chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Pulmonary haemorrhage
Clinical narrative: passed away; blood in lungs; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) and PULMONARY HAEMORRHAGE (blood in lungs) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DEATH (passed away) (seriousness criteria death and medically significant) and PULMONARY HAEMORRHAGE (blood in lungs) (seriousness criteria death and medically significant). The patient died on 18-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.; Reported Cause(s) of Death: unknown cause of death
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Malaise, Pollakiuria, Pulmonary embolism, Thrombosis
Clinical narrative: Went to ICU with 4 blood clots  in the left leg from the hip-down; Pulmonary embolism; Unable to walk; Used to go to the bathroom (pee) 3-4 times at night; Not too well; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down) and PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included High cholesterol and Nerve pain. Concomitant products included ATORVASTATIN for High cholesterol, GABAPENTIN for Nerve pain, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well). The patient was treated with Surgery (To clear blood clots) for Thrombosis. At the time of the report, THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down), PULMONARY EMBOLISM (Pulmonary embolism), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inconclusive (Inconclusive) His lungs were clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the  2nd dose on 23rd or 24th of February 2021.   Patient reported being in ICU for 9 days and in acute care for 2 days. Prior to the surgery to clear blood clots, the Eliquis was stopped, had staples, put tubes through for the surgery and was put back on Eliquis afterwards.; 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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Went to ICU with 4 blood clots  in the left leg from the hip-down; Pulmonary embolism; Unable to walk; Used to go to the bathroom (pee) 3-4 times at night; Not too well; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down) and PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included High cholesterol and Nerve pain. Concomitant products included ATORVASTATIN for High cholesterol, GABAPENTIN for Nerve pain, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well). The patient was treated with Surgery (To clear blood clots) for Thrombosis. At the time of the report, THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down), PULMONARY EMBOLISM (Pulmonary embolism), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inconclusive (Inconclusive) His lungs were clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the  2nd dose on 23rd or 24th of February 2021.   Patient reported being in ICU for 9 days and in acute care for 2 days. Prior to the surgery to clear blood clots, the Eliquis was stopped, had staples, put tubes through for the surgery and was put back on Eliquis afterwards.; 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Dysgeusia, Ear discomfort, Ear pain
Clinical narrative: Inflamed right inner ear; Fluid in the right ear; Loss of hearing in the Right  Ear; Tinnitus Right Ear; Right Ear Hurts; Tight Inner Right Ear; Metallic Taste in the mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis. Concurrent medical conditions included Seasonal allergy and Deviated nasal septum.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Metallic Taste in the mouth). On 09-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear) (seriousness criterion medically significant), TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear). In May 2021, the patient experienced INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear). On 08-Apr-2021, DYSGEUSIA (Metallic Taste in the mouth) had resolved. On 30-May-2021, DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear), INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear) had resolved. At the time of the report, TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Acoustic stimulation tests: normal (normal) her sense of hearing had come back to normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment include Drained fluid from the Ear.  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.; 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inner ear inflammation, Middle ear effusion, Tinnitus
Clinical narrative: Inflamed right inner ear; Fluid in the right ear; Loss of hearing in the Right  Ear; Tinnitus Right Ear; Right Ear Hurts; Tight Inner Right Ear; Metallic Taste in the mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis. Concurrent medical conditions included Seasonal allergy and Deviated nasal septum.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Metallic Taste in the mouth). On 09-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear) (seriousness criterion medically significant), TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear). In May 2021, the patient experienced INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear). On 08-Apr-2021, DYSGEUSIA (Metallic Taste in the mouth) had resolved. On 30-May-2021, DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear), INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear) had resolved. At the time of the report, TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Acoustic stimulation tests: normal (normal) her sense of hearing had come back to normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment include Drained fluid from the Ear.  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.; 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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cough, Feeling cold, Headache, Hypoxia, Lower respiratory tract infection
Clinical narrative: Feeling cold; Oxygen saturation low; Intermittent headache; Feeling unwell; Pain in arm; Cough; Phlegm; Hypoxemia; Chest cold; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOXIA (Hypoxemia) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.  The patient's past medical history included Blood pressure high, Urinary tract disorder, Non-smoker and Abstains from alcohol. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for Blood pressure high, TAMSULOSIN for Urinary tract disorder.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). In June 2021, the patient experienced MALAISE (Feeling unwell), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache). In 2021, the patient experienced HYPOXIA (Hypoxemia) (seriousness criterion medically significant), LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm). On an unknown date, the patient experienced FEELING COLD (Feeling cold). In 2021, HYPOXIA (Hypoxemia), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm) had resolved. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold), MALAISE (Feeling unwell), PAIN IN EXTREMITY (Pain in arm), FEELING COLD (Feeling cold), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Oxygen saturation: 85 % (Low) 85.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Reporter stated that patient had other concomitant therapy of supplemental oxygen.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise, Oxygen saturation, Oxygen saturation decreased, Pain in extremity, Productive cough
Clinical narrative: Feeling cold; Oxygen saturation low; Intermittent headache; Feeling unwell; Pain in arm; Cough; Phlegm; Hypoxemia; Chest cold; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOXIA (Hypoxemia) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.  The patient's past medical history included Blood pressure high, Urinary tract disorder, Non-smoker and Abstains from alcohol. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for Blood pressure high, TAMSULOSIN for Urinary tract disorder.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). In June 2021, the patient experienced MALAISE (Feeling unwell), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache). In 2021, the patient experienced HYPOXIA (Hypoxemia) (seriousness criterion medically significant), LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm). On an unknown date, the patient experienced FEELING COLD (Feeling cold). In 2021, HYPOXIA (Hypoxemia), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm) had resolved. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold), MALAISE (Feeling unwell), PAIN IN EXTREMITY (Pain in arm), FEELING COLD (Feeling cold), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Oxygen saturation: 85 % (Low) 85.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Reporter stated that patient had other concomitant therapy of supplemental oxygen.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Therapeutic response shortened
Clinical narrative: Ankylosing spondylitis relapse; Wearing off effect; This spontaneous case was reported by a physician and describes the occurrence of ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) had not resolved and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) to be possibly related. No further causality assessment was provided for THERAPEUTIC RESPONSE SHORTENED (Wearing off effect).    Concomitant medications were not provided.  Treatment information was unknown.  The event Therapeutic response shortened " was reported for the co-suspect drug humira.  Company comment: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Coronary artery bypass, Diarrhoea, Dizziness, Nausea
Clinical narrative: Triple vessel bypass graft; Fractured wrist/ Wrist fracture; Osteopenia; Leg pain/ Pain in extremity; Diarrhea/ Diarrhoea; Dizzy spells/ Dizziness; Pain in hip/ Arthralgia; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of CORONARY ARTERY BYPASS (Triple vessel bypass graft), WRIST FRACTURE (Fractured wrist/ Wrist fracture), OSTEOPENIA (Osteopenia), PAIN IN EXTREMITY (Leg pain/ Pain in extremity), DIARRHOEA (Diarrhea/ Diarrhoea), DIZZINESS (Dizzy spells/ Dizziness), ARTHRALGIA (Pain in hip/ Arthralgia) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Triple vessel bypass graft (Coronary artery bypass). Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate free. In January 2021, the patient experienced WRIST FRACTURE (Fractured wrist/ Wrist fracture) (seriousness criterion hospitalization), OSTEOPENIA (Osteopenia) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Leg pain/ Pain in extremity) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea/ Diarrhoea) (seriousness criterion hospitalization), DIZZINESS (Dizzy spells/ Dizziness) (seriousness criterion hospitalization), ARTHRALGIA (Pain in hip/ Arthralgia) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). On an unknown date, the patient experienced CORONARY ARTERY BYPASS (Triple vessel bypass graft) (seriousness criterion hospitalization). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CORONARY ARTERY BYPASS (Triple vessel bypass graft) was resolving, WRIST FRACTURE (Fractured wrist/ Wrist fracture), OSTEOPENIA (Osteopenia) and ARTHRALGIA (Pain in hip/ Arthralgia) had not resolved, PAIN IN EXTREMITY (Leg pain/ Pain in extremity) outcome was unknown and DIARRHOEA (Diarrhea/ Diarrhoea), DIZZINESS (Dizzy spells/ Dizziness) and NAUSEA (Nausea) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Company comment: Very limited information regarding the events has been provided at this time. Further information has been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been request.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Osteopenia, Pain in extremity, Wrist fracture
Clinical narrative: Triple vessel bypass graft; Fractured wrist/ Wrist fracture; Osteopenia; Leg pain/ Pain in extremity; Diarrhea/ Diarrhoea; Dizzy spells/ Dizziness; Pain in hip/ Arthralgia; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of CORONARY ARTERY BYPASS (Triple vessel bypass graft), WRIST FRACTURE (Fractured wrist/ Wrist fracture), OSTEOPENIA (Osteopenia), PAIN IN EXTREMITY (Leg pain/ Pain in extremity), DIARRHOEA (Diarrhea/ Diarrhoea), DIZZINESS (Dizzy spells/ Dizziness), ARTHRALGIA (Pain in hip/ Arthralgia) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Triple vessel bypass graft (Coronary artery bypass). Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate free. In January 2021, the patient experienced WRIST FRACTURE (Fractured wrist/ Wrist fracture) (seriousness criterion hospitalization), OSTEOPENIA (Osteopenia) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Leg pain/ Pain in extremity) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea/ Diarrhoea) (seriousness criterion hospitalization), DIZZINESS (Dizzy spells/ Dizziness) (seriousness criterion hospitalization), ARTHRALGIA (Pain in hip/ Arthralgia) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). On an unknown date, the patient experienced CORONARY ARTERY BYPASS (Triple vessel bypass graft) (seriousness criterion hospitalization). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CORONARY ARTERY BYPASS (Triple vessel bypass graft) was resolving, WRIST FRACTURE (Fractured wrist/ Wrist fracture), OSTEOPENIA (Osteopenia) and ARTHRALGIA (Pain in hip/ Arthralgia) had not resolved, PAIN IN EXTREMITY (Leg pain/ Pain in extremity) outcome was unknown and DIARRHOEA (Diarrhea/ Diarrhoea), DIZZINESS (Dizzy spells/ Dizziness) and NAUSEA (Nausea) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Company comment: Very limited information regarding the events has been provided at this time. Further information has been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been request.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Cardiomegaly, Cerebrovascular accident, Feeling abnormal, Hepatomegaly
Clinical narrative: She had enlarged heart; She had enlarged liver; She is very angry that this happened to her.; She felt as if she was dying.; Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021; Within 7 days after receiving 2nd dose, she had a stroke.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.), FEELING ABNORMAL (She felt as if she was dying.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021). At the time of the report, CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.), CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.) and FEELING ABNORMAL (She felt as if she was dying.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided Treatment medication were not reported  Patient went to ER within those 7 days. Patient mentioned that her husband was also sick after receiving vaccine.  Action taken with mRNA-1273 in response to the events was not applicable.  As an intervention patient had 3 blood transfusions and was on ventilator  Based on the current available information and temporal association between the use of the product and the start date (within 7 days) of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date (within 7 days) of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She had enlarged heart; She had enlarged liver; She is very angry that this happened to her.; She felt as if she was dying.; Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021; Within 7 days after receiving 2nd dose, she had a stroke.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.), FEELING ABNORMAL (She felt as if she was dying.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021). At the time of the report, CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.), CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.) and FEELING ABNORMAL (She felt as if she was dying.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided Treatment medication were not reported  Patient went to ER within those 7 days. Patient mentioned that her husband was also sick after receiving vaccine.  Action taken with mRNA-1273 in response to the events was not applicable.  As an intervention patient had 3 blood transfusions and was on ventilator  Based on the current available information and temporal association between the use of the product and the start date (within 7 days) of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date (within 7 days) of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriosclerosis, Parkinson's disease
Clinical narrative: Cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease); Atherosclerotic Cardiovascular Disease; This spontaneous case was reported by a nurse and describes the occurrence of PARKINSON'S DISEASE (Cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease)) and ARTERIOSCLEROSIS (Atherosclerotic Cardiovascular Disease) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sinemet).    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARKINSON'S DISEASE (Cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease)) (seriousness criteria death and medically significant) and ARTERIOSCLEROSIS (Atherosclerotic Cardiovascular Disease) (seriousness criterion death). The patient died on 08-Jul-2021. The reported cause of death was parkinson's disease and Atherosclerotic cardiovascular disease. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient passed away (08Jul2021 at 4:10 PM). The HCP reported that the death certificate showed cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease). No concomitant medication details was provided. No treatment medication details was provided.  Very Limited information regarding the events has been provided at this time . Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time . Further information has been requested.; Reported Cause(s) of Death: Parkinson's Disease; Atherosclerotic Cardiovascular Disease
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given was beyond the use date (BUD) of 8July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) (seriousness criterion medically significant). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  The pharmacist reported that they had 5 refrigerated vials that went the beyond use date of 08JUL2021. Out of them 1 vial was used for 4 patients on 09JUL2021 and that was beyond the use date.   The pharmacist also reported that those vials were refrigerated on 08JUN2021and are not supposed to be given after its BUD of 08JUL2021.   The other 4 vials are still sealed, unused and kept for disposal.  No treatment information was provided by the reporter.  Company comment: This report refers to a case of Expired product administration error for mRNA-1273, with no associated adverse events. This appears to be non-serious, but RA has reported this as a serious event. However, more information is required to determine the serious criteria.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received does not contain any new information (NNI); Sender's Comments: This report refers to a case of Expired product administration error for mRNA-1273, with no associated adverse events. This appears to be non-serious, but RA has reported this as a serious event. However, more information is required to determine the serious criteria.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Loss of consciousness, Muscle spasms
Clinical narrative: she was going to pass out; started feeling bad; completely cramping, laid down on the floor until the ENT; chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (she was going to pass out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (oesophageal), Rotator cuff injury and Thyroid disorder. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (she was going to pass out) (seriousness criterion medically significant), FEELING ABNORMAL (started feeling bad), MUSCLE SPASMS (completely cramping, laid down on the floor until the ENT) and CHILLS (chills). On 25-Mar-2021, LOSS OF CONSCIOUSNESS (she was going to pass out) had resolved. At the time of the report, FEELING ABNORMAL (started feeling bad), MUSCLE SPASMS (completely cramping, laid down on the floor until the ENT) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment products included Pantoprazole 40 mg BID (after vaccine adverse event) Concomitant products included Valsartan HCTZ 160/25 QD Patient said she was informed she might have Vasovagal response. After staying the emergency room for 6 hours all of her blood work and test came back to normal. The heartburn did not change at all. Patient's new GI doctor suggested that she might be experiencing from inflammatory response from the vaccine and suggested to stay on Pantoprazole 40 mg and double the dose. Patient then spoke with her retired GI doctor who said that the vaccine might cause weaken her system and now its compromised. Patient said that her digestive system and quality of life has been affected after the vaccination. Consent to follow up with patient and health care professional given.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-253202 (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 event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Relapse; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Relapse) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Relapse) (seriousness criterion hospitalization). The patient was hospitalized for 7 days due to CONDITION AGGRAVATED. At the time of the report, CONDITION AGGRAVATED (Relapse) had resolved.            Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. Limited information regarding the event has been provided at this time and is insufficient for causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Live follow up received on 13-JUL-2021, contains no new information.; Sender's Comments: Limited information regarding the event has been provided at this time and is insufficient for causality assessment.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Hyperhidrosis, Hypophagia, Injection site erythema, Mobility decreased
Clinical narrative: vomiting; Injection site redness; delirious; oral intake reduced; mobility decreased; sweating; fever; This spontaneous case was reported by a physician and describes the occurrence of DELIRIUM (delirious) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Smoker (Former cigarette smoker) from 1970 to 1996. Concurrent medical conditions included Shellfish allergy (Hives), Allergy to antibiotic (Doxycycline- skin eruption) and Rheumatoid arthritis. Concomitant products included RISEDRONATE SODIUM (RISEDRONATE) for Bone disorder NOS, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Pain.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever) and INJECTION SITE ERYTHEMA (Injection site redness). On 14-Mar-2021, the patient experienced VOMITING (vomiting). On 14-Mar-2021, DELIRIUM (delirious), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.; 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting; Injection site redness; delirious; oral intake reduced; mobility decreased; sweating; fever; This spontaneous case was reported by a physician and describes the occurrence of DELIRIUM (delirious) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Smoker (Former cigarette smoker) from 1970 to 1996. Concurrent medical conditions included Shellfish allergy (Hives), Allergy to antibiotic (Doxycycline- skin eruption) and Rheumatoid arthritis. Concomitant products included RISEDRONATE SODIUM (RISEDRONATE) for Bone disorder NOS, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Pain.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever) and INJECTION SITE ERYTHEMA (Injection site redness). On 14-Mar-2021, the patient experienced VOMITING (vomiting). On 14-Mar-2021, DELIRIUM (delirious), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack after Moderna vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.