chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia, Thinking abnormal
Clinical narrative: Had problems with throat getting stuck/Heimlich to get food out; Sweating; Would drink water and have problems getting it down throat/Heimlich to get food out; Had problems breathing; can't think straight; Fever; Chills; Muscle soreness in back/Muscle soreness in legs; Muscle soreness in ankle; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Had problems with throat getting stuck/Heimlich to get food out) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle). On an unknown date, the patient experienced CHOKING (Had problems with throat getting stuck/Heimlich to get food out) (seriousness criterion medically significant). At the time of the report, CHOKING (Had problems with throat getting stuck/Heimlich to get food out), HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle) outcome was unknown.            Concominant medications included unknown cancer medications.  On an unknown date, treatment included the Heimlich maneuver.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Foaming at mouth, Headache
Clinical narrative: passed out; dizzy; moaning; gasping; foaming in the mouth; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DIZZINESS (dizzy), MOANING (moaning), DYSPNOEA (gasping), FOAMING AT MOUTH (foaming in the mouth), HEADACHE (headache) and FATIGUE (tired). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), DIZZINESS (dizzy), MOANING (moaning), DYSPNOEA (gasping), FOAMING AT MOUTH (foaming in the mouth), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Vital signs measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a severe reaction when he was getting in the car to leave. He was dizzy first then had a blank stare. After that he started moaning and gasping and foaming in the mouth then passed out. They called the paramedics. Vitals were normal and the patient was given the choice to go to the hospital but declined. Patient felt very tired and had a headache later.  No concomitant medications were reported. No corrective treatment was provided.  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. However, medical history and concomitant medication details are required for further evaluation.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up included correct DOB was confirmed; 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. However, medical history and concomitant medication details are required for further evaluation.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Moaning, Vital signs measurement
Clinical narrative: passed out; dizzy; moaning; gasping; foaming in the mouth; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DIZZINESS (dizzy), MOANING (moaning), DYSPNOEA (gasping), FOAMING AT MOUTH (foaming in the mouth), HEADACHE (headache) and FATIGUE (tired). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), DIZZINESS (dizzy), MOANING (moaning), DYSPNOEA (gasping), FOAMING AT MOUTH (foaming in the mouth), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Vital signs measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a severe reaction when he was getting in the car to leave. He was dizzy first then had a blank stare. After that he started moaning and gasping and foaming in the mouth then passed out. They called the paramedics. Vitals were normal and the patient was given the choice to go to the hospital but declined. Patient felt very tired and had a headache later.  No concomitant medications were reported. No corrective treatment was provided.  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. However, medical history and concomitant medication details are required for further evaluation.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up included correct DOB was confirmed; 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. However, medical history and concomitant medication details are required for further evaluation.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Inappropriate schedule of product administration
Clinical narrative: Hospitalized after 1st dose; second dose of the Moderna COVID-19 Vaccine on today, 14May2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalized after 1st dose) 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.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the Moderna COVID-19 Vaccine on today, 14May2021). On an unknown date, the patient experienced HOSPITALISATION (Hospitalized after 1st dose) (seriousness criterion hospitalization). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the Moderna COVID-19 Vaccine on today, 14May2021) had resolved. At the time of the report, HOSPITALISATION (Hospitalized after 1st dose) outcome was unknown.            No relevant concomitant medications were reported. The caller reported that both he and his mother received the first dose on 31-Mar-2021. His mother was then hospitalized due to unspecified reason. Due to the hospitalization, his mother missed her second dose. The caller then took her to receive her second dose on 14-May-2021. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Company comment: Very limited information regarding this event has been provided at this time. However, This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot #  unknown, with no associated AEs.; Sender's Comments: Very limited information regarding this event has been provided at this time. However, This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot #  unknown, with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Patient developed COVID after vaccination; She is now deceased; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (She is now deceased) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (previously had cancer twice). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), TICLOPIDINE HYDROCHLORIDE (TICLID), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient developed COVID after vaccination). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Patient developed COVID after vaccination) outcome was unknown.            It was reported that the patient previously had cancer twice, and her immune system was not what it should have been. The patient got really, really sick and had COVID at some point after receiving the vaccine.  No corrective treatment was provided.  Action taken with the drug in response to the events was not applicable.  Company comment: Very limited information regarding this event has been provided at this time. Noting the subject had received 1st dose of vaccine prior to COVID. However, based on the mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.; Sender's Comments: Very limited information regarding this event has been provided at this time. Noting the subject had received 1st dose of vaccine prior to COVID. However, based on the mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.; Reported Cause(s) of Death: Unknown cause of death
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Fatigue, Lymphoma
Clinical narrative: Lymphoma; Lump in her cheek described as cyst, but not hard, but soft fluidly on face; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Lymphoma) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included VITAMIN C [ASCORBIC ACID], ZINC, B COMPLEX + ENERGY, VITAMIN E NOS and CALCIUM for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced FATIGUE (Tired). On 09-May-2021, the patient experienced CYST (Lump in her cheek described as cyst, but not hard, but soft fluidly on face). On an unknown date, the patient experienced LYMPHOMA (Lymphoma) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Lymphoma), CYST (Lump in her cheek described as cyst, but not hard, but soft fluidly on face) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment: Very limited information regarding this event (lymphoma) has been provided at this time. Details regarding diagnostics and treatment is required for further evaluation. Based on the current available information and temporal association between the use of the product and the start date of the event (fatigue), a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event (lymphoma) has been provided at this time. Details regarding diagnostics and treatment is required for further evaluation. Based on the current available information and temporal association between the use of the product and the start date of the event (fatigue), a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Hemiplegia, Hypoaesthesia, Urinary incontinence
Clinical narrative: Right side of her body was paralyzed, couldn't move; Couldn't feel her face; Urinated herself; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPLEGIA (Right side of her body was paralyzed, couldn't move) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HEMIPLEGIA (Right side of her body was paralyzed, couldn't move) (seriousness criterion medically significant), HYPOAESTHESIA (Couldn't feel her face) and URINARY INCONTINENCE (Urinated herself). At the time of the report, HEMIPLEGIA (Right side of her body was paralyzed, couldn't move), HYPOAESTHESIA (Couldn't feel her face) and URINARY INCONTINENCE (Urinated herself) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: normal (normal) normal. On 13-May-2021, Body temperature: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The caller thought her mother was experiencing a stroke. They denied any numbness, fever, coughing and lethargy. No medications were taken for the symptoms and no concomitant medications were provided. The second dose of the vaccine is scheduled for 12-Jun-2021.  Company comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Gait disturbance, Speech disorder
Clinical narrative: could not keep balance; could not speak well; could not walk well; could not breath through nose; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of BALANCE DISORDER (could not keep balance), SPEECH DISORDER (could not speak well) and GAIT DISTURBANCE (could not walk well) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN/HYDROCHLOROTHIAZIDE) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced DYSPNOEA (could not breath through nose). On 16-Feb-2021, the patient experienced BALANCE DISORDER (could not keep balance) (seriousness criterion hospitalization) and SPEECH DISORDER (could not speak well) (seriousness criterion hospitalization). 16-Feb-2021, the patient experienced GAIT DISTURBANCE (could not walk well) (seriousness criterion hospitalization). The patient was hospitalized on 23-Feb-2021 due to BALANCE DISORDER, GAIT DISTURBANCE and SPEECH DISORDER. The patient was treated with Surgery for Balance disorder; Surgery for Speech disorder and Surgery for Gait disturbance. At the time of the report, BALANCE DISORDER (could not keep balance), SPEECH DISORDER (could not speak well), GAIT DISTURBANCE (could not walk well) and DYSPNOEA (could not breath through nose) outcome was unknown.            Treatment included acetaminophen after receiving injection.  911 was called on 23-Feb-2021 and patient taken to a medical center where she was admitted for an unspecified emergency surgery. Patient was on ventilator at time of report.   This case was linked to US-MODERNATX, INC.-MOD-2021-132568 (E2B Linked Report). This case was linked to MOD-2021-132568 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. US-MODERNATX, INC.-MOD-2021-132568:Case for first dose
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Pain, Pulmonary embolism
Clinical narrative: Blood Clots noted all over lungs; Abdominal pain radiating from right side to left side then to collar bone; Abdominal pain-right side; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Blood Clots noted all over lungs) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037421B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gallbladder pain.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain-right side). On 30-Apr-2021, the patient experienced PAIN (Abdominal pain radiating from right side to left side then to collar bone). On 04-May-2021, the patient experienced PULMONARY EMBOLISM (Blood Clots noted all over lungs) (seriousness criteria hospitalization and medically significant). On 30-Mar-2021, ABDOMINAL PAIN (Abdominal pain-right side) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood Clots noted all over lungs) and PAIN (Abdominal pain radiating from right side to left side then to collar bone) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Computerised tomogram: Blood clot noted on lungs (all over).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given IV and oral blood thinner medication as a treatment.  Company comment: Very limited information regarding this event has been provided at this time. It is not clear if abdominal pain was gallbladder pain and surgery was prior to onset of pulmonary embolism. Details of the events and discharge summary is required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. It is not clear if abdominal pain was gallbladder pain and surgery was prior to onset of pulmonary embolism. Details of the events and discharge summary is required for further evaluation.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparaesthesia, Transient ischaemic attack
Clinical narrative: Her left side of her arm  went numb; she is been evaluated for stroke and possible transient ischemic attack; This spontaneous case was reported by a patient and describes the occurrence of HEMIPARAESTHESIA (Her left side of her arm  went numb) and TRANSIENT ISCHAEMIC ATTACK (she is been evaluated for stroke and possible transient ischemic attack) in a 60-year-old female patient who received mRNA-1273 (batch no. 021b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HEMIPARAESTHESIA (Her left side of her arm  went numb) (seriousness criterion medically significant) and TRANSIENT ISCHAEMIC ATTACK (she is been evaluated for stroke and possible transient ischemic attack) (seriousness criterion medically significant). At the time of the report, HEMIPARAESTHESIA (Her left side of her arm  went numb) and TRANSIENT ISCHAEMIC ATTACK (she is been evaluated for stroke and possible transient ischemic attack) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Coeliac disease, Dizziness, Gait disturbance, Headache
Clinical narrative: full broad celiac reaction; got collapsed at living room; took 1 hour to reach her bedroom; upset stomach; dizziness; cannot go for work whole week; headache; nausea; body ache; This spontaneous case was reported by a consumer and describes the occurrence of COELIAC DISEASE (full broad celiac reaction) and LOSS OF CONSCIOUSNESS (got collapsed at living room) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Celiac disease and Gluten sensitivity.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced COELIAC DISEASE (full broad celiac reaction) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (got collapsed at living room) (seriousness criterion medically significant), GAIT DISTURBANCE (took 1 hour to reach her bedroom), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), IMPAIRED WORK ABILITY (cannot go for work whole week), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body ache). At the time of the report, COELIAC DISEASE (full broad celiac reaction), LOSS OF CONSCIOUSNESS (got collapsed at living room), GAIT DISTURBANCE (took 1 hour to reach her bedroom), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), IMPAIRED WORK ABILITY (cannot go for work whole week), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported events started within 5 minutes of receiving the vaccine. She  talked to her pharmacist first regarding the symptoms and also contacted her health care provider but a nurse told her these are all common side effects and recommended she go to the emergency room. The consumer denied to go to the emergency room.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's concurrent medical conditions of Celiac disease remains a confounder.; 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.  The patient's concurrent medical conditions of Celiac disease remains a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Loss of consciousness, Myalgia, Nausea
Clinical narrative: full broad celiac reaction; got collapsed at living room; took 1 hour to reach her bedroom; upset stomach; dizziness; cannot go for work whole week; headache; nausea; body ache; This spontaneous case was reported by a consumer and describes the occurrence of COELIAC DISEASE (full broad celiac reaction) and LOSS OF CONSCIOUSNESS (got collapsed at living room) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Celiac disease and Gluten sensitivity.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced COELIAC DISEASE (full broad celiac reaction) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (got collapsed at living room) (seriousness criterion medically significant), GAIT DISTURBANCE (took 1 hour to reach her bedroom), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), IMPAIRED WORK ABILITY (cannot go for work whole week), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body ache). At the time of the report, COELIAC DISEASE (full broad celiac reaction), LOSS OF CONSCIOUSNESS (got collapsed at living room), GAIT DISTURBANCE (took 1 hour to reach her bedroom), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), IMPAIRED WORK ABILITY (cannot go for work whole week), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported events started within 5 minutes of receiving the vaccine. She  talked to her pharmacist first regarding the symptoms and also contacted her health care provider but a nurse told her these are all common side effects and recommended she go to the emergency room. The consumer denied to go to the emergency room.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's concurrent medical conditions of Celiac disease remains a confounder.; 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.  The patient's concurrent medical conditions of Celiac disease remains a confounder.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Fatigue, Oxygen saturation
Clinical narrative: Some inflammation in the lungs; Severe shortness of breath/trouble breathing; Pain in the chest; Cough; Excessive tiredness; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMONITIS (Some inflammation in the lungs), DYSPNOEA (Severe shortness of breath/trouble breathing), CHEST PAIN (Pain in the chest), COUGH (Cough) and FATIGUE (Excessive tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PNEUMONITIS (Some inflammation in the lungs) (seriousness criterion hospitalization), DYSPNOEA (Severe shortness of breath/trouble breathing) (seriousness criterion hospitalization), CHEST PAIN (Pain in the chest) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization) and FATIGUE (Excessive tiredness) (seriousness criterion hospitalization). At the time of the report, PNEUMONITIS (Some inflammation in the lungs), DYSPNOEA (Severe shortness of breath/trouble breathing), CHEST PAIN (Pain in the chest), COUGH (Cough) and FATIGUE (Excessive tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Oxygen saturation: low Low. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested twice and both tests came negative..         Concomitant medication were not provided.  Treatment included Hospitalization in ER for 2 days  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-137829 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonitis, SARS-CoV-2 test
Clinical narrative: Some inflammation in the lungs; Severe shortness of breath/trouble breathing; Pain in the chest; Cough; Excessive tiredness; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMONITIS (Some inflammation in the lungs), DYSPNOEA (Severe shortness of breath/trouble breathing), CHEST PAIN (Pain in the chest), COUGH (Cough) and FATIGUE (Excessive tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PNEUMONITIS (Some inflammation in the lungs) (seriousness criterion hospitalization), DYSPNOEA (Severe shortness of breath/trouble breathing) (seriousness criterion hospitalization), CHEST PAIN (Pain in the chest) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization) and FATIGUE (Excessive tiredness) (seriousness criterion hospitalization). At the time of the report, PNEUMONITIS (Some inflammation in the lungs), DYSPNOEA (Severe shortness of breath/trouble breathing), CHEST PAIN (Pain in the chest), COUGH (Cough) and FATIGUE (Excessive tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Oxygen saturation: low Low. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested twice and both tests came negative..         Concomitant medication were not provided.  Treatment included Hospitalization in ER for 2 days  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-137829 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Retching
Clinical narrative: bad headache; tiredness; dry heaves; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (bad headache), FATIGUE (tiredness) and RETCHING (dry heaves) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included APIXABAN (ELIQUIS), CELECOXIB (CELEBREX), METOPROLOL SUCCINATE and LOSARTAN POTASSIUM for an unknown indication.    On 25-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 HEADACHE (bad headache) (seriousness criterion hospitalization), FATIGUE (tiredness) (seriousness criterion hospitalization) and RETCHING (dry heaves) (seriousness criterion hospitalization). At the time of the report, HEADACHE (bad headache), FATIGUE (tiredness) and RETCHING (dry heaves) outcome was unknown.            No treatment information provided.  Concomitant medications include Eliquis, Celebrex, High cholesterol drug, Metoprolol succinate, Losartan potassium.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-138131 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle rigidity, Myalgia, Pyrexia, Surgery
Clinical narrative: running nightly fevers; Body became very rigid; Walking with a walker; small intestine removal; Aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running nightly fevers) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ATORVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), GABAPENTIN, LAMOTRIGINE (LAMICTAL), LOSARTAN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), TIMOLOL, FLUTICASONE PROPIONATE (XHANCE) and THIAMAZOLE (METHIMAZOLE) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced PYREXIA (running nightly fevers) (seriousness criterion hospitalization). On an unknown date, the patient experienced MUSCLE RIGIDITY (Body became very rigid), GAIT DISTURBANCE (Walking with a walker), SURGERY (small intestine removal) and MYALGIA (Aches and pain). On 12-May-2021, PYREXIA (running nightly fevers) had resolved. At the time of the report, MUSCLE RIGIDITY (Body became very rigid), GAIT DISTURBANCE (Walking with a walker), SURGERY (small intestine removal) and MYALGIA (Aches and pain) outcome was unknown.            Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, causality in relation to the vaccine can not be excluded however the event of fever for 2 months is unlikely related to the vaccine; 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, causality in relation to the vaccine can not be excluded however the event of fever for 2 months is unlikely related to the vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: Difficulty swallowing; Difficulty breathing ¨she is breathing very strong, hard to talk ¨; Felt bad; Body pain; Muscle pain; Fatigue; Had headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨) in a 52-year-old female 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 information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced MALAISE (Felt bad), PAIN (Body pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Had headache). On 17-May-2021, the patient experienced DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨) (seriousness criterion life threatening) and DYSPHAGIA (Difficulty swallowing). At the time of the report, DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨), MALAISE (Felt bad), DYSPHAGIA (Difficulty swallowing), PAIN (Body pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Had headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia, fatigue and headache are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia, fatigue and headache are consistent with the product known safety profile
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Difficulty swallowing; Difficulty breathing ¨she is breathing very strong, hard to talk ¨; Felt bad; Body pain; Muscle pain; Fatigue; Had headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨) in a 52-year-old female 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 information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced MALAISE (Felt bad), PAIN (Body pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Had headache). On 17-May-2021, the patient experienced DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨) (seriousness criterion life threatening) and DYSPHAGIA (Difficulty swallowing). At the time of the report, DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨), MALAISE (Felt bad), DYSPHAGIA (Difficulty swallowing), PAIN (Body pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Had headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia, fatigue and headache are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia, fatigue and headache are consistent with the product known safety profile
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Took a generic version of Miralax and had anaphylactic reaction and ended up in ER; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the reporter's description of the event after taking Miralax and the temporal relationship occurring closer to Miralax dosing, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the reporter's description of the event after taking Miralax and the temporal relationship occurring closer to Miralax dosing, the event is assessed as unlikely related to mRNA-1273.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal haemorrhage, Internal haemorrhage, Limb discomfort, Pyrexia
Clinical narrative: Bleeding internally; Internal intestinal bleeding; Kidney function changed; Arm bothered her after receiving the vaccine; Very tired; Slight low-grade fever/Felt warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) and RENAL IMPAIRMENT (Kidney function changed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal bleeding, Kidney function abnormal and Aortic aneurysm. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Blood pressure management, SUCRALFATE, PANTOPRAZOLE, POTASSIUM CITRATE, SIMVASTATIN, METOPROLOL, IRBESARTAN and VITAMINS NOS for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm). On 07-May-2021, the patient experienced INTERNAL HAEMORRHAGE (Bleeding internally) (seriousness criterion medically significant), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) (seriousness criterion medically significant) and RENAL IMPAIRMENT (Kidney function changed) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding), RENAL IMPAIRMENT (Kidney function changed), LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included acetaminophen.  Company Comment  There is not enough information to ass the event of renal impairment as the exact condition was not describe.  However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded; Sender's Comments: There is not enough information to ass the event of renal impairment as the exact condition was not describe.  However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment
Clinical narrative: Bleeding internally; Internal intestinal bleeding; Kidney function changed; Arm bothered her after receiving the vaccine; Very tired; Slight low-grade fever/Felt warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) and RENAL IMPAIRMENT (Kidney function changed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal bleeding, Kidney function abnormal and Aortic aneurysm. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Blood pressure management, SUCRALFATE, PANTOPRAZOLE, POTASSIUM CITRATE, SIMVASTATIN, METOPROLOL, IRBESARTAN and VITAMINS NOS for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm). On 07-May-2021, the patient experienced INTERNAL HAEMORRHAGE (Bleeding internally) (seriousness criterion medically significant), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) (seriousness criterion medically significant) and RENAL IMPAIRMENT (Kidney function changed) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding), RENAL IMPAIRMENT (Kidney function changed), LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included acetaminophen.  Company Comment  There is not enough information to ass the event of renal impairment as the exact condition was not describe.  However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded; Sender's Comments: There is not enough information to ass the event of renal impairment as the exact condition was not describe.  However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded