chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Intracardiac mass, Left ventricular end-diastolic pressure increased, Metabolic function test normal, Mitral valve incompetence
Clinical narrative: Myalgias, neck pain, HA, fatigue 5/5. Fatigue intensified by 5/9 and onset of clear rhinorrhea;home COVID test negative then. By 5/13, all symptoms resolved except marked fatigue, low grade fever up to 99.2 and minimal dry cough. Evaluated at office appt 5/16 with extensive exam neg except mild right temporal tenderness and trace ankle edema. Admitted to anorexia/mild nausea without emesis and passage of small soft BMs with voiding. UA showed E.coli UTI but she denied symptoms. Was treated with Keflex 500 mg BID for 7 days for lack of any other diagnosis. CMP was normal, WBC 12,100 with mild increase in pmns but 600 eos, WESR 78, CRP 22.1, procalcitonin 0.21. Gaviscon allowed her to eat without gagging and she was started on famotidine 20 mg BID. Called on 5/21 to complain of vague high substernal tightness that was not exertional. A couple hours later she felt a "panic attack" with SOB returning from the mailbox that resolved with 0.25 mg Ativan. She slept well without orthopnea or PND but awoke in the AM with watery diarrhea, vertigo and nausea with vomiting. She had DOE that she attributed to anxiety. Called EMS and ER evaluation showed only minimal nonspecific EKG changes, BNP 3157, hs-troponin I 14,012, CRP 14.3, stable BUN/creat 13/0.9, CXR showed pulmonary vascular congestion. CT abdomen showed small bilateral pleural effusions, no pericardial effusion. Echo showed LVEF 30-35%, globel hypokinesis (last Echo 2009 with EF 65%). Full respatory viral PCR panel was negative. Hospital course: cath 5/23 with normal coronary arteries, global hypokinesis and LVEF 35-40%, elevated LVEDP 18 mmHg. Patient remained very fatigued and anorexic or nauseated throughout her hospitalization. hs-Troponin I trended down but remained markedly elevated w/ last measurement 10,617 on 5/24 w/ CPK down to 145 from maximum of only 366. DOE on 5/25 with increased pleural effusions on CXR. Required NC O2 that PM. Repeat Echo 5/26 with globular mass on the mitral valve leaflet apparatus or chordae, significant MR and LVEF 25-30%. By the AM of 5/27, she had ARF with BUN/creat 52/1.9, K+ 6.1 and drop in BPs to 105 systolic. TEE on 5/27 showed a 1.1x1.0 cm apparent vegetation on the chordae of the anterior mitral leaflet, moderate MR, EF 25-30%, Blood cultures are negative at 2 days. She was clinically much weaker and lacked any of her usual animation on the morning of 5/28. Another Echo excluded pericardial effusion. She expired on the morning of 5/28.  Of note, this was her 5th body stimulus to COVID as she had Moderna 1/20/21 & 2/17/21, first booster 10/26/21, mild COVID-19 infection that did not require professional care 11/22/21 and second booster 5/4/22. Perhaps FDA needs to be watching for reactions to 2nd boosters more closely!
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Oedema peripheral, Panic attack
Clinical narrative: Myalgias, neck pain, HA, fatigue 5/5. Fatigue intensified by 5/9 and onset of clear rhinorrhea;home COVID test negative then. By 5/13, all symptoms resolved except marked fatigue, low grade fever up to 99.2 and minimal dry cough. Evaluated at office appt 5/16 with extensive exam neg except mild right temporal tenderness and trace ankle edema. Admitted to anorexia/mild nausea without emesis and passage of small soft BMs with voiding. UA showed E.coli UTI but she denied symptoms. Was treated with Keflex 500 mg BID for 7 days for lack of any other diagnosis. CMP was normal, WBC 12,100 with mild increase in pmns but 600 eos, WESR 78, CRP 22.1, procalcitonin 0.21. Gaviscon allowed her to eat without gagging and she was started on famotidine 20 mg BID. Called on 5/21 to complain of vague high substernal tightness that was not exertional. A couple hours later she felt a "panic attack" with SOB returning from the mailbox that resolved with 0.25 mg Ativan. She slept well without orthopnea or PND but awoke in the AM with watery diarrhea, vertigo and nausea with vomiting. She had DOE that she attributed to anxiety. Called EMS and ER evaluation showed only minimal nonspecific EKG changes, BNP 3157, hs-troponin I 14,012, CRP 14.3, stable BUN/creat 13/0.9, CXR showed pulmonary vascular congestion. CT abdomen showed small bilateral pleural effusions, no pericardial effusion. Echo showed LVEF 30-35%, globel hypokinesis (last Echo 2009 with EF 65%). Full respatory viral PCR panel was negative. Hospital course: cath 5/23 with normal coronary arteries, global hypokinesis and LVEF 35-40%, elevated LVEDP 18 mmHg. Patient remained very fatigued and anorexic or nauseated throughout her hospitalization. hs-Troponin I trended down but remained markedly elevated w/ last measurement 10,617 on 5/24 w/ CPK down to 145 from maximum of only 366. DOE on 5/25 with increased pleural effusions on CXR. Required NC O2 that PM. Repeat Echo 5/26 with globular mass on the mitral valve leaflet apparatus or chordae, significant MR and LVEF 25-30%. By the AM of 5/27, she had ARF with BUN/creat 52/1.9, K+ 6.1 and drop in BPs to 105 systolic. TEE on 5/27 showed a 1.1x1.0 cm apparent vegetation on the chordae of the anterior mitral leaflet, moderate MR, EF 25-30%, Blood cultures are negative at 2 days. She was clinically much weaker and lacked any of her usual animation on the morning of 5/28. Another Echo excluded pericardial effusion. She expired on the morning of 5/28.  Of note, this was her 5th body stimulus to COVID as she had Moderna 1/20/21 & 2/17/21, first booster 10/26/21, mild COVID-19 infection that did not require professional care 11/22/21 and second booster 5/4/22. Perhaps FDA needs to be watching for reactions to 2nd boosters more closely!
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Procalcitonin, Pulmonary congestion, Red blood cell sedimentation rate increased, Respiratory viral panel
Clinical narrative: Myalgias, neck pain, HA, fatigue 5/5. Fatigue intensified by 5/9 and onset of clear rhinorrhea;home COVID test negative then. By 5/13, all symptoms resolved except marked fatigue, low grade fever up to 99.2 and minimal dry cough. Evaluated at office appt 5/16 with extensive exam neg except mild right temporal tenderness and trace ankle edema. Admitted to anorexia/mild nausea without emesis and passage of small soft BMs with voiding. UA showed E.coli UTI but she denied symptoms. Was treated with Keflex 500 mg BID for 7 days for lack of any other diagnosis. CMP was normal, WBC 12,100 with mild increase in pmns but 600 eos, WESR 78, CRP 22.1, procalcitonin 0.21. Gaviscon allowed her to eat without gagging and she was started on famotidine 20 mg BID. Called on 5/21 to complain of vague high substernal tightness that was not exertional. A couple hours later she felt a "panic attack" with SOB returning from the mailbox that resolved with 0.25 mg Ativan. She slept well without orthopnea or PND but awoke in the AM with watery diarrhea, vertigo and nausea with vomiting. She had DOE that she attributed to anxiety. Called EMS and ER evaluation showed only minimal nonspecific EKG changes, BNP 3157, hs-troponin I 14,012, CRP 14.3, stable BUN/creat 13/0.9, CXR showed pulmonary vascular congestion. CT abdomen showed small bilateral pleural effusions, no pericardial effusion. Echo showed LVEF 30-35%, globel hypokinesis (last Echo 2009 with EF 65%). Full respatory viral PCR panel was negative. Hospital course: cath 5/23 with normal coronary arteries, global hypokinesis and LVEF 35-40%, elevated LVEDP 18 mmHg. Patient remained very fatigued and anorexic or nauseated throughout her hospitalization. hs-Troponin I trended down but remained markedly elevated w/ last measurement 10,617 on 5/24 w/ CPK down to 145 from maximum of only 366. DOE on 5/25 with increased pleural effusions on CXR. Required NC O2 that PM. Repeat Echo 5/26 with globular mass on the mitral valve leaflet apparatus or chordae, significant MR and LVEF 25-30%. By the AM of 5/27, she had ARF with BUN/creat 52/1.9, K+ 6.1 and drop in BPs to 105 systolic. TEE on 5/27 showed a 1.1x1.0 cm apparent vegetation on the chordae of the anterior mitral leaflet, moderate MR, EF 25-30%, Blood cultures are negative at 2 days. She was clinically much weaker and lacked any of her usual animation on the morning of 5/28. Another Echo excluded pericardial effusion. She expired on the morning of 5/28.  Of note, this was her 5th body stimulus to COVID as she had Moderna 1/20/21 & 2/17/21, first booster 10/26/21, mild COVID-19 infection that did not require professional care 11/22/21 and second booster 5/4/22. Perhaps FDA needs to be watching for reactions to 2nd boosters more closely!
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Tenderness, Troponin I, Urinary tract infection
Clinical narrative: Myalgias, neck pain, HA, fatigue 5/5. Fatigue intensified by 5/9 and onset of clear rhinorrhea;home COVID test negative then. By 5/13, all symptoms resolved except marked fatigue, low grade fever up to 99.2 and minimal dry cough. Evaluated at office appt 5/16 with extensive exam neg except mild right temporal tenderness and trace ankle edema. Admitted to anorexia/mild nausea without emesis and passage of small soft BMs with voiding. UA showed E.coli UTI but she denied symptoms. Was treated with Keflex 500 mg BID for 7 days for lack of any other diagnosis. CMP was normal, WBC 12,100 with mild increase in pmns but 600 eos, WESR 78, CRP 22.1, procalcitonin 0.21. Gaviscon allowed her to eat without gagging and she was started on famotidine 20 mg BID. Called on 5/21 to complain of vague high substernal tightness that was not exertional. A couple hours later she felt a "panic attack" with SOB returning from the mailbox that resolved with 0.25 mg Ativan. She slept well without orthopnea or PND but awoke in the AM with watery diarrhea, vertigo and nausea with vomiting. She had DOE that she attributed to anxiety. Called EMS and ER evaluation showed only minimal nonspecific EKG changes, BNP 3157, hs-troponin I 14,012, CRP 14.3, stable BUN/creat 13/0.9, CXR showed pulmonary vascular congestion. CT abdomen showed small bilateral pleural effusions, no pericardial effusion. Echo showed LVEF 30-35%, globel hypokinesis (last Echo 2009 with EF 65%). Full respatory viral PCR panel was negative. Hospital course: cath 5/23 with normal coronary arteries, global hypokinesis and LVEF 35-40%, elevated LVEDP 18 mmHg. Patient remained very fatigued and anorexic or nauseated throughout her hospitalization. hs-Troponin I trended down but remained markedly elevated w/ last measurement 10,617 on 5/24 w/ CPK down to 145 from maximum of only 366. DOE on 5/25 with increased pleural effusions on CXR. Required NC O2 that PM. Repeat Echo 5/26 with globular mass on the mitral valve leaflet apparatus or chordae, significant MR and LVEF 25-30%. By the AM of 5/27, she had ARF with BUN/creat 52/1.9, K+ 6.1 and drop in BPs to 105 systolic. TEE on 5/27 showed a 1.1x1.0 cm apparent vegetation on the chordae of the anterior mitral leaflet, moderate MR, EF 25-30%, Blood cultures are negative at 2 days. She was clinically much weaker and lacked any of her usual animation on the morning of 5/28. Another Echo excluded pericardial effusion. She expired on the morning of 5/28.  Of note, this was her 5th body stimulus to COVID as she had Moderna 1/20/21 & 2/17/21, first booster 10/26/21, mild COVID-19 infection that did not require professional care 11/22/21 and second booster 5/4/22. Perhaps FDA needs to be watching for reactions to 2nd boosters more closely!
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis abnormal, Ventricular hypokinesia, Vertigo, Vomiting, White blood cell count
Clinical narrative: Myalgias, neck pain, HA, fatigue 5/5. Fatigue intensified by 5/9 and onset of clear rhinorrhea;home COVID test negative then. By 5/13, all symptoms resolved except marked fatigue, low grade fever up to 99.2 and minimal dry cough. Evaluated at office appt 5/16 with extensive exam neg except mild right temporal tenderness and trace ankle edema. Admitted to anorexia/mild nausea without emesis and passage of small soft BMs with voiding. UA showed E.coli UTI but she denied symptoms. Was treated with Keflex 500 mg BID for 7 days for lack of any other diagnosis. CMP was normal, WBC 12,100 with mild increase in pmns but 600 eos, WESR 78, CRP 22.1, procalcitonin 0.21. Gaviscon allowed her to eat without gagging and she was started on famotidine 20 mg BID. Called on 5/21 to complain of vague high substernal tightness that was not exertional. A couple hours later she felt a "panic attack" with SOB returning from the mailbox that resolved with 0.25 mg Ativan. She slept well without orthopnea or PND but awoke in the AM with watery diarrhea, vertigo and nausea with vomiting. She had DOE that she attributed to anxiety. Called EMS and ER evaluation showed only minimal nonspecific EKG changes, BNP 3157, hs-troponin I 14,012, CRP 14.3, stable BUN/creat 13/0.9, CXR showed pulmonary vascular congestion. CT abdomen showed small bilateral pleural effusions, no pericardial effusion. Echo showed LVEF 30-35%, globel hypokinesis (last Echo 2009 with EF 65%). Full respatory viral PCR panel was negative. Hospital course: cath 5/23 with normal coronary arteries, global hypokinesis and LVEF 35-40%, elevated LVEDP 18 mmHg. Patient remained very fatigued and anorexic or nauseated throughout her hospitalization. hs-Troponin I trended down but remained markedly elevated w/ last measurement 10,617 on 5/24 w/ CPK down to 145 from maximum of only 366. DOE on 5/25 with increased pleural effusions on CXR. Required NC O2 that PM. Repeat Echo 5/26 with globular mass on the mitral valve leaflet apparatus or chordae, significant MR and LVEF 25-30%. By the AM of 5/27, she had ARF with BUN/creat 52/1.9, K+ 6.1 and drop in BPs to 105 systolic. TEE on 5/27 showed a 1.1x1.0 cm apparent vegetation on the chordae of the anterior mitral leaflet, moderate MR, EF 25-30%, Blood cultures are negative at 2 days. She was clinically much weaker and lacked any of her usual animation on the morning of 5/28. Another Echo excluded pericardial effusion. She expired on the morning of 5/28.  Of note, this was her 5th body stimulus to COVID as she had Moderna 1/20/21 & 2/17/21, first booster 10/26/21, mild COVID-19 infection that did not require professional care 11/22/21 and second booster 5/4/22. Perhaps FDA needs to be watching for reactions to 2nd boosters more closely!
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Myalgias, neck pain, HA, fatigue 5/5. Fatigue intensified by 5/9 and onset of clear rhinorrhea;home COVID test negative then. By 5/13, all symptoms resolved except marked fatigue, low grade fever up to 99.2 and minimal dry cough. Evaluated at office appt 5/16 with extensive exam neg except mild right temporal tenderness and trace ankle edema. Admitted to anorexia/mild nausea without emesis and passage of small soft BMs with voiding. UA showed E.coli UTI but she denied symptoms. Was treated with Keflex 500 mg BID for 7 days for lack of any other diagnosis. CMP was normal, WBC 12,100 with mild increase in pmns but 600 eos, WESR 78, CRP 22.1, procalcitonin 0.21. Gaviscon allowed her to eat without gagging and she was started on famotidine 20 mg BID. Called on 5/21 to complain of vague high substernal tightness that was not exertional. A couple hours later she felt a "panic attack" with SOB returning from the mailbox that resolved with 0.25 mg Ativan. She slept well without orthopnea or PND but awoke in the AM with watery diarrhea, vertigo and nausea with vomiting. She had DOE that she attributed to anxiety. Called EMS and ER evaluation showed only minimal nonspecific EKG changes, BNP 3157, hs-troponin I 14,012, CRP 14.3, stable BUN/creat 13/0.9, CXR showed pulmonary vascular congestion. CT abdomen showed small bilateral pleural effusions, no pericardial effusion. Echo showed LVEF 30-35%, globel hypokinesis (last Echo 2009 with EF 65%). Full respatory viral PCR panel was negative. Hospital course: cath 5/23 with normal coronary arteries, global hypokinesis and LVEF 35-40%, elevated LVEDP 18 mmHg. Patient remained very fatigued and anorexic or nauseated throughout her hospitalization. hs-Troponin I trended down but remained markedly elevated w/ last measurement 10,617 on 5/24 w/ CPK down to 145 from maximum of only 366. DOE on 5/25 with increased pleural effusions on CXR. Required NC O2 that PM. Repeat Echo 5/26 with globular mass on the mitral valve leaflet apparatus or chordae, significant MR and LVEF 25-30%. By the AM of 5/27, she had ARF with BUN/creat 52/1.9, K+ 6.1 and drop in BPs to 105 systolic. TEE on 5/27 showed a 1.1x1.0 cm apparent vegetation on the chordae of the anterior mitral leaflet, moderate MR, EF 25-30%, Blood cultures are negative at 2 days. She was clinically much weaker and lacked any of her usual animation on the morning of 5/28. Another Echo excluded pericardial effusion. She expired on the morning of 5/28.  Of note, this was her 5th body stimulus to COVID as she had Moderna 1/20/21 & 2/17/21, first booster 10/26/21, mild COVID-19 infection that did not require professional care 11/22/21 and second booster 5/4/22. Perhaps FDA needs to be watching for reactions to 2nd boosters more closely!
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3 mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3 mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given  instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error,
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3mL. The prisoner had no adverse reaction or symptoms due to the dosing error.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3 mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3 mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Aphasia, Atrial fibrillation, Cognitive disorder, Dysarthria
Clinical narrative: Was thought patient had a stroke.  Cognitive impairment severity increased, Slurring of words, then unrecognizable verbage, seizure like shaking, when Medics arrived pt was in A-fib.  In hospital, he had little speech, couldn't lift right arm without pain, urination frequency increased/now wearing disposable undergarments.  Couldn't feed himself or get out of bed.  Was sent to rehab .  Irritable, anger, and now use of  walker always with assistance. not mobile on his own .  Surgery was postponed.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Loss of personal independence in daily activities, Mobility decreased, Pain, Pollakiuria
Clinical narrative: Was thought patient had a stroke.  Cognitive impairment severity increased, Slurring of words, then unrecognizable verbage, seizure like shaking, when Medics arrived pt was in A-fib.  In hospital, he had little speech, couldn't lift right arm without pain, urination frequency increased/now wearing disposable undergarments.  Couldn't feed himself or get out of bed.  Was sent to rehab .  Irritable, anger, and now use of  walker always with assistance. not mobile on his own .  Surgery was postponed.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Walking aid user
Clinical narrative: Was thought patient had a stroke.  Cognitive impairment severity increased, Slurring of words, then unrecognizable verbage, seizure like shaking, when Medics arrived pt was in A-fib.  In hospital, he had little speech, couldn't lift right arm without pain, urination frequency increased/now wearing disposable undergarments.  Couldn't feed himself or get out of bed.  Was sent to rehab .  Irritable, anger, and now use of  walker always with assistance. not mobile on his own .  Surgery was postponed.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Eye pain, Eyelid disorder, Fall, Magnetic resonance imaging
Clinical narrative: At 8:30 the night of the shot, eyes hurt so bad had to go to bed.  Next morning, got a cup of coffee in kitchen and walked to office 25' and my left hand shook so bad I spilled 80% of it until I got to office.  Then I set cup down and went to sit, and both of my knees gave out, and I fell into chair.  Then I picked up cup with left hand again (I am left handed) and tried to get a sip of coffee, and spilled the last 20% down my sweater.  Looked at a Personal Property of some lots where I used to live, and I could not read the papers I read the day before.....I could not read any print for a month......My eyesight at that time was  20/20.  I took a month before I could read again.  When I finally got in to see Dr, my eyes were supposed to be 10-12# of pressure, and they were L24 and R29.  At this time a month and a half later my eyes did not feel like they were going to blow out of my head.  Then Dr ordered a MRI because my eyelids were 1/2 closed and thought I had a mini-stroke.....findings were not.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Reading disorder, Tremor
Clinical narrative: At 8:30 the night of the shot, eyes hurt so bad had to go to bed.  Next morning, got a cup of coffee in kitchen and walked to office 25' and my left hand shook so bad I spilled 80% of it until I got to office.  Then I set cup down and went to sit, and both of my knees gave out, and I fell into chair.  Then I picked up cup with left hand again (I am left handed) and tried to get a sip of coffee, and spilled the last 20% down my sweater.  Looked at a Personal Property of some lots where I used to live, and I could not read the papers I read the day before.....I could not read any print for a month......My eyesight at that time was  20/20.  I took a month before I could read again.  When I finally got in to see Dr, my eyes were supposed to be 10-12# of pressure, and they were L24 and R29.  At this time a month and a half later my eyes did not feel like they were going to blow out of my head.  Then Dr ordered a MRI because my eyelids were 1/2 closed and thought I had a mini-stroke.....findings were not.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 year old patient was to receive the  COVID Pfizer vaccine and received the Janssen vaccine in error.
Age: 36.0
Sex: U
Vaccine: UNK, UNK
Symptoms: Unevaluable event
Clinical narrative: Pt diagnosed with Covid.  Pt had Covid Vaccine
Age: 36.0
Sex: U
Vaccine: UNK, UNK
Symptoms: COVID-19
Clinical narrative: Pt diagnosed with Covid.  Pt had Covid Vaccine
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Cerebrovascular accident, Computerised tomogram, Investigation, Thrombosis
Clinical narrative: STROKE; This is a spontaneous report received from contactable reporters (Consumers or other non HCPs) from License Party. Other Case identifiers: US-BRISTOL-MYERS SQUIBB COMPANY-2022-037994 (Company), BMS-2022-024502 (Company).  This case was received via Company (Reference number: 202200269859) on 28-Mar-2022. Information was received from a Consumer/other non health professional concerning a 63 Year(s) old Male patient, who received Suspect product APIXABAN for drug use for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for Drug use for unknown indication (from 06-Feb-2021), lot numbers: EL9269 and EN6203. On an unknown date, the patient experienced cerebrovascular accident(stroke) which was considered serious due to the following criteria: hospitalization and medical significance. Treatment included surgery. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. Relevant Laboratory & other Diagnostic Tests On an unknown date, CAT SCAN: Blood clot in brain. The reporter did not provide a causal assessment for event cerebrovascular accident to product APIXABAN. The reporter did not provide a causal assessment for event cerebrovascular accident to product COVID-19 VACCINE. The patient had COVID-19 shot, clarifies the product as the Pfizer COVID-19 vaccine and 3 weeks after caller got the second dose, caller had a blood clot in the brain, had a stroke, was rushed to the hospital and had brain surgery. They were able to do a cat scan and found the blood clot, did surgery, went through the groin area to get to the blood clot. The patient was taken no medication before, now on Eliquis. Tracking of Changes: 28-Mar-2022: Initial information was received.  APIXABAN (ELIQUIS) is under agreement with Company.; Sender's Comments: Company Comment: This patient had cerebrovascular accident(stroke) requiring surgery who was on therapy with apixaban and COVID-19 vaccination. Based on the limited information regarding nature of stroke (ischemic or hemorrhagic), relevant medical history and therapy details, it cannot be ascertained with reasonable possibility that suspect drugs caused or contributed to stroke.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: STROKE; This is a spontaneous report received from contactable reporters (Consumers or other non HCPs) from License Party. Other Case identifiers: US-BRISTOL-MYERS SQUIBB COMPANY-2022-037994 (Company), BMS-2022-024502 (Company).  This case was received via Company (Reference number: 202200269859) on 28-Mar-2022. Information was received from a Consumer/other non health professional concerning a 63 Year(s) old Male patient, who received Suspect product APIXABAN for drug use for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for Drug use for unknown indication (from 06-Feb-2021), lot numbers: EL9269 and EN6203. On an unknown date, the patient experienced cerebrovascular accident(stroke) which was considered serious due to the following criteria: hospitalization and medical significance. Treatment included surgery. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. Relevant Laboratory & other Diagnostic Tests On an unknown date, CAT SCAN: Blood clot in brain. The reporter did not provide a causal assessment for event cerebrovascular accident to product APIXABAN. The reporter did not provide a causal assessment for event cerebrovascular accident to product COVID-19 VACCINE. The patient had COVID-19 shot, clarifies the product as the Pfizer COVID-19 vaccine and 3 weeks after caller got the second dose, caller had a blood clot in the brain, had a stroke, was rushed to the hospital and had brain surgery. They were able to do a cat scan and found the blood clot, did surgery, went through the groin area to get to the blood clot. The patient was taken no medication before, now on Eliquis. Tracking of Changes: 28-Mar-2022: Initial information was received.  APIXABAN (ELIQUIS) is under agreement with Company.; Sender's Comments: Company Comment: This patient had cerebrovascular accident(stroke) requiring surgery who was on therapy with apixaban and COVID-19 vaccination. Based on the limited information regarding nature of stroke (ischemic or hemorrhagic), relevant medical history and therapy details, it cannot be ascertained with reasonable possibility that suspect drugs caused or contributed to stroke.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram
Clinical narrative: STROKE; This is a spontaneous report received from contactable reporters (Consumers or other non HCPs) from License Party. Other Case identifiers: US-BRISTOL-MYERS SQUIBB COMPANY-2022-037994 (Company), BMS-2022-024502 (Company).  This case was received via Company (Reference number: 202200269859) on 28-Mar-2022. Information was received from a Consumer/other non health professional concerning a 63 Year(s) old Male patient, who received Suspect product APIXABAN for drug use for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for Drug use for unknown indication (from 06-Feb-2021), lot numbers: EL9269 and EN6203. On an unknown date, the patient experienced cerebrovascular accident(stroke) which was considered serious due to the following criteria: hospitalization and medical significance. Treatment included surgery. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. Relevant Laboratory & other Diagnostic Tests On an unknown date, CAT SCAN: Blood clot in brain. The reporter did not provide a causal assessment for event cerebrovascular accident to product APIXABAN. The reporter did not provide a causal assessment for event cerebrovascular accident to product COVID-19 VACCINE. The patient had COVID-19 shot, clarifies the product as the Pfizer COVID-19 vaccine and 3 weeks after caller got the second dose, caller had a blood clot in the brain, had a stroke, was rushed to the hospital and had brain surgery. They were able to do a cat scan and found the blood clot, did surgery, went through the groin area to get to the blood clot. The patient was taken no medication before, now on Eliquis. Tracking of Changes: 28-Mar-2022: Initial information was received.  APIXABAN (ELIQUIS) is under agreement with Company.; Sender's Comments: Company Comment: This patient had cerebrovascular accident(stroke) requiring surgery who was on therapy with apixaban and COVID-19 vaccination. Based on the limited information regarding nature of stroke (ischemic or hemorrhagic), relevant medical history and therapy details, it cannot be ascertained with reasonable possibility that suspect drugs caused or contributed to stroke.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Angina pectoris, Blood test, Body temperature abnormal, Chest pain
Clinical narrative: Retrosternal chest pain, dyspnea, fatigue, hypersomnolence, night sweats
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Hypersomnia, Tachycardia
Clinical narrative: Retrosternal chest pain, dyspnea, fatigue, hypersomnolence, night sweats
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Retrosternal chest pain, dyspnea, fatigue, hypersomnolence, night sweats
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: Retrosternal chest pain, dyspnea, fatigue, hypersomnolence, night sweats
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Night sweats
Clinical narrative: Retrosternal chest pain, dyspnea, fatigue, hypersomnolence, night sweats
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary normal, COVID-19, Chest X-ray normal, Dyspnoea, Hypoxia
Clinical narrative: """69-year-old female past medical history of asthma, chronic obstructive pulmonary disease, hypertension and recent diagnosis of COVID-19 on 05/17 who is presenting to the emergency department today for worsening shortness of breath, wheezing consistent with her prior chronic obstructive pulmonary disease exacerbations.  Chronically on 3 L nasal cannula home. This is a 69 YO female with h/o COPD/asthma, metastatic lung cancer on keytruda (stable disease for about 2 years), HTN, recent COVID-19 infectino (3/2022), who presented for evaluation of shortness of breath.    Acute exacerbation of chronic obstructive pulmonary disease Acute on chronic respiratory failure Moderate persistent asthma  - continue prednisone 40 mg daily  - DuoNebs q.4 hours  - Zithromax and 500 mg daily  - concurrently on 3 L nasal cannula, wean as tolerated  - RVP was negative.  Note is made that recent positive COVID test was within 90 day window of her initial COVID infection.  - continued home Symbicort   Elevated troponin as high as 140- likely type 2 NSTEMI/demand mediated elevation.  Cardiology on consult. No CP. No known CAD, but heavy smoking history.  5/24 ECHO: ?  Left Ventricle: Systolic function is normal with an ejection fraction of 55 - 60%. ?  Tricuspid Valve: There is mild regurgitation. The right ventricular systolic pressure is moderately elevated, measuring 54 mmHg.    CARDS cleared for DC home. OP follow up needed.  OP stress test will be discussed.   Metastatic lung cancer - on Keytruda.  Follows with Dr.  Stable disease for 2 years   Hypertension - continue home lisinopril hydrochlorothiazide.   Ex smoker. -- approx 50 pack year smoker. Stopped 3/2022.    DC home with assist today. She declined Homecare services. Prednisone and Zithromax to complete 5 days."" "
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: """69-year-old female past medical history of asthma, chronic obstructive pulmonary disease, hypertension and recent diagnosis of COVID-19 on 05/17 who is presenting to the emergency department today for worsening shortness of breath, wheezing consistent with her prior chronic obstructive pulmonary disease exacerbations.  Chronically on 3 L nasal cannula home. This is a 69 YO female with h/o COPD/asthma, metastatic lung cancer on keytruda (stable disease for about 2 years), HTN, recent COVID-19 infectino (3/2022), who presented for evaluation of shortness of breath.    Acute exacerbation of chronic obstructive pulmonary disease Acute on chronic respiratory failure Moderate persistent asthma  - continue prednisone 40 mg daily  - DuoNebs q.4 hours  - Zithromax and 500 mg daily  - concurrently on 3 L nasal cannula, wean as tolerated  - RVP was negative.  Note is made that recent positive COVID test was within 90 day window of her initial COVID infection.  - continued home Symbicort   Elevated troponin as high as 140- likely type 2 NSTEMI/demand mediated elevation.  Cardiology on consult. No CP. No known CAD, but heavy smoking history.  5/24 ECHO: ?  Left Ventricle: Systolic function is normal with an ejection fraction of 55 - 60%. ?  Tricuspid Valve: There is mild regurgitation. The right ventricular systolic pressure is moderately elevated, measuring 54 mmHg.    CARDS cleared for DC home. OP follow up needed.  OP stress test will be discussed.   Metastatic lung cancer - on Keytruda.  Follows with Dr.  Stable disease for 2 years   Hypertension - continue home lisinopril hydrochlorothiazide.   Ex smoker. -- approx 50 pack year smoker. Stopped 3/2022.    DC home with assist today. She declined Homecare services. Prednisone and Zithromax to complete 5 days."" "
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Asthma, COVID-19, Chronic obstructive pulmonary disease
Clinical narrative: """69-year-old female past medical history of asthma, chronic obstructive pulmonary disease, hypertension and recent diagnosis of COVID-19 on 05/17 who is presenting to the emergency department today for worsening shortness of breath, wheezing consistent with her prior chronic obstructive pulmonary disease exacerbations.  Chronically on 3 L nasal cannula home. This is a 69 YO female with h/o COPD/asthma, metastatic lung cancer on keytruda (stable disease for about 2 years), HTN, recent COVID-19 infectino (3/2022), who presented for evaluation of shortness of breath.    Acute exacerbation of chronic obstructive pulmonary disease Acute on chronic respiratory failure Moderate persistent asthma  - continue prednisone 40 mg daily  - DuoNebs q.4 hours  - Zithromax and 500 mg daily  - concurrently on 3 L nasal cannula, wean as tolerated  - RVP was negative.  Note is made that recent positive COVID test was within 90 day window of her initial COVID infection.  - continued home Symbicort   Elevated troponin as high as 140- likely type 2 NSTEMI/demand mediated elevation.  Cardiology on consult. No CP. No known CAD, but heavy smoking history.  5/24 ECHO: ?  Left Ventricle: Systolic function is normal with an ejection fraction of 55 - 60%. ?  Tricuspid Valve: There is mild regurgitation. The right ventricular systolic pressure is moderately elevated, measuring 54 mmHg.    CARDS cleared for DC home. OP follow up needed.  OP stress test will be discussed.   Metastatic lung cancer - on Keytruda.  Follows with Dr.  Stable disease for 2 years   Hypertension - continue home lisinopril hydrochlorothiazide.   Ex smoker. -- approx 50 pack year smoker. Stopped 3/2022.    DC home with assist today. She declined Homecare services. Prednisone and Zithromax to complete 5 days."" "
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Electrocardiogram abnormal, Ex-tobacco user, Hypothyroidism
Clinical narrative: """69-year-old female past medical history of asthma, chronic obstructive pulmonary disease, hypertension and recent diagnosis of COVID-19 on 05/17 who is presenting to the emergency department today for worsening shortness of breath, wheezing consistent with her prior chronic obstructive pulmonary disease exacerbations.  Chronically on 3 L nasal cannula home. This is a 69 YO female with h/o COPD/asthma, metastatic lung cancer on keytruda (stable disease for about 2 years), HTN, recent COVID-19 infectino (3/2022), who presented for evaluation of shortness of breath.    Acute exacerbation of chronic obstructive pulmonary disease Acute on chronic respiratory failure Moderate persistent asthma  - continue prednisone 40 mg daily  - DuoNebs q.4 hours  - Zithromax and 500 mg daily  - concurrently on 3 L nasal cannula, wean as tolerated  - RVP was negative.  Note is made that recent positive COVID test was within 90 day window of her initial COVID infection.  - continued home Symbicort   Elevated troponin as high as 140- likely type 2 NSTEMI/demand mediated elevation.  Cardiology on consult. No CP. No known CAD, but heavy smoking history.  5/24 ECHO: ?  Left Ventricle: Systolic function is normal with an ejection fraction of 55 - 60%. ?  Tricuspid Valve: There is mild regurgitation. The right ventricular systolic pressure is moderately elevated, measuring 54 mmHg.    CARDS cleared for DC home. OP follow up needed.  OP stress test will be discussed.   Metastatic lung cancer - on Keytruda.  Follows with Dr.  Stable disease for 2 years   Hypertension - continue home lisinopril hydrochlorothiazide.   Ex smoker. -- approx 50 pack year smoker. Stopped 3/2022.    DC home with assist today. She declined Homecare services. Prednisone and Zithromax to complete 5 days."" "
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Respiratory viral panel, Right ventricular systolic pressure increased, SARS-CoV-2 test positive, Tricuspid valve incompetence, Troponin increased
Clinical narrative: """69-year-old female past medical history of asthma, chronic obstructive pulmonary disease, hypertension and recent diagnosis of COVID-19 on 05/17 who is presenting to the emergency department today for worsening shortness of breath, wheezing consistent with her prior chronic obstructive pulmonary disease exacerbations.  Chronically on 3 L nasal cannula home. This is a 69 YO female with h/o COPD/asthma, metastatic lung cancer on keytruda (stable disease for about 2 years), HTN, recent COVID-19 infectino (3/2022), who presented for evaluation of shortness of breath.    Acute exacerbation of chronic obstructive pulmonary disease Acute on chronic respiratory failure Moderate persistent asthma  - continue prednisone 40 mg daily  - DuoNebs q.4 hours  - Zithromax and 500 mg daily  - concurrently on 3 L nasal cannula, wean as tolerated  - RVP was negative.  Note is made that recent positive COVID test was within 90 day window of her initial COVID infection.  - continued home Symbicort   Elevated troponin as high as 140- likely type 2 NSTEMI/demand mediated elevation.  Cardiology on consult. No CP. No known CAD, but heavy smoking history.  5/24 ECHO: ?  Left Ventricle: Systolic function is normal with an ejection fraction of 55 - 60%. ?  Tricuspid Valve: There is mild regurgitation. The right ventricular systolic pressure is moderately elevated, measuring 54 mmHg.    CARDS cleared for DC home. OP follow up needed.  OP stress test will be discussed.   Metastatic lung cancer - on Keytruda.  Follows with Dr.  Stable disease for 2 years   Hypertension - continue home lisinopril hydrochlorothiazide.   Ex smoker. -- approx 50 pack year smoker. Stopped 3/2022.    DC home with assist today. She declined Homecare services. Prednisone and Zithromax to complete 5 days."" "
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: """69-year-old female past medical history of asthma, chronic obstructive pulmonary disease, hypertension and recent diagnosis of COVID-19 on 05/17 who is presenting to the emergency department today for worsening shortness of breath, wheezing consistent with her prior chronic obstructive pulmonary disease exacerbations.  Chronically on 3 L nasal cannula home. This is a 69 YO female with h/o COPD/asthma, metastatic lung cancer on keytruda (stable disease for about 2 years), HTN, recent COVID-19 infectino (3/2022), who presented for evaluation of shortness of breath.    Acute exacerbation of chronic obstructive pulmonary disease Acute on chronic respiratory failure Moderate persistent asthma  - continue prednisone 40 mg daily  - DuoNebs q.4 hours  - Zithromax and 500 mg daily  - concurrently on 3 L nasal cannula, wean as tolerated  - RVP was negative.  Note is made that recent positive COVID test was within 90 day window of her initial COVID infection.  - continued home Symbicort   Elevated troponin as high as 140- likely type 2 NSTEMI/demand mediated elevation.  Cardiology on consult. No CP. No known CAD, but heavy smoking history.  5/24 ECHO: ?  Left Ventricle: Systolic function is normal with an ejection fraction of 55 - 60%. ?  Tricuspid Valve: There is mild regurgitation. The right ventricular systolic pressure is moderately elevated, measuring 54 mmHg.    CARDS cleared for DC home. OP follow up needed.  OP stress test will be discussed.   Metastatic lung cancer - on Keytruda.  Follows with Dr.  Stable disease for 2 years   Hypertension - continue home lisinopril hydrochlorothiazide.   Ex smoker. -- approx 50 pack year smoker. Stopped 3/2022.    DC home with assist today. She declined Homecare services. Prednisone and Zithromax to complete 5 days."" "
Age: 39.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported; expired dose VARIVAX was administered; This spontaneous report was received from a nurse and refers to a 39-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAY-2022, the patient was administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # T012548, expiration date: 10-APR-2022 (strength, dose, anatomical location and route of administration were not provided) for prophylaxis; and a dose of sterile diluent, solution for injection/infusion (strength, dose, lot #, expiry date, indication, anatomical location, and route of administration were not provided) (expired product administered). No additional adverse events reported (no adverse event).
Age: 39.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; expired dose VARIVAX was administered; This spontaneous report was received from a nurse and refers to a 39-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAY-2022, the patient was administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # T012548, expiration date: 10-APR-2022 (strength, dose, anatomical location and route of administration were not provided) for prophylaxis; and a dose of sterile diluent, solution for injection/infusion (strength, dose, lot #, expiry date, indication, anatomical location, and route of administration were not provided) (expired product administered). No additional adverse events reported (no adverse event).
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Biopsy kidney
Clinical narrative: Pt developed hematuria and foaminess in urine 4-5 days after second Pfizer vaccine. Was admitted to hospital on 5/15 with AKI Cr 3s, underwent kidney biopsy showing MPO+ ANCA vasculitis with background IgA nephropathy. Started on pulse steroids and Rituximab with improvement of kidney function. Creatinine had peaked to 4 now improving to 3.