chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: Patient admitted for acute on chronic hypoxemic respiratory failure secondary to suspected AECOPD/AD IPF in the setting of COVID+ pneumonia. Vaccinated x3 with Moderna vaccine. No known COVID exposure. 2-3 word dyspnea and increased oxygen needs from 5L at baseline to 10L. Received ceftriaxone, doxycycline, dexamethasone, and Duoneb x3 in ER. Currently being reated albuterol PRN.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  hospice
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood creatinine increased, Blood potassium increased, COVID-19, Chest X-ray abnormal
Clinical narrative: Narrative:  Pt presented to ED on 10/16/2022. Patient is 81-year-old male presenting with vomiting and diarrhea. States vomited and has had 3 stools today. Granddaughter states emesis and stool are dark. Pt. has no complaints of pain but feels weak and fatigued. Significant past medical history. Patient says that on Friday he started having very frequent cough which soon followed by vomiting. Cough is nonproductive. Patient vomiting multiple times per day not able to keep any food or drink down. Patient states he also had some diarrhea on Friday and Saturday. Pt denies fevers/chills, CP, SOB, abd pain, dysuria, blood in urine/stool, muscle pain. Patient does state that his granddaughter lives with him, and she did have Covid recently. In ED, patient given Zofran, Lasix 40mg IV, insulin plus dextrose, and 1 L IV fluid. Patient admitted 10/16 through 10/18. HOSPITAL COURSE: Patient admitted due to several days of poor intake with vomiting and diarrhea, similar to family members. He was dry with elevated creatinine, but after fluid resuscitation it has returned to normal, and he is now drinking adequately and making good urine. He did not require any extra oxygen and never had respiratory distress, so thankfully his lungs were spared. Interestingly, he had covid with family about a month ago, and now all have diarrhea, suggesting this could actually be a separate virus with a prolonged positive test, but no way to confirm this, and does not much matter as supportive care only at this point. Recommend repeat Chem in 1-2 weeks, and at that time can consider resuming lasix if needed.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dehydration, Diarrhoea, Exposure to SARS-CoV-2, Faeces discoloured
Clinical narrative: Narrative:  Pt presented to ED on 10/16/2022. Patient is 81-year-old male presenting with vomiting and diarrhea. States vomited and has had 3 stools today. Granddaughter states emesis and stool are dark. Pt. has no complaints of pain but feels weak and fatigued. Significant past medical history. Patient says that on Friday he started having very frequent cough which soon followed by vomiting. Cough is nonproductive. Patient vomiting multiple times per day not able to keep any food or drink down. Patient states he also had some diarrhea on Friday and Saturday. Pt denies fevers/chills, CP, SOB, abd pain, dysuria, blood in urine/stool, muscle pain. Patient does state that his granddaughter lives with him, and she did have Covid recently. In ED, patient given Zofran, Lasix 40mg IV, insulin plus dextrose, and 1 L IV fluid. Patient admitted 10/16 through 10/18. HOSPITAL COURSE: Patient admitted due to several days of poor intake with vomiting and diarrhea, similar to family members. He was dry with elevated creatinine, but after fluid resuscitation it has returned to normal, and he is now drinking adequately and making good urine. He did not require any extra oxygen and never had respiratory distress, so thankfully his lungs were spared. Interestingly, he had covid with family about a month ago, and now all have diarrhea, suggesting this could actually be a separate virus with a prolonged positive test, but no way to confirm this, and does not much matter as supportive care only at this point. Recommend repeat Chem in 1-2 weeks, and at that time can consider resuming lasix if needed.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Frequent bowel movements, Hypophagia, SARS-CoV-2 test positive, Specific gravity urine increased
Clinical narrative: Narrative:  Pt presented to ED on 10/16/2022. Patient is 81-year-old male presenting with vomiting and diarrhea. States vomited and has had 3 stools today. Granddaughter states emesis and stool are dark. Pt. has no complaints of pain but feels weak and fatigued. Significant past medical history. Patient says that on Friday he started having very frequent cough which soon followed by vomiting. Cough is nonproductive. Patient vomiting multiple times per day not able to keep any food or drink down. Patient states he also had some diarrhea on Friday and Saturday. Pt denies fevers/chills, CP, SOB, abd pain, dysuria, blood in urine/stool, muscle pain. Patient does state that his granddaughter lives with him, and she did have Covid recently. In ED, patient given Zofran, Lasix 40mg IV, insulin plus dextrose, and 1 L IV fluid. Patient admitted 10/16 through 10/18. HOSPITAL COURSE: Patient admitted due to several days of poor intake with vomiting and diarrhea, similar to family members. He was dry with elevated creatinine, but after fluid resuscitation it has returned to normal, and he is now drinking adequately and making good urine. He did not require any extra oxygen and never had respiratory distress, so thankfully his lungs were spared. Interestingly, he had covid with family about a month ago, and now all have diarrhea, suggesting this could actually be a separate virus with a prolonged positive test, but no way to confirm this, and does not much matter as supportive care only at this point. Recommend repeat Chem in 1-2 weeks, and at that time can consider resuming lasix if needed.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting, White blood cell count normal
Clinical narrative: Narrative:  Pt presented to ED on 10/16/2022. Patient is 81-year-old male presenting with vomiting and diarrhea. States vomited and has had 3 stools today. Granddaughter states emesis and stool are dark. Pt. has no complaints of pain but feels weak and fatigued. Significant past medical history. Patient says that on Friday he started having very frequent cough which soon followed by vomiting. Cough is nonproductive. Patient vomiting multiple times per day not able to keep any food or drink down. Patient states he also had some diarrhea on Friday and Saturday. Pt denies fevers/chills, CP, SOB, abd pain, dysuria, blood in urine/stool, muscle pain. Patient does state that his granddaughter lives with him, and she did have Covid recently. In ED, patient given Zofran, Lasix 40mg IV, insulin plus dextrose, and 1 L IV fluid. Patient admitted 10/16 through 10/18. HOSPITAL COURSE: Patient admitted due to several days of poor intake with vomiting and diarrhea, similar to family members. He was dry with elevated creatinine, but after fluid resuscitation it has returned to normal, and he is now drinking adequately and making good urine. He did not require any extra oxygen and never had respiratory distress, so thankfully his lungs were spared. Interestingly, he had covid with family about a month ago, and now all have diarrhea, suggesting this could actually be a separate virus with a prolonged positive test, but no way to confirm this, and does not much matter as supportive care only at this point. Recommend repeat Chem in 1-2 weeks, and at that time can consider resuming lasix if needed.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Narrative:  80yoM presents to ED on 9/17/2022 with chief complaint of chills x7 days and SOB. Home COVID test positive. Reports dry intermittent cough. PMH significant for HF, ischemic CMP with EF 31-38% with AICD, pancytopenia, cirrhosis with esophageal varices, AF not on anticoagulation due to GI bleed, COPD, DOE/chronic hypoxemia on 2.5L oxygen, and CKD II. Admitted and treated with dexamethasone 6mg IV x1 dose. Transferred 9/18/22.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, COVID-19 pneumonia, Cough, Nausea, Pyrexia
Clinical narrative: Narrative:  This patient has been vaccinated with COVID 19 vaccine. It is unclear which vaccines, since there is no documentation in our facility. The patient presented to the ED on 11 June 2022 with cough, fever, and nausea. The patient was admitted to the hospital on 11 June with COVID 19 pneumonia and anemia. The patient was treated with antibiotics and with oxygen. The patient was discharged in stable condition on 17 June 2022. Reported per EUA.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Pyrexia, Tachycardia
Clinical narrative: Narrative:  This patient received two doses of Pfizer COVID 19 vaccine in Jan/Feb 2021. The patient presented to the ED on 28 June 2022 with fever, cough, and shortness of breath. The patient was admitted to the hospital with Covid pneumonia and tachycardia. The patient was treated with remdesivir, dexamethasone, and inhalers. The patient was discharged on 30 June 2022 in stable condition. Reported per EUA.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Injection site reaction, Pain, Pain in extremity
Clinical narrative: felt a pin sticking feeling on my right arm in there are the dose was administered.; Each month the spread grew worse and developed into a feeling like when my hands feel like their falling asleep of a scratchy feeling in patches over my entire  body; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 1, single (Lot number: 30155BA) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Tetanus (13 yrs ago took tetanus/whooping cough shot mix.  It reduced my mobility), for Immunization, reaction(s): "It reduced my mobility"; Whooping cough shot (13 yrs ago took tetanus/whooping cough shot mix.  It reduced my mobility), for Immunization, reaction(s): "It reduced my mobility". The following information was reported: PAIN IN EXTREMITY (disability) with onset 03Oct2021, outcome "not recovered", described as "Each month the spread grew worse and developed into a feeling like when my hands feel like their falling asleep of a scratchy feeling in patches over my entire  body"; VACCINATION SITE PAIN (disability) with onset 03Oct2021, outcome "not recovered", described as "felt a pin sticking feeling on my right arm in there are the dose was administered."; DYSPNOEA (disability) with onset 03Oct2021, outcome "not recovered", described as "shortness of breath". The events "felt a pin sticking feeling on my right arm in there are the dose was administered.", "each month the spread grew worse and developed into a feeling like when my hands feel like their falling asleep of a scratchy feeling in patches over my entire  body" and "shortness of breath" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Negative, notes: Hospital. Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, dyspnoea.  Clinical course: Patient Age group Adult (18-64 Years). After dose 1 patient Within 5 minutes she felt a pin Sticking feeling on her right arm in there are The dose was administered. By the end of The day it randomly spread to her toes and Other parts of her body. Each month the Spread grew worse and developed into a Feeling like when her hands feel like their Falling asleep of a scratchy feeling in Patches over her entire body. AE resulted in Doctor or other healthcare professional Office/clinic visit, Emergency Room/department or urgent care, Disability Or permanent damage]. No covid prior vaccination. No any other vaccine and other medication received in four weeks. Covid tested post vaccination as positive. No other medical history, no illness other than vaccine reactions.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Nasopharyngeal swab, Pain in extremity, Vaccination site pain
Clinical narrative: felt a pin sticking feeling on my right arm in there are the dose was administered.; Each month the spread grew worse and developed into a feeling like when my hands feel like their falling asleep of a scratchy feeling in patches over my entire  body; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 1, single (Lot number: 30155BA) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Tetanus (13 yrs ago took tetanus/whooping cough shot mix.  It reduced my mobility), for Immunization, reaction(s): "It reduced my mobility"; Whooping cough shot (13 yrs ago took tetanus/whooping cough shot mix.  It reduced my mobility), for Immunization, reaction(s): "It reduced my mobility". The following information was reported: PAIN IN EXTREMITY (disability) with onset 03Oct2021, outcome "not recovered", described as "Each month the spread grew worse and developed into a feeling like when my hands feel like their falling asleep of a scratchy feeling in patches over my entire  body"; VACCINATION SITE PAIN (disability) with onset 03Oct2021, outcome "not recovered", described as "felt a pin sticking feeling on my right arm in there are the dose was administered."; DYSPNOEA (disability) with onset 03Oct2021, outcome "not recovered", described as "shortness of breath". The events "felt a pin sticking feeling on my right arm in there are the dose was administered.", "each month the spread grew worse and developed into a feeling like when my hands feel like their falling asleep of a scratchy feeling in patches over my entire  body" and "shortness of breath" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Negative, notes: Hospital. Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, dyspnoea.  Clinical course: Patient Age group Adult (18-64 Years). After dose 1 patient Within 5 minutes she felt a pin Sticking feeling on her right arm in there are The dose was administered. By the end of The day it randomly spread to her toes and Other parts of her body. Each month the Spread grew worse and developed into a Feeling like when her hands feel like their Falling asleep of a scratchy feeling in Patches over her entire body. AE resulted in Doctor or other healthcare professional Office/clinic visit, Emergency Room/department or urgent care, Disability Or permanent damage]. No covid prior vaccination. No any other vaccine and other medication received in four weeks. Covid tested post vaccination as positive. No other medical history, no illness other than vaccine reactions.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Blood sodium decreased, Extra dose administered, Feeling abnormal
Clinical narrative: 73 year old woman h/o seronegative rheumatoid in remission previously received rituxan (off for 1 year) , RA in remission on Arava (treated for a few years), reports reaction to Remicade (after 3 infusions developed rigors during infusion and discontinued).  Her B cells were absent s/p rituxan therapy. Also, SARS Cov-2 IgG antibody nonprotected. Received 4 doses of moderna vaccine. One week after last dose in 11/2021, developed severe abdominal pain, then She noticed increased arthralgia, especially in the ankles and feet.  Also had  "electric shock muscle twitches." Pain was so severe, she was bedridden for 3 months.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infusion
Clinical narrative: 73 year old woman h/o seronegative rheumatoid in remission previously received rituxan (off for 1 year) , RA in remission on Arava (treated for a few years), reports reaction to Remicade (after 3 infusions developed rigors during infusion and discontinued).  Her B cells were absent s/p rituxan therapy. Also, SARS Cov-2 IgG antibody nonprotected. Received 4 doses of moderna vaccine. One week after last dose in 11/2021, developed severe abdominal pain, then She noticed increased arthralgia, especially in the ankles and feet.  Also had  "electric shock muscle twitches." Pain was so severe, she was bedridden for 3 months.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Bedridden, Electric shock sensation, Muscle twitching
Clinical narrative: 73 year old woman h/o seronegative rheumatoid in remission previously received rituxan (off for 1 year) , RA in remission on Arava (treated for a few years), reports reaction to Remicade (after 3 infusions developed rigors during infusion and discontinued).  Her B cells were absent s/p rituxan therapy. Also, SARS Cov-2 IgG antibody nonprotected. Received 4 doses of moderna vaccine. One week after last dose in 11/2021, developed severe abdominal pain, then She noticed increased arthralgia, especially in the ankles and feet.  Also had  "electric shock muscle twitches." Pain was so severe, she was bedridden for 3 months.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: 73 year old woman h/o seronegative rheumatoid in remission previously received rituxan (off for 1 year) , RA in remission on Arava (treated for a few years), reports reaction to Remicade (after 3 infusions developed rigors during infusion and discontinued).  Her B cells were absent s/p rituxan therapy. Also, SARS Cov-2 IgG antibody nonprotected. Received 4 doses of moderna vaccine. One week after last dose in 11/2021, developed severe abdominal pain, then She noticed increased arthralgia, especially in the ankles and feet.  Also had  "electric shock muscle twitches." Pain was so severe, she was bedridden for 3 months.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Diarrhoea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: 09/05/22 presents to ED for "abdominal pain and vomiting". PMHx of "CAD, CVA, emphysema, asthma, hypertension, hyperlipidemia, diabetes, arrhythmia with 2-1 AV block,pacemaker, GERD and BPH"
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, SARS-CoV-2 test positive, Vomiting
Clinical narrative: 09/05/22 presents to ED for "abdominal pain and vomiting". PMHx of "CAD, CVA, emphysema, asthma, hypertension, hyperlipidemia, diabetes, arrhythmia with 2-1 AV block,pacemaker, GERD and BPH"
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Acute respiratory failure, Anisocoria, Anticoagulant therapy, Aortic stenosis
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Bradycardia, COVID-19, Chest X-ray abnormal, Coma scale
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram thorax abnormal, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram normal
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Haemoptysis, Hypoxia, Injury, Intensive care
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke, Loss of consciousness, Lung disorder, Lung infiltration, Lung opacity
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Nothing by mouth order, Obesity, Polyuria, Positive airway pressure therapy
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary oedema, Pulse absent, Respiratory failure, Resuscitation, SARS-CoV-2 test positive
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Shock, Sputum culture positive, Staphylococcal infection, Tachypnoea, Troponin normal
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agonal respiration, Bradycardia, Cardioversion, Death, Dyspnoea
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Hyporesponsive to stimuli, Life support, Pulse absent, Pulseless electrical activity
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory distress, Resuscitation, Unresponsive to stimuli, Ventricular tachycardia
Clinical narrative: ED note from Emergency  Patient is a 76 y.o. female with extensive past medical cardiac and respiratory history including hypertension, dyslipidemia, diabetes, coronary artery disease, chronic obstructive pulmonary disease, AF, diastolic heart failure, aortic stenosis, mitral valve stenosis, chronic respiratory failure presenting to the emergency department with a chief concern of respiratory distress. Patient presents today via EMS for respiratory distress. Per report patient has significant history of severe COPD and had sudden onset of shortness of breath tonight. On EMS arrival patient had oxygen saturation in the 60s and decreased responsiveness. She had episode of bradycardia to 20s and per report brief loss of pulses which returned with with BVM assisted respirations. On arrival to the ED patient had agonal respirations, was unresponsive, bradycardic and found to be pulseless. ACLS initiated immediately. Patient initial rhythm of PEA. She received multiple rounds of EPI and was intubated with ROSC. She then went into VTACH with a pulse. Synchronized cardioversion x 2 without resolution. Patient given bolus of lidocaine with brief improvement. Few minutes later patient lost pulses again and ACLS again followed. Patient's husband arrived at bedside and requested to stop resuscitation. Patient declared at 10: 52pm.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Asthenia, Bradycardia, COVID-19, Cardiac stress test normal
Clinical narrative: 09/04/22 presents to EC ED for "chest pain". PMHx of "HTN, HLD, CVA with left-sided residual weakness"
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Ejection fraction, Electrocardiogram QT prolonged, SARS-CoV-2 test positive, Troponin increased
Clinical narrative: 09/04/22 presents to EC ED for "chest pain". PMHx of "HTN, HLD, CVA with left-sided residual weakness"
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, SARS-CoV-2 test positive
Clinical narrative: 09/04/22 presents to EC ED for "chest pain". PMHx of "HTN, HLD, CVA with left-sided residual weakness"
Sex: M
Vaccine: HPV9, MNQ, HPV9
Symptoms: Wrong patient received product
Clinical narrative: No additional AEs; HCP calling to report AE associated with GARDASIL 9. Caller reports 3rd dose accidentally administered to 14 year old patient on 9/23/22. No further information provided. No additional AEs, no PQCs. Caller requested AE letter be sent via email; This spontaneous report was received from other health professional and refers to a 14-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 23-SEP-2022, 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was accidentally administered to 14-year-old patient. No adverse event was reported.
Sex: M
Vaccine: HPV9, MNQ, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs; HCP calling to report AE associated with GARDASIL 9. Caller reports 3rd dose accidentally administered to 14 year old patient on 9/23/22. No further information provided. No additional AEs, no PQCs. Caller requested AE letter be sent via email; This spontaneous report was received from other health professional and refers to a 14-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 23-SEP-2022, 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was accidentally administered to 14-year-old patient. No adverse event was reported.
Age: 62.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Acute myocardial infarction, Chest discomfort, Electrocardiogram, Supraventricular tachycardia
Clinical narrative: heart rate increased rapidly to 162 for more than 2 hours/went to er/they told me I was in afb/ as doctors were watching me my heart went into sinus rhythm on its own.  I was not given any meds however with my health conditions, they kept me overnight.
Age: 62.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Atrial fibrillation, Cardiac stress test normal, Chest X-ray normal, Computerised tomogram normal, Electrocardiogram abnormal
Clinical narrative: heart rate increased rapidly to 162 for more than 2 hours/went to er/they told me I was in afb/ as doctors were watching me my heart went into sinus rhythm on its own.  I was not given any meds however with my health conditions, they kept me overnight.
Age: 62.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Heart rate increased
Clinical narrative: heart rate increased rapidly to 162 for more than 2 hours/went to er/they told me I was in afb/ as doctors were watching me my heart went into sinus rhythm on its own.  I was not given any meds however with my health conditions, they kept me overnight.
Age: 81.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect dose administered, No adverse event, Pain in extremity
Clinical narrative: Administered 0.5ml of the Pfizer covid bivalent gray cap booster dose instead of 0.3ml dose; Dose 1, 2, 3 MODERNA COVID-19 VACCINE; Dose 4 BNT162B2, BNT162B2 OMI BA.4-5; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:00 as dose 4 (booster), 0.5 ml single (Lot number: GH9693, Expiration Date: 30Jun2023) at the age of 81 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2022, outcome "recovered" (Oct2022), described as "Sore arm"; OVERDOSE (non-serious) with onset 05Oct2022 at 14:00, outcome "unknown", described as "Administered 0.5ml of the Pfizer covid bivalent gray cap booster dose instead of 0.3ml dose"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 05Oct2022 at 14:00, outcome "unknown", described as "Dose 1, 2, 3 MODERNA COVID-19 VACCINE; Dose 4 BNT162B2, BNT162B2 OMI BA.4-5". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Additional Information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) mentioned as None. Previous vaccines were Moderna. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect mentioned as None. Emergency Room and Physician Office visit mentioned as No. The patient provided regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event. The patient was given 0.5 ml dose rather than the 0.3 ml dose. 48 hours post vaccination the patient said she was feeling fine and the only side effects from the vaccination she had was a sore arm. The patient did not report any fever, headache or fatigue. It was unknown if prior vaccinations were given within four weeks. It was unknown if relevant tests were performed.  Follow-up (24Oct2022): This is a spontaneous follow-up report received from the contactable Pharmacist. This Pharmacist reported for a patient in response to HCP letter via follow-up activity. Updated information included: At risk classification removed; Suspect drug (vaccination start/stop time added; vaccination facility information updated); reaction (new event sore arm added) and additional information updated.
Age: 81.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Interchange of vaccine products, Overdose, Pain in extremity
Clinical narrative: Administered 0.5ml of the Pfizer covid bivalent gray cap booster dose instead of 0.3ml dose; Dose 1, 2, 3 MODERNA COVID-19 VACCINE; Dose 4 BNT162B2, BNT162B2 OMI BA.4-5; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:00 as dose 4 (booster), 0.5 ml single (Lot number: GH9693, Expiration Date: 30Jun2023) at the age of 81 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2022, outcome "recovered" (Oct2022), described as "Sore arm"; OVERDOSE (non-serious) with onset 05Oct2022 at 14:00, outcome "unknown", described as "Administered 0.5ml of the Pfizer covid bivalent gray cap booster dose instead of 0.3ml dose"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 05Oct2022 at 14:00, outcome "unknown", described as "Dose 1, 2, 3 MODERNA COVID-19 VACCINE; Dose 4 BNT162B2, BNT162B2 OMI BA.4-5". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Additional Information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) mentioned as None. Previous vaccines were Moderna. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect mentioned as None. Emergency Room and Physician Office visit mentioned as No. The patient provided regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event. The patient was given 0.5 ml dose rather than the 0.3 ml dose. 48 hours post vaccination the patient said she was feeling fine and the only side effects from the vaccination she had was a sore arm. The patient did not report any fever, headache or fatigue. It was unknown if prior vaccinations were given within four weeks. It was unknown if relevant tests were performed.  Follow-up (24Oct2022): This is a spontaneous follow-up report received from the contactable Pharmacist. This Pharmacist reported for a patient in response to HCP letter via follow-up activity. Updated information included: At risk classification removed; Suspect drug (vaccination start/stop time added; vaccination facility information updated); reaction (new event sore arm added) and additional information updated.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasal congestion
Clinical narrative: test positive; test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: CJ5342) for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 14:30 as dose 1, single (Lot number: EL3246), in left arm, on 20Feb2021 at 14:30 as dose 2, single (Lot number: EN9581), in left arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 31Mar2022 at 16:20 as dose 4 (booster), single (Lot number: FJ9943), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL SUCCINATE; ALENDRONATE; ATORVASTATIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Oct2022, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: I tested positive for covid 08Oct2022. Clinical course: 16Oct2022: she found this article today; It would have been so reassuring for them- had they not gotten covid a month after the bivalent booster. 12Sep2022- Received Pfizer bivalent. She tested positive for covid 08Oct2022. Her only symptom was nasal congestion. However since 12Oct she had no sense of smell. As a result she cannot taste anything. Her tongue does sense sweet, bitter, salty, etc. Her prescribed medications had remained the same since even before her first covid shot. Metoprolol succinate 25 mg daily tablet daily at bedtime. Alendronate 70 mg- 1 tablet weekly. Atorvastatin 10 mg- 1 tablet daily.