chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lipase normal, Lymphocyte count decreased, Lymphocyte count normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mean cell volume normal, Mean platelet volume normal, Metabolic function test, Monocyte count, Monocyte count normal
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neutrophil count increased, Neutrophil percentage decreased, Platelet count normal, Pulmonary embolism, Pulmonary mass
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell count normal, Red cell distribution width normal, Tachycardia, White blood cell count normal
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchiectasis, Computerised tomogram thorax abnormal, Haemoptysis, Platelet count normal, Pulmonary embolism
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary mass, Ultrasound scan normal, White blood cell count normal
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Haemoptysis, Headache, Night sweats, Pulmonary thrombosis
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Close exposure to COVID-19 virus  Care Coordination Progress Note RN (Registered Nurse)    COVID 19 MAB Infusion Navigator Post Infusion Outreach #1   Infusion Date: 4/12    Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Close exposure to COVID-19 virus  Care Coordination Progress Note RN (Registered Nurse)    COVID 19 MAB Infusion Navigator Post Infusion Outreach #1   Infusion Date: 4/12    Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Contact with and (suspected) exposure to covid-19 Dx
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Headache, Hypoaesthesia, Hypoaesthesia eye, Magnetic resonance imaging
Clinical narrative: MIGRAINE; NUMBNESS ON LEGS AND FACE; EXTREME NAUSEA; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, numbness on legs and face, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, extreme nausea and numbness on legs and face was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms, Nausea
Clinical narrative: MIGRAINE; NUMBNESS ON LEGS AND FACE; EXTREME NAUSEA; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, numbness on legs and face, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, extreme nausea and numbness on legs and face was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Echocardiogram
Clinical narrative: MIGRAINE; NUMBNESS ON LEGS AND FACE; EXTREME NAUSEA; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, numbness on legs and face, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, extreme nausea and numbness on legs and face was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging, Migraine, Nausea
Clinical narrative: MIGRAINE; NUMBNESS ON LEGS AND FACE; EXTREME NAUSEA; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, numbness on legs and face, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, extreme nausea and numbness on legs and face was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Venogram, Weight decreased
Clinical narrative: MIGRAINE; NUMBNESS ON LEGS AND FACE; EXTREME NAUSEA; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, numbness on legs and face, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, extreme nausea and numbness on legs and face was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Migraine, Nausea
Clinical narrative: MIGRAINE; NUMBNESS ON LEGS AND FACE; EXTREME NAUSEA; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, numbness on legs and face, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, extreme nausea and numbness on legs and face was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Increased tendency to bruise, Platelet count decreased
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute promyelocytic leukaemia, Biopsy bone marrow abnormal, Contusion, Gingival bleeding, Immunoglobulin therapy
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Leukocytosis, Platelet count decreased, Thrombocytopenia, White blood cell count increased
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Gingival bleeding, Hypoxia, Leukocytosis, Petechiae
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Respiratory failure, Shock, Thrombocytopenia, White blood cell count increased
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute leukaemia, Condition aggravated, Thrombocytopenia
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Thrombocytopenia
Clinical narrative: severe thrombocytopenia, ?worsening of acute leukemia
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: MAJOR HEART ATTACK, GOT PLACED WITH A STENT; This spontaneous report received from a patient concerned a 70-year-old male. The patient's weight, height, and medical history were not reported. Prior to the vaccination, patient was never on any medication. Patient had no pre-existing conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: not reported) dose was not reported, 1 total administered on 04-MAY-2021 at 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, four days after vaccination, the patient experienced major heart attack due to which he went in an ambulance (his spouse called 911) and was hospitalized on the same day. Patient was placed in ICU (intensive care unit) and got step down. On 10-MAY-2021, patient was discharged and he went home with a life vest. Patient was hospitalized for 3 days. No other side effects were reported. Patient got placed with a stent. Patient was discharged with Treatment medications (dates unspecified): lipitor 80 mg, losartan potassium 25 mg, plavix 75 mg, metoprolol succinate extended release 50mg, and baby aspirin 81 mg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from major heart attack on 17-MAY-2021. This report was serious (Hospitalization).; Sender's Comments: V0; 20210535227 -covid-19 vaccine ad26.cov2. s major heart attack. 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
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: GENERAL PAIN HURTING; INJECTION SITE RED; PAINFUL INJECTION SITE; INJECTION SITE HOT; 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: 201AZ1A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced injection site hot. On MAY-2021, the subject experienced injection site red. On MAY-2021, the subject experienced painful injection site. Treatment medications included: paracetamol. On 16-MAY-2021, the subject experienced general pain hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site red, painful injection site, injection site hot, and general pain hurting. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: I gave the vaccine 50 minutes outside the 6 hour window. I called patient and told her if she wanted another one we could give her one. She said it was fine and that she was not interested in getting a second one
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: I gave the vaccine 50 minutes outside the 6 hour window. I called patient and told her if she wanted another one we could give her one. She said it was fine and that she was not interested in getting a second one
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood disorder, Chest discomfort, Chest pain, Discomfort, Dizziness
Clinical narrative: Blood Clots (2 PE in right lung) Chills Memory Loss Numbness in limbs  Tingling in limbs Muscle weakness Rapid Heart Beat
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Palpitations, Pulmonary embolism, Tachycardia
Clinical narrative: Blood Clots (2 PE in right lung) Chills Memory Loss Numbness in limbs  Tingling in limbs Muscle weakness Rapid Heart Beat
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Chills, Computerised tomogram abnormal, Heart rate increased, Hypoaesthesia
Clinical narrative: Blood Clots (2 PE in right lung) Chills Memory Loss Numbness in limbs  Tingling in limbs Muscle weakness Rapid Heart Beat
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: Blood Clots (2 PE in right lung) Chills Memory Loss Numbness in limbs  Tingling in limbs Muscle weakness Rapid Heart Beat
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Hypoaesthesia, Pericarditis, Pleuritic pain
Clinical narrative: 5/18 chest pain when taking a deep breath, went to primary care and urgent care. The symptom relieved later. 5/19 hollowness and tightness on the left chest, numbness on the left arm, went to urgent care and transferred to ER because of abnormal cardiac enzymes. Hospitalized overnight. 5/20 Diagnosed with myocarditis. Discharged at 7pm.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: 5/18 chest pain when taking a deep breath, went to primary care and urgent care. The symptom relieved later. 5/19 hollowness and tightness on the left chest, numbness on the left arm, went to urgent care and transferred to ER because of abnormal cardiac enzymes. Hospitalized overnight. 5/20 Diagnosed with myocarditis. Discharged at 7pm.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Hypoaesthesia, Myocardial necrosis marker, Myocarditis
Clinical narrative: 5/18 chest pain when taking a deep breath, went to primary care and urgent care. The symptom relieved later. 5/19 hollowness and tightness on the left chest, numbness on the left arm, went to urgent care and transferred to ER because of abnormal cardiac enzymes. Hospitalized overnight. 5/20 Diagnosed with myocarditis. Discharged at 7pm.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Painful respiration
Clinical narrative: 5/18 chest pain when taking a deep breath, went to primary care and urgent care. The symptom relieved later. 5/19 hollowness and tightness on the left chest, numbness on the left arm, went to urgent care and transferred to ER because of abnormal cardiac enzymes. Hospitalized overnight. 5/20 Diagnosed with myocarditis. Discharged at 7pm.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Eating disorder, Oral discomfort, Speech disorder, Swollen tongue
Clinical narrative: Patient called PCP office on May5th, 2021 stated that 30-45minutes after receiving the vaccine on the 4/30 2021 that her mouth, tongue and gum, root of mouth was dark red and felt like she had burned her mouth, she was advised to go to the nearest Emergency room, but refused to have gone for treatment. Patient went to  see PCP on May 10th, no medication was ordered.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort, Tongue erythema
Clinical narrative: Patient called PCP office on May5th, 2021 stated that 30-45minutes after receiving the vaccine on the 4/30 2021 that her mouth, tongue and gum, root of mouth was dark red and felt like she had burned her mouth, she was advised to go to the nearest Emergency room, but refused to have gone for treatment. Patient went to  see PCP on May 10th, no medication was ordered.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival erythema, Oral discomfort, Oral mucosal erythema, Tongue erythema
Clinical narrative: Patient called PCP office on May5th, 2021 stated that 30-45minutes after receiving the vaccine on the 4/30 2021 that her mouth, tongue and gum, root of mouth was dark red and felt like she had burned her mouth, she was advised to go to the nearest Emergency room, but refused to have gone for treatment. Patient went to  see PCP on May 10th, no medication was ordered.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysphagia, Hypersensitivity, Pruritus, Swelling face
Clinical narrative: With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face broke out in hives and patient was shivering.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face broke out in hives and patient was shivering.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Lip swelling, Paraesthesia oral, Throat irritation, Urticaria
Clinical narrative: With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face broke out in hives and patient was shivering.
Age: 33.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: GAVE THE VACCINE 9 HOURS AFTER  DRAWING THE VACCINE; This spontaneous report received from a pharmacist concerned a 33 year old of unspecified 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced gave the vaccine 9 hours after drawing the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gave the vaccine 9 hours after drawing the vaccine was not reported. This report was non-serious.
Age: 33.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: GAVE THE VACCINE 9 HOURS AFTER  DRAWING THE VACCINE; This spontaneous report received from a pharmacist concerned a 33 year old of unspecified 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced gave the vaccine 9 hours after drawing the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gave the vaccine 9 hours after drawing the vaccine was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: 5/11/2021 DEVELOPED WHAT HE DESCRIBED AS RED BLOTCHES THAT BECOME MORE PRONOUNCED ON HIS CHEST.  HE APPLIED BENADRYL TOPICALLY.  ON 5/20/2021, AGAIN DEVELOPED BLOTCHES ON HIS THIGHS AND ALSO STATED THAT THE RIGHT SIDE OF THIS FACE WAS SWOLLEN & FELT LIKE HIS LIPS WERE BRUISED.  HE FILLED OUT A VAERS REPORT 525166 ON HIS OWN ON 5/20/2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oral discomfort, Rash, Rash macular, Swelling face
Clinical narrative: 5/11/2021 DEVELOPED WHAT HE DESCRIBED AS RED BLOTCHES THAT BECOME MORE PRONOUNCED ON HIS CHEST.  HE APPLIED BENADRYL TOPICALLY.  ON 5/20/2021, AGAIN DEVELOPED BLOTCHES ON HIS THIGHS AND ALSO STATED THAT THE RIGHT SIDE OF THIS FACE WAS SWOLLEN & FELT LIKE HIS LIPS WERE BRUISED.  HE FILLED OUT A VAERS REPORT 525166 ON HIS OWN ON 5/20/2021.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Patient felt warm, numbness in arms and legs, throat got numb and "tight."  Patient given Benedryl 50mg IV and transported to ER by EMS.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: Patient felt warm, numbness in arms and legs, throat got numb and "tight."  Patient given Benedryl 50mg IV and transported to ER by EMS.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Rash
Clinical narrative: Patient stated she took the vaccine on 2/23/21 and about 10 mins after she started itching and realized she had a rash on stomach, back, and chest and she felt flushed to the face and also a little rash on the neck. No c/o fever, body aches, fatigue and sob. As of 5/24/21 patient has no other symptoms and isn't feeling any symptoms. She stated her symptoms have already subsided 3 hours after the vaccine.  Patient reported she called her PCP to report the reaction, PCP informed her not to get the 2nd vaccine. Patient is allergic to polyethylene glycol
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: Patient stated she took the vaccine on 2/23/21 and about 10 mins after she started itching and realized she had a rash on stomach, back, and chest and she felt flushed to the face and also a little rash on the neck. No c/o fever, body aches, fatigue and sob. As of 5/24/21 patient has no other symptoms and isn't feeling any symptoms. She stated her symptoms have already subsided 3 hours after the vaccine.  Patient reported she called her PCP to report the reaction, PCP informed her not to get the 2nd vaccine. Patient is allergic to polyethylene glycol
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Rash morbilliform
Clinical narrative: Patient stated she took the vaccine on 2/23/21 and about 10 mins after she started itching and realized she had a rash on stomach, back, and chest and she felt flushed to the face and also a little rash on the neck. No c/o fever, body aches, fatigue and sob. As of 5/24/21 patient has no other symptoms and isn't feeling any symptoms. She stated her symptoms have already subsided 3 hours after the vaccine.  Patient reported she called her PCP to report the reaction, PCP informed her not to get the 2nd vaccine. Patient is allergic to polyethylene glycol
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced incorrect storage of drug, and poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of drug and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540338.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced incorrect storage of drug, and poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of drug and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540338.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Aphonia, Blindness, Blood test, Cerebrovascular accident
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Paralysis, Thrombosis, Transient ischaemic attack
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Fibrin D dimer
Clinical narrative: chest pain some of which had predated the vaccination but acutely worsened the evening after the vaccination,  followed by emesis, fever, myalgias. not resolving with usual asthma treatment.  Chest pain worsened over 24 - 48 hours resulting in evaluation in the ER.  Diagnosed with myopericarditis baseline EKG and lab work as below
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Myocarditis, Troponin
Clinical narrative: chest pain some of which had predated the vaccination but acutely worsened the evening after the vaccination,  followed by emesis, fever, myalgias. not resolving with usual asthma treatment.  Chest pain worsened over 24 - 48 hours resulting in evaluation in the ER.  Diagnosed with myopericarditis baseline EKG and lab work as below
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Condition aggravated, Echocardiogram normal, Electrocardiogram ST segment abnormal, Intensive care
Clinical narrative: chest pain some of which had predated the vaccination but acutely worsened the evening after the vaccination,  followed by emesis, fever, myalgias. not resolving with usual asthma treatment.  Chest pain worsened over 24 - 48 hours resulting in evaluation in the ER.  Diagnosed with myopericarditis baseline EKG and lab work as below
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Myocarditis, Pyrexia, Vomiting
Clinical narrative: chest pain some of which had predated the vaccination but acutely worsened the evening after the vaccination,  followed by emesis, fever, myalgias. not resolving with usual asthma treatment.  Chest pain worsened over 24 - 48 hours resulting in evaluation in the ER.  Diagnosed with myopericarditis baseline EKG and lab work as below