chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: we still got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   The reporter considered the sickness to be probably related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comment: This case was reported by the patient's relative via interactive digital media. The reporter stated that his/her grandparents took Influenza vaccine every year in November, they did not like it, because they had still got sick as usual at the time of reporting, so they did not see a point of it. The reporter thought that the event might had been related to product/device. Additional supportive information: This case was one of the three case reported by the same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR001584:Same reporter
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comment: This case was reported by the patient's relative via interactive digital media. The reporter stated that his/her cousins took Influenza vaccine every year in November, they did not like it, because they had still got sick as usual at the time of reporting, so they did not see a point of it. The reporter thought that the event might had been related to product/device. Additional supportive information: This case was one of the three case reported by the same reporter for different patient. Follow-up would not possible as no contact details were available.   The case was amended on 13-Jan-2023: The product name was updated from Flu vaccine to Influenza vaccine and event causality was updated from yes to possible.; Sender's Comments:  US-GSK-US2023AMR001600:same reporter US-GSK-US2023AMR001584:same reporter
Age: 66.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Asthenia, Back pain, Fatigue
Clinical narrative: Pain and ache in L-4 region, hard to bend over; Debilitating; Feeling tired,/exhaustion/weariness; This case was reported by a consumer via call center representative and described the occurrence of lumbar pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   The patient's past medical history included herpes virus infection (he had struggled with Herpes from a young age). Concomitant products included INFLUENZA VACCINE and lysine (L-Lysine).   On 30th December 2022, the patient received the 1st dose of Shingrix and the 3rd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced lumbar pain, debility and fatigue. On an unknown date, the outcome of the lumbar pain and debility were not recovered/not resolved and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the lumbar pain, debility and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's comments: The reporter was a male patient who had called up to report with adverse events after his 1st dose of Shingrix. The reporter had stated that he experienced feeling tired, exhaustion, weariness, pain and ache in L-4 region, it was hard to bend over, and debilitating. The reporter had also stated that he received a Covid - 19 vaccine booster (3rd booster- non specific) at the same time as his 1st dose of Shingrix vaccine. The reporter also stated that, he had received his flu shot a week earlier than his 1st dose of Shingrix vaccine (non specific). The reporter had also stated that he had struggled with Herpes from a young age. The reporter had consented to follow-up. Additional supportive information : It was unknown if the reporter considered the lumbar pain, debility and fatigue to be related to Covid - 19 vaccine.
Age: 64.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 64 YO got Havrix pediatric dose; 64 YO got Havrix pediatric; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 64-year-old patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 12th July 2022, the patient received Havrix 720. On 12th July 2022, unknown after receiving Havrix 720, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the adult patient received pediatric dose of Havrix vaccine. Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling abnormal, Fluid imbalance, Injection site erythema
Clinical narrative: Stated the syringe was full and she thinks she saw a volume of 2ml; shot administered higher than deltoid region; injection site pain; red at injection site; Shear volume caused feel faint; States the shear volume of fluid is what caused her to feel faint; felt incapacitated; fever; chills; felt sick; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 4th January 2023, unknown after receiving Shingrix, the patient experienced overdose and vaccine administered at inappropriate site. In January 2023, the patient experienced injection site pain, injection site erythema, felt faint, fluid imbalance, feeling abnormal, fever, chills and feeling unwell. On an unknown date, the outcome of the injection site pain, felt faint, fluid imbalance, feeling abnormal, fever, chills, feeling unwell, overdose and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, felt faint, fluid imbalance, feeling abnormal, fever, chills and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The consumer was the reporter. The patient received Shingrix in left deltoid region, but administered at a higher spot than normally given, near the joint area. The reporter stated that the shear volume of fluid was what caused her to feel faint.  The reporter stated the syringe was full and she thought she saw a volume of 2 ml. The reporter declined to provide PCP's (primary care physician) information as she wanted to speak with them first. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Shingrix near the joint area, which led to vaccine administered at inappropriate site and received more than the recommended volume of Shingrix, which led to overdose.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Overdose, Product administered at inappropriate site, Pyrexia
Clinical narrative: Stated the syringe was full and she thinks she saw a volume of 2ml; shot administered higher than deltoid region; injection site pain; red at injection site; Shear volume caused feel faint; States the shear volume of fluid is what caused her to feel faint; felt incapacitated; fever; chills; felt sick; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 4th January 2023, unknown after receiving Shingrix, the patient experienced overdose and vaccine administered at inappropriate site. In January 2023, the patient experienced injection site pain, injection site erythema, felt faint, fluid imbalance, feeling abnormal, fever, chills and feeling unwell. On an unknown date, the outcome of the injection site pain, felt faint, fluid imbalance, feeling abnormal, fever, chills, feeling unwell, overdose and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, felt faint, fluid imbalance, feeling abnormal, fever, chills and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The consumer was the reporter. The patient received Shingrix in left deltoid region, but administered at a higher spot than normally given, near the joint area. The reporter stated that the shear volume of fluid was what caused her to feel faint.  The reporter stated the syringe was full and she thought she saw a volume of 2 ml. The reporter declined to provide PCP's (primary care physician) information as she wanted to speak with them first. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Shingrix near the joint area, which led to vaccine administered at inappropriate site and received more than the recommended volume of Shingrix, which led to overdose.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site vesicles
Clinical narrative: Bubbly hematoma at injection site; Blood blister at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site hematoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 23rd December 2022, 7 days after receiving Shingrix, the patient experienced injection site hematoma and injection site blisters. On an unknown date, the outcome of the injection site hematoma and injection site blisters were unknown.   It was unknown if the reporter considered the injection site hematoma and injection site blisters to be related to Shingrix.     Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment:  The patient was on oral chemotherapy received 1st dose of Shingrix and 7 days later developed a big bubbly hematoma almost like a blood blister at the injection site. On 23rd December 2022 the patient went to the physician's office with a hematoma that took up a large space in the upper arm which was not specified.  The reporter wants to know if patient should receive the 2nd Shingrix vaccine at 1 month or 2 months or even if the patient should receive the 2nd vaccine. The vaccine administration facility was the same as primary reporter. The physician provided their information to be contacted for follow-up.  The reporter consented to follow up.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Angiogram cerebral abnormal, Arteriogram carotid abnormal, Blood creatinine increased
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium decreased, Blood thyroid stimulating hormone normal, Brain natriuretic peptide increased, COVID-19, Cerebral arteriosclerosis
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral infarction, Cerebrovascular accident, Computerised tomogram head abnormal, Computerised tomogram venography head, Confusional state
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Culture urine, Diastolic dysfunction, Echocardiogram abnormal, Ejection fraction, Electrocardiogram ambulatory
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Encephalopathy, Hyponatraemia, Hypophagia, Hypoxia, Illness
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Lacunar infarction, Lethargy, Magnetic resonance imaging head abnormal, Malaise, Malnutrition
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: QRS axis abnormal, Respiratory symptom, SARS-CoV-2 test positive, Troponin increased, Urinary tract infection
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis abnormal, Venogram
Clinical narrative: Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Haemorrhage, Hypoaesthesia, Orthosis user, Pain
Clinical narrative: The pharmacist gave me the shot and there was a sharp burning feeling.  He put pressure on it and took it off and I was bleeding profusely.  He applied pressure again, then when he turned to get the bandaid blood was running down my arm.  When I went home, and looked in the mirror, and realized the shot was not in the right spot.  Then as the day went on, I was having pains in my arm and pain radiating down my arm.  Thumb and index finger became numb.  Also woke me up out of sleep that night.  By day three, I was still  having the same problems and I went to urgent care.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Product administered at inappropriate site, Sleep disorder
Clinical narrative: The pharmacist gave me the shot and there was a sharp burning feeling.  He put pressure on it and took it off and I was bleeding profusely.  He applied pressure again, then when he turned to get the bandaid blood was running down my arm.  When I went home, and looked in the mirror, and realized the shot was not in the right spot.  Then as the day went on, I was having pains in my arm and pain radiating down my arm.  Thumb and index finger became numb.  Also woke me up out of sleep that night.  By day three, I was still  having the same problems and I went to urgent care.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dizziness, Fatigue, Hot flush
Clinical narrative: 12/13/2022 sore throat; dizziness; fatigue; diarrhea; hot flashes; tested positive for covid for 12 days.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: 12/13/2022 sore throat; dizziness; fatigue; diarrhea; hot flashes; tested positive for covid for 12 days.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Child was given vaccine combination Pediatrix ( DTAP-Hepatitis B- IPV ) along with a 2nd dose of IPV single dose IM -Sanofi Lot # VB901M . Hepatitis B #3 was too early  . Child received 2 doses of IPV . Same day child was given on schedule Rotavirus (Rota-Teq) Prevnar 13.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Cerebellar stroke, Computerised tomogram, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: After the bivalent vaccine, I suffered an ischemic stoke 4 weeks later with no know history of stokes in the family. It was in my left cerebellum.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna Bivalent Booster was given but only half of the dose. Wrong dosage given.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Erythema, Purulent discharge, Rash
Clinical narrative: Severe rash underarms with redness and puss draining from rash. Also experienced chest pains and chest pressure especially at night.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna Bivalent Booster was given to patient but was only given half the dose. Wrong dose given.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for third covid vaccine. She was late in getting her third one. It should have been given months before. Patient should have gotten the Pfizer Bivalent not the third Pfizer Covid vaccine. The bivalent for this age group was not available at the time the Covid vaccine was given.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Chest X-ray, Chest scan, Cognitive test
Clinical narrative: On February 14th I experienced a Transient Ischemic Stroke (TIA).  I was admitted to Emergency - Medical Center for treatment, testing and observation.  I was released the following afternoon (Feb. 15) upon completion of testing.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Magnetic resonance imaging, Neurological examination, SARS-CoV-2 test
Clinical narrative: On February 14th I experienced a Transient Ischemic Stroke (TIA).  I was admitted to Emergency - Medical Center for treatment, testing and observation.  I was released the following afternoon (Feb. 15) upon completion of testing.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: On February 14th I experienced a Transient Ischemic Stroke (TIA).  I was admitted to Emergency - Medical Center for treatment, testing and observation.  I was released the following afternoon (Feb. 15) upon completion of testing.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was only given half dose of Moderna Bivalent Booster. Patient was to be given 0.5mcg. Wrong dose given.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Anion gap increased, COVID-19, Hyperkalaemia
Clinical narrative: Patient received Moderna COVID vaccine on 1/4/22 and 2/1/22. On 1/3/23, patient tested positive for COVID. On 1/7/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia secondary to COVID19 infection, lactic acidosis and severe metabolic acidosis with increased anion gap, and AKI with hyperkalemia. As of today (1/13/23), patient is still admitted in the med/surg unit.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lactic acidosis, Metabolic acidosis, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 1/4/22 and 2/1/22. On 1/3/23, patient tested positive for COVID. On 1/7/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia secondary to COVID19 infection, lactic acidosis and severe metabolic acidosis with increased anion gap, and AKI with hyperkalemia. As of today (1/13/23), patient is still admitted in the med/surg unit.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Thrombosis, X-ray
Clinical narrative: blod clot
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Incorrect dosage for age 5 pediatric
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given half dose of Moderna Bivalent Booster and was suppose to receive 0.5mcg. Wrong dose given.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact
Clinical narrative: First injection, patient pulled away and patient didn't receive any amount of vaccine.  It was all on her skin.  Injected her a second time with correct amount.  Patient is ok.  This is the bivalent dose.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Cryotherapy, Skin lesion, Skin lesion removal, Squamous cell carcinoma
Clinical narrative: A lesion developed on right wrist about 2 weeks after shots..  round sore 8-9mm.  Grew  to 20mm and ulcerated..  Shave biopsy determined it was Acantholytic Squamous Cell Carcinoma.  After booster, numerous more lesions showed up.  All were removed by surgical excision.  Since then, any new new "growths" are removed using liq. N2.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ulcer
Clinical narrative: A lesion developed on right wrist about 2 weeks after shots..  round sore 8-9mm.  Grew  to 20mm and ulcerated..  Shave biopsy determined it was Acantholytic Squamous Cell Carcinoma.  After booster, numerous more lesions showed up.  All were removed by surgical excision.  Since then, any new new "growths" are removed using liq. N2.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Pyrexia, Ventricular extrasystoles
Clinical narrative: Symptoms occurred the night of 10/10/2022 after receiving vaccine fever; heart rate pvc;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored longer than recommended period of time (>28 days)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored (post puncture of vial) beyond recommended length of storage (>27 days)
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chest pain, Electrocardiogram normal, Pain in extremity, Sleep disorder
Clinical narrative: Heart fluttering, pain in chest, pain in left arm, waking up in middle of night due to pain  I went to the doctor three times. I went to primary, urgent care, and the hospital. All of the EKGs were normal but I?m still experiencing adverse effects
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Laboratory test, Visual field defect
Clinical narrative: Ischemic stroke occipital lobe w/ residual vision field deficit
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine vial stored post puncture for period of 28 days
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac disorder
Clinical narrative: I have recently been diagnosed with heart disease - I have not had this before, I dont know if its vaccine related or not
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Significantly worsening tinnitus
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chest pain
Clinical narrative: Patient received Moderna COVID vaccine on 2/6/21 (lot # 013M20A), 3/6/21 (lot # 029A21A), 11/24/21 (lot # 065F21A), and 4/13/21 (lot # 033K21A). On 1/9/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia due to COVID-19 pneumonia and chest pain NSTEMI likely 2/2 demand ischemia type 2 myocardial infarction.  As of today (1/13/23), patient is still admitted in the med/surg unit.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Myocardial ischaemia, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 2/6/21 (lot # 013M20A), 3/6/21 (lot # 029A21A), 11/24/21 (lot # 065F21A), and 4/13/21 (lot # 033K21A). On 1/9/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia due to COVID-19 pneumonia and chest pain NSTEMI likely 2/2 demand ischemia type 2 myocardial infarction.  As of today (1/13/23), patient is still admitted in the med/surg unit.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Choking, Dysphagia, Dyspnoea, Heart rate irregular
Clinical narrative: CHOKED ON FOOD; BONES HURT; HEART GOES REALLY FAST/ IRREGULAR HEARTBEAT; SWALLOWING DIFFICULTY; DIFFICULTY BREATHING AND FORGETS TO  BREATHE; SHE COULD NOT GET OUT OF BED (LITERALLY THE DAY AFTER SHE COULD NOT MOVE)/ COULD NOT LIFT HER PHONE; TINGLING IN FEET; MUSCLES HURT; This spontaneous report received from a patient concerned a 4 decade old female with unspecified race and ethnicity. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included: The patient used to be very active but currently not. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 30 years old. No concomitant medications were reported.  On an unspecified date (since the vaccination), the patient experienced swallowing difficulty, that patient chokes on food, had difficulty breathing and forgets how to breathe, had tingling in feet and had lots of issues. The patient had been recording these issues with doctor. The patient thought she had Guillain Barre Syndrome. The patient cannot function properly and it was annoying. The patient also reported that after receiving the vaccine she could not get out of bed (literally the day after she could not move) and was not able to lift her phone. The patient had gone to doctor and doctor had kept a list. The patient had muscles and bones hurt. The patient also had to stand up because her heart goes really fast/ irregular heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscles hurt, bones hurt, heart goes really fast/ irregular heartbeat, swallowing difficulty, difficulty breathing and forgets to breathe, tingling in feet, choked on food and she could not get out of bed (literally the day after she could not move)/ could not lift her phone was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230119928.; Sender's Comments: V0: 20230118624-CHOKED ON FOOD. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.