chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Ear discomfort, Electrocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Magnetic resonance imaging normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Scan with contrast, Suicidal ideation, Tinnitus, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan normal, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood count, Computerised tomogram head, Depression, Disorientation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Facial pain, Magnetic resonance imaging head normal, Magnetic resonance imaging normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: administration on the left leg; heart rate as high as 178 bpm/Heart rate over 100 bpm at rest; Extreme rise in blood pressure; Severe numbness in legs, arm; Severe numbness chest; Pinching in Heart; Pinching in  Neck; Pinching in  Arm/Pinching in Leg; Shortness of Breath/Difficulty Breathing; Chest tightness; Tingling sensation on face/cheeks; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left leg on 15Jul2021 at 18:30 (Lot Number: FA6780) at the age of 14-year-old as single dose for COVID-19 immunization. Medically history and concomitant medication were none. known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't received other vaccine within 4 weeks prior to the COVID vaccine. On 15Jul2021 at 09:00 PM, the patient experienced severe numbness in legs, arms and chest. Extreme rise in blood pressure and heart rate as high as 178 bpm. Moderate to Severe symptoms continue as of today (29Aug2021) Pinching in Heart, Neck, Arm and Leg. Shortness of Breath, Difficulty Breathing. Chest tightness. Tingling Sensation on face/cheeks. Heart rate over 100 bpm at rest. We have been to the emergency room 3 times Emergency room twice and (with held) once. The events resulted in emergency room/department or urgent care. No treatment was received. The outcome of vaccine administered at inappropriate site was unknown. The outcome of other events was not recovered.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Cardiac disorder, Chest discomfort, Dyspnoea, Heart rate
Clinical narrative: administration on the left leg; heart rate as high as 178 bpm/Heart rate over 100 bpm at rest; Extreme rise in blood pressure; Severe numbness in legs, arm; Severe numbness chest; Pinching in Heart; Pinching in  Neck; Pinching in  Arm/Pinching in Leg; Shortness of Breath/Difficulty Breathing; Chest tightness; Tingling sensation on face/cheeks; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left leg on 15Jul2021 at 18:30 (Lot Number: FA6780) at the age of 14-year-old as single dose for COVID-19 immunization. Medically history and concomitant medication were none. known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't received other vaccine within 4 weeks prior to the COVID vaccine. On 15Jul2021 at 09:00 PM, the patient experienced severe numbness in legs, arms and chest. Extreme rise in blood pressure and heart rate as high as 178 bpm. Moderate to Severe symptoms continue as of today (29Aug2021) Pinching in Heart, Neck, Arm and Leg. Shortness of Breath, Difficulty Breathing. Chest tightness. Tingling Sensation on face/cheeks. Heart rate over 100 bpm at rest. We have been to the emergency room 3 times Emergency room twice and (with held) once. The events resulted in emergency room/department or urgent care. No treatment was received. The outcome of vaccine administered at inappropriate site was unknown. The outcome of other events was not recovered.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Hypoaesthesia, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: administration on the left leg; heart rate as high as 178 bpm/Heart rate over 100 bpm at rest; Extreme rise in blood pressure; Severe numbness in legs, arm; Severe numbness chest; Pinching in Heart; Pinching in  Neck; Pinching in  Arm/Pinching in Leg; Shortness of Breath/Difficulty Breathing; Chest tightness; Tingling sensation on face/cheeks; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left leg on 15Jul2021 at 18:30 (Lot Number: FA6780) at the age of 14-year-old as single dose for COVID-19 immunization. Medically history and concomitant medication were none. known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't received other vaccine within 4 weeks prior to the COVID vaccine. On 15Jul2021 at 09:00 PM, the patient experienced severe numbness in legs, arms and chest. Extreme rise in blood pressure and heart rate as high as 178 bpm. Moderate to Severe symptoms continue as of today (29Aug2021) Pinching in Heart, Neck, Arm and Leg. Shortness of Breath, Difficulty Breathing. Chest tightness. Tingling Sensation on face/cheeks. Heart rate over 100 bpm at rest. We have been to the emergency room 3 times Emergency room twice and (with held) once. The events resulted in emergency room/department or urgent care. No treatment was received. The outcome of vaccine administered at inappropriate site was unknown. The outcome of other events was not recovered.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: administration on the left leg; heart rate as high as 178 bpm/Heart rate over 100 bpm at rest; Extreme rise in blood pressure; Severe numbness in legs, arm; Severe numbness chest; Pinching in Heart; Pinching in  Neck; Pinching in  Arm/Pinching in Leg; Shortness of Breath/Difficulty Breathing; Chest tightness; Tingling sensation on face/cheeks; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left leg on 15Jul2021 at 18:30 (Lot Number: FA6780) at the age of 14-year-old as single dose for COVID-19 immunization. Medically history and concomitant medication were none. known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't received other vaccine within 4 weeks prior to the COVID vaccine. On 15Jul2021 at 09:00 PM, the patient experienced severe numbness in legs, arms and chest. Extreme rise in blood pressure and heart rate as high as 178 bpm. Moderate to Severe symptoms continue as of today (29Aug2021) Pinching in Heart, Neck, Arm and Leg. Shortness of Breath, Difficulty Breathing. Chest tightness. Tingling Sensation on face/cheeks. Heart rate over 100 bpm at rest. We have been to the emergency room 3 times Emergency room twice and (with held) once. The events resulted in emergency room/department or urgent care. No treatment was received. The outcome of vaccine administered at inappropriate site was unknown. The outcome of other events was not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Embolism
Clinical narrative: embolism; This is a spontaneous report from a contactable consumer (patient himself). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 13Mar2021 at the age of 63 years old (Batch/Lot Number: EN6206, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy/drug store. Relevant medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin D3, amlodipine, losartan, and ubidecarenone (CO Q10); all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccination in the past months other than COVID 19 vaccine. It was confirmed that the product was Pfizer COVID-19 vaccine. After the 1st shot, the patient's reaction was embolism on an unspecified date in Mar2021. The patient went to the hospital and emergency room for embolism, and was there for about 4 days, 3 to 4 days. It was further reported that the patient was at the emergency room and they (the doctors) didn't report it; the doctors in the hospital didn't report it. The patient's general practitioner that sent him there (as reported) didn't report it. The patient spoke to the general practitioner and said that he had three other patients who had the same circumstance; they took it and within a day or afterwards, also had embolisms (further information not clarified). The patient stated that it was very surprising to him when he had his doctor telling him, and the doctors were saying they were not required to report and were expecting the people who get sick to report it. It was shocking to the patient and he was very, very irritated about the fact that the doctors were not reporting. The patient received the 2nd dose of COVID-19 vaccine on 05Apr2021 (Batch/Lot Number: ER8734, Expiration date: unknown), but the event "embolism" only occurred after the 1st shot. That time, the patient was already on blood thinner. They put him on apixaban (ELIQUIS); he would have couple of Eliquis. It was further clarified that he was on Eliquis only after the embolism, which happened after the 1st shot. But because he had the embolism, they put him on Eliquis for the 2nd shot. The episode happened after the 1st shot. The patient had no investigation assessment. Therapeutic measures were taken as a result of embolism, which included apixaban (ELIQUIS). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Embolism
Clinical narrative: embolism; This is a spontaneous report from a contactable consumer (patient himself). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 13Mar2021 at the age of 63 years old (Batch/Lot Number: EN6206, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy/drug store. Relevant medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin D3, amlodipine, losartan, and ubidecarenone (CO Q10); all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccination in the past months other than COVID 19 vaccine. It was confirmed that the product was Pfizer COVID-19 vaccine. After the 1st shot, the patient's reaction was embolism on an unspecified date in Mar2021. The patient went to the hospital and emergency room for embolism, and was there for about 4 days, 3 to 4 days. It was further reported that the patient was at the emergency room and they (the doctors) didn't report it; the doctors in the hospital didn't report it. The patient's general practitioner that sent him there (as reported) didn't report it. The patient spoke to the general practitioner and said that he had three other patients who had the same circumstance; they took it and within a day or afterwards, also had embolisms (further information not clarified). The patient stated that it was very surprising to him when he had his doctor telling him, and the doctors were saying they were not required to report and were expecting the people who get sick to report it. It was shocking to the patient and he was very, very irritated about the fact that the doctors were not reporting. The patient received the 2nd dose of COVID-19 vaccine on 05Apr2021 (Batch/Lot Number: ER8734, Expiration date: unknown), but the event "embolism" only occurred after the 1st shot. That time, the patient was already on blood thinner. They put him on apixaban (ELIQUIS); he would have couple of Eliquis. It was further clarified that he was on Eliquis only after the embolism, which happened after the 1st shot. But because he had the embolism, they put him on Eliquis for the 2nd shot. The episode happened after the 1st shot. The patient had no investigation assessment. Therapeutic measures were taken as a result of embolism, which included apixaban (ELIQUIS). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Laboratory test, Urticaria, Urticaria chronic
Clinical narrative: Dermal Hypersensitivity; Hives from knees to neck; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8733, patient was 68-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 26Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included HBP, hypothyroid. Concomitant medication(s) included irbesartan (IRBESARTAN); levothyroxine (LEVOTHYROXINE); melatonin (MELATONIN) all were taken for an unspecified indication within two weeks of vaccination, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6206, patient was 68-year-old at the time of vaccination), via Intramuscular route of administration, administered in Arm Left on 05Mar2021 at 01:PM as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No covid prior vaccination: No known allergies were reported. No family Medical History Relevant to AE(S). On 17Jun2021 at 01:00 PM, the patient experienced hives from knees to neck, dermal hypersensitivity. It was reported that events occurred after 3 months of second shot. No medical reason or cause has been established. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No Seriousness Criteria were reported. The patient underwent lab tests and procedures which included biopsy skin: dermal hypersensitivity on 29Jun2021, sars-cov-2 test: negative on 27Jun2021. Therapeutic measures were taken as a result of hives from knees to neck with steroids 60mg daily 1 week, 40mg QD (everyday) X 1 week., 20mg daily X 1 week and Zyrtec 20mg twice a day, plus Depomedrol shot 80 mg In, patient had not changed anything in my daily routine and was not sick. I continue Zyrtec twice a day. Hives left marks on legs and abdomen which are fading. I wonder if shot thru my immune system in overdrive. The outcome of event (hives from knees to neck) was Resolved with Sequel from 30Jul2021 and the outcome of event (Dermal Hypersensitivity) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Hypersensitivity, SARS-CoV-2 test, Urticaria
Clinical narrative: Dermal Hypersensitivity; Hives from knees to neck; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8733, patient was 68-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 26Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included HBP, hypothyroid. Concomitant medication(s) included irbesartan (IRBESARTAN); levothyroxine (LEVOTHYROXINE); melatonin (MELATONIN) all were taken for an unspecified indication within two weeks of vaccination, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6206, patient was 68-year-old at the time of vaccination), via Intramuscular route of administration, administered in Arm Left on 05Mar2021 at 01:PM as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No covid prior vaccination: No known allergies were reported. No family Medical History Relevant to AE(S). On 17Jun2021 at 01:00 PM, the patient experienced hives from knees to neck, dermal hypersensitivity. It was reported that events occurred after 3 months of second shot. No medical reason or cause has been established. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No Seriousness Criteria were reported. The patient underwent lab tests and procedures which included biopsy skin: dermal hypersensitivity on 29Jun2021, sars-cov-2 test: negative on 27Jun2021. Therapeutic measures were taken as a result of hives from knees to neck with steroids 60mg daily 1 week, 40mg QD (everyday) X 1 week., 20mg daily X 1 week and Zyrtec 20mg twice a day, plus Depomedrol shot 80 mg In, patient had not changed anything in my daily routine and was not sick. I continue Zyrtec twice a day. Hives left marks on legs and abdomen which are fading. I wonder if shot thru my immune system in overdrive. The outcome of event (hives from knees to neck) was Resolved with Sequel from 30Jul2021 and the outcome of event (Dermal Hypersensitivity) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Ventricular extrasystoles
Clinical narrative: PVC's and severe chest congestion after 6days of getting first doze; PVC's and severe chest congestion after 6days of getting first doze; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration, administered in arm left on 13Apr2021 (age at vaccination: 30-years-old) as dose 1, single for COVID-19 immunization. Patient was not pregnant at time of vaccination. Patient had no known allergies. The patient had covid prior vaccination. The patient has relevant medical history of minor thalassemia. Concomitant medications included levothyroxine sodium (SYNTHROID) 25mg, Prenatal vitamins. The patient reported, a reaction to Pfizer covid vaccine to get on the 13Apr2021. On 20Apr2021, the patient had experienced PVC's and severe chest congestion after 6 days of getting first dose which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient receives no other vaccine in four weeks. Therapeutic measures were taken as a result of the PVC's and severe chest congestion and included treatment with antibiotics for congestion, Metoprolol for PVC's. Patient had not tested for covid post vaccination. The Pfizer product had a causal effect to the adverse event. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bradycardia, Discomfort, Dizziness, Hyperhidrosis
Clinical narrative: oxygen saturation decreased; pale; diaphoretic; lightheaded; weak; feel like l'm going to faint; Heart rate decreased; that his legs felt heavy; he felt tired; This is a spontaneous report from a contactable other health care professional. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0101) via intramuscular route, administered in right arm on 06Aug2021 13:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to vaccine or vaccine components.   On 06Aug2021 13:42 the patient had oxygen saturation decreased, he was pale, diaphoretic, lightheaded, weak, feel like he was going to faint. After getting up to walk, HR (heart rate) and oxygen saturation decreased briefly (less than a minute). Blood pressure remained stable. Patient visited Doctor or other health care professional office/ clinic visit. Taken via wheelchair to Lab, assisted to stretcher chair with feet up, initial: 112/66, HR54, O2 Room air 99 percentage, Departure: 129/74, HR 51, O2 92 percentage RA and kept under direct RN observation for an hour, after standing and walking down the hall at 2pm with RN, Client states that legs felt heavy and he felt tired. O2 SAT while walking 91 percentage HR 51. After returning from walk, clients states he felt OK, But tired. Briefly after 02 SAT Dropped to 87percentage and HR to 47 and then back up after a few seconds to 95 percentage, HR 51. Oxygen saturation and HR Fluctuation between 90-99 percentage and 50-54 BP. BPM after this occurence although, alert and oriented throughout, expressed concern to wife regarding bradycardia, and room air oxygen saturation and offered to call (Name withheld). V-Safe Brochure with wife and instructed to report. assisted client to wheelchair and transported to private vehicle. Lab data included: BP (Illegible), HR 54, 60, 55, 51, 54, Resp: 16, 16, 10, 16, O2 Sat 99. 99, 98, 91, 95 (Captured as per best understanding), Oxygen Started: No, CPR indicated: No. Disposition: Stable, symptoms not completely resolved. Patient status on departure: (Illegible), oriental x3. calm, answers questions appropriately. Outcome of the events was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event oxygen saturation decreased cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor
Clinical narrative: oxygen saturation decreased; pale; diaphoretic; lightheaded; weak; feel like l'm going to faint; Heart rate decreased; that his legs felt heavy; he felt tired; This is a spontaneous report from a contactable other health care professional. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0101) via intramuscular route, administered in right arm on 06Aug2021 13:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to vaccine or vaccine components.   On 06Aug2021 13:42 the patient had oxygen saturation decreased, he was pale, diaphoretic, lightheaded, weak, feel like he was going to faint. After getting up to walk, HR (heart rate) and oxygen saturation decreased briefly (less than a minute). Blood pressure remained stable. Patient visited Doctor or other health care professional office/ clinic visit. Taken via wheelchair to Lab, assisted to stretcher chair with feet up, initial: 112/66, HR54, O2 Room air 99 percentage, Departure: 129/74, HR 51, O2 92 percentage RA and kept under direct RN observation for an hour, after standing and walking down the hall at 2pm with RN, Client states that legs felt heavy and he felt tired. O2 SAT while walking 91 percentage HR 51. After returning from walk, clients states he felt OK, But tired. Briefly after 02 SAT Dropped to 87percentage and HR to 47 and then back up after a few seconds to 95 percentage, HR 51. Oxygen saturation and HR Fluctuation between 90-99 percentage and 50-54 BP. BPM after this occurence although, alert and oriented throughout, expressed concern to wife regarding bradycardia, and room air oxygen saturation and offered to call (Name withheld). V-Safe Brochure with wife and instructed to report. assisted client to wheelchair and transported to private vehicle. Lab data included: BP (Illegible), HR 54, 60, 55, 51, 54, Resp: 16, 16, 10, 16, O2 Sat 99. 99, 98, 91, 95 (Captured as per best understanding), Oxygen Started: No, CPR indicated: No. Disposition: Stable, symptoms not completely resolved. Patient status on departure: (Illegible), oriental x3. calm, answers questions appropriately. Outcome of the events was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event oxygen saturation decreased cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate, Heart rate decreased
Clinical narrative: oxygen saturation decreased; pale; diaphoretic; lightheaded; weak; feel like l'm going to faint; Heart rate decreased; that his legs felt heavy; he felt tired; This is a spontaneous report from a contactable other health care professional. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0101) via intramuscular route, administered in right arm on 06Aug2021 13:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to vaccine or vaccine components.   On 06Aug2021 13:42 the patient had oxygen saturation decreased, he was pale, diaphoretic, lightheaded, weak, feel like he was going to faint. After getting up to walk, HR (heart rate) and oxygen saturation decreased briefly (less than a minute). Blood pressure remained stable. Patient visited Doctor or other health care professional office/ clinic visit. Taken via wheelchair to Lab, assisted to stretcher chair with feet up, initial: 112/66, HR54, O2 Room air 99 percentage, Departure: 129/74, HR 51, O2 92 percentage RA and kept under direct RN observation for an hour, after standing and walking down the hall at 2pm with RN, Client states that legs felt heavy and he felt tired. O2 SAT while walking 91 percentage HR 51. After returning from walk, clients states he felt OK, But tired. Briefly after 02 SAT Dropped to 87percentage and HR to 47 and then back up after a few seconds to 95 percentage, HR 51. Oxygen saturation and HR Fluctuation between 90-99 percentage and 50-54 BP. BPM after this occurence although, alert and oriented throughout, expressed concern to wife regarding bradycardia, and room air oxygen saturation and offered to call (Name withheld). V-Safe Brochure with wife and instructed to report. assisted client to wheelchair and transported to private vehicle. Lab data included: BP (Illegible), HR 54, 60, 55, 51, 54, Resp: 16, 16, 10, 16, O2 Sat 99. 99, 98, 91, 95 (Captured as per best understanding), Oxygen Started: No, CPR indicated: No. Disposition: Stable, symptoms not completely resolved. Patient status on departure: (Illegible), oriental x3. calm, answers questions appropriately. Outcome of the events was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event oxygen saturation decreased cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.