chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Endotracheal intubation, Pulseless electrical activity, Resuscitation, Syncope
Clinical narrative: post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report received from a contactable pharmacist. A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 20Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. It was reported that patient was not pregnant. Facility type vaccine was reported as unknown. The patient's medical history included acute respiratory failure with hypoxia, cardiac arrest, transaminitis, and diabetes. It was unknown if patient had COVID prior vaccination. The patient's concomitant medications were not reported. It was unknown if patient received other medications in two weeks and if she received any other vaccine in four weeks. The patient previously received first dose of BNT162B2 on unspecified date at single dose for COVID-19 immunisation, lisinopril and hydrochlorothiazide/triamterene (DYAZIDE) both reported as known allergies. It was reported that patient was brought in by emergency medical services (EMS) status post-cardiac arrest. Per EMS she was driving to urgent care (unclear why). She just got her second Pfizer vaccine. At urgent care she collapsed and cardiopulmonary resuscitation (CPR) was initiated immediately. EMS arrived and her initial rhythm was pulseless electrical activity (PEA). They placed a gel and administered 3 rounds of CPR with 3 onset epinephrine. No shockable rhythm. Patient arrived at hospital intubated and unresponsive on 20Apr2021. Duration of hospitalization was reported as two days. The events were reported as serious with criteria hospitalization and life-threatening illness (immediate risk of death from the event). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient was tested for COVID post-vaccination. The outcome of the events was resolving  Information on lot number/batch number has been requested.; Sender's Comments: The reported events would seem unlikely related to suspect vaccine BNT162B2, but more likely due to underlying cardiovascular morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report received from a contactable pharmacist. A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 20Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. It was reported that patient was not pregnant. Facility type vaccine was reported as unknown. The patient's medical history included acute respiratory failure with hypoxia, cardiac arrest, transaminitis, and diabetes. It was unknown if patient had COVID prior vaccination. The patient's concomitant medications were not reported. It was unknown if patient received other medications in two weeks and if she received any other vaccine in four weeks. The patient previously received first dose of BNT162B2 on unspecified date at single dose for COVID-19 immunisation, lisinopril and hydrochlorothiazide/triamterene (DYAZIDE) both reported as known allergies. It was reported that patient was brought in by emergency medical services (EMS) status post-cardiac arrest. Per EMS she was driving to urgent care (unclear why). She just got her second Pfizer vaccine. At urgent care she collapsed and cardiopulmonary resuscitation (CPR) was initiated immediately. EMS arrived and her initial rhythm was pulseless electrical activity (PEA). They placed a gel and administered 3 rounds of CPR with 3 onset epinephrine. No shockable rhythm. Patient arrived at hospital intubated and unresponsive on 20Apr2021. Duration of hospitalization was reported as two days. The events were reported as serious with criteria hospitalization and life-threatening illness (immediate risk of death from the event). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient was tested for COVID post-vaccination. The outcome of the events was resolving  Information on lot number/batch number has been requested.; Sender's Comments: The reported events would seem unlikely related to suspect vaccine BNT162B2, but more likely due to underlying cardiovascular morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Fall, Syncope
Clinical narrative: Patient received 1st Moderna vaccine Reaction: Seizures Severity: High
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Patient received 1st Moderna vaccine Reaction: Seizures Severity: High
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Hyperhidrosis, Hypotension, Loss of consciousness, Nausea
Clinical narrative: Within 3-minutes of vaccination, the patient reported dizziness, nausea, and feeling lightheaded. EMS evaluated the patient on-site. The patient reported a history of vasovagal syncope. Patient was hypotensive (85/40) with a FSBG of 102mg/dL. EMS administered 4mg PO Zofran and transported the patient to Emergency Department. The patient arrived at the ED, checked-in, took a phone call, then left without being seen.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Tunnel vision
Clinical narrative: Within 3-minutes of vaccination, the patient reported dizziness, nausea, and feeling lightheaded. EMS evaluated the patient on-site. The patient reported a history of vasovagal syncope. Patient was hypotensive (85/40) with a FSBG of 102mg/dL. EMS administered 4mg PO Zofran and transported the patient to Emergency Department. The patient arrived at the ED, checked-in, took a phone call, then left without being seen.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Hypotension, Nausea
Clinical narrative: Within 3-minutes of vaccination, the patient reported dizziness, nausea, and feeling lightheaded. EMS evaluated the patient on-site. The patient reported a history of vasovagal syncope. Patient was hypotensive (85/40) with a FSBG of 102mg/dL. EMS administered 4mg PO Zofran and transported the patient to Emergency Department. The patient arrived at the ED, checked-in, took a phone call, then left without being seen.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, Computerised tomogram abdomen abnormal, White blood cell count increased
Clinical narrative: Right lower quadrant abdominal pain; Acute Appendicittis; This spontaneous case was reported by a hospital (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Right lower quadrant abdominal pain) and APPENDICITIS (Acute Appendicittis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ABDOMINAL PAIN (Right lower quadrant abdominal pain) (seriousness criteria hospitalization prolonged and medically significant). On 24-Apr-2021, the patient experienced APPENDICITIS (Acute Appendicittis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 24-Apr-2021 due to ABDOMINAL PAIN, and then for 2 days due to APPENDICITIS. At the time of the report, ABDOMINAL PAIN (Right lower quadrant abdominal pain) and APPENDICITIS (Acute Appendicittis) had not resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Computerised tomogram: acute appendicitis (abnormal) ACUTE APPENDICITIS. On 24-Apr-2021, White blood cell count: 12,000 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL PAIN (Right lower quadrant abdominal pain) and APPENDICITIS (Acute Appendicittis) to be possibly related.    Patient is a 55-year old male that received the 2nd Moderna covid-19 vaccine on 11-Feb-2021 presented to the Emergency room on 24-Apr with complaint of right lower quadrant abdominal pain for 1 day. CT scan showed acute appendicitis.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain lower, Appendicitis, Computerised tomogram abdomen abnormal, White blood cell count increased
Clinical narrative: Right lower quadrant abdominal pain; Acute Appendicittis; This spontaneous case was reported by a hospital (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Right lower quadrant abdominal pain) and APPENDICITIS (Acute Appendicittis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ABDOMINAL PAIN (Right lower quadrant abdominal pain) (seriousness criteria hospitalization prolonged and medically significant). On 24-Apr-2021, the patient experienced APPENDICITIS (Acute Appendicittis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 24-Apr-2021 due to ABDOMINAL PAIN, and then for 2 days due to APPENDICITIS. At the time of the report, ABDOMINAL PAIN (Right lower quadrant abdominal pain) and APPENDICITIS (Acute Appendicittis) had not resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Computerised tomogram: acute appendicitis (abnormal) ACUTE APPENDICITIS. On 24-Apr-2021, White blood cell count: 12,000 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL PAIN (Right lower quadrant abdominal pain) and APPENDICITIS (Acute Appendicittis) to be possibly related.    Patient is a 55-year old male that received the 2nd Moderna covid-19 vaccine on 11-Feb-2021 presented to the Emergency room on 24-Apr with complaint of right lower quadrant abdominal pain for 1 day. CT scan showed acute appendicitis.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Redness, itching and hives developed to patient's chest, arms and stomach within the first 15 minutes of receiving the COVID vaccine. Benadryl 25mg IM provided to patient by clinic team with good resolve. Did not recur as per patient.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Erythema, Limb discomfort, Pruritus
Clinical narrative: Redness, itching and hives developed to patient's chest, arms and stomach within the first 15 minutes of receiving the COVID vaccine. Benadryl 25mg IM provided to patient by clinic team with good resolve. Did not recur as per patient.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Redness, itching and hives developed to patient's chest, arms and stomach within the first 15 minutes of receiving the COVID vaccine. Benadryl 25mg IM provided to patient by clinic team with good resolve. Did not recur as per patient.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amniotic cavity infection, Chills, Fatigue, Foetal death, Headache
Clinical narrative: Spontaneous vaginal delivery at 21 weeks gestation secondary to amniotic infection
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Premature labour, Pyrexia, SARS-CoV-2 test, Staphylococcal infection
Clinical narrative: Spontaneous vaginal delivery at 21 weeks gestation secondary to amniotic infection
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amniotic cavity infection, Delivery, Exposure during pregnancy, Premature delivery
Clinical narrative: Spontaneous vaginal delivery at 21 weeks gestation secondary to amniotic infection
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: She got shingles virus 7 days after vaccine unsure if related
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood magnesium, C-reactive protein, Chest X-ray
Clinical narrative: Hospitalized for acute pericarditis on 4/24/2021 at hospital, after presenting to ER with CP.  D/C on 4/25/21.  Prescribed Ibuprofen x 4 weeks and Colchicine x 3 mos at time of d/c from hospital and advised to limit activity. Followed up in student health office on 4/26/21. Patient stable and doing well.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Computerised tomogram thorax, Fibrin D dimer, Full blood count
Clinical narrative: Hospitalized for acute pericarditis on 4/24/2021 at hospital, after presenting to ER with CP.  D/C on 4/25/21.  Prescribed Ibuprofen x 4 weeks and Colchicine x 3 mos at time of d/c from hospital and advised to limit activity. Followed up in student health office on 4/26/21. Patient stable and doing well.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Metabolic function test, Pain, Red blood cell sedimentation rate
Clinical narrative: Hospitalized for acute pericarditis on 4/24/2021 at hospital, after presenting to ER with CP.  D/C on 4/25/21.  Prescribed Ibuprofen x 4 weeks and Colchicine x 3 mos at time of d/c from hospital and advised to limit activity. Followed up in student health office on 4/26/21. Patient stable and doing well.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test, Toxicologic test, Troponin, Urine analysis
Clinical narrative: Hospitalized for acute pericarditis on 4/24/2021 at hospital, after presenting to ER with CP.  D/C on 4/25/21.  Prescribed Ibuprofen x 4 weeks and Colchicine x 3 mos at time of d/c from hospital and advised to limit activity. Followed up in student health office on 4/26/21. Patient stable and doing well.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary normal, Chest pain, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram abnormal
Clinical narrative: Hospitalized for acute pericarditis on 4/24/2021 at hospital, after presenting to ER with CP.  D/C on 4/25/21.  Prescribed Ibuprofen x 4 weeks and Colchicine x 3 mos at time of d/c from hospital and advised to limit activity. Followed up in student health office on 4/26/21. Patient stable and doing well.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial necrosis marker increased, Myocarditis
Clinical narrative: Hospitalized for acute pericarditis on 4/24/2021 at hospital, after presenting to ER with CP.  D/C on 4/25/21.  Prescribed Ibuprofen x 4 weeks and Colchicine x 3 mos at time of d/c from hospital and advised to limit activity. Followed up in student health office on 4/26/21. Patient stable and doing well.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram thorax abnormal, Laboratory test, Pericarditis
Clinical narrative: Hospitalized for acute pericarditis on 4/24/2021 at hospital, after presenting to ER with CP.  D/C on 4/25/21.  Prescribed Ibuprofen x 4 weeks and Colchicine x 3 mos at time of d/c from hospital and advised to limit activity. Followed up in student health office on 4/26/21. Patient stable and doing well.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Immunoglobulin therapy, Laboratory test, Lumbar puncture, Unevaluable event
Clinical narrative: leg pain and face paralysis, hospitalized for Guillian Barre Syndrome for 5 days and received IVIG treatment.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: leg pain and face paralysis, hospitalized for Guillian Barre Syndrome for 5 days and received IVIG treatment.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Guillain-Barre syndrome, Pain, Pain in extremity
Clinical narrative: leg pain and face paralysis, hospitalized for Guillian Barre Syndrome for 5 days and received IVIG treatment.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: is a pleasant 52 year old male, presents with complains of feeling dizzy since Monday March 22, 2021 immediately after he had his first COVID vaccine.  Patient states it has been persistent since that time.  He reports the dizziness occurs only when he is moves his head while sitting up or standing up, resolves when he lays down.  States it is not spinning or rocking but more of j"just not feeling right"  Patient reports he as been noticing difficulty with swallowing but that resolved with taking Benadryl."
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia
Clinical narrative: is a pleasant 52 year old male, presents with complains of feeling dizzy since Monday March 22, 2021 immediately after he had his first COVID vaccine.  Patient states it has been persistent since that time.  He reports the dizziness occurs only when he is moves his head while sitting up or standing up, resolves when he lays down.  States it is not spinning or rocking but more of j"just not feeling right"  Patient reports he as been noticing difficulty with swallowing but that resolved with taking Benadryl."
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: The dat after my first dose I developed a sun burn feeling on my skin.  I noticed first on my legs, most strongly in the area of shins, and also on my arms.  There were also times I felt this sensation across my upper back and shoulders, and less frequently on my ears and face.  It seemed to vary in intensity and lasted for just over 2 weeks. There was never any redness, rash, itching, etc associated with this. My best description is that it felt like a mild sunburn.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Sunburn
Clinical narrative: The dat after my first dose I developed a sun burn feeling on my skin.  I noticed first on my legs, most strongly in the area of shins, and also on my arms.  There were also times I felt this sensation across my upper back and shoulders, and less frequently on my ears and face.  It seemed to vary in intensity and lasted for just over 2 weeks. There was never any redness, rash, itching, etc associated with this. My best description is that it felt like a mild sunburn.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Angiocardiogram, Asthenia, Burning sensation, Chills
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Condition aggravated, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Feeling cold, Headache, Laboratory test, Muscle tightness
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Percutaneous coronary intervention, Stent placement, Vomiting
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Catheterisation cardiac abnormal, Chest pain, Chills, Cold sweat
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coronary artery occlusion, Diarrhoea, Dyspepsia, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Joint stiffness, Muscle spasms, Oropharyngeal pain, Pain
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Percutaneous coronary intervention, Throat irritation, Troponin
Clinical narrative: Patient reports 3 days after getting Moderna shot started having indigestion worse in the morning, burning sensation from throat to chest, both sides jaw tightness comes and goes more in the morning with indigestion, bodyaches, headache, chills, clammy skin, both arms cramping, diarrhea x 4 episodes/d; tried Mylanta, Motrin- ineffective; drinking water; pain 8/10 in between throat and chest.  Presented to the emergency department 4/26/21, found to have ST elevation in 1 aVL with profound ST depressions in the anterior leads.  STEMI alert was called and patient brought to cath lab received PCI for total occlusion of  proximal circumflex.  Returned to cath lab 4/28/21 for staged intervention of 80% occluded LAD.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient reports having shingles after second Pfizer COVID vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary vein thrombosis, Pain in extremity, Peripheral swelling, Scan abnormal, Ultrasound Doppler
Clinical narrative: 4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Laboratory test, Pain in extremity, Peripheral swelling, Platelet count
Clinical narrative: 4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Thrombosis, Ultrasound scan abnormal
Clinical narrative: 4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain which doubles the pain he experienced on his first shot; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization. On an unknown date, the patient received his second dose and he experienced injection site pain which doubles the pain he experienced on his first shot. He was asking if he could apply ice or compress to the injected site. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: 5 days after vaccines,she started feeling dizziness and light headiness and its been 6 days since its started and not improving
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram, Inappropriate schedule of product administration, Throat tightness
Clinical narrative: Immediately after the injection, patient was lightheaded, had tremors, felt like he was gonna pass out, had a hard time breathing and couldnt swallow.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Immediately after the injection, patient was lightheaded, had tremors, felt like he was gonna pass out, had a hard time breathing and couldnt swallow.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Immediate post-injection reaction, Tremor
Clinical narrative: Immediately after the injection, patient was lightheaded, had tremors, felt like he was gonna pass out, had a hard time breathing and couldnt swallow.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Rotator cuff syndrome
Clinical narrative: Patient developed left shoulder pain one day after administration.  She then was unable to move the left arm or roll over in bed due to the pain in the left shoulder and arm.  She was initially treat with Ibuprofen 800 mg every 8 hours.  A MRI was ordered and denied by insurance  She is scheduled to see orthopedics
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Patient developed left shoulder pain one day after administration.  She then was unable to move the left arm or roll over in bed due to the pain in the left shoulder and arm.  She was initially treat with Ibuprofen 800 mg every 8 hours.  A MRI was ordered and denied by insurance  She is scheduled to see orthopedics
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous thrombosis, Magnetic resonance imaging head abnormal, Thrombotic cerebral infarction
Clinical narrative: Venous sinus thrombosis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis
Clinical narrative: Venous sinus thrombosis
Age: 53.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Blindness, Blindness unilateral, Computerised tomogram head, Computerised tomogram neck, Laboratory test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This 53-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route in the left arm on 28Mar2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history was reported as healthy. The patient had a known allergy to amoxicillin/clavulanic acid (AUGMENTIN). The patient did not receive any other vaccines within four weeks. The patient did not have COVID prior to the vaccination. Concomitant medication included over the counter (OTC) product (unspecified). Ten days after (as reported), on 10Apr2021, the patient had blood clot in retina of eye which caused temporary blindness. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was doing additional testing to see what damage occurred (test name and results not provided). The patient was not treated for blood clot in retina of eye and temporary blindness. The clinical outcomes of blood clot in retina of eye and temporary blindness was unknown. The patient was not tested for COVID-19 post vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Visual impairment
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This 53-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route in the left arm on 28Mar2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history was reported as healthy. The patient had a known allergy to amoxicillin/clavulanic acid (AUGMENTIN). The patient did not receive any other vaccines within four weeks. The patient did not have COVID prior to the vaccination. Concomitant medication included over the counter (OTC) product (unspecified). Ten days after (as reported), on 10Apr2021, the patient had blood clot in retina of eye which caused temporary blindness. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was doing additional testing to see what damage occurred (test name and results not provided). The patient was not treated for blood clot in retina of eye and temporary blindness. The clinical outcomes of blood clot in retina of eye and temporary blindness was unknown. The patient was not tested for COVID-19 post vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Blindness transient, Investigation, Retinal vascular thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This 53-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route in the left arm on 28Mar2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history was reported as healthy. The patient had a known allergy to amoxicillin/clavulanic acid (AUGMENTIN). The patient did not receive any other vaccines within four weeks. The patient did not have COVID prior to the vaccination. Concomitant medication included over the counter (OTC) product (unspecified). Ten days after (as reported), on 10Apr2021, the patient had blood clot in retina of eye which caused temporary blindness. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was doing additional testing to see what damage occurred (test name and results not provided). The patient was not treated for blood clot in retina of eye and temporary blindness. The clinical outcomes of blood clot in retina of eye and temporary blindness was unknown. The patient was not tested for COVID-19 post vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Full blood count, Metabolic function test, Muscle spasms, Platelet count decreased
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Swelling, Thrombocytopenia, Ultrasound Doppler abnormal
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Angiogram pulmonary abnormal, Anticoagulant therapy, Antiphospholipid antibodies, Antithrombin III
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood homocysteine normal, Blood smear test, C-reactive protein increased, Chest pain, Coagulation test normal
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Electrocardiogram normal, Fibrin D dimer increased, Full blood count
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Haptoglobin, Limb discomfort, Myalgia, Pain in extremity, Platelet count decreased
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet factor 4, Platelet morphology, Protein C, Protein S, Pulmonary embolism
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Thrombophlebitis superficial, Ultrasound Doppler abnormal, Venous occlusion
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest discomfort, Deep vein thrombosis, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy
Clinical narrative: The patient is an unusually physically active and fit 48 YOM who has enjoyed good health. He developed new pain in his big toe on 4/18 and over the next few days he developed some soreness of the large muscle groups of his thighs, which he attributed to Peloton riding and exercise. He did fly on 4/21 and returned on 4/25, where he took advil for leg pain. On 4/25 the patient felt a leg vessel that didn't seem right and went to the ED.  He was seen in the ED the morning of 4/26, where a D-Dimer showed an elevation of 15k (reference range of 0-500). Duplex US showed extensive DVTs b/l from the gastrocs to the popliteals, and including the post. Tibials of the left. He developed new CP today, so he decided to come in to the ED for further evaluation.  CT chest showed numerous segmental PE b/l. He had already taken his rivaroxaban for the night (1800). He was admitted to medicine unit for further evaluation and workup.   The patient has had some recent airline travel from the end of March through April 1st or 2nd and felt well afterwards. Johnson and Johnson administered 4/7/21.