chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Gait disturbance, Muscular weakness, Palpitations, Swelling
Clinical narrative: Tiredness in leg; in a wheelchair after second dose of vaccine; Swelling; Heart racing; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Tiredness in leg) and GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (no reported medical history).    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Tiredness in leg) (seriousness criterion disability), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) (seriousness criterion disability), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath). At the time of the report, MUSCULAR WEAKNESS (Tiredness in leg), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No relevant concomitant medications were reported. The patient was treated with prednisone and Percocet (oxycodone/paracetamol).; Sender's Comments: Based on the current available information and the 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: Incorrect route of product administration, Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: Felt pins and needles on her left arm; numbness/loss of sensation; pain from the top of her left shoulder to the tip of her fingers; second dose was not administered on the right spot-on top of shoulder; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Felt pins and needles on her left arm) and SENSORY LOSS (numbness/loss of sensation) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 023M20A) 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 reported.).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was not administered on the right spot-on top of shoulder). On 23-Mar-2021, the patient experienced PARAESTHESIA (Felt pins and needles on her left arm) (seriousness criterion hospitalization), SENSORY LOSS (numbness/loss of sensation) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (pain from the top of her left shoulder to the tip of her fingers). The patient was hospitalized from 31-Mar-2021 to 05-Apr-2021 due to PARAESTHESIA and SENSORY LOSS. On 22-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was not administered on the right spot-on top of shoulder) outcome was unknown. At the time of the report, PARAESTHESIA (Felt pins and needles on her left arm), SENSORY LOSS (numbness/loss of sensation) and PAIN IN EXTREMITY (pain from the top of her left shoulder to the tip of her fingers) outcome was unknown.            Tests were done to rule out heart attack and stroke. Electromyography (EMG) was also done. The results of the tests are unknown to the patient. She was advised to followup with her healthcare provider.  Based on the current information available and the temporal association between the product use and the start date of the events an causal relationship cannot be excluded. No information on the tests done to rule AMI or stroke is available and further information is requested.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the events an causal relationship cannot be excluded. No information on the tests done to rule AMI or stroke is available and further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Product dose omission issue
Clinical narrative: Develop Pneumonia; Cannot get the second shot of the vaccine ( almost 60 days after first shot ); This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Develop Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, INSULIN for Diabetes.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PNEUMONIA (Develop Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cannot get the second shot of the vaccine ( almost 60 days after first shot )). At the time of the report, PNEUMONIA (Develop Pneumonia) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Cannot get the second shot of the vaccine ( almost 60 days after first shot )) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: She was also diagnosed with pneumonia couple weeks ago; breathing problems; She also felt dizzy; chills; Fatigue; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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). Concomitant products included GABAPENTIN, GLIPIZIDE, LORAZEPAM and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication, METFORMIN.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Mar-2021, the patient experienced DYSPNOEA (breathing problems), DIZZINESS (She also felt dizzy), CHILLS (2 hours later, she experienced chills), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain). On 25-Mar-2021, the patient experienced PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago), DYSPNOEA (breathing problems), DIZZINESS (She also felt dizzy), CHILLS (2 hours later, she experienced chills), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pneumonia
Clinical narrative: She was also diagnosed with pneumonia couple weeks ago; breathing problems; She also felt dizzy; chills; Fatigue; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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). Concomitant products included GABAPENTIN, GLIPIZIDE, LORAZEPAM and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication, METFORMIN.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Mar-2021, the patient experienced DYSPNOEA (breathing problems), DIZZINESS (She also felt dizzy), CHILLS (2 hours later, she experienced chills), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain). On 25-Mar-2021, the patient experienced PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago), DYSPNOEA (breathing problems), DIZZINESS (She also felt dizzy), CHILLS (2 hours later, she experienced chills), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Pain in extremity, Pneumonia, Presyncope
Clinical narrative: almost passed out; Ear infection; Pneumonia; Arm hurt like crazy and couldnt lift up; This spontaneous case was reported by a health care professional and describes the occurrence of PNEUMONIA (Pneumonia) and PRESYNCOPE (almost passed out) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism (Blood clot disorder) and Clotting disorder (Blood clot in leg).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt like crazy and couldnt lift up ). On 03-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and EAR INFECTION (Ear infection). On an unknown date, the patient experienced PRESYNCOPE (almost passed out) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), PRESYNCOPE (almost passed out), EAR INFECTION (Ear infection) and PAIN IN EXTREMITY (Arm hurt like crazy and couldnt lift up ) 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.   The patient reports receiving a steroid shot on Saturday and almost passing out  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: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cellulitis, Chills, Headache, Injection site rash
Clinical narrative: bacterial infections; cellulitis; a slight temperature raise; headache; a slight fever; chills; developed a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (bacterial infections; cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INJECTION SITE RASH (developed a rash at the injection site). On 02-Apr-2021, the patient experienced HEADACHE (headache), PYREXIA (a slight fever) and CHILLS (chills). On an unknown date, the patient experienced CELLULITIS (bacterial infections; cellulitis) (seriousness criterion medically significant) and BODY TEMPERATURE INCREASED (a slight temperature raise). At the time of the report, CELLULITIS (bacterial infections; cellulitis), BODY TEMPERATURE INCREASED (a slight temperature raise), HEADACHE (headache), PYREXIA (a slight fever) and CHILLS (chills) outcome was unknown and INJECTION SITE RASH (developed a rash at the injection site) had not resolved. Not Provided          Treatment for the events included antibiotics, Duricef/cefadroxil 500mg per capsules.; Sender's Comments: Based on the current available information and the temporal association between the product sue and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bacterial infections; cellulitis; a slight temperature raise; headache; a slight fever; chills; developed a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (bacterial infections; cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INJECTION SITE RASH (developed a rash at the injection site). On 02-Apr-2021, the patient experienced HEADACHE (headache), PYREXIA (a slight fever) and CHILLS (chills). On an unknown date, the patient experienced CELLULITIS (bacterial infections; cellulitis) (seriousness criterion medically significant) and BODY TEMPERATURE INCREASED (a slight temperature raise). At the time of the report, CELLULITIS (bacterial infections; cellulitis), BODY TEMPERATURE INCREASED (a slight temperature raise), HEADACHE (headache), PYREXIA (a slight fever) and CHILLS (chills) outcome was unknown and INJECTION SITE RASH (developed a rash at the injection site) had not resolved. Not Provided          Treatment for the events included antibiotics, Duricef/cefadroxil 500mg per capsules.; Sender's Comments: Based on the current available information and the temporal association between the product sue and the start date of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypokinesia, Immobile
Clinical narrative: Immobility symptoms; Unable to move throughout the day and night; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (Immobility symptoms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal fusion surgery. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 04-Apr-2021, the patient experienced IMMOBILE (Immobility symptoms) (seriousness criterion medically significant) and HYPOKINESIA (Unable to move throughout the day and night). At the time of the report, IMMOBILE (Immobility symptoms), HYPOKINESIA (Unable to move throughout the day and night), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Patient asked for guidance for preferred pain relief medication. She was referred to consult her healthcare provider for treatment.  Products known to have been used by the patient, within two weeks prior to the event, included cholesterol and blood pressure medicines.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time.  The patient's immobility and hypokinesia events may be confounded by the spinal fusion surgery in her past medical history. The causality for fatigue and headache may be related to the mRNA vaccine.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Product dose omission issue, Vomiting
Clinical narrative: Dizziness; Vomiting; could not get the second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) and VOMITING (Vomiting) in an 81-year-old female patient who received mRNA-1273 (batch no. 0136204) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (could not get the second dose). At the time of the report, DIZZINESS (Dizziness), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (could not get the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Limited information regarding the dizziness and vomiting has been provided at this time and a causal relationship cannot be excluded.  It is not clear if the patient was hospitalized as the report only states they were taken to hospital. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the dizziness and vomiting has been provided at this time and a causal relationship cannot be excluded.  It is not clear if the patient was hospitalized as the report only states they were taken to hospital. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Product dose omission issue
Clinical narrative: hospitalization with heart issues; Missed his second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (hospitalization with heart issues) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 was reported.). Concomitant products included TICAGRELOR (BRILINTA), AMIODARONE, CLARITHROMYCIN (BIAXIN) and WARFARIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CARDIAC DISORDER (hospitalization with heart issues) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his second dose). The patient was hospitalized from 10-Mar-2021 to 25-Mar-2021 due to CARDIAC DISORDER. At the time of the report, CARDIAC DISORDER (hospitalization with heart issues) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed his second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received amiodarone, ticagrelor, clarithromycin and warfarin at the time of hospitalization.  Based on reporter's causality and time to onset, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and time to onset, the events are assessed as unlikely related to mRNA-1273.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Hypertension, Loss of consciousness, Palpitations
Clinical narrative: felt like she blacked out for a fewseconds; felt dizzy; Blood pressure high; Heart racing; Low sugar; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (felt like she blacked out for a fewseconds) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pre-eclampsia.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (felt like she blacked out for a fewseconds) (seriousness criterion medically significant), DIZZINESS (felt dizzy), HYPERTENSION (Blood pressure high), PALPITATIONS (Heart racing) and BLOOD GLUCOSE DECREASED (Low sugar). At the time of the report, LOSS OF CONSCIOUSNESS (felt like she blacked out for a fewseconds), DIZZINESS (felt dizzy), HYPERTENSION (Blood pressure high), PALPITATIONS (Heart racing) and BLOOD GLUCOSE DECREASED (Low sugar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment of these events were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic carcinoma, Vaccination site pain
Clinical narrative: Husband died because of terminal pancreatic cancer; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PANCREATIC CARCINOMA (Husband died because of terminal pancreatic cancer) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes. Concurrent medical conditions included Pancreatic cancer and Cancer (NOS) (for 30 years).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANCREATIC CARCINOMA (Husband died because of terminal pancreatic cancer) (seriousness criteria death and medically significant) and VACCINATION SITE PAIN (Sore arm). On 23-Feb-2021, VACCINATION SITE PAIN (Sore arm) outcome was unknown. The patient died on 23-Feb-2021. The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   He was on loads of different medication for cancer which the wife did not know about.  Treatment information was not provided.  As per the patient's wife on 23Feb2021, her husband died because of  terminal pancreatic cancer which she thinks is not related to the vaccine   This case was linked to US-MODERNATX, INC.-MOD-2021-069647  (Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be ruled out. US-MODERNATX, INC.-MOD-2021-069647:; Reported Cause(s) of Death: Pancreatic cancer
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: excessive side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (excessive side effects) in a female 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 VACCINATION COMPLICATION (excessive side effects) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (excessive side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset 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 onset date of the event, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Product dose omission issue, Upper limb fracture
Clinical narrative: Fell and broke shoulder; Fall; missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of UPPER LIMB FRACTURE (Fell and broke shoulder) and FALL (Fall) in an 85-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.     The patient's past medical history included No adverse event (No medical history reported).    On 18-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 UPPER LIMB FRACTURE (Fell and broke shoulder) (seriousness criteria disability and medically significant), FALL (Fall) (seriousness criteria disability and medically significant) and PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine). At the time of the report, UPPER LIMB FRACTURE (Fell and broke shoulder) and FALL (Fall) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications and medical history were not provided. Limited information was available as the called hung-up.  Very limited information regarding these events has been provided at this time. A causal relationship cannot be established.; Sender's Comments: Very limited information regarding these events has been provided at this time. A causal relationship cannot be established.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pharyngeal swelling
Clinical narrative: swelling in the throat; face flushed; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (swelling in the throat) in a female 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 relevant medical history reported).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (swelling in the throat) (seriousness criterion intervention required). On 03-Mar-2021, PHARYNGEAL SWELLING (swelling in the throat) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported. Treatment in the ER included a corticosteroid shot. The patient was told by ER doctor that the Moderna COVID-19 vaccine may be negated.  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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Head injury, SARS-CoV-2 test
Clinical narrative: hitting head; falling; weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAD INJURY (hitting head) and ASTHENIA (weakness) in a 74-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 relevant medical history).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ASTHENIA (weakness) (seriousness criterion hospitalization). On 11-Mar-2021, the patient experienced HEAD INJURY (hitting head) (seriousness criterion hospitalization). The patient was hospitalized from 11-Mar-2021 to 22-Mar-2021 due to ASTHENIA, FALL and HEAD INJURY. On 22-Mar-2021, HEAD INJURY (hitting head) had resolved. At the time of the report, ASTHENIA (weakness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) She also tested positive for covid-19 on 12Mar2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was transferred to nursing home after hospitalization (22Mar2021-30Mar2021). No concomitant medications were reported. 2nd dose of vaccine is scheduled for 22Apr2021.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.   This case was linked to MODERNATX, INC.-MOD-2021-069756 (E2B Linked Report).; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities MODERNATX, INC.-MOD-2021-069756:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: her lymphedema on her right arm became a cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (her lymphedema on her right arm became a cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema (lymphedema on her right arm for several years). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), ATENOLOL, FLUOXETINE, ISOSORBIDE MONONITRATE, RANOLAZINE, NIACIN, METFORMIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN and TRAZODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced CELLULITIS (her lymphedema on her right arm became a cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (her lymphedema on her right arm became a cellulitis) had resolved. Not Provided          As treatment took antibiotics (Doxycycline Monohydrate 100 mg) for 10 days.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pericarditis
Clinical narrative: Diagnosed with pericarditis; Severe breathing problems; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Pericarditis (He also had history of pericarditis when he was 21 years of age (which is from bacteria).), Pacemaker insertion (cardiac) (Patient has 2 pacemakers) and Sepsis.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PERICARDITIS (Diagnosed with pericarditis) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Severe breathing problems) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to DYSPNOEA and PERICARDITIS. At the time of the report, PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) outcome was unknown.            Concomitant medications were not reported.  The patient was under doctor's care.  Pericarditis came back after he took the second shot of the vaccine.  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: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pericarditis, SARS-CoV-2 test
Clinical narrative: Diagnosed with pericarditis; Severe breathing problems; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Pericarditis (He also had history of pericarditis when he was 21 years of age (which is from bacteria).), Pacemaker insertion (cardiac) (Patient has 2 pacemakers) and Sepsis.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PERICARDITIS (Diagnosed with pericarditis) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Severe breathing problems) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to DYSPNOEA and PERICARDITIS. At the time of the report, PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) outcome was unknown.            Concomitant medications were not reported.  The patient was under doctor's care.  Pericarditis came back after he took the second shot of the vaccine.  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: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: Mild chest pain; Body ache; Low grade fever (101°F); Head ache; Welt on the arm at the injection site about a week after being vaccinated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Mild chest pain), MYALGIA (Body ache), PYREXIA (Low grade fever (101°F)) and HEADACHE (Head ache) 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 provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Mild chest pain) (seriousness criterion hospitalization), MYALGIA (Body ache) (seriousness criterion hospitalization), PYREXIA (Low grade fever (101°F)) (seriousness criterion hospitalization), HEADACHE (Head ache) (seriousness criterion hospitalization) and VACCINATION SITE SWELLING (Welt on the arm at the injection site about a week after being vaccinated). At the time of the report, CHEST PAIN (Mild chest pain), MYALGIA (Body ache), PYREXIA (Low grade fever (101°F)), HEADACHE (Head ache) and VACCINATION SITE SWELLING (Welt on the arm at the injection site about a week after being vaccinated) 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.   The patient has no know history of COVID (had 2 negative tests; no antibody test was completed).   Concomitant product use was not reported. Treatment medication included dexamethasone which relieved the symptoms for a while. However, at the time of this report on 07-Apr-2021, the caller was on the way home from taking the patient back to the ER (emergency room) for the symptoms.  This case concerns a female of unknown age hospitalized with serious unexpected events of chest pain, pyrexia, myalgia, headache, and expected vaccination site swelling. Event onset with unknown latency after first dose mRNA-1273. Treated with dexamethasone. 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.; Sender's Comments: This case concerns a female of unknown age hospitalized with serious unexpected events of chest pain, pyrexia, myalgia, headache, and expected vaccination site swelling. Event onset with unknown latency after first dose mRNA-1273. Treated with dexamethasone. 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Angioedema of the lips; Itching of the left arm; rash of the left forearm; This spontaneous case was reported by a physician and describes the occurrence of ANGIOEDEMA (Angioedema of the lips) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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 provided).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Apr-2021, the patient experienced ANGIOEDEMA (Angioedema of the lips) (seriousness criterion medically significant), VACCINATION SITE PRURITUS (Itching of the left arm) and VACCINATION SITE RASH (rash of the left forearm). On 06-Apr-2021, ANGIOEDEMA (Angioedema of the lips), VACCINATION SITE PRURITUS (Itching of the left arm) and VACCINATION SITE RASH (rash of the left forearm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included the Oral Benadryl.; 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: F
Vaccine: COVID19
Symptoms: Pain, Thrombosis
Clinical narrative: Blood clot; Pain; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 30-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.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant) and PAIN (Pain). At the time of the report, THROMBOSIS (Blood clot) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Decreased appetite, Hypoxia, Insomnia, Paraesthesia
Clinical narrative: Reduced oxygen level; Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm; tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back; No appetite; Could not sleep; Speech problem; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Reduced oxygen level) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic pain. Concurrent medical conditions included Cancer and Speech disorder. Concomitant products included INSULIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOXIA (Reduced oxygen level) (seriousness criterion medically significant), BURNING SENSATION (Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm), PARAESTHESIA (tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back), DECREASED APPETITE (No appetite), INSOMNIA (Could not sleep) and SPEECH DISORDER (Speech problem). At the time of the report, HYPOXIA (Reduced oxygen level), BURNING SENSATION (Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm), PARAESTHESIA (tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back), DECREASED APPETITE (No appetite), INSOMNIA (Could not sleep) and SPEECH DISORDER (Speech problem) outcome was unknown.            Patient has not taken anything for treatment.  Company comment: 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Reduced oxygen level; Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm; tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back; No appetite; Could not sleep; Speech problem; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Reduced oxygen level) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic pain. Concurrent medical conditions included Cancer and Speech disorder. Concomitant products included INSULIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOXIA (Reduced oxygen level) (seriousness criterion medically significant), BURNING SENSATION (Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm), PARAESTHESIA (tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back), DECREASED APPETITE (No appetite), INSOMNIA (Could not sleep) and SPEECH DISORDER (Speech problem). At the time of the report, HYPOXIA (Reduced oxygen level), BURNING SENSATION (Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm), PARAESTHESIA (tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back), DECREASED APPETITE (No appetite), INSOMNIA (Could not sleep) and SPEECH DISORDER (Speech problem) outcome was unknown.            Patient has not taken anything for treatment.  Company comment: 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.