chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood uric acid increased, Headache, Hypersomnia
Clinical narrative: Patient did not report this event to the vaccination site for several months, which is why the report is just now being submitted.  Below is the exert from an email that patient sent me.  Upon asking his PCP about the reaction, he was instructed to reach out to the vaccination site to report the event.  "I received my first Pfizer shot on January 28, 2021 at 2:00PM.   felt fine when I left after the fifteen minutes waiting period.  I felt fine when I went to work the next morning.  However, when I returned home from work at about 1:00 PM I did not feel well.  My legs were very weak, upset stomach, headache, rash and some fever.  I stayed on the couch the remainder of Friday and slept,  I slept on Saturday for a total of approximately 22hrs and the same on Sunday.  I went to work on Monday even though I still did not feel very good.  It was several more days until I felt near normal.   About 10 days after the first shot, both of my feet began to swell and my toes began to turn purple and black.  My feet became extremely painful.  I went to the emergency room where they drew blood and said I had gout.  I was given a prescription for a 5 day packet of steroids.   That helped, but my feet reverted back to the swelling and extreme  pain within 1 day of no steroids.  I contacted my primary care doctor who prescribed an additional 10 day packet of steroids plus two other prescriptions that I do not remember.  I was in extreme pain and needed a walker to function.   I have had two follow up visits to my primary care doctor.  He did blood work which showed several results were outside of the normal range, however the gout indicator was within the normal range.  My RA level was 32 which is very high.  And, never have  had my RA factor number high prior to the shot.  He referred me to a RA specialist, but the appointment is still months away.     My feet are still somewhat swollen and walking is very uncomfortable and a little unsteady.  Before the shot, I was doing well.  My blood work was fine.   It has been almost 4 months and I still do not know when my feet will return to normal. I am no longer using a walker.   My Primary Care doctor advised me to report my adverse reactions."  Patient did received his 2nd Pfizer-BioNTech COVID-19 vaccine on 2/25/2021.  He states he "did not experience any effects from the second shot".  At this point I am not sure if the COVID-19 vaccine is the culprit with patients RA level, but did want to report this event since patient indicates the timing of the vaccination and his symptoms appear related.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia, Rash, Skin discolouration
Clinical narrative: Patient did not report this event to the vaccination site for several months, which is why the report is just now being submitted.  Below is the exert from an email that patient sent me.  Upon asking his PCP about the reaction, he was instructed to reach out to the vaccination site to report the event.  "I received my first Pfizer shot on January 28, 2021 at 2:00PM.   felt fine when I left after the fifteen minutes waiting period.  I felt fine when I went to work the next morning.  However, when I returned home from work at about 1:00 PM I did not feel well.  My legs were very weak, upset stomach, headache, rash and some fever.  I stayed on the couch the remainder of Friday and slept,  I slept on Saturday for a total of approximately 22hrs and the same on Sunday.  I went to work on Monday even though I still did not feel very good.  It was several more days until I felt near normal.   About 10 days after the first shot, both of my feet began to swell and my toes began to turn purple and black.  My feet became extremely painful.  I went to the emergency room where they drew blood and said I had gout.  I was given a prescription for a 5 day packet of steroids.   That helped, but my feet reverted back to the swelling and extreme  pain within 1 day of no steroids.  I contacted my primary care doctor who prescribed an additional 10 day packet of steroids plus two other prescriptions that I do not remember.  I was in extreme pain and needed a walker to function.   I have had two follow up visits to my primary care doctor.  He did blood work which showed several results were outside of the normal range, however the gout indicator was within the normal range.  My RA level was 32 which is very high.  And, never have  had my RA factor number high prior to the shot.  He referred me to a RA specialist, but the appointment is still months away.     My feet are still somewhat swollen and walking is very uncomfortable and a little unsteady.  Before the shot, I was doing well.  My blood work was fine.   It has been almost 4 months and I still do not know when my feet will return to normal. I am no longer using a walker.   My Primary Care doctor advised me to report my adverse reactions."  Patient did received his 2nd Pfizer-BioNTech COVID-19 vaccine on 2/25/2021.  He states he "did not experience any effects from the second shot".  At this point I am not sure if the COVID-19 vaccine is the culprit with patients RA level, but did want to report this event since patient indicates the timing of the vaccination and his symptoms appear related.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Urticaria
Clinical narrative: Within a minute, we had sat down and I looked over and I thought maybe she had gotten a sunburn - but then place where sun wouldn't have hit - were getting very red; it was looking  like - hives - back, arms, legs, face - all over her body. Rash didn't start the injection site - it was her other parts of the body. Warm to the touch and spreading. By like 10 minutes, it had reached full body. She didn't complain of itching. Nurses took her vitals - described heart as "tacky" -but as she calmed the heart was coming back to normal. She wasn't in any stress until I pointed it out and she looked and saw she had an issue. The nurses had been give her Benadryl that I had brought - gave her 27.5 dosage of it - two pills. 1/2 hour after taking the Benadryl everything had subsided and we left. There were no further symptoms with her skin. She still had congestion etc but no further skin issues. I called her Primary care doctor to alert her but they said they didn't need to see her.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Sensory disturbance, Skin warm, Urticaria
Clinical narrative: Within a minute, we had sat down and I looked over and I thought maybe she had gotten a sunburn - but then place where sun wouldn't have hit - were getting very red; it was looking  like - hives - back, arms, legs, face - all over her body. Rash didn't start the injection site - it was her other parts of the body. Warm to the touch and spreading. By like 10 minutes, it had reached full body. She didn't complain of itching. Nurses took her vitals - described heart as "tacky" -but as she calmed the heart was coming back to normal. She wasn't in any stress until I pointed it out and she looked and saw she had an issue. The nurses had been give her Benadryl that I had brought - gave her 27.5 dosage of it - two pills. 1/2 hour after taking the Benadryl everything had subsided and we left. There were no further symptoms with her skin. She still had congestion etc but no further skin issues. I called her Primary care doctor to alert her but they said they didn't need to see her.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Computerised tomogram abdomen, Vomiting
Clinical narrative: Abdominal pain and vomits, appendicitis diagnosed and surgery needed.; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 13:00 (Batch/Lot Number: EW0179), at the age of 15 years old as 1st dose, single for COVID-19 immunization. The patient had no medical history and no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient had abdominal pain and vomits, appendicitis was diagnosed and surgery (removal of appendix) was needed. The event occurred on 20May2021 04:00 and was hospitalized for 1 day. The patient underwent lab tests and procedures which included COVID test post vaccination nasal swab: negative on 20May2021. The outcome of the events was recovering.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Abdominal pain and vomits, appendicitis diagnosed and surgery needed.; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 13:00 (Batch/Lot Number: EW0179), at the age of 15 years old as 1st dose, single for COVID-19 immunization. The patient had no medical history and no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient had abdominal pain and vomits, appendicitis was diagnosed and surgery (removal of appendix) was needed. The event occurred on 20May2021 04:00 and was hospitalized for 1 day. The patient underwent lab tests and procedures which included COVID test post vaccination nasal swab: negative on 20May2021. The outcome of the events was recovering.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Inflammation of the heart resulting in shortness of breath and chest pain.  Admitted to Hospital ICU.  Given ant-inflammatory medicine, Motrin.  Sent to further ICU hospital for more comprehensive cardio care and then further ICU hospital for Cardio MRI.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Inflammation of the heart resulting in shortness of breath and chest pain.  Admitted to Hospital ICU.  Given ant-inflammatory medicine, Motrin.  Sent to further ICU hospital for more comprehensive cardio care and then further ICU hospital for Cardio MRI.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Inflammation
Clinical narrative: Inflammation of the heart resulting in shortness of breath and chest pain.  Admitted to Hospital ICU.  Given ant-inflammatory medicine, Motrin.  Sent to further ICU hospital for more comprehensive cardio care and then further ICU hospital for Cardio MRI.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Magnetic resonance imaging
Clinical narrative: Inflammation of the heart resulting in shortness of breath and chest pain.  Admitted to Hospital ICU.  Given ant-inflammatory medicine, Motrin.  Sent to further ICU hospital for more comprehensive cardio care and then further ICU hospital for Cardio MRI.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Inflammation of the heart resulting in shortness of breath and chest pain.  Admitted to Hospital ICU.  Given ant-inflammatory medicine, Motrin.  Sent to further ICU hospital for more comprehensive cardio care and then further ICU hospital for Cardio MRI.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: Terrible headaches 5 days. Finally improved some on days 6-7. Bad diarrhea. I initially didn?t report diarrhea, but when it persisted for two plus weeks I decided to file this report to give an update. I?m very concerned about taking the second shot and would like more information in potential complications after having such a bad reaction to the guest shot.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Terrible headaches 5 days. Finally improved some on days 6-7. Bad diarrhea. I initially didn?t report diarrhea, but when it persisted for two plus weeks I decided to file this report to give an update. I?m very concerned about taking the second shot and would like more information in potential complications after having such a bad reaction to the guest shot.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Symptoms of hives and rash developed 1 week after receiving Moderna vaccine.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Symptoms of hives and rash developed 1 week after receiving Moderna vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Discomfort, Injection site bruising, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Pt notes "lump" after first vaccination ~3 weeks ago. No pain, erythema. No systemic signs of infection.   PE: 2 cm mobile firm fluid-filled sac upper right arm. Non-tender. Skin pristine.   Likely seroma, less likely hematoma, other.    OK to vaccinate the other arm. Advised local measures and calling PCP. Advised urgent call with erythema, enlargement, systemic.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain
Clinical narrative: Pt notes "lump" after first vaccination ~3 weeks ago. No pain, erythema. No systemic signs of infection.   PE: 2 cm mobile firm fluid-filled sac upper right arm. Non-tender. Skin pristine.   Likely seroma, less likely hematoma, other.    OK to vaccinate the other arm. Advised local measures and calling PCP. Advised urgent call with erythema, enlargement, systemic.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site mass
Clinical narrative: Pt notes "lump" after first vaccination ~3 weeks ago. No pain, erythema. No systemic signs of infection.   PE: 2 cm mobile firm fluid-filled sac upper right arm. Non-tender. Skin pristine.   Likely seroma, less likely hematoma, other.    OK to vaccinate the other arm. Advised local measures and calling PCP. Advised urgent call with erythema, enlargement, systemic.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Pericarditis
Clinical narrative: Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; started feeling ill/not feeling well; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 22Apr2021 as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus has had it about 10 years or so, blood sugars have been good, ongoing supraventricular tachycardia had this diagnoses for about 4 years and is medication control, and amputee from an accident many years ago from an unknown date. Concomitant medication included carvedilol (COREG) taken for supraventricular tachycardia from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 on 26Mar2021 (Lot number: EN6208) at 56 years old for COVID-19 immunization in the left upper bicep and experienced brain bleed. No history of Pfizer vaccine other than the first dose. No additional vaccine administered on the same date or 4 weeks prior. No family history. On 08May2021, it was reported that the patient started feeling ill and was not feeling well. On 12May2021, the patient walked into a clinic since he was not feeling well. They found his blood pressure was really low and heart rate was really high so he sent to the emergency room and they admitted him. When at the emergency room they did a CTA which is a CT angiography. The patient was diagnosed with the pericarditis. The patient was admitted on 12May2021 for the pericarditis and pulmonary effusions. The pericarditis is what they were concerned about though. The reporter explains before this he was fairly healthy. The patient was discharged on Friday 14May2021. He was doing pretty well for a couple days but now he is not feeling well again. He was good on 18May2021 but then was not felt well since the 20May2021. He went to doctor on 21May2021. The patient underwent lab tests and procedures on an unspecified date which included CT angiography: pericarditis, CBC: normal,  Blood culture: negative, Flu test: negative, COVID-19 test: negative, RSV test: negative, Echocardiogram: normal. On 12May2021 blood pressure: really low and heart rate: really high. The events required physician's office and emergency room visit. The outcome of the events was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood culture, Blood pressure measurement, Echocardiogram, Full blood count
Clinical narrative: Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; started feeling ill/not feeling well; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 22Apr2021 as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus has had it about 10 years or so, blood sugars have been good, ongoing supraventricular tachycardia had this diagnoses for about 4 years and is medication control, and amputee from an accident many years ago from an unknown date. Concomitant medication included carvedilol (COREG) taken for supraventricular tachycardia from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 on 26Mar2021 (Lot number: EN6208) at 56 years old for COVID-19 immunization in the left upper bicep and experienced brain bleed. No history of Pfizer vaccine other than the first dose. No additional vaccine administered on the same date or 4 weeks prior. No family history. On 08May2021, it was reported that the patient started feeling ill and was not feeling well. On 12May2021, the patient walked into a clinic since he was not feeling well. They found his blood pressure was really low and heart rate was really high so he sent to the emergency room and they admitted him. When at the emergency room they did a CTA which is a CT angiography. The patient was diagnosed with the pericarditis. The patient was admitted on 12May2021 for the pericarditis and pulmonary effusions. The pericarditis is what they were concerned about though. The reporter explains before this he was fairly healthy. The patient was discharged on Friday 14May2021. He was doing pretty well for a couple days but now he is not feeling well again. He was good on 18May2021 but then was not felt well since the 20May2021. He went to doctor on 21May2021. The patient underwent lab tests and procedures on an unspecified date which included CT angiography: pericarditis, CBC: normal,  Blood culture: negative, Flu test: negative, COVID-19 test: negative, RSV test: negative, Echocardiogram: normal. On 12May2021 blood pressure: really low and heart rate: really high. The events required physician's office and emergency room visit. The outcome of the events was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Hypotension, Influenza virus test, Malaise
Clinical narrative: Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; started feeling ill/not feeling well; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 22Apr2021 as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus has had it about 10 years or so, blood sugars have been good, ongoing supraventricular tachycardia had this diagnoses for about 4 years and is medication control, and amputee from an accident many years ago from an unknown date. Concomitant medication included carvedilol (COREG) taken for supraventricular tachycardia from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 on 26Mar2021 (Lot number: EN6208) at 56 years old for COVID-19 immunization in the left upper bicep and experienced brain bleed. No history of Pfizer vaccine other than the first dose. No additional vaccine administered on the same date or 4 weeks prior. No family history. On 08May2021, it was reported that the patient started feeling ill and was not feeling well. On 12May2021, the patient walked into a clinic since he was not feeling well. They found his blood pressure was really low and heart rate was really high so he sent to the emergency room and they admitted him. When at the emergency room they did a CTA which is a CT angiography. The patient was diagnosed with the pericarditis. The patient was admitted on 12May2021 for the pericarditis and pulmonary effusions. The pericarditis is what they were concerned about though. The reporter explains before this he was fairly healthy. The patient was discharged on Friday 14May2021. He was doing pretty well for a couple days but now he is not feeling well again. He was good on 18May2021 but then was not felt well since the 20May2021. He went to doctor on 21May2021. The patient underwent lab tests and procedures on an unspecified date which included CT angiography: pericarditis, CBC: normal,  Blood culture: negative, Flu test: negative, COVID-19 test: negative, RSV test: negative, Echocardiogram: normal. On 12May2021 blood pressure: really low and heart rate: really high. The events required physician's office and emergency room visit. The outcome of the events was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Pleural effusion, Respiratory syncytial virus test, SARS-CoV-2 test
Clinical narrative: Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; started feeling ill/not feeling well; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 22Apr2021 as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus has had it about 10 years or so, blood sugars have been good, ongoing supraventricular tachycardia had this diagnoses for about 4 years and is medication control, and amputee from an accident many years ago from an unknown date. Concomitant medication included carvedilol (COREG) taken for supraventricular tachycardia from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 on 26Mar2021 (Lot number: EN6208) at 56 years old for COVID-19 immunization in the left upper bicep and experienced brain bleed. No history of Pfizer vaccine other than the first dose. No additional vaccine administered on the same date or 4 weeks prior. No family history. On 08May2021, it was reported that the patient started feeling ill and was not feeling well. On 12May2021, the patient walked into a clinic since he was not feeling well. They found his blood pressure was really low and heart rate was really high so he sent to the emergency room and they admitted him. When at the emergency room they did a CTA which is a CT angiography. The patient was diagnosed with the pericarditis. The patient was admitted on 12May2021 for the pericarditis and pulmonary effusions. The pericarditis is what they were concerned about though. The reporter explains before this he was fairly healthy. The patient was discharged on Friday 14May2021. He was doing pretty well for a couple days but now he is not feeling well again. He was good on 18May2021 but then was not felt well since the 20May2021. He went to doctor on 21May2021. The patient underwent lab tests and procedures on an unspecified date which included CT angiography: pericarditis, CBC: normal,  Blood culture: negative, Flu test: negative, COVID-19 test: negative, RSV test: negative, Echocardiogram: normal. On 12May2021 blood pressure: really low and heart rate: really high. The events required physician's office and emergency room visit. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, C-reactive protein normal, Echocardiogram, Electrocardiogram ST segment abnormal, Electrocardiogram abnormal
Clinical narrative: Allergic reaction; This is a spontaneous report from a non-contactable consumer. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on 20May2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on 21May2021. Went to the ER the next day. Put on allergy meds. Taken back to the hospital the night of the 23May2021 to an unknown date. Event did not result in death, was not life-threatening, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Therapeutic measures were taken as a result of the event which included Allergy medications. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Full blood count normal, Hypersensitivity, Paraesthesia, Petechiae
Clinical narrative: Allergic reaction; This is a spontaneous report from a non-contactable consumer. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on 20May2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on 21May2021. Went to the ER the next day. Put on allergy meds. Taken back to the hospital the night of the 23May2021 to an unknown date. Event did not result in death, was not life-threatening, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Therapeutic measures were taken as a result of the event which included Allergy medications. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time normal, Purpura, Red blood cell sedimentation rate normal, Swelling face, Urticaria
Clinical narrative: Allergic reaction; This is a spontaneous report from a non-contactable consumer. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on 20May2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on 21May2021. Went to the ER the next day. Put on allergy meds. Taken back to the hospital the night of the 23May2021 to an unknown date. Event did not result in death, was not life-threatening, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Therapeutic measures were taken as a result of the event which included Allergy medications. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a non-contactable consumer. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on 20May2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on 21May2021. Went to the ER the next day. Put on allergy meds. Taken back to the hospital the night of the 23May2021 to an unknown date. Event did not result in death, was not life-threatening, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Therapeutic measures were taken as a result of the event which included Allergy medications. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Communication barrier existed and after vaccine was administered it was discovered that true DOB showed that patient was 14 years old which is underage for the moderna vaccine (vaccination age >18 year old per guidelines currently) Pt did not vaccine any adverse reactions that were reported
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Communication barrier existed and after vaccine was administered it was discovered that true DOB showed that patient was 14 years old which is underage for the moderna vaccine (vaccination age >18 year old per guidelines currently) Pt did not vaccine any adverse reactions that were reported
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Flushing, Full blood count normal, Metabolic function test normal
Clinical narrative: Heart rate was 145/ tachycardia; chest tightness/pain; chest tightness/pain; dizziness; hot flushes; itchiness on throat and tightness; BP 147/90; itchiness on throat and tightness; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 14May2021 08:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included PVC < 1 %. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included ascorbic acid; vitamin b complex (VITAMIN B); curcuma longa root (TURMERIC CURCUMIN) and Multivitamins. The patient previously took ibuprofen and experienced drug allergy (known allergies: Ibuprofen). The patient experienced heart rate was 145/ tachycardia, chest tightness/pain, dizziness, hot flushes, itchiness on throat and tightness, bp 147/90 on 14May2021 08:45. Reported as: approximately 5 -10 minutes after being vaccinated, I had sudden chest tightness/pain followed by tachycardia, dizziness and hot flushes, with itchiness on throat and tightness.  Heart rate was 145 with BP 147/90. The adverse event result in Emergency room/department or urgent care. The patient received hydration with 0.9 NaCl to lower heart rate. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in May2021.  Information about lot/batch number has been requested.; Sender's Comments: Based on data given, the event tachycardia is assessed as possibly related to BNT162B2. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Throat irritation, Tryptase
Clinical narrative: Heart rate was 145/ tachycardia; chest tightness/pain; chest tightness/pain; dizziness; hot flushes; itchiness on throat and tightness; BP 147/90; itchiness on throat and tightness; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 14May2021 08:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included PVC < 1 %. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included ascorbic acid; vitamin b complex (VITAMIN B); curcuma longa root (TURMERIC CURCUMIN) and Multivitamins. The patient previously took ibuprofen and experienced drug allergy (known allergies: Ibuprofen). The patient experienced heart rate was 145/ tachycardia, chest tightness/pain, dizziness, hot flushes, itchiness on throat and tightness, bp 147/90 on 14May2021 08:45. Reported as: approximately 5 -10 minutes after being vaccinated, I had sudden chest tightness/pain followed by tachycardia, dizziness and hot flushes, with itchiness on throat and tightness.  Heart rate was 145 with BP 147/90. The adverse event result in Emergency room/department or urgent care. The patient received hydration with 0.9 NaCl to lower heart rate. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in May2021.  Information about lot/batch number has been requested.; Sender's Comments: Based on data given, the event tachycardia is assessed as possibly related to BNT162B2. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Chest pain, Dizziness, Heart rate
Clinical narrative: Heart rate was 145/ tachycardia; chest tightness/pain; chest tightness/pain; dizziness; hot flushes; itchiness on throat and tightness; BP 147/90; itchiness on throat and tightness; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 14May2021 08:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included PVC < 1 %. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included ascorbic acid; vitamin b complex (VITAMIN B); curcuma longa root (TURMERIC CURCUMIN) and Multivitamins. The patient previously took ibuprofen and experienced drug allergy (known allergies: Ibuprofen). The patient experienced heart rate was 145/ tachycardia, chest tightness/pain, dizziness, hot flushes, itchiness on throat and tightness, bp 147/90 on 14May2021 08:45. Reported as: approximately 5 -10 minutes after being vaccinated, I had sudden chest tightness/pain followed by tachycardia, dizziness and hot flushes, with itchiness on throat and tightness.  Heart rate was 145 with BP 147/90. The adverse event result in Emergency room/department or urgent care. The patient received hydration with 0.9 NaCl to lower heart rate. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in May2021.  Information about lot/batch number has been requested.; Sender's Comments: Based on data given, the event tachycardia is assessed as possibly related to BNT162B2. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Hypertension, Tachycardia, Throat irritation, Throat tightness
Clinical narrative: Heart rate was 145/ tachycardia; chest tightness/pain; chest tightness/pain; dizziness; hot flushes; itchiness on throat and tightness; BP 147/90; itchiness on throat and tightness; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 14May2021 08:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included PVC < 1 %. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included ascorbic acid; vitamin b complex (VITAMIN B); curcuma longa root (TURMERIC CURCUMIN) and Multivitamins. The patient previously took ibuprofen and experienced drug allergy (known allergies: Ibuprofen). The patient experienced heart rate was 145/ tachycardia, chest tightness/pain, dizziness, hot flushes, itchiness on throat and tightness, bp 147/90 on 14May2021 08:45. Reported as: approximately 5 -10 minutes after being vaccinated, I had sudden chest tightness/pain followed by tachycardia, dizziness and hot flushes, with itchiness on throat and tightness.  Heart rate was 145 with BP 147/90. The adverse event result in Emergency room/department or urgent care. The patient received hydration with 0.9 NaCl to lower heart rate. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in May2021.  Information about lot/batch number has been requested.; Sender's Comments: Based on data given, the event tachycardia is assessed as possibly related to BNT162B2. 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, COVID19, COVID19, COVID19
Symptoms: Bedridden, Impaired work ability, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: Patient felt like he had a permanent damage to his arm. He can't make full use of his arm.; felt very sick for over a week; pain in my arm that got the shot; flu like symptoms; pain at the injection site for over 30 days; This a spontaneous report from a contactable consumer (patient). A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date: unknown), dose 2 via unknown route of administration on 28Apr2021 as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date unknown), dose 1, via unknown route of administration on unknown date as single dose for COVID-19 immunisation. The patient received the coronavirus vaccines and received both vaccines. The first vaccine patient didn't feel anything but the second one he felt very sick for over a week and still had a lot of pain in his arm that got the shot on an unspecified date, and would like some help. He talked to his doctor and didn't really do anything. Patient had the pain at the injection site for over 30 days. Patient felt like he had a permanent damage to his arm on an unspecified date. He can't make full use of his arm. He had flu like symptoms on an unspecified date. His symptoms were very intense after dose 2. He couldn't get up for a week. He never felt this sick in entire life. There was a response to patient query, if patient received a second shot side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that body is building protection and should go away within a few days. Informed caller to follow up with HCP as Pfizer cannot provide any individual treatment recommendations. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Vaccination complication
Clinical narrative: Patient felt like he had a permanent damage to his arm. He can't make full use of his arm.; felt very sick for over a week; pain in my arm that got the shot; flu like symptoms; pain at the injection site for over 30 days; This a spontaneous report from a contactable consumer (patient). A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date: unknown), dose 2 via unknown route of administration on 28Apr2021 as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date unknown), dose 1, via unknown route of administration on unknown date as single dose for COVID-19 immunisation. The patient received the coronavirus vaccines and received both vaccines. The first vaccine patient didn't feel anything but the second one he felt very sick for over a week and still had a lot of pain in his arm that got the shot on an unspecified date, and would like some help. He talked to his doctor and didn't really do anything. Patient had the pain at the injection site for over 30 days. Patient felt like he had a permanent damage to his arm on an unspecified date. He can't make full use of his arm. He had flu like symptoms on an unspecified date. His symptoms were very intense after dose 2. He couldn't get up for a week. He never felt this sick in entire life. There was a response to patient query, if patient received a second shot side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that body is building protection and should go away within a few days. Informed caller to follow up with HCP as Pfizer cannot provide any individual treatment recommendations. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: Patient felt like he had a permanent damage to his arm. He can't make full use of his arm.; felt very sick for over a week; pain in my arm that got the shot; flu like symptoms; pain at the injection site for over 30 days; This a spontaneous report from a contactable consumer (patient). A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date: unknown), dose 2 via unknown route of administration on 28Apr2021 as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date unknown), dose 1, via unknown route of administration on unknown date as single dose for COVID-19 immunisation. The patient received the coronavirus vaccines and received both vaccines. The first vaccine patient didn't feel anything but the second one he felt very sick for over a week and still had a lot of pain in his arm that got the shot on an unspecified date, and would like some help. He talked to his doctor and didn't really do anything. Patient had the pain at the injection site for over 30 days. Patient felt like he had a permanent damage to his arm on an unspecified date. He can't make full use of his arm. He had flu like symptoms on an unspecified date. His symptoms were very intense after dose 2. He couldn't get up for a week. He never felt this sick in entire life. There was a response to patient query, if patient received a second shot side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that body is building protection and should go away within a few days. Informed caller to follow up with HCP as Pfizer cannot provide any individual treatment recommendations. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Influenza like illness, Limb deformity, Pain in extremity, Vaccination site pain
Clinical narrative: Patient felt like he had a permanent damage to his arm. He can't make full use of his arm.; felt very sick for over a week; pain in my arm that got the shot; flu like symptoms; pain at the injection site for over 30 days; This a spontaneous report from a contactable consumer (patient). A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date: unknown), dose 2 via unknown route of administration on 28Apr2021 as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date unknown), dose 1, via unknown route of administration on unknown date as single dose for COVID-19 immunisation. The patient received the coronavirus vaccines and received both vaccines. The first vaccine patient didn't feel anything but the second one he felt very sick for over a week and still had a lot of pain in his arm that got the shot on an unspecified date, and would like some help. He talked to his doctor and didn't really do anything. Patient had the pain at the injection site for over 30 days. Patient felt like he had a permanent damage to his arm on an unspecified date. He can't make full use of his arm. He had flu like symptoms on an unspecified date. His symptoms were very intense after dose 2. He couldn't get up for a week. He never felt this sick in entire life. There was a response to patient query, if patient received a second shot side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that body is building protection and should go away within a few days. Informed caller to follow up with HCP as Pfizer cannot provide any individual treatment recommendations. The outcome of the events was unknown.