chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chest pain, Swelling
Clinical narrative: stated that it feels like pressure and tight in her chest; left arm pit pain; stated that her left armpit is swollen; stated that it hurts through to her back; This is a spontaneous report from a contactable consumer or other non hcp. The consumer (mother) reported that a 25-year-old female patient (reporter's daughter) received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Jul2021 (age 25-years at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included heart history in family from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter caregiver (patient's mother), called on behalf of her daughter. Her daughter received her first dose of the vaccine on Wednesday 28Jul2021 and was experiencing left arm pit pain and swelling and chest pain that hurts through to her back in 2021. The reporter stated that she encouraged the patient to get the vaccine. Stated that they gave her Pfizer Wednesday. Stated that her armpit was swollen and painful and she was having pain in the chest in 2021. Stated that she asked her to give her the symptoms. It was internal and felt like pressure and tight in her chest. Stated that it hurt through to her back in 2021. This was for Pfizer Covid 19. Wanted to see if this was reported a lot. She wanted to know if this was normal. The reporter felt terrible because she hounded her to get the vaccination and she was going to have something from it. The patient had these pains last night and they subsided, and she was having them again. This was her first shot. Stated that she got it on 28Jul2021. Clarified that her left armpit was swollen and painful. Caller wanted to know if this was reported a lot and was this normal? Caller said her main concern was the heart pain and wanted to know if any heart conditions have been reported with the vaccine. She said there is "heart history in our family". She also said her daughter's doctor "is gone and our hospital is pretty jammed". The outcome of the events was reported as not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received both doses of the Pfizer covid vaccine and 4 weeks later became positive for covid; received both doses of the Pfizer covid vaccine and 4 weeks later became positive for covid; This is a spontaneous report from a contactable Physician. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot Number: EL1283) as dose 1, single, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EN6200) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, reporter stated that she was a physician and had a patient who received both doses of the Pfizer covid vaccine and 4 weeks later became positive for covid and was hospitalized. HCP wanted to know how quarantining works. She stated she touched her without gloves. Reporter stated, vaccinated with both doses back in January and February. Physician did confirm both herself and the patient received both doses of the Pfizer covid vaccine. Currently physician was not positive for covid. Her patient was positive for covid. The patient underwent lab tests and procedures on an unspecified date in 2021 which included sars-cov-2 test: positive. The outcome of events was unknown.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The case will be reassessed if additional information becomes available on the vaccination dates and the event onset date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chest pain, Fibrin D dimer increased, Fibrin degradation products, Lung opacity
Clinical narrative: I suffered from an episode of tacchycardia resulting in admission to the hospital; CT Angio Chest revealed subpleural groundglass opacification in the bilateral lower lobes and in the left upper lobe and right middle lobe most pronounced in the lower lungs; I also had a positive D-Dimer result of 1,250.; chest pains; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:00 (age at vaccination 55 years) as dose 1 single for covid-19 immunisation and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0171, Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 24Apr2021 12:00 (age at vaccination 55 years) as dose 2, single for COVID-19 immunisation. Relevant medical history included obesity. The patient received Vitamins within 2 weeks of vaccination. There was no past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021, the patient began experiencing chest pains. On 10Jun2021 19:00, she suffered from an episode of tachycardia resulting in admission to the hospital, CT Angio Chest revealed subpleural ground glass opacification in the bilateral lower lobes and in the left upper lobe and right middle lobe most pronounced in the lower lungs and she also had a positive D-Dimer result of 1,250. The adverse events were result at Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization Prolonged. On 10Jun2021, the patient underwent lab tests and procedures which includes CT Angio Chest revealed subpleural ground glass opacification in the bilateral lower lobes and in the left upper lobe and right middle lobe most pronounced in the lower lungs. She also had a positive D-Dimer result of 1,250. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the treatment for the events. The outcome of the events was recovering whereas chest pains was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: I suffered from an episode of tacchycardia resulting in admission to the hospital; CT Angio Chest revealed subpleural groundglass opacification in the bilateral lower lobes and in the left upper lobe and right middle lobe most pronounced in the lower lungs; I also had a positive D-Dimer result of 1,250.; chest pains; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:00 (age at vaccination 55 years) as dose 1 single for covid-19 immunisation and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0171, Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 24Apr2021 12:00 (age at vaccination 55 years) as dose 2, single for COVID-19 immunisation. Relevant medical history included obesity. The patient received Vitamins within 2 weeks of vaccination. There was no past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021, the patient began experiencing chest pains. On 10Jun2021 19:00, she suffered from an episode of tachycardia resulting in admission to the hospital, CT Angio Chest revealed subpleural ground glass opacification in the bilateral lower lobes and in the left upper lobe and right middle lobe most pronounced in the lower lungs and she also had a positive D-Dimer result of 1,250. The adverse events were result at Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization Prolonged. On 10Jun2021, the patient underwent lab tests and procedures which includes CT Angio Chest revealed subpleural ground glass opacification in the bilateral lower lobes and in the left upper lobe and right middle lobe most pronounced in the lower lungs. She also had a positive D-Dimer result of 1,250. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the treatment for the events. The outcome of the events was recovering whereas chest pains was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coma, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; This is a spontaneous report from a contactable consumer (patient).    This 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:00 (Batch/Lot Number: ER8733) as single dose (at 44 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No family history of heart disease or comorbities.  The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergy. The patient  stated that: on 15Apr2021, two weeks after my initial Covid vaccine I had a heart attack that put me in a coma for 9 days. The events required a visit to the emergency room.  Therapeutic measures were taken as a result of the events included Stent in LAD. The outcome of  the events was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Seriousness criteria of the events was reported as serious (hospitalization, medically significant, life threatening).
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arterial repair, Chest discomfort, Coma, Coronary arterial stent insertion, Coronary artery dissection
Clinical narrative: Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; This is a spontaneous report from a contactable consumer (patient).    This 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:00 (Batch/Lot Number: ER8733) as single dose (at 44 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No family history of heart disease or comorbities.  The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergy. The patient  stated that: on 15Apr2021, two weeks after my initial Covid vaccine I had a heart attack that put me in a coma for 9 days. The events required a visit to the emergency room.  Therapeutic measures were taken as a result of the events included Stent in LAD. The outcome of  the events was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Seriousness criteria of the events was reported as serious (hospitalization, medically significant, life threatening).
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; This is a spontaneous report from a contactable consumer (patient).    This 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:00 (Batch/Lot Number: ER8733) as single dose (at 44 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No family history of heart disease or comorbities.  The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergy. The patient  stated that: on 15Apr2021, two weeks after my initial Covid vaccine I had a heart attack that put me in a coma for 9 days. The events required a visit to the emergency room.  Therapeutic measures were taken as a result of the events included Stent in LAD. The outcome of  the events was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Seriousness criteria of the events was reported as serious (hospitalization, medically significant, life threatening).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: got COVID; got COVID; This is a spontaneous report from a contactable pharmacist.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Feb2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. on an unspecified date of 2021 the patient experienced that he got covid.The patient got his first does in Feb and then got COVID and was hospitalized and treated with Remdesivir. The patient did receive his second dose last week. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: got positive on an unspecified date of 2021. Therapeutic measures were taken as Remdesivir  as a result of got covid. The outcome of event was recovered on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like vaccination date and COVID infection date needed for a full meaningful medical assessment
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I want to report a death from a Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient's wife). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6207) as dose 1, single; via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6204) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died from the Pfizer vaccine on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: I want to report a death from a Pfizer vaccine
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: They have thousands of deaths, including her mother; This is a spontaneous report from a non-contactable consumer (patient's daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated they have thousands of deaths, including her mother (the patient). The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: They have thousands of deaths, including her mother
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: I have flu like symptoms after I received the COVID Vaccine from Pfizer; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms after patient received the covid vaccine from Pfizer on an unspecified date. Limited information available over the call. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dizziness, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: I have flu like symptoms after I received the COVID Vaccine from Pfizer; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms after patient received the covid vaccine from Pfizer on an unspecified date. Limited information available over the call. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Muscular weakness, Myalgia, Thrombosis
Clinical narrative: Feeling weak, no energy; Muscle aches; Fatigue; Muscle weakness; I got HDV /I have got blood clot on my leg; This is a spontaneous report from contactable consumer (patient) from a Pfizer Sponsored Program. A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7485), via intramuscular route administered in left arm on 29Jul2021 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization. Medical history included Blood clot in leg. Concomitant medications included rivaroxaban (XARELTO) 5mg, once in a day, oral taken for Blood clot in leg since 3 years. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that patient got HDV or got blood clot on his leg. He was on Xarelto for 3 years. On an unspecified date, patient experienced blood clot on his leg. On 29Jul2021, couple of hours after vaccination, the patient experienced feeling weak, muscle aches, fatigue, muscle weakness and No energy. No investigation assessment. Patient would like to know if he should receive the medical attention and how long this would last and he was still experiencing the side effects (at the time of report). The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away, after taking Covid shots; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unspecified date as single dose for COVID-19 immunization. The patient passed away, after taking Covid shots on an unspecified date. Cause of death was unknown. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away, after taking Covid shots shots
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My mom would still be alive today if she hadn't been given the jab.; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a female patient (mom) that:  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose number unknown via an unspecified route of administration on an unspecified date (at an unspecified age  of vaccination) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient died on an unspecified date. The course of events was as follows: My mom would still be alive today if she hadn't been given the jab. It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: My mom would still be alive today if she hadn't been given the jab.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Balance disorder, Blood test, Demyelination, Magnetic resonance imaging head
Clinical narrative: Nerve demyelination; Muscle weakness; She moves slowly and has to use a cane for balance; She was started on Vitamin D for a deficiency that was discovered; Trouble getting off the toilet; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 16Mar2021 (60-years-old at the time of vaccination) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), via an unspecified route of administration on 24Feb2021 (60-years-old at the time of vaccination) as dose 1, single for covid-19 immunization. On 20Mar2021 patient reported she first noticed she was having trouble getting off the toilet. She was experiencing muscle weakness in her left leg that was leading to foot drop. She moves slowly and had to use a cane for balance. She had seen 2 neurologist who believe this was nerve demyelination, was seeing a doctor since April. She had MRI's done of her brain and spine, also she had blood work done to test for other diseases. She was started on Vitamin D for a deficiency that was discovered. On an unspecified date, the patient underwent lab tests and procedures which included blood work: unknown result, magnetic resonance imaging (MRI) Brain: they cannot figure out what is wrong, magnetic resonance imaging spine: they cannot figure out what is wrong, nerve test: they cannot figure out what is wrong. Therapeutic measures were taken as a result of she was started on vitamin d for a deficiency that was discovered. The clinical outcome of the events was unknown at the time of report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Nerve stimulation test, Vitamin D deficiency
Clinical narrative: Nerve demyelination; Muscle weakness; She moves slowly and has to use a cane for balance; She was started on Vitamin D for a deficiency that was discovered; Trouble getting off the toilet; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 16Mar2021 (60-years-old at the time of vaccination) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), via an unspecified route of administration on 24Feb2021 (60-years-old at the time of vaccination) as dose 1, single for covid-19 immunization. On 20Mar2021 patient reported she first noticed she was having trouble getting off the toilet. She was experiencing muscle weakness in her left leg that was leading to foot drop. She moves slowly and had to use a cane for balance. She had seen 2 neurologist who believe this was nerve demyelination, was seeing a doctor since April. She had MRI's done of her brain and spine, also she had blood work done to test for other diseases. She was started on Vitamin D for a deficiency that was discovered. On an unspecified date, the patient underwent lab tests and procedures which included blood work: unknown result, magnetic resonance imaging (MRI) Brain: they cannot figure out what is wrong, magnetic resonance imaging spine: they cannot figure out what is wrong, nerve test: they cannot figure out what is wrong. Therapeutic measures were taken as a result of she was started on vitamin d for a deficiency that was discovered. The clinical outcome of the events was unknown at the time of report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19 on 24Jul2021; Tested positive for Covid-19 on 24Jul2021; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in Arm Left on 10Feb2021 (at the age of 55-year-old) (Batch/Lot Number: EL3247) as dose 2, single, and dose 1 via intramuscular, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EL3247) as dose 1, single (at the age of 55-year-old) for covid-19 immunisation. Medical history and was unknown. The known allergies was also unknown. The patient concomitant medications were not reported. Any other medications the patient received within 2 weeks of vaccination and patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested positive for covid-19 on 24Jul2021.  The adverse event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether patient received any treatment or not. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Jul2021 Nasal Swab. Device date was reported as 02Aug2021. The outcome of event was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event vaccination failure and covid 19 and the suspect drug BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This vaccine got my grandfather sick and now he s no more; This is a spontaneous report from a Pfizer sponsored program based on information received from a Consumer about the grandfather.  A male patient of an unspecified age received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history  and concomitant medications were not reported.  The patient  became  sick  and died  on an unspecified date.   It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sickness
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: received their first dose of the Pfizer covid vaccine on 24JUL2021 but both of them tested positive after the first dose; received their first dose of the Pfizer covid vaccine on 24JUL2021 but both of them tested positive after the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (husband) that a male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/lot number: Not Provided, Expiry Date: Not Provided), via an unspecified route of administration on 24Jul2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, received their first dose of the Pfizer covid vaccine on 24Jul2021 but both of them tested positive after the first dose. This report related to a study or programme. Reason for no lot number: of Pfizer covid vaccine: Other: Support agent disconnected prior to completion of transfer. No voice contact made between this safety agent and the Caller. Full details not obtained.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after 4hours of receiving it; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter mentioned that a family member (the patient) who received the Pfizer Covid-19 vaccine died after 4hours of receiving it. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died after 4hours of receiving it
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeat; heart rate 103 beats per minute; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), dose 2 via an unspecified route of administration, administered in upper left arm on 29Jan2021 as single dose for COVID-19 immunization (at the age of 30-year-old). Medical history included infertility female. The patient's concomitant medications were not reported. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3302) via an unspecified route of administration on an unspecified date for COVID-19 immunization (at the age of 30-year-old). Prior vaccination (within 4 weeks) no medication were reported. On an unspecified date in Feb2021, the patient experienced rapid heartbeat; heart rate 103 beats per minute. Patient got vaccinated end of the 29Jan2021, her second dose and then she had been having her rapid heartbeat and issues with that she had been since February this issue, she thought that could be possible side effect. She came across an article and she just got put on Beta blocker (treatment) on Thursday included Atenolol 25 mg and Progesterone because she ended up going to the ER (Emergency Room) because she had heart rate 103 beats per minute and then by the time she went to the ER and it went down little bit but she had to put on IV Metoprolol to get down. Patient was wondering if that side effect of the vaccine or something. She asked that if should tell her provider to kind of health what's going on with her. The patient underwent lab tests and procedures which included heart rate: 103 beats per minute on an unspecified date in Feb2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I know four people who had a stroke; This is a spontaneous report from a contactable consumer or other non hcp. This Consumer reported for 2 of 4 patients that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated know four people who had a stroke on an unspecified date. The reporter if led is an ingredient used in the Pfizer COVID-19 vaccine. She received some information through an e-mail. It said to stay away from vaccinated people because the virus starts shedding. She reported that the patient had a heart attack post vaccination. This was serious it needed to addressed by doctors. The reporter mentioned that as per the e-mail 45000 people died from the vaccines. Some of the doctors are saying breastfeeding mother's are poisoning their child. This information is available on the website and written by the best doctors. The email they received contains Pfizer's number. The reporter asked if Pfizer-BioNTech COVID-19 vaccine shed the virus. She asked if breastfeeding mothers stay near vaccinated people and if that can harm the child. Reporter told children particles are used in the vaccine. Reporter also asked if any deaths reported with the Pfizer COVID-19 vaccine and if the vaccine is safe. The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. The outcome of the event was unknown.  The lot number was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccinated in Feb and got Covid recently; Vaccinated in Feb and got Covid recently; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Feb2021 as dose 2, single; dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced vaccinated in feb and got covid recently in 2021. Patient stated, he is feeling better. He wanted to know that do we have a Covid booster trial can he participate in. The patient underwent lab tests and procedures which included sars-cov-2 test was got covid recently in 2021. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: caught COVID; caught COVID; This is a spontaneous report from a contactable other Health Care Professional (Nurse). This report was communicated via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown dose number, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced caught covid. The case was assessed as serious (medically significant). The clinical course was as follows: Nurse reported that two extended family members of daughter, both vaccinated with the Pfizer COVID-19 vaccine, caught COVID from an unvaccinated individual. Said they experienced symptoms. Symptoms were at worse point on day 7. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to Drug Ineffectiveness cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: caught COVID; caught COVID; This is a spontaneous report from a contactable Nurse. A contactable Nurse reported similar events for 2 patients. This is 2 of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), unknown dose via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient caught covid from an unvaccinated individual. Reportedly, patient experienced symptoms. Symptoms were at worse point on day 7. Event took place after use of product. The patient underwent lab tests and procedures which included covid: caught COVID from an unvaccinated individual on an unspecified date. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events of  DI ,Covid 19 and suspect drug BNT162B2 cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This is a spontaneous report from a contactable other hcp(patient). A female patient of 62-Year-old received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date (at the age of 61 year old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Historical vaccine included BNT162B2 as 1st dose for covid-19 immunization. The patient experienced atrial fibrillation on an unspecified date. The reporter filed a safety report with Pfizer and is reporting having an episode of atrial fibrillation after receiving her second dose of the Pfizer Covid-19 vaccine. She Asked if there have been any reports of this being associated with the Pfizer Covid-19 vaccine.  She had done a little research, and found some ventricular things but nothing atrial. Outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event" Atrial fibrillation " and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive test for COVID at end of Jul2021; Positive test for COVID at end of Jul2021; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, age at vaccination 45-year-old) as dose number unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not receive Covid prior vaccination. The patient had positive test for Covid at end of Jul2021 and experienced symptoms similar to head cold or mild flu. AE resulted in doctor or other healthcare professional office/clinic visit. Lab data included Covid test of result positive reported in Jul2021. It was unknown if treatment received. The outcome of the event positive test for Covid at end of Jul2021 (Covid-19) was recovering.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, SARS-CoV-2 test
Clinical narrative: we both got COVID possitive PCRs results.; we both got COVID possitive PCRs results.; minor pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced We both got Covid positive Pcrs results., Minor pain on 2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date with we both got COVID positive PCRs results. The outcome for all the events was Unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, SARS-CoV-2 test
Clinical narrative: we both got COVID possitive PCRs results.; we both got COVID possitive PCRs results.; minor pain; This is a spontaneous report from Pfizer. A contactable consumer reported for a female patient (daughter).  A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that the reporter received vaccine back in Apr and the patient (daughter) just turned 12 on Jul2021. We travelled to get her 2nd dose and unfortunately, we both got COVID positive PCRs results on an unspecified date. Our main purpose was to thank all the Pfizer team, for creating the vaccine. Honestly, we had minor pain and issues while going through COVID, still will be isolated for 10 more days and wanted to thank you and all the Pfizer team for creating this. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on we both got COVID positive PCRs results on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID; I tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 22May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not reported. On 24Jul2021, patient was diagnosed with COVID. Patient had mild symptoms and loss of taste and smell. Patient stated symptoms were mild and was not in the hospital and the vaccine was not 100% effective to begin with, did not consider this an adverse event because it seemed like the vaccine worked like it was supposed to. It was not until patient saw the example in the note sent today (attached) then realized that a positive test (after both doses) was considered an adverse event. The patient underwent lab test and procedures included COVID test was positive on 24Jul2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My friend, received both shots of the vaccine a few months back.  She know has COVID.; My friend, received both shots of the vaccine a few months back.  She know has COVID.; This is a spontaneous report from a contactable consumer. A 48-year-old non-pregnant female patient received first dose of BNT162B2(reported as "COVID vaccine", via an unspecified route of administration on an unspecified date, at 48-year-old, as single dose (Batch/Lot number was not reported)  and a second dose of BNT162B2(reported as "COVID vaccine", via an unspecified route of administration on an unspecified date, at 48-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included compromised immune system. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines with 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient received both shots of the vaccine a few months back and she had COVID on 31Jul2021. The patient underwent lab tests included Covid-19 (with unknown test type): positive on 31Jul2021. It was unknown if the patient received any treatment. The outcome of events was recovering.  Pfizer is a marketing authorization holder of COVID vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID vaccine has submitted the same report to the regulatory authorities.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got COVID after having vaccine; Got COVID after having vaccine; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (reported as "COVID 19 vaccine"), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got covid after having vaccine on an unspecified date. The outcome of events was unknown.  Pfizer is a marketing authorization holder of COVID 19 vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID 19 vaccine has submitted the same report to the regulatory authorities.  The lot number for the vaccine, [Vaccine, BNT162B2], was not provided and will be requested during follow up.