chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Catheterisation cardiac, Chest pain, Chills, Condition aggravated
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocardial infarction
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Oropharyngeal pain, Pain, Poor quality sleep, Sleep disorder
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Throat irritation, Troponin
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Chest pain, Chills, Magnetic resonance imaging, Myocardial infarction
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Catheterisation cardiac abnormal, Chest pain, Coronary artery disease, Echocardiogram abnormal
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Left ventricular dysfunction, Magnetic resonance imaging heart, Viral myocarditis
Clinical narrative: I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diabetic ketoacidosis
Clinical narrative: Severe insulin spike which lead to Diabetic ketoacidoses, which lead to the death on 3/21/2021.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood insulin increased, Condition aggravated, Death, Diabetes mellitus, Diabetic ketoacidosis
Clinical narrative: Severe insulin spike which lead to Diabetic ketoacidoses, which lead to the death on 3/21/2021.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site paraesthesia, Malaise, Pruritus, Taste disorder, Throat irritation
Clinical narrative: Itching throughout the body, throat feeling scratchy, rash, blood pressure kept rising extremely high, swelling of the face, dizziness, faint, weak, cough.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Blood test, Chest X-ray, Cough
Clinical narrative: Itching throughout the body, throat feeling scratchy, rash, blood pressure kept rising extremely high, swelling of the face, dizziness, faint, weak, cough.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Hypertension, Pruritus, Rash
Clinical narrative: Itching throughout the body, throat feeling scratchy, rash, blood pressure kept rising extremely high, swelling of the face, dizziness, faint, weak, cough.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Syncope, Throat irritation
Clinical narrative: Itching throughout the body, throat feeling scratchy, rash, blood pressure kept rising extremely high, swelling of the face, dizziness, faint, weak, cough.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Urticaria, Vomiting
Clinical narrative: Anaphylaxis to Moderna Covid Vaccine
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis to Moderna Covid Vaccine
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Nausea, Oropharyngeal discomfort, Pruritus, Urticaria
Clinical narrative: Anaphylaxis to Moderna Covid Vaccine
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Headache, Hypoacusis, Migraine
Clinical narrative: Intermittent numbness/tingling in extremities and face, started about 1.5hrs after vaccination and had initial reaction within minutes of vaccine (shaking, shooting pain in L shoulder to head, dizzy, blurred vision, thought was going to pass out; these symptoms resolved within 45 minutes). Symptoms last about 5 min at a time. Is still happening.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Vision blurred
Clinical narrative: Intermittent numbness/tingling in extremities and face, started about 1.5hrs after vaccination and had initial reaction within minutes of vaccine (shaking, shooting pain in L shoulder to head, dizzy, blurred vision, thought was going to pass out; these symptoms resolved within 45 minutes). Symptoms last about 5 min at a time. Is still happening.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Pain, Paraesthesia, Tremor
Clinical narrative: Intermittent numbness/tingling in extremities and face, started about 1.5hrs after vaccination and had initial reaction within minutes of vaccine (shaking, shooting pain in L shoulder to head, dizzy, blurred vision, thought was going to pass out; these symptoms resolved within 45 minutes). Symptoms last about 5 min at a time. Is still happening.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Presyncope
Clinical narrative: Felt like she was going to pass out; Dizziness; She couldn't function properly; Felt cross eyed; Dull headache; Shoulder pain at injection site; Chills; Fever; A spontaneous report was received from  a customer concerning a 26-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, chills, fever, dizziness, dull headache, feeling cross eyed, inability to function properly, and feeling like she was going to pass out.   The patient's past medical history included migraine and gastritis. Concomitant medication included migraine medication: imitrex, sumatriptan and meclavine.  On 24-DEC-2020, prior to the onset of the events, the patient received a dose mRNA-1273 (lot/batch or dose number not reported) intramuscularly on the right arm for prophylaxis of COVID-19 infection.   On 24-DEC-2020, the patient experienced shoulder pain at injection site, chills and fever that evening. On 25-DEC-2020, the right arm was still hurting. On 26-DEC-2020, she had dizziness, a dull headache felt cross eyed and felt that she couldn't function properly. The headache increased intensity making her to go to the hospital on 01-JAN-2021. She felt like she was going to pass out. Information about whether or not she was admitted was not provided.  Laboratory reports were not provided. Treatment information included taking her migraine medications and going to the hospital.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 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 the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vision blurred
Clinical narrative: Felt like she was going to pass out; Dizziness; She couldn't function properly; Felt cross eyed; Dull headache; Shoulder pain at injection site; Chills; Fever; A spontaneous report was received from  a customer concerning a 26-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, chills, fever, dizziness, dull headache, feeling cross eyed, inability to function properly, and feeling like she was going to pass out.   The patient's past medical history included migraine and gastritis. Concomitant medication included migraine medication: imitrex, sumatriptan and meclavine.  On 24-DEC-2020, prior to the onset of the events, the patient received a dose mRNA-1273 (lot/batch or dose number not reported) intramuscularly on the right arm for prophylaxis of COVID-19 infection.   On 24-DEC-2020, the patient experienced shoulder pain at injection site, chills and fever that evening. On 25-DEC-2020, the right arm was still hurting. On 26-DEC-2020, she had dizziness, a dull headache felt cross eyed and felt that she couldn't function properly. The headache increased intensity making her to go to the hospital on 01-JAN-2021. She felt like she was going to pass out. Information about whether or not she was admitted was not provided.  Laboratory reports were not provided. Treatment information included taking her migraine medications and going to the hospital.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 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 the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rheumatoid arthritis
Clinical narrative: Diagnosed with rheumatoid arthritis; Tiny bump on her arm; A spontaneous report was received from a consumer concerning a 72-years-old  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rheumatoid arthritis, tiny bump on her arm/ lymphadenopathy.  The patient's medical history included was rheumatoid arthritis.  No relevant Concomitant medication was cortisone injection .   On 04FEB2021, approximately 11 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030l20a) through Intramuscular route for prophylaxis of COVID-19 infection.   On 04FEB2021, after vaccination patient experienced rheumatoid arthritis, tiny bump on her arm/ lymphadenopathy. The event rheumatoid arthritis was medically significant. Treatment for the rheumatoid arthritis included etanercept .Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, rheumatoid arthritis ,tiny bump on her arm/ lymphadenopathy  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 these events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypotension, Syncope
Clinical narrative: Faint; Had vertigo; decreased blood pressure; increased heart rate; A Spontaneous report was received from a consumer concerning, a 67 years-old,  female patient, who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced vertigo and fainted/syncope.  The patient medical history was not provided. No relevant concomitant medications are provided.  On 11 Feb 2021, approximately 15 days prior to the onset of the events the patient received their first dose of mRNA1273(lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021,the patient experienced the events of vertigo, fainted, heart rate increased, and low blood pressure. The patient reported that she took blood pressure medicine and was normal now.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events,  faint, and vertigo, were unknown.; Reporter's Comments: This case concerns a 67-year-old female who experienced a serious unexpected event of syncope along with nonserious events of unexpected vertigo, decreased blood pressure and increased heart rate.  Event onset occurred 15 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Faint; Had vertigo; decreased blood pressure; increased heart rate; A Spontaneous report was received from a consumer concerning, a 67 years-old,  female patient, who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced vertigo and fainted/syncope.  The patient medical history was not provided. No relevant concomitant medications are provided.  On 11 Feb 2021, approximately 15 days prior to the onset of the events the patient received their first dose of mRNA1273(lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021,the patient experienced the events of vertigo, fainted, heart rate increased, and low blood pressure. The patient reported that she took blood pressure medicine and was normal now.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events,  faint, and vertigo, were unknown.; Reporter's Comments: This case concerns a 67-year-old female who experienced a serious unexpected event of syncope along with nonserious events of unexpected vertigo, decreased blood pressure and increased heart rate.  Event onset occurred 15 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Dizziness; Weakness; Swollen lymph nodes; Barely walk; Fatigue; Larger patch of hives; Arm pain; large hives as well as small patches of hives; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Larger patch of hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ANGIOEDEMA (Larger patch of hives) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives) and CHILLS (Chills). On 27-Feb-2021, the patient experienced GAIT INABILITY (Barely walk), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, ANGIOEDEMA (Larger patch of hives), GAIT INABILITY (Barely walk), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This case concerns a 78 Y/O M with a serious unexpected event of angioedema and non-serious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy.  Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 78 Y/O M with a serious unexpected event of angioedema and nonserious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy.  Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Lymphadenopathy, Pain in extremity, Urticaria
Clinical narrative: Dizziness; Weakness; Swollen lymph nodes; Barely walk; Fatigue; Larger patch of hives; Arm pain; large hives as well as small patches of hives; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Larger patch of hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ANGIOEDEMA (Larger patch of hives) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives) and CHILLS (Chills). On 27-Feb-2021, the patient experienced GAIT INABILITY (Barely walk), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, ANGIOEDEMA (Larger patch of hives), GAIT INABILITY (Barely walk), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This case concerns a 78 Y/O M with a serious unexpected event of angioedema and non-serious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy.  Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 78 Y/O M with a serious unexpected event of angioedema and nonserious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy.  Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Incomplete course of vaccination, Pain in extremity
Clinical narrative: Broken Hip; fall; Miss the 42 day window to recieve the second dose; Sore Arm; A spontaneous report was received from a Consumer concering her sister, 84-year-old female patient, who received Moderna's COVID-19 and experienced sore arm/pain in extremity, fall, broken hip/hip fracture, miss the 42 day window to receive the second dose/incomplete course of vaccination.  The patients's medical history included parkinson's disease. Concomitant medications reported included warfarin, I-toxin, memantine, L-dopa, carbidopa, Iron tablet, pantoprazole, vitamin D, imipramine.  On 20-Jan-2021, prior to the onset of event, the patient received the first dose of mRNA-1273  (lot number 029K20A) intramuscularly for COVID-19 infection prophylaxis. Following administration of the vaccine the patient experienced a sore arm.  On 17-Feb-2021, She fell in the home and broke her hip. She was hospitalized and that  was a medically significant event. She missed the 42 day window to receive the second dose due to prolonged hospitalization. Treatment was provided for the injury.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events sore arm, fall, hip fracture, miss the 42 day window to receive the second dose was unknown.; Reporter's Comments: This report refers to a case of missed dose for mRNA-1273, lot not applicable. Additionally, it was incidentally reported a not related hospitalization due a fall and a hip fracture and some vaccination site events. Based on reporter's causality, the serious adverse events of fall and hip fracture is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the vaccine site event, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Osteomyelitis, Pyrexia
Clinical narrative: Fever (down to 100F); Bone infection in finger; A spontaneous report  was received from a consumer concerning a 74-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bone infection in finger and fever down to 100 F   Medical history or concomitant product use was not reported.   On 06-Feb-2021, the patient received his first of the two planned doses of mRNA-1273 (batch number: 043L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 15-Feb-2021 patient diagnosed with a probable bone infection in finger with fever 100 f. Treatment information was not provided.   The action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events developed bone infection in finger and fever down to 100 F were 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 events, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Eyelid sensory disorder, Headache, Hypoaesthesia, SARS-CoV-2 test positive
Clinical narrative: His left face is drooping; Numbness to right face; Numbness to right eye; Headache pain behind his left ear; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARALYSIS (His left face is drooping) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness to right face), EYELID SENSORY DISORDER (Numbness to right eye) and HEADACHE (Headache pain behind his left ear). On 07-Mar-2021, the patient experienced FACIAL PARALYSIS (His left face is drooping) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (His left face is drooping), HYPOAESTHESIA (Numbness to right face), EYELID SENSORY DISORDER (Numbness to right eye) and HEADACHE (Headache pain behind his left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Fatigue
Clinical narrative: Broken blood vessels all over white of left eye; Fatigue; A spontaneous report was received from a 59-year-old female patient , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and broken blood vessels all over white of left eye/eye haemorrhage.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin and acetylsalicylic acid (low dose).  On 10 Mar 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273(Batch number: 010a21a) on left arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, after receiving mRNA-127, the patient experienced fatigue which lasted for 6 hours. On 12 Mar 2021, the patient experienced broken blood vessels all over white of left eye.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, fatigue was considered as resolved on 11 Mar 2021. The outcome of event broken blood vessels all over white of left eye 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 the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Dyspnoea, Fatigue
Clinical narrative: throat was swelling; pain in jaw to ear; tongue was numb; could not feel her swallow reflex; blood pressure was elevated to 185/Unknown; pulse was 131bpm; aching and pain in throat area; shortness of breath; felt like the lymph nodes in her throat were achy; felt like the lymph nodes in her throat were swelling; chills; tiredness; This spontaneous case was reported by a consumer, who is a 62 year old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced throat was swelling, felt like the lymph nodes in her throat were swelling,felt like the lymph nodes in her throat were achy (Lymph node pain), pain in jaw to ear (Pain in jaw), tongue was numb (Hypoaesthesia oral), could not feel her swallow reflex (Hyporeflexia), blood pressure was elevated to 185/ unknown (Blood pressure increased), pulse was 131 bpm (Heart rate increased), aching and pain in throat area (Oropharyngeal pain), shortness of breath (Dyspnoea), chills (Chills) and tiredness (Fatigue).     The patient's past medical history included No adverse event (No medical history reported).    On 17 Mar 2021, 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 047A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 17 Mar 2021, the patient experienced felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, and chills. The patient went to the emergency room. While there, the patient's tongue was numb and she could not feel her swallow reflex, her blood pressure was elevated to 185/ unknown, pulse was 131 bpm. The patient was at the emergency room for 4 hours before the symptoms subsided. Treatment medications included prednisone for 3 days and Benadryl 50 mg every 6 hours. Since then, the patient was feeling shortness of breath and tiredness.     The outcome of the events of felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, chills, tongue was numb, could not feel her swallow reflex, blood pressure was elevated to 185/ unknown and pulse was 131 bpm was resolved on 17 Mar 2021. The outcome of shortness of breath and tiredness was unknown.   Action taken with mRNA-1273 in response to the events was unknown.; Sender's Comments: This case concerns a 62 Y/O F with serious unexpected pharyngeal swelling and NS unexpected oropharyngeal pain, jaw pain, hypoaesthesia oral, hyporeflexia, blood pressure increased, heart rate increased, dyspnea, and expected lymphadenopathy, lymph node pain, chills, fatigue. Event onset day 1 after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypoaesthesia oral, Hyporeflexia, Lymph node pain
Clinical narrative: throat was swelling; pain in jaw to ear; tongue was numb; could not feel her swallow reflex; blood pressure was elevated to 185/Unknown; pulse was 131bpm; aching and pain in throat area; shortness of breath; felt like the lymph nodes in her throat were achy; felt like the lymph nodes in her throat were swelling; chills; tiredness; This spontaneous case was reported by a consumer, who is a 62 year old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced throat was swelling, felt like the lymph nodes in her throat were swelling,felt like the lymph nodes in her throat were achy (Lymph node pain), pain in jaw to ear (Pain in jaw), tongue was numb (Hypoaesthesia oral), could not feel her swallow reflex (Hyporeflexia), blood pressure was elevated to 185/ unknown (Blood pressure increased), pulse was 131 bpm (Heart rate increased), aching and pain in throat area (Oropharyngeal pain), shortness of breath (Dyspnoea), chills (Chills) and tiredness (Fatigue).     The patient's past medical history included No adverse event (No medical history reported).    On 17 Mar 2021, 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 047A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 17 Mar 2021, the patient experienced felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, and chills. The patient went to the emergency room. While there, the patient's tongue was numb and she could not feel her swallow reflex, her blood pressure was elevated to 185/ unknown, pulse was 131 bpm. The patient was at the emergency room for 4 hours before the symptoms subsided. Treatment medications included prednisone for 3 days and Benadryl 50 mg every 6 hours. Since then, the patient was feeling shortness of breath and tiredness.     The outcome of the events of felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, chills, tongue was numb, could not feel her swallow reflex, blood pressure was elevated to 185/ unknown and pulse was 131 bpm was resolved on 17 Mar 2021. The outcome of shortness of breath and tiredness was unknown.   Action taken with mRNA-1273 in response to the events was unknown.; Sender's Comments: This case concerns a 62 Y/O F with serious unexpected pharyngeal swelling and NS unexpected oropharyngeal pain, jaw pain, hypoaesthesia oral, hyporeflexia, blood pressure increased, heart rate increased, dyspnea, and expected lymphadenopathy, lymph node pain, chills, fatigue. Event onset day 1 after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.