chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Nasopharyngitis
Clinical narrative: On Friday May 21 2021 at noon, I had the 2nd dose of Pfizer vaccine,  on 2nd day, May 22 2021, at 4pm, suddenly I had terrible chill, low fever, headache, extreme tiredness,  the symptoms were unbearable, grade 4, I went bed but could not sleep well. For common cold, fever and headache usually I can fall in sleep and wake up with normal, but this vaccine AE was destructive to the entire body.  I didn't have sufficient energy to grab a glass of water to drink, but took a huge effort. This symptom lasted 26-30 hours till Sunday afternoon, the extreme chill and pain went resolved, I was able to walk downstairs.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: On Friday May 21 2021 at noon, I had the 2nd dose of Pfizer vaccine,  on 2nd day, May 22 2021, at 4pm, suddenly I had terrible chill, low fever, headache, extreme tiredness,  the symptoms were unbearable, grade 4, I went bed but could not sleep well. For common cold, fever and headache usually I can fall in sleep and wake up with normal, but this vaccine AE was destructive to the entire body.  I didn't have sufficient energy to grab a glass of water to drink, but took a huge effort. This symptom lasted 26-30 hours till Sunday afternoon, the extreme chill and pain went resolved, I was able to walk downstairs.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Adverse event: PERICARDITIS.  Acute onset pounding tachycardia, HR 120 standing, HR 95 lying down, fever, malaise on 4/28/2021. On 4/29/2021, symptoms unchanged, tachycardia and fever persisted, esophageal discomfort developed. Sought emergency medical treatment at free-standing hospital ER due to persistent tachycardia. No diagnosis at this visit; provider sidetracked by recent history of concurrent diarrhea that had worsened significantly after Pfizer vaccine #2, but that was not the purpose of my visit. ECG, radiographs, routine bloodwork, cardiac isoenzymes all deemed normal Symptoms became much worse overnight, with significant chest pain, particularly associated with breathing and lying down, noticeable esophageal pain, trembling, fever. Sought emergency medical treatment again at different hospital ER.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Frequent bowel movements, Muscle atrophy, SARS-CoV-2 test, Weight decreased
Clinical narrative: Adverse event: PERICARDITIS.  Acute onset pounding tachycardia, HR 120 standing, HR 95 lying down, fever, malaise on 4/28/2021. On 4/29/2021, symptoms unchanged, tachycardia and fever persisted, esophageal discomfort developed. Sought emergency medical treatment at free-standing hospital ER due to persistent tachycardia. No diagnosis at this visit; provider sidetracked by recent history of concurrent diarrhea that had worsened significantly after Pfizer vaccine #2, but that was not the purpose of my visit. ECG, radiographs, routine bloodwork, cardiac isoenzymes all deemed normal Symptoms became much worse overnight, with significant chest pain, particularly associated with breathing and lying down, noticeable esophageal pain, trembling, fever. Sought emergency medical treatment again at different hospital ER.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest pain, Computerised tomogram thorax, Condition aggravated, Electrocardiogram abnormal
Clinical narrative: Adverse event: PERICARDITIS.  Acute onset pounding tachycardia, HR 120 standing, HR 95 lying down, fever, malaise on 4/28/2021. On 4/29/2021, symptoms unchanged, tachycardia and fever persisted, esophageal discomfort developed. Sought emergency medical treatment at free-standing hospital ER due to persistent tachycardia. No diagnosis at this visit; provider sidetracked by recent history of concurrent diarrhea that had worsened significantly after Pfizer vaccine #2, but that was not the purpose of my visit. ECG, radiographs, routine bloodwork, cardiac isoenzymes all deemed normal Symptoms became much worse overnight, with significant chest pain, particularly associated with breathing and lying down, noticeable esophageal pain, trembling, fever. Sought emergency medical treatment again at different hospital ER.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Painful respiration, Pericarditis, Pyrexia, Scan with contrast
Clinical narrative: Adverse event: PERICARDITIS.  Acute onset pounding tachycardia, HR 120 standing, HR 95 lying down, fever, malaise on 4/28/2021. On 4/29/2021, symptoms unchanged, tachycardia and fever persisted, esophageal discomfort developed. Sought emergency medical treatment at free-standing hospital ER due to persistent tachycardia. No diagnosis at this visit; provider sidetracked by recent history of concurrent diarrhea that had worsened significantly after Pfizer vaccine #2, but that was not the purpose of my visit. ECG, radiographs, routine bloodwork, cardiac isoenzymes all deemed normal Symptoms became much worse overnight, with significant chest pain, particularly associated with breathing and lying down, noticeable esophageal pain, trembling, fever. Sought emergency medical treatment again at different hospital ER.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: Adverse event: PERICARDITIS.  Acute onset pounding tachycardia, HR 120 standing, HR 95 lying down, fever, malaise on 4/28/2021. On 4/29/2021, symptoms unchanged, tachycardia and fever persisted, esophageal discomfort developed. Sought emergency medical treatment at free-standing hospital ER due to persistent tachycardia. No diagnosis at this visit; provider sidetracked by recent history of concurrent diarrhea that had worsened significantly after Pfizer vaccine #2, but that was not the purpose of my visit. ECG, radiographs, routine bloodwork, cardiac isoenzymes all deemed normal Symptoms became much worse overnight, with significant chest pain, particularly associated with breathing and lying down, noticeable esophageal pain, trembling, fever. Sought emergency medical treatment again at different hospital ER.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Dry eye, Dystonia, Eye pain, Eye swelling
Clinical narrative: Patient started feeling unwell the day after vaccination: developed facial twitching - "as if the twitching was rolling across my face from one side to the other"; c/o fever; Covid-like symptoms; left side of face started drooping and resting posture was different (per patient). Individual sought care: had an MRI to evaluate for possible stroke - none seen on MRI. She saw multiple doctors for evaluation  - PCP, neurology, and cardiology (I believe) and had many tests performed for evaluation. Of note: cranial nerve inflammation documented per patient. Her right eye is still twitching and she has "been very ill". Patient states she will not receive any other Covid vaccines and has not been the same since she received her vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Headache, Hypoaesthesia, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: Patient started feeling unwell the day after vaccination: developed facial twitching - "as if the twitching was rolling across my face from one side to the other"; c/o fever; Covid-like symptoms; left side of face started drooping and resting posture was different (per patient). Individual sought care: had an MRI to evaluate for possible stroke - none seen on MRI. She saw multiple doctors for evaluation  - PCP, neurology, and cardiology (I believe) and had many tests performed for evaluation. Of note: cranial nerve inflammation documented per patient. Her right eye is still twitching and she has "been very ill". Patient states she will not receive any other Covid vaccines and has not been the same since she received her vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: Patient started feeling unwell the day after vaccination: developed facial twitching - "as if the twitching was rolling across my face from one side to the other"; c/o fever; Covid-like symptoms; left side of face started drooping and resting posture was different (per patient). Individual sought care: had an MRI to evaluate for possible stroke - none seen on MRI. She saw multiple doctors for evaluation  - PCP, neurology, and cardiology (I believe) and had many tests performed for evaluation. Of note: cranial nerve inflammation documented per patient. Her right eye is still twitching and she has "been very ill". Patient states she will not receive any other Covid vaccines and has not been the same since she received her vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Visual impairment
Clinical narrative: Patient started feeling unwell the day after vaccination: developed facial twitching - "as if the twitching was rolling across my face from one side to the other"; c/o fever; Covid-like symptoms; left side of face started drooping and resting posture was different (per patient). Individual sought care: had an MRI to evaluate for possible stroke - none seen on MRI. She saw multiple doctors for evaluation  - PCP, neurology, and cardiology (I believe) and had many tests performed for evaluation. Of note: cranial nerve inflammation documented per patient. Her right eye is still twitching and she has "been very ill". Patient states she will not receive any other Covid vaccines and has not been the same since she received her vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Cardiovascular evaluation, Central nervous system inflammation, Cranial nerve disorder, Facial paralysis
Clinical narrative: Patient started feeling unwell the day after vaccination: developed facial twitching - "as if the twitching was rolling across my face from one side to the other"; c/o fever; Covid-like symptoms; left side of face started drooping and resting posture was different (per patient). Individual sought care: had an MRI to evaluate for possible stroke - none seen on MRI. She saw multiple doctors for evaluation  - PCP, neurology, and cardiology (I believe) and had many tests performed for evaluation. Of note: cranial nerve inflammation documented per patient. Her right eye is still twitching and she has "been very ill". Patient states she will not receive any other Covid vaccines and has not been the same since she received her vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Laboratory test, Magnetic resonance imaging head normal, Malaise
Clinical narrative: Patient started feeling unwell the day after vaccination: developed facial twitching - "as if the twitching was rolling across my face from one side to the other"; c/o fever; Covid-like symptoms; left side of face started drooping and resting posture was different (per patient). Individual sought care: had an MRI to evaluate for possible stroke - none seen on MRI. She saw multiple doctors for evaluation  - PCP, neurology, and cardiology (I believe) and had many tests performed for evaluation. Of note: cranial nerve inflammation documented per patient. Her right eye is still twitching and she has "been very ill". Patient states she will not receive any other Covid vaccines and has not been the same since she received her vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Posture abnormal, Pyrexia
Clinical narrative: Patient started feeling unwell the day after vaccination: developed facial twitching - "as if the twitching was rolling across my face from one side to the other"; c/o fever; Covid-like symptoms; left side of face started drooping and resting posture was different (per patient). Individual sought care: had an MRI to evaluate for possible stroke - none seen on MRI. She saw multiple doctors for evaluation  - PCP, neurology, and cardiology (I believe) and had many tests performed for evaluation. Of note: cranial nerve inflammation documented per patient. Her right eye is still twitching and she has "been very ill". Patient states she will not receive any other Covid vaccines and has not been the same since she received her vaccination.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atypical pneumonia, COVID-19, Chest X-ray abnormal, Cough, Diarrhoea
Clinical narrative: Dx COVID; signs and symptoms:  Patient was initially discharged from the hospital with covid19. At the time patient was stable on room air. Patient had been feeling worse, hypoxic upon arrival to the ER with increased work of breathing satting 81% on room air. Patient was placed on 15 L nonrebreather with improvement in his O2 sat. dx COVID pneumonia with superimposed bacterial pneumonia.  Treatment:  IV antibiotics, systemic steroids, supplemental oxygen.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, Haemoglobin decreased, Headache, Hypoxia, Influenza A virus test
Clinical narrative: Dx COVID; signs and symptoms:  Patient was initially discharged from the hospital with covid19. At the time patient was stable on room air. Patient had been feeling worse, hypoxic upon arrival to the ER with increased work of breathing satting 81% on room air. Patient was placed on 15 L nonrebreather with improvement in his O2 sat. dx COVID pneumonia with superimposed bacterial pneumonia.  Treatment:  IV antibiotics, systemic steroids, supplemental oxygen.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza B virus test, Lung opacity, Malaise, Myalgia, Platelet count normal
Clinical narrative: Dx COVID; signs and symptoms:  Patient was initially discharged from the hospital with covid19. At the time patient was stable on room air. Patient had been feeling worse, hypoxic upon arrival to the ER with increased work of breathing satting 81% on room air. Patient was placed on 15 L nonrebreather with improvement in his O2 sat. dx COVID pneumonia with superimposed bacterial pneumonia.  Treatment:  IV antibiotics, systemic steroids, supplemental oxygen.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia bacterial, Pyrexia, SARS-CoV-2 test positive, White blood cell count normal
Clinical narrative: Dx COVID; signs and symptoms:  Patient was initially discharged from the hospital with covid19. At the time patient was stable on room air. Patient had been feeling worse, hypoxic upon arrival to the ER with increased work of breathing satting 81% on room air. Patient was placed on 15 L nonrebreather with improvement in his O2 sat. dx COVID pneumonia with superimposed bacterial pneumonia.  Treatment:  IV antibiotics, systemic steroids, supplemental oxygen.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, Feeling abnormal, Hypoxia
Clinical narrative: Dx COVID; signs and symptoms:  Patient was initially discharged from the hospital with covid19. At the time patient was stable on room air. Patient had been feeling worse, hypoxic upon arrival to the ER with increased work of breathing satting 81% on room air. Patient was placed on 15 L nonrebreather with improvement in his O2 sat. dx COVID pneumonia with superimposed bacterial pneumonia.  Treatment:  IV antibiotics, systemic steroids, supplemental oxygen.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia bacterial, Superinfection
Clinical narrative: Dx COVID; signs and symptoms:  Patient was initially discharged from the hospital with covid19. At the time patient was stable on room air. Patient had been feeling worse, hypoxic upon arrival to the ER with increased work of breathing satting 81% on room air. Patient was placed on 15 L nonrebreather with improvement in his O2 sat. dx COVID pneumonia with superimposed bacterial pneumonia.  Treatment:  IV antibiotics, systemic steroids, supplemental oxygen.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt admitted to hosp with sepsis and respiratory failure; positive for COVID; placed on antibiotics and BiPAP; did not respond well to BiPAP; required intubation; experienced AKI; hepatorenal syndrome; poor candidate for renal replacement therapy; condition declined; DNR; comfort care; pt extubated and died in the hosp
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, COVID-19, Death, Endotracheal intubation, Hepatorenal syndrome
Clinical narrative: pt admitted to hosp with sepsis and respiratory failure; positive for COVID; placed on antibiotics and BiPAP; did not respond well to BiPAP; required intubation; experienced AKI; hepatorenal syndrome; poor candidate for renal replacement therapy; condition declined; DNR; comfort care; pt extubated and died in the hosp
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, Respiratory failure, SARS-CoV-2 test positive, Sepsis
Clinical narrative: pt admitted to hosp with sepsis and respiratory failure; positive for COVID; placed on antibiotics and BiPAP; did not respond well to BiPAP; required intubation; experienced AKI; hepatorenal syndrome; poor candidate for renal replacement therapy; condition declined; DNR; comfort care; pt extubated and died in the hosp
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt admitted to hos with AHRF due to COVID; started on dexamethasone, heparin, zosyn, vancomycin, amiodarone drip; required intubation; multiple complex medical problems and on high risk medications; vasopressors for BP support; renal function worsened; pt coded and went into PEA; resuscitated successfully; pt's condition worsened; eventually comfort care measures; pt died in the hosp
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19, Cardio-respiratory arrest, Death
Clinical narrative: pt admitted to hos with AHRF due to COVID; started on dexamethasone, heparin, zosyn, vancomycin, amiodarone drip; required intubation; multiple complex medical problems and on high risk medications; vasopressors for BP support; renal function worsened; pt coded and went into PEA; resuscitated successfully; pt's condition worsened; eventually comfort care measures; pt died in the hosp
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Pulseless electrical activity, Renal impairment, Resuscitation
Clinical narrative: pt admitted to hos with AHRF due to COVID; started on dexamethasone, heparin, zosyn, vancomycin, amiodarone drip; required intubation; multiple complex medical problems and on high risk medications; vasopressors for BP support; renal function worsened; pt coded and went into PEA; resuscitated successfully; pt's condition worsened; eventually comfort care measures; pt died in the hosp
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebellar infarction, Interchange of vaccine products, Magnetic resonance imaging head abnormal, Tinnitus, Vertigo
Clinical narrative: 48 y/o F w/ no PMH, healthy marathon runner, well hydrated who had her moderna booster vaccine on 11/19/2021.  Patient developed cerebellar stroke (with confirming imaging) on 11/22/2021 believed to be embolic (patient found to have PFO).  Patient had signs of sudden onset vertigo/loss of balance.  Patient since in neuro rehab, recovering gain of function
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White matter lesion
Clinical narrative: 48 y/o F w/ no PMH, healthy marathon runner, well hydrated who had her moderna booster vaccine on 11/19/2021.  Patient developed cerebellar stroke (with confirming imaging) on 11/22/2021 believed to be embolic (patient found to have PFO).  Patient had signs of sudden onset vertigo/loss of balance.  Patient since in neuro rehab, recovering gain of function
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial septal defect, Balance disorder, Cardiac monitoring normal, Cerebellar stroke, Coagulation test normal
Clinical narrative: 48 y/o F w/ no PMH, healthy marathon runner, well hydrated who had her moderna booster vaccine on 11/19/2021.  Patient developed cerebellar stroke (with confirming imaging) on 11/22/2021 believed to be embolic (patient found to have PFO).  Patient had signs of sudden onset vertigo/loss of balance.  Patient since in neuro rehab, recovering gain of function
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax normal, Fibrin D dimer increased, Magnetic resonance imaging head abnormal, Ultrasound Doppler normal, Vertigo
Clinical narrative: 48 y/o F w/ no PMH, healthy marathon runner, well hydrated who had her moderna booster vaccine on 11/19/2021.  Patient developed cerebellar stroke (with confirming imaging) on 11/22/2021 believed to be embolic (patient found to have PFO).  Patient had signs of sudden onset vertigo/loss of balance.  Patient since in neuro rehab, recovering gain of function
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: I was called and informed that my daughter received the adult dose of the second COVID 19 vaccine. She experienced fever up to 102-103 F, was lethargic, could not move her left arm (where it was administered for 3 days.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Lethargy, Mobility decreased, Pyrexia
Clinical narrative: I was called and informed that my daughter received the adult dose of the second COVID 19 vaccine. She experienced fever up to 102-103 F, was lethargic, could not move her left arm (where it was administered for 3 days.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Chest X-ray, Chest pain, Computerised tomogram thorax abnormal, Electrocardiogram
Clinical narrative: Myocarditis, biopsy proven, complicated by cardiogenic shock and complete hear block.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematology test, Hilar lymphadenopathy, Left atrial enlargement, Lung disorder, Mediastinitis
Clinical narrative: Myocarditis, biopsy proven, complicated by cardiogenic shock and complete hear block.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pain, Pain in extremity, Pleural effusion, Pulmonary oedema
Clinical narrative: Myocarditis, biopsy proven, complicated by cardiogenic shock and complete hear block.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tissue infiltration, Troponin increased
Clinical narrative: Myocarditis, biopsy proven, complicated by cardiogenic shock and complete hear block.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrioventricular block complete, Biopsy heart abnormal, Cardiogenic shock, Myocarditis
Clinical narrative: Myocarditis, biopsy proven, complicated by cardiogenic shock and complete hear block.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Chest pain, Discomfort, Hypoaesthesia, Hypotension
Clinical narrative: Chest pain , nausea, head ache and left arm tingling sensation for 1 day
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging heart, Myocarditis, Troponin increased
Clinical narrative: Chest pain , nausea, head ache and left arm tingling sensation for 1 day
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Catheterisation cardiac normal, Chest pain, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Chest pain , nausea, head ache and left arm tingling sensation for 1 day
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myocarditis, Nausea, Paraesthesia, Scan with contrast abnormal
Clinical narrative: Chest pain , nausea, head ache and left arm tingling sensation for 1 day
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Chest pain , nausea, head ache and left arm tingling sensation for 1 day
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Individual called clinic and reported he had been experiencing intermittent lightheadedness with positional changes (such as going from laying to sitting or sitting to standing). Denied ever having passed-out. Denied having sought medical evaluation to this time. States symptoms lasted 3 days then subsided. Has not experienced recurrence to this time.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Individual called clinic and reported he had been experiencing intermittent lightheadedness with positional changes (such as going from laying to sitting or sitting to standing). Denied ever having passed-out. Denied having sought medical evaluation to this time. States symptoms lasted 3 days then subsided. Has not experienced recurrence to this time.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocardial infarction, Palpitations
Clinical narrative: I received my second shot of Pfizer Covid 19 Vaccine. About a week later I had heart palpitations, and chest pains that felt like I was having a heart attack. It would occur both when inactive (sitting) and when exercising both during the day and at night. It went on for about 3-4 weeks. Then went away. I seem to have recovered.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: I received my second shot of Pfizer Covid 19 Vaccine. About a week later I had heart palpitations, and chest pains that felt like I was having a heart attack. It would occur both when inactive (sitting) and when exercising both during the day and at night. It went on for about 3-4 weeks. Then went away. I seem to have recovered.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pain, Palpitations
Clinical narrative: I received my second shot of Pfizer Covid 19 Vaccine. About a week later I had heart palpitations, and chest pains that felt like I was having a heart attack. It would occur both when inactive (sitting) and when exercising both during the day and at night. It went on for about 3-4 weeks. Then went away. I seem to have recovered.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: I received my second shot of Pfizer Covid 19 Vaccine. About a week later I had heart palpitations, and chest pains that felt like I was having a heart attack. It would occur both when inactive (sitting) and when exercising both during the day and at night. It went on for about 3-4 weeks. Then went away. I seem to have recovered.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other AE reported; expired dose of MMR II was administered to a patient; This spontaneous report was received from an office manager and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 22-NOV-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S037501 with expiration date on 20-NOV-2021, therapy type rHA (exact dose, route of administration were unknown) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; dose of PNEUMOVAX 23 expired on 8/23/2021 and was administered on 11/21/2021; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history or concomitant medications was provided. On 21-NOV-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 ml, lot was reported as # T007383 verified as valid lot, expiration date: 23-AUG-2021, for prophylaxis (frequency and route of administration were not reported). No additional adverse event (AE) was reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first dose of GARDASIL 9 at age 14 and second dose on 11/17/21 at age 17; This spontaneous report was received from an office administrator and refers to a 17-year-old patient of an unknown gender. No information regarding the patient's concurrent condition, medical history or concomitant medications was provided.  On an unknown date approximatelly in 2018, reported as when the patient was 14 years old, he was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of adnimistration, lot # and expiration date were not reported) for prophylaxis. On 17-NOV-2021, the patient came into the office and received the secon dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis. The vaccines were not given at the recommended dose interval (Inappropriate schedule of vaccine administered).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S037498, expiration date 20-NOV-2021, 0.5 milliliter (formulation, concentration, dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No temperature excursion occurred. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no known side effects; expired dose of VAQTA that was administered to a patient; This spontaneous report was received from a registered nurse and refers to the patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 22-NOV-2021, the patient was vaccinated intramuscularly with 0.5 milliliter of hepatitis a virus inactivated [MRC-5 CELLS] (VAQTA) (lot # T013546, expiry date: 28-OCT-2021; site of administration and formulation were not reported) for prophylaxis (Expired product administered).   The reporter confirmed that the administered dose of hepatitis a virus inactivated [MRC-5 CELLS] (VAQTA) had not had any temperature excursions.   There was no adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; vaccine that underwent a temperature excursion was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not provided.  On 08-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T025369, expiration date 01-DEC-2022 (dose, route and site of administration was not reported) which underwent a temperature excursion.  No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine that underwent temperature excursion was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not provided.  On 16-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T025369, expiration date 01-DEC-2022 (dose, route and site of administration was not reported) which underwent a temperature excursion.  No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine that underwent temperature excursion was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not provided.  On 08-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T025369, expiration date 01-DEC-2022 (dose, route and site of administration was not reported) which underwent a temperature excursion.  No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: one dose of GARDASIL 9 was improperly stored on 11/18/2021 and was administered to a patient on the same day; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 18-NOV-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028582, expiration date: 04-MAR-2023 (dose, route of administration and anatomical location were not reported). Temperature excursion was on 18-NOV-2021 in the temperature of 48 degrees Fahrenheit for 1 hour and 26 minutes.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PNEUMOVAX 23 dose administered to a paitent in a shorter interval than recommended; This spontaneous report was received from a vaccine administrator and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.          On 22-NOV-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for prophylaxis. It was reported that this dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was administered in a shorter interval than recommended.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: dose of GARDASIL 9 was improperly stored on 11/18/2021 and was administered to a patient on the same day; This spontaneous report was received from a regustered nurse and refers to a patient of unknown age and gender.No information regarding the patient's concurrent condition, medical history or concomitant medications was provided. On 18-NOV-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # T028582 and expiration date: 04-MAR-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in too high temperature of 48 degrees Fahrenheit (F) for 1 hour and 26 minutes. There was no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA008723:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient returned to office today to receive thrid dose of GARDASIL 9, received first dose November 2020; patient returned to office today to receive thrid dose of GARDASIL 9, received first dose November 2020; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unknown day in November 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown day in February 2021, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On 24-NOV-2021 (reported as today), the patient returned to the office to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis (inappropriate schedule of product administration, circumstance or information capable of leading to medication error). The reporter was unable to provide the patient information as she was at another office location.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event details were provided; expired vaccine administered; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. Her medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 30-NOV-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024367, expiration date was provided as 08-AUG-2021 however upon internal validation it was established as 06-AUG-2021, at the dose of 0.5 milliliter (strength, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered).  It was stated, that the patient did not have any other reactions or events since the suspect vaccine administration (no adverse event). No other details were provided.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No other AE reported; administration of improperly stored RECOMBIVAX HB; This spontaneous report was received from a nurse referring to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies was provided.  On 23-NOV-2021, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (0.5 ml ;lot number T032918 has been verified to be a valid lot number, expiration date reported and established as 12-NOV-2022; route and anatomical location of administration were not reported) for prophylaxis (product storage error).   The involved vaccine was exposed to a temperature excursion of below 36 grades Fahrenheit (F) (34.8 F) for 45 minutes with previous temperature excursions of 34.8 F for 13 hours 55 minutes and 33.9 F for 26 hours 30 minutes. No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAXHIB was administered after a temperature excursion; This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 01-DEC-2021, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T037651 has been verified to be a valid lot number and expiration date was 20-JUL-2023; strength, dose and route were not reported) for prophylaxis after a temperature excursion of 46.9 Fahrenheit (F) for 30 minutes (product storage error). Previous temperature excursion was reported as 48 F for 30 minutes.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000969:
Age: 28.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; consumer received their 1st dose of GARDASIL-9 on 11/19/2021 and their 2nd dose on 12/3/2021; This spontaneous report was received from a nurse, referring to a 28-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 19-NOV-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T030746, expiration date: 16-MAR-2023, dose, strength and route were not provided) for prophylaxis. On 03-DEC-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T030746, expiration date: 16-MAR-2023, dose, strength and route were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No AE; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 02-DEC-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T028303, expiration date: 20-AUG-2022, 0.5 milliliter for prophylaxis (route of administration was not provided) (incorrect product storage). The varicella virus vaccine live (oka/merck)(VARIVAX) underwent temperature excursion of 25.5 degree Fahrenheit for  9 hours and 42 minutes; 23.7 degree Fahrenheit for 13 hours and 27 minutes. Previous temperature excursion was not detected. No additional adverse event was provided.
Age: 45.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently received a 4th dose of GARDASIL 9 at the age of 46 years old; inadvertently received a 4th dose of GARDASIL 9 at the age of 46 years old; No other AE; This spontaneous report was received from an office manager referring to a 46 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date at the age of 45 years old, the patient was vaccinated with 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date at the age of 46 years old, the patient inadvertently received a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (extra dose administered and product administered to patient of inappropriate age). No adverse event occurred.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect dose administered
Clinical narrative: when the needle was pulled out of the patient's arm, a drop of the medicine came out of the needle.; No additional information; This spontaneous report as received from a consumer (reported as office manager) (conflicting information: also reported as physician), referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter stated that on an unknown date, a nurse administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine (strength, route, lot number and expiration date were unknown) for prophylaxis to a patient and when the needle was pulled out of the patient's arm, a drop of the medicine came out of the needle (incorrect dose administered). It was reported that the patient received partial dose.The mom of the patient wanted to know if her daughter cold be revaccinated. The office would like to know if 1 drop at the end of the needle following a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination warrants revaccination. No additional information.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information available or provided; underwent a multiple temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 30-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T027789, expiration date 27-FEB-2023, 0.5 milliliter) after a temperature excursion for prophylaxis (product storage error). Temperature excursion was 54.1 F for 1 hour and 43 minutes; 47.8F for 1 hour and 0 minutes; 46.4F for 1 hour and 54 minutes; 46.6F for 6 hours and 0 minutes; 40.0 F for 1 hour and 18 minutes; 32.1 F for 1 hour and 6 minutes; 32.9F for 13 hours and 18 minutes; 33.8F for 60 hours and 12 minutes. No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional information available or provided; Product storage error; This spontaneous report as received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#T027789 with expiration date: 27-FEB-2023, dose: 0.5 ml, route and strength were unknown) underwent multiple temperature excursions and was then administered to a patient for prophylaxis on 30-SEP-2021 (product storage error). No additional information available or provided.  Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced the temperature excursion below 54.1 Fahrenheit degrees (F) for 1 hour and 43 minutes; 47. 8F for 1 hour and 0 minutes; 46. 4F for 1 hour and 54 minutes; 46. 6F for 6 hours and 0 minutes; 40. 0F for 1 hour and 18 minutes; 32. 1F for 1 hour and 6 minutes; 32. 9F for 13 hours and 18 minutes; 33. 8F for 60 hours and 12 minutes. All excursions prior to administration listed above.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Administration of expired VARlVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 07-DEC-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S033952, expiration date 24-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events reported. No product quality complaints reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 had been involved in multiple low temperature excursion and was administered; This spontaneous report has been received from a medical assistant referring to a 12 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had been involved in multiple low temperature excursions of 35 degree Fahrenheit(F) for 0.25 hour (on 03-NOV-2021), 0.75 hour(on 04-NOV-2021), 0.5 hour(on 05-NOV-2021) and 0.25 hour(on 12-NOV-2021), respectively. The previous excursions were unknown. On 12-NOV-2021, the patient was vaccinated with the improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # T030749, expiration date 16-MAR-2023; strength, dose, frequency, route and anatomical location were not reported) for prophylaxis(product storage error).   No additional adverse event (AE) was reported, and no further information provided.