chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: I started having shortness of breath and went to the emergency room.  It was determined I had blood clots in both lungs based on a CT Scan; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Lot Number: EW0153) as 2ND DOSE,SINGLE for covid-19 immunisation. Medical history included Sleep apnoea. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication(s) included phentermine hydrochloride (LOMAIRA); fluoxetine; loratadine (CLARITIN); diphenhydramine and Charlotte24 (unspecified). The patient previously took morphine and tetracycline and experienced drug allergy. Patient took the first dose of bnt162b2 (lot number EN6207) in right arm on 17Mar2021 for covid-19 immunisation.  The patient started having shortness of breath and went to the emergency room on 10May2021. It was determined she had blood clots in both lungs based on a CT Scan. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient hospitalized for two days. Patient received blood thinners as treatment. The patient had covid test type post vaccination nasal swab on 14May2021 with negative result. The outcome was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Dizziness, Feeling abnormal, Headache
Clinical narrative: not getting much sleep; headache; thought she was having a stroke; blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse; going to pass out; disoriented; her diastolic reading was high and her pulse; not feeling good; nauseous; ears were ringing; This is a spontaneous report from a contactable consumer reported for herself.  A 77-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot for immunization and she had a horrible reaction to the flu shot 20 years ago and she had not had any vaccinations since. Patient stated she would like to see if she should receive the second dose of the Pfizer COVID vaccine after a reaction to the first dose. Patient stated she received the first dose on 29Apr2021. Patient stated on Saturday 01May2021 two days later she thought she was having a stroke and her husband called (number) and the ambulance came and took her to the hospital. Patient stated her blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse. Patient stated she felt nauseous, her ears were ringing,  she thought she was going to pass out, disoriented and just not feeling good. Patient stated she went back home and she takes a low dose atenolol for her blood pressure because that usually keeps her blood pressure even kill. Patient stated having her blood pressure go up that high was really scary. Patient stated she had been taking two of her blood pressure pills and Tylenol. Patient stated it was okay by her doctor to take two pills since they are a low dose. Patient stated on Tuesday (04May2021) she started to feel like a new person and her blood pressure was great. Patient stated on Wednesday (05May2021) she was nauseous, had a headache, wasn't feeling too great and her blood pressure went back up. Patient stated while experiencing the side effects she was not getting much sleep and this could have contributed to her blood pressure rising. Patient stated she was told by family members that she would not have side effects with the first dose so she was surprised she did and went into the vaccination optimistic that she wouldn't have side effects. Patient stated she was hesitant to receive this vaccination due her reaction 20 years ago but her doctor convinced her that she needed to have it. Patient would like to know if the second dose will produce worse side effects than the first. Patient stated her reaction happened two to three days after receiving the vaccine and she was wondering if that was normal. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypersensitivity, Hypertension, Illness, Memory impairment
Clinical narrative: not getting much sleep; headache; thought she was having a stroke; blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse; going to pass out; disoriented; her diastolic reading was high and her pulse; not feeling good; nauseous; ears were ringing; This is a spontaneous report from a contactable consumer reported for herself.  A 77-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot for immunization and she had a horrible reaction to the flu shot 20 years ago and she had not had any vaccinations since. Patient stated she would like to see if she should receive the second dose of the Pfizer COVID vaccine after a reaction to the first dose. Patient stated she received the first dose on 29Apr2021. Patient stated on Saturday 01May2021 two days later she thought she was having a stroke and her husband called (number) and the ambulance came and took her to the hospital. Patient stated her blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse. Patient stated she felt nauseous, her ears were ringing,  she thought she was going to pass out, disoriented and just not feeling good. Patient stated she went back home and she takes a low dose atenolol for her blood pressure because that usually keeps her blood pressure even kill. Patient stated having her blood pressure go up that high was really scary. Patient stated she had been taking two of her blood pressure pills and Tylenol. Patient stated it was okay by her doctor to take two pills since they are a low dose. Patient stated on Tuesday (04May2021) she started to feel like a new person and her blood pressure was great. Patient stated on Wednesday (05May2021) she was nauseous, had a headache, wasn't feeling too great and her blood pressure went back up. Patient stated while experiencing the side effects she was not getting much sleep and this could have contributed to her blood pressure rising. Patient stated she was told by family members that she would not have side effects with the first dose so she was surprised she did and went into the vaccination optimistic that she wouldn't have side effects. Patient stated she was hesitant to receive this vaccination due her reaction 20 years ago but her doctor convinced her that she needed to have it. Patient would like to know if the second dose will produce worse side effects than the first. Patient stated her reaction happened two to three days after receiving the vaccine and she was wondering if that was normal. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Presyncope, Tinnitus, Urine analysis
Clinical narrative: not getting much sleep; headache; thought she was having a stroke; blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse; going to pass out; disoriented; her diastolic reading was high and her pulse; not feeling good; nauseous; ears were ringing; This is a spontaneous report from a contactable consumer reported for herself.  A 77-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot for immunization and she had a horrible reaction to the flu shot 20 years ago and she had not had any vaccinations since. Patient stated she would like to see if she should receive the second dose of the Pfizer COVID vaccine after a reaction to the first dose. Patient stated she received the first dose on 29Apr2021. Patient stated on Saturday 01May2021 two days later she thought she was having a stroke and her husband called (number) and the ambulance came and took her to the hospital. Patient stated her blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse. Patient stated she felt nauseous, her ears were ringing,  she thought she was going to pass out, disoriented and just not feeling good. Patient stated she went back home and she takes a low dose atenolol for her blood pressure because that usually keeps her blood pressure even kill. Patient stated having her blood pressure go up that high was really scary. Patient stated she had been taking two of her blood pressure pills and Tylenol. Patient stated it was okay by her doctor to take two pills since they are a low dose. Patient stated on Tuesday (04May2021) she started to feel like a new person and her blood pressure was great. Patient stated on Wednesday (05May2021) she was nauseous, had a headache, wasn't feeling too great and her blood pressure went back up. Patient stated while experiencing the side effects she was not getting much sleep and this could have contributed to her blood pressure rising. Patient stated she was told by family members that she would not have side effects with the first dose so she was surprised she did and went into the vaccination optimistic that she wouldn't have side effects. Patient stated she was hesitant to receive this vaccination due her reaction 20 years ago but her doctor convinced her that she needed to have it. Patient would like to know if the second dose will produce worse side effects than the first. Patient stated her reaction happened two to three days after receiving the vaccine and she was wondering if that was normal. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: not getting much sleep; headache; thought she was having a stroke; blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse; going to pass out; disoriented; her diastolic reading was high and her pulse; not feeling good; nauseous; ears were ringing; This is a spontaneous report from a contactable consumer reported for herself.  A 77-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot for immunization and she had a horrible reaction to the flu shot 20 years ago and she had not had any vaccinations since. Patient stated she would like to see if she should receive the second dose of the Pfizer COVID vaccine after a reaction to the first dose. Patient stated she received the first dose on 29Apr2021. Patient stated on Saturday 01May2021 two days later she thought she was having a stroke and her husband called (number) and the ambulance came and took her to the hospital. Patient stated her blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse. Patient stated she felt nauseous, her ears were ringing,  she thought she was going to pass out, disoriented and just not feeling good. Patient stated she went back home and she takes a low dose atenolol for her blood pressure because that usually keeps her blood pressure even kill. Patient stated having her blood pressure go up that high was really scary. Patient stated she had been taking two of her blood pressure pills and Tylenol. Patient stated it was okay by her doctor to take two pills since they are a low dose. Patient stated on Tuesday (04May2021) she started to feel like a new person and her blood pressure was great. Patient stated on Wednesday (05May2021) she was nauseous, had a headache, wasn't feeling too great and her blood pressure went back up. Patient stated while experiencing the side effects she was not getting much sleep and this could have contributed to her blood pressure rising. Patient stated she was told by family members that she would not have side effects with the first dose so she was surprised she did and went into the vaccination optimistic that she wouldn't have side effects. Patient stated she was hesitant to receive this vaccination due her reaction 20 years ago but her doctor convinced her that she needed to have it. Patient would like to know if the second dose will produce worse side effects than the first. Patient stated her reaction happened two to three days after receiving the vaccine and she was wondering if that was normal. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure diastolic, Blood pressure increased, Blood pressure measurement, Blood pressure systolic, Cerebrovascular accident
Clinical narrative: not getting much sleep; headache; thought she was having a stroke; blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse; going to pass out; disoriented; her diastolic reading was high and her pulse; not feeling good; nauseous; ears were ringing; This is a spontaneous report from a contactable consumer reported for herself.  A 77-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot for immunization and she had a horrible reaction to the flu shot 20 years ago and she had not had any vaccinations since. Patient stated she would like to see if she should receive the second dose of the Pfizer COVID vaccine after a reaction to the first dose. Patient stated she received the first dose on 29Apr2021. Patient stated on Saturday 01May2021 two days later she thought she was having a stroke and her husband called (number) and the ambulance came and took her to the hospital. Patient stated her blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse. Patient stated she felt nauseous, her ears were ringing,  she thought she was going to pass out, disoriented and just not feeling good. Patient stated she went back home and she takes a low dose atenolol for her blood pressure because that usually keeps her blood pressure even kill. Patient stated having her blood pressure go up that high was really scary. Patient stated she had been taking two of her blood pressure pills and Tylenol. Patient stated it was okay by her doctor to take two pills since they are a low dose. Patient stated on Tuesday (04May2021) she started to feel like a new person and her blood pressure was great. Patient stated on Wednesday (05May2021) she was nauseous, had a headache, wasn't feeling too great and her blood pressure went back up. Patient stated while experiencing the side effects she was not getting much sleep and this could have contributed to her blood pressure rising. Patient stated she was told by family members that she would not have side effects with the first dose so she was surprised she did and went into the vaccination optimistic that she wouldn't have side effects. Patient stated she was hesitant to receive this vaccination due her reaction 20 years ago but her doctor convinced her that she needed to have it. Patient would like to know if the second dose will produce worse side effects than the first. Patient stated her reaction happened two to three days after receiving the vaccine and she was wondering if that was normal. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Headache, Heart rate, Heart rate increased
Clinical narrative: not getting much sleep; headache; thought she was having a stroke; blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse; going to pass out; disoriented; her diastolic reading was high and her pulse; not feeling good; nauseous; ears were ringing; This is a spontaneous report from a contactable consumer reported for herself.  A 77-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot for immunization and she had a horrible reaction to the flu shot 20 years ago and she had not had any vaccinations since. Patient stated she would like to see if she should receive the second dose of the Pfizer COVID vaccine after a reaction to the first dose. Patient stated she received the first dose on 29Apr2021. Patient stated on Saturday 01May2021 two days later she thought she was having a stroke and her husband called (number) and the ambulance came and took her to the hospital. Patient stated her blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse. Patient stated she felt nauseous, her ears were ringing,  she thought she was going to pass out, disoriented and just not feeling good. Patient stated she went back home and she takes a low dose atenolol for her blood pressure because that usually keeps her blood pressure even kill. Patient stated having her blood pressure go up that high was really scary. Patient stated she had been taking two of her blood pressure pills and Tylenol. Patient stated it was okay by her doctor to take two pills since they are a low dose. Patient stated on Tuesday (04May2021) she started to feel like a new person and her blood pressure was great. Patient stated on Wednesday (05May2021) she was nauseous, had a headache, wasn't feeling too great and her blood pressure went back up. Patient stated while experiencing the side effects she was not getting much sleep and this could have contributed to her blood pressure rising. Patient stated she was told by family members that she would not have side effects with the first dose so she was surprised she did and went into the vaccination optimistic that she wouldn't have side effects. Patient stated she was hesitant to receive this vaccination due her reaction 20 years ago but her doctor convinced her that she needed to have it. Patient would like to know if the second dose will produce worse side effects than the first. Patient stated her reaction happened two to three days after receiving the vaccine and she was wondering if that was normal. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Malaise, Nausea, Tinnitus
Clinical narrative: not getting much sleep; headache; thought she was having a stroke; blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse; going to pass out; disoriented; her diastolic reading was high and her pulse; not feeling good; nauseous; ears were ringing; This is a spontaneous report from a contactable consumer reported for herself.  A 77-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot for immunization and she had a horrible reaction to the flu shot 20 years ago and she had not had any vaccinations since. Patient stated she would like to see if she should receive the second dose of the Pfizer COVID vaccine after a reaction to the first dose. Patient stated she received the first dose on 29Apr2021. Patient stated on Saturday 01May2021 two days later she thought she was having a stroke and her husband called (number) and the ambulance came and took her to the hospital. Patient stated her blood pressure systolic reading was higher than 220 and her diastolic reading was high and her pulse. Patient stated she felt nauseous, her ears were ringing,  she thought she was going to pass out, disoriented and just not feeling good. Patient stated she went back home and she takes a low dose atenolol for her blood pressure because that usually keeps her blood pressure even kill. Patient stated having her blood pressure go up that high was really scary. Patient stated she had been taking two of her blood pressure pills and Tylenol. Patient stated it was okay by her doctor to take two pills since they are a low dose. Patient stated on Tuesday (04May2021) she started to feel like a new person and her blood pressure was great. Patient stated on Wednesday (05May2021) she was nauseous, had a headache, wasn't feeling too great and her blood pressure went back up. Patient stated while experiencing the side effects she was not getting much sleep and this could have contributed to her blood pressure rising. Patient stated she was told by family members that she would not have side effects with the first dose so she was surprised she did and went into the vaccination optimistic that she wouldn't have side effects. Patient stated she was hesitant to receive this vaccination due her reaction 20 years ago but her doctor convinced her that she needed to have it. Patient would like to know if the second dose will produce worse side effects than the first. Patient stated her reaction happened two to three days after receiving the vaccine and she was wondering if that was normal. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE details; Expired dose administered; This spontaneous report was received from a pharmacist and refers to a 47-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 18-MAY-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) 0.5 milliliter, lot # S013683 was confirmed to be valid, expiration date 05-MAY-2021, (route and site of administration were not reported) for prophylaxis. The vaccine had no temperature excursion. No additional adverse event details were reported.
Sex: U
Vaccine: MMR, MMR
Symptoms: Product storage error
Clinical narrative: No additional AE details; Expired dose administered; This spontaneous report was received from a pharmacist and refers to a 47-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 18-MAY-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) 0.5 milliliter, lot # S013683 was confirmed to be valid, expiration date 05-MAY-2021, (route and site of administration were not reported) for prophylaxis. The vaccine had no temperature excursion. No additional adverse event details were reported.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin normal, Blood calcium increased, Blood chloride normal, Blood creatinine increased, Blood glucose normal
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood test, Blood urea normal, C-reactive protein increased
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carbon dioxide normal, Cardiac monitoring normal, Chest X-ray normal, Chest pain, Chills
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cytomegalovirus test negative, Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Epstein-Barr virus antibody positive
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Inflammation, Magnetic resonance imaging normal, Myocarditis
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Pain, Painful respiration, Platelet count decreased, Protein total normal
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, Tachycardia, Troponin increased
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Chest X-ray normal, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Intensive care, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: 5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath,  Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Patient without any past medical history received first dose of Moderna 5/16/21 presented to ED on 5/18/21 with chest pain.  Diagnosed with myopericarditis.  Hospitalized for 2 days, treated with colchicine and prednisone with improvement in symptoms.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: Patient without any past medical history received first dose of Moderna 5/16/21 presented to ED on 5/18/21 with chest pain.  Diagnosed with myopericarditis.  Hospitalized for 2 days, treated with colchicine and prednisone with improvement in symptoms.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide normal, Troponin increased
Clinical narrative: Patient without any past medical history received first dose of Moderna 5/16/21 presented to ED on 5/18/21 with chest pain.  Diagnosed with myopericarditis.  Hospitalized for 2 days, treated with colchicine and prednisone with improvement in symptoms.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, C-reactive protein increased, Chest pain, Chills, Echocardiogram abnormal
Clinical narrative: Patient without any past medical history received first dose of Moderna 5/16/21 presented to ED on 5/18/21 with chest pain.  Diagnosed with myopericarditis.  Hospitalized for 2 days, treated with colchicine and prednisone with improvement in symptoms.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction, Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myalgia
Clinical narrative: Patient without any past medical history received first dose of Moderna 5/16/21 presented to ED on 5/18/21 with chest pain.  Diagnosed with myopericarditis.  Hospitalized for 2 days, treated with colchicine and prednisone with improvement in symptoms.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Patient without any past medical history received first dose of Moderna 5/16/21 presented to ED on 5/18/21 with chest pain.  Diagnosed with myopericarditis.  Hospitalized for 2 days, treated with colchicine and prednisone with improvement in symptoms.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: ERRONEOUSLY ADMINISTERED 1ML OF THE JANSSEN COVID-19 VACCINE INSTEAD OF 0.5ML; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced erroneously administered 1ml of the janssen covid-19 vaccine instead of 0.5ml. On 18-MAY-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine  was not applicable. The outcome of the erroneously administered 1ml of the janssen covid-19 vaccine instead of 0.5ml and vaccine exposure during pregnancy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534599 and 20210534748.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Overdose
Clinical narrative: ERRONEOUSLY ADMINISTERED 1ML OF THE JANSSEN COVID-19 VACCINE INSTEAD OF 0.5ML; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced erroneously administered 1ml of the janssen covid-19 vaccine instead of 0.5ml. On 18-MAY-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine  was not applicable. The outcome of the erroneously administered 1ml of the janssen covid-19 vaccine instead of 0.5ml and vaccine exposure during pregnancy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534599 and 20210534748.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Computerised tomogram thorax abnormal, Groin pain, Motor dysfunction
Clinical narrative: CLOTS IN LUNG; BLOOD CLOTS IN BACK; SEVERE ABDOMINAL PAIN; GROIN PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient reported that on an unspecified date in MAR-2021, within 5 days of the shot, the adverse reaction began with severe back pain (subsumed under blood clots in back) and abdominal pains. After two additional weeks and four doctor's appointments, the pain was so severe, patient went to the emergency room on 14-APR-2021. A computerised tomogram (CT) scan with contrast revealed clots in lung and back. Patient consulted with his doctor and decided to go to the emergency room. Patient was still suffering from severe abdominal and back pain, especially when sitting or laying down. On 2021, pain had moved to the groin area as well. Laboratory data included: CT scan (NR: not provided) revealed clots in lung and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe abdominal pain, and groin pain, and the outcome of blood clots in back and clots in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210536709-COVID-19 VACCINE AD26.COV2.S-Clots in lung, Blood clots in back . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pulmonary thrombosis, Thrombosis, X-ray normal
Clinical narrative: CLOTS IN LUNG; BLOOD CLOTS IN BACK; SEVERE ABDOMINAL PAIN; GROIN PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient reported that on an unspecified date in MAR-2021, within 5 days of the shot, the adverse reaction began with severe back pain (subsumed under blood clots in back) and abdominal pains. After two additional weeks and four doctor's appointments, the pain was so severe, patient went to the emergency room on 14-APR-2021. A computerised tomogram (CT) scan with contrast revealed clots in lung and back. Patient consulted with his doctor and decided to go to the emergency room. Patient was still suffering from severe abdominal and back pain, especially when sitting or laying down. On 2021, pain had moved to the groin area as well. Laboratory data included: CT scan (NR: not provided) revealed clots in lung and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe abdominal pain, and groin pain, and the outcome of blood clots in back and clots in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210536709-COVID-19 VACCINE AD26.COV2.S-Clots in lung, Blood clots in back . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Computerised tomogram, Groin pain, Pulmonary thrombosis, Thrombosis
Clinical narrative: CLOTS IN LUNG; BLOOD CLOTS IN BACK; SEVERE ABDOMINAL PAIN; GROIN PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient reported that on an unspecified date in MAR-2021, within 5 days of the shot, the adverse reaction began with severe back pain (subsumed under blood clots in back) and abdominal pains. After two additional weeks and four doctor's appointments, the pain was so severe, patient went to the emergency room on 14-APR-2021. A computerised tomogram (CT) scan with contrast revealed clots in lung and back. Patient consulted with his doctor and decided to go to the emergency room. Patient was still suffering from severe abdominal and back pain, especially when sitting or laying down. On 2021, pain had moved to the groin area as well. Laboratory data included: CT scan (NR: not provided) revealed clots in lung and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe abdominal pain, and groin pain, and the outcome of blood clots in back and clots in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210536709-COVID-19 VACCINE AD26.COV2.S-Clots in lung, Blood clots in back . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Diarrhoea, Illness, Migraine, Ocular hyperaemia
Clinical narrative: VOMITING; BORDERLINE MIGRAINES; DIARRHEA; COULD NOT EVEN GET OUT OF BED; RIGHT EYE BLOODSHOT DUE TO A BLOOD VESSEL BURSTING IN EYE.; EXTREMELY ILL; PAINFUL HEADACHES; NAUSEA; This spontaneous report received from a consumer concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery, and overweight. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested   No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, borderline migraines, diarrhea, could not even get out of bed, right eye bloodshot due to a blood vessel bursting in eye., extremely ill, painful headaches, and nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the extremely ill, nausea, vomiting, diarrhea, could not even get out of bed, right eye bloodshot due to a blood vessel bursting in eye., painful headaches and borderline migraines was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Diarrhoea, Headache, Malaise, Migraine
Clinical narrative: VOMITING; BORDERLINE MIGRAINES; DIARRHEA; COULD NOT EVEN GET OUT OF BED; RIGHT EYE BLOODSHOT DUE TO A BLOOD VESSEL BURSTING IN EYE.; EXTREMELY ILL; PAINFUL HEADACHES; NAUSEA; This spontaneous report received from a consumer concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery, and overweight. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested   No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, borderline migraines, diarrhea, could not even get out of bed, right eye bloodshot due to a blood vessel bursting in eye., extremely ill, painful headaches, and nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the extremely ill, nausea, vomiting, diarrhea, could not even get out of bed, right eye bloodshot due to a blood vessel bursting in eye., painful headaches and borderline migraines was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: VOMITING; BORDERLINE MIGRAINES; DIARRHEA; COULD NOT EVEN GET OUT OF BED; RIGHT EYE BLOODSHOT DUE TO A BLOOD VESSEL BURSTING IN EYE.; EXTREMELY ILL; PAINFUL HEADACHES; NAUSEA; This spontaneous report received from a consumer concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery, and overweight. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested   No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, borderline migraines, diarrhea, could not even get out of bed, right eye bloodshot due to a blood vessel bursting in eye., extremely ill, painful headaches, and nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the extremely ill, nausea, vomiting, diarrhea, could not even get out of bed, right eye bloodshot due to a blood vessel bursting in eye., painful headaches and borderline migraines was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac assistance device user, Death, Dyspnoea, Resuscitation, Syncope
Clinical narrative: Wife called pharmacy to report her husband (patient in this report) died one day after his vaccination.  She indicated that he complained of only an achy arm the day before he passed out face up with his eye closed unresponsive on 5/21/2021 at 5:00 PM.  She called 911, gave rescue breathes until paramedics came, He was transported where he was later pronounce dead.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular fibrillation
Clinical narrative: Wife called pharmacy to report her husband (patient in this report) died one day after his vaccination.  She indicated that he complained of only an achy arm the day before he passed out face up with his eye closed unresponsive on 5/21/2021 at 5:00 PM.  She called 911, gave rescue breathes until paramedics came, He was transported where he was later pronounce dead.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Loss of consciousness, Pain in extremity, Resuscitation, Unresponsive to stimuli
Clinical narrative: Wife called pharmacy to report her husband (patient in this report) died one day after his vaccination.  She indicated that he complained of only an achy arm the day before he passed out face up with his eye closed unresponsive on 5/21/2021 at 5:00 PM.  She called 911, gave rescue breathes until paramedics came, He was transported where he was later pronounce dead.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Injection site pain, Nausea, Pain
Clinical narrative: Woke up in the middle of the night with body aches, shivering. Fever of 101 (fever has continued to persist ranging from 100-101 whilst taking acetaminophen), Vomiting/nausea, Significant tenderness at injection site, Fluctuating between feeling very hot and very cold.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Woke up in the middle of the night with body aches, shivering. Fever of 101 (fever has continued to persist ranging from 100-101 whilst taking acetaminophen), Vomiting/nausea, Significant tenderness at injection site, Fluctuating between feeling very hot and very cold.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Spontaneous nosebleeds. Severe and several times a day. Lasting around 30 minutes each time.