chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: intermittent loss of vision; sparkles/blue blob; visual "blacking out" with movement (mainly when standing up); This is a spontaneous report from a contactable consumer (patient). An 18-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Batch/Lot Number: ER8735) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history included hypermobility, connective spectrum, mild acne, and oral allergy syndrome with many fresh fruits (self- limited) from an unknown date. Concomitant medications included spironolactone taken for an unspecified indication and tretinoin (RETIN A) taken for acne, both start and stop date 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 not been tested for COVID-19. On an unspecified date in May2021, it was reported that the patient experienced intermittent loss of vision with sparkles/blue blob and visual "blacking out" with movement (mainly when standing up). The patient had a doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit because of the events. Treatment was unknown. The outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Blindness transient, Cyanopsia, Visual impairment
Clinical narrative: intermittent loss of vision; sparkles/blue blob; visual "blacking out" with movement (mainly when standing up); This is a spontaneous report from a contactable consumer (patient). An 18-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Batch/Lot Number: ER8735) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history included hypermobility, connective spectrum, mild acne, and oral allergy syndrome with many fresh fruits (self- limited) from an unknown date. Concomitant medications included spironolactone taken for an unspecified indication and tretinoin (RETIN A) taken for acne, both start and stop date 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 not been tested for COVID-19. On an unspecified date in May2021, it was reported that the patient experienced intermittent loss of vision with sparkles/blue blob and visual "blacking out" with movement (mainly when standing up). The patient had a doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit because of the events. Treatment was unknown. The outcome of the events was not recovered.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Hypotension, Loss of consciousness, Seizure
Clinical narrative: Blacked out within 5 minutes; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 03Aug2021 at 15:45 (Lot Number: FC3180) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure on an unknown date. The patient had no known allergies. The patient did not have COVID-19 prior to vaccination. The patient has not been tested post vaccination. Concomitant medications included metoprolol tartrate (manufacturer unknown) and escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported and unspecified multivitamin.  The patient previously received Tdap on 23Jul2021 on the right arm (at 30 years old) for immunization. The patient blacked out within 5 minutes at 15:45 (as reported) after the vaccination on 03Aug2021. The patient was relocated to a chair and blacked out again.  The patient received an Epi pen injection as treatment for the event. The event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Blacked out within 5 minutes; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 03Aug2021 at 15:45 (Lot Number: FC3180) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure on an unknown date. The patient had no known allergies. The patient did not have COVID-19 prior to vaccination. The patient has not been tested post vaccination. Concomitant medications included metoprolol tartrate (manufacturer unknown) and escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported and unspecified multivitamin.  The patient previously received Tdap on 23Jul2021 on the right arm (at 30 years old) for immunization. The patient blacked out within 5 minutes at 15:45 (as reported) after the vaccination on 03Aug2021. The patient was relocated to a chair and blacked out again.  The patient received an Epi pen injection as treatment for the event. The event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Immune thrombocytopenia, Superior sagittal sinus thrombosis
Clinical narrative: Immune thrombocytopeniasuperior sagiittal sinus thrombosis; Immune thrombocytopeniasuperior sagiittal sinus thrombosis; Patient received BNT162B2 dose 2 on 8may2021 and dose 1 on 17may 2021.; This is a spontaneous report from a contactable physician. physician reported for a 26-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0182 and expiration date not reported), via an Intramuscular route of administration on an unspecified anatomical location on 08May2021, (at the age 26-year-old) as a dose 2, single for covid-19 immunisation and patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0170 and expiration date not reported), via an Intramuscular route of administration on an unspecified anatomical location on 17May2021, (at the age 26-year-old) as a dose 1, single for covid-19 immunisation. Patient had no Known allergies. The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient did not have COVID-19 prior or since vaccination. The patient was tested for Covid post vaccination. On 09Jun2021 Patient experienced Immune thrombocytopenia superior sagittal sinus thrombosis adverse event resulted in Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient hospitalized for 21 days. Patient received treatment Initially steroids and rituximab. Then anticoagulation. Then craniotomy for increased ICP. On 22Jul2021 Patient underwent lab test, which was covid test type post vaccination, which was Nasal Swab result was Negative. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the available information in the case, the causal association between the events Immune thrombocytopenia, superior sagiittal sinus thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia, Inappropriate schedule of product administration, SARS-CoV-2 test, Superior sagittal sinus thrombosis
Clinical narrative: Immune thrombocytopeniasuperior sagiittal sinus thrombosis; Immune thrombocytopeniasuperior sagiittal sinus thrombosis; Patient received BNT162B2 dose 2 on 8may2021 and dose 1 on 17may 2021.; This is a spontaneous report from a contactable physician. physician reported for a 26-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0182 and expiration date not reported), via an Intramuscular route of administration on an unspecified anatomical location on 08May2021, (at the age 26-year-old) as a dose 2, single for covid-19 immunisation and patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0170 and expiration date not reported), via an Intramuscular route of administration on an unspecified anatomical location on 17May2021, (at the age 26-year-old) as a dose 1, single for covid-19 immunisation. Patient had no Known allergies. The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient did not have COVID-19 prior or since vaccination. The patient was tested for Covid post vaccination. On 09Jun2021 Patient experienced Immune thrombocytopenia superior sagittal sinus thrombosis adverse event resulted in Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient hospitalized for 21 days. Patient received treatment Initially steroids and rituximab. Then anticoagulation. Then craniotomy for increased ICP. On 22Jul2021 Patient underwent lab test, which was covid test type post vaccination, which was Nasal Swab result was Negative. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the available information in the case, the causal association between the events Immune thrombocytopenia, superior sagiittal sinus thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: Four days after receiving vaccine started having chest pain; This is a spontaneous report from a contactable consumer (patient). A 16 years old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left at age of 16 years on 03Jul2021 (Lot Number: EW0186) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications, patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left at age of 15 years on 12Jun2021 (lot number: EW0177) for covid-19 immunisation. Four days after receiving vaccine patient started having chest pain on 07Jul2021 10:00 and hospitalized for 4 days, unspecified medication was received as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care (as reported). Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Four days after receiving vaccine started having chest pain; This is a spontaneous report from a contactable consumer (patient). A 16 years old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left at age of 16 years on 03Jul2021 (Lot Number: EW0186) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications, patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left at age of 15 years on 12Jun2021 (lot number: EW0177) for covid-19 immunisation. Four days after receiving vaccine patient started having chest pain on 07Jul2021 10:00 and hospitalized for 4 days, unspecified medication was received as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care (as reported). Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: Four days after receiving vaccine started having chest pain; This is a spontaneous report from a contactable consumer (patient). A 16 years old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left at age of 16 years on 03Jul2021 (Lot Number: EW0186) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications, patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left at age of 15 years on 12Jun2021 (lot number: EW0177) for covid-19 immunisation. Four days after receiving vaccine patient started having chest pain on 07Jul2021 10:00 and hospitalized for 4 days, unspecified medication was received as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care (as reported). Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes normal, Blood test normal, Chest pain, Electrocardiogram normal, Heart rate increased
Clinical narrative: chest pains; heart rate has been faster than normal; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 19-year-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 29Jul2021 14:15 (at the age of 19 years) as dose 1, single for covid-19 immunisation. Patient Medical history was not included. Concomitant medication(s) included ibuprofen (UNKNOWN MANUFACTURER) taken for an unspecified indication, start and stop date were not reported. Patient had no reported allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and Since the vaccination, patient was not tested for COVID-19. The patient received Ibuprofen within 2 weeks of vaccination.  Patient had been having chest pains and heart rate has been faster than normal. Patient went to the hospital on august 1st and EKG, and blood work came back clear. Patient stated "They didn't give me an MRI and I've started feeling this way since the day I got my vaccine which was 29Jul2021. The adverse led to Hospitalization. On 29Jul2021 the patient underwent lab tests and procedures which included heart rate found to be faster than normal. On unspecified date of Aug2021 the patient underwent lab tests and procedures which included blood test and electrocardiogram found to be clear. Patient did not receive any treatment for events. The outcome of the event was not recovered.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test normal
Clinical narrative: chest pains; heart rate has been faster than normal; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 19-year-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 29Jul2021 14:15 (at the age of 19 years) as dose 1, single for covid-19 immunisation. Patient Medical history was not included. Concomitant medication(s) included ibuprofen (UNKNOWN MANUFACTURER) taken for an unspecified indication, start and stop date were not reported. Patient had no reported allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and Since the vaccination, patient was not tested for COVID-19. The patient received Ibuprofen within 2 weeks of vaccination.  Patient had been having chest pains and heart rate has been faster than normal. Patient went to the hospital on august 1st and EKG, and blood work came back clear. Patient stated "They didn't give me an MRI and I've started feeling this way since the day I got my vaccine which was 29Jul2021. The adverse led to Hospitalization. On 29Jul2021 the patient underwent lab tests and procedures which included heart rate found to be faster than normal. On unspecified date of Aug2021 the patient underwent lab tests and procedures which included blood test and electrocardiogram found to be clear. Patient did not receive any treatment for events. The outcome of the event was not recovered.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: chest pains; heart rate has been faster than normal; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 19-year-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 29Jul2021 14:15 (at the age of 19 years) as dose 1, single for covid-19 immunisation. Patient Medical history was not included. Concomitant medication(s) included ibuprofen (UNKNOWN MANUFACTURER) taken for an unspecified indication, start and stop date were not reported. Patient had no reported allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and Since the vaccination, patient was not tested for COVID-19. The patient received Ibuprofen within 2 weeks of vaccination.  Patient had been having chest pains and heart rate has been faster than normal. Patient went to the hospital on august 1st and EKG, and blood work came back clear. Patient stated "They didn't give me an MRI and I've started feeling this way since the day I got my vaccine which was 29Jul2021. The adverse led to Hospitalization. On 29Jul2021 the patient underwent lab tests and procedures which included heart rate found to be faster than normal. On unspecified date of Aug2021 the patient underwent lab tests and procedures which included blood test and electrocardiogram found to be clear. Patient did not receive any treatment for events. The outcome of the event was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Dizziness, Investigation, Optic nerve injury, Photopsia
Clinical narrative: Blindness in Right Eye; Dizzyness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 24Feb2021 15:00 (at the age of 65-years-old) as dose 1, single; and then received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 24Feb2021 (at the age of 65-years-old) as dose 2, single both for covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included TLIF; kidney pain in Aug2020; inguinal hernia and Covid-19 infection both on 23Jan2020. There were no concomitant medications. On 18May2021, the patient experienced blindness in right eye and dizzyness. The patient was hospitalized for the reported events for 3 days. The patient underwent lab tests and procedures which included polymerase chain reaction (nasal swab): unknown result on 22Jul2021; and sars-cov-1 test: positive on 23Jan2020. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment was unknown. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Thrombosis
Clinical narrative: Blindness in Right Eye; Dizzyness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 24Feb2021 15:00 (at the age of 65-years-old) as dose 1, single; and then received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 24Feb2021 (at the age of 65-years-old) as dose 2, single both for covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included TLIF; kidney pain in Aug2020; inguinal hernia and Covid-19 infection both on 23Jan2020. There were no concomitant medications. On 18May2021, the patient experienced blindness in right eye and dizzyness. The patient was hospitalized for the reported events for 3 days. The patient underwent lab tests and procedures which included polymerase chain reaction (nasal swab): unknown result on 22Jul2021; and sars-cov-1 test: positive on 23Jan2020. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment was unknown. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Dizziness, Inappropriate schedule of product administration, Polymerase chain reaction, SARS-CoV-1 test
Clinical narrative: Blindness in Right Eye; Dizzyness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 24Feb2021 15:00 (at the age of 65-years-old) as dose 1, single; and then received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 24Feb2021 (at the age of 65-years-old) as dose 2, single both for covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included TLIF; kidney pain in Aug2020; inguinal hernia and Covid-19 infection both on 23Jan2020. There were no concomitant medications. On 18May2021, the patient experienced blindness in right eye and dizzyness. The patient was hospitalized for the reported events for 3 days. The patient underwent lab tests and procedures which included polymerase chain reaction (nasal swab): unknown result on 22Jul2021; and sars-cov-1 test: positive on 23Jan2020. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment was unknown. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Blindness unilateral, Botulinum toxin injection, COVID-19, Computerised tomogram
Clinical narrative: Blindness in Right Eye; Dizzyness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 24Feb2021 15:00 (at the age of 65-years-old) as dose 1, single; and then received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 24Feb2021 (at the age of 65-years-old) as dose 2, single both for covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included TLIF; kidney pain in Aug2020; inguinal hernia and Covid-19 infection both on 23Jan2020. There were no concomitant medications. On 18May2021, the patient experienced blindness in right eye and dizzyness. The patient was hospitalized for the reported events for 3 days. The patient underwent lab tests and procedures which included polymerase chain reaction (nasal swab): unknown result on 22Jul2021; and sars-cov-1 test: positive on 23Jan2020. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment was unknown. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Magnetic resonance imaging, Optic ischaemic neuropathy, Photopsia
Clinical narrative: Blindness in Right Eye; Dizzyness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 24Feb2021 15:00 (at the age of 65-years-old) as dose 1, single; and then received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 24Feb2021 (at the age of 65-years-old) as dose 2, single both for covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included TLIF; kidney pain in Aug2020; inguinal hernia and Covid-19 infection both on 23Jan2020. There were no concomitant medications. On 18May2021, the patient experienced blindness in right eye and dizzyness. The patient was hospitalized for the reported events for 3 days. The patient underwent lab tests and procedures which included polymerase chain reaction (nasal swab): unknown result on 22Jul2021; and sars-cov-1 test: positive on 23Jan2020. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment was unknown. The outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Gait inability, Joint swelling
Clinical narrative: Swelling and bruised left leg pain so severe can't walk; Swelling and bruised left leg pain so severe can't walk; Swelling and bruised left leg pain so severe can't walk/ leg still painful; Swelling and bruised left leg pain so severe can't walk; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Jul2021 at 10:00 (age at vaccination: 65-year-old, non-pregnant) (Batch/Lot Number: FA3980) as DOSE 1, SINGLE for covid-19 immunization at a Pharmacy or Drug Store. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. The patient previously took Cortisone shot in left knee on 25Jun2021. Patient had known drug allergies to Codiene. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jul2021, the patient experienced swelling and bruised left leg pain so severe can't walk. Two weeks later leg still painful and difficult to walk. The patient underwent lab tests and procedures which included Sars-Cov-2 test: unknown results on an unknown date in 2021. Patient did not receive any treatment for the events. The events resulted in emergency room visit. There was no hospitalization/ prolonged hospitalization reported. The seriousness criteria reported as disability. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Gait disturbance, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Swelling and bruised left leg pain so severe can't walk; Swelling and bruised left leg pain so severe can't walk; Swelling and bruised left leg pain so severe can't walk/ leg still painful; Swelling and bruised left leg pain so severe can't walk; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Jul2021 at 10:00 (age at vaccination: 65-year-old, non-pregnant) (Batch/Lot Number: FA3980) as DOSE 1, SINGLE for covid-19 immunization at a Pharmacy or Drug Store. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. The patient previously took Cortisone shot in left knee on 25Jun2021. Patient had known drug allergies to Codiene. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jul2021, the patient experienced swelling and bruised left leg pain so severe can't walk. Two weeks later leg still painful and difficult to walk. The patient underwent lab tests and procedures which included Sars-Cov-2 test: unknown results on an unknown date in 2021. Patient did not receive any treatment for the events. The events resulted in emergency room visit. There was no hospitalization/ prolonged hospitalization reported. The seriousness criteria reported as disability. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia, Tremor
Clinical narrative: Numbness in hands, fingers and arms (Both); Tingling sensation in fingers and hands; Twinging in hands and body.; This is a spontaneous report from a contactable consumer, the patient. An unspecified aged elderly male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 31Jul2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had history of known allergies to sulfur (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included statin from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Aug2021 at 00:00, the patient experienced numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of events numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body were not resolved at the time of this report.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Numbness in hands, fingers and arms (Both); Tingling sensation in fingers and hands; Twinging in hands and body.; This is a spontaneous report from a contactable consumer, the patient. An unspecified aged elderly male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 31Jul2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had history of known allergies to sulfur (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included statin from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Aug2021 at 00:00, the patient experienced numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of events numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body were not resolved at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Heart rate decreased, Swelling face
Clinical narrative: Hives; Face swelled; Dizzy; Heart rate dropped; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ewo198; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 02Aug2021 16:00 (at age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Other medical history was none. Known allergies reported as yes (not specified). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 17:00 patient experienced hives, face swelled, dizzy, heart rate dropped, vomiting and diarrhea. Patient did not receive any treatment for adverse event. Patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: dropped on 02Aug2021. The outcome of all the events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives; Face swelled; Dizzy; Heart rate dropped; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ewo198; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 02Aug2021 16:00 (at age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Other medical history was none. Known allergies reported as yes (not specified). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 17:00 patient experienced hives, face swelled, dizzy, heart rate dropped, vomiting and diarrhea. Patient did not receive any treatment for adverse event. Patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: dropped on 02Aug2021. The outcome of all the events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Heart rate, Heart rate decreased, Swelling face
Clinical narrative: Hives; Face swelled; Dizzy; Heart rate dropped; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ewo198; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 02Aug2021 16:00 (at age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Other medical history was none. Known allergies reported as yes (not specified). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 17:00 patient experienced hives, face swelled, dizzy, heart rate dropped, vomiting and diarrhea. Patient did not receive any treatment for adverse event. Patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: dropped on 02Aug2021. The outcome of all the events was recovering.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Neck pain, Phantom limb syndrome, Tinnitus
Clinical narrative: head fogginess; Dizziness; ear-ringing; Difficulty sleeping; "phantom" neck pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 06May2021 at 11:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) from unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 02Apr2021 at 15:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021, after the second dose of vaccination until the date of this report (3 months),  the patient experienced continued head fogginess, dizziness, ear-ringing, difficulty sleeping, "phantom" neck pain. All of this began after 2nd dose and had continued. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events head fogginess, dizziness, ear-ringing, difficulty sleeping, and "phantom" neck pain was not recovered at the time of this report.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Insomnia, Neck pain, Tinnitus
Clinical narrative: head fogginess; Dizziness; ear-ringing; Difficulty sleeping; "phantom" neck pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 06May2021 at 11:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) from unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 02Apr2021 at 15:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021, after the second dose of vaccination until the date of this report (3 months),  the patient experienced continued head fogginess, dizziness, ear-ringing, difficulty sleeping, "phantom" neck pain. All of this began after 2nd dose and had continued. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events head fogginess, dizziness, ear-ringing, difficulty sleeping, and "phantom" neck pain was not recovered at the time of this report.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dyspnoea, Endotracheal intubation, Intensive care, Lip swelling
Clinical narrative: shortness of breath; facial swelling; angioedema; swollen tongue and lips; swollen tongue and lips; This is a spontaneous report from a contactable pharmacist. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 03Aug2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 55-year-old. Medical history included ongoing hypertension, cirrhosis, obesity, prediabetes, allergies to Lisinopril, adhesive tape and Silicones. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lisinopril; acetaminophen; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); gabapentin from 03Aug2021 to an unspecified stop date; hydrochlorothiazide; levothyroxine; metformin; oxycodone; venlafaxine. On 04Aug2021, the patient presented to the hospital with shortness of breath and facial swelling. At the ED, he was found to have angioedema with swollen tongue and lips. Patient was currently intubated with mechanical ventilation. Pt is currently sedated and being treated with decadron, Benadryl and famotidine. The patient was hospitalized from 04Aug2021 to 05Aug2021. The outcome of events was not recovered. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19; Since the vaccination, it was unknown if the patient been tested for COVID-19. The case was reported as serious with seriousness criteria of hospitalization, life threatening.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on temporal relationship. 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: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: shortness of breath; facial swelling; angioedema; swollen tongue and lips; swollen tongue and lips; This is a spontaneous report from a contactable pharmacist. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 03Aug2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 55-year-old. Medical history included ongoing hypertension, cirrhosis, obesity, prediabetes, allergies to Lisinopril, adhesive tape and Silicones. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lisinopril; acetaminophen; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); gabapentin from 03Aug2021 to an unspecified stop date; hydrochlorothiazide; levothyroxine; metformin; oxycodone; venlafaxine. On 04Aug2021, the patient presented to the hospital with shortness of breath and facial swelling. At the ED, he was found to have angioedema with swollen tongue and lips. Patient was currently intubated with mechanical ventilation. Pt is currently sedated and being treated with decadron, Benadryl and famotidine. The patient was hospitalized from 04Aug2021 to 05Aug2021. The outcome of events was not recovered. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19; Since the vaccination, it was unknown if the patient been tested for COVID-19. The case was reported as serious with seriousness criteria of hospitalization, life threatening.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on temporal relationship. 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.