chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: unknown; reason why batch/lot was unknown: misplaced/discarded) via an unspecified route of administration at left arm on 21Jan2021 09:45 AM at a single dose for COVID-19 immunization. Medical history included anxiety, high blood pressure (HBP). Since Covid - short of breath still racing heart. Allergies to medications, food, or other products included penicillin and apple juice. Prior to vaccination, the patient was diagnosed with COVID-19 (short of breath still racing heart). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included niacin, lisinopril, venlafaxine and montluskat for allergy. Facility where the most recent COVID-19 vaccine was administered was at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included tired, feel bad/weak, sore arm, fever 100.3; with start date on 22Jan2021 at 03:00 PM. The events were reported as non-serious. The outcome of events was resolving. Treatment Tylenol received for fever. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: unknown; reason why batch/lot was unknown: misplaced/discarded) via an unspecified route of administration at left arm on 21Jan2021 09:45 AM at a single dose for COVID-19 immunization. Medical history included anxiety, high blood pressure (HBP). Since Covid - short of breath still racing heart. Allergies to medications, food, or other products included penicillin and apple juice. Prior to vaccination, the patient was diagnosed with COVID-19 (short of breath still racing heart). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included niacin, lisinopril, venlafaxine and montluskat for allergy. Facility where the most recent COVID-19 vaccine was administered was at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included tired, feel bad/weak, sore arm, fever 100.3; with start date on 22Jan2021 at 03:00 PM. The events were reported as non-serious. The outcome of events was resolving. Treatment Tylenol received for fever. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: unknown; reason why batch/lot was unknown: misplaced/discarded) via an unspecified route of administration at left arm on 21Jan2021 09:45 AM at a single dose for COVID-19 immunization. Medical history included anxiety, high blood pressure (HBP). Since Covid - short of breath still racing heart. Allergies to medications, food, or other products included penicillin and apple juice. Prior to vaccination, the patient was diagnosed with COVID-19 (short of breath still racing heart). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included niacin, lisinopril, venlafaxine and montluskat for allergy. Facility where the most recent COVID-19 vaccine was administered was at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included tired, feel bad/weak, sore arm, fever 100.3; with start date on 22Jan2021 at 03:00 PM. The events were reported as non-serious. The outcome of events was resolving. Treatment Tylenol received for fever. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Sciatica
Clinical narrative: sciatica with pain radiating from lower back to glute and then down to the left foot; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247), intramuscular in the left arm on 19Jan2021 at 13:15 at a single dose in the Nursing Home/Senior Living Facility for COVID-19 immunization. Medical history included stroke, hodgkin's lymphoma, cerebral vasculitis, seizures, chronic venous insufficiency, and had COVID prior to vaccination. Concomitant medication included levetiracetam (KEPPRA), apixaban (ELIQUIS), and levothyroxine sodium (SYNTHROID). The patient experienced sciatica with pain radiating from lower back to glute and then down to the left foot on 19Jan2021. Leg feels like it is going to give out. The patient did not receive treatment for the event. The patient was not tested for COVID post vaccination. The patient was recovering from the event.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sciatica
Clinical narrative: sciatica with pain radiating from lower back to glute and then down to the left foot; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247), intramuscular in the left arm on 19Jan2021 at 13:15 at a single dose in the Nursing Home/Senior Living Facility for COVID-19 immunization. Medical history included stroke, hodgkin's lymphoma, cerebral vasculitis, seizures, chronic venous insufficiency, and had COVID prior to vaccination. Concomitant medication included levetiracetam (KEPPRA), apixaban (ELIQUIS), and levothyroxine sodium (SYNTHROID). The patient experienced sciatica with pain radiating from lower back to glute and then down to the left foot on 19Jan2021. Leg feels like it is going to give out. The patient did not receive treatment for the event. The patient was not tested for COVID post vaccination. The patient was recovering from the event.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate irregular, Loss of consciousness
Clinical narrative: Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Insomnia, Loss of consciousness, Pain in extremity
Clinical narrative: Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Diarrhoea
Clinical narrative: Severe lower stomach cramps; diarrhea; some bloody stool; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 64-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL32495-21), via an unspecified route of administration at Left arm on 20Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, allergies to Latex and allergies to shellfish. Concomitant medication included rosuvastatin calcium (CRESTOR), raloxifene hydrochloride (EVISTA), tramadol, ibuprofen 600 mg received within 2 weeks of vaccination. The patient previously took iodine and experienced allergies to Iodine, codeine and experienced allergies to codeine, oxytetracycline (TERRAMYCIN) and experienced allergies to Terramycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe lower stomach cramps and diarrhea since 22Jan2021 19:30 and still having this issue to include some bloody stool on 22Jan2021 12:30. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Haematochezia
Clinical narrative: Severe lower stomach cramps; diarrhea; some bloody stool; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 64-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL32495-21), via an unspecified route of administration at Left arm on 20Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, allergies to Latex and allergies to shellfish. Concomitant medication included rosuvastatin calcium (CRESTOR), raloxifene hydrochloride (EVISTA), tramadol, ibuprofen 600 mg received within 2 weeks of vaccination. The patient previously took iodine and experienced allergies to Iodine, codeine and experienced allergies to codeine, oxytetracycline (TERRAMYCIN) and experienced allergies to Terramycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe lower stomach cramps and diarrhea since 22Jan2021 19:30 and still having this issue to include some bloody stool on 22Jan2021 12:30. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cognitive disorder, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aldolase, Blood creatine phosphokinase, Blood folate, Blood thyroid stimulating hormone, C-reactive protein
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cognitive disorder, Fall, Feeling abnormal, Fine motor skill dysfunction, Full blood count
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Headache, Impaired work ability, Loss of personal independence in daily activities, Magnetic resonance imaging brain
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Metabolic function test, Muscular weakness, Neurological examination
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, Red blood cell sedimentation rate, SARS-CoV-2 test negative, Tremor, Vitamin B12
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cognitive disorder, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Severe Myalgias x24 hours; Fever to 102F x72 hours; Fatigue; Weakness; Brain Fog; Cognitive Dysfunction; POTS; This is a spontaneous report from a contactable physician (patient) reported that a 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular on 15Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included allergies to penicillin. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 26Dec2020 at a single dose on the left arm for COVID-19 immunization. The patient experienced severe myalgias x24 hours, fever to 102F x72 hours, fatigue/weakness/brain fog/cognitive dysfunction/POTS on 15Jan2021. Ongoing since administration of vaccine. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jan2021 x72 hours, SARS-CoV-2 test: negative on 21Jan2021. No treatment received for the events. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior to vaccination. Tested for COVID post vaccination via nasal swab on 21Jan2021, which was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Neck pain
Clinical narrative: Bell's Palsy; progressed to left facial drooping; loss of taste on anterior part of tongue; decreased tear production in my left eye; started with left neck pain; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 23-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 09Jan2021 at 04:30 PM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was reported as none. Concomitant medications in two weeks prior to the vaccination included oral contraceptive pill (OCPs). Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 04:00 PM at Left arm for COVID-19 immunisation, lot number: EK5730. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 22Jan2021 03:00 PM (Symptom onset was 2 weeks after second vaccine) patient initially started to experience left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye. Presentation consistent with Bell's Palsy. Patient started a course of methylprednisolone the day of the report with no improvement yet. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient had not recovered from the events, at the time of the report.; Sender's Comments: The events left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye are considered possibly related to the suspect product based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Facial paralysis, Lacrimation decreased, Neck pain
Clinical narrative: Bell's Palsy; progressed to left facial drooping; loss of taste on anterior part of tongue; decreased tear production in my left eye; started with left neck pain; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 23-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 09Jan2021 at 04:30 PM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was reported as none. Concomitant medications in two weeks prior to the vaccination included oral contraceptive pill (OCPs). Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 04:00 PM at Left arm for COVID-19 immunisation, lot number: EK5730. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 22Jan2021 03:00 PM (Symptom onset was 2 weeks after second vaccine) patient initially started to experience left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye. Presentation consistent with Bell's Palsy. Patient started a course of methylprednisolone the day of the report with no improvement yet. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient had not recovered from the events, at the time of the report.; Sender's Comments: The events left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye are considered possibly related to the suspect product based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest X-ray, Chest pain, Chills, Computerised tomogram
Clinical narrative: Trouble breathing; Lightheaded/dizzy; Chills; Sore all over; Weakness in legs; Chest pain; This is a spontaneous report from a contactable consumer (patient).  This 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 12Jan2021 at a single dose on the left arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. No known allergies. Pre-vaccination COVID test was not performed. On 13Jan2021, at 05:00 PM, the patient had lightheaded/dizzy, chills, sore all over, weakness in legs, chest pain and trouble breathing. On 14Jan2021, COVID test (Nasal Swab) was done and resulted negative. The events required an emergency room visit. Then, the patient was hospitalized for 3 days due to the events. Therapeutic measures taken as result of the events included ibuprofen and 2 other medications. The patient was recovering from the events.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram abnormal, Myocarditis, Pain
Clinical narrative: Trouble breathing; Lightheaded/dizzy; Chills; Sore all over; Weakness in legs; Chest pain; This is a spontaneous report from a contactable consumer (patient).  This 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 12Jan2021 at a single dose on the left arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. No known allergies. Pre-vaccination COVID test was not performed. On 13Jan2021, at 05:00 PM, the patient had lightheaded/dizzy, chills, sore all over, weakness in legs, chest pain and trouble breathing. On 14Jan2021, COVID test (Nasal Swab) was done and resulted negative. The events required an emergency room visit. Then, the patient was hospitalized for 3 days due to the events. Therapeutic measures taken as result of the events included ibuprofen and 2 other medications. The patient was recovering from the events.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Trouble breathing; Lightheaded/dizzy; Chills; Sore all over; Weakness in legs; Chest pain; This is a spontaneous report from a contactable consumer (patient).  This 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 12Jan2021 at a single dose on the left arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. No known allergies. Pre-vaccination COVID test was not performed. On 13Jan2021, at 05:00 PM, the patient had lightheaded/dizzy, chills, sore all over, weakness in legs, chest pain and trouble breathing. On 14Jan2021, COVID test (Nasal Swab) was done and resulted negative. The events required an emergency room visit. Then, the patient was hospitalized for 3 days due to the events. Therapeutic measures taken as result of the events included ibuprofen and 2 other medications. The patient was recovering from the events.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain, SARS-CoV-2 test negative
Clinical narrative: Trouble breathing; Lightheaded/dizzy; Chills; Sore all over; Weakness in legs; Chest pain; This is a spontaneous report from a contactable consumer (patient).  This 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 12Jan2021 at a single dose on the left arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. No known allergies. Pre-vaccination COVID test was not performed. On 13Jan2021, at 05:00 PM, the patient had lightheaded/dizzy, chills, sore all over, weakness in legs, chest pain and trouble breathing. On 14Jan2021, COVID test (Nasal Swab) was done and resulted negative. The events required an emergency room visit. Then, the patient was hospitalized for 3 days due to the events. Therapeutic measures taken as result of the events included ibuprofen and 2 other medications. The patient was recovering from the events.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Condition aggravated, Dysstasia
Clinical narrative: muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergies. 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. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Multiple sclerosis relapse, Muscular weakness, Systemic inflammatory response syndrome
Clinical narrative: muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergies. 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. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date.  Information on the lot/batch number has been requested.