chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself.  A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself.  A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cold sweat, Dry mouth, Feeling abnormal, Feeling hot
Clinical narrative: She had an arrhythmia; got really hot all the way down her body; hands were sweaty and clammy; hands were sweaty and clammy; fast heart beat; Dry mouth; She didn't feel good at all; arm soreness; felt like she had a big hot flash; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 13:50 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. No other vaccines were given within 4 weeks. The patient medical history was not reported. There were no concomitant medications.  The patient previously took sucrose and experienced drug hypersensitivity, flu vaccine for influenza  immunization (never had a reaction after having a flu vaccine/'I am not allergic to eggs), tetanus vaccine for immunization (The last one she had was 10 or more years ago)  and experienced soreness. On 10Apr2021, The patient experienced  arrhythmia,  got really hot all the way down her body, hands were sweaty and clammy, fast heart beat, dry mouth,  she didn't feel good at all, arm soreness, felt like she had a big hot flash. The patient underwent lab tests and procedures which included heart rate: fast on 10Apr2021. The clinical course is as follows. Within the first 5 minutes of receiving the vaccine she got really hot all the way down her body. Her hands were hands sweaty and clammy. arm soreness. She had an arrhythmia, her heart was pounding fast. She belly breathed and kept calm. She didn't feel good at all. This all lasted for about 5 minutes. She has a pretty good immune system. She was not nervous about getting the vaccine. She had childhood vaccinations and had no problems. She was not nauseated. She just felt like she had a big hot flash through her body. Her mouth was dry. The adverse events did not require a visit to the physician office or emergency room.  The clinical outcome of the events got really hot all the way down her body, hand were sweaty and clammy, fast heart beat,  didn't feel good at all, Dry mouth  was recovered on 10Apr2021 while arm soreness was recovered on 13Apr2021 and while arrhythmia, felt like a big hot flush was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hot flush, Hyperhidrosis, Pain in extremity
Clinical narrative: She had an arrhythmia; got really hot all the way down her body; hands were sweaty and clammy; hands were sweaty and clammy; fast heart beat; Dry mouth; She didn't feel good at all; arm soreness; felt like she had a big hot flash; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 13:50 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. No other vaccines were given within 4 weeks. The patient medical history was not reported. There were no concomitant medications.  The patient previously took sucrose and experienced drug hypersensitivity, flu vaccine for influenza  immunization (never had a reaction after having a flu vaccine/'I am not allergic to eggs), tetanus vaccine for immunization (The last one she had was 10 or more years ago)  and experienced soreness. On 10Apr2021, The patient experienced  arrhythmia,  got really hot all the way down her body, hands were sweaty and clammy, fast heart beat, dry mouth,  she didn't feel good at all, arm soreness, felt like she had a big hot flash. The patient underwent lab tests and procedures which included heart rate: fast on 10Apr2021. The clinical course is as follows. Within the first 5 minutes of receiving the vaccine she got really hot all the way down her body. Her hands were hands sweaty and clammy. arm soreness. She had an arrhythmia, her heart was pounding fast. She belly breathed and kept calm. She didn't feel good at all. This all lasted for about 5 minutes. She has a pretty good immune system. She was not nervous about getting the vaccine. She had childhood vaccinations and had no problems. She was not nauseated. She just felt like she had a big hot flash through her body. Her mouth was dry. The adverse events did not require a visit to the physician office or emergency room.  The clinical outcome of the events got really hot all the way down her body, hand were sweaty and clammy, fast heart beat,  didn't feel good at all, Dry mouth  was recovered on 10Apr2021 while arm soreness was recovered on 13Apr2021 and while arrhythmia, felt like a big hot flush was unknown.   Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Bursitis, Monoplegia, Myalgia
Clinical narrative: Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder; his arm was paralyzed and was hurting a lot/arm was painful; It is a sharp, burning, stabbing pain; Arm was paralyzed; Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle; Injection was too low/Injection point was a little lower than expected; he had shoulder pain; This is a spontaneous report from a contactable consumer.   A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE (at age of 42 year old )for covid-19 immunisation.  Medical history included he's had bursitis previously and that the symptoms lasted 6 weeks to 6 months (reported both lengths of time, unsure which is correct duration).     The patient's concomitant medications were not reported.  On 16Apr2021, the patient experienced he had shoulder pain and the injection was too low/Injection point was a little lower than expected. On 17Apr2021, the patient experienced muscle pain at the deltoid/intense muscle pain in the deltoid muscle.  On 20Apr2021, the patient experienced arm was paralyzed , Joint pain in shoulder, It felt like bursitis when he had it before on another part of his shoulder, his arm was paralyzed and was hurting a lot/arm was painful, It is a sharp, burning, stabbing pain.Outcome of the events Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle, Joint pain in shoulder, his arm was paralyzed and was hurting a lot/arm was painful, he had shoulder pain was not recovered. Outcome of Arm was paralyzed, Injection was too low/Injection point was a little lower than expected, It felt like bursitis when he had it before on another part of his shoulder, It is a sharp, burning, stabbing pain was unknown.   Information about lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder; his arm was paralyzed and was hurting a lot/arm was painful; It is a sharp, burning, stabbing pain; Arm was paralyzed; Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle; Injection was too low/Injection point was a little lower than expected; he had shoulder pain; This is a spontaneous report from a contactable consumer.   A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE (at age of 42 year old )for covid-19 immunisation.  Medical history included he's had bursitis previously and that the symptoms lasted 6 weeks to 6 months (reported both lengths of time, unsure which is correct duration).     The patient's concomitant medications were not reported.  On 16Apr2021, the patient experienced he had shoulder pain and the injection was too low/Injection point was a little lower than expected. On 17Apr2021, the patient experienced muscle pain at the deltoid/intense muscle pain in the deltoid muscle.  On 20Apr2021, the patient experienced arm was paralyzed , Joint pain in shoulder, It felt like bursitis when he had it before on another part of his shoulder, his arm was paralyzed and was hurting a lot/arm was painful, It is a sharp, burning, stabbing pain.Outcome of the events Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle, Joint pain in shoulder, his arm was paralyzed and was hurting a lot/arm was painful, he had shoulder pain was not recovered. Outcome of Arm was paralyzed, Injection was too low/Injection point was a little lower than expected, It felt like bursitis when he had it before on another part of his shoulder, It is a sharp, burning, stabbing pain was unknown.   Information about lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Diarrhoea, Fall, Hyperhidrosis
Clinical narrative: lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same  patient/reporter, different AE/first dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Pain in extremity, Pyrexia, Vertigo
Clinical narrative: lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same  patient/reporter, different AE/first dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same  patient/reporter, different AE/first dose.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Echocardiogram, Electrocardiogram
Clinical narrative: Myocarditis; Troponins greater than 11,000; Mild Fever; Chills; Malaise; Chest pain; Body Aches; Cough; Headache; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported for a 18-year-old male patient that:  This is a spontaneous report from a contactable other hcp.   A 18-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included ongoing attention deficit hyperactivity disorder (ADD) , ongoing autism. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose1 received on 10Mar2021, LOT: Unknown for COVID-19 Immunization. Concomitant medication(s) included risperidone (RISPERDAL) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; methylphenidate (METHYLPHENIDATE) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing.  The patient presented to the ER two days after receiving his second dose of the vaccine. The patient experienced myocarditis (hospitalization 01Apr2021 to 03Apr2021, medically significant) on 01Apr2021 with outcome of unknown, patient was post ICU admission, chest pain  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , body aches (hospitalization) on 30Mar2021 with outcome of unknown , cough (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , headache  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , nausea  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , troponins greater than 11,000 (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , mild fever (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , chills (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , malaise (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included echocardiogram: unknown result on  unknown date, electrocardiogram: no acute changes on 01Apr2021, electrocardiogram: abnormal with ST elevation  on 19Apr2021 and patient needed to consult with Cardiology, COVID-19 antigen test: negative   on unknown date. The patient was treated in the ICU, exact treatment unknown at this time.  Information about Lot/batch number is requested.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported)  to reported events is probable.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myocarditis, Nausea, Pain
Clinical narrative: Myocarditis; Troponins greater than 11,000; Mild Fever; Chills; Malaise; Chest pain; Body Aches; Cough; Headache; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported for a 18-year-old male patient that:  This is a spontaneous report from a contactable other hcp.   A 18-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included ongoing attention deficit hyperactivity disorder (ADD) , ongoing autism. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose1 received on 10Mar2021, LOT: Unknown for COVID-19 Immunization. Concomitant medication(s) included risperidone (RISPERDAL) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; methylphenidate (METHYLPHENIDATE) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing.  The patient presented to the ER two days after receiving his second dose of the vaccine. The patient experienced myocarditis (hospitalization 01Apr2021 to 03Apr2021, medically significant) on 01Apr2021 with outcome of unknown, patient was post ICU admission, chest pain  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , body aches (hospitalization) on 30Mar2021 with outcome of unknown , cough (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , headache  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , nausea  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , troponins greater than 11,000 (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , mild fever (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , chills (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , malaise (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included echocardiogram: unknown result on  unknown date, electrocardiogram: no acute changes on 01Apr2021, electrocardiogram: abnormal with ST elevation  on 19Apr2021 and patient needed to consult with Cardiology, COVID-19 antigen test: negative   on unknown date. The patient was treated in the ICU, exact treatment unknown at this time.  Information about Lot/batch number is requested.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported)  to reported events is probable.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Troponin, Troponin increased
Clinical narrative: Myocarditis; Troponins greater than 11,000; Mild Fever; Chills; Malaise; Chest pain; Body Aches; Cough; Headache; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported for a 18-year-old male patient that:  This is a spontaneous report from a contactable other hcp.   A 18-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included ongoing attention deficit hyperactivity disorder (ADD) , ongoing autism. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose1 received on 10Mar2021, LOT: Unknown for COVID-19 Immunization. Concomitant medication(s) included risperidone (RISPERDAL) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; methylphenidate (METHYLPHENIDATE) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing.  The patient presented to the ER two days after receiving his second dose of the vaccine. The patient experienced myocarditis (hospitalization 01Apr2021 to 03Apr2021, medically significant) on 01Apr2021 with outcome of unknown, patient was post ICU admission, chest pain  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , body aches (hospitalization) on 30Mar2021 with outcome of unknown , cough (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , headache  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , nausea  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , troponins greater than 11,000 (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , mild fever (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , chills (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , malaise (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included echocardiogram: unknown result on  unknown date, electrocardiogram: no acute changes on 01Apr2021, electrocardiogram: abnormal with ST elevation  on 19Apr2021 and patient needed to consult with Cardiology, COVID-19 antigen test: negative   on unknown date. The patient was treated in the ICU, exact treatment unknown at this time.  Information about Lot/batch number is requested.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported)  to reported events is probable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid after she got the vaccine; got Covid after she got the vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:  unknown), single dose, dose 1 via an unspecified route of administration on 02Apr2021 for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient got COVID after she got the vaccine on an unspecified date and was hospitalized for the event for 6 days. Laboratory tests and procedures included sars-cov-2 test: positive on an unknown date. The outcome of COVID after she got the vaccine was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted the Covid 19 virus; contracted the Covid 19 virus; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an unspecified route of administration, on 18Mar2021 at age of 71-year) as a single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported.  He had his first Covid 19 vaccine on 18Mar2021. He came down with the Covid 19 virus after receiving the vaccine and was in the hospital and was treated with plasma and antivirals. He doesn't know how he got the Covid 19 virus he wore his mask everywhere. Pt was hospitalized for the event. The clinical outcome of the event was unknown.   Information about the Lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dehydration, Dizziness, Malaise, Nausea
Clinical narrative: Lightheaded and dizzy; Nauseous; Dehydrated; Lightheaded and dizzy; Atrial fibrillation with rapid ventricular response; Not feeling well; This is a spontaneous report from a contactable consumer.   A 79-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at the age of 79 years old, (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 Batch/Lot number was E or F, N6205;) as a single dose, for covid-19 immunisation. Medical history included diabetes from 2009, coronary artery disease from Jan2020, and atrial fibrillation and Shingrix Vaccine/NDC, Lot Number, Expiration Date not known by caller.Vaccination Date:  Jul2018. Concomitant medications were not reported.  On 17Apr2021, the patient reported not feeling well. 18Apr2021 she woke up in the morning and was lightheaded and dizzy.  She was also nauseous.States she called an ambulance. She was found to be in Atrial Fibrillation. she also found out when she got to the Emergency Room that she was dehydrated.  States she does not know if that ties in with the vaccine or not.  She  states someone told her she should be drinking a lot of water since she had the vaccines; asks if this is true. She was admitted to the hospital on Sunday 18Apr2021 and was released yesterday afternoon 20Apr2021.On 19Apr2021, she was lightheaded and dizzy, nauseous. She also  experienced atrial fibrillation with rapid ventricular response and was dehydrated. The patient was admitted to the hospital on 18Apr2021 and released on 20Apr2021.  The  outcome of the events of  not feeling well, lightheaded and dizzy, nauseous were recovered on 20Apr2021, the remaining events was unknown.          .
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin mass
Clinical narrative: Body is full of bumps was reported as worsened / bumps are on body from stomach to inner thighs/ It is spreading all over arms; The bumps are spreading. It is painful. She is off work. She cannot even work. She got the steroid pills; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 16Apr2021 09:00 (Lot Number: EP7534) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot number: EP6455) at 9 am on 26Mar2021, administered in arm right for COVID-19 immunization. Clinical course: After vaccination, her body was full of bumps (also reported as body is full of bumps was worsened). She had to go the emergency room, and they gave her steroid pills. It was not clearing up from the steroid pills. She had to leave work today. She went to the clinic today, and they gave her a steroid shot. The bumps were on her body from her stomach to her inner thighs. This all started on 16Apr2021 after the second vaccine. It was spreading all over her arms. The bumps were spreading. It was painful. She was off work. She could not even work. She got the steroid pills, Methylprednisolone on 18Apr2021. She started with 6 tablets and decrease by one tablet per day for 6 days. The events required to visit emergency room and physician office. No prior vaccinations received within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer. The event seriousness was provided as unspecified by reporter. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Type 2 diabetes mellitus
Clinical narrative: experiencing higher glucose than usual. Type 2 diabetic. Running 20 to 40 points higher than usual.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. It was reported that after 2nd covid vaccine on March 10, the patient was experiencing higher glucose than usual. Type 2 diabetic. Running 20 to 40 points higher than usual. It started about week after 2nd shot and continues to present. The patient mentioned that there was nothing different in his/her eating or activity or meds. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: COVID vaccine causing her arm, hand and face to go numb; COVID vaccine causing her arm, hand and face to go numb; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer (manufacturer control number: UNT-2021-006890). A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included ongoing pulmonary arterial hypertension. Co-suspect medication was treprostinil sodium (TYVASO) via inhalation route at 60-120 ug (10-20 breaths), four times a day for pulmonary arterial hypertension from 29Jun2018, Concomitant medications bosentan (TRACLEER) and tadalafil (ADCIRCA). The patient was admitted to the hospital (in Apr2021) with possible adverse event from COVID vaccine causing her arm, hand and face to go numb on 13Apr2021. The action taken with treprostinil was unknown. The clinical outcomes of the "COVID vaccine causing her arm, hand and face to go numb" were unknown.  Case Description: This case is a spontaneous report received on 14Apr2021, from a consumer via (pharmacy name). This 40-year-old, 125-lb, female patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 29Jun2018 for primary pulmonary arterial hypertension. The current dose was reported as 60-120 ug (10-20 breaths), four times a day (QID) (off label use), via inhalation (IH) route. On 13Apr2021, the patient experienced the event term of COVID vaccine causing her arm, hand and face to go numb (hypoaesthesia, hospitalized).  Co-suspect included coronavirus disease (COVID-19) vaccine. Concomitant medications included Tracleer (bosentan) and Adcirca (tadalafil). Relevant medical history included primary pulmonary arterial hypertension. On 13Apr2021, 2 years, 9 months, and 16 days after initiating IH Tyvaso, the patient was admitted to the hospital with possible adverse event from COVID vaccine causing her arm, hand and face to go numb. Action taken with IH Tyvaso was not reported for the event of hypoaesthesia. Action taken with Covid-19 vaccine was not applicable for the event of hypoaesthesia. At the time of reporting, the outcome of hypoaesthesia and off label use was unknown. The reporter did not provide causality for the event of hypoaesthesia.   Case Comment: The company has assessed the serious adverse event of hypoaesthesia as not related to IH treprostinil and TD-300/A device. The event was likely post vaccination with COVID vaccine.  Pfizer is a marketing authorization holder of BNT162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. Information about BNT162b2 vaccine lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Laboratory test
Clinical narrative: Cerebral venous sinus thrombosis; This is a spontaneous report from a contactable consumer, the patient. This 69-year-old male patient the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration in the left arm on an unspecified date as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 08Mar2021, the patient experienced cerebral venous sinus thrombosis and treated with PRADAXA. The patient underwent multiple "over 100" unspecified lab tests in the hospital with unknown results. The patient was hospitalized for cerebral venous sinus thrombosis from 26Mar2021 to 28Mar2021. The clinical outcome of cerebral venous sinus thrombosis was improved/resolving.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Cardiac amyloidosis, Congestive cardiomyopathy, Cough, Dyspnoea
Clinical narrative: cardiac amyloidosis; Dilated cardiomyopathy (I42.0); left ventricular hypertrophy (LVH); has increased on fatigue; cannot take breath well occasionally on exertion; abdominal swelling; weight gain/ weight had increased from 217 lbs to 227 lbs; dry cough since Covid shot; This is a spontaneous report received from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for Covid-19 immunization on an unspecified date. He reported that on 27Mar2021 he got the 2nd COVID Pfizer shot and has increased on fatigue now and cannot take breath well occasionally on exertion, also reported some abdominal swelling, none in legs. He reported weight gain but can la flat and no issues on resting conditions. He also reported dry cough since COVID shot but did not have any of such issues after the 1st dose. No fever, no dizziness or passing out. Diagnosis: Dilated cardiomyopathy (I42.0) -Left ventricular ejection fraction (LVEF) 25-30. Left ventricular hypertrophy (LVH) was diagnosed with cardiac amyloidosis. His weight had increased from 217 lbs to 227 lbs - reported shob but no edema, they discussed increasing furosemide (LASIX) to 40/d from 20 daily for a week and reassess. Also suspect COVID vaccine related immune phenomenon. Treatment received for the events (Dilated cardiomyopathy, Left ventricular hypertrophy, cardiac amyloidosis and weight gain). Events (has increased on fatigue, cannot take breath well occasionally on exertion, abdominal swelling, weight gain and dry cough since COVID shot) onset date was on unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported cardiac amyloidosis, Dilated cardiomyopathy, and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information on the patient's medical history, underlying medical conditions would be helpful for the Company to make a more meaningful causality assessment.   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 RA, IEC, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Fatigue, Left ventricular hypertrophy, Weight, Weight increased
Clinical narrative: cardiac amyloidosis; Dilated cardiomyopathy (I42.0); left ventricular hypertrophy (LVH); has increased on fatigue; cannot take breath well occasionally on exertion; abdominal swelling; weight gain/ weight had increased from 217 lbs to 227 lbs; dry cough since Covid shot; This is a spontaneous report received from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for Covid-19 immunization on an unspecified date. He reported that on 27Mar2021 he got the 2nd COVID Pfizer shot and has increased on fatigue now and cannot take breath well occasionally on exertion, also reported some abdominal swelling, none in legs. He reported weight gain but can la flat and no issues on resting conditions. He also reported dry cough since COVID shot but did not have any of such issues after the 1st dose. No fever, no dizziness or passing out. Diagnosis: Dilated cardiomyopathy (I42.0) -Left ventricular ejection fraction (LVEF) 25-30. Left ventricular hypertrophy (LVH) was diagnosed with cardiac amyloidosis. His weight had increased from 217 lbs to 227 lbs - reported shob but no edema, they discussed increasing furosemide (LASIX) to 40/d from 20 daily for a week and reassess. Also suspect COVID vaccine related immune phenomenon. Treatment received for the events (Dilated cardiomyopathy, Left ventricular hypertrophy, cardiac amyloidosis and weight gain). Events (has increased on fatigue, cannot take breath well occasionally on exertion, abdominal swelling, weight gain and dry cough since COVID shot) onset date was on unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported cardiac amyloidosis, Dilated cardiomyopathy, and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information on the patient's medical history, underlying medical conditions would be helpful for the Company to make a more meaningful causality assessment.   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 RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient's husband) reported for a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was asking for his wife who is scheduled to get a second dose tomorrow 22Apr2021. However, he wants to reschedule the appointment because the doctor informed them not to take the second dose yet because his wife (patient) has pneumonia. They might miss the second dose appointment. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021454451 same drug and patient, different event and drug dose