chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Coughing and nasal symptoms are listed as possible signs of Covid19 infection; reporting body aches; fever; watery eyes; sneezing; dry cough; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included Exposure to SARS-CoV-2 (around an elderly co-worker that tested positive for Covid19 infection). Concomitant medications were not reported.  The patient experienced body aches (not 'itch' as reported), fever, watery eyes, sneezing, and a dry cough. Caller wanted to know if these symptoms are normal? Coughing and nasal symptoms were listed as possible signs of covid19 infection. The patient had been around an elderly co-worker that tested positive for Covid19 infection, caller did not find out until after receiving his first dose. He spent 4 - 5 hours with him, before getting his shot. If he tests positive for Covid19 infection, how does that affect his next dose which was scheduled for 01Mar2021? The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Coughing and nasal symptoms are listed as possible signs of Covid19 infection; reporting body aches; fever; watery eyes; sneezing; dry cough; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included Exposure to SARS-CoV-2 (around an elderly co-worker that tested positive for Covid19 infection). Concomitant medications were not reported.  The patient experienced body aches (not 'itch' as reported), fever, watery eyes, sneezing, and a dry cough. Caller wanted to know if these symptoms are normal? Coughing and nasal symptoms were listed as possible signs of covid19 infection. The patient had been around an elderly co-worker that tested positive for Covid19 infection, caller did not find out until after receiving his first dose. He spent 4 - 5 hours with him, before getting his shot. If he tests positive for Covid19 infection, how does that affect his next dose which was scheduled for 01Mar2021? The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Headache
Clinical narrative: Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Joint pain; Soreness in the arm; Temperature went up to like 101 degrees/fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), lot number: EH9899, via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunization.  Medical history included none.  There were no concomitant medications. The patient stated he had the COVID shot a week ago and as of now, he has no symptoms until the soreness in the arm but that was natural. The patient had joint pain starting yesterday, day before and today like it was his temperature, it went up to like 101 degrees. The patient was asking if that is normal. The patient stated the fever was today which is 29Jan2021 and still experiencing.  The patient took couple Tylenol. The outcome of the event fever was not recovered as of reporting time; while the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Erythema, Nasal congestion, Nausea, Pruritus
Clinical narrative: congested; nauseous; threw up; itchiness; red spots on my arm; I lost my taste and I feel not having taste right now; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Two hours after receiving the vaccine on 27Jan2021, the patient experienced a really bad reaction, itchiness, and red spots on the arm. Around 11:00 on 27Jan2021, the patient got nauseous and threw up. The patient went home and lay down, woke up and lost taste on an unspecified date. The patient felt not having taste "now" on 30Jan2021. On 30Jan2021 the patient was really congested. The outcomes of itchiness, red spots on the arm, nauseous, and threw up were unknown. The outcomes of lost taste and really congested were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: congested; nauseous; threw up; itchiness; red spots on my arm; I lost my taste and I feel not having taste right now; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Two hours after receiving the vaccine on 27Jan2021, the patient experienced a really bad reaction, itchiness, and red spots on the arm. Around 11:00 on 27Jan2021, the patient got nauseous and threw up. The patient went home and lay down, woke up and lost taste on an unspecified date. The patient felt not having taste "now" on 30Jan2021. On 30Jan2021 the patient was really congested. The outcomes of itchiness, red spots on the arm, nauseous, and threw up were unknown. The outcomes of lost taste and really congested were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Disturbance in attention, Dysphemia, Feeling drunk, Pain
Clinical narrative: It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer.  Medical history was none.  There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Vaccination site swelling
Clinical narrative: It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer.  Medical history was none.  There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain
Clinical narrative: Dizzy; nauseous; exhausted; soreness; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old male patient, who is 50-year-old the date of vaccination, received bnt162b2 (BNT162B2), lot number: EL8982, via an unspecified route of administration on Arm Left, on 28Jan2021 12:00 as SINGLE DOSE (second dose) for COVID-19 immunization.  Medical history included High Blood Pressure. The patient received first dose of bnt162b2 (BNT162B2), lot number=EL3248, on 07Jan2021 at 12:00 on left arm. Concomitant medication included hydrochlorothiazide. On 28Jan2021 12:15, the patient experienced dizzy, nauseous, exhausted, soreness. The outcome of the events was not recovered. No treatment was received for the events. The patient did not have COVID prior vaccination. The patient was not tested post vaccination.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for the Covid virus on 02Feb; tested positive for the Covid virus on 02Feb.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 3rd of 3 reports. An 89-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138460 same drug/event, different patients
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Sore arm at injection site; chills; fatigue; This is a spontaneous report from a contactable consumer. A non-pregnant 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONN), via an unspecified route of administration, in the left arm, on 28Jan2021 (at the age of 88 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 28Jan2021, the patient experienced sore arm at injection site, chills, fatigue. The patient did not receive any treatment for the sore arm at injection site, chills, fatigue. The clinical outcome of sore arm at injection site, chills, fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: 2 days post injection general malaise; Injection site soreness 4 hours post injection; This is a spontaneous report from a non-contactable consumer, the patient. This elderly female patient of unknown age  received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL 9265), dose 1 , single dose via an unspecified route of administration in the left arm on 26Jan2021 at 12:00 PM for COVID-19 vaccination. There was no relevant medical history. There were no known allergies. The patient was not pregnant.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 05:00 PM, the patient experienced injection site soreness 4 hours post injection. On 28Jan2021 2 days post injection, the patient had general malaise. No treatment was received for the events. The clinical outcome of injection site soreness and general malaise was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Nausea
Clinical narrative: Severe epigastric pain for one  hour with nausea, then nausea/queasy/sore abdomen for 24 hours.; Severe epigastric pain for one  hour with nausea, then nausea/queasy/sore abdomen for 24 hours.; Severe epigastric pain for one hour with nausea, then nausea/queasy/sore abdomen for 24 hours.; This is a spontaneous report from a  non-contactable consumer.  A female patient of an unspecified age started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231);  via an unspecified route of administration in the Left arm, on 06Jan2021 at 12:45 as  SINGLE DOSE for covid-19 vaccination. Medical history included hypothyroidism. Concomitant medication in two weeks of received vaccine was received (details were not provided).  The patient previously took lisinopril and experienced drug hypersensitivity.  The facility in which the vaccine was given was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 06Jan2021 at 14:00 The patient experienced Severe epigastric pain for one hour with nausea, then nausea, queasy and sore abdomen for 24 hours. Treatment included Zofran sublingual as a result of severe epigastric pain, nausea/queasy and sore abdomen. The clinical outcome of the events Severe epigastric pain was recovered on 06Jan2021 at 15:00 which nausea, queasy and sore abdomen was recovered on 07Jan2021.    No follow up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Full body chills; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in Jan2021 (at the age of 24-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included anxiety and depression. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. In Jan2021, the patient experienced full body chills. No treatment was provided for the event body chills. The outcome of the event body chills was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145063 same reporter/patient/vaccine, different dose/event
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart injury, Pulmonary embolism, Pulmonary hypertension
Clinical narrative: multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation.  Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly.  The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 .  These are probably intercurrent medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Dyspnoea exertional, Ejection fraction decreased, Gait disturbance
Clinical narrative: multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation.  Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly.  The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 .  These are probably intercurrent medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hilar lymphadenopathy, Pulmonary embolism, Pulmonary hypertension, Pulmonary mass, Stress echocardiogram
Clinical narrative: multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation.  Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly.  The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 .  These are probably intercurrent medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation.  Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly.  The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 .  These are probably intercurrent medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Heart rate, Heart rate increased, Heart rate irregular, Intracardiac thrombus
Clinical narrative: stroke; blood clot in the heart; Hospitalization with racing and irregular heart beat; Hospitalization with racing and irregular heart beat; loss of motor function; This is a spontaneous report from a non-contactable consumer.  A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. If other vaccine in four weeks was unknown. Other medications in two weeks was unknown. If covid prior vaccination was unknown. If covid tested post vaccination was unknown. Known allergies was unknown. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date for COVID-19 immunization. Patient experienced hospitalization with racing and irregular heartbeat, blood clot in the heart, stroke, loss of motor function on an unspecified date. Treatment included intubation. The outcome of the events was unknown. Events resulted in hospitalization, life threatening illness (immediate risk of death from the event).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction
Clinical narrative: stroke; blood clot in the heart; Hospitalization with racing and irregular heart beat; Hospitalization with racing and irregular heart beat; loss of motor function; This is a spontaneous report from a non-contactable consumer.  A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. If other vaccine in four weeks was unknown. Other medications in two weeks was unknown. If covid prior vaccination was unknown. If covid tested post vaccination was unknown. Known allergies was unknown. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date for COVID-19 immunization. Patient experienced hospitalization with racing and irregular heartbeat, blood clot in the heart, stroke, loss of motor function on an unspecified date. Treatment included intubation. The outcome of the events was unknown. Events resulted in hospitalization, life threatening illness (immediate risk of death from the event).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died; This is a spontaneous report from a contactable consumer (parent's patient).  A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route on 13Feb2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Feb2021 the patient died. The cause of death was unknown. An autopsy was not performed. No COVID prior vaccination. The patient had not been tested for COVID post vaccination.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: Patient died
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Fatigue, Nausea, Thrombosis
Clinical narrative: blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contactable consumer.   An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3248), via an unspecified route of administration at single dose in the left arm on 19Jan2021 14:00 for covid-19 immunisation. Medical history included heart problems, pacemaker. Concomitant medication included heparin.  The patient experienced death cause: heart problems on 20Jan2021, blood clot  on an unspecified date with outcome of unknown that required hospitalization, tired on 19Jan2021 with outcome of unknown, nauseous on 19Jan2021 with outcome of unknown. The patient was hospitalized for blood clot from 16Jan2021 to 18Jan2021. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: The patient was tired and nauseous about 3 hours after her vaccine. She had been in the hospital 16Jan2021 to 18Jan2021 for a blood clot. The patient died at her home on 20Jan2021 between 4 and 7 pm. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: death cause: Heart Problems
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Cardiomyopathy, Chest pain, Chills, Dyspnoea
Clinical narrative: small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Myocardial infarction, Rhinorrhoea, SARS-CoV-2 antibody test
Clinical narrative: small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Scan, Vaccination site erythema, Vaccination site induration
Clinical narrative: small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dermatitis, Immunisation, Influenza immunisation, Pneumococcal immunisation, Psoriasis
Clinical narrative: large patch of psoriasis on his arm above the elbow, typical psoriasis on his palms and his hands flared; peel crack get nasty; big chunks of skin that crack; Initial information received on 14-Jan-2021 regarding an unsolicited valid non-serious case received from physician.  This case is linked to case 2021SA011846.  This case involves adult male patient of unknown age who had large patch of psoriasis on his arm above the elbow, typical Psoriasis on his palms and his hands flared (psoriasis), peel crack got nasty (skin exfoliation) and big chunks of skin got crack (skin fissures), after receiving INFLUENZA VACCINE or PNEUMOCOCCAL VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspects INFLUENZA VACCINE produced by unknown manufacturer or PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur [lot numbers and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (as reported last year), the patient developed large patch of psoriasis on his arm above the elbow, typical Psoriasis on his palms and his hands flared (psoriasis), peel crack get nasty (skin exfoliation) and big chunks of skin that crack (skin fissures)  (non-serious) (Unknown latency),  following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for all reported events.  There will be no information on the batch number to be requested for this case.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Skin exfoliation, Skin fissures
Clinical narrative: large patch of psoriasis on his arm above the elbow, typical psoriasis on his palms and his hands flared; peel crack get nasty; big chunks of skin that crack; Initial information received on 14-Jan-2021 regarding an unsolicited valid non-serious case received from physician.  This case is linked to case 2021SA011846.  This case involves adult male patient of unknown age who had large patch of psoriasis on his arm above the elbow, typical Psoriasis on his palms and his hands flared (psoriasis), peel crack got nasty (skin exfoliation) and big chunks of skin got crack (skin fissures), after receiving INFLUENZA VACCINE or PNEUMOCOCCAL VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspects INFLUENZA VACCINE produced by unknown manufacturer or PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur [lot numbers and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (as reported last year), the patient developed large patch of psoriasis on his arm above the elbow, typical Psoriasis on his palms and his hands flared (psoriasis), peel crack get nasty (skin exfoliation) and big chunks of skin that crack (skin fissures)  (non-serious) (Unknown latency),  following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for all reported events.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Pain in extremity
Clinical narrative: feeling icky; still got a sore arm; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient with unknown demography who experienced icky (Sticky skin) and a sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious icky feeling (sticky skin) and a sore arm (pain in extremity), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  The outcome of both the events was unknown at the time of reporting.  There will be no information on the batch number for this case.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyskinesia, Pain
Clinical narrative: Increased [pain, uncontrolled movement of bilateral leg, no appetite,
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Nausea, Pyrexia
Clinical narrative: Back pain 9/10, nausea, dizziness and fever 101 ~14 hours after dose administered
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased
Clinical narrative: Temperature of 100.4 with increased weakness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm, severe headache for at least 5 days
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymph node pain, Myalgia
Clinical narrative: 22 hours after the vaccination I received almost all of the side effects. They were extreme for 48 hours. They included (fever, head-ache, vomiting, chills, muscle pain, joint pain, swelling and extreme pain in my lymph nodes.  Let me note that I am 69 years old with no health conditions. I am not on any medication and in perfect health.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: 22 hours after the vaccination I received almost all of the side effects. They were extreme for 48 hours. They included (fever, head-ache, vomiting, chills, muscle pain, joint pain, swelling and extreme pain in my lymph nodes.  Let me note that I am 69 years old with no health conditions. I am not on any medication and in perfect health.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Resident noted with emesis x3 on day shift, afrebrile. Resident continues to have small amount of emesis. T. 100.5 went down to 99.6, P. 103 BP. 190/93 O2. 96% Dr. notified. Will continue to monitor.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient felt lightheaded and dizzy immediately post vaccination. Observed patient for 30 minutes after which she felt better and left on her own.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Lethargy, Pain
Clinical narrative: First dose: Headache for 1 week   Second dose: headache, body aches, diarrhea, lethargy
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypotension
Clinical narrative: Patient became weak and lightheaded after receiving vaccination. Pt states she ahs had some problems with low blood pressure lately. Observed patient for 30 minutes after which she felt better and left on her own.