chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: VIIIth nerve injury, VIIth nerve injury, Vertigo, Vision blurred
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Cutaneous sarcoidosis, Disturbance in attention, Eye pain
Clinical narrative: recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin; a slight headache; a month after the 2nd shot I ran a fever that lasted 3 weeks. the first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy.  This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy.  This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy.  This lasted for a few weeks but no fever.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 26Mar2021 13:00 as 2nd dose, single for COVID-19 immunisation. Medical history included autoimmune disease suspected. Concomitant medications included losartan; hydrochlorothiazide; atorvastatin and tadalafil (TADAL). The patient previously received first dose of BNT162B2 on 06Mar2021 for COVID-19 immunization (first dose, administration time: 11:00 PM, anatomical location: arm left). A week after the 2nd shot (Apr2021), patient felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever. Event resulted to a Doctor or other healthcare professional office/clinic visit; no treatment received. A month after the 2nd shot (26Apr2021 01:00 AM) patient ran a fever that lasted 3 weeks. The first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5. Eyes still hurt and fever was controlled by aspirin during day. It was not a normal fever and he did have a slight headache. Recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin. He felt fine now. Note extensive blood tests and sonograms/xrays turned up nothing that would cause such a prolonged fever. "I've never run a fever for more than 4 or 5 days. I also hardly ever get sick". Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Covid test post vaccination: Nasal Swab negative and blood test negative both on 26Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event sarcoidosis was unknown, while recovered on an unspecified date for the other events.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pyrexia, SARS-CoV-2 test
Clinical narrative: recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin; a slight headache; a month after the 2nd shot I ran a fever that lasted 3 weeks. the first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy.  This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy.  This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy.  This lasted for a few weeks but no fever.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 26Mar2021 13:00 as 2nd dose, single for COVID-19 immunisation. Medical history included autoimmune disease suspected. Concomitant medications included losartan; hydrochlorothiazide; atorvastatin and tadalafil (TADAL). The patient previously received first dose of BNT162B2 on 06Mar2021 for COVID-19 immunization (first dose, administration time: 11:00 PM, anatomical location: arm left). A week after the 2nd shot (Apr2021), patient felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever. Event resulted to a Doctor or other healthcare professional office/clinic visit; no treatment received. A month after the 2nd shot (26Apr2021 01:00 AM) patient ran a fever that lasted 3 weeks. The first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5. Eyes still hurt and fever was controlled by aspirin during day. It was not a normal fever and he did have a slight headache. Recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin. He felt fine now. Note extensive blood tests and sonograms/xrays turned up nothing that would cause such a prolonged fever. "I've never run a fever for more than 4 or 5 days. I also hardly ever get sick". Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Covid test post vaccination: Nasal Swab negative and blood test negative both on 26Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event sarcoidosis was unknown, while recovered on an unspecified date for the other events.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant at time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03May2021 16:45 (Lot Number: ER8730) as single dose (at the age of 50-years-old) for COVID-19 immunization. Medical history included asthma, migraine, and back pain. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced tinnitus/hearing loss. Got the shot on 03May2021 and it started right before leaving the facility, reported it to the staff. Started out mild and has gotten progressively worse each day. Adverse event start date started on 03May2021 05:00 PM. No treatment received for adverse events. The outcome of the events was not recovered. Reporter did not consider events as serious. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Device Date : 24May2021  Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis, Therapeutic response unexpected
Clinical narrative: Patient had unexpected improvement in her symptoms of myasthenia gravis after the second dose of vaccine; Patient had unexpected improvement in her symptoms of myasthenia gravis after the second dose of vaccine; This is a spontaneous report from a contactable physician. A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing myasthenia gravis. Prior to vaccination, the patient was the patient diagnosed with COVID-19. She was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at 1st dose, single dose for COVID-19 immunization. The patient experienced unexpected improvement in her symptoms of myasthenia gravis after the second dose of vaccine on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event "Patient had unexpected improvement in symptoms of myasthenia gravis after the second dose of vaccine" cannot be excluded.  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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) unknown dose number, via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) (at age 82 years old) as single dose for covid-19 immunisation. There was no relevant medical history. The patient's concomitant medication was not reported. The reporter wanted to report a possible connection to an adverse event from the Pfizer COVID vaccine. The patient had the vaccine in either January or February and last week he had a heart attack. The reporter stated that he was okay. He was not completely "out of the woods" right now but he was extremely healthy and what had happened was kind of unusual. After this, the patient was given some kind of statin (unspecified). Since the heart attack, he had a lot of tests but the reporter didn't know. As for the treatment, the reporter responded that "Yes, they are having there. They are under the care of doctor now." Outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: The doctor told the patient to wait 3 months to get the second dose; tested positive for Covid 19 after receiving the first dose of the Pfizer Covid 19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, support from a contactable pharmacist. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534; Expiration Date: 31Jul2021), intramuscular, administered in arm left on 18Mar2021 (at the age of 47-years-old) as 1st dose, 0.3 ml single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Pharmacist had a 47-year-old female patient who tested positive for Covid 19 after receiving the first dose of the Pfizer Covid 19 vaccine on 18Mar2021. Her doctor said to wait 3 months before getting the second dose of the vaccine. Pharmacist is trying to get the patient to come in for it now however she is hesitant. Was asking if it is okay to get it now and if it is suggested to wait 2 or three months after testing positive to get it. The doctor said to wait two months before getting the next dose. Was asking if the patient should get the vaccine and if it is suggested to wait 2 months after testing positive for Covid. The patient was told that she needed to wait three months and is hesitant to get it. The pharmacist suggests she get the vaccine. The patient does not have any no long-term effects and is isolated. She is super nervous. There was nothing on the web about this. A couple of different doctors said a couple of different things. The patient has recovered and no lingering symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Mar2021. The outcome of the event was recovered on an unspecified date in 2021.  Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Electrocardiogram, Heart rate
Clinical narrative: atrial  fibrillation at a rate of 144 for 1hr&30 min; BNT162B2 (lot number ewoke 8) on 22Apr2021 as 2nd dose; This is a spontaneous report from a contactable healthcare professional (patient himself). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 22Apr2021 (Batch/Lot Number: ewoke 8) as 2nd dose, single; and via intramuscular route administered in right arm on 22Apr2021 11:00 (Batch/Lot Number: ep7553) as 1st dose, single for COVID-19 immunisation. Medical history included known allergies: PCN. The patient's concomitant medications were not reported. Patient was not diagnosed with COVID prior vaccination. The patient experienced atrial fibrillation at a rate of 144 for 1hr&30 min on 14May2021 18:30. Event resulted in emergency room/ department or urgent care. Treatment included EKG x3, Chest x-ray, Blood work, Aspiran. Outcome of the event was recovering. Patient was not COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event atrial fibrillation and the suspect drug.  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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: atrial  fibrillation at a rate of 144 for 1hr&30 min; BNT162B2 (lot number ewoke 8) on 22Apr2021 as 2nd dose; This is a spontaneous report from a contactable healthcare professional (patient himself). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 22Apr2021 (Batch/Lot Number: ewoke 8) as 2nd dose, single; and via intramuscular route administered in right arm on 22Apr2021 11:00 (Batch/Lot Number: ep7553) as 1st dose, single for COVID-19 immunisation. Medical history included known allergies: PCN. The patient's concomitant medications were not reported. Patient was not diagnosed with COVID prior vaccination. The patient experienced atrial fibrillation at a rate of 144 for 1hr&30 min on 14May2021 18:30. Event resulted in emergency room/ department or urgent care. Treatment included EKG x3, Chest x-ray, Blood work, Aspiran. Outcome of the event was recovering. Patient was not COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event atrial fibrillation and the suspect drug.  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.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Renal impairment, Urinary tract obstruction
Clinical narrative: kidney dysfunction; blockage of the kidney; creatinine was high; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Apr2021 (Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization and felt dizzy. On 01May2021, the patient experienced kidney dysfunction and blockage of the kidney. On the same date, when his bloodwork was checked by the doctor, his creatinine was high. The patient has not gone through this before and thought it must be a side effect of the COVID-19 Vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Feeling abnormal, Illness
Clinical narrative: chills; pretty sick; fever/on and off fever.; felt terrible; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported) as 2ND DOSE SINGLE for COVID-19 immunisation. The patient's medical history eight stents. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 first dose on an unspecified date for COVID-19 immunisation. It was reported that the patient got the 1st COVID shot and after his 1st shot he was fine. After his 2nd, he had it on 14May2021 because he was a veteran, he was fine. On Friday, Saturday and Sunday he was fine. On Monday (unspecified date) he had chills and was pretty sick to this day, 8 day later he has had an on and off fever. The patient went to the emergency room and they kept him for 4 hours, he had blood test but, of course they didn't give him a COVID test at that time. They said blood was fine, it just had to run its course. This past Saturday (unknown date), they (patient and the reporter) went and took a COVID test and they found out they were both negative and he still has the chills. He felt terrible. He mentioned that he was compromised, he had problems, he had eight stents. It was added that he was compromised due to 8 stents. She asked if this was antibodies. The patient took a blood test and did "intravenous" (unspecified).  Fever of 103 then it "goes normal. Then 98.1. She stated two people in their family have died. They queried how long this will last, the fever on and off, high low, high low, and if it was normal. The reporter thought it may be three days, that he would have it. This was the 8th day that he had a temperature that goes up and down. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: chills; pretty sick; fever/on and off fever.; felt terrible; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported) as 2ND DOSE SINGLE for COVID-19 immunisation. The patient's medical history eight stents. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 first dose on an unspecified date for COVID-19 immunisation. It was reported that the patient got the 1st COVID shot and after his 1st shot he was fine. After his 2nd, he had it on 14May2021 because he was a veteran, he was fine. On Friday, Saturday and Sunday he was fine. On Monday (unspecified date) he had chills and was pretty sick to this day, 8 day later he has had an on and off fever. The patient went to the emergency room and they kept him for 4 hours, he had blood test but, of course they didn't give him a COVID test at that time. They said blood was fine, it just had to run its course. This past Saturday (unknown date), they (patient and the reporter) went and took a COVID test and they found out they were both negative and he still has the chills. He felt terrible. He mentioned that he was compromised, he had problems, he had eight stents. It was added that he was compromised due to 8 stents. She asked if this was antibodies. The patient took a blood test and did "intravenous" (unspecified).  Fever of 103 then it "goes normal. Then 98.1. She stated two people in their family have died. They queried how long this will last, the fever on and off, high low, high low, and if it was normal. The reporter thought it may be three days, that he would have it. This was the 8th day that he had a temperature that goes up and down. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Disease recurrence, Ear pain, Epistaxis, Gastrointestinal disorder
Clinical narrative: I had nose bleeds.  That was odd as never had a nose bleed.  I blew my nose and blood spewed out.; My ears feel funny, like pain; Flu like symptoms like 3 - 4 weeks after the vaccination; I had breast soreness; GI issues; her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating; her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating; I have migraines 2-3 times a week with auras, pain, dizziness disorientation, etc..; body pain; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 13Mar2021 at 08:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included known allergies: sulfa and tetra, some kind of autoimmune thing with no name and migraines (when she was still ovulating). The patient's concomitant medications were not reported. On 10Apr2021 at 04:00, the patient had nose bleeds which was odd as she never had a nosebleed. She blew her nose and blood spewed out. Her ears felt funny, like pain, body pain. The patient also had flu like symptoms like 3 - 4 weeks after the vaccination. She did hurt for about 2-3 weeks. Her body was feeling like 12years ago as far as hormones. She thought she was going to get a period. She was 62. She had breast soreness, GI issues, and her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating. She had migraines 2-3 times a week with auras, pain, dizziness, disorientation, etc. It sounded like a stroke, but it is not a stroke. With regards to treatment, the patient mentioned none (really) as she just checked with the neurologist about them. The patient had no COVID prior vaccination and was not tested post vaccination. The events had not resolved.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Migraine with aura, Pain
Clinical narrative: I had nose bleeds.  That was odd as never had a nose bleed.  I blew my nose and blood spewed out.; My ears feel funny, like pain; Flu like symptoms like 3 - 4 weeks after the vaccination; I had breast soreness; GI issues; her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating; her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating; I have migraines 2-3 times a week with auras, pain, dizziness disorientation, etc..; body pain; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 13Mar2021 at 08:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included known allergies: sulfa and tetra, some kind of autoimmune thing with no name and migraines (when she was still ovulating). The patient's concomitant medications were not reported. On 10Apr2021 at 04:00, the patient had nose bleeds which was odd as she never had a nosebleed. She blew her nose and blood spewed out. Her ears felt funny, like pain, body pain. The patient also had flu like symptoms like 3 - 4 weeks after the vaccination. She did hurt for about 2-3 weeks. Her body was feeling like 12years ago as far as hormones. She thought she was going to get a period. She was 62. She had breast soreness, GI issues, and her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating. She had migraines 2-3 times a week with auras, pain, dizziness, disorientation, etc. It sounded like a stroke, but it is not a stroke. With regards to treatment, the patient mentioned none (really) as she just checked with the neurologist about them. The patient had no COVID prior vaccination and was not tested post vaccination. The events had not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: did pass out while getting the shot/ fainted after 1st shot; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information team and a Pfizer-sponsored program, . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number and Expiration date were unknown) as the 1st dose, single dose for COVID-19 immunization. Relevant medical history included cardiogenic syncope from an unknown date and unknown if ongoing and cardiac arrest one time. The patient's concomitant medications were not reported. The reporter stated that the patient (reporter's wife) received the first dose of the Pfizer COVID-19 vaccine and did pass out while getting the shot on an unspecified date. The reporter stated that it was not from the vaccine itself, but the patient had a condition known as cardiogenic syncope, that when she got blood drawn, she tends to faint; she even went into cardiac arrest one time. The reporter would like to know the efficacy of the vaccine after receiving one dose to make a determination if the risk of the patient having the cardiogenic syncope again was worth the need to receive the second dose or not. It was further reported that the patient had cardiogenic syncope, and fainted after 1st shot on an unspecified date. The reporter stated that this was not due to medication, but due to the cardiogenic syncope, which was present prior to receiving the vaccine. The reporter would like to know the efficacy rate of receiving only 1 vaccine (dose). The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The event syncope is likely due to the underlying cardiogenic syncope and is unrelated to suspect product BNT162B2. 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.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Laboratory test, Myalgia, Overdose, Pain in extremity
Clinical narrative: blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Product preparation error, Thrombosis
Clinical narrative: blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Feeling abnormal, Hypersensitivity
Clinical narrative: She has allergies; Cough like an asthmatic cough.; I sounded a little hoarse afterwards; I felt a weird feeling in my trachea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included anaphylactic reaction in the past to mushroom & Penicillin. The patient's concomitant medications were not reported. The patient delayed her second Pfizer Covid 19 Vaccine until 24May2021 thinking the symptoms may not be too bad if any. She was asking if she should take the second Pfizer Covid 19 Vaccine. She was advised not to get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or had a severe allergic reaction to any ingredient of the vaccine. The patient received the first dose of Pfizer Covid 19 Vaccine on 24March2021. About 45 minutes after receiving the vaccine (24March2021), she felt a weird feeling in her trachea that immediately went away while talking with her son. She sounded a little hoarse afterwards in May2021. She also experienced a cough like an asthmatic cough in May2021. She took her inhaler and it helped. She had anaphylactic reaction in the past to mushroom & Penicillin. Her mother's allergist advised it may have been her body reacting. In May2021, she had allergies and reported walking a good distance to her car after the vaccine without her mask on. The patient also mentioned taking Antihistamine. Therapeutic measures were taken as a result of she has allergies (hypersensitivity), cough like an asthmatic cough. (cough). The event "I felt a weird feeling in my trachea" resolved on 24Mar2021, "Cough like an asthmatic cough" resolved in May2021, while the outcome of the rest of the events was unknown.   Information on the batch/lot number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, SARS-CoV-2 test
Clinical narrative: ITP; This is a spontaneous report from a contactable physician. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 14May2021 (batch/lot number was not reported), as unknown, single dose, at age 33 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included systemic lupus erythematosus (reported as "h/o SLE0") from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 18May2021, the patient experienced ITP (immune thrombocytopenia). The event required hospitalization on an unspecified date with duration 4 days. Treatment included Decadron 40 mg IV x 4 days. On 21May2021, the patient underwent COVID-19 nasal swab with result: negative. The patient recovered from the event on an unspecified date.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Vomiting; Headache; Dizziness; When walking she grabs onto the wall; has no appetite and is really tired; head feels like she is going in circles; has no appetite and is really tired; This is a spontaneous report from a contactable consumer (patient's friend). A 68-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included patient is a diabetic and takes unspecified medications for it. Two weeks after getting the vaccine (May2021), the patient experienced dizziness, vomiting, and headache. The patient has no appetite and is really tired. It was reported that it might be the patient's sugar as she is diabetic and takes medications for it. The patient needs her machine to check her sugar and hasn't done that yet and she needs to know what to do.  It was also reported that when walking she grabs onto the wall, like she is going to fall. Her head feels like she is going in circles and it's been 2 weeks of that. The events required physician office visit. The outcome of the events was not recovered.  Information about lot/batch has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vomiting; Headache; Dizziness; When walking she grabs onto the wall; has no appetite and is really tired; head feels like she is going in circles; has no appetite and is really tired; This is a spontaneous report from a contactable consumer (patient's friend). A 68-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included patient is a diabetic and takes unspecified medications for it. Two weeks after getting the vaccine (May2021), the patient experienced dizziness, vomiting, and headache. The patient has no appetite and is really tired. It was reported that it might be the patient's sugar as she is diabetic and takes medications for it. The patient needs her machine to check her sugar and hasn't done that yet and she needs to know what to do.  It was also reported that when walking she grabs onto the wall, like she is going to fall. Her head feels like she is going in circles and it's been 2 weeks of that. The events required physician office visit. The outcome of the events was not recovered.  Information about lot/batch has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Had limited functionality in that arm now/A couple hours after the vaccine she couldn't move it at all; Arm has been messed up; She can pinpoint the exact location, because that is where it hurts the most; It hurts all the time/her whole left arm hurts; This is a spontaneous report from contactable nurse (patient). A 59-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284) via an unspecified route of administration, administered into left arm on 12Jan2021 (at the age of 59-year-old) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685) administered into right arm on 22Dec2020 (at the age of 59-year-old) for COVID-19 immunization. It was reported that patient received the second dose of the vaccine on 12Jan2021 and has had limited functionality in that arm now; it was further reported that a couple hours after the vaccine she couldn't move it at all. It was also reported that her arm has been messed up since 12Jan2021. The patient can show people exactly where her shot was given, she can pinpoint the exact location, because that is where it hurts the most, but now her whole left arm hurts it hurts all the time. The events had limited functionality in that arm now/a couple hours after the vaccine she couldn't move it at all and arm has been messed up was reported as serious, medically significant. The patient received treatment for the events reported, she took Tylenol. Outcome of event arm has been messed up was not recovered while the outcome of all other events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported vaccination site movement impairment and limb discomfort.  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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Dizziness, Electrocardiogram, Heart rate
Clinical narrative: Passed out roughly 4 minutes after injection; Low bpm afterwards when paramedic showed up (30-40); sweating; EKG showed PVC of heart; dizziness; disorientation; low energyand weakness; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 10:30 at age of 24 years old, (Lot Number: W01768721) as 1st dose, single for covid-19 immunisation. Medical history included known allergies: Augmentin.  Any other medications the patient received within 2 weeks of vaccination was none. Clinical course reported that: Passed out roughly 4 minutes after injection. Woke up after 2 minutes sweating. Low bpm afterwards when paramedic showed up (30-40). 2 IV bags administered. EKG showed PVC of heart. Still have dizziness and disorientation as well as low energy and weakness 4 days later. Adverse events onset date reported as 20May2021 10:30 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome for events was not recovered. 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 Lot/Batch number was available. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Hyperhidrosis, Loss of consciousness, Ventricular extrasystoles
Clinical narrative: Passed out roughly 4 minutes after injection; Low bpm afterwards when paramedic showed up (30-40); sweating; EKG showed PVC of heart; dizziness; disorientation; low energyand weakness; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 10:30 at age of 24 years old, (Lot Number: W01768721) as 1st dose, single for covid-19 immunisation. Medical history included known allergies: Augmentin.  Any other medications the patient received within 2 weeks of vaccination was none. Clinical course reported that: Passed out roughly 4 minutes after injection. Woke up after 2 minutes sweating. Low bpm afterwards when paramedic showed up (30-40). 2 IV bags administered. EKG showed PVC of heart. Still have dizziness and disorientation as well as low energy and weakness 4 days later. Adverse events onset date reported as 20May2021 10:30 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome for events was not recovered. 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 Lot/Batch number was available. Additional information has been requested.