chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood gases, Chest X-ray, Computerised tomogram thorax, Dyspnoea
Clinical narrative: anaphylaxis; acute respiratory failure; short of breath; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 14Apr2021 10:00 (at age 52 years old) (Lot Number: EW0151) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included diabetes mellitus (DM), hyperlipidemia, hypothyroidism, morbid obesity, mild mitral regurgitation (MR), hypertension (HTN), and known allergies to latex, all from unspecified date date and unknown if ongoing. No covid prior to vaccination. Covid tested post vaccination on 14Apr2021 with negative result. Concomitant medications included carvedilol (CARVEDILOL 1A PHARMA); lisinopril; fenofibrate; sitagliptin (JANUVIA); insulin lispro (HUMALOG); levothyroxine sodium (SYNTHROID); metformin; amlodipine besilate (NORVASC); vitamin d nos; magnesium; pravastatin; ASA; cinnamomum verum (CINNAMON); ferrous sulfate; all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 24Mar2021 (at age 52 years old) (lot no: ER8753 or ER 8733??) for COVID-19 immunization. No other vaccine in four weeks. The patient received second Pfizer COVID injection at 10 am. She waited 15 minutes then left facility. Within the next 5-10 minutes she became short of breath. She went to ER around 10:45 am and treated for anaphylaxis. She was put on the vent by 11 am or so for acute respiratory failure. She was negative for COVID, pulmonary emboli, and pneumonia. She had to be transferred to higher acuity hospital by critical care ambulance. She now is in ICU at a hospital on ventilator. The events occurred on 14Apr2021 at 10:30 AM. The events results in emergency room/department or urgent care, hospitalization. Treatment for events was reported as medical ER treatment then transferred to a hospital. The patient had not recovered from the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Myocardial necrosis marker, Respiratory failure
Clinical narrative: anaphylaxis; acute respiratory failure; short of breath; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 14Apr2021 10:00 (at age 52 years old) (Lot Number: EW0151) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included diabetes mellitus (DM), hyperlipidemia, hypothyroidism, morbid obesity, mild mitral regurgitation (MR), hypertension (HTN), and known allergies to latex, all from unspecified date date and unknown if ongoing. No covid prior to vaccination. Covid tested post vaccination on 14Apr2021 with negative result. Concomitant medications included carvedilol (CARVEDILOL 1A PHARMA); lisinopril; fenofibrate; sitagliptin (JANUVIA); insulin lispro (HUMALOG); levothyroxine sodium (SYNTHROID); metformin; amlodipine besilate (NORVASC); vitamin d nos; magnesium; pravastatin; ASA; cinnamomum verum (CINNAMON); ferrous sulfate; all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 24Mar2021 (at age 52 years old) (lot no: ER8753 or ER 8733??) for COVID-19 immunization. No other vaccine in four weeks. The patient received second Pfizer COVID injection at 10 am. She waited 15 minutes then left facility. Within the next 5-10 minutes she became short of breath. She went to ER around 10:45 am and treated for anaphylaxis. She was put on the vent by 11 am or so for acute respiratory failure. She was negative for COVID, pulmonary emboli, and pneumonia. She had to be transferred to higher acuity hospital by critical care ambulance. She now is in ICU at a hospital on ventilator. The events occurred on 14Apr2021 at 10:30 AM. The events results in emergency room/department or urgent care, hospitalization. Treatment for events was reported as medical ER treatment then transferred to a hospital. The patient had not recovered from the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test negative
Clinical narrative: anaphylaxis; acute respiratory failure; short of breath; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 14Apr2021 10:00 (at age 52 years old) (Lot Number: EW0151) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included diabetes mellitus (DM), hyperlipidemia, hypothyroidism, morbid obesity, mild mitral regurgitation (MR), hypertension (HTN), and known allergies to latex, all from unspecified date date and unknown if ongoing. No covid prior to vaccination. Covid tested post vaccination on 14Apr2021 with negative result. Concomitant medications included carvedilol (CARVEDILOL 1A PHARMA); lisinopril; fenofibrate; sitagliptin (JANUVIA); insulin lispro (HUMALOG); levothyroxine sodium (SYNTHROID); metformin; amlodipine besilate (NORVASC); vitamin d nos; magnesium; pravastatin; ASA; cinnamomum verum (CINNAMON); ferrous sulfate; all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 24Mar2021 (at age 52 years old) (lot no: ER8753 or ER 8733??) for COVID-19 immunization. No other vaccine in four weeks. The patient received second Pfizer COVID injection at 10 am. She waited 15 minutes then left facility. Within the next 5-10 minutes she became short of breath. She went to ER around 10:45 am and treated for anaphylaxis. She was put on the vent by 11 am or so for acute respiratory failure. She was negative for COVID, pulmonary emboli, and pneumonia. She had to be transferred to higher acuity hospital by critical care ambulance. She now is in ICU at a hospital on ventilator. The events occurred on 14Apr2021 at 10:30 AM. The events results in emergency room/department or urgent care, hospitalization. Treatment for events was reported as medical ER treatment then transferred to a hospital. The patient had not recovered from the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Anaphylactic reaction, Dyspnoea, SARS-CoV-2 test
Clinical narrative: anaphylaxis; acute respiratory failure; short of breath; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 14Apr2021 10:00 (at age 52 years old) (Lot Number: EW0151) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included diabetes mellitus (DM), hyperlipidemia, hypothyroidism, morbid obesity, mild mitral regurgitation (MR), hypertension (HTN), and known allergies to latex, all from unspecified date date and unknown if ongoing. No covid prior to vaccination. Covid tested post vaccination on 14Apr2021 with negative result. Concomitant medications included carvedilol (CARVEDILOL 1A PHARMA); lisinopril; fenofibrate; sitagliptin (JANUVIA); insulin lispro (HUMALOG); levothyroxine sodium (SYNTHROID); metformin; amlodipine besilate (NORVASC); vitamin d nos; magnesium; pravastatin; ASA; cinnamomum verum (CINNAMON); ferrous sulfate; all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 24Mar2021 (at age 52 years old) (lot no: ER8753 or ER 8733??) for COVID-19 immunization. No other vaccine in four weeks. The patient received second Pfizer COVID injection at 10 am. She waited 15 minutes then left facility. Within the next 5-10 minutes she became short of breath. She went to ER around 10:45 am and treated for anaphylaxis. She was put on the vent by 11 am or so for acute respiratory failure. She was negative for COVID, pulmonary emboli, and pneumonia. She had to be transferred to higher acuity hospital by critical care ambulance. She now is in ICU at a hospital on ventilator. The events occurred on 14Apr2021 at 10:30 AM. The events results in emergency room/department or urgent care, hospitalization. Treatment for events was reported as medical ER treatment then transferred to a hospital. The patient had not recovered from the events.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Dizziness, Hypersensitivity, Nausea
Clinical narrative: Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Post-traumatic stress disorder, Pulse abnormal
Clinical narrative: Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Loss of consciousness, Nausea, Pallor
Clinical narrative: Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Tinnitus, Vision blurred, Vital capacity
Clinical narrative: Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Left side of face is paralyzed,bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (61-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. The patient experienced left side of face is paralyzed, bell's palsy (Paralysis on the Left part of the Face) on 14Apr2021 with outcome of not recovered. No treatment was given.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Left side of face is paralyzed,bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (61-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. The patient experienced left side of face is paralyzed, bell's palsy (Paralysis on the Left part of the Face) on 14Apr2021 with outcome of not recovered. No treatment was given.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Paraesthesia, Pharyngeal paraesthesia, Pruritus, Throat irritation
Clinical narrative: Throat swelling, difficult to swallow.  I left Kroger about 15 min after vaccination.  I ended up going back in due to symptoms and was given an injection of Benedryl.  Symptoms starting reducing shortly after.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: Throat swelling, difficult to swallow.  I left Kroger about 15 min after vaccination.  I ended up going back in due to symptoms and was given an injection of Benedryl.  Symptoms starting reducing shortly after.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood urine present, Pain in extremity
Clinical narrative: This  96  year old female received the Covid shot on   3/15/21      and went to the ED on   3/29/21    and  again on 4/22/21 and was admitted  on   4/22/21     with weakness, leg pain, blood in urine, displaced transverse fracture of shaft of right femur and died on  4/23/21 .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood urine present, Death, Femur fracture, Pain in extremity
Clinical narrative: This  96  year old female received the Covid shot on   3/15/21      and went to the ED on   3/29/21    and  again on 4/22/21 and was admitted  on   4/22/21     with weakness, leg pain, blood in urine, displaced transverse fracture of shaft of right femur and died on  4/23/21 .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lipase increased, Pancreatitis
Clinical narrative: Acute Pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 08Mar2021 at 10:00 (at the age of 46-years-old) (Batch/Lot Number: EN6205) as a single dose and dose 2 via an unspecified route of administration, administered in the left arm on 07Apr2021 at 09:45 (at the age of 46-years-old)  (Batch/Lot Number: ER8729) as a single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 22Mar2021 with a negative result and via nasal swab on 15Apr2021 with a negative result. Concomitant medication included lisinopril. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced acute pancreatitis after the first dose on 20Mar2021 at 22:45 or 23:45. He was hospitalized for 3 or 5 days. After the second dose again the patient was hospitalized for acute pancreatitis. The event required an emergency room visit. Treatment for acute pancreatitis was reported as hospital stay. The outcome of acute pancreatitis was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pancreatitis acute, SARS-CoV-2 test
Clinical narrative: Acute Pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 08Mar2021 at 10:00 (at the age of 46-years-old) (Batch/Lot Number: EN6205) as a single dose and dose 2 via an unspecified route of administration, administered in the left arm on 07Apr2021 at 09:45 (at the age of 46-years-old)  (Batch/Lot Number: ER8729) as a single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 22Mar2021 with a negative result and via nasal swab on 15Apr2021 with a negative result. Concomitant medication included lisinopril. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced acute pancreatitis after the first dose on 20Mar2021 at 22:45 or 23:45. He was hospitalized for 3 or 5 days. After the second dose again the patient was hospitalized for acute pancreatitis. The event required an emergency room visit. Treatment for acute pancreatitis was reported as hospital stay. The outcome of acute pancreatitis was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Bradycardia, Cardiac monitoring, Chest X-ray, Computerised tomogram abdomen
Clinical narrative: heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm.  The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered.  No follow up attempts are possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Echocardiogram, Heart rate decreased, Laboratory test, Palpitations
Clinical narrative: heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm.  The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered.  No follow up attempts are possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Troponin
Clinical narrative: heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm.  The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered.  No follow up attempts are possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Bradycardia, Cardiac monitoring
Clinical narrative: heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm.  The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered.  No follow up attempts are possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram abdomen, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm.  The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered.  No follow up attempts are possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate, Palpitations, SARS-CoV-2 test, Troponin
Clinical narrative: heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm.  The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered.  No follow up attempts are possible. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Eyelid disorder, Periorbital swelling, Pruritus, Skin burning sensation
Clinical narrative: Four days after her initial dose administration, the patient was seen at an urgent care for hives, redness, itching, and eye swelling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Eye swelling, Pruritus, Urticaria
Clinical narrative: Four days after her initial dose administration, the patient was seen at an urgent care for hives, redness, itching, and eye swelling.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Intensive care, Myalgia, Pulmonary thrombosis
Clinical narrative: massive pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 10:40 (Batch/Lot Number: EN6199) at 0.3 mL, single dose for COVID-19 immunization. Medical history included overweight and high blood pressure. Family history of her sister included medical conditions after dementia including a blood clot in pancreas and leg a few years ago. Her other sister had a blood clot in her leg within the last year. The patient's concomitant medications were not reported. The first dose of the Covid-19 vaccine on 08Mar2021. On 17Mar2021 she had symptoms and went to the emergency room on 18Mar2021. She was diagnosed with a massive pulmonary embolism in both lungs. She had a procedure and was in ICU for 2.5 days. They put a needle in her arm and gave her medication for the blood clots and monitored her very closely for two hours. They continued to monitor her for 24 hours but not as close. There was no previous immunization/ vaccination and no vaccine administered on the same date of the Pfizer suspect. The event required a visit to the emergency room and was hospitalized for 3 days (18Mar2021-21Mar2021). She does not have the results of any tests that were performed. The outcome of the event was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pulmonary embolism
Clinical narrative: massive pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 10:40 (Batch/Lot Number: EN6199) at 0.3 mL, single dose for COVID-19 immunization. Medical history included overweight and high blood pressure. Family history of her sister included medical conditions after dementia including a blood clot in pancreas and leg a few years ago. Her other sister had a blood clot in her leg within the last year. The patient's concomitant medications were not reported. The first dose of the Covid-19 vaccine on 08Mar2021. On 17Mar2021 she had symptoms and went to the emergency room on 18Mar2021. She was diagnosed with a massive pulmonary embolism in both lungs. She had a procedure and was in ICU for 2.5 days. They put a needle in her arm and gave her medication for the blood clots and monitored her very closely for two hours. They continued to monitor her for 24 hours but not as close. There was no previous immunization/ vaccination and no vaccine administered on the same date of the Pfizer suspect. The event required a visit to the emergency room and was hospitalized for 3 days (18Mar2021-21Mar2021). She does not have the results of any tests that were performed. The outcome of the event was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Cough, Dyspnoea, Fibrin D dimer increased, Lung opacity
Clinical narrative: acute dyspnea started 4/10, 1 day after second vaccination, no other provoking factors, symptoms persisted for 3 days, CT chest 4/13 showed extensive bilateral PE
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Pulmonary embolism, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: acute dyspnea started 4/10, 1 day after second vaccination, no other provoking factors, symptoms persisted for 3 days, CT chest 4/13 showed extensive bilateral PE
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea, Pulmonary embolism
Clinical narrative: acute dyspnea started 4/10, 1 day after second vaccination, no other provoking factors, symptoms persisted for 3 days, CT chest 4/13 showed extensive bilateral PE
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Jaw disorder, Paraesthesia, Throat tightness
Clinical narrative: Per patient report: I had the first dose of Covid 19/Moderna Vaccine today (4/18/2021) @ around 11:30am. At around 11:50-11:55am I started to have difficulty swallowing, tingling in my face, tightness in my throat, flush feeling, slight stiffness in my jaw and I was a little dizzy. These symptoms didn't last long. Then around 7:30pm I had a bit of dizziness and my throat felt a bit tight again and I felt like I had a very slight problem swallowing. I feel ok now.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Hot flush, Joint stiffness, Paraesthesia
Clinical narrative: Per patient report: I had the first dose of Covid 19/Moderna Vaccine today (4/18/2021) @ around 11:30am. At around 11:50-11:55am I started to have difficulty swallowing, tingling in my face, tightness in my throat, flush feeling, slight stiffness in my jaw and I was a little dizzy. These symptoms didn't last long. Then around 7:30pm I had a bit of dizziness and my throat felt a bit tight again and I felt like I had a very slight problem swallowing. I feel ok now.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Per patient report: I had the first dose of Covid 19/Moderna Vaccine today (4/18/2021) @ around 11:30am. At around 11:50-11:55am I started to have difficulty swallowing, tingling in my face, tightness in my throat, flush feeling, slight stiffness in my jaw and I was a little dizzy. These symptoms didn't last long. Then around 7:30pm I had a bit of dizziness and my throat felt a bit tight again and I felt like I had a very slight problem swallowing. I feel ok now.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Fatigue, Hyperaesthesia, Mobility decreased, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks).   On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pulmonary mass, Pyrexia, Skin discolouration, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks).   On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Contusion, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks).   On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary mass, Pyrexia, SARS-CoV-2 test, Skin discolouration, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks).   On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.