chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female patient was administered the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular (left arm) on 17Jan2021 16:30 at single dose for Covid-19 immunization. The patient was administered the first dose of BNT162B2 (lot number: EL0140) on 29Dec2020 at left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient previously took Amoxicillin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 (also reported as "day 6 post vaccine"), the patient experienced small bump at site with redness and mild itchiness. There was no treatment received for the adverse event. The outcome of events was unknown. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Eye swelling
Clinical narrative: all of her joints that had been previously hurt in the past started killing her; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient received at a clinic the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left upper arm on 14Jan2021 08:15 (quarter of 8 in the morning) at a single dose for COVID-19 immunization. The patient's second dose was scheduled on 04Feb2021. Medical history hurtful joints, 2 bad knees she has had surgery, pain in her elbow that she had injured in the past, and unspecified reactions to a number of medications like penicillin she can't take, and severe arthritis. There were no concomitant medications.  The patient previously took swine flu vaccine in 1976), and stated to have a terrible reaction, she has not had another vaccine since 1976, however she did have the flu shot last 2021 and she had no reaction to that, but in 1976 to the swine flu vaccine she ran a super high fever for a week, she did not get Guillain barre from it. Patient also previously took aspirin and ibuprofen (MOTRIN) and reported that she can't those.  The patient stated that all of her joints that had been previously hurt in the past started killing her, she turned over and woke up with the pain  on 14Jan2021 about 23:00 or 24:00. Patient further described that she started having pain in her elbow that she had injured in the past and also her wrists and it hurt so bad. The patient reported to take paracetamol (TYLENOL) as the remedy that took about 4-5 days for it to go away. The patient recovered from the event (reported as fine now) on 19Jan2021.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: all of her joints that had been previously hurt in the past started killing her; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient received at a clinic the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left upper arm on 14Jan2021 08:15 (quarter of 8 in the morning) at a single dose for COVID-19 immunization. The patient's second dose was scheduled on 04Feb2021. Medical history hurtful joints, 2 bad knees she has had surgery, pain in her elbow that she had injured in the past, and unspecified reactions to a number of medications like penicillin she can't take, and severe arthritis. There were no concomitant medications.  The patient previously took swine flu vaccine in 1976), and stated to have a terrible reaction, she has not had another vaccine since 1976, however she did have the flu shot last 2021 and she had no reaction to that, but in 1976 to the swine flu vaccine she ran a super high fever for a week, she did not get Guillain barre from it. Patient also previously took aspirin and ibuprofen (MOTRIN) and reported that she can't those.  The patient stated that all of her joints that had been previously hurt in the past started killing her, she turned over and woke up with the pain  on 14Jan2021 about 23:00 or 24:00. Patient further described that she started having pain in her elbow that she had injured in the past and also her wrists and it hurt so bad. The patient reported to take paracetamol (TYLENOL) as the remedy that took about 4-5 days for it to go away. The patient recovered from the event (reported as fine now) on 19Jan2021.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Feeling abnormal, Stridor, Swelling
Clinical narrative: Anaphylaxis reaction; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9263) via an unspecified route of administration in the left arm on 25Jan2021 at 10:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included Meniere's disease, glucose tolerance impaired (prediabetic) and allergy. The patient was receiving unspecified concomitant medications. She received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 05Jan2021 at 15:45 in the right arm. On 25Jan2021 at 10:45, the patient experienced anaphylaxis reaction. The event resulted in emergency room/department or urgent care, hospitalization for 1 day, life-threatening illness (immediate risk of death from the event). Corrective treatments taken as a result of the event included epinephrine (EPIPEN) and steroids. The patient had no COVID-19 prior to vaccination; she underwent nasal swab on 25Jan2021 with negative result. The patient recovered from the event in Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Wheezing
Clinical narrative: Anaphylaxis reaction; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9263) via an unspecified route of administration in the left arm on 25Jan2021 at 10:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included Meniere's disease, glucose tolerance impaired (prediabetic) and allergy. The patient was receiving unspecified concomitant medications. She received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 05Jan2021 at 15:45 in the right arm. On 25Jan2021 at 10:45, the patient experienced anaphylaxis reaction. The event resulted in emergency room/department or urgent care, hospitalization for 1 day, life-threatening illness (immediate risk of death from the event). Corrective treatments taken as a result of the event included epinephrine (EPIPEN) and steroids. The patient had no COVID-19 prior to vaccination; she underwent nasal swab on 25Jan2021 with negative result. The patient recovered from the event in Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Dyspnoea, Swollen tongue
Clinical narrative: Anaphylaxis reaction; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9263) via an unspecified route of administration in the left arm on 25Jan2021 at 10:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included Meniere's disease, glucose tolerance impaired (prediabetic) and allergy. The patient was receiving unspecified concomitant medications. She received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 05Jan2021 at 15:45 in the right arm. On 25Jan2021 at 10:45, the patient experienced anaphylaxis reaction. The event resulted in emergency room/department or urgent care, hospitalization for 1 day, life-threatening illness (immediate risk of death from the event). Corrective treatments taken as a result of the event included epinephrine (EPIPEN) and steroids. The patient had no COVID-19 prior to vaccination; she underwent nasal swab on 25Jan2021 with negative result. The patient recovered from the event in Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, SARS-CoV-2 test negative
Clinical narrative: Anaphylaxis reaction; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9263) via an unspecified route of administration in the left arm on 25Jan2021 at 10:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included Meniere's disease, glucose tolerance impaired (prediabetic) and allergy. The patient was receiving unspecified concomitant medications. She received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 05Jan2021 at 15:45 in the right arm. On 25Jan2021 at 10:45, the patient experienced anaphylaxis reaction. The event resulted in emergency room/department or urgent care, hospitalization for 1 day, life-threatening illness (immediate risk of death from the event). Corrective treatments taken as a result of the event included epinephrine (EPIPEN) and steroids. The patient had no COVID-19 prior to vaccination; she underwent nasal swab on 25Jan2021 with negative result. The patient recovered from the event in Jan2021.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her face, it has slowly gotten worse and now has a drooping eye, worsening facial numbness and droop.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid ptosis, Hypoaesthesia, Swelling face
Clinical narrative: She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her face, it has slowly gotten worse and now has a drooping eye, worsening facial numbness and droop.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Muscle spasms, Nausea
Clinical narrative: 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photophobia, Pyrexia
Clinical narrative: 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio decreased
Clinical narrative: Dramatic unexplained drop in INR from 2.9 on January 11, 2021 to 1.3 on January 25, 2021; This is a spontaneous report from a contactable consumer (patient). This 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) via an unspecified route of administration in the right arm on 21Jan2021 at 09:45 at single dose for COVID-19 immunisation. Vaccination facility type: urgent care center. The patient did not receive other vaccines in four weeks. Relevant medical history included recent stroke, cardiac failure congestive, chronic obstructive pulmonary disease, chronic renal failure, diabetes, high cholesterol, SP aortic valve replacement, atherosclerotic cardiovascular disease and COVID-19 (the patient had COVID-19 prior to vaccination). Concomitant medications included hydralazine, carvedilol, warfarin and isosorbide. On 25Jan2021 at 09:00, the patient experienced dramatic unexplained drop in INR from 2.9 on 11Jan2021 to 1.3 on 25Jan2021. The event resulted in life-threatening illness (immediate risk of death from the event). Corrective treatment taken as a result of the event included subcutaneous enoxaparin sodium (LOVENOX) twice daily. The patient was not tested for COVID-19 after the vaccination. At the time of the report, the outcome of the event was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Apparent life threatening event, International normalised ratio decreased
Clinical narrative: Dramatic unexplained drop in INR from 2.9 on January 11, 2021 to 1.3 on January 25, 2021; This is a spontaneous report from a contactable consumer (patient). This 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) via an unspecified route of administration in the right arm on 21Jan2021 at 09:45 at single dose for COVID-19 immunisation. Vaccination facility type: urgent care center. The patient did not receive other vaccines in four weeks. Relevant medical history included recent stroke, cardiac failure congestive, chronic obstructive pulmonary disease, chronic renal failure, diabetes, high cholesterol, SP aortic valve replacement, atherosclerotic cardiovascular disease and COVID-19 (the patient had COVID-19 prior to vaccination). Concomitant medications included hydralazine, carvedilol, warfarin and isosorbide. On 25Jan2021 at 09:00, the patient experienced dramatic unexplained drop in INR from 2.9 on 11Jan2021 to 1.3 on 25Jan2021. The event resulted in life-threatening illness (immediate risk of death from the event). Corrective treatment taken as a result of the event included subcutaneous enoxaparin sodium (LOVENOX) twice daily. The patient was not tested for COVID-19 after the vaccination. At the time of the report, the outcome of the event was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness neurosensory, Full blood count normal, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: Patient did not receive the 2nd dose as scheduled; Sick; Hearing loss (left ear); This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for himself. A 63 (unit unspecified) male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 25Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hearing loss (left ear) on 27Dec2020 with outcome of recovering. He only had 60% hearing. Therapeutic measures were taken as a result of the event and included treatment with unspecified medication. Now hearing was 90% back. Furthermore, the patient did not receive the 2nd dose on 16Jan2021 as scheduled as he was sick. The reporter stated that he didn't know if hearing loss (left ear) had to do with the vaccine. He asked the doctor, he didn't know either, he said it could be stress or virus.   The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Metabolic function test normal, Thyroid function test normal
Clinical narrative: Patient did not receive the 2nd dose as scheduled; Sick; Hearing loss (left ear); This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for himself. A 63 (unit unspecified) male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 25Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hearing loss (left ear) on 27Dec2020 with outcome of recovering. He only had 60% hearing. Therapeutic measures were taken as a result of the event and included treatment with unspecified medication. Now hearing was 90% back. Furthermore, the patient did not receive the 2nd dose on 16Jan2021 as scheduled as he was sick. The reporter stated that he didn't know if hearing loss (left ear) had to do with the vaccine. He asked the doctor, he didn't know either, he said it could be stress or virus.   The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Malaise
Clinical narrative: Patient did not receive the 2nd dose as scheduled; Sick; Hearing loss (left ear); This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for himself. A 63 (unit unspecified) male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 25Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hearing loss (left ear) on 27Dec2020 with outcome of recovering. He only had 60% hearing. Therapeutic measures were taken as a result of the event and included treatment with unspecified medication. Now hearing was 90% back. Furthermore, the patient did not receive the 2nd dose on 16Jan2021 as scheduled as he was sick. The reporter stated that he didn't know if hearing loss (left ear) had to do with the vaccine. He asked the doctor, he didn't know either, he said it could be stress or virus.   The information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wrong patient
Clinical narrative: Systemic: Other- unk if related to vaccine, Error: Wrong Patient (documentation in EMR)
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Systemic: Other- unk if related to vaccine, Error: Wrong Patient (documentation in EMR)
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Pyrexia, Rash, Rash erythematous, SARS-CoV-2 test negative
Clinical narrative: Systemic: Other- unk if related to vaccine, Error: Wrong Patient (documentation in EMR)
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scab, Seizure, Swelling, Unresponsive to stimuli
Clinical narrative: Systemic: Other- unk if related to vaccine, Error: Wrong Patient (documentation in EMR)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Ultrasound scan, X-ray
Clinical narrative: I feel pain in my LEFT arm, it feels like I've been punched on it; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 84, unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (right arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she took the vaccine on 15Jan2021 and did it in her right arm, but she felt pain in her left arm on an unspecified date and it felt like she had been punched on it. Her second dose was scheduled on 05Feb2021. Outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: I feel pain in my LEFT arm, it feels like I've been punched on it; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 84, unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (right arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she took the vaccine on 15Jan2021 and did it in her right arm, but she felt pain in her left arm on an unspecified date and it felt like she had been punched on it. Her second dose was scheduled on 05Feb2021. Outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Resuscitation, Syncope
Clinical narrative: dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection.  The death and syncope more likely are associated with the patient underlying medical conditions.  More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment.  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.; Reported Cause(s) of Death: Dead
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Computerised tomogram head, Full blood count, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging neck, Metabolic function test, Pain, Pain in extremity
Clinical narrative: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Viral titre
Clinical narrative: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Pain
Clinical narrative: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Feeling abnormal, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Discomfort, Dizziness, Heart rate increased
Clinical narrative: Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Paraesthesia
Clinical narrative: Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: she died; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247, expiration date: 31May2021) via an unspecified route of administration in left deltoid on 28Jan2021 13:20 at single dose for COVID-19 immunization. Medical history included asthma; optic neuritis. Concomitant medication included glatiramer acetate (COPAXONE) for optic neuritis, at the scene there was an injectable for optic neuritis, physician believed it was glatiramer acetate, he did not know the dosage, but it was three times per week. Sixteen hours after receiving the vaccine patient was found dead at her home. The cause of death was unknown. They just knew within 24 hours of receiving the vaccine in her left deltoid she died. Patient did not indicate she had any allergies or co-morbidities. One autopsy had been done, but it was pending. The actual date patient away if it was 28Jan2021 or 29Jan2021 was unknown as well at this time. The physician only knew she was found dead in home 16 hours after getting the vaccine. The physician stated he did not know what that dose was and questioned if it was 0.5ml. At end of call, physician stated he expected someone to call him back so they can determine the relationship of this to the vaccine. There were no additional vaccines administered on the same date of the Pfizer suspect. No vaccinations within 4 weeks. The outcome of the event was fatal.; Sender's Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.; Reported Cause(s) of Death: she died
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Death
Clinical narrative: she died; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247, expiration date: 31May2021) via an unspecified route of administration in left deltoid on 28Jan2021 13:20 at single dose for COVID-19 immunization. Medical history included asthma; optic neuritis. Concomitant medication included glatiramer acetate (COPAXONE) for optic neuritis, at the scene there was an injectable for optic neuritis, physician believed it was glatiramer acetate, he did not know the dosage, but it was three times per week. Sixteen hours after receiving the vaccine patient was found dead at her home. The cause of death was unknown. They just knew within 24 hours of receiving the vaccine in her left deltoid she died. Patient did not indicate she had any allergies or co-morbidities. One autopsy had been done, but it was pending. The actual date patient away if it was 28Jan2021 or 29Jan2021 was unknown as well at this time. The physician only knew she was found dead in home 16 hours after getting the vaccine. The physician stated he did not know what that dose was and questioned if it was 0.5ml. At end of call, physician stated he expected someone to call him back so they can determine the relationship of this to the vaccine. There were no additional vaccines administered on the same date of the Pfizer suspect. No vaccinations within 4 weeks. The outcome of the event was fatal.; Sender's Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.; Reported Cause(s) of Death: she died