chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspepsia, Dyspnoea
Clinical narrative: I am still not feeling well; high levels of troponin; I was diagnosed with enteritis which is inflammation of the small intestine; transaminitis having high liver enzymes; feeling pain in my left side of the neck; I fainted; I felt a burning sensation in my stomach; I felt dizziness; shortness of breath; I began to vomit all over; pain in my left arm; chills; sweats; chest pains; palpitations; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 11Oct2021 (Batch/Lot Number: FE3592) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient medical history was not reported. It was unknown if patient had known allergies. There were no concomitant medications. On 11Oct2021, immediately after receiving the first dose of the Pfizer vaccine, patient felt a burning sensation in her stomach which she have never experienced before. She felt dizziness and shortness of breath. She fainted then she began to vomit all over (name withheld). She felt pain in her left arm, chills, and sweats. The next day (12Oct2021), she continued to have the burning sensation in her stomach. She also started feeling pain in her left side of the neck along with her left arm pain. Further in the week (Oct2021), she started feeling chest pains/palpitations. She felt the burning sensation in her stomach for a week. She released something green/dark in color in her stool. A Doctor said it appeared to be mucus. She have been to the hospital 5 times since she had the vaccine. On 17Oct2021, she was told that she had high levels of troponin and had to have her heart monitored, she was diagnosed with enteritis which is inflammation of the small intestine, transaminitis having high liver enzymes. And as of today (21Oct2021), she was still not feeling well. The events were considered as serious resulting to disability or permanent damage. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Enteritis, Faeces discoloured, Hyperhidrosis, Investigation, Liver function test
Clinical narrative: I am still not feeling well; high levels of troponin; I was diagnosed with enteritis which is inflammation of the small intestine; transaminitis having high liver enzymes; feeling pain in my left side of the neck; I fainted; I felt a burning sensation in my stomach; I felt dizziness; shortness of breath; I began to vomit all over; pain in my left arm; chills; sweats; chest pains; palpitations; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 11Oct2021 (Batch/Lot Number: FE3592) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient medical history was not reported. It was unknown if patient had known allergies. There were no concomitant medications. On 11Oct2021, immediately after receiving the first dose of the Pfizer vaccine, patient felt a burning sensation in her stomach which she have never experienced before. She felt dizziness and shortness of breath. She fainted then she began to vomit all over (name withheld). She felt pain in her left arm, chills, and sweats. The next day (12Oct2021), she continued to have the burning sensation in her stomach. She also started feeling pain in her left side of the neck along with her left arm pain. Further in the week (Oct2021), she started feeling chest pains/palpitations. She felt the burning sensation in her stomach for a week. She released something green/dark in color in her stool. A Doctor said it appeared to be mucus. She have been to the hospital 5 times since she had the vaccine. On 17Oct2021, she was told that she had high levels of troponin and had to have her heart monitored, she was diagnosed with enteritis which is inflammation of the small intestine, transaminitis having high liver enzymes. And as of today (21Oct2021), she was still not feeling well. The events were considered as serious resulting to disability or permanent damage. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mucous stools, Neck pain, Palpitations, Syncope
Clinical narrative: I am still not feeling well; high levels of troponin; I was diagnosed with enteritis which is inflammation of the small intestine; transaminitis having high liver enzymes; feeling pain in my left side of the neck; I fainted; I felt a burning sensation in my stomach; I felt dizziness; shortness of breath; I began to vomit all over; pain in my left arm; chills; sweats; chest pains; palpitations; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 11Oct2021 (Batch/Lot Number: FE3592) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient medical history was not reported. It was unknown if patient had known allergies. There were no concomitant medications. On 11Oct2021, immediately after receiving the first dose of the Pfizer vaccine, patient felt a burning sensation in her stomach which she have never experienced before. She felt dizziness and shortness of breath. She fainted then she began to vomit all over (name withheld). She felt pain in her left arm, chills, and sweats. The next day (12Oct2021), she continued to have the burning sensation in her stomach. She also started feeling pain in her left side of the neck along with her left arm pain. Further in the week (Oct2021), she started feeling chest pains/palpitations. She felt the burning sensation in her stomach for a week. She released something green/dark in color in her stool. A Doctor said it appeared to be mucus. She have been to the hospital 5 times since she had the vaccine. On 17Oct2021, she was told that she had high levels of troponin and had to have her heart monitored, she was diagnosed with enteritis which is inflammation of the small intestine, transaminitis having high liver enzymes. And as of today (21Oct2021), she was still not feeling well. The events were considered as serious resulting to disability or permanent damage. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transaminases increased, Vaccination site pain, Vomiting
Clinical narrative: I am still not feeling well; high levels of troponin; I was diagnosed with enteritis which is inflammation of the small intestine; transaminitis having high liver enzymes; feeling pain in my left side of the neck; I fainted; I felt a burning sensation in my stomach; I felt dizziness; shortness of breath; I began to vomit all over; pain in my left arm; chills; sweats; chest pains; palpitations; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 11Oct2021 (Batch/Lot Number: FE3592) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient medical history was not reported. It was unknown if patient had known allergies. There were no concomitant medications. On 11Oct2021, immediately after receiving the first dose of the Pfizer vaccine, patient felt a burning sensation in her stomach which she have never experienced before. She felt dizziness and shortness of breath. She fainted then she began to vomit all over (name withheld). She felt pain in her left arm, chills, and sweats. The next day (12Oct2021), she continued to have the burning sensation in her stomach. She also started feeling pain in her left side of the neck along with her left arm pain. Further in the week (Oct2021), she started feeling chest pains/palpitations. She felt the burning sensation in her stomach for a week. She released something green/dark in color in her stool. A Doctor said it appeared to be mucus. She have been to the hospital 5 times since she had the vaccine. On 17Oct2021, she was told that she had high levels of troponin and had to have her heart monitored, she was diagnosed with enteritis which is inflammation of the small intestine, transaminitis having high liver enzymes. And as of today (21Oct2021), she was still not feeling well. The events were considered as serious resulting to disability or permanent damage. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Computerised tomogram abdomen abnormal
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Oct2021 at 16:00 (Batch/Lot Number: 8020) (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included celiac disease and endometriosis. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. On 16Oct2021 at 06:00, the patient experienced appendicitis. The patient was hospitalized on an unspecified date due to appendicitis for 3 days. The event resulted in emergency room/department or urgent care. The patient had emergency appendectomy due to the event. Outcome of event was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Oct2021 at 16:00 (Batch/Lot Number: 8020) (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included celiac disease and endometriosis. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. On 16Oct2021 at 06:00, the patient experienced appendicitis. The patient was hospitalized on an unspecified date due to appendicitis for 3 days. The event resulted in emergency room/department or urgent care. The patient had emergency appendectomy due to the event. Outcome of event was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Chest pain, Electrocardiogram, Laboratory test, Stress cardiomyopathy
Clinical narrative: TAKO TSUBO; This is a spontaneous report from a contactable nurse (patient).  A 65-year-old non-pregnant (also at the time of vaccination) female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Right on 07Oct2021 (Batch/Lot Number: FC 3183) at the age of 65-year-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at the hospital.  Medical history included migraine, glaucoma, and hyperlipidaemia.  The patient had allergy with TOPAMAX. The patient had unspecified concomitant medications. The patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on unknown date (Batch/Lot No: EJ1685) then the 2nd dose on 14Jan2021 (Batch/Lot No: EL1238) for COVID-19 immunization. The patient then had the 3rd dose (booster) on 07Oct2021. The patient was not diagnosed with COVID-19 prior to vaccination. On 10Oct2021 08:30, the patient had chest pain radiating down both shoulders &arms then had shortness of breath (SOB). The patient then had emergency department (ED) visit and had electrocardiogram (EKG) and labs. The patient the had emergency cardiac catheterization and had a diagnosis of takotsubo the patient was then admitted in ICU overnight in Oct2021. It was also reported that the patient had doctor or other healthcare professional office/clinic visit due to the event.  The patient was hospitalized for 2 days in Oct2021. Since the vaccination, the patient been tested for COVID-19 and showed negative in nasopharyngeal on 10Oct2021. The patient received cardiac cath and medications (unspecified). The patient was recovering from the event.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Takotsubo syndrome cannot be excluded.  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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: TAKO TSUBO; This is a spontaneous report from a contactable nurse (patient).  A 65-year-old non-pregnant (also at the time of vaccination) female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Right on 07Oct2021 (Batch/Lot Number: FC 3183) at the age of 65-year-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at the hospital.  Medical history included migraine, glaucoma, and hyperlipidaemia.  The patient had allergy with TOPAMAX. The patient had unspecified concomitant medications. The patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on unknown date (Batch/Lot No: EJ1685) then the 2nd dose on 14Jan2021 (Batch/Lot No: EL1238) for COVID-19 immunization. The patient then had the 3rd dose (booster) on 07Oct2021. The patient was not diagnosed with COVID-19 prior to vaccination. On 10Oct2021 08:30, the patient had chest pain radiating down both shoulders &arms then had shortness of breath (SOB). The patient then had emergency department (ED) visit and had electrocardiogram (EKG) and labs. The patient the had emergency cardiac catheterization and had a diagnosis of takotsubo the patient was then admitted in ICU overnight in Oct2021. It was also reported that the patient had doctor or other healthcare professional office/clinic visit due to the event.  The patient was hospitalized for 2 days in Oct2021. Since the vaccination, the patient been tested for COVID-19 and showed negative in nasopharyngeal on 10Oct2021. The patient received cardiac cath and medications (unspecified). The patient was recovering from the event.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Takotsubo syndrome cannot be excluded.  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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test, SARS-CoV-2 antibody test, Stress cardiomyopathy
Clinical narrative: TAKO TSUBO; This is a spontaneous report from a contactable nurse (patient).  A 65-year-old non-pregnant (also at the time of vaccination) female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Right on 07Oct2021 (Batch/Lot Number: FC 3183) at the age of 65-year-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at the hospital.  Medical history included migraine, glaucoma, and hyperlipidaemia.  The patient had allergy with TOPAMAX. The patient had unspecified concomitant medications. The patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on unknown date (Batch/Lot No: EJ1685) then the 2nd dose on 14Jan2021 (Batch/Lot No: EL1238) for COVID-19 immunization. The patient then had the 3rd dose (booster) on 07Oct2021. The patient was not diagnosed with COVID-19 prior to vaccination. On 10Oct2021 08:30, the patient had chest pain radiating down both shoulders &arms then had shortness of breath (SOB). The patient then had emergency department (ED) visit and had electrocardiogram (EKG) and labs. The patient the had emergency cardiac catheterization and had a diagnosis of takotsubo the patient was then admitted in ICU overnight in Oct2021. It was also reported that the patient had doctor or other healthcare professional office/clinic visit due to the event.  The patient was hospitalized for 2 days in Oct2021. Since the vaccination, the patient been tested for COVID-19 and showed negative in nasopharyngeal on 10Oct2021. The patient received cardiac cath and medications (unspecified). The patient was recovering from the event.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Takotsubo syndrome cannot be excluded.  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: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Diarrhoea, Ear swelling, Erythema, Impaired work ability
Clinical narrative: Narrative:  ***NOTE: previously reported to VAERS; VAERS ID 1808079 E-Report Number 687643 date 10/22/21; please review both reports*** The patient reported the morning after COVID vaccine on 10/16/21 his face and upper lip and behind both ears were very swollen, tender and hot. Later that day his L arm was swollen, hot and red. He also reported that he had a bad rash to his face, behind ears, neck arms, chest and groin with itching and progressive worsening the next day. Pt also reported he was nauseated, with vomiting and diarrhea on the dat after the vaccine, which continued; he requested something for nausea on 10/22/21. He reports that he had to take off work on 10/18/21 and 10/19/21, and worked from home on 10/20/21. On 10/22/21 he stated he had a burning sensation to face, neck, chest, arms and genitals. Reported cold showers and cetirizine twice daily had been providing some relief. Denied shortness of breath, wheezing, coughing, dizziness and/or lightheadedness, difficulty swallowing.On physical exam 10/22/21, ear lobes erythemic and  swollen, hot and tender to touch. No swelling to tongue. Erythema and swelling to face, eyelids, earlobes, chest, neck, bilateral upper arms, with L arm > R arm, and chest with warmth to touch. On 10/26/21, patient symptoms improved, but still with rash to arms, face, and chest. Still with headache, fatigue, and diarrhea. Had dry cough and tingling feelings in his arms. On 10/29/21, patient stated ace and ears better - no longer red, hot, tingling or swelling, but L Arm and L side of chest - although improving daily - still a little red with some warmth. On physical exam, mild erythema/warmth to Left upper arm/Left side of chest. He started feeling better after taking the steroids within 46-72 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Nausea, Paraesthesia, Peripheral swelling, Rash
Clinical narrative: Narrative:  ***NOTE: previously reported to VAERS; VAERS ID 1808079 E-Report Number 687643 date 10/22/21; please review both reports*** The patient reported the morning after COVID vaccine on 10/16/21 his face and upper lip and behind both ears were very swollen, tender and hot. Later that day his L arm was swollen, hot and red. He also reported that he had a bad rash to his face, behind ears, neck arms, chest and groin with itching and progressive worsening the next day. Pt also reported he was nauseated, with vomiting and diarrhea on the dat after the vaccine, which continued; he requested something for nausea on 10/22/21. He reports that he had to take off work on 10/18/21 and 10/19/21, and worked from home on 10/20/21. On 10/22/21 he stated he had a burning sensation to face, neck, chest, arms and genitals. Reported cold showers and cetirizine twice daily had been providing some relief. Denied shortness of breath, wheezing, coughing, dizziness and/or lightheadedness, difficulty swallowing.On physical exam 10/22/21, ear lobes erythemic and  swollen, hot and tender to touch. No swelling to tongue. Erythema and swelling to face, eyelids, earlobes, chest, neck, bilateral upper arms, with L arm > R arm, and chest with warmth to touch. On 10/26/21, patient symptoms improved, but still with rash to arms, face, and chest. Still with headache, fatigue, and diarrhea. Had dry cough and tingling feelings in his arms. On 10/29/21, patient stated ace and ears better - no longer red, hot, tingling or swelling, but L Arm and L side of chest - although improving daily - still a little red with some warmth. On physical exam, mild erythema/warmth to Left upper arm/Left side of chest. He started feeling better after taking the steroids within 46-72 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Skin warm, Swelling face, Tenderness, Vomiting
Clinical narrative: Narrative:  ***NOTE: previously reported to VAERS; VAERS ID 1808079 E-Report Number 687643 date 10/22/21; please review both reports*** The patient reported the morning after COVID vaccine on 10/16/21 his face and upper lip and behind both ears were very swollen, tender and hot. Later that day his L arm was swollen, hot and red. He also reported that he had a bad rash to his face, behind ears, neck arms, chest and groin with itching and progressive worsening the next day. Pt also reported he was nauseated, with vomiting and diarrhea on the dat after the vaccine, which continued; he requested something for nausea on 10/22/21. He reports that he had to take off work on 10/18/21 and 10/19/21, and worked from home on 10/20/21. On 10/22/21 he stated he had a burning sensation to face, neck, chest, arms and genitals. Reported cold showers and cetirizine twice daily had been providing some relief. Denied shortness of breath, wheezing, coughing, dizziness and/or lightheadedness, difficulty swallowing.On physical exam 10/22/21, ear lobes erythemic and  swollen, hot and tender to touch. No swelling to tongue. Erythema and swelling to face, eyelids, earlobes, chest, neck, bilateral upper arms, with L arm > R arm, and chest with warmth to touch. On 10/26/21, patient symptoms improved, but still with rash to arms, face, and chest. Still with headache, fatigue, and diarrhea. Had dry cough and tingling feelings in his arms. On 10/29/21, patient stated ace and ears better - no longer red, hot, tingling or swelling, but L Arm and L side of chest - although improving daily - still a little red with some warmth. On physical exam, mild erythema/warmth to Left upper arm/Left side of chest. He started feeling better after taking the steroids within 46-72 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Cough, Diarrhoea, Ear swelling, Erythema
Clinical narrative: Narrative:  ***NOTE: previously reported to VAERS; VAERS ID 1808079 E-Report Number 687643 date 10/22/21; please review both reports*** The patient reported the morning after COVID vaccine on 10/16/21 his face and upper lip and behind both ears were very swollen, tender and hot. Later that day his L arm was swollen, hot and red. He also reported that he had a bad rash to his face, behind ears, neck arms, chest and groin with itching and progressive worsening the next day. Pt also reported he was nauseated, with vomiting and diarrhea on the dat after the vaccine, which continued; he requested something for nausea on 10/22/21. He reports that he had to take off work on 10/18/21 and 10/19/21, and worked from home on 10/20/21. On 10/22/21 he stated he had a burning sensation to face, neck, chest, arms and genitals. Reported cold showers and cetirizine twice daily had been providing some relief. Denied shortness of breath, wheezing, coughing, dizziness and/or lightheadedness, difficulty swallowing.On physical exam 10/22/21, ear lobes erythemic and  swollen, hot and tender to touch. No swelling to tongue. Erythema and swelling to face, eyelids, earlobes, chest, neck, bilateral upper arms, with L arm > R arm, and chest with warmth to touch. On 10/26/21, patient symptoms improved, but still with rash to arms, face, and chest. Still with headache, fatigue, and diarrhea. Had dry cough and tingling feelings in his arms. On 10/29/21, patient stated ace and ears better - no longer red, hot, tingling or swelling, but L Arm and L side of chest - although improving daily - still a little red with some warmth. On physical exam, mild erythema/warmth to Left upper arm/Left side of chest. He started feeling better after taking the steroids within 46-72 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Impaired work ability, Lip swelling, Nausea, Paraesthesia
Clinical narrative: Narrative:  ***NOTE: previously reported to VAERS; VAERS ID 1808079 E-Report Number 687643 date 10/22/21; please review both reports*** The patient reported the morning after COVID vaccine on 10/16/21 his face and upper lip and behind both ears were very swollen, tender and hot. Later that day his L arm was swollen, hot and red. He also reported that he had a bad rash to his face, behind ears, neck arms, chest and groin with itching and progressive worsening the next day. Pt also reported he was nauseated, with vomiting and diarrhea on the dat after the vaccine, which continued; he requested something for nausea on 10/22/21. He reports that he had to take off work on 10/18/21 and 10/19/21, and worked from home on 10/20/21. On 10/22/21 he stated he had a burning sensation to face, neck, chest, arms and genitals. Reported cold showers and cetirizine twice daily had been providing some relief. Denied shortness of breath, wheezing, coughing, dizziness and/or lightheadedness, difficulty swallowing.On physical exam 10/22/21, ear lobes erythemic and  swollen, hot and tender to touch. No swelling to tongue. Erythema and swelling to face, eyelids, earlobes, chest, neck, bilateral upper arms, with L arm > R arm, and chest with warmth to touch. On 10/26/21, patient symptoms improved, but still with rash to arms, face, and chest. Still with headache, fatigue, and diarrhea. Had dry cough and tingling feelings in his arms. On 10/29/21, patient stated ace and ears better - no longer red, hot, tingling or swelling, but L Arm and L side of chest - although improving daily - still a little red with some warmth. On physical exam, mild erythema/warmth to Left upper arm/Left side of chest. He started feeling better after taking the steroids within 46-72 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Skin warm, Swelling face
Clinical narrative: Narrative:  ***NOTE: previously reported to VAERS; VAERS ID 1808079 E-Report Number 687643 date 10/22/21; please review both reports*** The patient reported the morning after COVID vaccine on 10/16/21 his face and upper lip and behind both ears were very swollen, tender and hot. Later that day his L arm was swollen, hot and red. He also reported that he had a bad rash to his face, behind ears, neck arms, chest and groin with itching and progressive worsening the next day. Pt also reported he was nauseated, with vomiting and diarrhea on the dat after the vaccine, which continued; he requested something for nausea on 10/22/21. He reports that he had to take off work on 10/18/21 and 10/19/21, and worked from home on 10/20/21. On 10/22/21 he stated he had a burning sensation to face, neck, chest, arms and genitals. Reported cold showers and cetirizine twice daily had been providing some relief. Denied shortness of breath, wheezing, coughing, dizziness and/or lightheadedness, difficulty swallowing.On physical exam 10/22/21, ear lobes erythemic and  swollen, hot and tender to touch. No swelling to tongue. Erythema and swelling to face, eyelids, earlobes, chest, neck, bilateral upper arms, with L arm > R arm, and chest with warmth to touch. On 10/26/21, patient symptoms improved, but still with rash to arms, face, and chest. Still with headache, fatigue, and diarrhea. Had dry cough and tingling feelings in his arms. On 10/29/21, patient stated ace and ears better - no longer red, hot, tingling or swelling, but L Arm and L side of chest - although improving daily - still a little red with some warmth. On physical exam, mild erythema/warmth to Left upper arm/Left side of chest. He started feeling better after taking the steroids within 46-72 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tenderness, Vomiting
Clinical narrative: Narrative:  ***NOTE: previously reported to VAERS; VAERS ID 1808079 E-Report Number 687643 date 10/22/21; please review both reports*** The patient reported the morning after COVID vaccine on 10/16/21 his face and upper lip and behind both ears were very swollen, tender and hot. Later that day his L arm was swollen, hot and red. He also reported that he had a bad rash to his face, behind ears, neck arms, chest and groin with itching and progressive worsening the next day. Pt also reported he was nauseated, with vomiting and diarrhea on the dat after the vaccine, which continued; he requested something for nausea on 10/22/21. He reports that he had to take off work on 10/18/21 and 10/19/21, and worked from home on 10/20/21. On 10/22/21 he stated he had a burning sensation to face, neck, chest, arms and genitals. Reported cold showers and cetirizine twice daily had been providing some relief. Denied shortness of breath, wheezing, coughing, dizziness and/or lightheadedness, difficulty swallowing.On physical exam 10/22/21, ear lobes erythemic and  swollen, hot and tender to touch. No swelling to tongue. Erythema and swelling to face, eyelids, earlobes, chest, neck, bilateral upper arms, with L arm > R arm, and chest with warmth to touch. On 10/26/21, patient symptoms improved, but still with rash to arms, face, and chest. Still with headache, fatigue, and diarrhea. Had dry cough and tingling feelings in his arms. On 10/29/21, patient stated ace and ears better - no longer red, hot, tingling or swelling, but L Arm and L side of chest - although improving daily - still a little red with some warmth. On physical exam, mild erythema/warmth to Left upper arm/Left side of chest. He started feeling better after taking the steroids within 46-72 hours.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Lethargy, Pyrexia, Urticaria
Clinical narrative: Friday had a Temp of 101.4, broke about 3 AM and felt fine. Saturday Night Started getting Hives under her watch on wrist. Took 2 Benadryl/hydrocortisone cream. Woke up at 1:30AM and was covered on arms with Hives. Took cold shower for itching. Went away for 2 days and now they are coming and going since the shot on her arms. She continues to take benadryl without much relief.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Pruritus, Urticaria
Clinical narrative: Friday had a Temp of 101.4, broke about 3 AM and felt fine. Saturday Night Started getting Hives under her watch on wrist. Took 2 Benadryl/hydrocortisone cream. Woke up at 1:30AM and was covered on arms with Hives. Took cold shower for itching. Went away for 2 days and now they are coming and going since the shot on her arms. She continues to take benadryl without much relief.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Confusional state, Diarrhoea, Feeling abnormal
Clinical narrative: noted head rushing, confusion, dazed, difficulty concentrating, headache, muscle pains, muscle tenderness, joint pain, nausea vomiting, ringing in the ears.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Myalgia, Nausea, Vertigo, Vomiting
Clinical narrative: noted head rushing, confusion, dazed, difficulty concentrating, headache, muscle pains, muscle tenderness, joint pain, nausea vomiting, ringing in the ears.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood creatine phosphokinase increased, Confusional state, Disturbance in attention, Head discomfort
Clinical narrative: noted head rushing, confusion, dazed, difficulty concentrating, headache, muscle pains, muscle tenderness, joint pain, nausea vomiting, ringing in the ears.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Nausea, Tinnitus, Vomiting
Clinical narrative: noted head rushing, confusion, dazed, difficulty concentrating, headache, muscle pains, muscle tenderness, joint pain, nausea vomiting, ringing in the ears.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Feeling abnormal, Hyperhidrosis, Pruritus
Clinical narrative: I experienced my left arm becoming hot and sweaty, difficulty breathing, itchiness, dizziness, difficulty swallowing, lips became numb and my blood pressure became high. I also experienced fatigue, nausea, vomiting and joint aches.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: I experienced my left arm becoming hot and sweaty, difficulty breathing, itchiness, dizziness, difficulty swallowing, lips became numb and my blood pressure became high. I also experienced fatigue, nausea, vomiting and joint aches.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypertension, Hypoaesthesia oral, Nausea, Pruritus
Clinical narrative: I experienced my left arm becoming hot and sweaty, difficulty breathing, itchiness, dizziness, difficulty swallowing, lips became numb and my blood pressure became high. I also experienced fatigue, nausea, vomiting and joint aches.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Vomiting
Clinical narrative: I experienced my left arm becoming hot and sweaty, difficulty breathing, itchiness, dizziness, difficulty swallowing, lips became numb and my blood pressure became high. I also experienced fatigue, nausea, vomiting and joint aches.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER EXPIRED BY 5 HOURS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213B21A, expiry: 11-APR-2022) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced vaccine administered after expired by 5 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after expired by 5 hours was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED AFTER EXPIRED BY 5 HOURS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213B21A, expiry: 11-APR-2022) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced vaccine administered after expired by 5 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after expired by 5 hours was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN WHEN EXPIRED BY 5 HOURS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213B21A, expiry: 11-APR-2022) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced vaccine given when expired by 5 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given when expired by 5 hours was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE GIVEN WHEN EXPIRED BY 5 HOURS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213B21A, expiry: 11-APR-2022) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced vaccine given when expired by 5 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given when expired by 5 hours was not reported. This report was non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, diabetes, and congestive heart failure, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, diabetes, and congestive heart failure, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: is requesting a third dose now; is requesting a third dose now.; No additional AEs or PQC reported; patient has received PNEUMOVAX 23 in October 2011 and again in September 2014; This spontaneous report was received from a pharmacy intern and refers to a 71-year-old patient of an unknown gender. Medical history included stem cell transplant in April 2011. There was no information about the patient's concurrent conditions and conomitant medications provided.  In October 2011, the patient received first dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration).  In September 2014, the patient received second dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) (exact dose, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration).  The patient was requesting now a third dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) (inappropriate schedule of product administration; circumstance or information capable of leading to medication error). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous report was received from other health professional referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 12-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) lot # S032036, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The vaccine had expired on 10-OCT-2021 (expired product administered). Concomitant therapies included sterile diluent. lot #S024969, expiration date 17-MAR-2022.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number U016976, expiration date 24-NOV-2022 (route of administration not reported) for prophylaxis (product storage error).  The vaccine underwent a temperature excursion of 10 degrees Farhrenheit fo 6 hours. No previous temperature excursions detected.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Adverse event, Product storage error
Clinical narrative: Medical Assistant calling to report a limited adverse event on a dose of PROQUAD; PROQUAD that was administered improperly stored during a temperature excursion; This spontaneous report was received from a medical assitant referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 05-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T034614, expiration date 10-APR-2022 (route of administration not provided) for prophylaxis (product storage error).  On that same date, the patient experienced a limited adverse event.      The outcome of adverse event as well as its causal relationship with measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) were not reported.  The vaccine underwent a temperature excursion between 6 degrees Farhrenheit (°F) and 14°F, with an average of 8.5°F for 18 minutes, and between 6 degrees Farhrenheit (°F) and 14°F, with an average of 11.9°F for 1 hour. No previous temperature excursions reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant referring to a 54-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 16-SEP-2021, the patient was vaccinated with an improperly stored dose ofvaricella virus vaccine live (oka/merck)(VARIVAX) lot number T032317, expiration date 22-SEP-2022  (dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion between 6 degrees Farhrenheit (°F) and 14°F, with an average of 8.5°F for 18 minutes, and between 6 degrees Farhrenheit (°F) and 14°F, with an average of 11.9°F for 1 hour. No previous temperature excursions reported.