chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash started slow and now covers most of my body; This is a spontaneous report received from a contactable consumer, the patient.  A 70-years-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in left arm on 02Mar2021 at 12:00 PM as a single dose for COVID-19 vaccination (at the age of 70-years). Medical history included high blood pressure, high cholesterol and the patient was alcoholic and recovering from it. The patient did not have allergies to medications, food or other products. Past drug of the patient included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in left arm on 09Feb2021 at 12:00 PM as a single dose for COVID-19 vaccination (at the age of 70-years). The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Concomitant medications were not reported. On 05Mar2021, the patient experienced rash which started slowly and now covered most of patient's body. The adverse event resulted in visit to doctor or other healthcare professional office/clinic. The patient was told to take Claritin (MANUFACTURER UNKNOWN) and Benedryl (MANUFACTURER UNKNOWN) at night as a treatment of the event rash. At the time of this report, the patient was not recovered from the event rash.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: neuropathy in hand; This is a spontaneous report from a contactable other health professional (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 13Mar2021 10:30 (Lot Number: EN6207) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included restless legs syndrome, attention deficit hyperactivity disorder (ADHD), mitral valve prolapse (MVP), and R ORIF clavicle. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had no allergic reactions. The patient was not pregnant at the time of vaccination. On 04Apr2021, the patient experienced neuropathy in hand.  The patient did not receive any treatment for the reported event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on information available a causal relationship between event "neuropathy in hand" and BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in hand; This is a spontaneous report from a contactable other health professional (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 13Mar2021 10:30 (Lot Number: EN6207) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included restless legs syndrome, attention deficit hyperactivity disorder (ADHD), mitral valve prolapse (MVP), and R ORIF clavicle. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had no allergic reactions. The patient was not pregnant at the time of vaccination. On 04Apr2021, the patient experienced neuropathy in hand.  The patient did not receive any treatment for the reported event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on information available a causal relationship between event "neuropathy in hand" and BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient was not pregnant. The patient medical history was not reported. Concomitant medication included ADVIL 12 HOUR (IBUPROFEN). There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 10:00 PM the patient had experienced Sore arm at injection site, Some chills in the night and very tired and slow moving today. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. On 15Mar2021, the patient had PCR test (Polymerase chain reaction) nasal Swab and resulted as positive. On 18Mar2021 and 20Mar 2021, the patient had PCR test nasal swab and resulted as Negative. On an unspecified date, the outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Movement disorder, Polymerase chain reaction, Vaccination site pain
Clinical narrative: The patient was not pregnant. The patient medical history was not reported. Concomitant medication included ADVIL 12 HOUR (IBUPROFEN). There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 10:00 PM the patient had experienced Sore arm at injection site, Some chills in the night and very tired and slow moving today. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. On 15Mar2021, the patient had PCR test (Polymerase chain reaction) nasal Swab and resulted as positive. On 18Mar2021 and 20Mar 2021, the patient had PCR test nasal swab and resulted as Negative. On an unspecified date, the outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Developed a blood clotting; This is a spontaneous report received from Pfizer sponsored program.   A contactable consumer (patient) of unknown age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) on an unknown date at single dose for COVID-19 immunization. The first dose of vaccine was received on 24Feb2021. Medical history and concomitant drugs were not reported. The consumer reported that two weeks after she had her second dose of Pfizer vaccine she developed a blood clotting. The treatment has been very costly. The outcome of the event was unknown.  Follow-up attempts are needed. Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021229192 same patient, different vaccine dose/event
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulopathy
Clinical narrative: Developed a blood clotting; This is a spontaneous report received from Pfizer sponsored program.   A contactable consumer (patient) of unknown age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) on an unknown date at single dose for COVID-19 immunization. The first dose of vaccine was received on 24Feb2021. Medical history and concomitant drugs were not reported. The consumer reported that two weeks after she had her second dose of Pfizer vaccine she developed a blood clotting. The treatment has been very costly. The outcome of the event was unknown.  Follow-up attempts are needed. Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021229192 same patient, different vaccine dose/event
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Developed a blood clotting; This is a spontaneous report received from Pfizer sponsored program.   A contactable consumer (patient) of unknown age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) on an unknown date at single dose for COVID-19 immunization. The first dose of vaccine was received on 24Feb2021. Medical history and concomitant drugs were not reported. The consumer reported that two weeks after she had her second dose of Pfizer vaccine she developed a blood clotting. The treatment has been very costly. The outcome of the event was unknown.  Follow-up attempts are needed. Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021229192 same patient, different vaccine dose/event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Muscle twitching, Nasopharyngitis, Opisthotonus, Parosmia
Clinical narrative: I had a seizure with no prior history; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of unspecified age and unknow if pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 1st dose, single and she experienced headache and fatigue. It was reported that patient had a severe reaction to second dose of COVID vaccine. She had seizure with no prior history. She was concerned about getting a booster shot. Also want to know what ingredient in vaccine caused this. Proposed response was reported as speak from the attached documents regarding ingredients. It was asked if she was allergic to any ingredient of the vaccine. Without knowing if she was allergic to a specific ingredient it would be difficult to say what caused her reaction. Referred to health care professional (HCP). The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: I had a seizure with no prior history; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of unspecified age and unknow if pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 1st dose, single and she experienced headache and fatigue. It was reported that patient had a severe reaction to second dose of COVID vaccine. She had seizure with no prior history. She was concerned about getting a booster shot. Also want to know what ingredient in vaccine caused this. Proposed response was reported as speak from the attached documents regarding ingredients. It was asked if she was allergic to any ingredient of the vaccine. Without knowing if she was allergic to a specific ingredient it would be difficult to say what caused her reaction. Referred to health care professional (HCP). The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: I had a seizure with no prior history; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of unspecified age and unknow if pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 1st dose, single and she experienced headache and fatigue. It was reported that patient had a severe reaction to second dose of COVID vaccine. She had seizure with no prior history. She was concerned about getting a booster shot. Also want to know what ingredient in vaccine caused this. Proposed response was reported as speak from the attached documents regarding ingredients. It was asked if she was allergic to any ingredient of the vaccine. Without knowing if she was allergic to a specific ingredient it would be difficult to say what caused her reaction. Referred to health care professional (HCP). The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Nausea, Vomiting
Clinical narrative: Within 15 mins I was sweating and nausea, shaking, I passed out for less than 30 secs. I was shaking.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood test, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Within 15 mins I was sweating and nausea, shaking, I passed out for less than 30 secs. I was shaking.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Within 15 mins I was sweating and nausea, shaking, I passed out for less than 30 secs. I was shaking.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Colitis, Computerised tomogram abdomen, Constipation, Diarrhoea
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Sigmoidoscopy abnormal
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, COVID-19, Chills
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Intensive care, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Acute respiratory failure, Alanine aminotransferase increased, Aortic arteriosclerosis, Aspartate aminotransferase increased
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride increased
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine normal, Blood potassium increased, Blood sodium increased, Blood urea increased, COVID-19 pneumonia
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carbon dioxide increased, Cardiomegaly, Chest X-ray abnormal, Chest tube insertion, Computerised tomogram thorax abnormal
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cytokine release syndrome, Death, Dyspnoea, Eosinophil percentage decreased, Gastrointestinal tube insertion
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit increased, Haemoglobin normal, Hepatic enzyme increased, Hyperglycaemia, Intensive care
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung opacity, Monocyte percentage, Neutrophil percentage increased, Platelet count normal, Pneumomediastinum
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia bacterial, Pneumothorax, Protein total decreased, Respiratory viral panel, SARS-CoV-2 test positive
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sepsis, Subcutaneous emphysema, Troponin I normal, Ultrasound Doppler, White blood cell count increased
Clinical narrative: ED to Hosp-Admission Discharged  3/14/2021 - 4/14/2021 (31 days) Hospital  Physician Last attending ? Treatment team Severe sepsis (/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                            Date: 4/14/2021 Admission Date: 3/14/2021       Length of stay: 31 Days PCP: PA Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis (/HCC) Yes       Shortness of breath Yes       Acute respiratory failure with hypoxemia (/HCC) Yes       2019 novel coronavirus?infected pneumonia (NCIP) Yes       Elevated liver enzymes Yes       Hyponatremia Yes       Hypothyroidism Yes       Essential hypertension Yes       Hyperlipidemia Yes             Disposition: Patient Expired on 4/13/2021 at 23:25 _                 Hospital Course   HPI:    patient is a 68 y.o. female presented with covid pneumonia complicated with pneumomediastinum and pneumothorax   Severe sepsis POA complicated by acute hypoxic respiratory failure, cytokine release syndrome, Covid pneumonia with superimposed bacterial PNA  Complicated by pneumomediastinum, subcutaneous emphysema on 3/29 Right apical pneumothorax Status post ant.chest tube insertion 4/4 and lateral chest tube insertion 4/6, Completed Remdesivir therapy and is on Decadron. Completed 8 days of Cefepime for superimposed bacterial infection.  Hyperglycemia without DM2 ICU Acquired Weakness Hypothyroidism  HL  HTN    Patient was placed on comfort measures on 4/13/21.  Family was at bedside including husband, son, daughter, and sister. Morphine gtt was infusing up until the patient passed at 2325.  The patient appeared to be resting comfortably with no signs of pain or respiratory distress.  The patient stopped breathing and this RN was called to the bedside around 1120. She was pronounced at 1125 4/13/21.  Family was at bedside. Funeral home was notified and the body was sent to the morgue.     _
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Patient reported golf-ball sized nodule and redness within 24 hours post vaccination. This reduced over 4 weeks but then shoulder immobility started at week 5.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Imaging procedure, Nodule, Periarthritis
Clinical narrative: Patient reported golf-ball sized nodule and redness within 24 hours post vaccination. This reduced over 4 weeks but then shoulder immobility started at week 5.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: Extreme ongoing (10 weeks so far) nerve pain; muscle pain; joint pain; weakness  in all 4 extremities and hips and shoulders; numbness and tingling in all extremities with the right side being the worst; numbness and tingling in all extremities with the right side being the worst; I am unable to do activities that I used to do; This is spontaneous report from contactable nurse (patient). A 54-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Feb2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration administered in right arm on 05Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included asthma. The patient had known allergies with gluten, latex. Concomitant medication(s) received within 2 weeks of vaccination included vitamin d3; multi vitamin, b complex. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 13:15, the patient experienced extreme ongoing (10 weeks so far) nerve pain, muscle pain, joint pain and weakness in all 4 extremities and hips and shoulders with the right side being the worst. Also with numbness and tingling in all extremities with the right side being the worst. The pain and weakness are severe and debilitating. The patient unable to do activities that used to do and also had to cut down work hours as cannot tolerate the pain and adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone, labs, specialists, physiotherapy, acupuncture. The seriousness of the event was considered as disabling/incapacitating by reporter. Outcome of the events was not recovered.  Device Date : 05May2021 Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Lethargy, Loss of personal independence in daily activities, Muscular weakness, Myalgia
Clinical narrative: Extreme ongoing (10 weeks so far) nerve pain; muscle pain; joint pain; weakness  in all 4 extremities and hips and shoulders; numbness and tingling in all extremities with the right side being the worst; numbness and tingling in all extremities with the right side being the worst; I am unable to do activities that I used to do; This is spontaneous report from contactable nurse (patient). A 54-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Feb2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration administered in right arm on 05Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included asthma. The patient had known allergies with gluten, latex. Concomitant medication(s) received within 2 weeks of vaccination included vitamin d3; multi vitamin, b complex. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 13:15, the patient experienced extreme ongoing (10 weeks so far) nerve pain, muscle pain, joint pain and weakness in all 4 extremities and hips and shoulders with the right side being the worst. Also with numbness and tingling in all extremities with the right side being the worst. The pain and weakness are severe and debilitating. The patient unable to do activities that used to do and also had to cut down work hours as cannot tolerate the pain and adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone, labs, specialists, physiotherapy, acupuncture. The seriousness of the event was considered as disabling/incapacitating by reporter. Outcome of the events was not recovered.  Device Date : 05May2021 Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.