chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Asthenia, Gait disturbance, Hyperpyrexia
Clinical narrative: Legs were yellow; sore throat; Lost my voice; Fever of 109F; could not raise body from floor becasue joints were hurting; could not raise her body from the floor because her joints were hurting; legs felt like jelly legs; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever of 109F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history given). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL).   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced GAIT DISTURBANCE (could not raise body from floor becasue joints were hurting) and ARTHRALGIA (could not raise her body from the floor because her joints were hurting). On 14-Apr-2021, the patient experienced HYPERPYREXIA (Fever of 109F) (seriousness criterion medically significant), YELLOW SKIN (Legs were yellow), OROPHARYNGEAL PAIN (sore throat) and APHONIA (Lost my voice). On an unknown date, the patient experienced ASTHENIA (legs felt like jelly legs). At the time of the report, HYPERPYREXIA (Fever of 109F), GAIT DISTURBANCE (could not raise body from floor becasue joints were hurting), YELLOW SKIN (Legs were yellow), OROPHARYNGEAL PAIN (sore throat), APHONIA (Lost my voice) and ASTHENIA (legs felt like jelly legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Additional medications listed are: "blood pressure meds, cholesterol meds, antidepressants, anti-seizure meds".  Company Comment  This case concerns a 65-year-old female with a serious unexpected event of hyperpyrexia, and nonserious unexpected oropharyngeal pain, aphonia, asthenia, gait disturbance, yellow skin, and expected arthralgia. Event onset 3 days after first dose mRNA-1273. Event outcomes unknown. Based on 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.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Yellow skin
Clinical narrative: Legs were yellow; sore throat; Lost my voice; Fever of 109F; could not raise body from floor becasue joints were hurting; could not raise her body from the floor because her joints were hurting; legs felt like jelly legs; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever of 109F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history given). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL).   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced GAIT DISTURBANCE (could not raise body from floor becasue joints were hurting) and ARTHRALGIA (could not raise her body from the floor because her joints were hurting). On 14-Apr-2021, the patient experienced HYPERPYREXIA (Fever of 109F) (seriousness criterion medically significant), YELLOW SKIN (Legs were yellow), OROPHARYNGEAL PAIN (sore throat) and APHONIA (Lost my voice). On an unknown date, the patient experienced ASTHENIA (legs felt like jelly legs). At the time of the report, HYPERPYREXIA (Fever of 109F), GAIT DISTURBANCE (could not raise body from floor becasue joints were hurting), YELLOW SKIN (Legs were yellow), OROPHARYNGEAL PAIN (sore throat), APHONIA (Lost my voice) and ASTHENIA (legs felt like jelly legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Additional medications listed are: "blood pressure meds, cholesterol meds, antidepressants, anti-seizure meds".  Company Comment  This case concerns a 65-year-old female with a serious unexpected event of hyperpyrexia, and nonserious unexpected oropharyngeal pain, aphonia, asthenia, gait disturbance, yellow skin, and expected arthralgia. Event onset 3 days after first dose mRNA-1273. Event outcomes unknown. Based on 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies, Antiphospholipid antibodies positive, Erythema, Feeling abnormal, Malaise
Clinical narrative: Lupus butterfly rash on his face; he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line; That night his arm swelled and hurt; he couldn't use his arm; That night his arm swelled and hurt.; The arm was rock hard; he didn't feel right until 4 pm; brain fog; his face turned plum red; test for Lupus came back as potential positive; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) in a 59-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.     Concurrent medical conditions included Scleroderma.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) (seriousness criterion medically significant), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard) and MALAISE (he didn't feel right until 4 pm). 11-Apr-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard), MALAISE (he didn't feel right until 4 pm) and FEELING ABNORMAL (brain fog) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies: Positive.     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.   Concomitant medications were 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Peripheral swelling, Systemic lupus erythematosus rash, Vaccination site induration, Vaccination site movement impairment
Clinical narrative: Lupus butterfly rash on his face; he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line; That night his arm swelled and hurt; he couldn't use his arm; That night his arm swelled and hurt.; The arm was rock hard; he didn't feel right until 4 pm; brain fog; his face turned plum red; test for Lupus came back as potential positive; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) in a 59-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.     Concurrent medical conditions included Scleroderma.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) (seriousness criterion medically significant), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard) and MALAISE (he didn't feel right until 4 pm). 11-Apr-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard), MALAISE (he didn't feel right until 4 pm) and FEELING ABNORMAL (brain fog) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies: Positive.     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.   Concomitant medications were 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lupus butterfly rash on his face; he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line; That night his arm swelled and hurt; he couldn't use his arm; That night his arm swelled and hurt.; The arm was rock hard; he didn't feel right until 4 pm; brain fog; his face turned plum red; test for Lupus came back as potential positive; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) in a 59-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.     Concurrent medical conditions included Scleroderma.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) (seriousness criterion medically significant), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard) and MALAISE (he didn't feel right until 4 pm). 11-Apr-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard), MALAISE (he didn't feel right until 4 pm) and FEELING ABNORMAL (brain fog) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies: Positive.     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.   Concomitant medications were 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Concussion, Limb injury, Loss of consciousness
Clinical narrative: blacked out twice in the morning; felt like they got a concussion; scraped their shoulder in the process; felt weaker than normal and weakness; fever; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice in the morning) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history).    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice in the morning) (seriousness criterion medically significant), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous). The patient was treated with Bed rest (Hydration) for Limb injury. At the time of the report, LOSS OF CONSCIOUSNESS (blacked out twice in the morning), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        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 medication given patient got hydration and taken rest.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: blacked out twice in the morning; felt like they got a concussion; scraped their shoulder in the process; felt weaker than normal and weakness; fever; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice in the morning) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history).    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice in the morning) (seriousness criterion medically significant), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous). The patient was treated with Bed rest (Hydration) for Limb injury. At the time of the report, LOSS OF CONSCIOUSNESS (blacked out twice in the morning), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        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 medication given patient got hydration and taken rest.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia
Clinical narrative: Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   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 AUTOIMMUNE HAEMOLYTIC ANAEMIA (Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine) outcome was unknown. Not Provided    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.   The patient has not provided with any treatment medication. No concomitant medications were provided  Company Comment  Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seizure since an unknown date. Concomitant products included TOPIRAMATE (TOPAMAX) for Seizure.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No treatment medication information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Device occlusion, Epistaxis, Pain in extremity, Ultrasound scan
Clinical narrative: leg hurting; Leg was completely clotted; 10 days was blowing blood clots out of his nose; blowing blood clots out of his nose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg hurting), DEVICE OCCLUSION (Leg was completely clotted) and DEVICE OCCLUSION (10 days was blowing blood clots out of his nose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery disease since an unknown date, Blood pressure (controlled blood pressure) since an unknown date, Diabetes (controlled diabetes) since an unknown date, Cholesterol (controlled cholesterol) since an unknown date and Stent placement (history of 7 stents in heart) since an unknown date. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL, LOSARTAN, ATORVASTATIN and EMPAGLIFLOZIN, LINAGLIPTIN (GLYXAMBI) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg hurting) (seriousness criterion hospitalization), DEVICE OCCLUSION (Leg was completely clotted) (seriousness criteria hospitalization and disability), DEVICE OCCLUSION (10 days was blowing blood clots out of his nose) (seriousness criterion hospitalization) and EPISTAXIS (blowing blood clots out of his nose). At the time of the report, PAIN IN EXTREMITY (leg hurting), DEVICE OCCLUSION (Leg was completely clotted), DEVICE OCCLUSION (10 days was blowing blood clots out of his nose) and EPISTAXIS (blowing blood clots out of his nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Ultrasound scan: (abnormal) 85% plaque Plaque build up in main artery of leg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient have allergy to denies and  had a history of PAD Patient given Xarelto as treatment.  Please update the narrative by replacing Thrombus with Device Occlusion. Please delete the wording Occult Blood and add Epistaxis.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: dizzy; breathlessness/could not breathe; rashes under her neck with itchiness; heart rate very high; weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), DYSPNOEA (breathlessness/could not breathe), RASH PRURITIC (rashes under her neck with itchiness), HEART RATE INCREASED (heart rate very high) and ASTHENIA (weak) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizzy) (seriousness criterion hospitalization), DYSPNOEA (breathlessness/could not breathe) (seriousness criterion hospitalization), RASH PRURITIC (rashes under her neck with itchiness) (seriousness criterion hospitalization), HEART RATE INCREASED (heart rate very high) (seriousness criterion hospitalization) and ASTHENIA (weak) (seriousness criterion hospitalization). The patient was hospitalized on 15-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA, HEART RATE INCREASED and RASH PRURITIC. At the time of the report, DIZZINESS (dizzy), DYSPNOEA (breathlessness/could not breathe), RASH PRURITIC (rashes under her neck with itchiness), HEART RATE INCREASED (heart rate very high) and ASTHENIA (weak) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 180,140,120 (Inconclusive) checked 3 times and results are given above respectively.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: dizzy; breathlessness/could not breathe; rashes under her neck with itchiness; heart rate very high; weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), DYSPNOEA (breathlessness/could not breathe), RASH PRURITIC (rashes under her neck with itchiness), HEART RATE INCREASED (heart rate very high) and ASTHENIA (weak) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizzy) (seriousness criterion hospitalization), DYSPNOEA (breathlessness/could not breathe) (seriousness criterion hospitalization), RASH PRURITIC (rashes under her neck with itchiness) (seriousness criterion hospitalization), HEART RATE INCREASED (heart rate very high) (seriousness criterion hospitalization) and ASTHENIA (weak) (seriousness criterion hospitalization). The patient was hospitalized on 15-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA, HEART RATE INCREASED and RASH PRURITIC. At the time of the report, DIZZINESS (dizzy), DYSPNOEA (breathlessness/could not breathe), RASH PRURITIC (rashes under her neck with itchiness), HEART RATE INCREASED (heart rate very high) and ASTHENIA (weak) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 180,140,120 (Inconclusive) checked 3 times and results are given above respectively.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis
Clinical narrative: nuerosweet syndrome; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (nuerosweet syndrome) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (nuerosweet syndrome) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to ACUTE FEBRILE NEUTROPHILIC DERMATOSIS. At the time of the report, ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (nuerosweet syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-080668 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Inappropriate schedule of product administration
Clinical narrative: anaphylactic reaction; I had my 2nd Moderna COVID-19 shot near the end of the 42 day window; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my 2nd Moderna COVID-19 shot near the end of the 42 day window). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my 2nd Moderna COVID-19 shot near the end of the 42 day window) had resolved.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Palpitations, Troponin increased
Clinical narrative: Greater amount of tightnessin breath; Heart palpitation; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Greater amount of tightnessin breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Greater amount of tightnessin breath) (seriousness criterion hospitalization), PALPITATIONS (Heart palpitation) and PAIN (Pain). At the time of the report, DYSPNOEA (Greater amount of tightnessin breath), PALPITATIONS (Heart palpitation) and PAIN (Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin increased: high Troponin levels high 600's.         Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Intentional dose omission, Peripheral nerve lesion, Stress, Urinary tract infection
Clinical narrative: Urinary tract infection; sciatic nerve; stressed; can't walk; Cancelled 2nd dose because sick in hospital; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed), GAIT DISTURBANCE (can't walk) and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital). The patient was hospitalized on 17-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed) and GAIT DISTURBANCE (can't walk) outcome was unknown and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment includes IV Antibiotics Bactrim Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoperitoneum
Clinical narrative: Hemoperitoneum; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HAEMOPERITONEUM (Hemoperitoneum) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant Medical history Reported).   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, the patient experienced HAEMOPERITONEUM (Hemoperitoneum) (seriousness criterion hospitalization). The patient was hospitalized on 17-Apr-2021 due to HAEMOPERITONEUM. At the time of the report, HAEMOPERITONEUM (Hemoperitoneum) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On the night of 16-Apr-2021 into the morning of 17-Apr-2021 patient began to experience severe abdominal pain. CT scan was preformed while the patient was in the emergency room and patient was diagnosed with a hemoperitoneum. The nurse practitioner was unsure of where the bleeding is coming from. Nurse practitioner did not have any information on the patient's first dose of the Moderna vaccine. The patient was admitted to the hospital.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications and treatment details were provided.  Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Herpes zoster, Rash pruritic
Clinical narrative: Cellulitis; Shingles; Itchy rash on the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Apr-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) (unknown route) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash on the neck). On 18-Apr-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and HERPES ZOSTER (Shingles). At the time of the report, CELLULITIS (Cellulitis), HERPES ZOSTER (Shingles) and RASH PRURITIC (Itchy rash on the neck) outcome was unknown.            No concomitant medications are reported. Treatment medications includes; Tx: Neosporin, Valtrex and Keflex Action taken with mRNA-1273 in response to the event was not applicable. 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: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died in his sleep 2 days after receiving 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Patient died in his sleep 2 days after receiving 1st dose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. Death occurred on 12-Feb-2021 The patient died on 12-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  The patient's wife went to wake him up but he was found dead in his sleep. She was hearing impaired and was not able to give any other information.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  This is a case of sudden death in a 84-year-old male, who died 2 days after receiving ffirst dose of vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of sudden death in a 84-year-old male, who died 2 days after receiving ffirst dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death: Patient died in his sleep 2 days after receiving 1st dose
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cerebrovascular accident, Confusional state, Erythema, Fatigue
Clinical narrative: Stroke like symptoms; Confusion; Fog; Blurred speech; Respiratory rate fell; Blood pressure elevated dangerously; Turned red for 15 minutes; Fatigue; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke like symptoms) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke like symptoms) (seriousness criterion medically significant), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Fog), SPEECH DISORDER (Blurred speech), RESPIRATORY RATE DECREASED (Respiratory rate fell), BLOOD PRESSURE INCREASED (Blood pressure elevated dangerously), ERYTHEMA (Turned red for 15 minutes), FATIGUE (Fatigue) and HEADACHE (headache). On 24-Feb-2021, SPEECH DISORDER (Blurred speech), RESPIRATORY RATE DECREASED (Respiratory rate fell), BLOOD PRESSURE INCREASED (Blood pressure elevated dangerously) and ERYTHEMA (Turned red for 15 minutes) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke like symptoms) outcome was unknown and CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Fog), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.            Treatment: ibuprofen (Advil) 15 minutes after the first shot she got asthma attack. Soon after second shot she turned red for 15 minutes, blood pressure elevated dangerously, had blurred speech, confusion and respiratory rate fell which created stroke like symptoms. All the symptoms resolved in a day. She was transported to the emergency room. Patient was still having fatigue, fog, head ache and confusion 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 MODERNATX, INC.-MOD-2021-081243 (E2B Linked Report).; 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 MODERNATX, INC.-MOD-2021-081243:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Respiratory rate decreased, Speech disorder
Clinical narrative: Stroke like symptoms; Confusion; Fog; Blurred speech; Respiratory rate fell; Blood pressure elevated dangerously; Turned red for 15 minutes; Fatigue; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke like symptoms) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke like symptoms) (seriousness criterion medically significant), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Fog), SPEECH DISORDER (Blurred speech), RESPIRATORY RATE DECREASED (Respiratory rate fell), BLOOD PRESSURE INCREASED (Blood pressure elevated dangerously), ERYTHEMA (Turned red for 15 minutes), FATIGUE (Fatigue) and HEADACHE (headache). On 24-Feb-2021, SPEECH DISORDER (Blurred speech), RESPIRATORY RATE DECREASED (Respiratory rate fell), BLOOD PRESSURE INCREASED (Blood pressure elevated dangerously) and ERYTHEMA (Turned red for 15 minutes) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke like symptoms) outcome was unknown and CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Fog), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.            Treatment: ibuprofen (Advil) 15 minutes after the first shot she got asthma attack. Soon after second shot she turned red for 15 minutes, blood pressure elevated dangerously, had blurred speech, confusion and respiratory rate fell which created stroke like symptoms. All the symptoms resolved in a day. She was transported to the emergency room. Patient was still having fatigue, fog, head ache and confusion 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 MODERNATX, INC.-MOD-2021-081243 (E2B Linked Report).; 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 MODERNATX, INC.-MOD-2021-081243:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vaso-Vagal syncope in the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Vaso-Vagal syncope in the 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SYNCOPE (Vaso-Vagal syncope in the 1st dose) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Vaso-Vagal syncope in the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the event was provided. Patient decided not to get 2nd shot due to syncope with first dose.  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.; 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: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test, Secretion discharge
Clinical narrative: Pneumonia; Positive for COVID; Had a lot of mucous; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (Positive for COVID) in an 88-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.     Concurrent medical conditions included Congestive heart failure.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (Positive for COVID) (seriousness criterion hospitalization). On an unknown date, the patient experienced SECRETION DISCHARGE (Had a lot of mucous). The patient was hospitalized from 17-Apr-2021 to 19-Apr-2021 due to COVID-19 and PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (Positive for COVID) and SECRETION DISCHARGE (Had a lot of mucous) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment information provided.  Company comment: Limited information regarding the pneumonia and mucus secretion has been provided at this time and a causal relationship cannot be excluded.  Positive Covid test unlikely related to vaccine administration; Sender's Comments: Limited information regarding the pneumonia and mucus secretion has been provided at this time and a causal relationship cannot be excluded.  Positive Covid test unlikely related to vaccine administration