hospital stay. Determined to have hereditary elliptocytosis. Immune response from Pfizer due to underlying blood disorder caused this (now diagnosed with hereditary elliptocytosis). Patient was told to skip the second shot, but need guidance and have no one to refer to as his condition is very rare and there is not enough information with the vaccine. Patient also required urgent care and doctor or other healthcare professional office/clinic visit.  No treatment was received. Patient did not have COVID prior vaccination. Patient has been tested COVID by nasal swab post vaccination on 22Mar2021 and revealed negative. Patient had a blood antibodies test for COVID on 05May2021 and revealed negative. Outcome of the events was recovered.   Information on batch and lot number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemolytic anaemia, Jaundice, Laboratory test normal, Nausea, Night sweats
Clinical narrative: hemolytic anemia; hereditary elliptocytosis; This is a spontaneous report from contactable consumer (patient) reported for himself that a 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included blood disorder, mild asthma. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA inhaler); montelukast sodium (SINGULAIR). Patient previously received flu shot on 26Feb2021 for immunization. Patient experienced hemalytic anemia on 13Mar2021 following the 1st dose of Pfizer covid vaccine. Required a 3-day hospital stay. Determined to have hereditary elliptocytosis. Immune response from Pfizer due to underlying blood disorder caused this (now diagnosed with hereditary elliptocytosis). Patient was told to skip the second shot, but need guidance and have no one to refer to as his condition is very rare and there is not enough information with the vaccine. Patient also required urgent care and doctor or other healthcare professional office/clinic visit.  No treatment was received. Patient did not have COVID prior vaccination. Patient has been tested COVID by nasal swab post vaccination on 22Mar2021 and revealed negative. Patient had a blood antibodies test for COVID on 05May2021 and revealed negative. Outcome of the events was recovered.   Information on batch and lot number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Viral test negative
Clinical narrative: hemolytic anemia; hereditary elliptocytosis; This is a spontaneous report from contactable consumer (patient) reported for himself that a 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included blood disorder, mild asthma. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA inhaler); montelukast sodium (SINGULAIR). Patient previously received flu shot on 26Feb2021 for immunization. Patient experienced hemalytic anemia on 13Mar2021 following the 1st dose of Pfizer covid vaccine. Required a 3-day hospital stay. Determined to have hereditary elliptocytosis. Immune response from Pfizer due to underlying blood disorder caused this (now diagnosed with hereditary elliptocytosis). Patient was told to skip the second shot, but need guidance and have no one to refer to as his condition is very rare and there is not enough information with the vaccine. Patient also required urgent care and doctor or other healthcare professional office/clinic visit.  No treatment was received. Patient did not have COVID prior vaccination. Patient has been tested COVID by nasal swab post vaccination on 22Mar2021 and revealed negative. Patient had a blood antibodies test for COVID on 05May2021 and revealed negative. Outcome of the events was recovered.   Information on batch and lot number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Elliptocytosis hereditary, Haemolytic anaemia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: hemolytic anemia; hereditary elliptocytosis; This is a spontaneous report from contactable consumer (patient) reported for himself that a 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included blood disorder, mild asthma. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA inhaler); montelukast sodium (SINGULAIR). Patient previously received flu shot on 26Feb2021 for immunization. Patient experienced hemalytic anemia on 13Mar2021 following the 1st dose of Pfizer covid vaccine. Required a 3-day hospital stay. Determined to have hereditary elliptocytosis. Immune response from Pfizer due to underlying blood disorder caused this (now diagnosed with hereditary elliptocytosis). Patient was told to skip the second shot, but need guidance and have no one to refer to as his condition is very rare and there is not enough information with the vaccine. Patient also required urgent care and doctor or other healthcare professional office/clinic visit.  No treatment was received. Patient did not have COVID prior vaccination. Patient has been tested COVID by nasal swab post vaccination on 22Mar2021 and revealed negative. Patient had a blood antibodies test for COVID on 05May2021 and revealed negative. Outcome of the events was recovered.   Information on batch and lot number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Myocarditis, Nausea, Pain
Clinical narrative: woke today, 19May at 1 am with bad chest pain and tingling down his arm; woke today, 19May at 1 am with bad chest pain and tingling down his arm; pericarditis; myocarditis; He still felt off on Tuesday; then felt malaise later in the day; This is a spontaneous report from a non-contactable consumer. A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for covid-19 immunisation. Clinical course, after vaccination, patient felt fine most of 16May2021, and then felt malaise later on 16May2021, and took off from work on 17May2021. He still felt off on 18May2021 and woke on 19May2021 at 1 am with bad chest pain and tingling down his arm. He was admitted. Patient was diagnosed with myocarditis and pericarditis. His tropic level was 11. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleurisy, Sleep disorder
Clinical narrative: woke today, 19May at 1 am with bad chest pain and tingling down his arm; woke today, 19May at 1 am with bad chest pain and tingling down his arm; pericarditis; myocarditis; He still felt off on Tuesday; then felt malaise later in the day; This is a spontaneous report from a non-contactable consumer. A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for covid-19 immunisation. Clinical course, after vaccination, patient felt fine most of 16May2021, and then felt malaise later on 16May2021, and took off from work on 17May2021. He still felt off on 18May2021 and woke on 19May2021 at 1 am with bad chest pain and tingling down his arm. He was admitted. Patient was diagnosed with myocarditis and pericarditis. His tropic level was 11. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Feeling abnormal, Laboratory test, Malaise, Myocarditis
Clinical narrative: woke today, 19May at 1 am with bad chest pain and tingling down his arm; woke today, 19May at 1 am with bad chest pain and tingling down his arm; pericarditis; myocarditis; He still felt off on Tuesday; then felt malaise later in the day; This is a spontaneous report from a non-contactable consumer. A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for covid-19 immunisation. Clinical course, after vaccination, patient felt fine most of 16May2021, and then felt malaise later on 16May2021, and took off from work on 17May2021. He still felt off on 18May2021 and woke on 19May2021 at 1 am with bad chest pain and tingling down his arm. He was admitted. Patient was diagnosed with myocarditis and pericarditis. His tropic level was 11. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pericarditis
Clinical narrative: woke today, 19May at 1 am with bad chest pain and tingling down his arm; woke today, 19May at 1 am with bad chest pain and tingling down his arm; pericarditis; myocarditis; He still felt off on Tuesday; then felt malaise later in the day; This is a spontaneous report from a non-contactable consumer. A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for covid-19 immunisation. Clinical course, after vaccination, patient felt fine most of 16May2021, and then felt malaise later on 16May2021, and took off from work on 17May2021. He still felt off on 18May2021 and woke on 19May2021 at 1 am with bad chest pain and tingling down his arm. He was admitted. Patient was diagnosed with myocarditis and pericarditis. His tropic level was 11. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Gastrointestinal inflammation, Scan with contrast
Clinical narrative: Extreme abdominal pain with inflammation of the intestines; Extreme abdominal pain with inflammation of the intestines; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EP6955, at the age of 38-year, on 13May2021 13:00 at single dose in left arm for COVID-19 immunization. Medical history included crohns disease, allergies to sulfa and pristique. The patient had no covid prior vaccination. The patient had not tested Covid post vaccination. Concomitant medications included omeprazole (PROTONIX) and paroxetine hydrochloride (PAXIL). The patient had not received other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, Lot number ER8732, on 22Apr2021 13:00 in right arm. The patient experienced Extreme abdominal pain with inflammation of the intestines on 14May2021 12:00. Both events resulted in Emergency room/department or urgent care and Hospitalization. Duration of hospitalization was 4 days. Treatment included steroids, antibiotics, fluids, pain medicine. The outcome of both events was resolving.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Extreme abdominal pain with inflammation of the intestines; Extreme abdominal pain with inflammation of the intestines; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EP6955, at the age of 38-year, on 13May2021 13:00 at single dose in left arm for COVID-19 immunization. Medical history included crohns disease, allergies to sulfa and pristique. The patient had no covid prior vaccination. The patient had not tested Covid post vaccination. Concomitant medications included omeprazole (PROTONIX) and paroxetine hydrochloride (PAXIL). The patient had not received other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, Lot number ER8732, on 22Apr2021 13:00 in right arm. The patient experienced Extreme abdominal pain with inflammation of the intestines on 14May2021 12:00. Both events resulted in Emergency room/department or urgent care and Hospitalization. Duration of hospitalization was 4 days. Treatment included steroids, antibiotics, fluids, pain medicine. The outcome of both events was resolving.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Gastrointestinal inflammation
Clinical narrative: Extreme abdominal pain with inflammation of the intestines; Extreme abdominal pain with inflammation of the intestines; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EP6955, at the age of 38-year, on 13May2021 13:00 at single dose in left arm for COVID-19 immunization. Medical history included crohns disease, allergies to sulfa and pristique. The patient had no covid prior vaccination. The patient had not tested Covid post vaccination. Concomitant medications included omeprazole (PROTONIX) and paroxetine hydrochloride (PAXIL). The patient had not received other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, Lot number ER8732, on 22Apr2021 13:00 in right arm. The patient experienced Extreme abdominal pain with inflammation of the intestines on 14May2021 12:00. Both events resulted in Emergency room/department or urgent care and Hospitalization. Duration of hospitalization was 4 days. Treatment included steroids, antibiotics, fluids, pain medicine. The outcome of both events was resolving.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Inflammation
Clinical narrative: having a heart attack might feel like; tightening around upper body especially around the base of heart; inflammation; heart beat became rapid; short of breath; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 18May2021 04:15 PM (Lot Number: EW0165) at single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and migraines/psoriasis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in right arm on 27Apr2021 04:15 PM (Lot Number: EW0175) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tightening around upper body especially around the base of heart, accompanied by inflammation. Her heart beat became rapid and she was short of breath. The event start date and time was reported as 18May2021 07:30 PM. It was also reported this happened "4.5 hours after injection". The event lasted 25 minutes. The patient felt what she assumed having a heart attack might feel like. The events were reported as non-serious. The patient did not receive treatment. The outcome of event was resolved. The patient has not been tested for COVID-19 since the vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased, Inflammation
Clinical narrative: having a heart attack might feel like; tightening around upper body especially around the base of heart; inflammation; heart beat became rapid; short of breath; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 18May2021 04:15 PM (Lot Number: EW0165) at single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and migraines/psoriasis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in right arm on 27Apr2021 04:15 PM (Lot Number: EW0175) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tightening around upper body especially around the base of heart, accompanied by inflammation. Her heart beat became rapid and she was short of breath. The event start date and time was reported as 18May2021 07:30 PM. It was also reported this happened "4.5 hours after injection". The event lasted 25 minutes. The patient felt what she assumed having a heart attack might feel like. The events were reported as non-serious. The patient did not receive treatment. The outcome of event was resolved. The patient has not been tested for COVID-19 since the vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: having a heart attack might feel like; tightening around upper body especially around the base of heart; inflammation; heart beat became rapid; short of breath; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 18May2021 04:15 PM (Lot Number: EW0165) at single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and migraines/psoriasis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in right arm on 27Apr2021 04:15 PM (Lot Number: EW0175) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tightening around upper body especially around the base of heart, accompanied by inflammation. Her heart beat became rapid and she was short of breath. The event start date and time was reported as 18May2021 07:30 PM. It was also reported this happened "4.5 hours after injection". The event lasted 25 minutes. The patient felt what she assumed having a heart attack might feel like. The events were reported as non-serious. The patient did not receive treatment. The outcome of event was resolved. The patient has not been tested for COVID-19 since the vaccination.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Pericarditis, Troponin increased
Clinical narrative: Woke up with severe chest pain two days after receiving the vaccine. Was taken to the ER and was admitted for elevated enzyme level and pain.  Inflammation around the heart.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Computerised tomogram thorax abnormal, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: Woke up with severe chest pain two days after receiving the vaccine. Was taken to the ER and was admitted for elevated enzyme level and pain.  Inflammation around the heart.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myocardial necrosis marker increased, Pericarditis
Clinical narrative: Woke up with severe chest pain two days after receiving the vaccine. Was taken to the ER and was admitted for elevated enzyme level and pain.  Inflammation around the heart.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure decreased, Blood pressure measurement, Body temperature, Chest X-ray
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Disturbance in attention, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Laboratory test, Laboratory test abnormal, Pain, Peripheral swelling
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Chest X-ray, Chest pain, Condition aggravated
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Deafness unilateral, Diarrhoea, Fatigue, Full blood count
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Insomnia, Joint swelling, Myalgia, Neutrophil count abnormal
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet disorder, Pyrexia, Red blood cell sedimentation rate, Thinking abnormal, Weight decreased
Clinical narrative: Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: symptoms got worse and are just kind of staying the same now; throwing up; Vertigo; Dizziness; Nausea; This is a spontaneous report from a contactable consumer. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0175), via intramuscular, administered in arm left (shoulder) on 24May2021 at 16:00 (at the age of 20-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included seasonal allergy. Family medical history included "his mom has Meniere's disease, it comes in rare spurts". Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) 2 sprays per nostril daily in the morning  and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) 1 tablet by mouth every morning, both started on an unspecified date (been using them since he was like 12 years old), ongoing, taken for seasonal allergy. The patient previously received first dose of bnt162b2 (Lot Number: EW0176, Expiry date: unknown), administered in left shoulder on 03May2021 at about 16:00 for COVID-19 immunization and experienced soreness. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient reported that he was having really bad side effects. He clarified that he had bad vertigo such that he could not do anything, but lay in the bed without getting dizzy. The dizziness was so bad that if he ate sitting up, he got nauseous and threw it all up. He reported that his symptoms all came on together. On 25May2021, after he ate, he felt like he could throw up but did not. On 26May2021, the patient ended up throwing up his dinner. He took Tylenol because it was recommended on 25May2021 and 26May2021. On 27May2021, his symptoms got worse and were just kind of staying the same. The nausea was if he moved his head around for a while like when walking, sitting up straight, or moving around for a while. Laying down was the only thing that did not make him feel sick. On the same day, he went to the emergency room and they diagnosed him with vertigo, but they did not know what was wrong. They prescribed him Meclizine for the dizziness. He was taking 1 tablet 3 times a day by mouth. The events dizziness and vertigo resulted in emergency room but not visited physician office. The patient did not undergo any relevant tests. The outcome of all the events was not recovered.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: symptoms got worse and are just kind of staying the same now; throwing up; Vertigo; Dizziness; Nausea; This is a spontaneous report from a contactable consumer. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0175), via intramuscular, administered in arm left (shoulder) on 24May2021 at 16:00 (at the age of 20-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included seasonal allergy. Family medical history included "his mom has Meniere's disease, it comes in rare spurts". Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) 2 sprays per nostril daily in the morning  and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) 1 tablet by mouth every morning, both started on an unspecified date (been using them since he was like 12 years old), ongoing, taken for seasonal allergy. The patient previously received first dose of bnt162b2 (Lot Number: EW0176, Expiry date: unknown), administered in left shoulder on 03May2021 at about 16:00 for COVID-19 immunization and experienced soreness. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient reported that he was having really bad side effects. He clarified that he had bad vertigo such that he could not do anything, but lay in the bed without getting dizzy. The dizziness was so bad that if he ate sitting up, he got nauseous and threw it all up. He reported that his symptoms all came on together. On 25May2021, after he ate, he felt like he could throw up but did not. On 26May2021, the patient ended up throwing up his dinner. He took Tylenol because it was recommended on 25May2021 and 26May2021. On 27May2021, his symptoms got worse and were just kind of staying the same. The nausea was if he moved his head around for a while like when walking, sitting up straight, or moving around for a while. Laying down was the only thing that did not make him feel sick. On the same day, he went to the emergency room and they diagnosed him with vertigo, but they did not know what was wrong. They prescribed him Meclizine for the dizziness. He was taking 1 tablet 3 times a day by mouth. The events dizziness and vertigo resulted in emergency room but not visited physician office. The patient did not undergo any relevant tests. The outcome of all the events was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Myocardial necrosis marker increased
Clinical narrative: Fever of a 101.8 dizziness chest pains shortness of breath chills sweats hospitalized or elevated enzymes and heart
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Fever of a 101.8 dizziness chest pains shortness of breath chills sweats hospitalized or elevated enzymes and heart
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Laboratory test, Myocardial necrosis marker increased, Pyrexia, Ultrasound scan
Clinical narrative: Fever of a 101.8 dizziness chest pains shortness of breath chills sweats hospitalized or elevated enzymes and heart
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Fatality. Death occurred
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient was diagonised with blood clot few days after J&J covid vaccine. Patient was treated in the hospital and doing better.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood disorder, Thrombosis
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient was diagonised with blood clot few days after J&J covid vaccine. Patient was treated in the hospital and doing better.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, Unevaluable event
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ELEVATED C-REACTIVE PROTEIN OF 54.4 POST VACCINE; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included asplenia at 30 years due to idiopathic thrombocytopenic purpura, and concurrent conditions included polymyalgia rheumatic (2 years ago) and received steroids for treatment. The patient's immunity was not good since she was 60 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included prednisone 10 milligram (since 2 years). On an unspecified date in 2021 (after vaccination), the patient experienced very mild effects which included headache, muscle aches and elevated C-reactive protein of 54.4 (unit not reported). On an unspecified date, the patient had antibody test for two times which was negative (suspected immunological vaccine failure). The patient's laboratory data included: C-reactive protein increased (NR: not provided) 54.4 (unit not reported), and SARS-CoV-2 antibody test (negative) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle aches, elevated c-reactive protein of 54.4 post vaccine and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210601375-covid-19 vaccine ad26.cov2.s-Suspected Immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein, Fatigue, Headache, Malaise
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ELEVATED C-REACTIVE PROTEIN OF 54.4 POST VACCINE; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included asplenia at 30 years due to idiopathic thrombocytopenic purpura, and concurrent conditions included polymyalgia rheumatic (2 years ago) and received steroids for treatment. The patient's immunity was not good since she was 60 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included prednisone 10 milligram (since 2 years). On an unspecified date in 2021 (after vaccination), the patient experienced very mild effects which included headache, muscle aches and elevated C-reactive protein of 54.4 (unit not reported). On an unspecified date, the patient had antibody test for two times which was negative (suspected immunological vaccine failure). The patient's laboratory data included: C-reactive protein increased (NR: not provided) 54.4 (unit not reported), and SARS-CoV-2 antibody test (negative) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle aches, elevated c-reactive protein of 54.4 post vaccine and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210601375-covid-19 vaccine ad26.cov2.s-Suspected Immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ELEVATED C-REACTIVE PROTEIN OF 54.4 POST VACCINE; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included asplenia at 30 years due to idiopathic thrombocytopenic purpura, and concurrent conditions included polymyalgia rheumatic (2 years ago) and received steroids for treatment. The patient's immunity was not good since she was 60 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included prednisone 10 milligram (since 2 years). On an unspecified date in 2021 (after vaccination), the patient experienced very mild effects which included headache, muscle aches and elevated C-reactive protein of 54.4 (unit not reported). On an unspecified date, the patient had antibody test for two times which was negative (suspected immunological vaccine failure). The patient's laboratory data included: C-reactive protein increased (NR: not provided) 54.4 (unit not reported), and SARS-CoV-2 antibody test (negative) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle aches, elevated c-reactive protein of 54.4 post vaccine and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210601375-covid-19 vaccine ad26.cov2.s-Suspected Immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Headache, Myalgia, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ELEVATED C-REACTIVE PROTEIN OF 54.4 POST VACCINE; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included asplenia at 30 years due to idiopathic thrombocytopenic purpura, and concurrent conditions included polymyalgia rheumatic (2 years ago) and received steroids for treatment. The patient's immunity was not good since she was 60 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included prednisone 10 milligram (since 2 years). On an unspecified date in 2021 (after vaccination), the patient experienced very mild effects which included headache, muscle aches and elevated C-reactive protein of 54.4 (unit not reported). On an unspecified date, the patient had antibody test for two times which was negative (suspected immunological vaccine failure). The patient's laboratory data included: C-reactive protein increased (NR: not provided) 54.4 (unit not reported), and SARS-CoV-2 antibody test (negative) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle aches, elevated c-reactive protein of 54.4 post vaccine and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210601375-covid-19 vaccine ad26.cov2.s-Suspected Immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS