chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dizziness, Electrocardiogram normal, Paraesthesia
Clinical narrative: This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and sulfa drug allergy. The patient received COVID-19 VACCINE (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021; 13:04 in the left deltoid. The pharmacist reports in 11-MAR-2021 and 12-MAR-2021, they combined volume from separate vials, most likely did not do so for this specific patient though. Concomitant medication included brimonidine tartrate, furosemide, metoprolol tartrate, tocopheral, topiramate, and vitamins nos and a Compound Hormone Replacement therapy made in a pharmacy. On 11-MAR-2021 after injection, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120, and impending doom about one minute after the vaccine shot. EMS was called, took her BP (Blood Pressure) which was 170/110 mmHg and HR (Heart Rate) was 120, O2 (Oxygen saturation) was 97% and her mobile EKG (electrocardiogram) was normal prior to the transport. The patient had been to the ER for same complaints prior to vaccination, but they could not figure out what was wrong and those visits resulted being normal. The patient's symptoms became worsened and she agreed to go to the hospital. The patient was discharged from the hospital on 11-MAR-2021, the same day she received the vaccine. On 17-MAR-2021, the patient had been admitted back to the hospital and she was doing better on 18-MAR-2021. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart  rate (NR: not provided) 120 units unspecified, and Oxygen saturation (NR: not provided) 97 %. The action taken with COVID-19 VACCINE was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, impending doom and hypertension was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from patient on 29-MAR-2021. The following information was updated and incorporated into the case narrative : Patient tab (added date of hospital admission, Disease tab - added sulfa drug allergy), event tab changes made (RRT of feeling anxious to impending doom/feeling anxious, onset date added for the event of impending doom, seriousness for shortness of breath, heart rate 120, and impending doom changed to hospitalization and hospital address updated), Concomitant drugs added in product tab (Lasix, Lopressor, Multivitamin, Topamax, Vitamin E, Alphagan eye drops, Compound Hormone Replacement therapy) and narrative changes done (discharge date).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood pressure measurement, Chest pain, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and sulfa drug allergy. The patient received COVID-19 VACCINE (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021; 13:04 in the left deltoid. The pharmacist reports in 11-MAR-2021 and 12-MAR-2021, they combined volume from separate vials, most likely did not do so for this specific patient though. Concomitant medication included brimonidine tartrate, furosemide, metoprolol tartrate, tocopheral, topiramate, and vitamins nos and a Compound Hormone Replacement therapy made in a pharmacy. On 11-MAR-2021 after injection, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120, and impending doom about one minute after the vaccine shot. EMS was called, took her BP (Blood Pressure) which was 170/110 mmHg and HR (Heart Rate) was 120, O2 (Oxygen saturation) was 97% and her mobile EKG (electrocardiogram) was normal prior to the transport. The patient had been to the ER for same complaints prior to vaccination, but they could not figure out what was wrong and those visits resulted being normal. The patient's symptoms became worsened and she agreed to go to the hospital. The patient was discharged from the hospital on 11-MAR-2021, the same day she received the vaccine. On 17-MAR-2021, the patient had been admitted back to the hospital and she was doing better on 18-MAR-2021. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart  rate (NR: not provided) 120 units unspecified, and Oxygen saturation (NR: not provided) 97 %. The action taken with COVID-19 VACCINE was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, impending doom and hypertension was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from patient on 29-MAR-2021. The following information was updated and incorporated into the case narrative : Patient tab (added date of hospital admission, Disease tab - added sulfa drug allergy), event tab changes made (RRT of feeling anxious to impending doom/feeling anxious, onset date added for the event of impending doom, seriousness for shortness of breath, heart rate 120, and impending doom changed to hospitalization and hospital address updated), Concomitant drugs added in product tab (Lasix, Lopressor, Multivitamin, Topamax, Vitamin E, Alphagan eye drops, Compound Hormone Replacement therapy) and narrative changes done (discharge date).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, Hypertension, Oxygen saturation
Clinical narrative: This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and sulfa drug allergy. The patient received COVID-19 VACCINE (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021; 13:04 in the left deltoid. The pharmacist reports in 11-MAR-2021 and 12-MAR-2021, they combined volume from separate vials, most likely did not do so for this specific patient though. Concomitant medication included brimonidine tartrate, furosemide, metoprolol tartrate, tocopheral, topiramate, and vitamins nos and a Compound Hormone Replacement therapy made in a pharmacy. On 11-MAR-2021 after injection, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120, and impending doom about one minute after the vaccine shot. EMS was called, took her BP (Blood Pressure) which was 170/110 mmHg and HR (Heart Rate) was 120, O2 (Oxygen saturation) was 97% and her mobile EKG (electrocardiogram) was normal prior to the transport. The patient had been to the ER for same complaints prior to vaccination, but they could not figure out what was wrong and those visits resulted being normal. The patient's symptoms became worsened and she agreed to go to the hospital. The patient was discharged from the hospital on 11-MAR-2021, the same day she received the vaccine. On 17-MAR-2021, the patient had been admitted back to the hospital and she was doing better on 18-MAR-2021. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart  rate (NR: not provided) 120 units unspecified, and Oxygen saturation (NR: not provided) 97 %. The action taken with COVID-19 VACCINE was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, impending doom and hypertension was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from patient on 29-MAR-2021. The following information was updated and incorporated into the case narrative : Patient tab (added date of hospital admission, Disease tab - added sulfa drug allergy), event tab changes made (RRT of feeling anxious to impending doom/feeling anxious, onset date added for the event of impending doom, seriousness for shortness of breath, heart rate 120, and impending doom changed to hospitalization and hospital address updated), Concomitant drugs added in product tab (Lasix, Lopressor, Multivitamin, Topamax, Vitamin E, Alphagan eye drops, Compound Hormone Replacement therapy) and narrative changes done (discharge date).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Chest pain, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and sulfa drug allergy. The patient received COVID-19 VACCINE (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021; 13:04 in the left deltoid. The pharmacist reports in 11-MAR-2021 and 12-MAR-2021, they combined volume from separate vials, most likely did not do so for this specific patient though. Concomitant medication included brimonidine tartrate, furosemide, metoprolol tartrate, tocopheral, topiramate, and vitamins nos and a Compound Hormone Replacement therapy made in a pharmacy. On 11-MAR-2021 after injection, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120, and impending doom about one minute after the vaccine shot. EMS was called, took her BP (Blood Pressure) which was 170/110 mmHg and HR (Heart Rate) was 120, O2 (Oxygen saturation) was 97% and her mobile EKG (electrocardiogram) was normal prior to the transport. The patient had been to the ER for same complaints prior to vaccination, but they could not figure out what was wrong and those visits resulted being normal. The patient's symptoms became worsened and she agreed to go to the hospital. The patient was discharged from the hospital on 11-MAR-2021, the same day she received the vaccine. On 17-MAR-2021, the patient had been admitted back to the hospital and she was doing better on 18-MAR-2021. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart  rate (NR: not provided) 120 units unspecified, and Oxygen saturation (NR: not provided) 97 %. The action taken with COVID-19 VACCINE was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, impending doom and hypertension was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from patient on 29-MAR-2021. The following information was updated and incorporated into the case narrative : Patient tab (added date of hospital admission, Disease tab - added sulfa drug allergy), event tab changes made (RRT of feeling anxious to impending doom/feeling anxious, onset date added for the event of impending doom, seriousness for shortness of breath, heart rate 120, and impending doom changed to hospitalization and hospital address updated), Concomitant drugs added in product tab (Lasix, Lopressor, Multivitamin, Topamax, Vitamin E, Alphagan eye drops, Compound Hormone Replacement therapy) and narrative changes done (discharge date).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Hypertension
Clinical narrative: This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and sulfa drug allergy. The patient received COVID-19 VACCINE (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021; 13:04 in the left deltoid. The pharmacist reports in 11-MAR-2021 and 12-MAR-2021, they combined volume from separate vials, most likely did not do so for this specific patient though. Concomitant medication included brimonidine tartrate, furosemide, metoprolol tartrate, tocopheral, topiramate, and vitamins nos and a Compound Hormone Replacement therapy made in a pharmacy. On 11-MAR-2021 after injection, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120, and impending doom about one minute after the vaccine shot. EMS was called, took her BP (Blood Pressure) which was 170/110 mmHg and HR (Heart Rate) was 120, O2 (Oxygen saturation) was 97% and her mobile EKG (electrocardiogram) was normal prior to the transport. The patient had been to the ER for same complaints prior to vaccination, but they could not figure out what was wrong and those visits resulted being normal. The patient's symptoms became worsened and she agreed to go to the hospital. The patient was discharged from the hospital on 11-MAR-2021, the same day she received the vaccine. On 17-MAR-2021, the patient had been admitted back to the hospital and she was doing better on 18-MAR-2021. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart  rate (NR: not provided) 120 units unspecified, and Oxygen saturation (NR: not provided) 97 %. The action taken with COVID-19 VACCINE was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, impending doom and hypertension was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from patient on 29-MAR-2021. The following information was updated and incorporated into the case narrative : Patient tab (added date of hospital admission, Disease tab - added sulfa drug allergy), event tab changes made (RRT of feeling anxious to impending doom/feeling anxious, onset date added for the event of impending doom, seriousness for shortness of breath, heart rate 120, and impending doom changed to hospitalization and hospital address updated), Concomitant drugs added in product tab (Lasix, Lopressor, Multivitamin, Topamax, Vitamin E, Alphagan eye drops, Compound Hormone Replacement therapy) and narrative changes done (discharge date).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Patient developed redness and swelling to left arm after 2nd Pfizer COVID vaccine that has been persisting for the past 21 days. Patient has positive DVT in her left arm from ultrasound on 3/31/21. Patient has history of breast cancer with lymph node removal to the left side. No current breast cancer diagnosis and lymph node unable to drain in left arm.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Erythema, Lymphadenopathy, Peripheral swelling, Ultrasound scan
Clinical narrative: Patient developed redness and swelling to left arm after 2nd Pfizer COVID vaccine that has been persisting for the past 21 days. Patient has positive DVT in her left arm from ultrasound on 3/31/21. Patient has history of breast cancer with lymph node removal to the left side. No current breast cancer diagnosis and lymph node unable to drain in left arm.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood alkaline phosphatase, Proteinuria, Urine analysis
Clinical narrative: kidney stone; severe pain; minimal soreness injection site; very tired; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 11:14 (Batch/Lot number: EN6206) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included apixaban (ELIQUIS) and denosumab (PROLIA). On 09Mar2021, patient experienced minimal soreness at the injection site and was very tired so she slept the rest of the day. On 10Mar2021 to 11Mar2021, patient experienced intermittent upper R/L flank discomfort. On 12Mar2021, supine to stand: patient experienced severe pain (10+)/ 30 min/ upper R internal, posterior flank (kidney site); reported to PCP; urinalysis ordered re: kidney stone. On 15Mar2021, patient experienced PCP URINE PROTEIN 1+, PH 9.0 (High), suspect side effects result of Pfizer Covid vaccine on 09Mar2021, 3 days earlier both findings described as potential adverse effects of this vaccine. Post-15Mar2021 starting 16Mar2021, side effects gradually lessened (diurnal number of voids; void volume, reduced diurnal: # of voids; void volume, reduced: chronic negative fluid balance). On 19Mar2021, f/u basic metabolic panel: sodium: 143; chloride 107 (High); potassium: 5.5 (High); urinalysis; urine protein 7.0; ph 7.0. Outcome of the events kidney stone and minimal soreness injection site was recovering and of the events very tired and severe pain was recovered on an unspecified date.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood chloride, Blood potassium, Blood sodium, Fatigue, Nephrolithiasis
Clinical narrative: kidney stone; severe pain; minimal soreness injection site; very tired; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 11:14 (Batch/Lot number: EN6206) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included apixaban (ELIQUIS) and denosumab (PROLIA). On 09Mar2021, patient experienced minimal soreness at the injection site and was very tired so she slept the rest of the day. On 10Mar2021 to 11Mar2021, patient experienced intermittent upper R/L flank discomfort. On 12Mar2021, supine to stand: patient experienced severe pain (10+)/ 30 min/ upper R internal, posterior flank (kidney site); reported to PCP; urinalysis ordered re: kidney stone. On 15Mar2021, patient experienced PCP URINE PROTEIN 1+, PH 9.0 (High), suspect side effects result of Pfizer Covid vaccine on 09Mar2021, 3 days earlier both findings described as potential adverse effects of this vaccine. Post-15Mar2021 starting 16Mar2021, side effects gradually lessened (diurnal number of voids; void volume, reduced diurnal: # of voids; void volume, reduced: chronic negative fluid balance). On 19Mar2021, f/u basic metabolic panel: sodium: 143; chloride 107 (High); potassium: 5.5 (High); urinalysis; urine protein 7.0; ph 7.0. Outcome of the events kidney stone and minimal soreness injection site was recovering and of the events very tired and severe pain was recovered on an unspecified date.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Protein urine, Urine analysis, Vaccination site pain
Clinical narrative: kidney stone; severe pain; minimal soreness injection site; very tired; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 11:14 (Batch/Lot number: EN6206) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included apixaban (ELIQUIS) and denosumab (PROLIA). On 09Mar2021, patient experienced minimal soreness at the injection site and was very tired so she slept the rest of the day. On 10Mar2021 to 11Mar2021, patient experienced intermittent upper R/L flank discomfort. On 12Mar2021, supine to stand: patient experienced severe pain (10+)/ 30 min/ upper R internal, posterior flank (kidney site); reported to PCP; urinalysis ordered re: kidney stone. On 15Mar2021, patient experienced PCP URINE PROTEIN 1+, PH 9.0 (High), suspect side effects result of Pfizer Covid vaccine on 09Mar2021, 3 days earlier both findings described as potential adverse effects of this vaccine. Post-15Mar2021 starting 16Mar2021, side effects gradually lessened (diurnal number of voids; void volume, reduced diurnal: # of voids; void volume, reduced: chronic negative fluid balance). On 19Mar2021, f/u basic metabolic panel: sodium: 143; chloride 107 (High); potassium: 5.5 (High); urinalysis; urine protein 7.0; ph 7.0. Outcome of the events kidney stone and minimal soreness injection site was recovering and of the events very tired and severe pain was recovered on an unspecified date.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood chloride increased, Blood potassium increased, Blood sodium normal, Discomfort, Fatigue
Clinical narrative: kidney stone; severe pain; minimal soreness injection site; very tired; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 11:14 (Batch/Lot number: EN6206) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included apixaban (ELIQUIS) and denosumab (PROLIA). On 09Mar2021, patient experienced minimal soreness at the injection site and was very tired so she slept the rest of the day. On 10Mar2021 to 11Mar2021, patient experienced intermittent upper R/L flank discomfort. On 12Mar2021, supine to stand: patient experienced severe pain (10+)/ 30 min/ upper R internal, posterior flank (kidney site); reported to PCP; urinalysis ordered re: kidney stone. On 15Mar2021, patient experienced PCP URINE PROTEIN 1+, PH 9.0 (High), suspect side effects result of Pfizer Covid vaccine on 09Mar2021, 3 days earlier both findings described as potential adverse effects of this vaccine. Post-15Mar2021 starting 16Mar2021, side effects gradually lessened (diurnal number of voids; void volume, reduced diurnal: # of voids; void volume, reduced: chronic negative fluid balance). On 19Mar2021, f/u basic metabolic panel: sodium: 143; chloride 107 (High); potassium: 5.5 (High); urinalysis; urine protein 7.0; ph 7.0. Outcome of the events kidney stone and minimal soreness injection site was recovering and of the events very tired and severe pain was recovered on an unspecified date.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain, Metabolic function test, Pain, Protein urine, Protein urine absent
Clinical narrative: kidney stone; severe pain; minimal soreness injection site; very tired; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 11:14 (Batch/Lot number: EN6206) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included apixaban (ELIQUIS) and denosumab (PROLIA). On 09Mar2021, patient experienced minimal soreness at the injection site and was very tired so she slept the rest of the day. On 10Mar2021 to 11Mar2021, patient experienced intermittent upper R/L flank discomfort. On 12Mar2021, supine to stand: patient experienced severe pain (10+)/ 30 min/ upper R internal, posterior flank (kidney site); reported to PCP; urinalysis ordered re: kidney stone. On 15Mar2021, patient experienced PCP URINE PROTEIN 1+, PH 9.0 (High), suspect side effects result of Pfizer Covid vaccine on 09Mar2021, 3 days earlier both findings described as potential adverse effects of this vaccine. Post-15Mar2021 starting 16Mar2021, side effects gradually lessened (diurnal number of voids; void volume, reduced diurnal: # of voids; void volume, reduced: chronic negative fluid balance). On 19Mar2021, f/u basic metabolic panel: sodium: 143; chloride 107 (High); potassium: 5.5 (High); urinalysis; urine protein 7.0; ph 7.0. Outcome of the events kidney stone and minimal soreness injection site was recovering and of the events very tired and severe pain was recovered on an unspecified date.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Renal pain, Somnolence, Urine analysis, pH urine increased
Clinical narrative: kidney stone; severe pain; minimal soreness injection site; very tired; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 11:14 (Batch/Lot number: EN6206) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included apixaban (ELIQUIS) and denosumab (PROLIA). On 09Mar2021, patient experienced minimal soreness at the injection site and was very tired so she slept the rest of the day. On 10Mar2021 to 11Mar2021, patient experienced intermittent upper R/L flank discomfort. On 12Mar2021, supine to stand: patient experienced severe pain (10+)/ 30 min/ upper R internal, posterior flank (kidney site); reported to PCP; urinalysis ordered re: kidney stone. On 15Mar2021, patient experienced PCP URINE PROTEIN 1+, PH 9.0 (High), suspect side effects result of Pfizer Covid vaccine on 09Mar2021, 3 days earlier both findings described as potential adverse effects of this vaccine. Post-15Mar2021 starting 16Mar2021, side effects gradually lessened (diurnal number of voids; void volume, reduced diurnal: # of voids; void volume, reduced: chronic negative fluid balance). On 19Mar2021, f/u basic metabolic panel: sodium: 143; chloride 107 (High); potassium: 5.5 (High); urinalysis; urine protein 7.0; ph 7.0. Outcome of the events kidney stone and minimal soreness injection site was recovering and of the events very tired and severe pain was recovered on an unspecified date.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: kidney stone; severe pain; minimal soreness injection site; very tired; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 11:14 (Batch/Lot number: EN6206) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included apixaban (ELIQUIS) and denosumab (PROLIA). On 09Mar2021, patient experienced minimal soreness at the injection site and was very tired so she slept the rest of the day. On 10Mar2021 to 11Mar2021, patient experienced intermittent upper R/L flank discomfort. On 12Mar2021, supine to stand: patient experienced severe pain (10+)/ 30 min/ upper R internal, posterior flank (kidney site); reported to PCP; urinalysis ordered re: kidney stone. On 15Mar2021, patient experienced PCP URINE PROTEIN 1+, PH 9.0 (High), suspect side effects result of Pfizer Covid vaccine on 09Mar2021, 3 days earlier both findings described as potential adverse effects of this vaccine. Post-15Mar2021 starting 16Mar2021, side effects gradually lessened (diurnal number of voids; void volume, reduced diurnal: # of voids; void volume, reduced: chronic negative fluid balance). On 19Mar2021, f/u basic metabolic panel: sodium: 143; chloride 107 (High); potassium: 5.5 (High); urinalysis; urine protein 7.0; ph 7.0. Outcome of the events kidney stone and minimal soreness injection site was recovering and of the events very tired and severe pain was recovered on an unspecified date.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Erythema, Hot flush, Tinnitus
Clinical narrative: Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing.  It is a high pitched tone.  Mostly my left ear.  Hasn't stopped for six weeks now; Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing.  It is a high pitched tone.  Mostly my left ear.  Hasn't stopped for six weeks now; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203 and expiration date: Not available), via an unspecified route of administration in the left arm on 25Feb2021 at 04:15 PM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patients medical history included Hashimotos Thyroiditis and Autoimmune Disorder. The patient had Latex, Zythromax, Remeron allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 25Feb2021 at 04:30 PM, the patient experienced face immediate got bright red and my ears started ringing. The tone was reported to be high pitched mostly in the left ear and it has not stopped for six weeks. The patient received Lipo Flavonoid and acupuncture as treatment for the events. The patient underwent hearing test whose reports were not provided. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, disability, or permanent damage. The clinical outcome of events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Erythema, Tinnitus
Clinical narrative: Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing.  It is a high pitched tone.  Mostly my left ear.  Hasn't stopped for six weeks now; Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing.  It is a high pitched tone.  Mostly my left ear.  Hasn't stopped for six weeks now; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203 and expiration date: Not available), via an unspecified route of administration in the left arm on 25Feb2021 at 04:15 PM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patients medical history included Hashimotos Thyroiditis and Autoimmune Disorder. The patient had Latex, Zythromax, Remeron allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 25Feb2021 at 04:30 PM, the patient experienced face immediate got bright red and my ears started ringing. The tone was reported to be high pitched mostly in the left ear and it has not stopped for six weeks. The patient received Lipo Flavonoid and acupuncture as treatment for the events. The patient underwent hearing test whose reports were not provided. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, disability, or permanent damage. The clinical outcome of events was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: developed tinnitus, fever 101.9, aches (couldn't lift head up for 12 hours)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Magnetic resonance imaging normal, Pain, Pyrexia, Tinnitus
Clinical narrative: developed tinnitus, fever 101.9, aches (couldn't lift head up for 12 hours)
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea, Stridor
Clinical narrative: Anaphylactic reaction; started choking; Difficulty breathing; throat closed up; This is a spontaneous report from a contactable consumers. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 14:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing bleeding issues states was diagnosed at age 27, ongoing heart issues states was diagnosed a long time ago , ongoing compromised autoimmune issues diagnosed at age 27. States this is because of her Ulcerative Colitis diagnosed at age 27 , 2 cardiac arrests they were in 2018 and 2020 , 4 strokes. patient took the first Pfizer vaccine, and had an anaphylactic reaction to it, her throat closed up. she had the reaction about 10-15 minutes after she got the shot. she had difficulty breathing again but was able to use her inhaler and was able to open it up. States she thought she would go into shock and started choking and had difficulty breathing again. Her inhaler was able to open her up. Confirmed this was all the same night, 20Mar2021. Outcome of events: States the symptoms have all improved and think they are gone. The outcome of the events was recovered in 2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Choking, Dyspnoea, Throat tightness
Clinical narrative: Anaphylactic reaction; started choking; Difficulty breathing; throat closed up; This is a spontaneous report from a contactable consumers. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 14:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing bleeding issues states was diagnosed at age 27, ongoing heart issues states was diagnosed a long time ago , ongoing compromised autoimmune issues diagnosed at age 27. States this is because of her Ulcerative Colitis diagnosed at age 27 , 2 cardiac arrests they were in 2018 and 2020 , 4 strokes. patient took the first Pfizer vaccine, and had an anaphylactic reaction to it, her throat closed up. she had the reaction about 10-15 minutes after she got the shot. she had difficulty breathing again but was able to use her inhaler and was able to open it up. States she thought she would go into shock and started choking and had difficulty breathing again. Her inhaler was able to open her up. Confirmed this was all the same night, 20Mar2021. Outcome of events: States the symptoms have all improved and think they are gone. The outcome of the events was recovered in 2021.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Chills, Computerised tomogram, Decreased appetite
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Endoscopy, Hepatobiliary scan, Magnetic resonance imaging, Nausea
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological examination, Urine analysis, Vomiting, Weight decreased
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Adult failure to thrive, Asthenia, Blood culture negative, CSF glucose increased
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF protein normal, CSF red blood cell count positive, CSF white blood cell count, Condition aggravated, Cryptococcus test
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.