chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Computerised tomogram thorax abnormal, Death, Endotracheal intubation, Lung opacity
Clinical narrative: respiratory failure/Hypoxemic respiratory failure; ARDS; This is a spontaneous report from a contactable physician. A 78-years-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), intramuscular in arm right on 11May2021 (at the age of 78-years-old) (Lot Number: EW0176) as single dose for COVID-19 immunization. Medical history included HTN (hypertension), penicillin allergy. Concomitant medications included hydralazine; terazosin; rosuvastatin; atenolol; losartan; amlodipine received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient previously took atorvastatin (LIPITOR) and experienced allergies to lipitor, alendronate sodium (FOSAMAX) and experienced allergies to Fosamax. Historical vaccine included first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) intramuscular in arm right on 20Apr2021 (at the age of 77-years-old) (Lot Number: ER8735) as single dose for COVID-19 immunization. 2 days after receiving the second dose of the covid-19 vaccine, there was the development of SOB (Shortness of breath) on 13May2021. She presented to the ED 1 week after receiving the vaccine for worsening symptoms and imaging in May2021 revealed pulmonary infiltrates. She developed respiratory failure and was intubated for ARDS (acute respiratory distress syndrome). She ultimately passed away on 30May2021. All events onset on 13May2021. The events resulted in Emergency room/department or urgent care, hospitalization, patient died. The patient was hospitalized for 11 days. Treatment received for the events included antibiotics, steroids, mechanical ventilation. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 19May2021 and showed negative. The outcome of the events was fatal. The patient died on 30May2021. Cause of death was reported as hypoxemic respiratory failure. An autopsy was not performed.; Sender's Comments: Based on the close temporal relationship, the association between the events fatal hypoxic respiratory failure and ARDS with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: SOB; ARDS; pulmonary infiltrates; respiratory failure/Hypoxemic respiratory failure
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory failure
Clinical narrative: respiratory failure/Hypoxemic respiratory failure; ARDS; This is a spontaneous report from a contactable physician. A 78-years-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), intramuscular in arm right on 11May2021 (at the age of 78-years-old) (Lot Number: EW0176) as single dose for COVID-19 immunization. Medical history included HTN (hypertension), penicillin allergy. Concomitant medications included hydralazine; terazosin; rosuvastatin; atenolol; losartan; amlodipine received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient previously took atorvastatin (LIPITOR) and experienced allergies to lipitor, alendronate sodium (FOSAMAX) and experienced allergies to Fosamax. Historical vaccine included first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) intramuscular in arm right on 20Apr2021 (at the age of 77-years-old) (Lot Number: ER8735) as single dose for COVID-19 immunization. 2 days after receiving the second dose of the covid-19 vaccine, there was the development of SOB (Shortness of breath) on 13May2021. She presented to the ED 1 week after receiving the vaccine for worsening symptoms and imaging in May2021 revealed pulmonary infiltrates. She developed respiratory failure and was intubated for ARDS (acute respiratory distress syndrome). She ultimately passed away on 30May2021. All events onset on 13May2021. The events resulted in Emergency room/department or urgent care, hospitalization, patient died. The patient was hospitalized for 11 days. Treatment received for the events included antibiotics, steroids, mechanical ventilation. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 19May2021 and showed negative. The outcome of the events was fatal. The patient died on 30May2021. Cause of death was reported as hypoxemic respiratory failure. An autopsy was not performed.; Sender's Comments: Based on the close temporal relationship, the association between the events fatal hypoxic respiratory failure and ARDS with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: SOB; ARDS; pulmonary infiltrates; respiratory failure/Hypoxemic respiratory failure
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram, Cough, Decreased appetite, Dyspnoea
Clinical narrative: respiratory failure/Hypoxemic respiratory failure; ARDS; This is a spontaneous report from a contactable physician. A 78-years-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), intramuscular in arm right on 11May2021 (at the age of 78-years-old) (Lot Number: EW0176) as single dose for COVID-19 immunization. Medical history included HTN (hypertension), penicillin allergy. Concomitant medications included hydralazine; terazosin; rosuvastatin; atenolol; losartan; amlodipine received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient previously took atorvastatin (LIPITOR) and experienced allergies to lipitor, alendronate sodium (FOSAMAX) and experienced allergies to Fosamax. Historical vaccine included first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) intramuscular in arm right on 20Apr2021 (at the age of 77-years-old) (Lot Number: ER8735) as single dose for COVID-19 immunization. 2 days after receiving the second dose of the covid-19 vaccine, there was the development of SOB (Shortness of breath) on 13May2021. She presented to the ED 1 week after receiving the vaccine for worsening symptoms and imaging in May2021 revealed pulmonary infiltrates. She developed respiratory failure and was intubated for ARDS (acute respiratory distress syndrome). She ultimately passed away on 30May2021. All events onset on 13May2021. The events resulted in Emergency room/department or urgent care, hospitalization, patient died. The patient was hospitalized for 11 days. Treatment received for the events included antibiotics, steroids, mechanical ventilation. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 19May2021 and showed negative. The outcome of the events was fatal. The patient died on 30May2021. Cause of death was reported as hypoxemic respiratory failure. An autopsy was not performed.; Sender's Comments: Based on the close temporal relationship, the association between the events fatal hypoxic respiratory failure and ARDS with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: SOB; ARDS; pulmonary infiltrates; respiratory failure/Hypoxemic respiratory failure
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Hyperhidrosis, Laboratory test, Pulmonary congestion, X-ray
Clinical narrative: respiratory failure/Hypoxemic respiratory failure; ARDS; This is a spontaneous report from a contactable physician. A 78-years-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), intramuscular in arm right on 11May2021 (at the age of 78-years-old) (Lot Number: EW0176) as single dose for COVID-19 immunization. Medical history included HTN (hypertension), penicillin allergy. Concomitant medications included hydralazine; terazosin; rosuvastatin; atenolol; losartan; amlodipine received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient previously took atorvastatin (LIPITOR) and experienced allergies to lipitor, alendronate sodium (FOSAMAX) and experienced allergies to Fosamax. Historical vaccine included first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) intramuscular in arm right on 20Apr2021 (at the age of 77-years-old) (Lot Number: ER8735) as single dose for COVID-19 immunization. 2 days after receiving the second dose of the covid-19 vaccine, there was the development of SOB (Shortness of breath) on 13May2021. She presented to the ED 1 week after receiving the vaccine for worsening symptoms and imaging in May2021 revealed pulmonary infiltrates. She developed respiratory failure and was intubated for ARDS (acute respiratory distress syndrome). She ultimately passed away on 30May2021. All events onset on 13May2021. The events resulted in Emergency room/department or urgent care, hospitalization, patient died. The patient was hospitalized for 11 days. Treatment received for the events included antibiotics, steroids, mechanical ventilation. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 19May2021 and showed negative. The outcome of the events was fatal. The patient died on 30May2021. Cause of death was reported as hypoxemic respiratory failure. An autopsy was not performed.; Sender's Comments: Based on the close temporal relationship, the association between the events fatal hypoxic respiratory failure and ARDS with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: SOB; ARDS; pulmonary infiltrates; respiratory failure/Hypoxemic respiratory failure
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Respiratory failure, SARS-CoV-2 test, Scan
Clinical narrative: respiratory failure/Hypoxemic respiratory failure; ARDS; This is a spontaneous report from a contactable physician. A 78-years-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), intramuscular in arm right on 11May2021 (at the age of 78-years-old) (Lot Number: EW0176) as single dose for COVID-19 immunization. Medical history included HTN (hypertension), penicillin allergy. Concomitant medications included hydralazine; terazosin; rosuvastatin; atenolol; losartan; amlodipine received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient previously took atorvastatin (LIPITOR) and experienced allergies to lipitor, alendronate sodium (FOSAMAX) and experienced allergies to Fosamax. Historical vaccine included first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) intramuscular in arm right on 20Apr2021 (at the age of 77-years-old) (Lot Number: ER8735) as single dose for COVID-19 immunization. 2 days after receiving the second dose of the covid-19 vaccine, there was the development of SOB (Shortness of breath) on 13May2021. She presented to the ED 1 week after receiving the vaccine for worsening symptoms and imaging in May2021 revealed pulmonary infiltrates. She developed respiratory failure and was intubated for ARDS (acute respiratory distress syndrome). She ultimately passed away on 30May2021. All events onset on 13May2021. The events resulted in Emergency room/department or urgent care, hospitalization, patient died. The patient was hospitalized for 11 days. Treatment received for the events included antibiotics, steroids, mechanical ventilation. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 19May2021 and showed negative. The outcome of the events was fatal. The patient died on 30May2021. Cause of death was reported as hypoxemic respiratory failure. An autopsy was not performed.; Sender's Comments: Based on the close temporal relationship, the association between the events fatal hypoxic respiratory failure and ARDS with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: SOB; ARDS; pulmonary infiltrates; respiratory failure/Hypoxemic respiratory failure
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Sudden death
Clinical narrative: Sudden death in sleep; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8730, expiration date unknown) via an unspecified route of administration on 29Mar2021 at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and event onset. Patient had no COVID-19 prior vaccination. Medical history was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received antihistamine within 2 weeks of vaccination. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EN6205, expiration date unknown) on 08Mar2021 at age of 40-year-old for COVID-19 Immunization. On 08Apr2021, patient had sudden death in sleep. Autopsy was done with no autopsy result available. No treatment received for the event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Reported Cause(s) of Death: Sudden death in sleep
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Sudden death in sleep; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8730, expiration date unknown) via an unspecified route of administration on 29Mar2021 at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and event onset. Patient had no COVID-19 prior vaccination. Medical history was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received antihistamine within 2 weeks of vaccination. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EN6205, expiration date unknown) on 08Mar2021 at age of 40-year-old for COVID-19 Immunization. On 08Apr2021, patient had sudden death in sleep. Autopsy was done with no autopsy result available. No treatment received for the event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Reported Cause(s) of Death: Sudden death in sleep
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Echocardiogram, Myocarditis
Clinical narrative: Began with chest pain, diagnosed with Myocarditis next day. Cardiac catheter and overnight stay at hospital. Currently continuing treatment.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Catheterisation cardiac abnormal, Chest pain, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Began with chest pain, diagnosed with Myocarditis next day. Cardiac catheter and overnight stay at hospital. Currently continuing treatment.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autoscopy, Balance disorder, Chest X-ray, Dizziness
Clinical narrative: Fainted the morning following the vaccine; Weakness; dizziness/feeling of almost fainting/second time of feeling faint; "out of body" feeling; brain foggy; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 36-years-old female patient received bnt162b2 (BNT162B2; brand: Pfizer), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:15 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE dose for covid-19 immunization, at the age at vaccination date of 36 years old. Patient was not pregnant. The patient medical history was not reported. No known allergies. Historical vaccine included first dose of BNT162B2 (brand: Pfizer; lot number: EW0161; vaccine location: Left arm) on 24Apr2021 14:15 (24hr) for covid-19 immunization.  Concomitant medication included oral contraceptive taken for an unspecified indication, start and stop date were not reported. Events reported as: Fainted the morning following the vaccine. Weakness, dizziness, "out of body" feeling, brain foggy, feeling of almost fainting continued for a full weeks after the second dose. Went to emergency room on second time of feeling faint. Referred patient to a cardiologist. Echocardiogram was performed and heart monitor worn. Somewhere in the middle of the second week, the weird feelings gradually became less and less, but didn't completely stop until 2+ weeks after second dose. Echocardiogram, blood pressure, blood tests, all normal. Doctors weren't sure why patient was feeling this way, but it clearly started after she received the vaccine. All events on 16May2021 09:00 with outcome of recovered.  The patient underwent lab tests which included blood pressure: normal, blood test: normal, echocardiogram: normal, all on unknown date.  Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for events included: Increase hydration with Pedialyte, food, rest. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Laboratory test, Nervousness, Syncope
Clinical narrative: Fainted the morning following the vaccine; Weakness; dizziness/feeling of almost fainting/second time of feeling faint; "out of body" feeling; brain foggy; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 36-years-old female patient received bnt162b2 (BNT162B2; brand: Pfizer), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:15 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE dose for covid-19 immunization, at the age at vaccination date of 36 years old. Patient was not pregnant. The patient medical history was not reported. No known allergies. Historical vaccine included first dose of BNT162B2 (brand: Pfizer; lot number: EW0161; vaccine location: Left arm) on 24Apr2021 14:15 (24hr) for covid-19 immunization.  Concomitant medication included oral contraceptive taken for an unspecified indication, start and stop date were not reported. Events reported as: Fainted the morning following the vaccine. Weakness, dizziness, "out of body" feeling, brain foggy, feeling of almost fainting continued for a full weeks after the second dose. Went to emergency room on second time of feeling faint. Referred patient to a cardiologist. Echocardiogram was performed and heart monitor worn. Somewhere in the middle of the second week, the weird feelings gradually became less and less, but didn't completely stop until 2+ weeks after second dose. Echocardiogram, blood pressure, blood tests, all normal. Doctors weren't sure why patient was feeling this way, but it clearly started after she received the vaccine. All events on 16May2021 09:00 with outcome of recovered.  The patient underwent lab tests which included blood pressure: normal, blood test: normal, echocardiogram: normal, all on unknown date.  Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for events included: Increase hydration with Pedialyte, food, rest. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood test, Dizziness, Echocardiogram
Clinical narrative: Fainted the morning following the vaccine; Weakness; dizziness/feeling of almost fainting/second time of feeling faint; "out of body" feeling; brain foggy; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 36-years-old female patient received bnt162b2 (BNT162B2; brand: Pfizer), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:15 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE dose for covid-19 immunization, at the age at vaccination date of 36 years old. Patient was not pregnant. The patient medical history was not reported. No known allergies. Historical vaccine included first dose of BNT162B2 (brand: Pfizer; lot number: EW0161; vaccine location: Left arm) on 24Apr2021 14:15 (24hr) for covid-19 immunization.  Concomitant medication included oral contraceptive taken for an unspecified indication, start and stop date were not reported. Events reported as: Fainted the morning following the vaccine. Weakness, dizziness, "out of body" feeling, brain foggy, feeling of almost fainting continued for a full weeks after the second dose. Went to emergency room on second time of feeling faint. Referred patient to a cardiologist. Echocardiogram was performed and heart monitor worn. Somewhere in the middle of the second week, the weird feelings gradually became less and less, but didn't completely stop until 2+ weeks after second dose. Echocardiogram, blood pressure, blood tests, all normal. Doctors weren't sure why patient was feeling this way, but it clearly started after she received the vaccine. All events on 16May2021 09:00 with outcome of recovered.  The patient underwent lab tests which included blood pressure: normal, blood test: normal, echocardiogram: normal, all on unknown date.  Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for events included: Increase hydration with Pedialyte, food, rest. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Fainted the morning following the vaccine; Weakness; dizziness/feeling of almost fainting/second time of feeling faint; "out of body" feeling; brain foggy; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 36-years-old female patient received bnt162b2 (BNT162B2; brand: Pfizer), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:15 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE dose for covid-19 immunization, at the age at vaccination date of 36 years old. Patient was not pregnant. The patient medical history was not reported. No known allergies. Historical vaccine included first dose of BNT162B2 (brand: Pfizer; lot number: EW0161; vaccine location: Left arm) on 24Apr2021 14:15 (24hr) for covid-19 immunization.  Concomitant medication included oral contraceptive taken for an unspecified indication, start and stop date were not reported. Events reported as: Fainted the morning following the vaccine. Weakness, dizziness, "out of body" feeling, brain foggy, feeling of almost fainting continued for a full weeks after the second dose. Went to emergency room on second time of feeling faint. Referred patient to a cardiologist. Echocardiogram was performed and heart monitor worn. Somewhere in the middle of the second week, the weird feelings gradually became less and less, but didn't completely stop until 2+ weeks after second dose. Echocardiogram, blood pressure, blood tests, all normal. Doctors weren't sure why patient was feeling this way, but it clearly started after she received the vaccine. All events on 16May2021 09:00 with outcome of recovered.  The patient underwent lab tests which included blood pressure: normal, blood test: normal, echocardiogram: normal, all on unknown date.  Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for events included: Increase hydration with Pedialyte, food, rest. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine administered off label to patient less than 18 years old.   Patient's mother made aware that patient may complete the series off label.  Mother requested to complete the series, next dose due 7/5/21
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine administered off label to patient less than 18 years old.   Patient's mother made aware that patient may complete the series off label.  Mother requested to complete the series, next dose due 7/5/21
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eczema, Fatigue, Nausea, Psoriasis
Clinical narrative: Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Cough, Cystitis, Headache, Rash
Clinical narrative: Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation, Swelling
Clinical narrative: Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Akinesia, Aphasia, Asthenia, Dysarthria, Dyspnoea exertional
Clinical narrative: I got sick the 26th-28th of May. I couldn't get out of bed. On June 6th, I went to the doctor and they sent me home. They couldn't find anything. That night, I fell. My husband couldn't understand what I was saying, I was just mumbling like I had a stroke. I had high blood pressure. The ER said my heart was swollen and the next day I got pneumonias. They gave me antibiotics, an inhaler, and Mucinex.   The cardiologist said my heart is swollen and it will take weeks for it to go down
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Mobility decreased, Myocarditis
Clinical narrative: I got sick the 26th-28th of May. I couldn't get out of bed. On June 6th, I went to the doctor and they sent me home. They couldn't find anything. That night, I fell. My husband couldn't understand what I was saying, I was just mumbling like I had a stroke. I had high blood pressure. The ER said my heart was swollen and the next day I got pneumonias. They gave me antibiotics, an inhaler, and Mucinex.   The cardiologist said my heart is swollen and it will take weeks for it to go down
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Unresponsive to stimuli
Clinical narrative: I got sick the 26th-28th of May. I couldn't get out of bed. On June 6th, I went to the doctor and they sent me home. They couldn't find anything. That night, I fell. My husband couldn't understand what I was saying, I was just mumbling like I had a stroke. I had high blood pressure. The ER said my heart was swollen and the next day I got pneumonias. They gave me antibiotics, an inhaler, and Mucinex.   The cardiologist said my heart is swollen and it will take weeks for it to go down
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiomegaly, Fall, Hypertension, Malaise
Clinical narrative: I got sick the 26th-28th of May. I couldn't get out of bed. On June 6th, I went to the doctor and they sent me home. They couldn't find anything. That night, I fell. My husband couldn't understand what I was saying, I was just mumbling like I had a stroke. I had high blood pressure. The ER said my heart was swollen and the next day I got pneumonias. They gave me antibiotics, an inhaler, and Mucinex.   The cardiologist said my heart is swollen and it will take weeks for it to go down
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pneumonia, Speech disorder
Clinical narrative: I got sick the 26th-28th of May. I couldn't get out of bed. On June 6th, I went to the doctor and they sent me home. They couldn't find anything. That night, I fell. My husband couldn't understand what I was saying, I was just mumbling like I had a stroke. I had high blood pressure. The ER said my heart was swollen and the next day I got pneumonias. They gave me antibiotics, an inhaler, and Mucinex.   The cardiologist said my heart is swollen and it will take weeks for it to go down
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient presented to walk in care for second dose of COVID vaccine on 6/9/21. Vaccine card stated 6/9 as the 2nd dose however should have been 6/16/21 as 1st dose was administered on 5/26/21. It was not caught prior to administration of vaccine.  The following day (6/10), patient was called to explain the error however he stated he was "feeling fine" and did not have any concerns at the time.  There has been no additional follow up with the patient to this date.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase MB increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Influenza virus test negative
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, N-terminal prohormone brain natriuretic peptide normal, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Troponin I increased
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Viral titre
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase MB normal, Blood immunoglobulin G, Blood test, C-reactive protein normal, COVID-19
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Coxsackie virus test, Cytomegalovirus test, Echocardiogram, Echovirus test
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Epstein-Barr virus test negative, Headache, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test negative, N-terminal prohormone brain natriuretic peptide, Pain, Parvovirus B19 test negative, Pericarditis
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory viral panel, SARS-CoV-2 test positive, Troponin increased, Viral test
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Day 1 no symptoms Day 2 fever, aches Day 3 headaches Day 4 severe chest pain only  - hospitalized until day 6 Diagnosed with Pericarditis
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy liver, Blood test, Chills, Chromaturia, Feeding disorder
Clinical narrative: pt with acute liver injury  - hospitalized. LFTs abnormal 1-2 weeks after receiving vaccine. Initially thought due to reactivation of hepatitis B vs autoimmune hepatitis. Ultimately required liver transplant for acute liver failure, received 6/20 at
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hepatitis B DNA increased, Nausea, Urine analysis, Yellow skin
Clinical narrative: pt with acute liver injury  - hospitalized. LFTs abnormal 1-2 weeks after receiving vaccine. Initially thought due to reactivation of hepatitis B vs autoimmune hepatitis. Ultimately required liver transplant for acute liver failure, received 6/20 at
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Acute hepatic failure, Biopsy liver abnormal, Condition aggravated, HBV-DNA polymerase increased
Clinical narrative: pt with acute liver injury  - hospitalized. LFTs abnormal 1-2 weeks after receiving vaccine. Initially thought due to reactivation of hepatitis B vs autoimmune hepatitis. Ultimately required liver transplant for acute liver failure, received 6/20 at
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hepatic enzyme increased, Hepatitis B, Hepatitis B core antibody positive, Hepatitis D antibody negative
Clinical narrative: pt with acute liver injury  - hospitalized. LFTs abnormal 1-2 weeks after receiving vaccine. Initially thought due to reactivation of hepatitis B vs autoimmune hepatitis. Ultimately required liver transplant for acute liver failure, received 6/20 at
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatitis acute, Nausea, Syncope, Vomiting
Clinical narrative: pt with acute liver injury  - hospitalized. LFTs abnormal 1-2 weeks after receiving vaccine. Initially thought due to reactivation of hepatitis B vs autoimmune hepatitis. Ultimately required liver transplant for acute liver failure, received 6/20 at
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute hepatic failure, Autoimmune hepatitis, Biopsy liver abnormal, Condition aggravated, Hepatitis B reactivation
Clinical narrative: pt with acute liver injury  - hospitalized. LFTs abnormal 1-2 weeks after receiving vaccine. Initially thought due to reactivation of hepatitis B vs autoimmune hepatitis. Ultimately required liver transplant for acute liver failure, received 6/20 at
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Liver function test abnormal, Liver injury, Liver transplant
Clinical narrative: pt with acute liver injury  - hospitalized. LFTs abnormal 1-2 weeks after receiving vaccine. Initially thought due to reactivation of hepatitis B vs autoimmune hepatitis. Ultimately required liver transplant for acute liver failure, received 6/20 at
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Aspiration, Cardiac tamponade, Heart rate increased, Pericarditis, Pneumonia
Clinical narrative: Patient received the COVID vaccine in the early part of 2021 (Manufacturer and dates unknown - do not have access to registry and patient is non-verbal and unable to provide information). Patient has had frequent admissions since.  It started in March - Hospitalized from 3/27-4/5 for a large pericardial effusion with cardiac tamponade.  The source was thought to be viral and the patient was treated with colchicine and NSAIDS.  Drains were also placed.  1L of fluid was drained.  Cultures were negative for organisms.  She was re-hospitalized from 4/6 to 4/19 - again with a left pleural effusion and a pericardial effusion.  Readmitted on 4/26 -6/1 - pleural effusion that was drained, thought to be from aspiration from bolus tube feeds.  She was again hospitalized on 6/7-6/23 for recurrent aspiration pneumonia.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Aspiration, Cardiac tamponade, Culture negative, Drain placement, Echocardiogram abnormal
Clinical narrative: Patient received the COVID vaccine in the early part of 2021 (Manufacturer and dates unknown - do not have access to registry and patient is non-verbal and unable to provide information). Patient has had frequent admissions since.  It started in March - Hospitalized from 3/27-4/5 for a large pericardial effusion with cardiac tamponade.  The source was thought to be viral and the patient was treated with colchicine and NSAIDS.  Drains were also placed.  1L of fluid was drained.  Cultures were negative for organisms.  She was re-hospitalized from 4/6 to 4/19 - again with a left pleural effusion and a pericardial effusion.  Readmitted on 4/26 -6/1 - pleural effusion that was drained, thought to be from aspiration from bolus tube feeds.  She was again hospitalized on 6/7-6/23 for recurrent aspiration pneumonia.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pericardial effusion, Pleural effusion, Pneumonia aspiration, Thoracic cavity drainage
Clinical narrative: Patient received the COVID vaccine in the early part of 2021 (Manufacturer and dates unknown - do not have access to registry and patient is non-verbal and unable to provide information). Patient has had frequent admissions since.  It started in March - Hospitalized from 3/27-4/5 for a large pericardial effusion with cardiac tamponade.  The source was thought to be viral and the patient was treated with colchicine and NSAIDS.  Drains were also placed.  1L of fluid was drained.  Cultures were negative for organisms.  She was re-hospitalized from 4/6 to 4/19 - again with a left pleural effusion and a pericardial effusion.  Readmitted on 4/26 -6/1 - pleural effusion that was drained, thought to be from aspiration from bolus tube feeds.  She was again hospitalized on 6/7-6/23 for recurrent aspiration pneumonia.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest X-ray abnormal, Chest pain, Echocardiogram abnormal, Ejection fraction
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram T wave abnormal, Fibrin D dimer, Headache, Immunoglobulin therapy
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Left ventricular dysfunction, Mitral valve incompetence, Myalgia, N-terminal prohormone brain natriuretic peptide increased
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Painful respiration, Pericardial effusion, Tachycardia, Troponin I increased
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Anticoagulant therapy, Chest pain, Computerised tomogram thorax, Discomfort
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fibrin D dimer increased, Intensive care, Myocarditis
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Painful respiration, Pleuritic pain, Tachycardia, Troponin increased, Vomiting
Clinical narrative: Patient is a 14-year-old male with past medical history of ADD and HD currently on Adderall 25 mg XR who presents to the emergency department complaining of 1 hour acute onset chest pain associated shortness of breath pain is sharp and stabbing in nature mid to left side of his chest constant and worse with breathing.  There has been 1 episode of vomiting associated with the symptoms.  Symptoms do seem to be improving since onset.  When he still in significant discomfort on arrival.  No nausea no vomiting currently.  He did receive a 2nd COVID-19 vaccine on Monday which was Pfizer vaccine.