chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lagophthalmos, Magnetic resonance imaging normal, Neck pain, Swelling
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 15:15 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. Medical history included hypertension (HTN), gastrooesophageal reflux disease (GERD), total hysterectomy and osteoarthritis, all from an unknown date and unknown if ongoing. The patient was not pregnant. There were no known drug allergies. Concomitant medication included celecoxib (CELEBREX), omeprazole magnesium (PRILOSEC), estradiol (ESTRACE), metoprolol succinate (TOPROL XL) and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). It was reported that the patient experienced right sided neck pain which began a couple of days after vaccination on 06Feb2021 07:00. On 05Feb2021, her right eye was twitchy. On 06Feb2021, the right side of her face felt swollen. It felt like when you go to the dentist and get numbed. She tried drinking a liquid and it ran out of the right side of her mouth. She went to urgent care and they sent her to the emergency department. She had a CAT-scan, MRI and blood work done which all came back normal. Her right eye was not closing all of the way and they diagnosed her with Bell's Palsy on 07Feb2021. She was prescribed a course of prednisone and Valtrex. She has continued to have right-sided facial paralysis and her right eye will not close. She had had severe pain in her right eye and had to tape it shut to sleep and often during the day because it dries out. She was using Systaine eye drops every couple of hours and an eye gel at night. She was concerned about getting the second dose because she does not want this to get worse. There were no other vaccines in four weeks. There was no COVID prior to vaccination and was not COVID tested post vaccination. The outcome of the event was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Magnetic resonance imaging
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 15:15 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. Medical history included hypertension (HTN), gastrooesophageal reflux disease (GERD), total hysterectomy and osteoarthritis, all from an unknown date and unknown if ongoing. The patient was not pregnant. There were no known drug allergies. Concomitant medication included celecoxib (CELEBREX), omeprazole magnesium (PRILOSEC), estradiol (ESTRACE), metoprolol succinate (TOPROL XL) and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). It was reported that the patient experienced right sided neck pain which began a couple of days after vaccination on 06Feb2021 07:00. On 05Feb2021, her right eye was twitchy. On 06Feb2021, the right side of her face felt swollen. It felt like when you go to the dentist and get numbed. She tried drinking a liquid and it ran out of the right side of her mouth. She went to urgent care and they sent her to the emergency department. She had a CAT-scan, MRI and blood work done which all came back normal. Her right eye was not closing all of the way and they diagnosed her with Bell's Palsy on 07Feb2021. She was prescribed a course of prednisone and Valtrex. She has continued to have right-sided facial paralysis and her right eye will not close. She had had severe pain in her right eye and had to tape it shut to sleep and often during the day because it dries out. She was using Systaine eye drops every couple of hours and an eye gel at night. She was concerned about getting the second dose because she does not want this to get worse. There were no other vaccines in four weeks. There was no COVID prior to vaccination and was not COVID tested post vaccination. The outcome of the event was not recovered.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anal incontinence, Chest pain, Death, Fatigue, Malaise
Clinical narrative: The patient's wife refers that he was not feeling well and was getting worse as time went by till he passed at 10:30pm on February 2, 2021.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urinary incontinence
Clinical narrative: The patient's wife refers that he was not feeling well and was getting worse as time went by till he passed at 10:30pm on February 2, 2021.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: The patient's wife refers that he was not feeling well and was getting worse as time went by till he passed at 10:30pm on February 2, 2021.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: He got the vaccine, 2 days later patient stated that he had a full body red, itching rash.  He went to the ER where they prescribed Famotadine, hydroxyzine and Prednisone for next 5 days.  When the allergy clinic saw the patient on 2/16/21, the rash was already gone.   He has subsequently recovered completely.  He informed the allergy clinic that he tried to see his PCP but they referred him to the ER.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash pruritic
Clinical narrative: He got the vaccine, 2 days later patient stated that he had a full body red, itching rash.  He went to the ER where they prescribed Famotadine, hydroxyzine and Prednisone for next 5 days.  When the allergy clinic saw the patient on 2/16/21, the rash was already gone.   He has subsequently recovered completely.  He informed the allergy clinic that he tried to see his PCP but they referred him to the ER.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed a rash on both feet day after vaccination. Rash resolved with hydrocortisone 2.5% cream, Benadryl, and Allegra after 3 days.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Patient developed a rash on both feet day after vaccination. Rash resolved with hydrocortisone 2.5% cream, Benadryl, and Allegra after 3 days.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Angioedema, Cardiac arrest, Cardiac pacemaker insertion, Catheterisation cardiac
Clinical narrative: Cardiac arrest within 5 min of vaccine injection
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Flushing, Hypersensitivity, Loss of consciousness, Road traffic accident
Clinical narrative: Cardiac arrest within 5 min of vaccine injection
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia, Urticaria, Vital signs measurement
Clinical narrative: Cardiac arrest within 5 min of vaccine injection
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest within 5 min of vaccine injection
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Areflexia, Blood test, Dizziness, Gait disturbance, Headache
Clinical narrative: Patient received vaccine in left deltoid at 9:03 am on Jan 20, 2021.  She had no immediate clinical issues.   At approximately, 10:00 pm on Jan 21, 2021, the patient had a sudden period of unsteadiness leading to a fall at home in her restroom.  She did not have LOC.  EMS summoned and found her to be alert and transported to local ED.  Workup included head imaging (negative for acute illness), laboratory (only remarkable for low potassium, 3.2, UA and CBC normal) and discharged.  Over course of several days, persistent gait difficulty noted.  Sent back to ED for IVF and imaging on 1/25/21.  MR Brain negative for acute event (ischemia or bleed) and labs essentially normal.  Patient received IVF (1 L NS) and discharged. Symptoms persisted and outpatient work up ensued.   ENT evaluation for vertigo negative on Monday Feb 1, 2021 (ENG negative and no response to Epley maneuever) Neurology consulted and saw patient on Feb 4, 2021.  Examination abnormal (primarily with "very strongly positive Romberg sign, reduced vibration in lower extremities, and 1+ patellar reflexes and absent ankle jerks" Working diagnosis of suspected Guillan Barre (post vaccination) Subsequent Testing:   C spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy T-spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy EMG/NCV-2/11/21-"essentially normal study" Lumbar puncture-normal OP and acellular CSF.  Protein 36
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging, Somnolence
Clinical narrative: Patient received vaccine in left deltoid at 9:03 am on Jan 20, 2021.  She had no immediate clinical issues.   At approximately, 10:00 pm on Jan 21, 2021, the patient had a sudden period of unsteadiness leading to a fall at home in her restroom.  She did not have LOC.  EMS summoned and found her to be alert and transported to local ED.  Workup included head imaging (negative for acute illness), laboratory (only remarkable for low potassium, 3.2, UA and CBC normal) and discharged.  Over course of several days, persistent gait difficulty noted.  Sent back to ED for IVF and imaging on 1/25/21.  MR Brain negative for acute event (ischemia or bleed) and labs essentially normal.  Patient received IVF (1 L NS) and discharged. Symptoms persisted and outpatient work up ensued.   ENT evaluation for vertigo negative on Monday Feb 1, 2021 (ENG negative and no response to Epley maneuever) Neurology consulted and saw patient on Feb 4, 2021.  Examination abnormal (primarily with "very strongly positive Romberg sign, reduced vibration in lower extremities, and 1+ patellar reflexes and absent ankle jerks" Working diagnosis of suspected Guillan Barre (post vaccination) Subsequent Testing:   C spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy T-spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy EMG/NCV-2/11/21-"essentially normal study" Lumbar puncture-normal OP and acellular CSF.  Protein 36
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood potassium decreased, CSF cell count normal, Electromyogram normal, Fall
Clinical narrative: Patient received vaccine in left deltoid at 9:03 am on Jan 20, 2021.  She had no immediate clinical issues.   At approximately, 10:00 pm on Jan 21, 2021, the patient had a sudden period of unsteadiness leading to a fall at home in her restroom.  She did not have LOC.  EMS summoned and found her to be alert and transported to local ED.  Workup included head imaging (negative for acute illness), laboratory (only remarkable for low potassium, 3.2, UA and CBC normal) and discharged.  Over course of several days, persistent gait difficulty noted.  Sent back to ED for IVF and imaging on 1/25/21.  MR Brain negative for acute event (ischemia or bleed) and labs essentially normal.  Patient received IVF (1 L NS) and discharged. Symptoms persisted and outpatient work up ensued.   ENT evaluation for vertigo negative on Monday Feb 1, 2021 (ENG negative and no response to Epley maneuever) Neurology consulted and saw patient on Feb 4, 2021.  Examination abnormal (primarily with "very strongly positive Romberg sign, reduced vibration in lower extremities, and 1+ patellar reflexes and absent ankle jerks" Working diagnosis of suspected Guillan Barre (post vaccination) Subsequent Testing:   C spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy T-spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy EMG/NCV-2/11/21-"essentially normal study" Lumbar puncture-normal OP and acellular CSF.  Protein 36
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Gait disturbance, Guillain-Barre syndrome, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Patient received vaccine in left deltoid at 9:03 am on Jan 20, 2021.  She had no immediate clinical issues.   At approximately, 10:00 pm on Jan 21, 2021, the patient had a sudden period of unsteadiness leading to a fall at home in her restroom.  She did not have LOC.  EMS summoned and found her to be alert and transported to local ED.  Workup included head imaging (negative for acute illness), laboratory (only remarkable for low potassium, 3.2, UA and CBC normal) and discharged.  Over course of several days, persistent gait difficulty noted.  Sent back to ED for IVF and imaging on 1/25/21.  MR Brain negative for acute event (ischemia or bleed) and labs essentially normal.  Patient received IVF (1 L NS) and discharged. Symptoms persisted and outpatient work up ensued.   ENT evaluation for vertigo negative on Monday Feb 1, 2021 (ENG negative and no response to Epley maneuever) Neurology consulted and saw patient on Feb 4, 2021.  Examination abnormal (primarily with "very strongly positive Romberg sign, reduced vibration in lower extremities, and 1+ patellar reflexes and absent ankle jerks" Working diagnosis of suspected Guillan Barre (post vaccination) Subsequent Testing:   C spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy T-spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy EMG/NCV-2/11/21-"essentially normal study" Lumbar puncture-normal OP and acellular CSF.  Protein 36
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Nerve conduction studies normal, Neurological examination abnormal, Romberg test positive
Clinical narrative: Patient received vaccine in left deltoid at 9:03 am on Jan 20, 2021.  She had no immediate clinical issues.   At approximately, 10:00 pm on Jan 21, 2021, the patient had a sudden period of unsteadiness leading to a fall at home in her restroom.  She did not have LOC.  EMS summoned and found her to be alert and transported to local ED.  Workup included head imaging (negative for acute illness), laboratory (only remarkable for low potassium, 3.2, UA and CBC normal) and discharged.  Over course of several days, persistent gait difficulty noted.  Sent back to ED for IVF and imaging on 1/25/21.  MR Brain negative for acute event (ischemia or bleed) and labs essentially normal.  Patient received IVF (1 L NS) and discharged. Symptoms persisted and outpatient work up ensued.   ENT evaluation for vertigo negative on Monday Feb 1, 2021 (ENG negative and no response to Epley maneuever) Neurology consulted and saw patient on Feb 4, 2021.  Examination abnormal (primarily with "very strongly positive Romberg sign, reduced vibration in lower extremities, and 1+ patellar reflexes and absent ankle jerks" Working diagnosis of suspected Guillan Barre (post vaccination) Subsequent Testing:   C spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy T-spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy EMG/NCV-2/11/21-"essentially normal study" Lumbar puncture-normal OP and acellular CSF.  Protein 36
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis normal
Clinical narrative: Patient received vaccine in left deltoid at 9:03 am on Jan 20, 2021.  She had no immediate clinical issues.   At approximately, 10:00 pm on Jan 21, 2021, the patient had a sudden period of unsteadiness leading to a fall at home in her restroom.  She did not have LOC.  EMS summoned and found her to be alert and transported to local ED.  Workup included head imaging (negative for acute illness), laboratory (only remarkable for low potassium, 3.2, UA and CBC normal) and discharged.  Over course of several days, persistent gait difficulty noted.  Sent back to ED for IVF and imaging on 1/25/21.  MR Brain negative for acute event (ischemia or bleed) and labs essentially normal.  Patient received IVF (1 L NS) and discharged. Symptoms persisted and outpatient work up ensued.   ENT evaluation for vertigo negative on Monday Feb 1, 2021 (ENG negative and no response to Epley maneuever) Neurology consulted and saw patient on Feb 4, 2021.  Examination abnormal (primarily with "very strongly positive Romberg sign, reduced vibration in lower extremities, and 1+ patellar reflexes and absent ankle jerks" Working diagnosis of suspected Guillan Barre (post vaccination) Subsequent Testing:   C spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy T-spine MRI-negative for demyelinating lesions, ischemic changes or significant degenerative myelopathy EMG/NCV-2/11/21-"essentially normal study" Lumbar puncture-normal OP and acellular CSF.  Protein 36
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Paraesthesia oral, Pharyngeal swelling, Pruritus
Clinical narrative: anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp.  A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp.  A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysgeusia, Flushing, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp.  A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Throat irritation, Tremor
Clinical narrative: anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp.  A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be 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: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Pain in extremity
Clinical narrative: Passed away; Slight soreness in arm; A regulatory report was received from a pharmacist concerning a 72-year-old male patient who received Moderna covid-19 vaccine and death occurred 4 days after the vaccine and also experienced soreness in his arm after the vaccine administration.  The patient's medical history includes diabetes mellitus, Hypertension, Hypercholesterolemia, CVD, previous stroke and Depression. No relevant concomitant medications were reported. No information on allergies.   On 4-FEB-2021 at 10:43 am, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine for the prophylaxis of covid-19 infection.   He had soreness in his arm the day following the shot, but he had no other symptoms.   He passed away on 08-FEB-2021 at 10 am. As per his wife, they never made it to the hospital, and he had poor health prior to vaccination.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable.  The outcome of the event death is fatal.; Reporter's Comments: This is a 72 year old male with hx of diabetes mellitus, hypertension, hypercholesterolemia, and CVD who died 4 days after the vaccine was administered. No autopsy report provided. No further information is expected in this regulatory report case.; Reported Cause(s) of Death: Unknown cause of death
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Injection site pain
Clinical narrative: Passed away; Slight soreness in arm; A regulatory report was received from a pharmacist concerning a 72-year-old male patient who received Moderna covid-19 vaccine and death occurred 4 days after the vaccine and also experienced soreness in his arm after the vaccine administration.  The patient's medical history includes diabetes mellitus, Hypertension, Hypercholesterolemia, CVD, previous stroke and Depression. No relevant concomitant medications were reported. No information on allergies.   On 4-FEB-2021 at 10:43 am, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine for the prophylaxis of covid-19 infection.   He had soreness in his arm the day following the shot, but he had no other symptoms.   He passed away on 08-FEB-2021 at 10 am. As per his wife, they never made it to the hospital, and he had poor health prior to vaccination.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable.  The outcome of the event death is fatal.; Reporter's Comments: This is a 72 year old male with hx of diabetes mellitus, hypertension, hypercholesterolemia, and CVD who died 4 days after the vaccine was administered. No autopsy report provided. No further information is expected in this regulatory report case.; Reported Cause(s) of Death: Unknown cause of death
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Condition aggravated, Dyspnoea, Hypertension, Malaise
Clinical narrative: elevated blood pressure; had trouble breathing; Pneumonia; didn't feel well; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 04Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included diabetes, chronic obstructive pulmonary disease (COPD), high blood pressure, high cholesterol, and prior lung cancer. The patient was not pregnant. The patient had no known allergies. Concomitant medications included insulin detemir (LEVEMIR), metoprolol, umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA), metformin, levothyroxine, saxagliptin hydrochloride (ONGLYZA), and atorvastatin. The patient received first dose of bnt162b2 on 14Jan2021, 10:30 for COVID-19 immunization. It was reported that 2 nights following vaccine, patient had trouble breathing and didn't feel well on 07Feb2021, 12:30. Patient started to feel better but again two days later, she had trouble breathing and elevated blood pressure on 09Feb2021. Patient was admitted to the hospital for 2 days due to the events on an unspecified date and was diagnosed with pneumonia. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. There was unspecified treatment for the events. It was reported that patient was currently hospitalized. The patient did not have other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: elevated blood pressure; had trouble breathing; Pneumonia; didn't feel well; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 04Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included diabetes, chronic obstructive pulmonary disease (COPD), high blood pressure, high cholesterol, and prior lung cancer. The patient was not pregnant. The patient had no known allergies. Concomitant medications included insulin detemir (LEVEMIR), metoprolol, umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA), metformin, levothyroxine, saxagliptin hydrochloride (ONGLYZA), and atorvastatin. The patient received first dose of bnt162b2 on 14Jan2021, 10:30 for COVID-19 immunization. It was reported that 2 nights following vaccine, patient had trouble breathing and didn't feel well on 07Feb2021, 12:30. Patient started to feel better but again two days later, she had trouble breathing and elevated blood pressure on 09Feb2021. Patient was admitted to the hospital for 2 days due to the events on an unspecified date and was diagnosed with pneumonia. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. There was unspecified treatment for the events. It was reported that patient was currently hospitalized. The patient did not have other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Malaise, Pneumonia
Clinical narrative: elevated blood pressure; had trouble breathing; Pneumonia; didn't feel well; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 04Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included diabetes, chronic obstructive pulmonary disease (COPD), high blood pressure, high cholesterol, and prior lung cancer. The patient was not pregnant. The patient had no known allergies. Concomitant medications included insulin detemir (LEVEMIR), metoprolol, umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA), metformin, levothyroxine, saxagliptin hydrochloride (ONGLYZA), and atorvastatin. The patient received first dose of bnt162b2 on 14Jan2021, 10:30 for COVID-19 immunization. It was reported that 2 nights following vaccine, patient had trouble breathing and didn't feel well on 07Feb2021, 12:30. Patient started to feel better but again two days later, she had trouble breathing and elevated blood pressure on 09Feb2021. Patient was admitted to the hospital for 2 days due to the events on an unspecified date and was diagnosed with pneumonia. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. There was unspecified treatment for the events. It was reported that patient was currently hospitalized. The patient did not have other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago.  The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious.  Information on lot/batch has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia, Peripheral swelling, Vaccination site pain
Clinical narrative: had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago.  The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious.  Information on lot/batch has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago.  The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious.  Information on lot/batch has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Hypoaesthesia, Joint swelling
Clinical narrative: had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago.  The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious.  Information on lot/batch has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Off label use, Pain, Pain in extremity, Paraesthesia
Clinical narrative: had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago.  The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious.  Information on lot/batch has been requested.