chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cerebral venous sinus thrombosis, Jugular vein thrombosis, Magnetic resonance imaging, Transverse sinus thrombosis
Clinical narrative: Brain clot: acute thrombosis of the Left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (reported as 19Mar2021; pending clarification). (Batch/Lot Number: EL9266) as single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included desogestrel, ethinylestradiol (PIMTREA) taken for an unspecified indication, start and stop date were not reported. The patient previously took diflucan and experienced allergy. The patient experienced brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis (hospitalization, disability, life threatening) on 10Mar2021 12:45. The patient was hospitalized for brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis for 6 days. The patient was treated with Heparin and Coumadin. The event resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received the second dose of bnt162b2 on an unspecified date (reported as 18Mar2021; pending clarification), lot number: EN6204, on right arm. The patient was recovering from the event. The patient was not diagnosed with COVID prior to vaccination. Patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the current available information, the events occurred prior to BNT162B2 administration (this information need be clarified). The reported events are considered as an intercurrent or underlying condition which is not related to the suspected drug at this time.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac arrest, Hyperglycaemia, Lung infiltration, Pulmonary embolism
Clinical narrative: Acute pulmonary embolism; cardiac arrest; atrial fibrillation with rvr; pulmonary infiltrate right upper lobe; hyperglycemia; This is a spontaneous report from a contactable Nurse (patient herself). A 68-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Dec2020 11:45 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation at a hospital, at 68 years old. Patient is not pregnant. Medical history included hypothyroid from an unknown date. Patient has no COVID prior vaccination and has not tested for COVID post vaccination. Patient has no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced acute pulmonary embolism, cardiac arrest, atrial fibrillation with rvr, pulmonary infiltrate right upper lobe, hyperglycemia on 21Feb2021 05:00 which required Emergency room/department or urgent care. The patient was hospitalized (unspecified date) due to the events for 4 days.  Therapeutic measures were taken included cardioversion twice and embolectomy. Outcome of the events was recovered with sequelae (with lasting effects) on an unspecified date. Seriousness criteria was hospitalization and life-threatening.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.  A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose  for covid-19 immunisation  .  Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity.  The patient experienced arm was starting to go numb/get heavy  on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms  on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry  on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him  on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling  on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events.  The patient underwent lab tests and procedures which included heart rate: started elevating   on 08Apr2021 , sars-cov-2 test: negative   on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA).   The patient visited her PCP and a  Bloodwork was scheduled.  Follow up information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.  A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose  for covid-19 immunisation  .  Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity.  The patient experienced arm was starting to go numb/get heavy  on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms  on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry  on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him  on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling  on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events.  The patient underwent lab tests and procedures which included heart rate: started elevating   on 08Apr2021 , sars-cov-2 test: negative   on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA).   The patient visited her PCP and a  Bloodwork was scheduled.  Follow up information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Bone pain, Chapped lips, Chromaturia, Dehydration
Clinical narrative: arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.  A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose  for covid-19 immunisation  .  Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity.  The patient experienced arm was starting to go numb/get heavy  on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms  on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry  on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him  on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling  on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events.  The patient underwent lab tests and procedures which included heart rate: started elevating   on 08Apr2021 , sars-cov-2 test: negative   on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA).   The patient visited her PCP and a  Bloodwork was scheduled.  Follow up information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Lip blister, Muscle spasms, Myalgia
Clinical narrative: arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.  A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose  for covid-19 immunisation  .  Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity.  The patient experienced arm was starting to go numb/get heavy  on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms  on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry  on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him  on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling  on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events.  The patient underwent lab tests and procedures which included heart rate: started elevating   on 08Apr2021 , sars-cov-2 test: negative   on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA).   The patient visited her PCP and a  Bloodwork was scheduled.  Follow up information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.  A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose  for covid-19 immunisation  .  Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity.  The patient experienced arm was starting to go numb/get heavy  on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms  on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry  on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him  on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling  on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events.  The patient underwent lab tests and procedures which included heart rate: started elevating   on 08Apr2021 , sars-cov-2 test: negative   on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA).   The patient visited her PCP and a  Bloodwork was scheduled.  Follow up information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: stroke; Brain bleed; Brain blood clot; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program named Corporate (Pfizer) Social Media Platforms. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:15 as single dose for covid-19 immunisation.  Medical history reported as none.  The patient's concomitant medications were not reported.  The patient experienced brain blood clot on 25Mar2021 08:00 , stroke and brain bleed on an unspecified date.  The patient was hospitalized for brain blood clot, stroke, brain bleed for 7 days.  Therapeutic measures were taken as a result of brain blood clot, stroke, brain bleed included Ventillator.  The patient died on 02Apr2021.  An autopsy was not performed. The outcome of events was fatal. No other vaccine in four weeks; No covid prior vaccination.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain blood clot; stroke; Brain bleed
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aneurysm, Death, Dizziness, Musculoskeletal stiffness, Nausea
Clinical narrative: stroke; Brain bleed; Brain blood clot; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program named Corporate (Pfizer) Social Media Platforms. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:15 as single dose for covid-19 immunisation.  Medical history reported as none.  The patient's concomitant medications were not reported.  The patient experienced brain blood clot on 25Mar2021 08:00 , stroke and brain bleed on an unspecified date.  The patient was hospitalized for brain blood clot, stroke, brain bleed for 7 days.  Therapeutic measures were taken as a result of brain blood clot, stroke, brain bleed included Ventillator.  The patient died on 02Apr2021.  An autopsy was not performed. The outcome of events was fatal. No other vaccine in four weeks; No covid prior vaccination.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain blood clot; stroke; Brain bleed
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulseless electrical activity, Seizure, Vomiting
Clinical narrative: stroke; Brain bleed; Brain blood clot; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program named Corporate (Pfizer) Social Media Platforms. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:15 as single dose for covid-19 immunisation.  Medical history reported as none.  The patient's concomitant medications were not reported.  The patient experienced brain blood clot on 25Mar2021 08:00 , stroke and brain bleed on an unspecified date.  The patient was hospitalized for brain blood clot, stroke, brain bleed for 7 days.  Therapeutic measures were taken as a result of brain blood clot, stroke, brain bleed included Ventillator.  The patient died on 02Apr2021.  An autopsy was not performed. The outcome of events was fatal. No other vaccine in four weeks; No covid prior vaccination.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain blood clot; stroke; Brain bleed
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Paraplegia
Clinical narrative: guillain barre syndrome; Paralysis from the waist down; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 09:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced Guillain-Barre syndrome and Paralysis from the waist down on 21Mar2021 13:00. Adverse event (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Therapeutic measures were taken as a result of events included Intravenous immunoglobulin (IVIG) and now needing long term care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was tested for COVID-19. The outcome of the events was recovering.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My mother passed away/death cause: natural causes; This is a spontaneous report from a contactable consumer for patient (reporter's mother).   A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 74 years old, via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  Medical history included Stage 4 metastatic lung cancer, Diabetes type 2, Hypertension. Other medications in two weeks was Yes, while unspecified. The reporter reported that my mother passed away/death cause: natural causes on 05Apr2021 07:00.  4 days after receiving this vaccine. No treatment received. An autopsy was not performed. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Information on batch/lot number has been requested.; Reported Cause(s) of Death: My mother passed away/death cause: natural causes
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: fainted; felt dizzy and lightheaded; heart palpitations; sweaty; glucose levels in my body dropped to 50; not felt like myself; felt sick after eating; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received the first dose of bnt162b2 via an unspecified route of administration, administered in Left arm on 01Apr2021 15:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was allergic with Bactrim and Iodine. The patient was not pregnant. 5 minutes after receiving her first dose of the COVID-19 vaccine, she fainted. In the days following (Apr2021), she had felt dizzy and lightheaded, had suffered from heart palpitations and had been very sweaty. Her glucose levels in her body dropped to 50. She had not felt like herself and also had felt sick after eating. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient received the treatment (Multiple doctor's visits) for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations, Syncope
Clinical narrative: fainted; felt dizzy and lightheaded; heart palpitations; sweaty; glucose levels in my body dropped to 50; not felt like myself; felt sick after eating; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received the first dose of bnt162b2 via an unspecified route of administration, administered in Left arm on 01Apr2021 15:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was allergic with Bactrim and Iodine. The patient was not pregnant. 5 minutes after receiving her first dose of the COVID-19 vaccine, she fainted. In the days following (Apr2021), she had felt dizzy and lightheaded, had suffered from heart palpitations and had been very sweaty. Her glucose levels in her body dropped to 50. She had not felt like herself and also had felt sick after eating. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient received the treatment (Multiple doctor's visits) for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Myalgia, Pain in extremity, Rhabdomyolysis, SARS-CoV-2 test
Clinical narrative: severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; Pain in my left arm from vaccine started on Wednesday; Wednesday I worked on upper body and arm/chest/back muscle pains began/On Thursday, I worked on legs and severe quad/glute/hip muscle pain began; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:30 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included reported as none. Concomitant Therapy included multivitamin, joint suppliment. The patient was hospitalized with severe rhabdomyolysis a few days after receiving his first dose of the Pfizer vaccine. He received the vaccine Tuesday 23Mar2021 and went to the gym Wednesday 24Mar2021 and Thursday 25Mar2021. Pain in his left arm from vaccine started on Wednesday and additional muscle pain was induced post workout on both days. Wednesday he worked on upper body and arm/chest/back muscle pains began. On Thursday, he worked on legs and severe quad/glute/hip muscle pain began. Saturday (27Mar2021) he began urinating the color of Coca-Cola and could not walk. Sunday (28Mar2021) he was hospitalized with a creatine phosphokinase (CK) level of 209,000 U/L with no preexisting health conditions that would cause his CK levels to be so extreme. Adverse event severe rhabdomyolysis was started on 27Mar2021 09:00 AM and resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 7 days. Therapeutic measures were taken as a result of severe rhabdomyolysis included IV fluids. The outcome of the events was recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Asthenia, Dizziness, Dyspnoea, Heart rate
Clinical narrative: hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization.  Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hot flush, Pharyngeal swelling, Tinnitus
Clinical narrative: hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization.  Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood clot (life threatening) on an unspecified date. Event as reported: Patient had a blood clot due to our vaccine. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Hypotension, Investigation
Clinical narrative: bradycardia; hypotension; This is a spontaneous report from a contactable nurse (Registered nurse with title of Infection Preventionist). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269; expiration date: 01May2021) via an unspecified route of administration on 26Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was with bradycardia, hypotension (seriousness criteria: hospitalization, death) and she passed away in the emergency room (ER), critical labs, she didn't even make it one day, the reporter send her out and she passed away in the ER. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Sender's Comments: A causal relationship between BNT162B2  and the events hypotension,bradycardia cannot be excluded based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .; Reported Cause(s) of Death: bradycardia; hypotension
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery occlusion
Clinical narrative: Left internal carotid artery occlusion; This is a spontaneous report from a contactable physician. A 30-year-old male patient received bnt162b2, via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced left internal carotid artery occlusion on 04Apr2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. It was unknown if treatment received. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: her blood pressure started to go up; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported since the caller unwilling to complete the report) via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal) (reported as "she has been on same dosage of blood pressure medicine for years"). The patient's concomitant medications were not reported. After patient had her second dose Pfizer COVID 19 vaccination on 13Feb2021 that shortly afterwards, a couple weeks later, even though caller has been on same blood pressure medications for many years on the same dosage, her blood pressure has gone up starting around the 09Mar2021 (pending clarification). She reported that it went up so high she had to go to the Emergency Room on Saturday night. The doctor in the Emergency Room told her, "there is no way this could be associated with the vaccine." She was currently taking double the amount of blood pressure medication she was prior to receiving the Pfizer COVID-19 vaccine. She would like to report this event and also inquire if this side effect has been reported to be associated with the vaccine. As of 14Apr2021, caller stated that all of a sudden her blood pressure has become so elevated she had to go to the emergency room on Saturday night. The event onset date was provided as "10Apr2021" (pending clarification)). Caller stated that she would like to find out if anyone else has experienced this or file a report about it. The outcome of the event was unknown. The case was not serious.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Drowning, Malaise
Clinical narrative: Drowning; He didn't feel well; This is a spontaneous report from a contactable consumer (patient's wife). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in left arm on 05Mar202113:00 (Lot Number: En6198) as single dose for COVID-19 immunisation. Medical history included hypertensive cardio disease, remote myocardial infraction. No COVID prior vaccination. No known allergies. No COVID was tested post vaccination. There were no concomitant medications. No other vaccine was received in four weeks. The patient didn't feel well Saturday on 06Mar2021 12:00 AM, went surfing Sunday morning on 07Mar2021 as usual for the last 60 yrs. He was in excellent shape and surfed every day. At about 7am the reporter received a phone call that the patient had been pulled from the water unresponsive. But what the reporter didn't understand was he had his arm over his board. But his face was in the water. The reporter realize he drowned but something happened before that. The events resulted in Emergency room/department or urgent care. It was unknown if patient received treatment for events. The patient died on 07Mar2021. An autopsy was performed that revealed drowning. The outcome of event didn't feel well was unknown.; Reported Cause(s) of Death: Drowning; Autopsy-determined Cause(s) of Death: Drowning
Sex: M
Vaccine: COVID19
Symptoms: Death, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: died about a month ago; two weeks after testing positive for the virus; two weeks after testing positive for the virus; This is a spontaneous report from a non-contactable consumer.  An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at SINGLE DOSE for covid-19 immunisation.  Medical history included pre-diabetes and atrial fibrillation (Underlying health issues). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient died about a month ago, two weeks after testing positive for the virus. The death occurred about four weeks after the second dose of the Pfizer/BNT vaccine. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Deceased
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Intracranial aneurysm
Clinical narrative: Brain Aneurysm; This is a spontaneous report from a contactable consumer. A 50-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 08Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, no known allergies. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), and patient had birth control. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received first dose of bnt162b2 on 18Mar2021 04:00 pm at the age of 50-year-old at right arm as single dose for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced brain aneurysm on 11Apr2021 13:00 with outcome of recovering. Patient received aneurysm coil as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Eye haemorrhage, Headache
Clinical narrative: right eye hemorrhage; whole part of my eye is dark blood red; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced right eye hemorrhage; whole part of my eye is dark blood red (medically significant) on 07Mar2021 with outcome of unknown, headache off and on ever since patient had that first vaccine (non-serious) on an unspecified date in 2021 with outcome of unknown. Patient did not know if this were related to the vaccine. Patient had the second vaccine on 09Mar2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Red blood cell count, Red blood cell count decreased, White blood cell count, White blood cell count increased
Clinical narrative: She has been extremely, extremely ill; red blood cells they are very low; white blood cells have taken over; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 86; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the second vaccination and since then she has been extremely, extremely ill and was told that the patient is not going to make it have been told her that is due to the vaccine because there are issues with her red blood cells they are very low and her white blood cells have taken over. The reporter added that it was life threatening as the patient is dying. It was further reported that the patient is in the hospital getting blood transfusion. The outcome of events was unknown.  Information on about lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Influenza like illness, Loss of consciousness, Rhabdomyolysis
Clinical narrative: Flu-like symptoms; Rhabdomyolysis; loss of consciousness; dehydration; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 (at the age of 47-years old) as single dose for COVID-19 immunisation. The patient received the first dose on 05Mar2021 in arm left (lot number EN6198). Medical history included hypertension and gastrooesophageal reflux disease (GERD). The patient had n known allergy. He did not have COVID prior vaccination and he was not COVID tested post vaccination. Concomitant medications included omeprazole and hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ). The patient experienced flu-like symptoms starting 6-8 hours after shot and continuing into the following day, rhabdomyolysis, loss of consciousness and dehydration. Adverse event start time was reported as 06:30 PM. The patient was hospitalized 3 days in ICU, plus 3 additional days. The events resulted in resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization and life-threatening illness (immediate risk of death from the event). The events were treated with IV Fluids and treatment to raise sodium. The outcome of event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dehydration, Hallucination, Insomnia, Rash
Clinical narrative: acute confusion; hallucinations; Second shot caused severe insomnia on 2nd day to present; dehydration; UTI; rash on left check/neck; This is a spontaneous report from a contactable consumer (patient's parent)   An 18-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 24Mar2021 09:15 (Lot Number: EN6204) as single dose for covid-19 immunisation. First dose (lot number EN6206) was administered on 03Mar2021 10:30 AM (left arm). No other vaccine was received in four weeks.  Medical history included periventricular leukomalacia, cerebral palsy, chronic liver disease. There were no concomitant medications. The patient previously took tylenol and experienced drug hypersensitivity. The patient experienced hallucinations on 30Mar2021, second shot caused severe insomnia on 2nd day to present on 25Mar2021 18:00, acute confusion on 30Mar2021 18:00, dehydration on 25Mar2021 17:00, urinary tract infection on 25Mar2021 17:00, rash on left check/neck on 25Mar2021 17:00. The patient was hospitalized for the events for 11 days to use meds to get her sleep, mind under control, and an antibiotic. Currently still in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Apr2021 and on 04Apr2021. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urinary tract infection
Clinical narrative: acute confusion; hallucinations; Second shot caused severe insomnia on 2nd day to present; dehydration; UTI; rash on left check/neck; This is a spontaneous report from a contactable consumer (patient's parent)   An 18-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 24Mar2021 09:15 (Lot Number: EN6204) as single dose for covid-19 immunisation. First dose (lot number EN6206) was administered on 03Mar2021 10:30 AM (left arm). No other vaccine was received in four weeks.  Medical history included periventricular leukomalacia, cerebral palsy, chronic liver disease. There were no concomitant medications. The patient previously took tylenol and experienced drug hypersensitivity. The patient experienced hallucinations on 30Mar2021, second shot caused severe insomnia on 2nd day to present on 25Mar2021 18:00, acute confusion on 30Mar2021 18:00, dehydration on 25Mar2021 17:00, urinary tract infection on 25Mar2021 17:00, rash on left check/neck on 25Mar2021 17:00. The patient was hospitalized for the events for 11 days to use meds to get her sleep, mind under control, and an antibiotic. Currently still in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Apr2021 and on 04Apr2021. The outcome of the events was not recovered.