chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; A spontaneous report was received from a consumer concerning a 55-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced seizure.  The patient's medical history, as provided by the reporter, included epilepsy. Concomitant medications included lamotrigine and levetiracetam.  On 13 Jan 2021, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced medically significant event, seizure and was hospitalized.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event seizure was resolved on 28 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe vomiting for one hour non stop; A spontaneous report was received from a consumer concerning a 70 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed severe vomiting.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 17 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Feb 2021, he had severe vomiting for 1 hour non stop. He was hospitalised on that day and received treatment for that. On 19 Feb 2021, he was discharged from hospital.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The event, vomiting, was considered resolved on 19 Feb 2021.; Reporter'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: 98.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Chills, Consciousness fluctuating, Hypertension, Urinary tract infection
Clinical narrative: in and out of consciousness; blood pressure was 170/112; severe chills; UTI; A spontaneous report was received from a consumer, concerning a 98-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/ chills, blood pressure was 170/112/ hypertension, was in and out of consciousness/ consciousness fluctuating, chronic heart failure/ cardiac failure chronic and urinary tract infection (UTI).  The patient's medical history included were chronic heart failure and urinary tract infection. Concomitant medication included was apixaban.  On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, same day of receiving vaccine, the patient experienced severe chills, blood pressure was 170/112, and was in and out of consciousness. She was hospitalized and remained at the hospital.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, were considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. However, advanced age, history of chronic heart failure and concurrent underlying urinary tract infection may remain as risk factors. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: Light energy; Fever; Arm hurt pretty bad; Chills; Body aches; Fatigue; Passed out twice; Felt like ran over by truck; A spontaneous report was received from a consume who is a female patient who passed out twice/ loss of consciousness, felt like she was run over by truck/ feeling abnormal, fatigue, chills, body aches/ myalgia, fever/ pyrexia, arm hurt pretty bad/ pain in extremity and light energy/ asthenia.  The patient's medical history was not reported. Patient's concomitant reported included Lexapro and Spironolactone.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041l20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, same day of receiving vaccine, the patient passed out twice and felt like she was run over by truck. She also experienced fatigue, chills, body aches, fever and arm hurt pretty bad. On 21 Jan 2021, 2 days later, she had light energy.  No treatment information was reported.  Action taken with mrna-1273 in response to the events was not reported.   The outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (pyrexia, pain in extremity, chills, myalgia, asthenia, fatigue, feeling abnormal) a causal relationship cannot be excluded. Very limited information regarding the event (LOC) has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Light energy; Fever; Arm hurt pretty bad; Chills; Body aches; Fatigue; Passed out twice; Felt like ran over by truck; A spontaneous report was received from a consume who is a female patient who passed out twice/ loss of consciousness, felt like she was run over by truck/ feeling abnormal, fatigue, chills, body aches/ myalgia, fever/ pyrexia, arm hurt pretty bad/ pain in extremity and light energy/ asthenia.  The patient's medical history was not reported. Patient's concomitant reported included Lexapro and Spironolactone.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041l20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, same day of receiving vaccine, the patient passed out twice and felt like she was run over by truck. She also experienced fatigue, chills, body aches, fever and arm hurt pretty bad. On 21 Jan 2021, 2 days later, she had light energy.  No treatment information was reported.  Action taken with mrna-1273 in response to the events was not reported.   The outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (pyrexia, pain in extremity, chills, myalgia, asthenia, fatigue, feeling abnormal) a causal relationship cannot be excluded. Very limited information regarding the event (LOC) has been provided at this time. Further information has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; A spontaneous report was received from a consumer (patient), concerning himself, an 84-years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness.  The patient's medical history included major brain surgery one year ago due to a major fall off a ladder, a blood clot in his head, seizure and a pacemaker placement several years ago. Current condition included needs cane or walker. Concomitant medications reported were levetiracetam, pantoprazole, allopurinol, apixaban, carvedilol and rosuvastatin.  On 02 Feb 2021, prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A), intramuscular for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced dizziness that was pretty severe and needs cane and walker when standing. Patient stated that he was feeling better today on 10 Feb 2021, than past two days. Reportedly, patient was inquiring about his second dose scheduled on 02 Mar 2021. Treatment details were not provided.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, dizziness was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: bulls eye rash on same arm injected; A spontaneous report was received from a 45-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bull's eye rash on same injected arm/Lyme's disease.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, 16 days after receiving the vaccine, the patient developed a bull's eye rash on same arm of injection.   On 03 Feb 2021 the patient was diagnosed with lyme's disease. The patient was prescribed a 21-day regiment of doxycycline.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), Lyme's disease was unknown.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Lyme's disease is assessed as unlikely related.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Seizure
Clinical narrative: Seizure; Neurologically confused; A spontaneous report was received from a consumer concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced a seizure and was neurologically confused (confusional state).  The patient's current conditions included epilepsy. Concomitant product use was not provided by the reporter.  On 26-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 22-FEB-2021, right before the patient was supposed to get the second dose of vaccine, she had a seizure and was hospitalized. The same day, patient was neurologically confused. The patient underwent different unknown tests including computerized tomography. On 24-FEB-2021, the patient was discharged from hospital.   No treatment information was provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, seizure and confusional state were resolved/recovered; Reporter's Comments: Based on reporter's causality and the prior history of epilepsy, the events are assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Dizziness, Fatigue
Clinical narrative: Bell's Palsy; Felt lightheaded and dizziness; Fatigue; A spontaneous report was received from a consumer concerning an 83 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy, Dizziness, and Fatigue.  The patient's medical history and concomitant medications were not reported.  On 03-FEB-2021, prior to the onset of events, the patient received his first dose of two planned doses of mRNA-1273 (lot# unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 04-MAR-2021, the patient was taken to ER and was diagnosed with a mild case of Bell's palsy. He also felt dizziness, lightheaded, and fatigue. Attending doctor at the Veterans Administration said he could take the vaccine but his primary care physician advised him to wait a week. Treatment included prednisone and valacyclovir.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of events, Bell's Palsy, Dizziness, and Fatigue, were unknown.; Reporter'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: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke shortly after the first dose; A spontaneous report was received from a consumer concerning an 81 year old, male patient who experienced stroke shortly after the first dose (cerebrovascular accident).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  It was reported that the patient experienced stroke shortly after the first dose.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event of stroke shortly after the first dose (cerebrovascular accident) was considered unknown.; Reporter's Comments: This is a case of sudden death in a 93-year-old female subject with no medical hx reported who suffered a stroke (unspecified days)  after receiving first dose of vaccine. Very limited information has been provided at this time. Further information will be pursued..
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Pyrexia, Restlessness, Seizure
Clinical narrative: Spasms like seizures; Fidgeting non-stop; Barring their teeth like a grimace; Low-grade fever; A spontaneous report was received on 10 Mar 2021 from a consumer concerning a 81-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spasms like seizures/ seizure, fidgeting non-stop/restlessness, barring their teeth like a grimace/bruxism and low-grade fever/pyrexia.   The patient's medical history included COVID-19 and severe Alzheimer's disease. Concomitant product use was not provided.   On 09 Mar 2021, approximately 1 day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.    On 10 Mar 2021, the patient experienced low-grade fever, spasms like seizures, fidgeting non-stop and barring their teeth like a grimace. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, spasms like seizures, fidgeting non-stop, barring their teeth like a grimace, and low-grade fever, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysarthria, Fatigue, Feeling hot, Speech disorder
Clinical narrative: Mini stroke thing; Hot; 15-20 sec she had hard time talking; Mumbling; Fatigue; Chills; A spontaneous report was received from a consumer concerning his wife a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, hot/ feeling hot, chills and for 15-20 sec she had hard time talking/ dysarthria, mumbling/ speech disorder, like mini stroke thing/ transient ischaemic attack.  The patient's medical history included high blood pressure. Concomitant medications included pill for high blood pressure.  On 08 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm (non-dominant) for prophylaxis of COVID-19 infection. On 08 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, on the same night the patient experienced felt fatigue, hot, chills and for 15-20 sec the patient had hard time talking, mumbling, like mini stroke thing a medically significant event.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, fatigue, hot, chills and for 15-20 sec she had hard time talking, mumbling, like mini stroke thing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's medical history of high blood pressure is a risk factor for stroke and hence remains a confounder for causality. The patient did not consent for the follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Mini stroke thing; Hot; 15-20 sec she had hard time talking; Mumbling; Fatigue; Chills; A spontaneous report was received from a consumer concerning his wife a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, hot/ feeling hot, chills and for 15-20 sec she had hard time talking/ dysarthria, mumbling/ speech disorder, like mini stroke thing/ transient ischaemic attack.  The patient's medical history included high blood pressure. Concomitant medications included pill for high blood pressure.  On 08 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm (non-dominant) for prophylaxis of COVID-19 infection. On 08 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, on the same night the patient experienced felt fatigue, hot, chills and for 15-20 sec the patient had hard time talking, mumbling, like mini stroke thing a medically significant event.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, fatigue, hot, chills and for 15-20 sec she had hard time talking, mumbling, like mini stroke thing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's medical history of high blood pressure is a risk factor for stroke and hence remains a confounder for causality. The patient did not consent for the follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Stomach is crampy; Muscle joints hurt; Bad headache; Chills; Threw up; Bad fever; Passed out; Loose bowels; Sweating; A spontaneous report was received from a consumer concerning a 53 years old male patient who developed passed out/loss of consciousness, diabetic/diabetes mellitus, loose bowels/diarrhoea, bad fever/pyrexia, sweating/hyperhidrosis, muscle joints hurt/myalgia, stomach is crampy/abdominal pain, bad headache/headache, threw up/vomiting and chills.     The patient's medical history included diabetes and sinus infection. Products known to have been used by the patient, within two weeks prior to the event, included Metformin and sinus medication.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 036A21A) on 8 Mar 2021 in the left arm for prophylaxis of COVID-19 infection.    On 9 Mar 2021 around 10 AM the patient started feeling bad. Patient threw up, had loose bowels, bad fever, couldn't get warm for 3 hours, was sweating, and passed out. On 10 Mar 2021 patient stated that all his muscle joints hurt, and his stomach is crampy, and has a bad headache and chills. The medically significant event is loss of consciousness. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) passed out, diabetic, loose bowels, bad fever, sweating, muscle joints hurt, stomach is crampy, bad headache, threw up and chills was not reported.; Reporter'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: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Myalgia, Pyrexia, Vomiting
Clinical narrative: Stomach is crampy; Muscle joints hurt; Bad headache; Chills; Threw up; Bad fever; Passed out; Loose bowels; Sweating; A spontaneous report was received from a consumer concerning a 53 years old male patient who developed passed out/loss of consciousness, diabetic/diabetes mellitus, loose bowels/diarrhoea, bad fever/pyrexia, sweating/hyperhidrosis, muscle joints hurt/myalgia, stomach is crampy/abdominal pain, bad headache/headache, threw up/vomiting and chills.     The patient's medical history included diabetes and sinus infection. Products known to have been used by the patient, within two weeks prior to the event, included Metformin and sinus medication.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 036A21A) on 8 Mar 2021 in the left arm for prophylaxis of COVID-19 infection.    On 9 Mar 2021 around 10 AM the patient started feeling bad. Patient threw up, had loose bowels, bad fever, couldn't get warm for 3 hours, was sweating, and passed out. On 10 Mar 2021 patient stated that all his muscle joints hurt, and his stomach is crampy, and has a bad headache and chills. The medically significant event is loss of consciousness. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) passed out, diabetic, loose bowels, bad fever, sweating, muscle joints hurt, stomach is crampy, bad headache, threw up and chills was not reported.; Reporter'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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Cardiac dysfunction, Cardiac failure, Dyspnoea, Oedema peripheral
Clinical narrative: Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure.  The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital.  Action taken with mRNA-1273 in response to the events was not reported.   The seriousness criteria for all the events was hospitalization.  The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Oliguria, Renal failure
Clinical narrative: Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure.  The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital.  Action taken with mRNA-1273 in response to the events was not reported.   The seriousness criteria for all the events was hospitalization.  The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance, Neuropathy peripheral
Clinical narrative: Acute neuropathy pain in their left foot particularly in the lateral aspect; Made walking difficult and running (which they do frequently) impossibl; Two weeks of significant discomfort; A spontaneous report  was received from a Physician concerning a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced acute neuropathy pain in their left foot particularly in the lateral aspect/neuropathy peripheral, made walking difficult/gait disturbance and two weeks of significant discomfort/discomfort.  The patient's medical history included kidney removed because of cancer. Concomitant medications reported included vitamin d3, calcium carbonate, cyanocobalamin, calcium levomefolate and curcumin.  On 9 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 024M20A) in the left arm for prophylaxis of COVID-19 infection.   On 21 Feb 2021, the patient experienced medically significant event acute neuropathy pain in their left foot particularly in the lateral aspect, made walking difficult and two weeks of significant discomfort.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, acute neuropathy pain in their left foot particularly in the lateral aspect was considered resolving (gotten gradually better). The outcome of events, made walking difficult and two weeks of significant discomfort was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Nausea, Night sweats, Pyrexia
Clinical narrative: blood clot; Fever; sick feeling; chills; nausea; night sweats; A spontaneous report was received from a healthcare professional concerning a 31-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick feeling/illness, chills, nausea, night sweats, blood clot/thrombosis, and fever/pyrexia.  The patient's medical history included Cystic Fibrosis and only has half of their liver. No relevant concomitant medications were reported.  On 26-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26JAN2021, the patient began experiencing symptoms including sick feeing, chills, nausea, and night sweats. The patient had blood clot and fever on 21-FEB-2021. Patient was admitted into the hospital on 22-FEB-2021 and discharged on 26-FEB-2021. He received the following tests while in the hospital: MRI, Bone Density, and LABS.  Treatment of the events included Eliquis.   Action taken with mRNA-1273 in response to the events was not reported.   On 25 Feb 2021 the outcome of event, fever was resolved. The outcome of events, sick feeling, chills, nausea, night sweats, blood clot were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; Fever; sick feeling; chills; nausea; night sweats; A spontaneous report was received from a healthcare professional concerning a 31-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick feeling/illness, chills, nausea, night sweats, blood clot/thrombosis, and fever/pyrexia.  The patient's medical history included Cystic Fibrosis and only has half of their liver. No relevant concomitant medications were reported.  On 26-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26JAN2021, the patient began experiencing symptoms including sick feeing, chills, nausea, and night sweats. The patient had blood clot and fever on 21-FEB-2021. Patient was admitted into the hospital on 22-FEB-2021 and discharged on 26-FEB-2021. He received the following tests while in the hospital: MRI, Bone Density, and LABS.  Treatment of the events included Eliquis.   Action taken with mRNA-1273 in response to the events was not reported.   On 25 Feb 2021 the outcome of event, fever was resolved. The outcome of events, sick feeling, chills, nausea, night sweats, blood clot were unknown.; Reporter'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: Breast haemorrhage
Clinical narrative: Bleeding breast; A spontaneous report was received from a consumer concerning a 63 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced breast bleeding.   The patient's medical history was not reported. No concomitant medications were reported.   On 05-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 10-Mar-2021 patient experienced some blood from breast. The patient's doctor recommended an emergency mammogram.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome events, breast bleeding, was considered unknown.; Reporter's Comments: This case concerns a 63 year-old, female patient, who experienced some blood from breast 6 days after the first dose of mRNA. The patient's doctor recommended an emergency mammogram. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Dysarthria, Fatigue, Hypoaesthesia
Clinical narrative: Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced  dizziness, tiredness, slurred speech, numbness,  blurred vision, stroke,  very very lethargic and had tingling in face and fingers, lost speech, lost eyesight.  The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided.  On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also  lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak.  Patient went to hospital and treatment activities for events was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight  was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine.  Critical details such as the onset date of the event is lacking.  Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced  dizziness, tiredness, slurred speech, numbness,  blurred vision, stroke,  very very lethargic and had tingling in face and fingers, lost speech, lost eyesight.  The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided.  On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also  lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak.  Patient went to hospital and treatment activities for events was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight  was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine.  Critical details such as the onset date of the event is lacking.  Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Atrial fibrillation, Throat tightness
Clinical narrative: Patient report to have been in A-fib for three days after receiving first dose of vaccine; Throat closure; Felt like anaphylaxis; A spontaneous report was received from a consumer who was a 53-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed atrial fibrillation and an anaphylactic reaction.    The patient's medical history included heart failure and allergies to butter and NSAIDS.  Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, diltiazem, apixaban, lisinopril and loratadine.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 040A21A) on 11 Mar 2021 in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient reported that he experienced a moderate reaction; throat closure (not complete).  He stated that it felt like anaphylaxis.  He also reported having a numb tongue. He reported that the reaction was not immediate and that  it started about four hours after the vaccine.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, atrial fibrillation, was considered recovered/resolved. The outcome of the event, anaphylactic reaction, was considered recovering/resolving.; Reporter's Comments: This case concerns a 53-year-old male who experienced a serious anaphylactic reaction with serious unexpected event of atrial fibrillation and throat closure.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Atrial fibrillation resolved, and anaphylaxis resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized with a diagnosis of covid; A spontaneous report was received from a healthcare professional concerning a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized with a diagnosis of Covid-19.  The patient's medical history and concomitant product use was not provided by the reporter.  On 12-Feb-2021, the patient received their first of two planned doses of mRNA-1273  (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, post the first dose of vaccination, she was hospitalized with a diagnosis of Covid-19. The patient was treated with monoclonal antibodies and her last treatment were on 01-Mar-2021. The physician understood that it is recommended to wait 90 days before vaccination and wanted to clarify that information before giving the second dose.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event hospitalized with a diagnosis of Covid-19 was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Akathisia, Arthritis reactive, Chills, Extrapyramidal disorder, Psychomotor hyperactivity
Clinical narrative: like "Reiter's"; a need to run around the house...unable to sit still...fidgeting; shaking; it felt like extra pyramidal symptoms; like "akathisias"; fever; severe shivering; A spontaneous report was received from a nurse who was a 41-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a sudden need to run around the house, was unable to sit still, was fidgeting, had a fever, shaking, severe shivering and felt like she had extra pyramidal symptoms, like Reiter's, like akathisias.  The patient's medical history provided included: allergies to penicillin and clindamycin and Covid-19 in November 2020.  No Relevant concomitant medications were reported.  On 16 Feb 2021, approximately 12 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) for prophylaxis of COVID-19 infection.   On 16 Feb 2021, 12 hours after vaccination administration, the patient suddenly had a need to run around the house and was unable to sit still.  She reported that she was fidgeting for about 25 minutes. On the same day, the patient also had a fever and she was shaking and severely shivering. The patient reported that it felt like "extra pyramidal symptoms," like Reiter's" and "akathisias."  She reported that the symptoms lasted approximately two hours.    Treatment information provided included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, developed a sudden need to run around the house, was unable to sit still, was fidgeting, had a fever, shaking, severe shivering and felt like she had extra pyramidal symptoms, like Reiter's, like akathisias, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Fever is consistent with the product known safety profile
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: like "Reiter's"; a need to run around the house...unable to sit still...fidgeting; shaking; it felt like extra pyramidal symptoms; like "akathisias"; fever; severe shivering; A spontaneous report was received from a nurse who was a 41-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a sudden need to run around the house, was unable to sit still, was fidgeting, had a fever, shaking, severe shivering and felt like she had extra pyramidal symptoms, like Reiter's, like akathisias.  The patient's medical history provided included: allergies to penicillin and clindamycin and Covid-19 in November 2020.  No Relevant concomitant medications were reported.  On 16 Feb 2021, approximately 12 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) for prophylaxis of COVID-19 infection.   On 16 Feb 2021, 12 hours after vaccination administration, the patient suddenly had a need to run around the house and was unable to sit still.  She reported that she was fidgeting for about 25 minutes. On the same day, the patient also had a fever and she was shaking and severely shivering. The patient reported that it felt like "extra pyramidal symptoms," like Reiter's" and "akathisias."  She reported that the symptoms lasted approximately two hours.    Treatment information provided included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, developed a sudden need to run around the house, was unable to sit still, was fidgeting, had a fever, shaking, severe shivering and felt like she had extra pyramidal symptoms, like Reiter's, like akathisias, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Fever is consistent with the product known safety profile
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Loss of consciousness, Urinary incontinence
Clinical narrative: Passed out; she lost control of bladder; Blood pressure low; A spontaneous report was received from a consumer concerning a 53-years-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out (loss of consciousness) and lost control of bladder (urinary incontinence) and blood pressure low(hypotension).  Patient's past medical history included, low blood pressure. It was normally on the lower end. She had fainted 10-15 times in her life. The patient was going through menopause and had been having hot flashes. Products known to have been used by patient with in past two weeks  included bupropion hydrochloride and vitamins nos.  On 02-Mar-2021, 5-7 minutes before the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010A21A or 010AZ1A illegible), intramuscularly in left arm  for prophylaxis of COVID-19 infection.   On 02-Mar-2021, the patient passed out. She lost control of bladder. They took her into room, her blood pressure went low and passed out, they got her blood pressure back up she came around in a couple minutes. They called 911 but no ambulance came. When the patient felt good enough to leave, then they sent them home. She felt effects for rest of day, but felt normal the next day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The events of passed out (loss of consciousness) and lost control of bladder (urinary incontinence), blood pressure low(hypotension) resolved on 03-Mar-2021.; Reporter'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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Coordination abnormal, Dysarthria, Fatigue, Headache
Clinical narrative: Symptoms like a stroke; Slurring her words; Became uncoordinated; Not feeling 100%; Very nauseous; Little headache; Tired for a few days; A spontaneous report  was received from a consumer concerning a 77-year-old female patient who experienced slurring her words (dysarthria), became uncoordinated (coordination) abnormal and had symptoms like a stroke (cerebrovascular) accident, felt very nauseous (Nausea) and not feeling 100% (Malaise).  The patient's medical history was not provided. Relevant concomitant medications reported included Baby Aspirin and Vitamins NOS for unknown indication.  On 10 Mar 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: 048AZIA) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient began slurring their words, became uncoordinated and had symptoms like a stroke. The patient was also very nauseous and went to the emergency room. The event, symptoms like a stroke was considered medically significant.  On, the same day, the patient was discharged. The patient still was not feeling 100% still.  No Treatment information were provided.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  On an unknown date, the outcome of the event, was slurring their words, became uncoordinated and had symptoms like a stroke, felt very nauseous and not feeling 100% resolved on 11MAR2021.; Reporter'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.