chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: C-reactive protein normal, CSF protein increased, CSF white blood cell count increased, Computerised tomogram abdomen normal, Computerised tomogram head normal
Clinical narrative: Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-side facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP.  Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100 mg BID 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes rollup into his head . He also complained of sharp pain upon extending his RUE AND RLE. Exam showed b/l inability to close eyes, description of Bells phenomenom, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignant process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timeline detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein; negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malginacyny. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram spine, Computerised tomogram thorax normal, Cytology normal, Electromyogram abnormal, Facial pain
Clinical narrative: Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-side facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP.  Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100 mg BID 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes rollup into his head . He also complained of sharp pain upon extending his RUE AND RLE. Exam showed b/l inability to close eyes, description of Bells phenomenom, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignant process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timeline detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein; negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malginacyny. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Facial paresis, Flow cytometry, Full blood count normal, Guillain-Barre syndrome, Headache
Clinical narrative: Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-side facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP.  Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100 mg BID 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes rollup into his head . He also complained of sharp pain upon extending his RUE AND RLE. Exam showed b/l inability to close eyes, description of Bells phenomenom, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignant process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timeline detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein; negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malginacyny. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Intervertebral disc space narrowing, Lumbar puncture abnormal, Magnetic resonance imaging head abnormal
Clinical narrative: Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-side facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP.  Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100 mg BID 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes rollup into his head . He also complained of sharp pain upon extending his RUE AND RLE. Exam showed b/l inability to close eyes, description of Bells phenomenom, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignant process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timeline detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein; negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malginacyny. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Metabolic function test normal, Muscle spasms, Neurological examination abnormal, Pain
Clinical narrative: Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-side facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP.  Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100 mg BID 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes rollup into his head . He also complained of sharp pain upon extending his RUE AND RLE. Exam showed b/l inability to close eyes, description of Bells phenomenom, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignant process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timeline detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein; negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malginacyny. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Prostatic specific antigen normal, Red blood cell sedimentation rate normal, Spinal osteoarthritis, Tenderness, Treponema test negative
Clinical narrative: Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-side facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP.  Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100 mg BID 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes rollup into his head . He also complained of sharp pain upon extending his RUE AND RLE. Exam showed b/l inability to close eyes, description of Bells phenomenom, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignant process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timeline detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein; negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malginacyny. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vitamin B12 normal
Clinical narrative: Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-side facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP.  Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100 mg BID 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes rollup into his head . He also complained of sharp pain upon extending his RUE AND RLE. Exam showed b/l inability to close eyes, description of Bells phenomenom, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignant process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timeline detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein; negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malginacyny. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: lower back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6200) at the age of 72 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "heart condition" (unspecified if ongoing); "for Bones" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for bone disorder. The following information was reported: BACK PAIN (non-serious) with onset 25Feb2021, outcome "not recovered", described as "lower back pain". Therapeutic measures were taken as a result of back pain.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that until the day of the report the patient had lower back pain and patient has been applying heat and taking paracetamol (TYLENOL) and ibuprofen (ADVIL). The reporter wanted to know if it is a side effect of the vaccine and could her injection with denosumab a week prior the vaccine could had been an issue.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiomyopathy, Haemophilus infection, Haemophilus test positive, Hypoxia
Clinical narrative: Patient had breakthrough infection and expired.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mental status changes, Multiple organ dysfunction syndrome, Pneumonia, SARS-CoV-2 test positive, Septic shock
Clinical narrative: Patient had breakthrough infection and expired.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection, Ventricular tachycardia
Clinical narrative: Patient had breakthrough infection and expired.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough infection and expired.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiac arrest, Death, SARS-CoV-2 test positive
Clinical narrative: Had breakthrough infection and expired.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Vaccine breakthrough infection
Clinical narrative: Had breakthrough infection and expired.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: hx of CLL admitted with AHRF secondary to COVID pneumonia; placed on BIPAP; developed bilateral Pulmonary Embolus, started on Lovenox; had NSTEMI secondary to cardiac strain; experienced loculated pleural effusion and pneumothorax requiring a chest tube; placed on broad spectrum antibiotics; pt's condition worsened; DNR; pt died in the hosp
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Anticoagulant therapy, COVID-19 pneumonia, Cardiac disorder
Clinical narrative: hx of CLL admitted with AHRF secondary to COVID pneumonia; placed on BIPAP; developed bilateral Pulmonary Embolus, started on Lovenox; had NSTEMI secondary to cardiac strain; experienced loculated pleural effusion and pneumothorax requiring a chest tube; placed on broad spectrum antibiotics; pt's condition worsened; DNR; pt died in the hosp
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest tube insertion, Death, Pleural effusion, Pneumothorax, Positive airway pressure therapy
Clinical narrative: hx of CLL admitted with AHRF secondary to COVID pneumonia; placed on BIPAP; developed bilateral Pulmonary Embolus, started on Lovenox; had NSTEMI secondary to cardiac strain; experienced loculated pleural effusion and pneumothorax requiring a chest tube; placed on broad spectrum antibiotics; pt's condition worsened; DNR; pt died in the hosp
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: hx of CLL admitted with AHRF secondary to COVID pneumonia; placed on BIPAP; developed bilateral Pulmonary Embolus, started on Lovenox; had NSTEMI secondary to cardiac strain; experienced loculated pleural effusion and pneumothorax requiring a chest tube; placed on broad spectrum antibiotics; pt's condition worsened; DNR; pt died in the hosp
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pt developed PE but also was a 2 PPD smoker but recently had cut down to 0.5ppd
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: Pt developed PE but also was a 2 PPD smoker but recently had cut down to 0.5ppd
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Extra dose administered, Fatigue, Nausea, Off label use
Clinical narrative: I experienced abdominal pain, my feet turned blue and shingles.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Cyanosis, Herpes zoster
Clinical narrative: I experienced abdominal pain, my feet turned blue and shingles.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Troponin increased
Clinical narrative: Developed chest pain 3 days after vaccination, and was seen at ER.  Testing at ER showed signs of acute heart inflammation.  Was hospitalized for 2 days (10/15/21-10/17/21).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Developed chest pain 3 days after vaccination, and was seen at ER.  Testing at ER showed signs of acute heart inflammation.  Was hospitalized for 2 days (10/15/21-10/17/21).
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:00 (Lot number: Fe3590) at the age of 41 years as dose 3 (booster), single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. ior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), for Covid-19 immunization. The following information was reported: PERICARDITIS (disability) with onset 19Oct2021 07:00, outcome "not recovered", described as "Pericarditis". The event "pericarditis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pericarditis which included ibuprofen and colchicine. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Considering the plausible drug-event temporal association and known safety profile, there is a reasonable possibility that event of Pericarditis was related to suspect drug bnt162b2 (BNT162B2) administration.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:00 (Lot number: Fe3590) at the age of 41 years as dose 3 (booster), single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. ior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), for Covid-19 immunization. The following information was reported: PERICARDITIS (disability) with onset 19Oct2021 07:00, outcome "not recovered", described as "Pericarditis". The event "pericarditis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pericarditis which included ibuprofen and colchicine. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Considering the plausible drug-event temporal association and known safety profile, there is a reasonable possibility that event of Pericarditis was related to suspect drug bnt162b2 (BNT162B2) administration.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine normal, Blood glucose increased, Chest X-ray normal, Full blood count normal, Myoglobin blood
Clinical narrative: Patient received second dose of Pfizer/BioNTech COVID-19 vaccine on 9/27 then subsequently developed chest pain on 10/3 and was seen in ED on 10/4. Patient was diagnosed with new-onset pericarditis and discharged on ibuprofen and colchicine but continued to have symptoms. Patient was seen by cardiologist on 12/3 and recommended that this incident be reported to VAERS.  This is excerpt from the cardiology note: 1. Pericarditis. Dx in October, had syptoms 3 days after getting her COVID  booster. Was transfered to heart hospital where she was seen by cardiology,  had echo with pericarial effusion and started on colchicine. She is almost done  with the colchine (3 mo). EKG today ok, normal. Echo done about 10 days after  starting colchine showed no pericardial fluid only bright pericardium.  No further Rx for now, syptoms resolved.  Will follow closely, no signs of  pericardial constriction at this time.  Notes from heart state that this side  effect was not reported to VAERS (will check to see if it was reported on initial  ER visit).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Patient received second dose of Pfizer/BioNTech COVID-19 vaccine on 9/27 then subsequently developed chest pain on 10/3 and was seen in ED on 10/4. Patient was diagnosed with new-onset pericarditis and discharged on ibuprofen and colchicine but continued to have symptoms. Patient was seen by cardiologist on 12/3 and recommended that this incident be reported to VAERS.  This is excerpt from the cardiology note: 1. Pericarditis. Dx in October, had syptoms 3 days after getting her COVID  booster. Was transfered to heart hospital where she was seen by cardiology,  had echo with pericarial effusion and started on colchicine. She is almost done  with the colchine (3 mo). EKG today ok, normal. Echo done about 10 days after  starting colchine showed no pericardial fluid only bright pericardium.  No further Rx for now, syptoms resolved.  Will follow closely, no signs of  pericardial constriction at this time.  Notes from heart state that this side  effect was not reported to VAERS (will check to see if it was reported on initial  ER visit).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Chest pain, Echocardiogram abnormal, Electrocardiogram normal
Clinical narrative: Patient received second dose of Pfizer/BioNTech COVID-19 vaccine on 9/27 then subsequently developed chest pain on 10/3 and was seen in ED on 10/4. Patient was diagnosed with new-onset pericarditis and discharged on ibuprofen and colchicine but continued to have symptoms. Patient was seen by cardiologist on 12/3 and recommended that this incident be reported to VAERS.  This is excerpt from the cardiology note: 1. Pericarditis. Dx in October, had syptoms 3 days after getting her COVID  booster. Was transfered to heart hospital where she was seen by cardiology,  had echo with pericarial effusion and started on colchicine. She is almost done  with the colchine (3 mo). EKG today ok, normal. Echo done about 10 days after  starting colchine showed no pericardial fluid only bright pericardium.  No further Rx for now, syptoms resolved.  Will follow closely, no signs of  pericardial constriction at this time.  Notes from heart state that this side  effect was not reported to VAERS (will check to see if it was reported on initial  ER visit).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Low density lipoprotein normal, Myoglobin blood decreased, Pericardial effusion, Pericarditis
Clinical narrative: Patient received second dose of Pfizer/BioNTech COVID-19 vaccine on 9/27 then subsequently developed chest pain on 10/3 and was seen in ED on 10/4. Patient was diagnosed with new-onset pericarditis and discharged on ibuprofen and colchicine but continued to have symptoms. Patient was seen by cardiologist on 12/3 and recommended that this incident be reported to VAERS.  This is excerpt from the cardiology note: 1. Pericarditis. Dx in October, had syptoms 3 days after getting her COVID  booster. Was transfered to heart hospital where she was seen by cardiology,  had echo with pericarial effusion and started on colchicine. She is almost done  with the colchine (3 mo). EKG today ok, normal. Echo done about 10 days after  starting colchine showed no pericardial fluid only bright pericardium.  No further Rx for now, syptoms resolved.  Will follow closely, no signs of  pericardial constriction at this time.  Notes from heart state that this side  effect was not reported to VAERS (will check to see if it was reported on initial  ER visit).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Patient received second dose of Pfizer/BioNTech COVID-19 vaccine on 9/27 then subsequently developed chest pain on 10/3 and was seen in ED on 10/4. Patient was diagnosed with new-onset pericarditis and discharged on ibuprofen and colchicine but continued to have symptoms. Patient was seen by cardiologist on 12/3 and recommended that this incident be reported to VAERS.  This is excerpt from the cardiology note: 1. Pericarditis. Dx in October, had syptoms 3 days after getting her COVID  booster. Was transfered to heart hospital where she was seen by cardiology,  had echo with pericarial effusion and started on colchicine. She is almost done  with the colchine (3 mo). EKG today ok, normal. Echo done about 10 days after  starting colchine showed no pericardial fluid only bright pericardium.  No further Rx for now, syptoms resolved.  Will follow closely, no signs of  pericardial constriction at this time.  Notes from heart state that this side  effect was not reported to VAERS (will check to see if it was reported on initial  ER visit).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 11/12/21 presents to EC ED for "multiple seizure activity and increased confusion". PMHx of "atrial fibrillation, hypertension, dementia with psychosis".
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Mental status changes, SARS-CoV-2 test positive, Seizure
Clinical narrative: 11/12/21 presents to EC ED for "multiple seizure activity and increased confusion". PMHx of "atrial fibrillation, hypertension, dementia with psychosis".
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Confusional state, SARS-CoV-2 test positive, Seizure like phenomena
Clinical narrative: 11/12/21 presents to EC ED for "multiple seizure activity and increased confusion". PMHx of "atrial fibrillation, hypertension, dementia with psychosis".
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase normal, Blood albumin decreased, Blood creatinine normal, Blood lactate dehydrogenase increased, Blood potassium normal
Clinical narrative: hospitalized due to COVID
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urea increased, C-reactive protein increased, COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal
Clinical narrative: hospitalized due to COVID
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Fibrin D dimer, Hyperhidrosis, Lung opacity
Clinical narrative: hospitalized due to COVID
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Procalcitonin, SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: hospitalized due to COVID
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized due to COVID
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip pain, Lip swelling, Oral herpes
Clinical narrative: This is an addendum to my Agency report filed at the Health Center on 11/4/2021.    On 11/6/2021 I experienced hives and continued having swelling of my lips. I have not ever had lip fillers or injections.  I continue to have intermittent lip swelling and hives several times a week. Each time I take Benedryl which relieves the symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: This is an addendum to my Agency report filed at the Health Center on 11/4/2021.    On 11/6/2021 I experienced hives and continued having swelling of my lips. I have not ever had lip fillers or injections.  I continue to have intermittent lip swelling and hives several times a week. Each time I take Benedryl which relieves the symptoms.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: administration error: patient only 14
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration error: patient only 14
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Computerised tomogram head, Fatigue, Headache
Clinical narrative: EVER SINCE PATIENT GOT THE SHOT AND HAD NOT BEEN THE SAME; STOMACH PAIN; STOMACH SPASM; WOKE UP MANY TIMES DURING NIGHT IN PAIN; EXTREMITIES FELT LIKE SKIN BADLY BURNED; HORRIBLE ARM PAIN; NAUSEA; LEFT SIDE FACE NUMB AND TORSO NUMB; PAIN; DEATHLY ILL; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was actively played sports. The patient had not overweight and had no underlining ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced pain. On AUG-2021, the patient experienced deathly ill. On AUG-2021, the patient experienced stomach pain. On AUG-2021, the patient experienced stomach spasm. On AUG-2021, the patient experienced woke up many times during night in pain. On AUG-2021, the patient experienced extremities felt like skin badly burned. On AUG-2021, the patient experienced horrible arm pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced left side face numb and torso numb. On 13-AUG-2021, the patient experienced ever since patient got the shot and had not been the same. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and CT scan (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill, and ever since patient got the shot and had not been the same, stomach pain, stomach spasm, waken up many times during night in pain, extremities felt like skin badly burned, horrible arm pain, and nausea on OCT-2021, was recovering from left side face numb and torso numb, and the outcome of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Hypoaesthesia, Malaise, Muscle twitching, Nausea
Clinical narrative: EVER SINCE PATIENT GOT THE SHOT AND HAD NOT BEEN THE SAME; STOMACH PAIN; STOMACH SPASM; WOKE UP MANY TIMES DURING NIGHT IN PAIN; EXTREMITIES FELT LIKE SKIN BADLY BURNED; HORRIBLE ARM PAIN; NAUSEA; LEFT SIDE FACE NUMB AND TORSO NUMB; PAIN; DEATHLY ILL; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was actively played sports. The patient had not overweight and had no underlining ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced pain. On AUG-2021, the patient experienced deathly ill. On AUG-2021, the patient experienced stomach pain. On AUG-2021, the patient experienced stomach spasm. On AUG-2021, the patient experienced woke up many times during night in pain. On AUG-2021, the patient experienced extremities felt like skin badly burned. On AUG-2021, the patient experienced horrible arm pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced left side face numb and torso numb. On 13-AUG-2021, the patient experienced ever since patient got the shot and had not been the same. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and CT scan (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill, and ever since patient got the shot and had not been the same, stomach pain, stomach spasm, waken up many times during night in pain, extremities felt like skin badly burned, horrible arm pain, and nausea on OCT-2021, was recovering from left side face numb and torso numb, and the outcome of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: EVER SINCE PATIENT GOT THE SHOT AND HAD NOT BEEN THE SAME; STOMACH PAIN; STOMACH SPASM; WOKE UP MANY TIMES DURING NIGHT IN PAIN; EXTREMITIES FELT LIKE SKIN BADLY BURNED; HORRIBLE ARM PAIN; NAUSEA; LEFT SIDE FACE NUMB AND TORSO NUMB; PAIN; DEATHLY ILL; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was actively played sports. The patient had not overweight and had no underlining ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced pain. On AUG-2021, the patient experienced deathly ill. On AUG-2021, the patient experienced stomach pain. On AUG-2021, the patient experienced stomach spasm. On AUG-2021, the patient experienced woke up many times during night in pain. On AUG-2021, the patient experienced extremities felt like skin badly burned. On AUG-2021, the patient experienced horrible arm pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced left side face numb and torso numb. On 13-AUG-2021, the patient experienced ever since patient got the shot and had not been the same. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and CT scan (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill, and ever since patient got the shot and had not been the same, stomach pain, stomach spasm, waken up many times during night in pain, extremities felt like skin badly burned, horrible arm pain, and nausea on OCT-2021, was recovering from left side face numb and torso numb, and the outcome of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.