chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Vaccination site pain
Clinical narrative: soreness on injection site; insomnia; minor headache; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jul2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included melatonin (MELATONIN GUMMIES) for unknown indication from an unknown date. The patient did not have any allergies to medications, food or other products. On 29Jul2021 at 14:00, the patient experienced soreness on injection site, insomnia and minor headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness on injection site, insomnia and minor headache were recovered with sequelae on an unknown date in 2021 at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles within 60 days of the vaccination shot; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8736) via an unspecified route of administration in the right arm on 28Apr2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease. The patient did not have allergies to medications, food, or other products. Concomitant medication included mesalazine (MESALAMINE); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the right arm on 01Apr2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jun2021, the patient experienced shingles within 60 days of the vaccination shot. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were taken as a result of event and included treatment with antiviral tablets valacyclovir (MANUFACTURER UNKNOWN) and unspecified steroid eye drops. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles within 60 days of the vaccination shot was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging head, Paraesthesia
Clinical narrative: Tingling in cheeks and face which progressed to bells palsy on right side of face.; Tingling in cheeks and face which progressed to bells palsy on right side of face.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN0175) via an unspecified route of administration, administered in arm left on 06May2021 15:30 (age at the time of vaccination was 45-year-old) as dose 2, single for COVID-19 immunization. Medical history included food allergy (Shellfish). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN0151) via an unspecified route of administration, administered in arm left on 15Apr2021 15:15 (age at the time of vaccination was 45-year-old) as dose 1, single for COVID-19 immunization. On 07May2021 12:15, the patient experienced tingling in cheeks and face which progressed to bells palsy on right side of face. The patient received treatment for AEs as Antiviral Medication, Head MRI, antibiotic. The adverse event result in physician office visit and emergency room visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient underwent lab tests and procedures which included Head MRI: result unknown on an unknown date. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site mass, Vaccination site pain
Clinical narrative: soreness; lump in his injected arm; I touch it and I feel it kind of a little bit sore/dull ache; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 17May2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date as single for covid-19 immunisation. On an unspecified date of 2021 the patient reports that since then, he had been feeling soreness and a lump in his injected arm. Patient stated, "I feel like they got me on the nerve" and also, "I touch it and I feel it kind of a little bit sore, no redness. Just a dull ache every once in a while". Patient had been monitoring his blood pressure and heart rate and reports that "everything is good". The outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient reported for herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, via an unspecified route of administration, administered in Arm Left on 16Jul2021 between 9:00-9:30 am (Batch/Lot Number: EW0196) as dose 1, single for COVID-19 immunization. Medical history included sinus pressure which is only two or three times a year and allergy (she does take allergy medicine. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) taken for allergy, start and stop date were not reported. The patient reported that she got her first vaccine 25 days ago. She had morning and evening headaches every day since 18Jul2021. The patient was experiencing headache for 25 days and ongoing. She doesn't suffer from migraines or headaches, only when she has sinus pressure which was only two or three times a year. She also had a COVID test on Sunday (31Jul2021) and it was negative. She was scheduled for her second dose on Friday 06Aug2021 and she needs to know if she should take the second dose and adverse effects if anyone was experiencing them. Treatment received was over the counter Tylenol. She does take allergy medicine. She takes Zyrtec D and Flonase. Her husband got the vaccine and he is not experiencing headaches. Her husband has the same lot number. The patient had no previous immunization/vaccine administered on the same day as the COVID vaccine or within 4 weeks. The event did not require a visit to the emergency room or physician's office. The outcome of the event was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Soar throat; Cough; Temperature of 100.6; Body aches; This is a spontaneous report received from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an intramuscular route of administration in the left arm on 27Jul2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Concomitant medications were not reported. On 01Aug2021 at 08:00, the patient had sore throat, cough, temperature of 100.6 (unspecified units) and body aches. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021, the patient underwent COVID test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat, cough, temperature of 100.6 and body aches were resolving at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Soar throat; Cough; Temperature of 100.6; Body aches; This is a spontaneous report received from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an intramuscular route of administration in the left arm on 27Jul2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Concomitant medications were not reported. On 01Aug2021 at 08:00, the patient had sore throat, cough, temperature of 100.6 (unspecified units) and body aches. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021, the patient underwent COVID test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat, cough, temperature of 100.6 and body aches were resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Burning sensation, Chest discomfort, Chest pain
Clinical narrative: chest pain; Shortness of breath; Nerve shocks throughout her extremities and body; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; severe panic attacks; anxiety; burning sensation; constant headache; fatigue; had convulsions; almost blacking out but not fully; brain fog/felt very off, like a high feeling; she experienced chills; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route of administration on 31Mar2021 (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her first dose of the Pfizer COVID-19 vaccine on 31Mar2021 and was still having severe reactions 5 months later. 20 minutes after receiving the vaccine felt very off, like a high feeling and later that night, the same day as she received the vaccine, she experienced chills, almost blacking out but not fully, she got in the shower shaking with chills and had convulsions while she was in the shower. For the next 2 weeks, she was very out of it, like a zombie state, constant headache, brain fog, chest pain, shortness of breath and fatigue. Nerve shocks throughout her extremities and body, when she would try to sleep her stomach, head, and chest would have a burning and buzzing, like someone hit her with a tuning fork, severe panic attacks throughout the night (all of this was persisting thus far except for the panic attacks and the brain fog). When dozing off her body would jerk, and she would wake gasping for air. She still had an extreme burning sensation in her chest, arms and stomach, and when it reaches her stomach, she had a doom like feeling, anxiety, and that burning sensation only comes on late evening and at night until starts to wear off around 11 or noon the next day. She could still get up and operate, she was a stat at home Mom, she really felt like she could not go on like this. Safety inquired if the patient had thoughts to hurt herself, because she did mention that she could not continue like this in front of her child she was very scared and in severe pain every morning. The patient wanted to know if there had been any reports of this and how long this last. She had been to multiple doctors, emergency room, currently any and all testing that has been done has came back normal, so the doctors had just diagnosed her with extreme/severe anxiety. The clinical outcome of the events constant headache, felt very off, she experienced chills, almost blacking out but not fully, constant headache, brain fog, chest pain, Shortness of breath, fatigue, Nerve shocks throughout her extremities and body was not recovered and remaining all other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: chest pain; Shortness of breath; Nerve shocks throughout her extremities and body; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; severe panic attacks; anxiety; burning sensation; constant headache; fatigue; had convulsions; almost blacking out but not fully; brain fog/felt very off, like a high feeling; she experienced chills; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route of administration on 31Mar2021 (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her first dose of the Pfizer COVID-19 vaccine on 31Mar2021 and was still having severe reactions 5 months later. 20 minutes after receiving the vaccine felt very off, like a high feeling and later that night, the same day as she received the vaccine, she experienced chills, almost blacking out but not fully, she got in the shower shaking with chills and had convulsions while she was in the shower. For the next 2 weeks, she was very out of it, like a zombie state, constant headache, brain fog, chest pain, shortness of breath and fatigue. Nerve shocks throughout her extremities and body, when she would try to sleep her stomach, head, and chest would have a burning and buzzing, like someone hit her with a tuning fork, severe panic attacks throughout the night (all of this was persisting thus far except for the panic attacks and the brain fog). When dozing off her body would jerk, and she would wake gasping for air. She still had an extreme burning sensation in her chest, arms and stomach, and when it reaches her stomach, she had a doom like feeling, anxiety, and that burning sensation only comes on late evening and at night until starts to wear off around 11 or noon the next day. She could still get up and operate, she was a stat at home Mom, she really felt like she could not go on like this. Safety inquired if the patient had thoughts to hurt herself, because she did mention that she could not continue like this in front of her child she was very scared and in severe pain every morning. The patient wanted to know if there had been any reports of this and how long this last. She had been to multiple doctors, emergency room, currently any and all testing that has been done has came back normal, so the doctors had just diagnosed her with extreme/severe anxiety. The clinical outcome of the events constant headache, felt very off, she experienced chills, almost blacking out but not fully, constant headache, brain fog, chest pain, Shortness of breath, fatigue, Nerve shocks throughout her extremities and body was not recovered and remaining all other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Investigation, Nerve injury, Panic attack
Clinical narrative: chest pain; Shortness of breath; Nerve shocks throughout her extremities and body; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; severe panic attacks; anxiety; burning sensation; constant headache; fatigue; had convulsions; almost blacking out but not fully; brain fog/felt very off, like a high feeling; she experienced chills; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route of administration on 31Mar2021 (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her first dose of the Pfizer COVID-19 vaccine on 31Mar2021 and was still having severe reactions 5 months later. 20 minutes after receiving the vaccine felt very off, like a high feeling and later that night, the same day as she received the vaccine, she experienced chills, almost blacking out but not fully, she got in the shower shaking with chills and had convulsions while she was in the shower. For the next 2 weeks, she was very out of it, like a zombie state, constant headache, brain fog, chest pain, shortness of breath and fatigue. Nerve shocks throughout her extremities and body, when she would try to sleep her stomach, head, and chest would have a burning and buzzing, like someone hit her with a tuning fork, severe panic attacks throughout the night (all of this was persisting thus far except for the panic attacks and the brain fog). When dozing off her body would jerk, and she would wake gasping for air. She still had an extreme burning sensation in her chest, arms and stomach, and when it reaches her stomach, she had a doom like feeling, anxiety, and that burning sensation only comes on late evening and at night until starts to wear off around 11 or noon the next day. She could still get up and operate, she was a stat at home Mom, she really felt like she could not go on like this. Safety inquired if the patient had thoughts to hurt herself, because she did mention that she could not continue like this in front of her child she was very scared and in severe pain every morning. The patient wanted to know if there had been any reports of this and how long this last. She had been to multiple doctors, emergency room, currently any and all testing that has been done has came back normal, so the doctors had just diagnosed her with extreme/severe anxiety. The clinical outcome of the events constant headache, felt very off, she experienced chills, almost blacking out but not fully, constant headache, brain fog, chest pain, Shortness of breath, fatigue, Nerve shocks throughout her extremities and body was not recovered and remaining all other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: chest pain; Shortness of breath; Nerve shocks throughout her extremities and body; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; stomach, head, and chest would have a burning and buzzing; severe panic attacks; anxiety; burning sensation; constant headache; fatigue; had convulsions; almost blacking out but not fully; brain fog/felt very off, like a high feeling; she experienced chills; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route of administration on 31Mar2021 (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her first dose of the Pfizer COVID-19 vaccine on 31Mar2021 and was still having severe reactions 5 months later. 20 minutes after receiving the vaccine felt very off, like a high feeling and later that night, the same day as she received the vaccine, she experienced chills, almost blacking out but not fully, she got in the shower shaking with chills and had convulsions while she was in the shower. For the next 2 weeks, she was very out of it, like a zombie state, constant headache, brain fog, chest pain, shortness of breath and fatigue. Nerve shocks throughout her extremities and body, when she would try to sleep her stomach, head, and chest would have a burning and buzzing, like someone hit her with a tuning fork, severe panic attacks throughout the night (all of this was persisting thus far except for the panic attacks and the brain fog). When dozing off her body would jerk, and she would wake gasping for air. She still had an extreme burning sensation in her chest, arms and stomach, and when it reaches her stomach, she had a doom like feeling, anxiety, and that burning sensation only comes on late evening and at night until starts to wear off around 11 or noon the next day. She could still get up and operate, she was a stat at home Mom, she really felt like she could not go on like this. Safety inquired if the patient had thoughts to hurt herself, because she did mention that she could not continue like this in front of her child she was very scared and in severe pain every morning. The patient wanted to know if there had been any reports of this and how long this last. She had been to multiple doctors, emergency room, currently any and all testing that has been done has came back normal, so the doctors had just diagnosed her with extreme/severe anxiety. The clinical outcome of the events constant headache, felt very off, she experienced chills, almost blacking out but not fully, constant headache, brain fog, chest pain, Shortness of breath, fatigue, Nerve shocks throughout her extremities and body was not recovered and remaining all other events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Thyroid mass
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the arm right on 18Jan2021 as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other products. The patient did not take any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the right arm on 28Feb2021 as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021, the patient was diagnosed to have thyroid nodule on both sides of the neck. The patient have slight sore throat from it but it went away but it came back last Month and it hurt to swallow; during ultrasound the patient was diagnosed to have thyroid nodule on both sides of the neck: they recommended to do biopsy for right side as it was big. The patient did not have any family history of cancer or thyroid problems and was otherwise healthy individual. The patient could not think of anything else that caused sudden development of nodule except COVID 19 vaccine. She was scared and worried. Therapeutic measures were taken as a result of the event which included treatment with Diagnostic tx. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event thyroid nodule on both sides of the neck was not resolved at the time of reporting.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Menstrual disorder, Nervousness, Rectal haemorrhage
Clinical narrative: had a horrible like a rectum bleeding; Really bad menstrual period; Nervous; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 (Lot Number: EW0164) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 20Apr2021, approximately six days later, the patient had a horrible like a rectum bleeding and really bad menstrual period that made her nervous. The patient was not aware that it could be a side effect until she talked to her doctor. The patient had a recent lab work (2021) and it was normal. The events resulted to the physician office visit. No treatment was received for the events. Patient was unsure about taking the second vaccine because of what happened. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just tested positive for Covid 19; I just tested positive for Covid 19; If there are none what do you do; This is a spontaneous report from a contactable consumer (patient) and forwarded as an Adverse Event and Medical Inquiry by the  team on 03Aug2021.  A 64-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included bladder cancer (2 yr) survivor and patient's husband who was positive was asthmatic and HP. The patient's concomitant medications were not reported. It was reported that the patient had vaccine back in Jan Feb. Patient just tested positive for Covid 19. The (State) board of health recommended an antibody test in 3 wks. It was stated that If there were none what do they do. The outcome of the events was unknown.   Information about lot/batch has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fatigue, Nausea, Pruritus
Clinical narrative: Full body itchy painful hives/welts; Full body itchy painful hives/welts; fatigue; light-headedness/dizziness; nausea; unable to stand for more than a few minutes at a time continuing on Day 6 after second dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer RXPathways.   A 31-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jul2021 at age of 31 years old (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  None Medical history.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 at age of 31 years old (Batch/Lot Number: EW0217) as DOSE 1, SINGLE for covid-19 immunisation.  The patient experienced Full body itchy painful hives/welts, fatigue, light-headedness, dizziness, nausea, unable to stand for more than a few minutes at a time continuing Day 6 after second dose (this report is written on Day 6 and these symptoms are still ongoing even with prescription steroids (a steroid shot).  Started date of events was on 31Jul2021. The events resulting Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient claimed a severe adverse reaction to COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test (Rapid Test, Nasal Swab): negative on 01Aug2021, sars-cov-2 test (Nasal Swab, PCR): negative  on 01Aug2021.  Therapeutic measures were taken as a result of all events. The outcome of all events was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Full body itchy painful hives/welts; Full body itchy painful hives/welts; fatigue; light-headedness/dizziness; nausea; unable to stand for more than a few minutes at a time continuing on Day 6 after second dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer RXPathways.   A 31-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jul2021 at age of 31 years old (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  None Medical history.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 at age of 31 years old (Batch/Lot Number: EW0217) as DOSE 1, SINGLE for covid-19 immunisation.  The patient experienced Full body itchy painful hives/welts, fatigue, light-headedness, dizziness, nausea, unable to stand for more than a few minutes at a time continuing Day 6 after second dose (this report is written on Day 6 and these symptoms are still ongoing even with prescription steroids (a steroid shot).  Started date of events was on 31Jul2021. The events resulting Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient claimed a severe adverse reaction to COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test (Rapid Test, Nasal Swab): negative on 01Aug2021, sars-cov-2 test (Nasal Swab, PCR): negative  on 01Aug2021.  Therapeutic measures were taken as a result of all events. The outcome of all events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Contusion, Haemorrhage, Head discomfort, Muscle spasms
Clinical narrative: Bleeding; Easily bruising; Muscle twitching; cramps; Head pressure; Abdominal cramping; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 05:00 PM, at the age of 65-years-old, (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported.  Historical vaccine includes BNT162B2, DOSE 1, SINGLE received on 04Mar2021 05:00 PM. Prior to vaccination, the patient has not been diagnosed with COVID-19. On Apr2021, the patient experienced bleeding, easily bruising, muscle twitching, cramps, head pressure, and abdominal cramping. All symptoms persistent for months.  The events include emergency room/department or urgent care and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 22Jul2021.  The outcome of the events was not recovered. No treatment was received for the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, SARS-CoV-2 test
Clinical narrative: Bleeding; Easily bruising; Muscle twitching; cramps; Head pressure; Abdominal cramping; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 05:00 PM, at the age of 65-years-old, (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported.  Historical vaccine includes BNT162B2, DOSE 1, SINGLE received on 04Mar2021 05:00 PM. Prior to vaccination, the patient has not been diagnosed with COVID-19. On Apr2021, the patient experienced bleeding, easily bruising, muscle twitching, cramps, head pressure, and abdominal cramping. All symptoms persistent for months.  The events include emergency room/department or urgent care and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 22Jul2021.  The outcome of the events was not recovered. No treatment was received for the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: pins and needles in both arms and legs, also on face.; This is a spontaneous report from a contactable physician, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 20359-01) via an unspecified route of administration in the left arm on 24Dec2020 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took influenza vaccine (FLU VACCINE) on 10Dec2021 within four weeks prior to COVID vaccine. Patient had no known allergies to food, medication or other products. On 24Dec2020 at 13:00, the patient experienced pins and needles in both arms and legs and also on face. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of pins and needles in both arms and legs and face and included treatment with prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pins and needles in both arms and legs and face was resolved with sequelae at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a non-contactable consumer (patient) by a Pfizer sponsored program COVAX US Support.    A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced fever in 2021; patient wondering how long it will take before she can take Tylenol.  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.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Cough, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: cough; Headache; loss of taste; fatigue; This is a spontaneous report from a contactable consumer (Pfizer employee).  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  Previously the patient received first dose of bnt162b2 in Mar2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: unknown results. Covid test type post vaccination: unknown. The patient underwent lab tests and procedures which included covid test: unknown results on unknown date. On Jul2021 the patient experienced cough, headache, loss of taste, fatigue. It was unknown if treatment was given. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID despite being fully vaccinated with BNT162b2.(Blood test); Patient tested positive for COVID despite being fully vaccinated with BNT162b2.(Blood test); This is a spontaneous report from a contactable consumer.  A 21-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and dose 2 intramuscular, administered in Arm Left on 31Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation at School or Student Health Clinic. The age at vaccination was reported as 21 years. The patient's medical history and concomitant medications were not reported. 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. Since the vaccination, the patient has been tested for COVID-19. On 20Jul2021, the patient tested positive for COVID despite being fully vaccinated with BNT162b2. The lab test included patient had blood test (SARS-CoV-2 test), result: positive for COVID despite being fully vaccinated on 20Jul2021. The adverse event required doctor or other healthcare professional office/clinic visit. The patient not received treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Myalgia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The following day I had gotten tested (Rapid/PCR-based tests) and the results for both experiments came back positive.; The following day I had gotten tested (Rapid/PCR-based tests) and the results for both experiments came back positive.; body fatigue; muscle soreness; This is a spontaneous report from a contactable consumer reported for himself. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3247; Expiration date was not reported), via intramuscular, administered in Arm Left on 16Feb2021 11:15 (at the age of 26-years-old) as DOSE 2, SINGLE and first dose via intramuscular, administered in Arm Left on 26Jan2021 11:15 (Batch/Lot Number: EL3247; at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history, known allergies, concomitant or other medications the patient received within 2 weeks of vaccination, other vaccines within 4 weeks prior to the COVID vaccine included none. Patient did not have covid prior vaccination and had not been tested for covid post vaccination. The patient started to feel symptoms on 28Jul2021 17:00. Had fever, cough, body fatigue and muscle soreness that rapidly appeared. The following day (29Jul2021) patient had gotten tested (rapid/PCR-based tests) and the results for both experiments came back positive. The patient underwent lab tests and procedures which included two sars-cov-2 tests: positive on 29Jul2021. Event seriousness criteria included none and the event was not serious. No treatment was received. Conclusion stated that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective or preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the event covid-19, Fatigue and muscle pain was recovering and other event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 and experienced COVID-19 symptoms after being exposed to an individual that was COVID positive.; Patient tested positive for COVID-19 and experienced COVID-19 symptoms after being exposed to an individual that was COVID positive; This is a spontaneous report from two contactable consumers. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) dose 1, single and dose 2 single; both given via an unspecified route of administration, on an unspecified date, for covid-19 immunization. The patient's medical history included the patient was exposed to an individual that was COVID positive. Concomitant medications were not reported. The patient was not pregnant during the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient tested positive for covid-19 on 01Aug2021 and experienced covid-19 symptoms after being exposed to an individual that was covid positive. The reporter assessed the case as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. No treatment was administered for the event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a Representative.   An elderly female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE. Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as a dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as a dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Other vaccine received in four weeks and If COVID prior vaccination were unknown. Patient was tested for COVID post vaccination. The patient experienced break thru infection of covid virus. positive test on Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on Jul2021 Break thru infection of covid virus. Positive test. Events resulted in the Doctor or other health care professional office/clinic visit. Events treatment included in the Infusion. Outcome of the event was recovering.  No Follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Choking, Drooling, Dysphagia, Oropharyngeal spasm
Clinical narrative: choking; scratchy throat; the muscles in her throat started seizing up completely within minutes; couldn't swallow whatsoever/no muscle control with swallowing; she couldn't control her spit; fingertips started turning blue; anaphylactic shock; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in right arm (reported: right upper arm) on 19Mar2021 12:30 (at the age of 48 years old) as dose 1, single for COVID-19 immunization. Medical history included triple negative breast cancer from 2017 to an unknown date, CREST (an autoimmune disorder that affects the scleroderma), and asthma from an unknown date. Concomitant medications include unspecified blood pressure and asthma medications. The patient received her 1st dose of COVID vaccine on 19Mar2021 and on the same day had anaphylactic shock. She reported she got the shot and within 10 minutes she had a really scratchy throat and she reported it to the nurse. The muscles in her throat started seizing up completely within minutes. She stated she did not have trouble breathing but she couldn't swallow whatsoever, she couldn't control her spit, when she tried to swallow, she was choking as she had no muscle control with swallowing. She also relayed her fingertips started turning blue. She was given an epi pen for the events. She was transported in the emergency room (ER) for 8 hours but was not admitted. The outcome of the events was unknown.