chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Palpitations, Pruritus
Clinical narrative: extreme fatigue; weird top of head feeling; headaches on sides; neck pain; mild numbness on left side of face with random twitching/numbness on left hand with random pinching feeling; left side of face with random twitching; heart palpitations; cold & clammy hands; hot & sweaty feet; hot & sweaty feet; back pain; boils; pain leg with a bump; pain leg with a bump; itchy face; jaw tightness; Paramedics said blood pressure is 211 and took me to ER/Ever since I've being suffering of BP spikes; chest pain; blurred vision; confusion; 2 min after vaccine felt heat waves; nausea; dizziness/felt faint; This is a spontaneous report from a contactable consumer (patient).  A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26May2021 11:30 (Batch/Lot Number: EW0178) as DOSE 1, SINGLE  (age at vaccination 53-years-old) for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient did not have allergies. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 25 ug taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Facility type Vaccine was Pharmacy or Drug Store.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 11:32, the patient experienced 2 min after vaccine felt heat waves, nausea, dizziness, felt faint but did not. On 26May2021 11:45, Paramedics said blood pressure was 211 and took her to ER. The consumer reported ever since she had been suffering of BP spikes, nausea, dizziness, extreme fatigue, confusion, blurred vision, weird top of head feeling, headaches on sides, neck pain, mild numbness on left side face with random twitching, numbness on left hand with random pinching feeling, chest pain, heart palpitations, cold & clammy hands, hot & sweaty feet, back pain, boils, pain leg with a bump, itchy face, and jaw tightness. Being in ER 5 times and haven't work in 2 months. AE's  resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment was received for the events. Outcome of the events was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. .
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Vaccination site warmth, Vision blurred
Clinical narrative: extreme fatigue; weird top of head feeling; headaches on sides; neck pain; mild numbness on left side of face with random twitching/numbness on left hand with random pinching feeling; left side of face with random twitching; heart palpitations; cold & clammy hands; hot & sweaty feet; hot & sweaty feet; back pain; boils; pain leg with a bump; pain leg with a bump; itchy face; jaw tightness; Paramedics said blood pressure is 211 and took me to ER/Ever since I've being suffering of BP spikes; chest pain; blurred vision; confusion; 2 min after vaccine felt heat waves; nausea; dizziness/felt faint; This is a spontaneous report from a contactable consumer (patient).  A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26May2021 11:30 (Batch/Lot Number: EW0178) as DOSE 1, SINGLE  (age at vaccination 53-years-old) for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient did not have allergies. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 25 ug taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Facility type Vaccine was Pharmacy or Drug Store.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 11:32, the patient experienced 2 min after vaccine felt heat waves, nausea, dizziness, felt faint but did not. On 26May2021 11:45, Paramedics said blood pressure was 211 and took her to ER. The consumer reported ever since she had been suffering of BP spikes, nausea, dizziness, extreme fatigue, confusion, blurred vision, weird top of head feeling, headaches on sides, neck pain, mild numbness on left side face with random twitching, numbness on left hand with random pinching feeling, chest pain, heart palpitations, cold & clammy hands, hot & sweaty feet, back pain, boils, pain leg with a bump, itchy face, and jaw tightness. Being in ER 5 times and haven't work in 2 months. AE's  resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment was received for the events. Outcome of the events was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. .
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Pain in chest bending over; Shortness breath 4th day; Injection side swelling; Injection site redness; Injection site pain; Chills; Fever; Tightening/numbness injection site ongoing; Tightening/numbness injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficient anemia and latex allergy. The patient had known allergies to sulfamethoxazole; trimethoprim (BACTRIM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 03:15, the patient experienced injection site swelling/redness/pain, chills, fever and tightening/numbness injection site. On 07May2021, fourth day of vaccination, the patient experienced shortness breath and pain in chest bending over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness breath, injection site swelling/redness/pain, chills, fever and pain in chest bending over was recovered with sequelae on an unknown date in May2021; while that of the tightening/numbness injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain in chest bending over; Shortness breath 4th day; Injection side swelling; Injection site redness; Injection site pain; Chills; Fever; Tightening/numbness injection site ongoing; Tightening/numbness injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficient anemia and latex allergy. The patient had known allergies to sulfamethoxazole; trimethoprim (BACTRIM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 03:15, the patient experienced injection site swelling/redness/pain, chills, fever and tightening/numbness injection site. On 07May2021, fourth day of vaccination, the patient experienced shortness breath and pain in chest bending over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness breath, injection site swelling/redness/pain, chills, fever and pain in chest bending over was recovered with sequelae on an unknown date in May2021; while that of the tightening/numbness injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Pyrexia, Skin tightness
Clinical narrative: Pain in chest bending over; Shortness breath 4th day; Injection side swelling; Injection site redness; Injection site pain; Chills; Fever; Tightening/numbness injection site ongoing; Tightening/numbness injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficient anemia and latex allergy. The patient had known allergies to sulfamethoxazole; trimethoprim (BACTRIM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 03:15, the patient experienced injection site swelling/redness/pain, chills, fever and tightening/numbness injection site. On 07May2021, fourth day of vaccination, the patient experienced shortness breath and pain in chest bending over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness breath, injection site swelling/redness/pain, chills, fever and pain in chest bending over was recovered with sequelae on an unknown date in May2021; while that of the tightening/numbness injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site hypoaesthesia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain in chest bending over; Shortness breath 4th day; Injection side swelling; Injection site redness; Injection site pain; Chills; Fever; Tightening/numbness injection site ongoing; Tightening/numbness injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficient anemia and latex allergy. The patient had known allergies to sulfamethoxazole; trimethoprim (BACTRIM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 03:15, the patient experienced injection site swelling/redness/pain, chills, fever and tightening/numbness injection site. On 07May2021, fourth day of vaccination, the patient experienced shortness breath and pain in chest bending over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness breath, injection site swelling/redness/pain, chills, fever and pain in chest bending over was recovered with sequelae on an unknown date in May2021; while that of the tightening/numbness injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05May2021 at 16:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23May2021 at 00:00, the patient had shingles diagnosis. The event resulted in doctor or other healthcare professional office/clinic visit. On 26May2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the event shingles was not resolved at the time of this report.   Information on lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05May2021 at 16:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23May2021 at 00:00, the patient had shingles diagnosis. The event resulted in doctor or other healthcare professional office/clinic visit. On 26May2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the event shingles was not resolved at the time of this report.   Information on lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Blood fibrinogen increased, Blood lactate dehydrogenase normal, C-reactive protein normal
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Chills, Coxsackie virus test negative, Cytomegalovirus test
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cytomegalovirus test negative, Echocardiogram, Echocardiogram normal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Feeling of body temperature change, Fibrin D dimer normal
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: HIV test negative, Hepatitis C test negative, Human herpes virus 6 serology negative, Inflammation, Interleukin level
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial necrosis marker increased, Myocarditis, Parvovirus B19 test negative, Parvovirus B19 test positive, Platelet count normal
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative, Troponin I increased, White blood cell count decreased
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Chest pain, Myocardial infarction, Myocarditis, Pericarditis
Clinical narrative: Admitted for heart attack; Chest pain; Myocarditis/inflamed; Pericarditis/inflamed; multiple things; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed) and PERICARDITIS (Pericarditis/inflamed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Admitted for heart attack) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (Myocarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening), PERICARDITIS (Pericarditis/inflamed) (seriousness criteria hospitalization, medically significant and life threatening) and ADVERSE EVENT (multiple things). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN, MYOCARDIAL INFARCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERIN TE) for Chest pain, at an unspecified dose and frequency and COLCHICINE at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Admitted for heart attack), CHEST PAIN (Chest pain), MYOCARDITIS (Myocarditis/inflamed), PERICARDITIS (Pericarditis/inflamed) and ADVERSE EVENT (multiple things) outcome was unknown.            Concomitant product use was not provided by the reporter The patient was given multiple intravenous (IV) drips to treat multiple things. The patient took colchicine for a month and was discharged with it.   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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information On 04-Aug-2021: Follow up received on 04-AUG-2021 contained No New Information; 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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Chills, Insomnia, Lymphadenopathy, Pain
Clinical narrative: Fever 101-103; chills; sweating; major joint pain; headache; sore arm; swelling of lymph nodes in neck and shoulder; inability to sleep; leg pain; bone pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27May2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications included paroxetine hydrochloride (PAXIL) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient previously took aspirin (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021 at 14:30, the patient experienced fever 101-103, chills, sweating, major joint pain, headache, sore arm, swelling of lymph nodes in neck and shoulder, inability to sleep, leg pain, bone pain. All in a 28 hours period. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 27May2021, the patient underwent body temperature and the result was 101-103 (UNSPECIFIED UNITS). The clinical outcome of the events fever 101-103, chills, sweating, major joint pain, headache, sore arm, swelling of lymph nodes in neck and shoulder, inability to sleep, leg pain, bone pain was not recovered.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: Fever 101-103; chills; sweating; major joint pain; headache; sore arm; swelling of lymph nodes in neck and shoulder; inability to sleep; leg pain; bone pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27May2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications included paroxetine hydrochloride (PAXIL) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient previously took aspirin (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021 at 14:30, the patient experienced fever 101-103, chills, sweating, major joint pain, headache, sore arm, swelling of lymph nodes in neck and shoulder, inability to sleep, leg pain, bone pain. All in a 28 hours period. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 27May2021, the patient underwent body temperature and the result was 101-103 (UNSPECIFIED UNITS). The clinical outcome of the events fever 101-103, chills, sweating, major joint pain, headache, sore arm, swelling of lymph nodes in neck and shoulder, inability to sleep, leg pain, bone pain was not recovered.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Chills, Headache
Clinical narrative: Fever 101-103; chills; sweating; major joint pain; headache; sore arm; swelling of lymph nodes in neck and shoulder; inability to sleep; leg pain; bone pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27May2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications included paroxetine hydrochloride (PAXIL) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient previously took aspirin (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021 at 14:30, the patient experienced fever 101-103, chills, sweating, major joint pain, headache, sore arm, swelling of lymph nodes in neck and shoulder, inability to sleep, leg pain, bone pain. All in a 28 hours period. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 27May2021, the patient underwent body temperature and the result was 101-103 (UNSPECIFIED UNITS). The clinical outcome of the events fever 101-103, chills, sweating, major joint pain, headache, sore arm, swelling of lymph nodes in neck and shoulder, inability to sleep, leg pain, bone pain was not recovered.  Information on the lot/batch number has been requested.