chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Fatigue, Hypertension
Clinical narrative: On March 14,2021 I started having the feeling of a "heavy" chest & shortness of breath as I you had a chest cold, waves of nausea and very fatigue  I slept a lot  March 15, 2021  I tried to resume my normal activity still really fatigued but tried to exercise being I was walking 4 to 5 miles a day since November  After exercising  a couple hrs later my heart felt like it was beating in my throat and racing  happened thought the night . March 16, 2021- same thing on and off all day  heart racing  flushed face, Fatigue and went into the Emergency Room around 7 pm upon arrival my blood pressure was super high (being I'm on bp pills it has never been out of control and always been regulated until
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Palpitations
Clinical narrative: On March 14,2021 I started having the feeling of a "heavy" chest & shortness of breath as I you had a chest cold, waves of nausea and very fatigue  I slept a lot  March 15, 2021  I tried to resume my normal activity still really fatigued but tried to exercise being I was walking 4 to 5 miles a day since November  After exercising  a couple hrs later my heart felt like it was beating in my throat and racing  happened thought the night . March 16, 2021- same thing on and off all day  heart racing  flushed face, Fatigue and went into the Emergency Room around 7 pm upon arrival my blood pressure was super high (being I'm on bp pills it has never been out of control and always been regulated until
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram
Clinical narrative: On March 14,2021 I started having the feeling of a "heavy" chest & shortness of breath as I you had a chest cold, waves of nausea and very fatigue  I slept a lot  March 15, 2021  I tried to resume my normal activity still really fatigued but tried to exercise being I was walking 4 to 5 miles a day since November  After exercising  a couple hrs later my heart felt like it was beating in my throat and racing  happened thought the night . March 16, 2021- same thing on and off all day  heart racing  flushed face, Fatigue and went into the Emergency Room around 7 pm upon arrival my blood pressure was super high (being I'm on bp pills it has never been out of control and always been regulated until
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing, Laboratory test, Nausea, Palpitations
Clinical narrative: On March 14,2021 I started having the feeling of a "heavy" chest & shortness of breath as I you had a chest cold, waves of nausea and very fatigue  I slept a lot  March 15, 2021  I tried to resume my normal activity still really fatigued but tried to exercise being I was walking 4 to 5 miles a day since November  After exercising  a couple hrs later my heart felt like it was beating in my throat and racing  happened thought the night . March 16, 2021- same thing on and off all day  heart racing  flushed face, Fatigue and went into the Emergency Room around 7 pm upon arrival my blood pressure was super high (being I'm on bp pills it has never been out of control and always been regulated until
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Death
Clinical narrative: Based on the medical professionals caring for her, she took the vaccine on February 28,2021.  She became fatigued and never woke up.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue
Clinical narrative: Based on the medical professionals caring for her, she took the vaccine on February 28,2021.  She became fatigued and never woke up.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Myocardial infarction
Clinical narrative: Spouse indicated her husband (deceased) complained of neck pain, head fullness, and "I just don't feel right" within the first 30 minutes post vaccine.   She indicted he laid down at home, then 3 hours later got up and went into the bathroom.  Minutes later she found him lifeless on the floor.  EMS alerted (911).  Patient was provided CPR per EMS, taken to the local hospital, where he was unsuccessfully "coded" and pronounced dead.  ECG and cardiac enzyme were consistent with STEMI.    Due to the patient's having never having had any signs or symptoms of CAD, COPD, nor diagnoses of cardiac risk beyond mild HTN, age, gender, and elevated lipids, --- nor his having any family history of CAD  ---  and due to his first post vaccine symptoms have begun only 30 minutes after its receipt, and his sudden death taking place only four hours post vaccine, --- and that his family says he was feeling fine before the vaccine and at the time of its receipt --- I ordered an autopsy.  I also had a CRP lab run off of ER labs.  This was elevated at 50.  I asked that the state coroner / MD carrying out the autopsy to look for sign of inflammation in the heart / coronary arteries.    Several weeks later -- the state coroner advised me he did indeed find "inflammatory cells" in the endothelium of the coronary vessels, "not a common finding of MIs".   He also found coronary artery disease and a rupture of the myocardium, consistent with MI.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Autopsy, C-reactive protein increased, Cardio-respiratory arrest, Coronary artery disease
Clinical narrative: Spouse indicated her husband (deceased) complained of neck pain, head fullness, and "I just don't feel right" within the first 30 minutes post vaccine.   She indicted he laid down at home, then 3 hours later got up and went into the bathroom.  Minutes later she found him lifeless on the floor.  EMS alerted (911).  Patient was provided CPR per EMS, taken to the local hospital, where he was unsuccessfully "coded" and pronounced dead.  ECG and cardiac enzyme were consistent with STEMI.    Due to the patient's having never having had any signs or symptoms of CAD, COPD, nor diagnoses of cardiac risk beyond mild HTN, age, gender, and elevated lipids, --- nor his having any family history of CAD  ---  and due to his first post vaccine symptoms have begun only 30 minutes after its receipt, and his sudden death taking place only four hours post vaccine, --- and that his family says he was feeling fine before the vaccine and at the time of its receipt --- I ordered an autopsy.  I also had a CRP lab run off of ER labs.  This was elevated at 50.  I asked that the state coroner / MD carrying out the autopsy to look for sign of inflammation in the heart / coronary arteries.    Several weeks later -- the state coroner advised me he did indeed find "inflammatory cells" in the endothelium of the coronary vessels, "not a common finding of MIs".   He also found coronary artery disease and a rupture of the myocardium, consistent with MI.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery thrombosis, Death, Electrocardiogram abnormal, Feeling abnormal, Head discomfort
Clinical narrative: Spouse indicated her husband (deceased) complained of neck pain, head fullness, and "I just don't feel right" within the first 30 minutes post vaccine.   She indicted he laid down at home, then 3 hours later got up and went into the bathroom.  Minutes later she found him lifeless on the floor.  EMS alerted (911).  Patient was provided CPR per EMS, taken to the local hospital, where he was unsuccessfully "coded" and pronounced dead.  ECG and cardiac enzyme were consistent with STEMI.    Due to the patient's having never having had any signs or symptoms of CAD, COPD, nor diagnoses of cardiac risk beyond mild HTN, age, gender, and elevated lipids, --- nor his having any family history of CAD  ---  and due to his first post vaccine symptoms have begun only 30 minutes after its receipt, and his sudden death taking place only four hours post vaccine, --- and that his family says he was feeling fine before the vaccine and at the time of its receipt --- I ordered an autopsy.  I also had a CRP lab run off of ER labs.  This was elevated at 50.  I asked that the state coroner / MD carrying out the autopsy to look for sign of inflammation in the heart / coronary arteries.    Several weeks later -- the state coroner advised me he did indeed find "inflammatory cells" in the endothelium of the coronary vessels, "not a common finding of MIs".   He also found coronary artery disease and a rupture of the myocardium, consistent with MI.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Myocardial necrosis marker, Myocardial rupture, Neck pain, Resuscitation
Clinical narrative: Spouse indicated her husband (deceased) complained of neck pain, head fullness, and "I just don't feel right" within the first 30 minutes post vaccine.   She indicted he laid down at home, then 3 hours later got up and went into the bathroom.  Minutes later she found him lifeless on the floor.  EMS alerted (911).  Patient was provided CPR per EMS, taken to the local hospital, where he was unsuccessfully "coded" and pronounced dead.  ECG and cardiac enzyme were consistent with STEMI.    Due to the patient's having never having had any signs or symptoms of CAD, COPD, nor diagnoses of cardiac risk beyond mild HTN, age, gender, and elevated lipids, --- nor his having any family history of CAD  ---  and due to his first post vaccine symptoms have begun only 30 minutes after its receipt, and his sudden death taking place only four hours post vaccine, --- and that his family says he was feeling fine before the vaccine and at the time of its receipt --- I ordered an autopsy.  I also had a CRP lab run off of ER labs.  This was elevated at 50.  I asked that the state coroner / MD carrying out the autopsy to look for sign of inflammation in the heart / coronary arteries.    Several weeks later -- the state coroner advised me he did indeed find "inflammatory cells" in the endothelium of the coronary vessels, "not a common finding of MIs".   He also found coronary artery disease and a rupture of the myocardium, consistent with MI.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Spouse indicated her husband (deceased) complained of neck pain, head fullness, and "I just don't feel right" within the first 30 minutes post vaccine.   She indicted he laid down at home, then 3 hours later got up and went into the bathroom.  Minutes later she found him lifeless on the floor.  EMS alerted (911).  Patient was provided CPR per EMS, taken to the local hospital, where he was unsuccessfully "coded" and pronounced dead.  ECG and cardiac enzyme were consistent with STEMI.    Due to the patient's having never having had any signs or symptoms of CAD, COPD, nor diagnoses of cardiac risk beyond mild HTN, age, gender, and elevated lipids, --- nor his having any family history of CAD  ---  and due to his first post vaccine symptoms have begun only 30 minutes after its receipt, and his sudden death taking place only four hours post vaccine, --- and that his family says he was feeling fine before the vaccine and at the time of its receipt --- I ordered an autopsy.  I also had a CRP lab run off of ER labs.  This was elevated at 50.  I asked that the state coroner / MD carrying out the autopsy to look for sign of inflammation in the heart / coronary arteries.    Several weeks later -- the state coroner advised me he did indeed find "inflammatory cells" in the endothelium of the coronary vessels, "not a common finding of MIs".   He also found coronary artery disease and a rupture of the myocardium, consistent with MI.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: femoral artery occlusion, right
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Chest X-ray, Laboratory test, Peripheral artery occlusion, Ultrasound scan
Clinical narrative: femoral artery occlusion, right
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Throat tightness, Tryptase, Urticaria
Clinical narrative: hives, lip swelling, shortness of breath, throat tightness
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lip swelling, Throat tightness, Urticaria
Clinical narrative: hives, lip swelling, shortness of breath, throat tightness
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anal incontinence, Chills, Constipation, Cough, Fatigue
Clinical narrative: Client reported sever GI issues began 6 hrs post vaccination; loose stools progressing to diarrhea, liquid stools, mucous stools then "tissue sloughing" with large amounts of mucous. Reported to an urgent care facility 24 hours post vaccination; recommended a high fiber diet and fluids.  GI issues continued. Reported to PCP on 3.22.21. Prescribed oral medication. Several hours after taking oral medication, stools changed to dark, "rust colored". Advised to go to the ER. ER performed an exam and Abdominal CT; dx. was inflammatory bowel. Prescribed steroid suppositories. PCP continued steroid medication for add'l. 3 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anal incontinence, Clostridium difficile infection, Functional gastrointestinal disorder
Clinical narrative: Client reported sever GI issues began 6 hrs post vaccination; loose stools progressing to diarrhea, liquid stools, mucous stools then "tissue sloughing" with large amounts of mucous. Reported to an urgent care facility 24 hours post vaccination; recommended a high fiber diet and fluids.  GI issues continued. Reported to PCP on 3.22.21. Prescribed oral medication. Several hours after taking oral medication, stools changed to dark, "rust colored". Advised to go to the ER. ER performed an exam and Abdominal CT; dx. was inflammatory bowel. Prescribed steroid suppositories. PCP continued steroid medication for add'l. 3 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Diarrhoea, Faeces discoloured, Full blood count, Inflammatory bowel disease
Clinical narrative: Client reported sever GI issues began 6 hrs post vaccination; loose stools progressing to diarrhea, liquid stools, mucous stools then "tissue sloughing" with large amounts of mucous. Reported to an urgent care facility 24 hours post vaccination; recommended a high fiber diet and fluids.  GI issues continued. Reported to PCP on 3.22.21. Prescribed oral medication. Several hours after taking oral medication, stools changed to dark, "rust colored". Advised to go to the ER. ER performed an exam and Abdominal CT; dx. was inflammatory bowel. Prescribed steroid suppositories. PCP continued steroid medication for add'l. 3 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test
Clinical narrative: Client reported sever GI issues began 6 hrs post vaccination; loose stools progressing to diarrhea, liquid stools, mucous stools then "tissue sloughing" with large amounts of mucous. Reported to an urgent care facility 24 hours post vaccination; recommended a high fiber diet and fluids.  GI issues continued. Reported to PCP on 3.22.21. Prescribed oral medication. Several hours after taking oral medication, stools changed to dark, "rust colored". Advised to go to the ER. ER performed an exam and Abdominal CT; dx. was inflammatory bowel. Prescribed steroid suppositories. PCP continued steroid medication for add'l. 3 weeks.
Sex: F
Vaccine: UNK, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: ibuprofen, and paracetamol. On 10-MAR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 13-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever. This report was non-serious.
Sex: F
Vaccine: UNK, COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: ibuprofen, and paracetamol. On 10-MAR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 13-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Fatigue, Pain, Rash
Clinical narrative: Rash (hot to touch, like a sunburn) on front of torso & R neck, burning sensation; escalation of her chronic pain (diffuse myalgias, arthralgias, neuropathy worse). Remaining symptomatic 3 weeks after initial eval.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Condition aggravated, Myalgia, Neuropathy peripheral
Clinical narrative: Rash (hot to touch, like a sunburn) on front of torso & R neck, burning sensation; escalation of her chronic pain (diffuse myalgias, arthralgias, neuropathy worse). Remaining symptomatic 3 weeks after initial eval.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Rash, Skin warm
Clinical narrative: Rash (hot to touch, like a sunburn) on front of torso & R neck, burning sensation; escalation of her chronic pain (diffuse myalgias, arthralgias, neuropathy worse). Remaining symptomatic 3 weeks after initial eval.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Influenza like illness, Rash macular
Clinical narrative: Rash (hot to touch, like a sunburn) on front of torso & R neck, burning sensation; escalation of her chronic pain (diffuse myalgias, arthralgias, neuropathy worse). Remaining symptomatic 3 weeks after initial eval.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Fainted immediately after the shot.   This is not the first time he has fainted after a shot, though.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted immediately after the shot.   This is not the first time he has fainted after a shot, though.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Onset of sx's 3/22/2021: Woke up in the middle of the night with headache, body aches, chills and low grade fever of 99.6. Sx's lasted through the week, and the patient made an appointment with PCP on 3/26/21.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia, Urine analysis
Clinical narrative: Onset of sx's 3/22/2021: Woke up in the middle of the night with headache, body aches, chills and low grade fever of 99.6. Sx's lasted through the week, and the patient made an appointment with PCP on 3/26/21.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antimitochondrial antibody, Antinuclear antibody, Borrelia test, Chills, Cytomegalovirus test
Clinical narrative: Onset of sx's 3/22/2021: Woke up in the middle of the night with headache, body aches, chills and low grade fever of 99.6. Sx's lasted through the week, and the patient made an appointment with PCP on 3/26/21.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epstein-Barr virus test, Full blood count, Headache, Hepatitis A antibody, Hepatitis A virus test
Clinical narrative: Onset of sx's 3/22/2021: Woke up in the middle of the night with headache, body aches, chills and low grade fever of 99.6. Sx's lasted through the week, and the patient made an appointment with PCP on 3/26/21.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis B core antibody, Hepatitis B surface antigen, Hepatitis C antibody, Laboratory test, Metabolic function test
Clinical narrative: Onset of sx's 3/22/2021: Woke up in the middle of the night with headache, body aches, chills and low grade fever of 99.6. Sx's lasted through the week, and the patient made an appointment with PCP on 3/26/21.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Smooth muscle antibody, Urine analysis
Clinical narrative: Onset of sx's 3/22/2021: Woke up in the middle of the night with headache, body aches, chills and low grade fever of 99.6. Sx's lasted through the week, and the patient made an appointment with PCP on 3/26/21.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Migraine, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Employee had a reaction of hives and itching after receiving the COVID vaccine.  This was documented on a clinic visit from 4/2/2021.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Employee had a reaction of hives and itching after receiving the COVID vaccine.  This was documented on a clinic visit from 4/2/2021.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Employee had a reaction of hives and itching after receiving the COVID vaccine.  This was documented on a clinic visit from 4/2/2021.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve incompetence, Brain natriuretic peptide increased, Chest X-ray abnormal, Chills, Dyspnoea
Clinical narrative: FLUID IN LUNGS; FLUID AROUND THE HEART; FLUID ON LEGS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported, frequency once total for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported.  On an unspecified date, the patient  experienced fluid on legs, fluid in lungs, and fluid around the heart and was hospitalized (date unspecified) for few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fluid on legs, fluid in lungs and fluid around the heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210420342-covid-19 vaccine ad26.cov2.s -Fluid in lungs, Fluid around the heart, Fluid on legs. This event(s) is considered unassessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Muscle tightness, Myalgia, Oedema peripheral, Pericardial effusion
Clinical narrative: FLUID IN LUNGS; FLUID AROUND THE HEART; FLUID ON LEGS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported, frequency once total for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported.  On an unspecified date, the patient  experienced fluid on legs, fluid in lungs, and fluid around the heart and was hospitalized (date unspecified) for few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fluid on legs, fluid in lungs and fluid around the heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210420342-covid-19 vaccine ad26.cov2.s -Fluid in lungs, Fluid around the heart, Fluid on legs. This event(s) is considered unassessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonitis, Pyrexia
Clinical narrative: FLUID IN LUNGS; FLUID AROUND THE HEART; FLUID ON LEGS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported, frequency once total for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported.  On an unspecified date, the patient  experienced fluid on legs, fluid in lungs, and fluid around the heart and was hospitalized (date unspecified) for few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fluid on legs, fluid in lungs and fluid around the heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210420342-covid-19 vaccine ad26.cov2.s -Fluid in lungs, Fluid around the heart, Fluid on legs. This event(s) is considered unassessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oedema peripheral, Pericardial effusion, Pulmonary oedema
Clinical narrative: FLUID IN LUNGS; FLUID AROUND THE HEART; FLUID ON LEGS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported, frequency once total for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported.  On an unspecified date, the patient  experienced fluid on legs, fluid in lungs, and fluid around the heart and was hospitalized (date unspecified) for few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fluid on legs, fluid in lungs and fluid around the heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210420342-covid-19 vaccine ad26.cov2.s -Fluid in lungs, Fluid around the heart, Fluid on legs. This event(s) is considered unassessable. The event(s) 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(s).
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypersensitivity, Pruritus, Rash
Clinical narrative: Pt received his first dose of Pfizer COVID vaccine on March 3. Subsequently developed rash 1 week later and was biopsied by Derm subsequently developed cellulitis of bx site and was given keflex. Then developed mouth ulcers/?thrush thought to possibly be Keflex side effect. Had fevers and chills week of 3/19, also body aches, anorexia, and malaise, on 4/13 he presented to ER with bilateral PE, Autoimmune hemolytic anemia (Cold agglutinin disease) and eosinophilia and skin rash resembling livido reticularuis. He was initially reported to be thrombocytopenic with platelet down to 77 but with lots of clumping. Platelet manual count reveled platelet normal at 160, however it was done after patient received IVIG and prednisone. HIT serology came back strongly positive at 2.58 however equivocal (does not neutralize heparin), patient was then switched to Xarelto.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autoimmune haemolytic anaemia, Biopsy skin abnormal, Candida infection, Chills, Decreased appetite
Clinical narrative: Pt received his first dose of Pfizer COVID vaccine on March 3. Subsequently developed rash 1 week later and was biopsied by Derm subsequently developed cellulitis of bx site and was given keflex. Then developed mouth ulcers/?thrush thought to possibly be Keflex side effect. Had fevers and chills week of 3/19, also body aches, anorexia, and malaise, on 4/13 he presented to ER with bilateral PE, Autoimmune hemolytic anemia (Cold agglutinin disease) and eosinophilia and skin rash resembling livido reticularuis. He was initially reported to be thrombocytopenic with platelet down to 77 but with lots of clumping. Platelet manual count reveled platelet normal at 160, however it was done after patient received IVIG and prednisone. HIT serology came back strongly positive at 2.58 however equivocal (does not neutralize heparin), patient was then switched to Xarelto.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eosinophilia, Heparin-induced thrombocytopenia, Injection site cellulitis, Malaise, Mouth ulceration
Clinical narrative: Pt received his first dose of Pfizer COVID vaccine on March 3. Subsequently developed rash 1 week later and was biopsied by Derm subsequently developed cellulitis of bx site and was given keflex. Then developed mouth ulcers/?thrush thought to possibly be Keflex side effect. Had fevers and chills week of 3/19, also body aches, anorexia, and malaise, on 4/13 he presented to ER with bilateral PE, Autoimmune hemolytic anemia (Cold agglutinin disease) and eosinophilia and skin rash resembling livido reticularuis. He was initially reported to be thrombocytopenic with platelet down to 77 but with lots of clumping. Platelet manual count reveled platelet normal at 160, however it was done after patient received IVIG and prednisone. HIT serology came back strongly positive at 2.58 however equivocal (does not neutralize heparin), patient was then switched to Xarelto.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pulmonary embolism, Pyrexia, Rash
Clinical narrative: Pt received his first dose of Pfizer COVID vaccine on March 3. Subsequently developed rash 1 week later and was biopsied by Derm subsequently developed cellulitis of bx site and was given keflex. Then developed mouth ulcers/?thrush thought to possibly be Keflex side effect. Had fevers and chills week of 3/19, also body aches, anorexia, and malaise, on 4/13 he presented to ER with bilateral PE, Autoimmune hemolytic anemia (Cold agglutinin disease) and eosinophilia and skin rash resembling livido reticularuis. He was initially reported to be thrombocytopenic with platelet down to 77 but with lots of clumping. Platelet manual count reveled platelet normal at 160, however it was done after patient received IVIG and prednisone. HIT serology came back strongly positive at 2.58 however equivocal (does not neutralize heparin), patient was then switched to Xarelto.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure, Dizziness, Hemiparesis, Imaging procedure, Loss of consciousness
Clinical narrative: LOSS OF MOBILITY ON LEFT SIDE; TINGLING OF FACE AND ARM; DIFFICULTY IN WALKING; NUMBNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, 3 minutes after vaccination the patient experienced loss of mobility on left side, tingling of face and arm, difficulty in walking and numbness. The patient left the place in an ambulance. She left the hospital and was still experiencing side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from loss of mobility on left side, tingling of face and arm, and difficulty in walking, and numbness. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 08-APR-2021 (Day0  08-Apr-2021). Upon review the following information was amended: Event of loss of mobility on left side was upgraded from non-serious to serious.; Sender's Comments: V1:20210416509- Covid-19 vaccine ad26.cov2.s-loss of mobility on left side. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary imaging procedure
Clinical narrative: LOSS OF MOBILITY ON LEFT SIDE; TINGLING OF FACE AND ARM; DIFFICULTY IN WALKING; NUMBNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, 3 minutes after vaccination the patient experienced loss of mobility on left side, tingling of face and arm, difficulty in walking and numbness. The patient left the place in an ambulance. She left the hospital and was still experiencing side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from loss of mobility on left side, tingling of face and arm, and difficulty in walking, and numbness. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 08-APR-2021 (Day0  08-Apr-2021). Upon review the following information was amended: Event of loss of mobility on left side was upgraded from non-serious to serious.; Sender's Comments: V1:20210416509- Covid-19 vaccine ad26.cov2.s-loss of mobility on left side. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood glucose, Dizziness, Dysarthria, Electrocardiogram
Clinical narrative: LOSS OF MOBILITY ON LEFT SIDE; TINGLING OF FACE AND ARM; DIFFICULTY IN WALKING; NUMBNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, 3 minutes after vaccination the patient experienced loss of mobility on left side, tingling of face and arm, difficulty in walking and numbness. The patient left the place in an ambulance. She left the hospital and was still experiencing side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from loss of mobility on left side, tingling of face and arm, and difficulty in walking, and numbness. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 08-APR-2021 (Day0  08-Apr-2021). Upon review the following information was amended: Event of loss of mobility on left side was upgraded from non-serious to serious.; Sender's Comments: V1:20210416509- Covid-19 vaccine ad26.cov2.s-loss of mobility on left side. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Pallor, Paraesthesia
Clinical narrative: LOSS OF MOBILITY ON LEFT SIDE; TINGLING OF FACE AND ARM; DIFFICULTY IN WALKING; NUMBNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, 3 minutes after vaccination the patient experienced loss of mobility on left side, tingling of face and arm, difficulty in walking and numbness. The patient left the place in an ambulance. She left the hospital and was still experiencing side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from loss of mobility on left side, tingling of face and arm, and difficulty in walking, and numbness. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 08-APR-2021 (Day0  08-Apr-2021). Upon review the following information was amended: Event of loss of mobility on left side was upgraded from non-serious to serious.; Sender's Comments: V1:20210416509- Covid-19 vaccine ad26.cov2.s-loss of mobility on left side. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: LOSS OF MOBILITY ON LEFT SIDE; TINGLING OF FACE AND ARM; DIFFICULTY IN WALKING; NUMBNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, 3 minutes after vaccination the patient experienced loss of mobility on left side, tingling of face and arm, difficulty in walking and numbness. The patient left the place in an ambulance. She left the hospital and was still experiencing side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from loss of mobility on left side, tingling of face and arm, and difficulty in walking, and numbness. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 08-APR-2021 (Day0  08-Apr-2021). Upon review the following information was amended: Event of loss of mobility on left side was upgraded from non-serious to serious.; Sender's Comments: V1:20210416509- Covid-19 vaccine ad26.cov2.s-loss of mobility on left side. 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.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Dehydration, Loss of consciousness, Urticaria
Clinical narrative: HEADACHE; FAINTED; POTASSIUM LOW; FALL; GENERALIZED ITCH OVER BODY; RASH OVER LEFT EYE; HIVES; FELT WEAK; This spontaneous report was received from a patient, a 55-year-old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included thyroid (sic), high blood pressure, cholesterol (sic) and penicillin allergy. The patient does not smoke and consumes alcohol only on special occasions. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with atorvastatin, and lisinopril. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: JJ041AZ1A, and expiry: unknown) dose was not reported, 1 total, administered on right arm on 01-APR-2021 at 10:08 for prophylactic vaccination. Concomitant medications included ezetimibe for 'cholesterol', diltiazem for high blood pressure, nebivolol hydrochloride for high blood pressure, levothyroxine/liothyronine for 'thyroid', liothyronine for 'thyroid', cetirizine hydrochloride, and hydrochlorothiazide.   On 01-APR-2021, post-vaccination, the patient felt weak initially. On the same day, approximately after 1-2 hours, she developed generalized itching over her body, hives and a rash developed over her left eye. On 02-APR-2021, the patient experienced dizziness, had a fall and fainted following which she visited the emergency room (ER) for further assessment. At the ER, she was given Benadryl (diphenhydramine hydrochloride), an unspecified drug for dizziness and her potassium level (NR: not provided) was found to be low at 3.1 (unit not provided). On 03-APR-2021, the patient experienced headache. On 06-APR-2021, she had a follow-up with her healthcare professional for the headache. On 08-APR-2021, she was seen by an eye doctor for the rash over her left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, and fall on 03-APR-2021, had not recovered from potassium low, rash over left eye, headache, and hives, and the outcome of generalized itch over body and felt weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417823-COVID-19 VACCINE AD26.COV2.S -Fainted. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood potassium, Blood potassium decreased, Fall, Headache
Clinical narrative: HEADACHE; FAINTED; POTASSIUM LOW; FALL; GENERALIZED ITCH OVER BODY; RASH OVER LEFT EYE; HIVES; FELT WEAK; This spontaneous report was received from a patient, a 55-year-old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included thyroid (sic), high blood pressure, cholesterol (sic) and penicillin allergy. The patient does not smoke and consumes alcohol only on special occasions. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with atorvastatin, and lisinopril. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: JJ041AZ1A, and expiry: unknown) dose was not reported, 1 total, administered on right arm on 01-APR-2021 at 10:08 for prophylactic vaccination. Concomitant medications included ezetimibe for 'cholesterol', diltiazem for high blood pressure, nebivolol hydrochloride for high blood pressure, levothyroxine/liothyronine for 'thyroid', liothyronine for 'thyroid', cetirizine hydrochloride, and hydrochlorothiazide.   On 01-APR-2021, post-vaccination, the patient felt weak initially. On the same day, approximately after 1-2 hours, she developed generalized itching over her body, hives and a rash developed over her left eye. On 02-APR-2021, the patient experienced dizziness, had a fall and fainted following which she visited the emergency room (ER) for further assessment. At the ER, she was given Benadryl (diphenhydramine hydrochloride), an unspecified drug for dizziness and her potassium level (NR: not provided) was found to be low at 3.1 (unit not provided). On 03-APR-2021, the patient experienced headache. On 06-APR-2021, she had a follow-up with her healthcare professional for the headache. On 08-APR-2021, she was seen by an eye doctor for the rash over her left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, and fall on 03-APR-2021, had not recovered from potassium low, rash over left eye, headache, and hives, and the outcome of generalized itch over body and felt weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417823-COVID-19 VACCINE AD26.COV2.S -Fainted. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE