chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product label issue
Clinical narrative: None. Package insert had expiration date at 12/31/2069, unknown to us, this was not correct. Moderna found with proper storage, vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration.  Viability check done by Moderna and was found to be viable and effective.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Liver function test increased
Clinical narrative: liver test elevation
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray normal, Cough, Device failure
Clinical narrative: Admission Date: 8/9/2022 Discharge Date: Aug 12, 2022  PRESENTING PROBLEM: Weakness Generalized weakness COVID-19   HOSPITAL COURSE: 87-year-old man who had a TAVR and pacemaker placement in June 2022 was recently discharged from the hospital 1 day ago.  He was hospitalized from 7/30/2022-8/8/2022 for Streptococcus bacteremia.  This was deemed secondary to a pocket of pacemaker pacemaker infection.  The TEE on that admission did not reveal any vegetations on the TAVR.  The pacemaker was revised with a leadless pacemaker on 08/05/2022.  He is placed on 2 g IV ceftriaxone to complete a 6 week therapy and follow-up with the ID team.  Was discharged on 08/08/2022.     Since the discharge patient felt very well.  He was mobile and active.  However last night he felt weak and has been coughing. He denies any chills. He felt like his temperature was up to 100° F. he denies shortness of breath chest pain palpitation. He is just so profoundly weak that he is not able to get out of bed and just staying in bed. His family brought him back chest x-ray in the emergency room did not show pneumonia. He is not needing any oxygen. His heart rate has been in 40s and pacemaker is not capturing. We adjusted pacer settings. Health center has reserved a Saturday morning TIMED NURSE Visit for patient to resume home antibiotic therapy support. Patient has all antibiotic supplies in the home, verified this information with patient's spouse. He will discharge home and follow up with PCP within one week.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Mobility decreased
Clinical narrative: Admission Date: 8/9/2022 Discharge Date: Aug 12, 2022  PRESENTING PROBLEM: Weakness Generalized weakness COVID-19   HOSPITAL COURSE: 87-year-old man who had a TAVR and pacemaker placement in June 2022 was recently discharged from the hospital 1 day ago.  He was hospitalized from 7/30/2022-8/8/2022 for Streptococcus bacteremia.  This was deemed secondary to a pocket of pacemaker pacemaker infection.  The TEE on that admission did not reveal any vegetations on the TAVR.  The pacemaker was revised with a leadless pacemaker on 08/05/2022.  He is placed on 2 g IV ceftriaxone to complete a 6 week therapy and follow-up with the ID team.  Was discharged on 08/08/2022.     Since the discharge patient felt very well.  He was mobile and active.  However last night he felt weak and has been coughing. He denies any chills. He felt like his temperature was up to 100° F. he denies shortness of breath chest pain palpitation. He is just so profoundly weak that he is not able to get out of bed and just staying in bed. His family brought him back chest x-ray in the emergency room did not show pneumonia. He is not needing any oxygen. His heart rate has been in 40s and pacemaker is not capturing. We adjusted pacer settings. Health center has reserved a Saturday morning TIMED NURSE Visit for patient to resume home antibiotic therapy support. Patient has all antibiotic supplies in the home, verified this information with patient's spouse. He will discharge home and follow up with PCP within one week.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: No adverse event
Clinical narrative: no adverse event
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swelling and pain in the lymph nodes in the same arm of the injection for several days (still ongoing)
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Deep vein thrombosis, Fatigue, Feeling cold, Pyrexia, Sensory disturbance
Clinical narrative: Second dose.  First and second dose resulted in fever followed by chills and extreme fatigue for 2 days.  On day 3 noted a sensation in right leg.  I could palpate a superficial thrombosis in my right leg below the knee.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Second dose.  First and second dose resulted in fever followed by chills and extreme fatigue for 2 days.  On day 3 noted a sensation in right leg.  I could palpate a superficial thrombosis in my right leg below the knee.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Pt brought in by family related fevers and generalized weakness. Treated with dexamethasone and remdesvir. Pt discharged to a snf.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient given pediatric dose. Patient should have received an adult dose due to his age.
Age: 47.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Cough, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Discharge Provider: Private MD Primary Care Provider at Discharge: Private MD  Admission Date: 8/10/2022 Discharge Date:  8/14/2022 PRESENTING PROBLEM: Sickle cell crisis (HCC) [D57.00]; COVID-19 [U07.1]; Sickle cell pain crisis (HCC) [D57.00]. HOSPITAL COURSE: The patient is a 47-year-old female with a history sickle cell disease as well as chronic pain syndrome which is narcotic dependent, history of DVT/PE on anticoagulation with Pradaxa as well as depression and anxiety, who presented with an acute sickle cell pain crisis on 08/10/2022. Patient also had noted a sore throat, with headache, cough and myalgias beginning on 08/08 with a home COVID test being positive on 08/09. At the time of admission, the patient was without hypoxia. Given her symptoms she was not a candidate for remdesivir or dexamethasone. Patient was admitted to the hospital service for further treatment of for COVID infection and sickle cell pain crisis. During the patient's hospitalization her hemoglobin remained stable, without any need for transfusion. Patient was treated with half-normal saline. Patient was continued on her home dose of Hydrea as well as Oxbryta. Patient was also continued on her home regimen MSIR, fentanyl patch, Neurontin, Elavil and Flexeril. IV Dilaudid was added to regimen at a dose of 2-3 mg every 2 hours. Patient's COVID infection was treated symptomatically with Tessalon Perles, Mucinex, and guaifenesin. With supportive care the patient's cough and sore throat improved. Patient's sickle cell pain crisis also improved, with pain returning to a tolerable level. As patient was clinically stable, she was discharged to home on 08/14/2022.
Age: 47.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, SARS-CoV-2 test positive, Sickle cell anaemia with crisis
Clinical narrative: Discharge Provider: Private MD Primary Care Provider at Discharge: Private MD  Admission Date: 8/10/2022 Discharge Date:  8/14/2022 PRESENTING PROBLEM: Sickle cell crisis (HCC) [D57.00]; COVID-19 [U07.1]; Sickle cell pain crisis (HCC) [D57.00]. HOSPITAL COURSE: The patient is a 47-year-old female with a history sickle cell disease as well as chronic pain syndrome which is narcotic dependent, history of DVT/PE on anticoagulation with Pradaxa as well as depression and anxiety, who presented with an acute sickle cell pain crisis on 08/10/2022. Patient also had noted a sore throat, with headache, cough and myalgias beginning on 08/08 with a home COVID test being positive on 08/09. At the time of admission, the patient was without hypoxia. Given her symptoms she was not a candidate for remdesivir or dexamethasone. Patient was admitted to the hospital service for further treatment of for COVID infection and sickle cell pain crisis. During the patient's hospitalization her hemoglobin remained stable, without any need for transfusion. Patient was treated with half-normal saline. Patient was continued on her home dose of Hydrea as well as Oxbryta. Patient was also continued on her home regimen MSIR, fentanyl patch, Neurontin, Elavil and Flexeril. IV Dilaudid was added to regimen at a dose of 2-3 mg every 2 hours. Patient's COVID infection was treated symptomatically with Tessalon Perles, Mucinex, and guaifenesin. With supportive care the patient's cough and sore throat improved. Patient's sickle cell pain crisis also improved, with pain returning to a tolerable level. As patient was clinically stable, she was discharged to home on 08/14/2022.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HOPITALIZED WITH COVID
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None. Package insert had expiration date at 12/31/2069, unknown to us, this was not correct. Moderna found with proper storage, the vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration. Viability check done by Moderna found vaccine to be viable and effective.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt did not meet age requirement for vaccine
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HOPITALIZED WITH COVID
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough infection August 12, 2022; last vaccine date before infection May 15, 2022
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Dyspnoea, Peripheral swelling, Renal impairment, SARS-CoV-2 test positive
Clinical narrative: pt presented with leg swelling and shortness of breath and decreased kidney funtion followed by cardio and nephrology. pt asymptomatic for covid was test at d/c for snf placement.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling right arm Although patient has breast cancer, no lymphnodes were removed during surgery over 5 years prior. Swelling persisted since 60 days (estimated) after injection dose #2. Both doses were given in right deltoid.
Age: 66.0
Sex: F
Vaccine: PNC15
Symptoms: Local reaction
Clinical narrative: Local reaction
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Eustachian tube disorder, Tinnitus
Clinical narrative: Tinnitus.  Visited ENT and also diagnosed with eustachian disorder.  Treated with nasal rinses using xlear and prescription for Singulair.  Tinnitus remains.
Age: 46.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema
Clinical narrative: Patient states that he had redness the "size of a quarter" since day of vaccination and on 08/15/2022 he noticed that the redness was  the "size of a dollar". He does not report any itching or pain at this time.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride decreased, Blood creatinine increased, Blood culture negative, Blood sodium decreased, Chest X-ray abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 8/14/2022 Discharge Date: Aug 17, 2022   PRESENTING PROBLEM: Shock [R57.9]   HOSPITAL COURSE: 62-year-old male with a past medical history significant for chronic systolic congestive heart failure with CardioMEMS in place in the setting of ischemic cardiomyopathy as well as history of VT status post pacemaker placed in addition to paroxysmal AFib presents in a state of shock.   Patient reports that he has been getting more swollen and gaining weight the outpatient setting.  Because of this, he had gone from taking 60 mg in the morning and 40 mg in the afternoon of torsemide to 80 mg in the morning 80 mg the afternoon of torsemide approximately 10 days prior to his admission to the hospital.  In addition to this, he states that maybe 1-2 days prior to his admission to the hospital he was also started on metolazone 2.5 mg orally daily.  He notes that he began to feel more fatigued and tired and he also noted he began to feel more dizzy.  When he had some notable confusion with his dizziness, he presented to the emergency department.   In the emergency department the patient was hypotensive with systolic blood pressures in the 70s and diastolic pressures in the 40s.  White count was elevated at 16000. Labs remarkable for elevated creatinine at 2.8.  High sensitivity troponin I was found to be 26 with repeat checked trending down at 19. Chest x-ray was remarkable for some pulmonary vascular congestion.  Patient was given a 250 mL fluid bolus and despite this, required norepinephrine and transfer to the intensive care unit.     Patient is able to quickly wean off of vasopressors in the intensive care unit.  Although he had been empirically placed on antibiotics, strong suspicion was had for hypovolemic shock.  Once blood cultures came back negative, broad-spectrum antibiotics were discontinued.   Patient had overall improvement in his renal function and eventual normalization of his renal function.  Noting that his chloride and sodium were still low and with positive orthostatic vital signs, he was started on slow infusion of IV fluids afternoon 8/16 at 50 mL/hour normal saline.  By morning 8/17, patient had significant clinical improvement with normalization of all labs.   Case was discussed with Cardiology.  Plan was for discharge home 08/17/2022 with outpatient follow-up with Cardiology and further evaluation of the patient's CardioMEMS device.  He was advised to continue his beta-blocker but hold off on his Entresto for now as well as his spironolactone and metolazone.  He was advised to utilize torsemide 40 mg once daily starting 08/18/2022 with up titration in the outpatient setting as needed.  Patient discharged in stable condition.  Throughout the patient's hospital course, he had no issues related to COVID-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Hypotension, Hypovolaemic shock
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 8/14/2022 Discharge Date: Aug 17, 2022   PRESENTING PROBLEM: Shock [R57.9]   HOSPITAL COURSE: 62-year-old male with a past medical history significant for chronic systolic congestive heart failure with CardioMEMS in place in the setting of ischemic cardiomyopathy as well as history of VT status post pacemaker placed in addition to paroxysmal AFib presents in a state of shock.   Patient reports that he has been getting more swollen and gaining weight the outpatient setting.  Because of this, he had gone from taking 60 mg in the morning and 40 mg in the afternoon of torsemide to 80 mg in the morning 80 mg the afternoon of torsemide approximately 10 days prior to his admission to the hospital.  In addition to this, he states that maybe 1-2 days prior to his admission to the hospital he was also started on metolazone 2.5 mg orally daily.  He notes that he began to feel more fatigued and tired and he also noted he began to feel more dizzy.  When he had some notable confusion with his dizziness, he presented to the emergency department.   In the emergency department the patient was hypotensive with systolic blood pressures in the 70s and diastolic pressures in the 40s.  White count was elevated at 16000. Labs remarkable for elevated creatinine at 2.8.  High sensitivity troponin I was found to be 26 with repeat checked trending down at 19. Chest x-ray was remarkable for some pulmonary vascular congestion.  Patient was given a 250 mL fluid bolus and despite this, required norepinephrine and transfer to the intensive care unit.     Patient is able to quickly wean off of vasopressors in the intensive care unit.  Although he had been empirically placed on antibiotics, strong suspicion was had for hypovolemic shock.  Once blood cultures came back negative, broad-spectrum antibiotics were discontinued.   Patient had overall improvement in his renal function and eventual normalization of his renal function.  Noting that his chloride and sodium were still low and with positive orthostatic vital signs, he was started on slow infusion of IV fluids afternoon 8/16 at 50 mL/hour normal saline.  By morning 8/17, patient had significant clinical improvement with normalization of all labs.   Case was discussed with Cardiology.  Plan was for discharge home 08/17/2022 with outpatient follow-up with Cardiology and further evaluation of the patient's CardioMEMS device.  He was advised to continue his beta-blocker but hold off on his Entresto for now as well as his spironolactone and metolazone.  He was advised to utilize torsemide 40 mg once daily starting 08/18/2022 with up titration in the outpatient setting as needed.  Patient discharged in stable condition.  Throughout the patient's hospital course, he had no issues related to COVID-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Laboratory test abnormal, Pulmonary congestion, Renal impairment, Shock
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 8/14/2022 Discharge Date: Aug 17, 2022   PRESENTING PROBLEM: Shock [R57.9]   HOSPITAL COURSE: 62-year-old male with a past medical history significant for chronic systolic congestive heart failure with CardioMEMS in place in the setting of ischemic cardiomyopathy as well as history of VT status post pacemaker placed in addition to paroxysmal AFib presents in a state of shock.   Patient reports that he has been getting more swollen and gaining weight the outpatient setting.  Because of this, he had gone from taking 60 mg in the morning and 40 mg in the afternoon of torsemide to 80 mg in the morning 80 mg the afternoon of torsemide approximately 10 days prior to his admission to the hospital.  In addition to this, he states that maybe 1-2 days prior to his admission to the hospital he was also started on metolazone 2.5 mg orally daily.  He notes that he began to feel more fatigued and tired and he also noted he began to feel more dizzy.  When he had some notable confusion with his dizziness, he presented to the emergency department.   In the emergency department the patient was hypotensive with systolic blood pressures in the 70s and diastolic pressures in the 40s.  White count was elevated at 16000. Labs remarkable for elevated creatinine at 2.8.  High sensitivity troponin I was found to be 26 with repeat checked trending down at 19. Chest x-ray was remarkable for some pulmonary vascular congestion.  Patient was given a 250 mL fluid bolus and despite this, required norepinephrine and transfer to the intensive care unit.     Patient is able to quickly wean off of vasopressors in the intensive care unit.  Although he had been empirically placed on antibiotics, strong suspicion was had for hypovolemic shock.  Once blood cultures came back negative, broad-spectrum antibiotics were discontinued.   Patient had overall improvement in his renal function and eventual normalization of his renal function.  Noting that his chloride and sodium were still low and with positive orthostatic vital signs, he was started on slow infusion of IV fluids afternoon 8/16 at 50 mL/hour normal saline.  By morning 8/17, patient had significant clinical improvement with normalization of all labs.   Case was discussed with Cardiology.  Plan was for discharge home 08/17/2022 with outpatient follow-up with Cardiology and further evaluation of the patient's CardioMEMS device.  He was advised to continue his beta-blocker but hold off on his Entresto for now as well as his spironolactone and metolazone.  He was advised to utilize torsemide 40 mg once daily starting 08/18/2022 with up titration in the outpatient setting as needed.  Patient discharged in stable condition.  Throughout the patient's hospital course, he had no issues related to COVID-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Troponin I increased, Weight increased, White blood cell count increased
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 8/14/2022 Discharge Date: Aug 17, 2022   PRESENTING PROBLEM: Shock [R57.9]   HOSPITAL COURSE: 62-year-old male with a past medical history significant for chronic systolic congestive heart failure with CardioMEMS in place in the setting of ischemic cardiomyopathy as well as history of VT status post pacemaker placed in addition to paroxysmal AFib presents in a state of shock.   Patient reports that he has been getting more swollen and gaining weight the outpatient setting.  Because of this, he had gone from taking 60 mg in the morning and 40 mg in the afternoon of torsemide to 80 mg in the morning 80 mg the afternoon of torsemide approximately 10 days prior to his admission to the hospital.  In addition to this, he states that maybe 1-2 days prior to his admission to the hospital he was also started on metolazone 2.5 mg orally daily.  He notes that he began to feel more fatigued and tired and he also noted he began to feel more dizzy.  When he had some notable confusion with his dizziness, he presented to the emergency department.   In the emergency department the patient was hypotensive with systolic blood pressures in the 70s and diastolic pressures in the 40s.  White count was elevated at 16000. Labs remarkable for elevated creatinine at 2.8.  High sensitivity troponin I was found to be 26 with repeat checked trending down at 19. Chest x-ray was remarkable for some pulmonary vascular congestion.  Patient was given a 250 mL fluid bolus and despite this, required norepinephrine and transfer to the intensive care unit.     Patient is able to quickly wean off of vasopressors in the intensive care unit.  Although he had been empirically placed on antibiotics, strong suspicion was had for hypovolemic shock.  Once blood cultures came back negative, broad-spectrum antibiotics were discontinued.   Patient had overall improvement in his renal function and eventual normalization of his renal function.  Noting that his chloride and sodium were still low and with positive orthostatic vital signs, he was started on slow infusion of IV fluids afternoon 8/16 at 50 mL/hour normal saline.  By morning 8/17, patient had significant clinical improvement with normalization of all labs.   Case was discussed with Cardiology.  Plan was for discharge home 08/17/2022 with outpatient follow-up with Cardiology and further evaluation of the patient's CardioMEMS device.  He was advised to continue his beta-blocker but hold off on his Entresto for now as well as his spironolactone and metolazone.  He was advised to utilize torsemide 40 mg once daily starting 08/18/2022 with up titration in the outpatient setting as needed.  Patient discharged in stable condition.  Throughout the patient's hospital course, he had no issues related to COVID-19.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product label issue
Clinical narrative: None. Package insert had expiration date at 12/31/2069, unknown to us, this was not correct. Moderna found that with proper storage, the vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Breath sounds abnormal, COVID-19, Chest X-ray normal, Cough, Dyspnoea
Clinical narrative: On day 1 after vaccination (08/10/2022) fever of up to 102F, which was gone by 08/11/2022. Several days later, 08/15/2022, began to cough and show signs of illness.  By 08/16/2022 at 4:00am, began to have difficulty breathing and was taken to the closest pediatric emergency room.  There, the following were seen: (1) obvious respiratory distress including belly breathing, (2) reduced oxygen saturation (as low as 91%), (3) rapid breathing (measured up to 50/min), (4) increased pulse (up to 150bpm), (5) decreased lung sounds on left side.  Treatment consisted of albuterol nebulizer and prescription for take-home albuterol inhaler. Seen following day (08/17/2022) by primary care, with some residual wheezing but improved vitals and normal appearance/behavior.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Influenza A virus test negative, Influenza B virus test, Oxygen saturation decreased
Clinical narrative: On day 1 after vaccination (08/10/2022) fever of up to 102F, which was gone by 08/11/2022. Several days later, 08/15/2022, began to cough and show signs of illness.  By 08/16/2022 at 4:00am, began to have difficulty breathing and was taken to the closest pediatric emergency room.  There, the following were seen: (1) obvious respiratory distress including belly breathing, (2) reduced oxygen saturation (as low as 91%), (3) rapid breathing (measured up to 50/min), (4) increased pulse (up to 150bpm), (5) decreased lung sounds on left side.  Treatment consisted of albuterol nebulizer and prescription for take-home albuterol inhaler. Seen following day (08/17/2022) by primary care, with some residual wheezing but improved vitals and normal appearance/behavior.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory distress, Respiratory rate increased, Respiratory syncytial virus test negative, SARS-CoV-2 test positive
Clinical narrative: On day 1 after vaccination (08/10/2022) fever of up to 102F, which was gone by 08/11/2022. Several days later, 08/15/2022, began to cough and show signs of illness.  By 08/16/2022 at 4:00am, began to have difficulty breathing and was taken to the closest pediatric emergency room.  There, the following were seen: (1) obvious respiratory distress including belly breathing, (2) reduced oxygen saturation (as low as 91%), (3) rapid breathing (measured up to 50/min), (4) increased pulse (up to 150bpm), (5) decreased lung sounds on left side.  Treatment consisted of albuterol nebulizer and prescription for take-home albuterol inhaler. Seen following day (08/17/2022) by primary care, with some residual wheezing but improved vitals and normal appearance/behavior.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: On day 1 after vaccination (08/10/2022) fever of up to 102F, which was gone by 08/11/2022. Several days later, 08/15/2022, began to cough and show signs of illness.  By 08/16/2022 at 4:00am, began to have difficulty breathing and was taken to the closest pediatric emergency room.  There, the following were seen: (1) obvious respiratory distress including belly breathing, (2) reduced oxygen saturation (as low as 91%), (3) rapid breathing (measured up to 50/min), (4) increased pulse (up to 150bpm), (5) decreased lung sounds on left side.  Treatment consisted of albuterol nebulizer and prescription for take-home albuterol inhaler. Seen following day (08/17/2022) by primary care, with some residual wheezing but improved vitals and normal appearance/behavior.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PATIENT RECEIVED UNDILUTED PFIZER COVID-19 VACCINE (5-11 YEARS) ORANGE CAP (NDC 59267105504). TREATMENT AND OUTCOME UNKNOWN. UNABLE TO REACH PATIENT OR CAREGIVER
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: I could feel my blood pressure rising and when I felt that I said something and I was at a medical facility they hooked me up to a monitor and my BP was like 167/94 and I was there for 2 hours after I received the vaccine before I left. I was hooked up to a monitor until I left. 1st 3/8/2021 Pfizer lot # EN6204. 2nd Pfizer 3/29/2021 lot # ER8733- I think it was a second vaccine that caused the reaction and was hooked up to the monitor with the blood pressure reaction, a doctor and a nurse was attending me but I do not have their names. 3rd Pfizer 10/12/2021 lot# FE3590- since the 3rd vaccine my blood pressure has been continuously elevated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient too young for this vaccine
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Product label issue
Clinical narrative: None. Package insert had expiration date, unknown to us, this was not correct. Moderna found with proper storage, vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration. Viability check done by Moderna found vaccine to be viable and effective.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient too young at time of first vaccine.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiovascular symptom, Syncope
Clinical narrative: presented with syncope and covid, had no acute pulmonary findings, pts cardiac symptoms monitored and d/c home
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Interchange of vaccine products, Pain in extremity, Throat tightness
Clinical narrative: Patient received vaccine and was asked to sit in the pharmacy waiting room for 15 minutes as she has received her first and second dose of the covid vaccine from a different manufacturer (Pfizer). During her fifteen minute wait, her husband came up to the technician and stated that she was finding her throat felt it was giving her the feeling of closing up. She also stated that her arm felt sore. Upon observing the patient, she seemed to be able to breathe and speak with no issues of breathing, rash, or any other symptoms of anaphylaxis however she kept touching at her throat and repeating she felt her throat felt like it was closing up- so I administered her 50mg (10ml) of Children's Benadryl. Upon administration of the Benadryl she stated she immediately felt better and that it was just her arm. She was given a bottle of water by the store manager and I informed they I would like to call for help, the husband felt that she was okay and better enough to go home. I stated that  if they felt like the symptoms were returning and then counseled on the symptoms of itching, rash, trouble breathing, swelling in any arms, throat or any body part they should seek immediate medical help. They said they would and they left the pharmacy. I followed up with the patient to obtain any information regarding the event and they stated they went to the emergency room/urgent care just to make sure she was okay because she felt dizzy on the car ride home.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Chest X-ray abnormal, Death
Clinical narrative: 2/22/22 pt with a positive COVID test, treated with Azithromycin and steroids by PCP outpatient; 3/3/22 pt to hospital with increasing SOB, hypoxia, ARF; transferred to ICU; O2 supplementation eventually requiring intubation; CXR showed lung volume diminished and multifocal pulmonary infiltrates, right > left; remdesivir, decadron, albuterol, AKI; condition worsened significantly; pt transitioned to DNR and pt expired in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, General physical health deterioration, Hypoxia, Intensive care
Clinical narrative: 2/22/22 pt with a positive COVID test, treated with Azithromycin and steroids by PCP outpatient; 3/3/22 pt to hospital with increasing SOB, hypoxia, ARF; transferred to ICU; O2 supplementation eventually requiring intubation; CXR showed lung volume diminished and multifocal pulmonary infiltrates, right > left; remdesivir, decadron, albuterol, AKI; condition worsened significantly; pt transitioned to DNR and pt expired in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Lung infiltration, SARS-CoV-2 test positive, Total lung capacity decreased
Clinical narrative: 2/22/22 pt with a positive COVID test, treated with Azithromycin and steroids by PCP outpatient; 3/3/22 pt to hospital with increasing SOB, hypoxia, ARF; transferred to ICU; O2 supplementation eventually requiring intubation; CXR showed lung volume diminished and multifocal pulmonary infiltrates, right > left; remdesivir, decadron, albuterol, AKI; condition worsened significantly; pt transitioned to DNR and pt expired in the hospital
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Arnold-Chiari malformation, Clumsiness, Electroencephalogram abnormal, Eye movement disorder, Headache
Clinical narrative: Patient experienced seizure like activity a little over a week after his second dose.  He has no prior hx of seizures.  He woke up from a nap groaning and then vomited.  He became unresponsive with his eyes open and deviating to the right.  He vomited several more times and remained unresponsive.  He had no response to painful stimuli.  An ambulance was called and after about 20 mins from the onset he closed his eyes and appeared to be sleeping.  Upon arrival in the ED he woke up.  He was slow to respond, complained of a headache and  vomited 2 more times.  He was admitted overnight for observation and did not experience any further episodes.  Over the next 5 days he appeared hyperactive and clumsy and has since returned to his normal self.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Magnetic resonance imaging head abnormal, Moaning, Psychomotor hyperactivity, Seizure like phenomena
Clinical narrative: Patient experienced seizure like activity a little over a week after his second dose.  He has no prior hx of seizures.  He woke up from a nap groaning and then vomited.  He became unresponsive with his eyes open and deviating to the right.  He vomited several more times and remained unresponsive.  He had no response to painful stimuli.  An ambulance was called and after about 20 mins from the onset he closed his eyes and appeared to be sleeping.  Upon arrival in the ED he woke up.  He was slow to respond, complained of a headache and  vomited 2 more times.  He was admitted overnight for observation and did not experience any further episodes.  Over the next 5 days he appeared hyperactive and clumsy and has since returned to his normal self.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Patient experienced seizure like activity a little over a week after his second dose.  He has no prior hx of seizures.  He woke up from a nap groaning and then vomited.  He became unresponsive with his eyes open and deviating to the right.  He vomited several more times and remained unresponsive.  He had no response to painful stimuli.  An ambulance was called and after about 20 mins from the onset he closed his eyes and appeared to be sleeping.  Upon arrival in the ED he woke up.  He was slow to respond, complained of a headache and  vomited 2 more times.  He was admitted overnight for observation and did not experience any further episodes.  Over the next 5 days he appeared hyperactive and clumsy and has since returned to his normal self.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Fatigue, Heart rate increased, Hypotension
Clinical narrative: 08/10/2022  I felt very tired my blood pressure was  extremely  low;   I had high heart rate.  I called my cardiologist and told him what was going on so he ordered a heart monitor.  I am being monitored for 3 days. After 3 days my cardiologist will review the readings and will decide what I have to do next. He either will give me medications or something else.  I will be going for a follow up with my PCP a week from tomorrow and cardiologist on  the month of September.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swollen and red rash around injection site.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Asthma, Basedow's disease, Cystitis noninfective
Clinical narrative: I received my third vaccine, a booster shot, and my life took a significant and dramatic downward negative turn concerning my physical health. I developed chronic, debilitating  headaches.  I was diagnosed with asthma.  I was diagnosed with multiple nodules on my thyroid and told I had Graves disease.  I now have an inflamed bladder that causes frequent urination- 20 times a day.  I also suffer from joint pain in my hands and feet, as well as a stiff neck.  I have seen 10 doctors and a physical therapist in the last nine months.  I am presently on several medications and have experienced minimal improvement.  My doctors and I firmly believe that these symptoms are the result of a serious ?vaccine injury?.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Headache, Immunisation reaction, Injury, Musculoskeletal stiffness
Clinical narrative: I received my third vaccine, a booster shot, and my life took a significant and dramatic downward negative turn concerning my physical health. I developed chronic, debilitating  headaches.  I was diagnosed with asthma.  I was diagnosed with multiple nodules on my thyroid and told I had Graves disease.  I now have an inflamed bladder that causes frequent urination- 20 times a day.  I also suffer from joint pain in my hands and feet, as well as a stiff neck.  I have seen 10 doctors and a physical therapist in the last nine months.  I am presently on several medications and have experienced minimal improvement.  My doctors and I firmly believe that these symptoms are the result of a serious ?vaccine injury?.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pollakiuria, Thyroid mass
Clinical narrative: I received my third vaccine, a booster shot, and my life took a significant and dramatic downward negative turn concerning my physical health. I developed chronic, debilitating  headaches.  I was diagnosed with asthma.  I was diagnosed with multiple nodules on my thyroid and told I had Graves disease.  I now have an inflamed bladder that causes frequent urination- 20 times a day.  I also suffer from joint pain in my hands and feet, as well as a stiff neck.  I have seen 10 doctors and a physical therapist in the last nine months.  I am presently on several medications and have experienced minimal improvement.  My doctors and I firmly believe that these symptoms are the result of a serious ?vaccine injury?.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated (2 doses mRNA).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Biopsy uterus normal, Ultrasound uterus normal, Uterine dilation and curettage, Uterine polyp
Clinical narrative: On May 10, I started to have some pretty intense back pain which I never had before. This lasted for a couple of weeks. On May 23, I had vaginal bleeding. I went to my urogynecologist who sent me to an oncologist because they could not get a tissue sample. The oncologist did a DNC on July 06th and it showed that there was benign polyps blocking the neck of the uterus. The removed it and biopsied which confirmed they were normal with no sign of cancer there or in the uterine wall. I have had no further issues.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: On May 10, I started to have some pretty intense back pain which I never had before. This lasted for a couple of weeks. On May 23, I had vaginal bleeding. I went to my urogynecologist who sent me to an oncologist because they could not get a tissue sample. The oncologist did a DNC on July 06th and it showed that there was benign polyps blocking the neck of the uterus. The removed it and biopsied which confirmed they were normal with no sign of cancer there or in the uterine wall. I have had no further issues.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Hypotension
Clinical narrative: Patient came to ED for generalized weakness and low blood pressure.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Burning sensation, Dysgeusia, Lymphadenopathy
Clinical narrative: Patient reports metallic taste in mouth from 8/2 and continues today. Also reports swollen glands in throat that began 8/4 and continues today. Reports burning in legs and aching joints that started 8/9 and continue today. Scheduled to see PCP 8/18/22.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest tube removal, Erythema, SARS-CoV-2 test positive, Swelling
Clinical narrative: Patient came to hospital for removal of pleural cath because it showed swelling and redness. During hospital course patient also found positive for COVID-19 infection. Patient without oxygen requirement. No indications for COVID-19 specific therapy. Patient discharged home once stable.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Pfizer vaccine for 6 mos - <5 years. Should have received Pfizer 5 yrs - < 11 years
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: 15 minutes after injection patient became dizzy and diaphoretic. Patient very pale and nauseated. No emesis noted. Patient able to regulate self after rest, water, and zyrtec.
Age: 68.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Nausea, Respiratory symptom, Vomiting
Clinical narrative: Patient came to ED with complaints of shortness of breath, upper respiratory symptoms, and nausea/vomiting.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Pulmonary oedema, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: The individual is currently hospitalized and tested positive for COVID-19. During the case investigation, the case's family member revealed that the case had a stroke after getting her first dose. We are unsure of if this was previously reported and have limited information about the event itself. We want to report it just in case it hadn't been done before. We also wanted to report that the case is currently hospitalized at Medical Center because she has fluid in her lungs, as well as a UTI.   If you need more information from us, please don't hesitate to reach out and we can look up when / where the case was vaccinated and assist with any further investigation.
Age: 22.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Blood bicarbonate increased, Blood culture, C-reactive protein normal, Heart rate decreased, Irritability
Clinical narrative: pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix.  Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Laboratory test, Lip discolouration, Liver function test normal, Metabolic acidosis, Metabolic function test abnormal
Clinical narrative: pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix.  Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Pyrexia, Respiratory arrest, Respiratory viral panel, Skin discolouration, Urine ketone body present
Clinical narrative: pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix.  Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: White blood cell count increased
Clinical narrative: pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix.  Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine was given via Intramuscular route instead of subcutaneous route.