chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Encephalopathy, Endotracheal intubation, Epstein-Barr viraemia, Fatigue, Haemodialysis
Clinical narrative: Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH.  Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemophagocytic lymphohistiocytosis, Hepatitis B core antibody positive, Hepatosplenomegaly, Hyperbilirubinaemia, Hypertriglyceridaemia
Clinical narrative: Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH.  Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker increased, Influenza like illness, Interleukin level increased, Laboratory test abnormal, Lung disorder
Clinical narrative: Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH.  Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Mental status changes, Myalgia, Natural killer cell activity normal, Procalcitonin increased
Clinical narrative: Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH.  Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Renal failure, Respiratory failure, Serum ferritin increased, Tachycardia
Clinical narrative: Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH.  Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia, Transaminases increased, Viral load increased
Clinical narrative: Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH.  Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced incorrect storage of drug. On 12-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of the incorrect storage of drug and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540069 and 20210540338.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced incorrect storage of drug. On 12-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of the incorrect storage of drug and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540069 and 20210540338.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Throat tightness
Clinical narrative: I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ew0182), via an unspecified route of administration at Left arm on 20May2021 12:00 (at the age of 33-year-old) as single for COVID-19 immunisation. Medical history included migraine, asthma and peanut allergy. Concomitant medications included rizatriptan and amitriptyline. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021 at 12:15, patient experienced i felt like my throat was swelling and closing up followed by swelling of the lip. Patient received Benadryl and Ventolin as treatment for event to reduced symptoms. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received. Therapeutic measures were taken as a result of i felt like my throat was swelling and closing up followed by swelling of the lip. The outcome of the events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Throat tightness
Clinical narrative: I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ew0182), via an unspecified route of administration at Left arm on 20May2021 12:00 (at the age of 33-year-old) as single for COVID-19 immunisation. Medical history included migraine, asthma and peanut allergy. Concomitant medications included rizatriptan and amitriptyline. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021 at 12:15, patient experienced i felt like my throat was swelling and closing up followed by swelling of the lip. Patient received Benadryl and Ventolin as treatment for event to reduced symptoms. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received. Therapeutic measures were taken as a result of i felt like my throat was swelling and closing up followed by swelling of the lip. The outcome of the events was recovering.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: Fever, bilateral arm numbness and shoulder pain
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pyrexia
Clinical narrative: Fever, bilateral arm numbness and shoulder pain
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Muscle spasms, Muscular weakness, Radiculitis brachial
Clinical narrative: On May 19 2021 and 8 hours later I could not move or use my right hand. Pain, numbness, weakness still occurring a week later.  Went to family doctor on Friday May 21 2021 and she diagnosed me with Brachial plexopathy from receiving the  vaccine. Sent me to neurologist.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brachial plexopathy, Hypoaesthesia, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: On May 19 2021 and 8 hours later I could not move or use my right hand. Pain, numbness, weakness still occurring a week later.  Went to family doctor on Friday May 21 2021 and she diagnosed me with Brachial plexopathy from receiving the  vaccine. Sent me to neurologist.
Age: 39.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Chest pain, Myocardial necrosis marker increased, Myocarditis, Pericarditis
Clinical narrative: I was in the hospital for 3 days with a heart condition.  My cardiologist thinks it was either pericarditis or myocarditis.
Age: 39.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Cardiac disorder, Myocarditis, Pericarditis
Clinical narrative: I was in the hospital for 3 days with a heart condition.  My cardiologist thinks it was either pericarditis or myocarditis.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Creatine urine increased, Feeling cold, Piloerection, Pruritus
Clinical narrative: I also have lupus and so I have some skin problems; itching on her back, bottom and back of her legs; dry skin; little chill bumps; This is a spontaneous report received from a contactable consumer (patient). This 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received two cortisone shots in ankle one on 12Jan2021 and the second was 08Feb2021 which was two days before she had first COVID shot. Patient previously received first dose on 10Feb2021 for COVID-19 immunization, and she did not have any immediately reactions and she sat at the clinic for 20 minutes and then went home. She was fine until the second day after the first dose she had a small amount of itching on her lower back when she went to shower, but it went away. After the second dose she started itching on her back, bottom and back of her legs and she showered and put lotion on because she had dry skin. That did not help so she took a diphenhydramine hydrochloride (BENADRYL), which helped and she was able to sleep. She reported that since then the had been having to take diphenhydramine hydrochloride nightly to be able to sleep because of the itching, she had to wake her husband up in the middle of the night to scratch back, its not too bad during the day but once she changed clothes or went to shower then it really started itching. She also had lupus and so she had some skin problems anyway. She called doctor and he sent her in some topical cream to put on itchy areas but it was three small tubes and its not enough to get to all the areas one to two times daily. It was Triamcinolone 0.1 ointment that he sent in. She didn't have a rash at all it just felt like a have little chill bumps but there was no redness or rash. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine calcium
Clinical narrative: I also have lupus and so I have some skin problems; itching on her back, bottom and back of her legs; dry skin; little chill bumps; This is a spontaneous report received from a contactable consumer (patient). This 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received two cortisone shots in ankle one on 12Jan2021 and the second was 08Feb2021 which was two days before she had first COVID shot. Patient previously received first dose on 10Feb2021 for COVID-19 immunization, and she did not have any immediately reactions and she sat at the clinic for 20 minutes and then went home. She was fine until the second day after the first dose she had a small amount of itching on her lower back when she went to shower, but it went away. After the second dose she started itching on her back, bottom and back of her legs and she showered and put lotion on because she had dry skin. That did not help so she took a diphenhydramine hydrochloride (BENADRYL), which helped and she was able to sleep. She reported that since then the had been having to take diphenhydramine hydrochloride nightly to be able to sleep because of the itching, she had to wake her husband up in the middle of the night to scratch back, its not too bad during the day but once she changed clothes or went to shower then it really started itching. She also had lupus and so she had some skin problems anyway. She called doctor and he sent her in some topical cream to put on itchy areas but it was three small tubes and its not enough to get to all the areas one to two times daily. It was Triamcinolone 0.1 ointment that he sent in. She didn't have a rash at all it just felt like a have little chill bumps but there was no redness or rash. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dry skin, Pruritus, Systemic lupus erythematosus
Clinical narrative: I also have lupus and so I have some skin problems; itching on her back, bottom and back of her legs; dry skin; little chill bumps; This is a spontaneous report received from a contactable consumer (patient). This 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received two cortisone shots in ankle one on 12Jan2021 and the second was 08Feb2021 which was two days before she had first COVID shot. Patient previously received first dose on 10Feb2021 for COVID-19 immunization, and she did not have any immediately reactions and she sat at the clinic for 20 minutes and then went home. She was fine until the second day after the first dose she had a small amount of itching on her lower back when she went to shower, but it went away. After the second dose she started itching on her back, bottom and back of her legs and she showered and put lotion on because she had dry skin. That did not help so she took a diphenhydramine hydrochloride (BENADRYL), which helped and she was able to sleep. She reported that since then the had been having to take diphenhydramine hydrochloride nightly to be able to sleep because of the itching, she had to wake her husband up in the middle of the night to scratch back, its not too bad during the day but once she changed clothes or went to shower then it really started itching. She also had lupus and so she had some skin problems anyway. She called doctor and he sent her in some topical cream to put on itchy areas but it was three small tubes and its not enough to get to all the areas one to two times daily. It was Triamcinolone 0.1 ointment that he sent in. She didn't have a rash at all it just felt like a have little chill bumps but there was no redness or rash. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported at 1 total, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in MAY-2021, the patient experienced pulmonary embolism and died from pulmonary embolism. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The medical examiner ruled that the cause of death was due to a pulmonary embolism and did not believe that the pulmonary embolism was caused by the covid-19 vaccine ad26.cov2.s and the reporter causality was not related to covid-19 vaccine ad26.cov2.s and where as company causality was possible to covid-19 vaccine ad26.cov2.s. This report was serious (Death).; Sender's Comments: V0- 20210537420 - Covid-19 vaccine ad26.cov2.s-pulmonary embolism This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: PULMONARY EMBOLISM
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported at 1 total, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in MAY-2021, the patient experienced pulmonary embolism and died from pulmonary embolism. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The medical examiner ruled that the cause of death was due to a pulmonary embolism and did not believe that the pulmonary embolism was caused by the covid-19 vaccine ad26.cov2.s and the reporter causality was not related to covid-19 vaccine ad26.cov2.s and where as company causality was possible to covid-19 vaccine ad26.cov2.s. This report was serious (Death).; Sender's Comments: V0- 20210537420 - Covid-19 vaccine ad26.cov2.s-pulmonary embolism This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: PULMONARY EMBOLISM
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head injury, Syncope
Clinical narrative: syncopal episode from standing, hit head
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Syncope
Clinical narrative: syncopal episode from standing, hit head
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Interchange of vaccine products
Clinical narrative: swelling in throat, very similar to previous vaccination Patient received Moderna # 1 on Jan 15th had difficulty swallowing, tingling on tongue and jitters Patient was recommended by PCP who also consulted H to receive the Janssen Vaccine.  Vaccine clinic spoke with ID specialist and looked at recommendation and decided to proceed with vaccinating patient
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Pharyngeal swelling
Clinical narrative: swelling in throat, very similar to previous vaccination Patient received Moderna # 1 on Jan 15th had difficulty swallowing, tingling on tongue and jitters Patient was recommended by PCP who also consulted H to receive the Janssen Vaccine.  Vaccine clinic spoke with ID specialist and looked at recommendation and decided to proceed with vaccinating patient
Age: 78.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Tinnitus
Clinical narrative: tinnitus, throat feeling tight
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Endotracheal intubation, Intensive care, Pyrexia, Resuscitation
Clinical narrative: FEVER, PASSED OUT, CARDIACT ARREST
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: FEVER, PASSED OUT, CARDIACT ARREST
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Computerised tomogram, Dizziness, Echocardiogram
Clinical narrative: FEVER, PASSED OUT, CARDIACT ARREST
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electroencephalogram, Headache, Injected limb mobility decreased, Injection site reaction, Magnetic resonance imaging
Clinical narrative: FEVER, PASSED OUT, CARDIACT ARREST
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Syncope
Clinical narrative: FEVER, PASSED OUT, CARDIACT ARREST
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Loss of consciousness, Pyrexia
Clinical narrative: FEVER, PASSED OUT, CARDIACT ARREST
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Anticoagulant therapy, Chest pain, Electrocardiogram normal, Pulmonary embolism
Clinical narrative: chest pain; myocarditis
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: chest pain; myocarditis
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Cardiac imaging procedure abnormal, Chest pain, Echocardiogram abnormal, Myocarditis
Clinical narrative: chest pain; myocarditis
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: SEQUENTIAL USE WITH MRNA VACCINE; This spontaneous report received from a health care professional concerned a 20 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient was previously treated with mrna 1273 for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sequential use with mrna vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use with mrna vaccine was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: SEQUENTIAL USE WITH MRNA VACCINE; This spontaneous report received from a health care professional concerned a 20 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient was previously treated with mrna 1273 for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sequential use with mrna vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use with mrna vaccine was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram normal, Tachycardia
Clinical narrative: Less than one minute upon receiving the injection my heart rate was elevated and continue to rise. Upon resting it remained at 120 bpm. My normal resting heart rate is 50. I could not get it to slow down with deep breathing. I was quickly monitored in my blood pressure was 157/90. My normal is 115/75. After 10 minutes it decreased to around 85 bpm at rest and 134/90 BP. I waited and it begin to rise again after five minutes. I felt dizzy and was monitored again and placed in a declined position. At this point my blood pressure was discovered to be high again and heart rate back up and they felt an irregular heartbeat. They recommended I go to the ER.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest discomfort, Dizziness, Electrocardiogram, Heart rate increased
Clinical narrative: Less than one minute upon receiving the injection my heart rate was elevated and continue to rise. Upon resting it remained at 120 bpm. My normal resting heart rate is 50. I could not get it to slow down with deep breathing. I was quickly monitored in my blood pressure was 157/90. My normal is 115/75. After 10 minutes it decreased to around 85 bpm at rest and 134/90 BP. I waited and it begin to rise again after five minutes. I felt dizzy and was monitored again and placed in a declined position. At this point my blood pressure was discovered to be high again and heart rate back up and they felt an irregular heartbeat. They recommended I go to the ER.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Hypertension, Immediate post-injection reaction
Clinical narrative: Less than one minute upon receiving the injection my heart rate was elevated and continue to rise. Upon resting it remained at 120 bpm. My normal resting heart rate is 50. I could not get it to slow down with deep breathing. I was quickly monitored in my blood pressure was 157/90. My normal is 115/75. After 10 minutes it decreased to around 85 bpm at rest and 134/90 BP. I waited and it begin to rise again after five minutes. I felt dizzy and was monitored again and placed in a declined position. At this point my blood pressure was discovered to be high again and heart rate back up and they felt an irregular heartbeat. They recommended I go to the ER.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Amphetamines negative, Amylase normal, Analgesic drug level, Analgesic drug level therapeutic
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anion gap, Antidepressant drug level, Aspartate aminotransferase normal, Bacterial test, Barbiturates negative
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basophil count decreased, Basophil percentage, Bilirubin urine, Blood albumin normal, Blood alcohol normal
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin decreased, Blood calcium normal, Blood chloride normal
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal, Blood lactic acid decreased, Blood magnesium normal
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood osmolarity decreased, Blood pH normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone decreased
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea decreased, Blood urine, Chromaturia, Computerised tomogram head normal, Conversion disorder
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crystal urine absent, Drug screen, Emotional distress, Eosinophil count normal, Eosinophil percentage
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear of injection, Fungal test negative, Glucose urine, Haematocrit normal, Haemoglobin normal
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Human chorionic gonadotropin negative, Immature granulocyte count, Laboratory test, Lipase normal, Lymphocyte count normal
Clinical narrative: After receiving the vaccine, patient felt faint. She was given water, juice, and candy. She was observed for a half hour. After she went to health class. She was not able to focus enough to type. She then went to her next class. She was told to put four apples into a bag. She still didn't feel well. She would put 5-10 apples in a bag. She then had a blank stare. Her teacher took her to the office. At 11:30 she began shaking uncontrollably. She was transported to the local ER. She had a normal CT scan of the head. She continued to shake and was transported to Hospital. The following morning she was given an EEG which was normal. The neurologist felt that her symptoms would resolve with time. She continues to shake and stutter one week out.