chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chills, Dyspnoea
Clinical narrative: sore arm; left ear ache; headache; sore throat; chills; sweats; fatigue; watery eyes; upper lip swollen; face swollen; tightness of chest; shortness of breathe; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 13Mar2021 14:00 (Lot Number: EN6207) as a single dose for covid-19 immunization. Medical history included penicillin allergies and allergies to baked egg whites. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications received within 2 weeks of vaccination. On 13Mar2021 15:00, the patient experienced sore arm, left earache, headache, sore throat, chills, sweats, fatigue, watery eyes, upper lip swollen, face swollen, tightness of chest and shortness of breathe. The events were considered serious with seriousness criteria of disabling/incapacitating. The adverse events resulted in the patient going to the emergency room/department or urgent care and the patient received treatment for the adverse events which included Benadryl. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Mar2021 with sequelae.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Electrocardiogram, Fatigue, Headache, Hyperhidrosis
Clinical narrative: sore arm; left ear ache; headache; sore throat; chills; sweats; fatigue; watery eyes; upper lip swollen; face swollen; tightness of chest; shortness of breathe; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 13Mar2021 14:00 (Lot Number: EN6207) as a single dose for covid-19 immunization. Medical history included penicillin allergies and allergies to baked egg whites. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications received within 2 weeks of vaccination. On 13Mar2021 15:00, the patient experienced sore arm, left earache, headache, sore throat, chills, sweats, fatigue, watery eyes, upper lip swollen, face swollen, tightness of chest and shortness of breathe. The events were considered serious with seriousness criteria of disabling/incapacitating. The adverse events resulted in the patient going to the emergency room/department or urgent care and the patient received treatment for the adverse events which included Benadryl. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Mar2021 with sequelae.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lacrimation increased, Lip swelling, Oral discomfort, Oropharyngeal pain
Clinical narrative: sore arm; left ear ache; headache; sore throat; chills; sweats; fatigue; watery eyes; upper lip swollen; face swollen; tightness of chest; shortness of breathe; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 13Mar2021 14:00 (Lot Number: EN6207) as a single dose for covid-19 immunization. Medical history included penicillin allergies and allergies to baked egg whites. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications received within 2 weeks of vaccination. On 13Mar2021 15:00, the patient experienced sore arm, left earache, headache, sore throat, chills, sweats, fatigue, watery eyes, upper lip swollen, face swollen, tightness of chest and shortness of breathe. The events were considered serious with seriousness criteria of disabling/incapacitating. The adverse events resulted in the patient going to the emergency room/department or urgent care and the patient received treatment for the adverse events which included Benadryl. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Mar2021 with sequelae.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Ear pain, Fatigue
Clinical narrative: sore arm; left ear ache; headache; sore throat; chills; sweats; fatigue; watery eyes; upper lip swollen; face swollen; tightness of chest; shortness of breathe; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 13Mar2021 14:00 (Lot Number: EN6207) as a single dose for covid-19 immunization. Medical history included penicillin allergies and allergies to baked egg whites. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications received within 2 weeks of vaccination. On 13Mar2021 15:00, the patient experienced sore arm, left earache, headache, sore throat, chills, sweats, fatigue, watery eyes, upper lip swollen, face swollen, tightness of chest and shortness of breathe. The events were considered serious with seriousness criteria of disabling/incapacitating. The adverse events resulted in the patient going to the emergency room/department or urgent care and the patient received treatment for the adverse events which included Benadryl. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Mar2021 with sequelae.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Lacrimation increased, Lip swelling, Oropharyngeal pain
Clinical narrative: sore arm; left ear ache; headache; sore throat; chills; sweats; fatigue; watery eyes; upper lip swollen; face swollen; tightness of chest; shortness of breathe; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 13Mar2021 14:00 (Lot Number: EN6207) as a single dose for covid-19 immunization. Medical history included penicillin allergies and allergies to baked egg whites. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications received within 2 weeks of vaccination. On 13Mar2021 15:00, the patient experienced sore arm, left earache, headache, sore throat, chills, sweats, fatigue, watery eyes, upper lip swollen, face swollen, tightness of chest and shortness of breathe. The events were considered serious with seriousness criteria of disabling/incapacitating. The adverse events resulted in the patient going to the emergency room/department or urgent care and the patient received treatment for the adverse events which included Benadryl. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Mar2021 with sequelae.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Swelling face
Clinical narrative: sore arm; left ear ache; headache; sore throat; chills; sweats; fatigue; watery eyes; upper lip swollen; face swollen; tightness of chest; shortness of breathe; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 13Mar2021 14:00 (Lot Number: EN6207) as a single dose for covid-19 immunization. Medical history included penicillin allergies and allergies to baked egg whites. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications received within 2 weeks of vaccination. On 13Mar2021 15:00, the patient experienced sore arm, left earache, headache, sore throat, chills, sweats, fatigue, watery eyes, upper lip swollen, face swollen, tightness of chest and shortness of breathe. The events were considered serious with seriousness criteria of disabling/incapacitating. The adverse events resulted in the patient going to the emergency room/department or urgent care and the patient received treatment for the adverse events which included Benadryl. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Mar2021 with sequelae.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Chest pain, Chills, Death, Dyspnoea
Clinical narrative: one day after the first injection (3/14/21) the patient stated she she myalgias, bodyaches and shortness of breath.  her condition continued and progressed to worsening shortness of breath, dizziness, sweating and palpitations that the patient went to the ED  on 3/16/21 chest xray was normal.  the patient was sent home.  she continued to have symptoms, she had a telephone appointment on 3/17/21 with another provider, there was concern for possible covid infection, she was booked for a covid test on 3/17/21 which was negative.  patient sent me an email Friday afternoon on 3/19/21 stating all of her symptoms and that she was concerned about her health and wanted to know if she should get her second dose.  she was booked for a telephone appointment with me for 3/24/21 to follow up with her however the patient was found unresponsive on 3/23/21 and taken to the ED where she was pronounced deceased.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Pain in extremity, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: one day after the first injection (3/14/21) the patient stated she she myalgias, bodyaches and shortness of breath.  her condition continued and progressed to worsening shortness of breath, dizziness, sweating and palpitations that the patient went to the ED  on 3/16/21 chest xray was normal.  the patient was sent home.  she continued to have symptoms, she had a telephone appointment on 3/17/21 with another provider, there was concern for possible covid infection, she was booked for a covid test on 3/17/21 which was negative.  patient sent me an email Friday afternoon on 3/19/21 stating all of her symptoms and that she was concerned about her health and wanted to know if she should get her second dose.  she was booked for a telephone appointment with me for 3/24/21 to follow up with her however the patient was found unresponsive on 3/23/21 and taken to the ED where she was pronounced deceased.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Death, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: one day after the first injection (3/14/21) the patient stated she she myalgias, bodyaches and shortness of breath.  her condition continued and progressed to worsening shortness of breath, dizziness, sweating and palpitations that the patient went to the ED  on 3/16/21 chest xray was normal.  the patient was sent home.  she continued to have symptoms, she had a telephone appointment on 3/17/21 with another provider, there was concern for possible covid infection, she was booked for a covid test on 3/17/21 which was negative.  patient sent me an email Friday afternoon on 3/19/21 stating all of her symptoms and that she was concerned about her health and wanted to know if she should get her second dose.  she was booked for a telephone appointment with me for 3/24/21 to follow up with her however the patient was found unresponsive on 3/23/21 and taken to the ED where she was pronounced deceased.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Palpitations, SARS-CoV-2 test negative, Unresponsive to stimuli
Clinical narrative: one day after the first injection (3/14/21) the patient stated she she myalgias, bodyaches and shortness of breath.  her condition continued and progressed to worsening shortness of breath, dizziness, sweating and palpitations that the patient went to the ED  on 3/16/21 chest xray was normal.  the patient was sent home.  she continued to have symptoms, she had a telephone appointment on 3/17/21 with another provider, there was concern for possible covid infection, she was booked for a covid test on 3/17/21 which was negative.  patient sent me an email Friday afternoon on 3/19/21 stating all of her symptoms and that she was concerned about her health and wanted to know if she should get her second dose.  she was booked for a telephone appointment with me for 3/24/21 to follow up with her however the patient was found unresponsive on 3/23/21 and taken to the ED where she was pronounced deceased.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye haemorrhage, Eye laser surgery, Photopsia, Retinal tear, Vitreous floaters
Clinical narrative: hemorrhages' in my right eye along with tears; Friday, 19Mar i started noticing flashes in my right eye; seeing lines like blood vessels; This is a spontaneous report from a contactable nurse (patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 16Mar2021 11:00 (63-years-old) as single dose for COVID-19 immunization. Medical history included GERD. Patient is not pregnant. Patient had no Covid prior vaccination. Patient was not Covid tested post vaccination. Facility type Vaccine: School or Student Health Clinic. Concomitant medications included aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX); omeprazole (PROTONIX); ergocalciferol (VIT D); ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); ascorbic acid (VIT C); cetirizine hydrochloride (ZYRAC). The patient previously took macrobid and experienced allergy. On 19Mar2021 12:00 Friday, the patient started noticing flashes in her right eye and started seeing lines like blood vessels. No pain, still had vision. Flashes on Sat, not so much sun and Monday saw ophthalmologist, saw hemorrhages' in her right eye along with tears. Appointed on Wednesday to see retina specialist.  Adverse event start date/time was reported as 19Mar2021 12:00. AE treatment was laser surgery to right eye. The outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, events eye hemorrhage, photopsia and abnormal vision are most likely from intercurrent medical condition not related to the use pf BNT162B2 vaccine.  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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye haemorrhage, Photopsia, Visual impairment
Clinical narrative: hemorrhages' in my right eye along with tears; Friday, 19Mar i started noticing flashes in my right eye; seeing lines like blood vessels; This is a spontaneous report from a contactable nurse (patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 16Mar2021 11:00 (63-years-old) as single dose for COVID-19 immunization. Medical history included GERD. Patient is not pregnant. Patient had no Covid prior vaccination. Patient was not Covid tested post vaccination. Facility type Vaccine: School or Student Health Clinic. Concomitant medications included aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX); omeprazole (PROTONIX); ergocalciferol (VIT D); ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); ascorbic acid (VIT C); cetirizine hydrochloride (ZYRAC). The patient previously took macrobid and experienced allergy. On 19Mar2021 12:00 Friday, the patient started noticing flashes in her right eye and started seeing lines like blood vessels. No pain, still had vision. Flashes on Sat, not so much sun and Monday saw ophthalmologist, saw hemorrhages' in her right eye along with tears. Appointed on Wednesday to see retina specialist.  Adverse event start date/time was reported as 19Mar2021 12:00. AE treatment was laser surgery to right eye. The outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, events eye hemorrhage, photopsia and abnormal vision are most likely from intercurrent medical condition not related to the use pf BNT162B2 vaccine.  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: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dysphagia, Headache, Hemiparesis
Clinical narrative: night of the 25th of March 2 a.m. Woke up in a very wet cold sweat and a splitting headache. Took three ibuprophen, went back to sleep, woke up at 06 a.m. Couldn't brush my teeth;  dropped my tooth brush; my wife said I was talking out of the side of my mouth and slurring my words. I stepped outside for a breath of fresh air; noticed that my left leg was dragging . I then took a step and fell, landing on a near by fence injuring my left bottom rib
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest injury, Cold sweat, Computerised tomogram, Dysarthria, Fall
Clinical narrative: night of the 25th of March 2 a.m. Woke up in a very wet cold sweat and a splitting headache. Took three ibuprophen, went back to sleep, woke up at 06 a.m. Couldn't brush my teeth;  dropped my tooth brush; my wife said I was talking out of the side of my mouth and slurring my words. I stepped outside for a breath of fresh air; noticed that my left leg was dragging . I then took a step and fell, landing on a near by fence injuring my left bottom rib
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Grip strength decreased, Headache, Magnetic resonance imaging
Clinical narrative: night of the 25th of March 2 a.m. Woke up in a very wet cold sweat and a splitting headache. Took three ibuprophen, went back to sleep, woke up at 06 a.m. Couldn't brush my teeth;  dropped my tooth brush; my wife said I was talking out of the side of my mouth and slurring my words. I stepped outside for a breath of fresh air; noticed that my left leg was dragging . I then took a step and fell, landing on a near by fence injuring my left bottom rib
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy with pain behind left ear and face droop (Left side); This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at  11:45 AM (Lot Number: EN 6205) as single dose for Covid-19 immunisation. Medical history included prostate cancer-seeds implant May 2017. Allergies to medication, food, or other products was none known. Concomitant medications included metoprolol succinate; lisinopril; pravastatin, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced Bell's palsy with outcome of not recovered, Pain behind left ear on 24Mar2021 with outcome of not recovered, Face droop (left side) on 29Mar2021 with outcome of not recovered. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment of Methylprednisone dose pack received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Flushing, Paraesthesia
Clinical narrative: Blood pressure was elevated; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ep7533) via an unspecified route of administration at arm left on 30Mar2021 10:00 as single dose for COVID-19 immunization. The patient has other medical history and concomitant medications was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had known allergies. The patient experienced started with sweating then lightheaded nausea and dizzy, 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated on 30Mar2021 10:15. Therapeutic measures were taken as a result of started with sweating then lightheaded nausea and dizzy 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated and was taken to hospital for observation. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Blood pressure was elevated; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ep7533) via an unspecified route of administration at arm left on 30Mar2021 10:00 as single dose for COVID-19 immunization. The patient has other medical history and concomitant medications was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had known allergies. The patient experienced started with sweating then lightheaded nausea and dizzy, 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated on 30Mar2021 10:15. Therapeutic measures were taken as a result of started with sweating then lightheaded nausea and dizzy 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated and was taken to hospital for observation. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Blood pressure was elevated; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy.  30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ep7533) via an unspecified route of administration at arm left on 30Mar2021 10:00 as single dose for COVID-19 immunization. The patient has other medical history and concomitant medications was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had known allergies. The patient experienced started with sweating then lightheaded nausea and dizzy, 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated on 30Mar2021 10:15. Therapeutic measures were taken as a result of started with sweating then lightheaded nausea and dizzy 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated and was taken to hospital for observation. The outcome of the events was recovering.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Client was accidentally given a dose of Moderna following a 1st dose of Pfizer. 1st dose date: 03/10/2021 (Pfizer). 2nd dose date: 04/01/2021 (Moderna). Client reported this to us today. Client did not note any adverse reactions.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Client was accidentally given a dose of Moderna following a 1st dose of Pfizer. 1st dose date: 03/10/2021 (Pfizer). 2nd dose date: 04/01/2021 (Moderna). Client reported this to us today. Client did not note any adverse reactions.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram, Incoherent, Pallor, Posture abnormal
Clinical narrative: patient became very weak; complained of burning in his chest; severe pain on his arm and back.; severe pain on his arm and back.; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 12Mar2021 11:30 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Patient received the first dose on 19Feb2021 12:00 on the left arm. Medical history included diabetes, hypertension (HTN), and heart attack. Concomitant medications included losartan, atorvastatin, fish oil, and an unspecified men's one a day multivitamin. 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 has no known allergies. On 12Mar2021 04:30, three hours after receiving the second dose, patient became very weak and complained of "burning" in his chest and severe pain on his arm and back. AEs resulted in: Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. Number of days of hospitalization is 25. Patient has not recovered from the events.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: patient became very weak; complained of burning in his chest; severe pain on his arm and back.; severe pain on his arm and back.; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 12Mar2021 11:30 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Patient received the first dose on 19Feb2021 12:00 on the left arm. Medical history included diabetes, hypertension (HTN), and heart attack. Concomitant medications included losartan, atorvastatin, fish oil, and an unspecified men's one a day multivitamin. 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 has no known allergies. On 12Mar2021 04:30, three hours after receiving the second dose, patient became very weak and complained of "burning" in his chest and severe pain on his arm and back. AEs resulted in: Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. Number of days of hospitalization is 25. Patient has not recovered from the events.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Chest pain, Pain in extremity
Clinical narrative: patient became very weak; complained of burning in his chest; severe pain on his arm and back.; severe pain on his arm and back.; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 12Mar2021 11:30 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Patient received the first dose on 19Feb2021 12:00 on the left arm. Medical history included diabetes, hypertension (HTN), and heart attack. Concomitant medications included losartan, atorvastatin, fish oil, and an unspecified men's one a day multivitamin. 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 has no known allergies. On 12Mar2021 04:30, three hours after receiving the second dose, patient became very weak and complained of "burning" in his chest and severe pain on his arm and back. AEs resulted in: Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. Number of days of hospitalization is 25. Patient has not recovered from the events.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral atrophy, Confusional state, Electroencephalogram, Headache, Laboratory test
Clinical narrative: My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Scan with contrast normal, Seizure, Vitamin B12 decreased
Clinical narrative: My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Confusional state, Headache, Magnetic resonance imaging
Clinical narrative: My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Thrombosis
Clinical narrative: My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Flushing, Hypoaesthesia oral, Throat irritation
Clinical narrative: Hypertension stress/shock
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Shock, Stress
Clinical narrative: Hypertension stress/shock
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Paraesthesia oral
Clinical narrative: Allergic reaction with mild-mod facial flushing, tongue tingling, no anaphylaxis Diphenhydramine given, no epinephrine, sent to ED, reaction resolved, pt reported similar reaction for for 1st dose
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hypersensitivity, Paraesthesia oral
Clinical narrative: Allergic reaction with mild-mod facial flushing, tongue tingling, no anaphylaxis Diphenhydramine given, no epinephrine, sent to ED, reaction resolved, pt reported similar reaction for for 1st dose
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis, Malaise
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mesenteric vein thrombosis, Nausea, Oedematous pancreatitis, Portal vein thrombosis
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Abnormal faeces, Bundle branch block right, Computerised tomogram abdomen, Decreased appetite
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Lipase normal, Muscle strain
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Oedema, Scan with contrast abnormal, Thrombosis, Vomiting
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper, Activated partial thromboplastin time shortened, Anticoagulant therapy, Computerised tomogram abdomen
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Factor V Leiden mutation, Fatigue, Haematocrit normal, Haemoglobin normal
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, International normalised ratio increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mean platelet volume normal, Platelet count normal, Protein C, Protein S, Red blood cell count normal
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Red cell distribution width normal, Scan with contrast abnormal, Thrombosis mesenteric vessel, Vomiting, White blood cell count abnormal
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Portal vein thrombosis, SARS-CoV-2 test
Clinical narrative: Symptoms:  Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging head abnormal
Clinical narrative: On Friday April 2 at around 6:00 PM, pt. reported feeling fine. She lives alone. Overnight, between 10:00 PM 4/2 and 3:00 AM, she began to feel loss of motor control in her right leg and arm. She had to drag herself to the bathroom. She tried to call her daughter, but could not use her right hand to find the correct button. She also could not use her mind properly. At 10;30 AM on Sunday 4/3 her daughter texted pt. to check on her, but pt. did not respond. At 2:30 PM on Sunday, daughter FaceTimed pt. and found her mother in bed, unable to speak. Daughter called 911 emergency services.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram, Echocardiogram, Magnetic resonance imaging abnormal
Clinical narrative: On Friday April 2 at around 6:00 PM, pt. reported feeling fine. She lives alone. Overnight, between 10:00 PM 4/2 and 3:00 AM, she began to feel loss of motor control in her right leg and arm. She had to drag herself to the bathroom. She tried to call her daughter, but could not use her right hand to find the correct button. She also could not use her mind properly. At 10;30 AM on Sunday 4/3 her daughter texted pt. to check on her, but pt. did not respond. At 2:30 PM on Sunday, daughter FaceTimed pt. and found her mother in bed, unable to speak. Daughter called 911 emergency services.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Motor dysfunction, Thinking abnormal
Clinical narrative: On Friday April 2 at around 6:00 PM, pt. reported feeling fine. She lives alone. Overnight, between 10:00 PM 4/2 and 3:00 AM, she began to feel loss of motor control in her right leg and arm. She had to drag herself to the bathroom. She tried to call her daughter, but could not use her right hand to find the correct button. She also could not use her mind properly. At 10;30 AM on Sunday 4/3 her daughter texted pt. to check on her, but pt. did not respond. At 2:30 PM on Sunday, daughter FaceTimed pt. and found her mother in bed, unable to speak. Daughter called 911 emergency services.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Anal inflammation, Arthritis, Chills, Dizziness
Clinical narrative: Presents to urgent care with swollen neck glands, joint inflammation, headache, non-bloody diarrhea following vaccination for Covid-19 6 days prior. Given Epi-peN
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Muscular weakness, Pharyngeal erythema, Stomatitis
Clinical narrative: Presents to urgent care with swollen neck glands, joint inflammation, headache, non-bloody diarrhea following vaccination for Covid-19 6 days prior. Given Epi-peN
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Diarrhoea, Headache, Lymphadenopathy, SARS-CoV-2 test negative
Clinical narrative: Presents to urgent care with swollen neck glands, joint inflammation, headache, non-bloody diarrhea following vaccination for Covid-19 6 days prior. Given Epi-peN
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient had a history of metastatic colon cancer and collapsed in cardiac arrest shortly after vaccination. CPR was initiated, she was transported to the Hospital ED. Attempts at resuscitation were unsuccessful. I did not care for this patient?my role was in filling out the death certificate. I am basing vaccine type being Pfizer based on media reports of what was being used at this site.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Resuscitation, Syncope
Clinical narrative: Patient had a history of metastatic colon cancer and collapsed in cardiac arrest shortly after vaccination. CPR was initiated, she was transported to the Hospital ED. Attempts at resuscitation were unsuccessful. I did not care for this patient?my role was in filling out the death certificate. I am basing vaccine type being Pfizer based on media reports of what was being used at this site.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Computerised tomogram, Concussion, Deep vein thrombosis, Electrocardiogram
Clinical narrative: blacked out; broke my nose; concussion; DVT; pulmonary embolisms; pain in the calf; minor risk of blood clot in surgery/blood clot was found; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 (also reported as 26Feb2021) 13:00 (Batch/Lot Number: em9810) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Lactose intolerant. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: em9810) on 04Feb2021 13:15 in left arm for COVID-19 immunization. On 26Feb2021 08:00, it was reported "after receiving my second Pfizer vaccine, I blacked out/lost consciousness, broke my nose, and had a concussion. I had maxillofacial surgery the next day to fix his nose. The surgeon informed him that there is a minor risk of blood clot in surgery, but he was not given an anticoagulant. Also on 26Feb2021 08:00, the patient experienced DVT, and pulmonary embolism. The patient was hospitalized from 26Feb2021 to an unspecified date. On Friday, 2Apr2021, Caller went to the hospital because of pain in the calf, and a blood clot was found. He was scanned with CT on lungs and blood clots were also found. Caller mentioned he had "deep vein thrombosis" and "pulmonary embolisms". He was given Lovenox and discharged on 4Apr2021. Caller is currently on anticoagulant Eliquis. 5 weeks later, the patient developed DVT, and now have pulmonary embolisms. The doctor has no way of deciding if the patient should stay on the anticoagulant for the standard time period, or if I will need it for the rest of my life." The events were assessed as serious. The patient was treated with surgery and anti-coagulants. The outcome of the events pain in the calf, and minor risk of blood clot in surgery/blood clot was found was unknown while recovering for the other events.  Follow-up information requested.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Electrocardiogram ambulatory, Electroencephalogram, Facial bones fracture, Loss of consciousness, Maxillofacial operation
Clinical narrative: blacked out; broke my nose; concussion; DVT; pulmonary embolisms; pain in the calf; minor risk of blood clot in surgery/blood clot was found; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 (also reported as 26Feb2021) 13:00 (Batch/Lot Number: em9810) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Lactose intolerant. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: em9810) on 04Feb2021 13:15 in left arm for COVID-19 immunization. On 26Feb2021 08:00, it was reported "after receiving my second Pfizer vaccine, I blacked out/lost consciousness, broke my nose, and had a concussion. I had maxillofacial surgery the next day to fix his nose. The surgeon informed him that there is a minor risk of blood clot in surgery, but he was not given an anticoagulant. Also on 26Feb2021 08:00, the patient experienced DVT, and pulmonary embolism. The patient was hospitalized from 26Feb2021 to an unspecified date. On Friday, 2Apr2021, Caller went to the hospital because of pain in the calf, and a blood clot was found. He was scanned with CT on lungs and blood clots were also found. Caller mentioned he had "deep vein thrombosis" and "pulmonary embolisms". He was given Lovenox and discharged on 4Apr2021. Caller is currently on anticoagulant Eliquis. 5 weeks later, the patient developed DVT, and now have pulmonary embolisms. The doctor has no way of deciding if the patient should stay on the anticoagulant for the standard time period, or if I will need it for the rest of my life." The events were assessed as serious. The patient was treated with surgery and anti-coagulants. The outcome of the events pain in the calf, and minor risk of blood clot in surgery/blood clot was found was unknown while recovering for the other events.  Follow-up information requested.