chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Blood creatine phosphokinase normal
Clinical narrative: 1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Dyspepsia
Clinical narrative: 1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Echocardiogram, Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Headache
Clinical narrative: 1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperventilation, Limb discomfort, Liver function test normal, Metabolic function test normal
Clinical narrative: 1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Myalgia, Palpitations, Paraesthesia
Clinical narrative: 1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pulmonary hypertension, Right atrial dilatation, Right ventricular dysfunction, Sleep disorder
Clinical narrative: 1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin I normal, Ultrasound scan normal, Ventricular extrasystoles
Clinical narrative: 1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: red, like a blood vessel had broken; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (red, like a blood vessel had broken) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (red, like a blood vessel had broken). At the time of the report, OCULAR HYPERAEMIA (red, like a blood vessel had broken) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-025085 (E2B Linked Report).; Sender's Comments:  MOD-2021-025085:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: temperature is down to 100; horrible headache; nausea; fever 102.9; chills; severe arm pain,body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe arm pain,body aches), BODY TEMPERATURE (temperature is down to 100), PYREXIA (fever 102.9), CHILLS (chills) and HEADACHE (horrible headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, CYCLOBENZAPRINE, DULOXETINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and OXYCODONE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (severe arm pain,body aches), PYREXIA (fever 102.9) and CHILLS (chills). On 04-Feb-2021, the patient experienced BODY TEMPERATURE (temperature is down to 100), HEADACHE (horrible headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (severe arm pain,body aches), BODY TEMPERATURE (temperature is down to 100), PYREXIA (fever 102.9), CHILLS (chills), HEADACHE (horrible headache) and NAUSEA (nausea) outcome was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: temperature is down to 100; horrible headache; nausea; fever 102.9; chills; severe arm pain,body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe arm pain,body aches), BODY TEMPERATURE (temperature is down to 100), PYREXIA (fever 102.9), CHILLS (chills) and HEADACHE (horrible headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, CYCLOBENZAPRINE, DULOXETINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and OXYCODONE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (severe arm pain,body aches), PYREXIA (fever 102.9) and CHILLS (chills). On 04-Feb-2021, the patient experienced BODY TEMPERATURE (temperature is down to 100), HEADACHE (horrible headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (severe arm pain,body aches), BODY TEMPERATURE (temperature is down to 100), PYREXIA (fever 102.9), CHILLS (chills), HEADACHE (horrible headache) and NAUSEA (nausea) outcome was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site warmth, Rash erythematous
Clinical narrative: Warm to the touch; Pink like sunburn; Redness maybe an1.5  inch and a half below the injection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch), RASH ERYTHEMATOUS (Pink like sunburn), INJECTION SITE ERYTHEMA (Redness maybe an1.5  inch and a half below the injection) and HEADACHE (Headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Headache). On 19-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch), RASH ERYTHEMATOUS (Pink like sunburn) and INJECTION SITE ERYTHEMA (Redness maybe an1.5  inch and a half below the injection). At the time of the report, INJECTION SITE WARMTH (Warm to the touch), RASH ERYTHEMATOUS (Pink like sunburn), INJECTION SITE ERYTHEMA (Redness maybe an1.5  inch and a half below the injection) and HEADACHE (Headache) 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 medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: f/u received on 28 Apr 2021, new ADR updated.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysarthria, Fatigue, Limb discomfort
Clinical narrative: my speech was slurred; I couln't stand up - my legs felt rubbery; chills; fatigue; fever (102°F); This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 102°f (High) 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: my speech was slurred; I couln't stand up - my legs felt rubbery; chills; fatigue; fever (102°F); This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 102°f (High) 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: All-over full body ache; Nausea; Headache; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All-over full body ache), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Low grade temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (All-over full body ache), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Low grade temperature). At the time of the report, PAIN (All-over full body ache) and HEADACHE (Headache) outcome was unknown and NAUSEA (Nausea) and PYREXIA (Low grade temperature) had worsened.            No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 08-jul-2021 contains No new information
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: arm is a little sore; fever (99.7°); body is aching; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm is a little sore), PYREXIA (fever (99.7°)) and MYALGIA (body is aching) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is a little sore), PYREXIA (fever (99.7°)) and MYALGIA (body is aching). At the time of the report, PAIN IN EXTREMITY (arm is a little sore), PYREXIA (fever (99.7°)) and MYALGIA (body is aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling Below Chin; Tingling Eye; Tingling Nose; Tingling Upper Lip; Tingling Chin; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling Eye), PARAESTHESIA (Tingling Nose), PARAESTHESIA ORAL (Tingling Upper Lip), PARAESTHESIA (Tingling Chin) and PARAESTHESIA (Tingling Below Chin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PARAESTHESIA (Tingling Eye), PARAESTHESIA (Tingling Nose), PARAESTHESIA ORAL (Tingling Upper Lip) and PARAESTHESIA (Tingling Chin). On an unknown date, the patient experienced PARAESTHESIA (Tingling Below Chin). At the time of the report, PARAESTHESIA (Tingling Eye), PARAESTHESIA (Tingling Nose), PARAESTHESIA ORAL (Tingling Upper Lip), PARAESTHESIA (Tingling Chin) and PARAESTHESIA (Tingling Below Chin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had been taking Benadryl. The patient went to ER where she was ruled out with a stroke and heart attack.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache
Clinical narrative: Coldness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Coldness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Coldness) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING COLD (Coldness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: redness at site of injection; swollen at site of injection; itchy at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness at site of injection), INJECTION SITE SWELLING (swollen at site of injection) and PRURITUS (itchy at site of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (redness at site of injection), INJECTION SITE SWELLING (swollen at site of injection) and PRURITUS (itchy at site of injection). At the time of the report, ERYTHEMA (redness at site of injection), INJECTION SITE SWELLING (swollen at site of injection) and PRURITUS (itchy at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: had a reaction; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (had a reaction) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALIROCUMAB (PRALUENT) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (had a reaction). At the time of the report, INJECTION SITE REACTION (had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Arm is extremely sore; nausea; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm is extremely sore), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE PAIN (Arm is extremely sore), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency and anti-nausea medication at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Arm is extremely sore), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Myalgia, Pruritus, Vaccination site warmth
Clinical narrative: Muscle soreness; Redness; Itching; Warm to touch at injection site; Swollen lymph node on her neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm to touch at injection site) and LYMPHADENOPATHY (Swollen lymph node on her neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced MYALGIA (Muscle soreness), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm to touch at injection site) and LYMPHADENOPATHY (Swollen lymph node on her neck). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle soreness), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm to touch at injection site) and LYMPHADENOPATHY (Swollen lymph node on her neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: uncomfortable with site of injection; site of injection swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (uncomfortable with site of injection) and VACCINATION SITE SWELLING (site of injection swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (uncomfortable with site of injection) and VACCINATION SITE SWELLING (site of injection swollen). At the time of the report, VACCINATION SITE REACTION (uncomfortable with site of injection) and VACCINATION SITE SWELLING (site of injection swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt very sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt very sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MALAISE (felt very sick). At the time of the report, MALAISE (felt very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD21-038351 (E2B Linked Report).; Sender's Comments:  MOD21-038351:
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Bronchitis
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of asthma (seems as the asthma is off charge) and bronchitis (seems as a very bad bronchitis) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included asthma. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced asthma (seems as the asthma is off charge) and bronchitis (seems as a very bad bronchitis). At the time of the report, asthma (seems as the asthma is off charge) and bronchitis (seems as a very bad bronchitis) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Vaccination site pain
Clinical narrative: pain at the injection site; referred pain to the opposite shoulder; watery diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), ARTHRALGIA (referred pain to the opposite shoulder) and DIARRHOEA (watery diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced DIARRHOEA (watery diarrhea). On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and ARTHRALGIA (referred pain to the opposite shoulder). At the time of the report, VACCINATION SITE PAIN (pain at the injection site), ARTHRALGIA (referred pain to the opposite shoulder) and DIARRHOEA (watery diarrhea) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reporter by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Heart rate increased, Palpitations
Clinical narrative: heart palpitation; Heart rate went as high as 160; It was very scary when she started having side effects to COVID; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitation), HEART RATE INCREASED (Heart rate went as high as 160) and ADVERSE EVENT (It was very scary when she started having side effects to COVID) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PALPITATIONS (heart palpitation), HEART RATE INCREASED (Heart rate went as high as 160) and ADVERSE EVENT (It was very scary when she started having side effects to COVID). At the time of the report, PALPITATIONS (heart palpitation), HEART RATE INCREASED (Heart rate went as high as 160) and ADVERSE EVENT (It was very scary when she started having side effects to COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling (hardness) - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site) outcome was unknown. Not Provided      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.