chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Heart rate increased, Loss of personal independence in daily activities, Malaise
Clinical narrative: procedure in which his heart was cut from top to bottom/pacemaker dependent; fast heart rate; afib; red dots on both of his arms; rash on both arms; dizzy; sick; very weak/no energy; hard time walking; cannot do the simplest of tasks; flutter; A spontaneous report was received from a Consumer concerning herself, a 57-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, Atrial flutter, very weak and no energy, hard time walking, and cannot do the simplest of tasks.  The patient's medical history included atrial fibrillation and had a pacemaker placed about 8-9 months ago.  Products known to have been used by the patient, within two weeks prior to the event were blood pressure medication, antiarrhythmics.  On 01 Mar 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 030m20a) via unknown route for prophylaxis of COVID-19 infection.  On 01 Mar 2021, after vaccination, the patient developed red dots on both of his arms. For next two days, the patient had rash on both arms, was dizzy, felt sick, developed fast heart rate; went to hospital twice for heart rate either 07 Mar 2021 or 13 Mar 2021.During first visit to hospital, fast rate was brought under control, while in the second visit, the patient had a procedure in which his heart was cut from top to bottom and was made pacemaker dependent. The atrial fibrillation could not be controlled for 26 hours and had a flutter which was not identified and could not be controlled. Flutter returned after stopping amlodipine and hence patient was restarted on amlodipine. The patient now feels very weak, has a hard time walking, has no energy, cannot do the simplest of tasks, still experiences fast heart rate and flutter every now and then.   No Laboratory investigations were provided. The Treatment information included pacemaker, amlodipine.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, atrial flutter, very weak and no energy, hard time walking, cannot do the simplest of tasks were unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: procedure in which his heart was cut from top to bottom/pacemaker dependent; fast heart rate; afib; red dots on both of his arms; rash on both arms; dizzy; sick; very weak/no energy; hard time walking; cannot do the simplest of tasks; flutter; A spontaneous report was received from a Consumer concerning herself, a 57-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, Atrial flutter, very weak and no energy, hard time walking, and cannot do the simplest of tasks.  The patient's medical history included atrial fibrillation and had a pacemaker placed about 8-9 months ago.  Products known to have been used by the patient, within two weeks prior to the event were blood pressure medication, antiarrhythmics.  On 01 Mar 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 030m20a) via unknown route for prophylaxis of COVID-19 infection.  On 01 Mar 2021, after vaccination, the patient developed red dots on both of his arms. For next two days, the patient had rash on both arms, was dizzy, felt sick, developed fast heart rate; went to hospital twice for heart rate either 07 Mar 2021 or 13 Mar 2021.During first visit to hospital, fast rate was brought under control, while in the second visit, the patient had a procedure in which his heart was cut from top to bottom and was made pacemaker dependent. The atrial fibrillation could not be controlled for 26 hours and had a flutter which was not identified and could not be controlled. Flutter returned after stopping amlodipine and hence patient was restarted on amlodipine. The patient now feels very weak, has a hard time walking, has no energy, cannot do the simplest of tasks, still experiences fast heart rate and flutter every now and then.   No Laboratory investigations were provided. The Treatment information included pacemaker, amlodipine.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, atrial flutter, very weak and no energy, hard time walking, cannot do the simplest of tasks were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pharyngeal haemorrhage, Stomatitis
Clinical narrative: throat is bleeding; the left side of inner mouth from left molar to upper left tonsil is raw; glands swelled; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL HAEMORRHAGE (throat is bleeding) in a 50-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 reported medical history).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PHARYNGEAL HAEMORRHAGE (throat is bleeding) (seriousness criterion medically significant), STOMATITIS (the left side of inner mouth from left molar to upper left tonsil is raw) and LYMPHADENOPATHY (glands swelled). At the time of the report, PHARYNGEAL HAEMORRHAGE (throat is bleeding), STOMATITIS (the left side of inner mouth from left molar to upper left tonsil is raw) and LYMPHADENOPATHY (glands swelled) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. No treatment drug provided   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Malaise, Skin lesion, Staphylococcal infection
Clinical narrative: staph infection around the same time as getting the vaccine; Skin Sores looking like Chickenpox (Majority on Torso and groin area); Painful and Swollen Lymph Nodes (Groin and Arm pit ); Malaise; Sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (staph infection around the same time as getting the vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced MALAISE (Malaise) and ARTHRALGIA (Sore left shoulder). On 26-Mar-2021, the patient experienced SKIN LESION (Skin Sores looking like Chickenpox (Majority on Torso and groin area)) and LYMPHADENOPATHY (Painful and Swollen Lymph Nodes (Groin and Arm pit )). On an unknown date, the patient experienced STAPHYLOCOCCAL INFECTION (staph infection around the same time as getting the vaccine) (seriousness criterion medically significant). On 23-Mar-2021, MALAISE (Malaise) and ARTHRALGIA (Sore left shoulder) had resolved. At the time of the report, STAPHYLOCOCCAL INFECTION (staph infection around the same time as getting the vaccine) outcome was unknown and SKIN LESION (Skin Sores looking like Chickenpox (Majority on Torso and groin area)) and LYMPHADENOPATHY (Painful and Swollen Lymph Nodes (Groin and Arm pit )) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: New adverse event; 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fall, Fatigue
Clinical narrative: blacked out/felt going down; feeling weak/could not stand and walk; bumped on floor; dizziness; nausea; headache; fatigue; chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 10:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (felt going down), seriousness criterion medically significant),  VACCINATION SITE PAIN, CHILLS,  DIZZINESS,ASTHENIA (she could not stand) (she could not walk)(feeling weak), FALL(bumped on floor), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (blacked out) (felt going down),  ASTHENIA(she could not stand),(she could not walk)(feeling weak), FALL  (bumped on floor), NAUSEA (nausea), HEADACHE (headache) ,VACCINATION SITE PAIN, CHILLS,  DIZZINESSand FATIGUE (fatigue) had resolved.            Concomitant medication: very low dose of cholesterol medication.   This case was linked to MOD-2021-060481 (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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Vaccination site pain
Clinical narrative: blacked out/felt going down; feeling weak/could not stand and walk; bumped on floor; dizziness; nausea; headache; fatigue; chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 10:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (felt going down), seriousness criterion medically significant),  VACCINATION SITE PAIN, CHILLS,  DIZZINESS,ASTHENIA (she could not stand) (she could not walk)(feeling weak), FALL(bumped on floor), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (blacked out) (felt going down),  ASTHENIA(she could not stand),(she could not walk)(feeling weak), FALL  (bumped on floor), NAUSEA (nausea), HEADACHE (headache) ,VACCINATION SITE PAIN, CHILLS,  DIZZINESSand FATIGUE (fatigue) had resolved.            Concomitant medication: very low dose of cholesterol medication.   This case was linked to MOD-2021-060481 (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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Seizure, Ventricular tachycardia, Vomiting
Clinical narrative: Convulsions; In and out of consciousness; extreme pain throughout the body; Vomiting; Inability to speak; Couldn't walk; Couldn't raise limbs; Sustained premature ventricular tachycardia; Heart collapsed to 20 BPM; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) in a 51-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 No adverse event (No historical condition reported).    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia) (seriousness criteria hospitalization, medically significant and life threatening), BRADYCARDIA (Heart collapsed to 20 BPM) (seriousness criteria hospitalization, medically significant and life threatening), SEIZURE (Convulsions) (seriousness criteria hospitalization prolonged and medically significant), SEIZURE (In and out of consciousness) (seriousness criterion hospitalization prolonged), PAIN (extreme pain throughout the body) (seriousness criterion hospitalization prolonged) and VOMITING (Vomiting) (seriousness criterion hospitalization prolonged). 23-Mar-2021, the patient experienced GAIT INABILITY (Couldn't walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs) (seriousness criterion hospitalization) and APHASIA (Inability to speak) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA, BRADYCARDIA, GAIT INABILITY, MUSCULOSKELETAL STIFFNESS and VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: 20 (Low) 20 BPM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) to be related.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Loss of consciousness; Lethargy; Feeling abnormal; Decreased Appetite; Dizziness; Abdominal pain upper; Fatigue; Headache; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A 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 reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE, ESTRADIOL (ESTROGEN) and DULOXETINE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea).   At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      Patient's treatment information include Tylenol for headache.   This case was linked to MOD-2021-061582 (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 two days after second dose of vaccination, a causal relationship cannot be excluded. Further information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Loss of consciousness, Nausea
Clinical narrative: Loss of consciousness; Lethargy; Feeling abnormal; Decreased Appetite; Dizziness; Abdominal pain upper; Fatigue; Headache; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A 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 reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE, ESTRADIOL (ESTROGEN) and DULOXETINE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea).   At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      Patient's treatment information include Tylenol for headache.   This case was linked to MOD-2021-061582 (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 two days after second dose of vaccination, a causal relationship cannot be excluded. Further information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Electrocardiogram, Fatigue, Hypertension
Clinical narrative: blood pressure went up high 200 systolic; body ache; soreness of left arm; chills; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure went up high 200 systolic) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 AMLODIPINE and METOPROLOL for an unknown indication.    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 PAIN (body ache), VACCINATION SITE PAIN (soreness of left arm), CHILLS (chills) and FATIGUE (tiredness). On 26-Mar-2021, the patient experienced HYPERTENSION (blood pressure went up high 200 systolic) (seriousness criterion hospitalization). The patient was hospitalized on 26-Mar-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (blood pressure went up high 200 systolic), PAIN (body ache), VACCINATION SITE PAIN (soreness of left arm), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: (High) increased. On 26-Mar-2021, Electrocardiogram: (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: blood pressure went up high 200 systolic; body ache; soreness of left arm; chills; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure went up high 200 systolic) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 AMLODIPINE and METOPROLOL for an unknown indication.    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 PAIN (body ache), VACCINATION SITE PAIN (soreness of left arm), CHILLS (chills) and FATIGUE (tiredness). On 26-Mar-2021, the patient experienced HYPERTENSION (blood pressure went up high 200 systolic) (seriousness criterion hospitalization). The patient was hospitalized on 26-Mar-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (blood pressure went up high 200 systolic), PAIN (body ache), VACCINATION SITE PAIN (soreness of left arm), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: (High) increased. On 26-Mar-2021, Electrocardiogram: (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ovarian cancer
Clinical narrative: Low grade ovarian cancer; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OVARIAN CANCER (Low grade ovarian cancer) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ultrasound scan NOS (The results were reported as normal and clear.) on 04-Mar-2021. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 13-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 13-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 26-Mar-2021, the patient experienced OVARIAN CANCER (Low grade ovarian cancer) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 13-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, OVARIAN CANCER (Low grade ovarian cancer) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy in a patient who was diagnosed with Ovarian Cancer after receiving the first dose of mRNA-1273. 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. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy in a patient who was diagnosed with Ovarian Cancer after receiving the first dose of mRNA-1273. 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. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: cellulitis; Redness of legs; swelling on the legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), ERYTHEMA (Redness of legs) and PERIPHERAL SWELLING (swelling on the legs). At the time of the report, CELLULITIS (cellulitis), ERYTHEMA (Redness of legs) and PERIPHERAL SWELLING (swelling on the legs) outcome was unknown.            On 29 Mar 2021, the patient went to emergency room (ER) and was diagnosed with cellulitis. Treatment information was not provided. No relevant concomitant medications was provided.  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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Major depression
Clinical narrative: itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; Major depressive episode; fever; chills; headache; fatigue; A spontaneous report was received from a consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/ pyrexia, chills, headache, fatigue, major depressive episode/ major depression, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site pruritus, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site induration, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site warmth, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site rash.  The patient's medical history was reported by the reporter as patient had a major depression well controlled with medicine. Concomitant medications taken by the patient included duloxetine hydrochloride.  On 15 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 044A21A) through unknown route at left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, patient developed fever (101.0 F for which she took an Aleve), chills for 24-36 hours, headache, fatigue for 3 -4 days. She took another Aleve the next day. On 20 Mar 2021 she had a major depressive episode. On 27 Mar 2021, she developed an itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site. Patient reported that she was doing a little better with the depression and the arm was hard and warm at the time of reporting too. The event major depressive episode was medically significant.  Treatment activities for event was done with naproxen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, chills was resolved on 18 Mar 2021, headache, fatigue was resolved on 20 Mar 2021, itchy at injection site was resolved on 27 Mar 2021, rash at injection site was resolved on 28 Mar 2021, major depressive episode was recovering/resolving, hard, warm at injection site was not recovered/ not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; Major depressive episode; fever; chills; headache; fatigue; A spontaneous report was received from a consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/ pyrexia, chills, headache, fatigue, major depressive episode/ major depression, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site pruritus, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site induration, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site warmth, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site rash.  The patient's medical history was reported by the reporter as patient had a major depression well controlled with medicine. Concomitant medications taken by the patient included duloxetine hydrochloride.  On 15 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 044A21A) through unknown route at left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, patient developed fever (101.0 F for which she took an Aleve), chills for 24-36 hours, headache, fatigue for 3 -4 days. She took another Aleve the next day. On 20 Mar 2021 she had a major depressive episode. On 27 Mar 2021, she developed an itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site. Patient reported that she was doing a little better with the depression and the arm was hard and warm at the time of reporting too. The event major depressive episode was medically significant.  Treatment activities for event was done with naproxen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, chills was resolved on 18 Mar 2021, headache, fatigue was resolved on 20 Mar 2021, itchy at injection site was resolved on 27 Mar 2021, rash at injection site was resolved on 28 Mar 2021, major depressive episode was recovering/resolving, hard, warm at injection site was not recovered/ not resolved.; 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized on 16-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Movement disorder, Nausea, Rash pruritic, Thrombosis
Clinical narrative: Blood clot in Left Arm; itchy rash from elbow to shoulder; lump on the underside of her biceps; nauseous; couldn't lift arm up; arm sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in Left Arm) in a 63-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 reported medical history.). Concomitant products included CLONAZEPAM for Anxiety, STEROIDS for Back disorder, CITALOPRAM and MORPHINE SULFATE for an unknown indication.    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 VACCINATION SITE PAIN (arm sore at the injection site). On 24-Mar-2021, the patient experienced MOVEMENT DISORDER (couldn't lift arm up). On 25-Mar-2021, the patient experienced RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps) and NAUSEA (nauseous). On 27-Mar-2021, the patient experienced THROMBOSIS (Blood clot in Left Arm) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in Left Arm), RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps), MOVEMENT DISORDER (couldn't lift arm up), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl for symptoms and Eliquis for blood clot.; 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: Vaccination site pain
Clinical narrative: Blood clot in Left Arm; itchy rash from elbow to shoulder; lump on the underside of her biceps; nauseous; couldn't lift arm up; arm sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in Left Arm) in a 63-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 reported medical history.). Concomitant products included CLONAZEPAM for Anxiety, STEROIDS for Back disorder, CITALOPRAM and MORPHINE SULFATE for an unknown indication.    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 VACCINATION SITE PAIN (arm sore at the injection site). On 24-Mar-2021, the patient experienced MOVEMENT DISORDER (couldn't lift arm up). On 25-Mar-2021, the patient experienced RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps) and NAUSEA (nauseous). On 27-Mar-2021, the patient experienced THROMBOSIS (Blood clot in Left Arm) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in Left Arm), RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps), MOVEMENT DISORDER (couldn't lift arm up), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl for symptoms and Eliquis for blood clot.; 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: Injection site cellulitis, Radiculitis brachial, Vaccination site infection
Clinical narrative: Patient's injection site has has become infected and that she has cellulitis; Brachial neuritis; Injection site has has become infected; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE CELLULITIS (Patient's injection site has has become infected and that she has cellulitis) 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 medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE CELLULITIS (Patient's injection site has has become infected and that she has cellulitis) (seriousness criterion medically significant) with VACCINATION SITE INFECTION (Injection site has has become infected) and RADICULITIS BRACHIAL (Brachial neuritis). At the time of the report, INJECTION SITE CELLULITIS (Patient's injection site has has become infected and that she has cellulitis) and RADICULITIS BRACHIAL (Brachial neuritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment for the events included steroids. When the steroids are stopped, the patient's condition flares up again. Patient has been referred to a Neurologist for treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-051579 (Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-051579: Crosslinked
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Contusion, Deep vein thrombosis, Dyspnoea
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (Severe Tachycardia/ Still very tachycardia) and FEELING ABNORMAL (Felt a little weird). On 03-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Could not get up), ASTHMA (Asthma) and ASTHENIA (Could not get up). On 04-Feb-2021, the patient experienced CONTUSION (Bruise on her right and left leg) and VACCINATION COMPLICATION (Had a reaction to the vaccine). On 01-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low). At the time of the report, DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg), TACHYCARDIA (Severe Tachycardia/ Still very tachycardia), DYSPNOEA (Difficulty breathing), FEELING ABNORMAL (Felt a little weird), FATIGUE (Could not get up), ASTHMA (Asthma), CONTUSION (Bruise on her right and left leg), ASTHENIA (Could not get up), VACCINATION COMPLICATION (Had a reaction to the vaccine), HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemoglobin: low gram per litre (Low) LOW. In March 2021, Red blood cell count: low cells per microlitre (Low) LOW.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment informations reported were Levalbuterol tartrate  and Rivaroxaba 20 mg   This case was linked to MOD-2021-059897 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Haemoglobin, Red blood cell count, Tachycardia
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (Severe Tachycardia/ Still very tachycardia) and FEELING ABNORMAL (Felt a little weird). On 03-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Could not get up), ASTHMA (Asthma) and ASTHENIA (Could not get up). On 04-Feb-2021, the patient experienced CONTUSION (Bruise on her right and left leg) and VACCINATION COMPLICATION (Had a reaction to the vaccine). On 01-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low). At the time of the report, DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg), TACHYCARDIA (Severe Tachycardia/ Still very tachycardia), DYSPNOEA (Difficulty breathing), FEELING ABNORMAL (Felt a little weird), FATIGUE (Could not get up), ASTHMA (Asthma), CONTUSION (Bruise on her right and left leg), ASTHENIA (Could not get up), VACCINATION COMPLICATION (Had a reaction to the vaccine), HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemoglobin: low gram per litre (Low) LOW. In March 2021, Red blood cell count: low cells per microlitre (Low) LOW.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment informations reported were Levalbuterol tartrate  and Rivaroxaba 20 mg   This case was linked to MOD-2021-059897 (Patient Link).